Petition for Writ of Certiorari — Micron Separations, Inc. v. Pall Corp.

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DEC

IN THE

SUPREME COURT OF THE UNITED STATES 3

OCTOBER TERM, 1995 ss

MICRON SEPARATIONS, INC.,

Petitioner,

Vv.

PALL CORPORATION,

Respondent.

On Petition for a Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

PETITION FOR A WRIT OF CERTIORARI

STEVEN M. BAUER

Counsel of Record

JOHN J. COTTER

TESTA, HURWITZ

& THIBEAULT

125 High Street

Boston, MA 02110

(617) 248-7000

Attorneys for Petitioner,

Micron Separations, Inc.

i

QUESTIONS PRESENTED

1. Ina patent infringement action in which the accused

product is clearly outside the literal scope of the patent

claim (i.e. where the patent claim requires a nylon resin to

have a ratio in the range of “about 5:1 to about 7:1,” and

the accused product has a ratio of 4:1), whether the court

can ignore the express limitations of the claim to conclude

that the product infringes under the “doctrine of

equivalents.”

2. On an appeal from an action to recover patent

infringement damages, whether an appellate court can issue

an order vastly increasing the damages award based solely

on evidence that the trial court excluded and that the

defendant never had an opportunity to rebut.

li

LIST OF PARTIES TO THE PROCEEDING

PURSUANT TO RULES 14(1)(b) and 29.1

The names of all parties in the court whose judgment is

sought to be reviewed appear in the caption of this Petition

for Writ of Certiorari.

LIST OF PARTIES PURSUANT TO RULE 29.1

Petitioner Micron Separations, Inc. does not have any

parent companies or subsidiaries.

PR ne ie 2

iil

TABLE OF CONTENTS

Page

QUESTION PRESENTED.............-.. NE Se i

LIST OF PARTIES TO THE PROCEEDING

PURSUANT TO RULES 14(1)(b) AND 29.1 ........02cce020+: il

LIST OF PARTIES PURSUANT TO RULE 29.1..........-. ii

TABLE OF CONTENTS. ........::ccccceeeseesseneeenensseenenenennenens iil

TABLE OF AUTHORITIES ...........-::ccscsseeceeerserreeeenennennes vi

OPINIONS BELOW............:ccccccsecsscesseeeessneeneesserssenneneneenns 3

JURISDICTION ............cccccssccsssscsssseercenrcsnscssccssnsssnrssenneenes 3

STATUTORY PROVISIONS INVOLVED...........---0-:20+0: 4

STATEMENT OF THE CASE.\.........-:ccssssseesserssesennsenennnens 7

1. Procedural History.............-:-sssssssseeseeseeenees 7

A. The Court Agreed MSI's Product

Does Not Fall Within The Literal

Claim Scope .............ceccsrssrssrcssesseees 8

B. The Damages Award .............::s+++++ 9

4 Similarities Between This Case

And Hilton Davis ...........:csscsessseesseseeseeees 10

iV

REASONS FOR GRANTING THE WRIT..................... 15

I. THE DOCTRINE OF EQUIVALENTS ISSUE

PRESENTS A FUNDAMENTAL QUESTION

OF PATENT LAW THAT REQUIRES

SUPREME COURT RESOLUTION ............ 16

I]. IN INCREASING DAMAGES, THE

FEDERAL CIRCUIT IGNORED THIS

COURT’S PROHIBITION AGAINST

RULING ON EVIDENCE NOT

INTRODUCED AT TRIAL .....0.........:ceeceeeees 21

CL A AFI cnccnsecnienscnatvcsnsitiblipdiisibadiaiiehatiideissbiopedibuiniaida 23

APPENDIX

A. Opinions of United States Court of Appeals for

the Federal Circuit (September 26, 1995)...... la

B. Memorandum and Orders of United

States District Court for the District of

Massachusetts in Favor of Plaintiff and

Against Defendant (May and June, 1991) ... 30a

C. Order of United States Court of Appeals

for the Federal Circuit denying Petition

for Rehearing (October 24, 1995).......... ... 112a

D. Judgment, United States Court of

Appeals for the Federal Circuit

to , __. | Renna eee On 113a

v

E. Excerpts from United States Patent and

Trademark Office file history for

United States Patent No. 4,340,479 ........... 114a

vi

TABLE OF AUTHORITIES

Cases Page

Ballard Medical Products v. Wright, 821 F.2d 642

CPOE. Cir. IGG7). sccsccsccssnssuciccniteesesinnensnieaiiemiieieatasten aa

Graver Tank & Mfg. Co. v. Linde Air Products Co..,

339 UB. GBS (0GGOD sccniscistiicssdiitapimmaaiiliaii 11,20

Hilton Davis Chem. Co. v. Warner-Jenkinson Co..,

62 F.3d 1512 (Fed. Cir. 1995) (en banc) (petition for

cert. pending, Warner Jenkinson Co. v. Hilton Davis

Chem. Co., No. 95-728, filed Nov. 6, 1995)............. passim

Markman v. Westview Instr., Inc., 52 F.3d 967

(Fed. Cir.) (en banc), cert. granted, 64 U.S.L.W.

3238 (No. 95-26, granted Sept. 27, 1995) .........cccseseeeeee 18

Quantum Corp. v. Rodime, PLC, 65 F.3d 1577

(Fed. Cat, 1996) .casscsscisinnicsticsecatisiiimenaniatiiiteiannts 15, 18

Singleton v. Wulff, 428 U.S. 106 (1976) . .....c.cccccceeseeeeeee 22

Statutes

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3S USC. § B11 .ccccccsscsicsinvcsssscesttietinenssaiicbenssdssininainaaeain -

35 U.S.C. 8 12%..<cccccsccsnceee 4,15, 17

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IN THE

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1995

MICRON SEPARATIONS, INC.,

Petitioner,

v.

PALL CORPORATION,

Respondent.

PETITION FOR WRIT OF CERTIORARI

Micron Separations, Inc. (“MSI”) respectfully petitions

for a writ of certiorari to review the judgment of the United

States Court of Appeals for the Federal Circuit, which

judgment relies on the Federal Circuit’s recent decision in

Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d

1512 (Fed. Cir. 1995) (en banc) (petition for cert. pending,

Warner Jenkinson Co. v. Hilton Davis Chem. Co., No. 95-

728, filed Nov. 6, 1995). The present case, like the Hilton

Davis case for which a petition for certiorari is now

pending, involves a question of fundamental importance to

patent law -- how far may infringement under the doctrine

of equivalents go when the accused device clearly does not

fall within the literal meaning of the patent claim at issue?

The petition for a writ of certiorari now pending before

this Court from the Hilton Davis case raises and fully

identifies many of the same doctrine of equivalents issues

2

that apply in this case. This case, and Hilton Davis, each

involve (i) membrane technology, (ii) a chemical patent

claim limitation specifying a range of values which was

narrowed during the patent application process, and (iii) an

accused product or process well outside the claimed range.

In view of the similar facts and identical legal issues in the

two cases, if this Court grants certiorari in the Hilton Davis

case, it should also grant certiorari in the present case. If

certiorari is granted in Hilton Davis, but not in this case, a

multimillion dollar judgment against Petitioner MSI

threatens its existence, and a subsequent reversal of Hilton

Davis would come too late to save it.

In addition, this case involves an important question of

the scope of an appellate court’s power to make findings

based on a one-sided testimonial record, without the benefit

of either trial court findings or rebuttal evidence on the

issue. The appellate court here, based on evidence that the

trial court excluded, ordered that damages for lost profits be

recalculated upward. This result is unfair because the

defendant will now be required to pay substantial additional

_ damages based solely on evidence it never had the chance

to rebut. Once again, the Federal Circuit has confused its

role regarding facts and law. This Court should grant

certiorari to review the proper role of the appellate court

regarding “facts” that have not been proven below.

OPINIONS BELOW

The Court of Appeals opinions are reported at 66 F.3d

1211 (Fed. Cir. 1995), and are reproduced beginning at

Appendix page la. The district court opinion reviewed by

the Court of Appeals is not reported, and is reproduced

beginning at Appendix page 30a. The district court issued

a subsequent written opinion after the appeal was filed and

briefed, reported at 792 F. Supp. 1298 (D. Mass. 1992).

JURISDICTION

The Court of Appeals judgment was entered on

September 26, 1995. A petition for rehearing was denied

on October 24, 1995. The jurisdiction of this Court is

invoked under 28 U.S.C. § 1254(1).

STATUTORY PROVISIONS INVOLVED

35 U.S.C. § 111(a) provides in pertinent part:

(1) Written application. -- An application for patent

shall be made, or authorized to be made, by the

inventor, except as otherwise provided in this title,

in writing to the Commissioner.

(2) Contents. -- Such application shall include --

(A) a specification as prescribed by section 112 of

this title...

35 U.S.C. § 112 provides in pertinent part:

The specification shall contain a written description

of the invention, and of the manner and process of

making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art

to which it pertains, or with which it is most nearly

connected, to make and use the same, and shall set

forth the best mode contemplated by the inventor of

carrying out his inverition.

The specification shall conclude with one or more

claims particularly pointing out and distinctly

claiming the subject matter which the applicant

regards as his invention.

*e ee EE *

An element in a claim for a combination may be

expressed as a means or step for performing a

specified function without the recital of structure,

5

material, or acts in support thereof, and such claim

shall be construed to cover the corresponding

structure, material, or acts described in the

specification and equivalents thereof.

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35 U.S.C. § 251 provides in pertinent part:

Whenever any patent is, through error without any

deceptive intention, deemed wholly or partly

inoperative or invalid, by reason of a defective

specification or drawing, or by reason of the

: patentee claiming more or less than he had a right to

claim in the patent, the Commissioner shall, on the

surrender of such patent and the payment of the fee

required by law, reissue the patent for the invention

disclosed in the original patent, and in accordance

with a new and amended application, for the

unexpired part of the term of the original patent. No

new matter shall be introduced into the application

for reissue.

*e+*#** * *

No reissued patent shall be granted enlarging the

scope of the claims of the original patent unless

applied for within two years from the grant of the

original patent.

35 U.S.C. § 271 provides in pertinent part:

(a) Except as otherwise provided in this title,

whoever without authority makes, uses or sells any

patented invention, within the United States during

the term of the patent therefor, infringes the patent.

35 U.S.C. § 305 provides in pertinent part:

In any reexamination proceeding under this chapter,

the patent owner will be permitted to propose any

amendment to his patent and a new claim or claims ©

thereto.... No proposed amended or new claim

enlarging the scope of a claim of the patent will be

permitted in a reexamination proceeding under this

chapter...

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4

é

STATEMENT OF THE CASE

This case presents two important questions. First,

whether an accused product can be deemed an infringement

of a patent when the accused product is clearly not within

the literal scope of any patent claim. In this case, the patent

claims in issue require a nylon resin to have a ratio of two

chemical units of between about 5:1 and 7:1, but the

accused product has a ratio of only 4:1. Although the trial

court explicitly held 4:1 was not “about 5:1,” a panel of the

United States Court of Appeals for the Federal Circuit,

relying upon its sharply divided en banc decision in Hilton

Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512

(Fed. Cir. 1995) (for which a petition for certiorari is now

pending), held that a product with a 4:1 ratio is

“equivalent” to one with an about 5:1 ratio and thus

infringes regardless of the claim limitations.

Second, this case presents the question of whether the

appellate court, based on evidence that had been excluded

at trial and that the accused infringer had no opportunity to

rebut, can make findings and order that damages be

recalculated upward. Based on such excluded evidence, the

Federal Circuit ordered recalculation to increase the

multimillion dollar damages award against a defendant who

never had an opportunity to offer any evidence on the key

damages issue. ee

1. Procedural History: Respondent Pall Corporation

(“Pall”) brought this lawsuit under 35 U.S.C. § 281 against

Petitioner MSI, charging that MSI’s nylon microfiltration

membranes and method for making them infringed the

8

product and process claims of Pall’s U. S. Patent

No. 4,340,479 (the “Pall Patent’). Pet. App. 2a.’

A. The Court Agreed MSI's Product Does Not Fall

Within The Literal Claim Scope. When the suit was filed,

MSI’s accused membranes were made with a material

known as Nylon-66, which has a ratio of certain chemical

units of 5:1. After the lawsuit began, MSI converted most

of its accused product line to a chemically distinct nylon,

Nylon-46, which has a ratio of 4:1, and which is not

literally covered by the claims. Pet. App. 8a, lla. During

the liability trial, MSI contended that its Nylon-46 products

did not infringe Pall's patent because they were made from

Nylon-46, a material which not only was not literally

covered by the claims, but also which MSI contended Pall

had disclaimed during the prosecution of the application

which resulted in issuance of the Pall patent. Pet. App. | la,

12a.

Nylon “membranes” are thin sheet-like objects with very small

“pores” which allow fluid to pass through the membrane, while

retaining bacteria and other materials that are larger than the pores.

Pet. App. 2a. One set of Pall's patent claims refers to a membrane

made from any of three specific nylon polymers, the commercial

names of which are Nylon-66, Nylon-610, and Nylon-6. Pet. App. 3a,

5a-6a. Another set of claims refers to nylons having a ratio of certain

chemicals of 5:1 to 7:1. Pet. App. 8a.

> The district court found that because of the chemical differences

between the claimed nylons and Nylon-46, Nylon-46 is not the type of

nylon required by the invention of the patent-in-suit, because it is not

one of the three named nylons and its 4:1 ratio falls outside the claimed

range in the ratio claims. Pet. App. 8a, lla. The ratio claims require

“a ratio CH;:NHCO of methylene CH, to amide NHCO groups within

the range of about 5:] to about 7:1. . .”, and the district court found

that the 4:1 ratio of Nylon-46 is not “about 5:1.” Pet. App. 8a, 1 la.

-

During prosecution of its patent application, Pall had

narrowed its claims from covering all nylons (with no ratio

range) to covering only those within a narrow range of

chemical ratios. Pet. App. 12a? At trial, although the

district court agreed with MSI that none of the patent

claims literally covered Nylon-46 products, it still found

that MSI’s products infringed the ratio claims under the

doctrine of equivalents. Pet. App. 16a.

B. The Damages Award. The district court

awarded Pall over $4 million in damages, including lost

profits. See Pet. App. 110a. In deciding the amount of lost

profits, a key issue before the district court was whether a

third party's product that Pall had licensed in settlement

also infringed the Pall patent. Pet. App. 20a-21a. The

district court excluded all of Pall's evidence offered to

prove infringement, and without making any findings on

was licensed. Pet. App. 21a, 100a. MSI then had no reason

or opportunity to rebut the excluded evidence of

infringement. Based on the license alone, the district court

basis for a narrow subclass of polyamide resins disclosed...”

phasis added). Pet. App. 54a, 1 15a. Pall also argued that “([t}he

range of CH;:NHCO ratios within the range from about 5:1 to about

7:1 is actually rather narrow. . - These limits constrain a rather

narrow range of CH,:NHCO ratios, and clearly exclude the vast

majority of polyamide resins. . ” (Emphasis added). Pet. App. 156a,

see 12a-13a. In response to these arguments, the Patent Office allowed

the narrowed ratio claims. Pet. App. 55a.

10

then denied Pall lost profits damages for the entire period

during which the third party’s product was offered. See

Pet. App. 21a.

After the district court stayed the injunction against

MSI's Nylon-46 products pending appeal, MSI appealed the

finding that its Nylon-46 product infringed, and both

parties appealed the damages award. Pet. App. 2a, 24a.

The Federal Circuit affirmed the liability decision, and

reversed and remanded on damages. Pet. App. 16a, 22a.

The court’s remand ordered recalculation of damages,

based purely on the assumption that the third party’s

product infringed, without having any evidence of record

from MSI on the infringement issue. See Pet. App. 21a-

22a. The Federal Circuit then denied MSI’s petition for

rehearing. Pet. App. 112a.

2. Similarities B This C and Hilton Davis.

There are remarkable similarities between the facts of this

case relating to the doctrine of equivalents and those of the

Hilton Davis case, for which a petition for certiorari is now

pending, Warner Jenkinson Co. v. Hilton Davis Chem. Co.,

‘No. 95-728. Those similarities provide sufficient grounds

to grant certiorari in this case and remand it to the Federal

Circuit, should the Court’ decide to review the same

important doctrine of equivalents issues raised in Hilton

Davis.

Most importantly, this case, like Hilton Davis, involves

the fundamental question of the scope of the doctrine of

equivalents. Pet. App. 11a; Hilton Davis, 62 F.3d at 1516.

This case and Hilton Davis also involve strikingly similar

facts. Each involves a patent on membrane technology,

with claims directed to certain narrow ranges of properties.

In Hilton Davis, the patentee narrowed its claims during the

11

patent application process to require the use of a pH range

of "from approximately 6.0 to 9.0." 62 F.3d at 1515-16.

Similarly, in this case Pall narrowed its claims to require

use of a nylon having a specific chemical ratio within a

range of "about 5:1 to about 7:1." Pet. App. 12a-13a. In

Hilton Davis, the court held that a process with a PH of 5.0

infringed even though the lower limit of the claim was

“approximately 6.0,” while the court in this case held that a

ratio of 4:1 infringed even though the lower limit of the

claim was “about 5:1.” See Hilton Davis, 62 F.3d at 1524:

Pet. App. 16a. In both Hilton Davis and this case, the court

found infringement even though the accused processes and

products were well below the claimed lower limit of the

ranges of the respective patents.

In ruling against Petitioner MS] in this case, the Federal

Circuit relied on Hilton Davis, which was a Closely divided

decision heard en banc in order “to consider the important

issues raised concerning the doctrine of equivalents.”

Hilton Davis, 62 F.3d at 1516.4 The court’s struggle to

resolve those issues in Hilton Davis produced wide

disagreement in five separate opinions.° Recognizing the

* The court of appeals in Hilton Davis sought briefing on two key

questions: “Does a finding of infringement under the doctrine of

equivalents require anything in addition to proof of the facts that there

are the same or substantially the same (a) function, (b) way, (c) result,

the so-called triple identity test of Graver Tank [& Manufacturing Co. ]

v. Linde Air Products Co., 339 U.S. 605 (1950), and cases relied on

therein?... Is application of the doctrine of equivalents by the trial

court to find infringement of the patentee's right to exclude, when there

is no literal infringement of the claim, discretionary in accordance with

the circumstances of the case?” 62 F.3d at 1516.

* Observing that this Court had “mapped the modern contours of the

doctrine of equivalents in its landmark Graver Tank decision”, Hilton

Davis, 62 F.3d at 1517, the court concluded that the doctrine gave a

iis i

12

fundamental nature of the issues, Judge Newman's

concurring opinion and several dissents suggested that it

would be appropriate for the Supreme Court to review the

doctrine of equivalents through that case. Hilton Davis, 62

F.3d at 1529 (Newman, J., concurring), 1545 (Plager, J.,

dissenting), and 1549 n.3 (Lourie, J., dissenting). Because

these issues are recurring, and indeed because the same

wrong committed in Hilton Davis is committed here, the

circuit judges’ suggestion for Supreme Court review is

particularly ripe.

Judge Plager’s dissent noted that the doctrine of

equivalents “is regularly used by patentees to seek greater

coverage for their patents than the patent statute grants,”

and argued that the doctrine “is a virtually uncontrolled and

unreviewable license to juries to find infringement if they

so choose.” Hilton Davis, 62 F.3d at 1537, 1538 (Plager,

J., dissenting). Judge Plager objected that the expansion of

the patent “is done largely without regard to and

independent of the express limitations of the patent claims

which may have brought about their allowance by the

[Patent Office] in the first place,” Hilton Davis, 62 F.3d at

1538 (Plager, J., dissenting), and he found no basis for a

doctrine broad enough to rescue patent holders from their

own failure to claim all that they lawfully might have

patent holder the right to establish infringement whenever a fact finder

determined that the differences between an accused product and the

product claimed in the patent were “insubstantial.” See Hilton Davis,

62 F.3d at 1521-22. As a result, “those who make only insubstantial

changes to a patented product or process are liable for infringement,

regardless of their awareness of the patent and its disclosure.” Hilton

Davis, 62 F.3d at 1520. The Hilton Davis court also held that although

the patent applicant had narrowed its patent claims in order to win

Patent Office approval, the doctrine of equivalents still would reach

into the surrendered area. See Hilton Davis, 62 F.3d at 1525.

ee _

13

claimed -- “[tJhe solution to the problem of inadequate or

incomplete claim drafting is not arbitrary after-the-fact

‘interpretation’ under the guise of ‘equivalents,’ whether by

judge or jury, that goes beyond anything in the claims

themselves.” Hilton Davis, 62 F.3d at 1541-42 (Plager, J.,

dissenting).

Judge Lourie’s dissent challenged the majority's

disregard of claim limitations, stating that “the

substantiality of the differences [between the patented and

accused processes] is still only one of the factors according

to Graver, arguably the most important factor, which a

court should consider in deciding whether to apply the

[doctrine of equivalents.” Hilton Davis, 62 F.3d at 1547

(Lourie, J., dissenting). Noting that “[t]he whole purpose

of the doctrine [of equivalents] is to defeat piracy and to do

justice to a patentee,” Judge Lourie said that “[i)ntent to

misappropriate someone-else’s invention is the hallmark of

a pirate, and intent must therefore not be excluded if a

suitable judgment is to be made concerning the

applicability of the [doctrine of equivalents].” Hilton

Davis, 62 F.3d at 1548 (Lourie, J., dissenting). The

majority, however, dismissed this theory, concluding that

“[iJnfringement is, and should remain, a strict liability

offense.” Hilton Davis, 62 F.3d at 1527.

Finally, Judge Nies’s dissent challenged the Hilton

Davis majority’s view that the patentee could reclaim under

the doctrine of equivalents what it had surrendered before

the Patent Office. Judge Nies pointed out that, “[iJn view

of the liberality in current claiming practice, the need for

the doctrine of equivalents because of difficulties in

drafting claims to cover an invention in all possible forms

is a rare case.” Hilton Davis, 62 F.3d at 1560 (Nies, J.,

dissenting). Judge Nies reasoned that “(hjaving narrowed

14

the claim’s range of pH to secure the Examiner’s

withdrawal of his prior rejection, [the patentee] may not

now resort to the doctrine to cover equivalents thereof.”

Hilton Davis, 62 F.3d at 1582 (Nies, J., dissenting). Judge

Nies also pointed out that a patentee could resort to the

statutory reissue procedure of 35 U.S.C. §§ 251, 252 to

seek protection beyond the patentee’s own agreed to claim

language in the original patent. Because the reissue statute

allows competitors to invoke “intervening rights,” however,

Judge Nies noted that “[t]he patentee is much better off

evading the reissue procedure which Congress had

provided, and resorting to its counterpart, the doctrine of

equivalents, created out of the judiciary's sense of

‘fairness."” Hilton Davis, 62 F.3d at 1560 (Nies, J.,

dissenting).

As in Hilton Davis, in the present case Pail narrowed its

claims before the Patent Office to cover only a membrane

prepared from a nylon resin having a chemical ratio “of

about 5:1 to about 7:1.” The Patent Act does not allow it to

now stretch its claims to cover a membrane prepared from a

resin having a 4:1 ratio.

a a

15

REASONS FOR GRANTING THE WRIT

This Court should grant certiorari to decide a

fundamental question of patent law in this case -- the scope

of protection against patent infringement. See 35 U.S.C. §

271(a). Although the appeals court here relied on the

recent Hilton Davis decision to conclude that MSI’s

product infringes, although it falls outside the terms of the

plaintiff's patent claim, the court has violated the Clearly

expressed statutory policy of the Patent Act (i) requiring

precise claiming to put the world on notice of the scope of

protection (35 U.S.C. § 112); (ii) specifying “equivalents”

protection only for a particular class of patents (35 U.S.C. §

112); (iii) requiring that reissue applications to broaden

claims can only be filed within two years of patent grant

(35 U.S.C. § 251); and (iv) requiring that claims broadened

in reexamination be held invalid (see 35 U.S.C. § 305).

The Hilton Davis petition for certiorari establishes

many sound reasons for Supreme Court review. Petitioner

MSI here also raises additional arguments, namely that the

Federal Circuit’s ruling in this case warrants review

because that ruling legitimizes after-the-fact enlargement of

the scope of a patent claim, in direct contradiction to the

Patent Act’s Statutory policy against enlarging claims in a

patent reexamination. See Quantum Corp. y. Rodime, PLC.

65 F.3d 1577, 1584 (Fed. Cir. 1995) (claims enlarged

during reexamination are invalid). Under the guise of the

doctrine of equivalents, the circuit court now allows

enlargement of a claim wel] beyond its literal terms,

without invalidating the enlarged claim. Failing to grant

certiorari in this case along with Hilton Davis allows the

multimillion dollar judgment against MSI to threaten its

existence, and Subsequent review and reversal of Hilton

Davis alone potentially would come too late to save it.

16

In addition, the Federal Circuit improperly resolved the

damages issue on appeal despite the absence of necessary

record evidence, exercising its power without consideration

of its proper role in the judicial process. At the damages

trial, Pall sought to prove it was entitled to lost profits

damages, and attempted to introduce evidence relating to a

third party product’s infringement in order to demonstrate

the absence of a non-infringing substitute. See Pet. App.

100a. The district court excluded that evidence and MSI

therefore never had a reason or an opportunity to introduce

rebuttal evidence. On appeal, the Federal Circuit reversed

and remanded, ordering recalculation of damages based

upon an assumed absence of non-infringing substitutes --

without any evidence that the third party’s product

infringed the patent and without allowing MSI an

opportunity to introduce rebuttal evidence that the third

party product did not infringe. In short, what the Federal

Circuit did was rule based on what the plaintiff hoped its

evidence might prove to the trial court, rather than based on

what the evidence actually was. This case needs review to

correct this improper exercise of judicial power, and

remand to require district court inquiry into whether the

third party products actually infringed, before damages can

be substantially increased based on an assumption that

remains unproven.

I. THE DOCTRINE OF EQUIVALENTS ISSUE

PRESENTS A FUNDAMENTAL QUESTION

OF PATENT LAW THAT REQUIRES

SUPREME COURT RESOLUTION

The decision in this case is of extraordinary, widespread

importance in the field of patent law. The recently filed

17

petition for certiorari in Warner-Jenkinson Co. v. Hilton

Davis Chem. Co., No. 95-728 (Nov. 6, 1995), fully

addresses most of the reasons that support granting

certiorari in this case also, and those reasons are not

repeated in detail here. Briefly, the Federal Circuit itself

has recognized the significance of the issues presented,

having ordered an en banc hearing in order “to consider the

important issues raised concerning the doctrine of

equivalents.” Hilton Davis, 62 F.3d at 1516. In addition,

one concurring opinion and two dissents in Hilton Davis

recognized that the doctrine of equivalents is appropriate

for this Court’s review. Hilton Davis, 62 F.3d at 1529

(Newman, J., concurring), 1545 (Plager, J., dissenting), and

1549 n.3 (Lourie, J., dissenting).

The Federal Circuit’s recent decisions in this case and

Hilton Davis give broad protection against “substantial”

“equivalents”, and are inconsistent with the Patent Act. In

addition to the reasons persuasively articulated in the

Hilton Davis petition, the decisions violate the statutory

policy embodied in the Patent Act. First, 35 U.S.C. § 112

requires that a patentee precisely draft its patent claims to

put the world on notice of the scope of protection. Using

the doctrine of equivalents to effectively expand claims

beyond their written scope frustrates that statutory

provision and defeats the purpose of the patent application

process, which allows a patent applicant ample

opportunities to obtain claims which adequately cover what

the applicant believes to be the invention. Second, 35

U.S.C. § 112 also specifies that only one particular class of

patents is to receive protection from “equivalents.” Third,

35 U.S.C. § 251, on patent reissue proceedings, provides

only a limited two year period in which to apply for claims

broader than those in the original patent. Allowing

18

subsequent broadening through the doctrine of equivalents

neutralizes that provision.

The absurdity of the Federal Circuit’s expansive

doctrine of equivalents is further shown by contrasting that

court’s recent treatment of a patent claim from a patent

reexamination proceeding with the enlarged patent claim at

issue here.° In Quantum Corp. v. Rodime, PLC, 65 F.3d

1577 (Fed. Cir. 1995), the patentee during reexamination

added the word “approximately” to the phrase “at least

600” tracks per inch, to make the patent claim read "at least

approximately 600” tracks per inch. Quantum, 65 F.3d at

1579. The Federal Circuit reviewed the reexamined claim |

against the language of section 305 and its policy, and held

that adding the word “approximately” impermissibly |

broadened the claim, making it invalid and unenforceable. |

Quantum, 65 F.3d at 1582, 1584. In contrast, the Federal |

Circuit here followed an entirely different policy, and

allowed the lower court to read “about 5:1” to mean “4:].”

Such a reading clearly broadens Pall's claim and permits

enforcement of what in a reissue proceeding doubtless

would be an invalid claim.

In addition, the decision here is at odds with another

recent en banc Federal Circuit decision for which this Court

has granted certiorari. In Markman v. Westview Instr., Inc.,

52 F.3d 967, 979 (Fed. Cir.) (en banc), cert. granted, 64

° In a reexamination proceeding, the Patent Office considers whether a

prior art patent or printed publication has any bearing on the

patentability of a claim or claims in an issued patent. 35 U.S.C. §§

304-305. The Patent Act permits the patent owner in a reexamination |

to amend its claims to avoid the prior art, but in doing so the patent |

owner may not "enlarg[e] the scope of a claim..." 35 U.S.C. § 305. |

That policy against enlargement of claims is frustrated by the Federal

Circuit’s broad doctrine of equivalents.

19

U.S.L.W. 3238 (No. 95-26, granted Sept. 27, 1995), the

Federal Circuit decided that interpreting claims to

determine whether they are infringed is a question of law

for the court. In contrast, in this case under the doctrine of

equivalents, the Federal Circuit ruled that determining

infringement is a question of fact. Pet. App. lla; see

Hilton Davis, 62 F. 3d at 1523. This inconsistent treatment

of infringement provides no logical guidance for businesses

legitimately seeking to market products free from claims of

patent infringement.

Because the doctrine of equivalents is now being

interpreted to permit patent holders te claim protections far

beyond the terms of the patent itself, its definition will

impact most if not all patent infringement lawsuits. The

Federal Circuit’s definition will promote great uncertainty

about the scope of patent protection, which can be expected

to spur additional patent litigation as patentees decide to

pursue suits against defendants who have not literally

infringed their patents, and will require the parties and

courts to undertake extensive inquiry into whether

“substantial differences” exist between the accused and

patented products or processes. That definition also may

adversely affect the ability of competitors to “design

around” a claimed invention, which is “one of the

important public benefits that justify awarding the patent

owner exclusive rights to his invention.” Hilton Davis, 62

F.3d at 1520. The uncertainty about the precise scope of

the protected invention to be “designed around” created by

a broad doctrine of equivalents inhibits a new inventor’s

ability and willingness to try to invent in the area of the

patent.

As pointed out in the petition in Hilton Davis, it is not

appropriate to leave the Federal Circuit to its own devices

20

in settling such an important question of patent law. The

Federal Circuit itself plainly acknowledged that it did not

feel empowered to solve the problems presented by the

doctrine of equivalents -- instead, in this case and in Hilton

Davis it invoked what it regarded as binding Supreme

Court precedent, thus conceding that it was constrained to

reach its interpretation of the doctrine of equivalents by this

Court’s Graver Tank decision and predecessor decisions.

See Pet. App. lla (citing Graver Tank as authority for

“substantial difference” test); Hilton Davis, 62 F.3d at

1517-20 (Graver Tank established “substantiality of the

differences” test, determined elements of “substantiality”

inquiry, and determined factual character of “equivalents”

question).

The dissents in Hilton Davis noted that authoritative

resolution of the continuing force of Graver Tank and of

the continuing role and contours of the doctrine of

equivalents must come from this Court. See Hilton Davis,

62 F.3d at 1539 (Plager, J., dissenting) (“in today’s opinion,

the majority abdicates this responsibility [to address the

problems caused by its readings of Supreme Court

decisions], leaving to the Supreme Court the obligation of

attending to the problem if it is to be attended to at all”).

Judge Lourie bluntly stated that “in light of Graver, it may

be that only the Supreme. Court, writing without the

confining strictures of Graver, can deal cleanly with this

issue.” Hilton Davis, 62 F.3d at 1549 n.3 (Lourie, J.,

dissenting).’ In fact, a member of the majority concluded

: Judge Lourie pointed to “the greater complexity of today’s patented

high technology inventions compared with those made 50 or more

years ago” as a reason for his conclusion that “Graver speaks to a time

that is long past.” Hilton Davis, 62 F.3d at 1549 n.3 (Lourie, J.,

dissenting).

21

that “any change in the legal and factual fundamentals so

explicitly laid out by the Supreme Court is beyond our

judicial authority.” Hilton Davis, 62 F.3d at 1529

(Newman, J., concurring).

Clearly, the Federal Circuit’s broad view of the doctrine

of equivalents goes far beyond what the doctrine was

intended to do, and stymies rational attempts at predicting

what infringes and what does not. Accordingly, this case

requires Supreme Court review.

II. IN INCREASING DAMAGES, THE FEDERAL

CIRCUIT IGNORED THIS COURT’S

PROHIBITION AGAINST RULING ON

EVIDENCE NOT INTRODUCED AT TRIAL

This case also involves the important question of

whether an appellate court may order that damages be

recalculated below based on a theory for which there was

no evidentiary support, because all evidence on that theory

was excluded by the trial court, and the defendant therefore

had no opportunity for rebuttal at trial. If the Federal

Circuit’s damages decision is allowed to stand, Petitioner

MSI will be required to pay millions of dollars in additional

damages when it has been denied the opportunity to offer

evidence on the key damages issue.

At trial in this case, Respondent Pall sought to prove

that it was entitled to lost profits damages, which required

proof of an absence of noninfringing substitutes. Pet App.

20a. To meet that requirement, Pall sought to introduce

evidence that a third party’s product was infringing, but the

district court excluded that evidence on the grounds that

Pall licensed the third party’s product pursuant to a

22

settlement agreement. Pet. App. 100a. Because the

evidence on infringement was excluded, MSI never had an

opportunity to introduce rebuttal evidence that the third

party’s product did not infringe. Accordingly, on appeal

the trial record was insufficient to establish whether or not

the third party’s product actually met the Pall patent claim

limitations and infringed the patent.

The Federal Circuit, however, ruled that the third

party’s product was in fact infringing, even though the trial

court never considered any evidence on that issue.

Pet. App. 21a. Clearly, the appellate court overstepped its

role, which is not to make rulings on what one party

expects or hopes the evidence will prove -- rather, the

appellate court’s role is to make rulings based on what the

evidence is.

Allowing this damages decision to stand frustrates the

requirement that appellate courts rule only on evidence

introduced into the record. This Court has held that it is

reversible error for an appeals court to rule upon evidence

never introduced into the trial record. See Singleton v.

Wulff, 428 U.S. 106, 120-21 (1976) (appellate court

improperly ruled on merits against petitioner where

petitioner had no opportunity to offer opposing evidence or

argument below); see also Ballard Medical Products v.

Wright, 821 F.2d 642, 643 (Fed. Cir. 1987) (appellate court

may consider only record as made before district court).

Because remanding for a recalculation of damages (rather

than an inquiry into the nature of the evidence) was

improper, this Court should grant certiorari on this issue

also.

23

CONCLUSION

The Petition for a Writ Certiorari should be granted.

Dated: December 21, 1995

Respectfully submitted,

STEVEN M. BAUER

Counsel of Record

JOHN J. COTTER

TESTA, HURWITZ

& THIBEAULT

125 High Street

Boston, MA 02110

(617) 248-7000

Attorneys for Petitioner,

Micron Separations, Inc.

INDEX TO APPENDIX

Opinions of United States Court of Appeals for

the Federal Circuit (September 26, 1995)...... la

Memorandum and Orders of United

States District Court for the District of

Massachusetts in Favor of Plaintiff and

Against Defendant (May and June, 1991) ... 30a

Order of United States Court of Appeals

for the Federal Circuit denying Petition

for Rehearing (October 24, 1995)......00...... 112a

Judgment, United States Court of

Appeals for the Federal Circuit

(September 26, 1995).........ccescscscoesssesseess 113a

Excerpts from United States Patent and

Trademark Office file history for

United States Patent No. 4,340,479 ........... 114a

la

United States Court of Appeals for the Federal Circuit

91-1393, -1394, -1409

PALL CORPORATION,

Plaintiff/Cross-Appellant,

V.

MICRON SEPARATIONS, INC.,

Defendant-Appelliant.

DECIDED: September 26, 1995

Before RICH, NEWMAN, and MAYER, Circuit Judges.

Opinion for the court filed by Circuit Judge NEWMAN.

Separate opinion, concurring in the judgment, filed by

Circuit Judge MAYER.

NEWMAN, Circuit Judge.

2a

Both parties appeal aspects of the judgment of the

United States District Court for the District of

Massachusetts, wherein Micron Separations, Inc. ("MSI")

was adjudged to have infringed a patent owned by Pall

Corporation ("Pall") relating to polyamide membranes that

are used in microfiltration. We affirm the judgment of

infringement, reverse as to willful infringement, modify the

damages award, and remand for recalculation of damages.

Background

Microfiltration membranes have an extremely small

pore size, and are used to remove unwanted microscopic

substances such as bacteria from fluids, or to separate and

retain desired microscopic substances such as antibodies.

Microfiltration membranes are used, for example, by

pharmaceutical companies in bacteria-free drug production,

by electronics manufacturers to purify water for chip

manufacture, by hospitals to filter contaminants from fluids

that are administered to patients, in diagnostics to detect the

presence of antibodies or antigens, and as transfer

membranes for identification of genetic characteristics. A

particularly useful pore size for microfiltration membranes

is about 0.22 micron, for this pore size yields the highest

flow rate consistent with retention of the 0.3 micron

' Pall Corp. v. Micron Separations, Inc., No. 86-1427-Y

(D. Mass. June 24, 1991). On Nov. 5, 1993 the-court decided to

hear this case en banc in order to consider the questions set forth

in the court's order of Jan 7, 1994. Having resolved those

questions in the case of Markman v. Westview Instruments, Inc.,

52 F.3d 967, 34 USPQ2d 1321 (Fed. Cir. 1995) (en banc), the

case has been returned to the panel for disposition in accordance

therewith.

3a

Pseudomonas diminutia bacteria; removal of these bacteria

is the standard criterion for sterilization by microfiltration.

Microfiltration membranes are not new, although

membranes of the prior art were generally subject to

deficiencies such as brittleness, excessive shrinkage, poor

solvent resistance, limited flow rate, excessive clogging,

and limited sterilizing ability. Microfiltration membranes

had previously been made from organic polymers, but those

membranes generally required the use of wetting agents for

filtration, for water does not flow well through microporous

membranes that are not instantly wettable. The addition of

wetting agents to facilitate flow is undesirable because it

adds impurities to the system.

In accordance with United States Patent No.

4,340,479, inventicn of Dr. David B. Pall ("the Pall

patent"), microfiltration membranes are made from organic

polymers called polyamides. The particular polyamides of

this invention are sometimes called "nylons," the generic

term for linear aliphatic polyamides. The polyamide

membranes at issue were made from the commercially

available polymers nylon 66 and nylon 46. The method of

making these membranes and the membranes themselves

are described in the Pall patent and in the district court's

opinion, and will be repeated only as necessary to explain

our decision.

2 In this common nomenclature for nylon

polyamides, integers signify the number of carbon atoms in

the monomers from which the polymer is made. For

example, in nylon 66 the first 6 represents the number of

carbon atoms derived from the diamine monomer, and the

second 6 represents the number of carbon atom in the

diacid monomer. Nylon 46 has 4 carbon atoms in the

diamine and 6 carbon atoms in the diacid.

4a

Membranes had been made of polyamides before

Dr. Pall's invention, but the prior membranes were either

soluble in alcohol or required the use of wetting agents for

efficient filtration. The membranes of the prior art also had

a surface skin of reduced porosity that retarded wettability

of the membrane material and increased the flow time. The

Pall patented membranes are naturally and instantaneously

wettable and alcohol-insoluble, with uniform pore size

throughout the membrane. They achieve efficient flow

without the use of wetting agents. The Pall membranes,

due to their improved properties and _ increased

effectiveness in microfiltration, achieved not only

commercial success but also scientific recognition. The

trial court found:

Dr. Pall and his associates were pioneers

both in the invention, development, and

commercialization of functional nylon

microfiltration membranes and in _ the

theory of microfiltration.

The Pall microfiltration membranes were made of nylon 66,

and were introduced into commerce in 1978. The Pall

patent issued in 1982. In 1983 MSI introduced a

microfiltration membrane made of nylon 66. Pall filed suit-

in 1986. In 1989 MSI converted most but not all of its

nylon 66 membrane production to nylon 46. The case came

to trial in 1991.

The district court held that the Pall patent was valid,

that MSI's nylon 66 membranes literally infringed the

patent's product claims, that MSI's nylon 46 membranes

infringed the product claims under the doctrine of

equivalents, and that MSI's process for producing the nylon

membranes infringed the patent's process claims under the

doctrine of equivalents. The court held that MSI's

Sa

infringement was willful to the limited extent of MSI's

continued manufacture of some nylon 66 membranes after

it had shifted most of its production to nylon 46. Although

MSI declared bankruptcy after the adverse district court

judgment,’ it remains operating under a stay of injunction

granted by the district court as to MSI's nylon 46

membranes."

MSI appeals the rulings of infringement and willful

infringement. Pall cross-appeals aspects of the damage

award.

INFRINGEMENT

Nylon 66 Membranes

A representative product claim of the Pall patent is:

34. A hydrophilic skinless alcohol-insoluble

polyamide resin membrane sheet of alcohol-

insoluble hydrophobic polyamide resin

selected from the group consisting of

polyhexamethylene adipamide,

polyhexamethylene sebacate, and poly-e-

caprolactam, and capable when completely

immersed in water of being wetted through

within no more than one second, and

reverting when heated to a temperature just

* In re Micron Separations, Inc., No. 91-41885-JFQ (Bankr.

D. Mass.).

* Pall Corp, v. Micron Separations, Inc., No. 86-1427-Y,

slip op. at 1.

i eT ee ee ee eee |

6a

below the softening temperature of the

membrane to a hydrophobic material which

is no longer wetted by water.

Nylon 66 is polyhexamethylene adipamide, named

in claim 34. It was not disputed that all of the limitations of

claim 34 were met by MSI's nylon 66 membranes, except

for the term "skinless," the meaning of which received

extensive attention at trial. MSI argued that the plain

meaning of "skinless" eliminated the MSI products from

infringement, because a photomicrograph showed a "skin"

on the MSI membranes. Pall’s position was that "skinless"

as used in the specification and claims should be

understood as a performance characteristic, for a skin is a

nonporous layer that impedes filtration.

Claim interpretation is a question of law Markman

v. Westview Instruments, Inc., 52 F.3d 967, 34 USPQ2d

1321 (Fed Cir. 1995) (en_banc). We review the

construction of the claims without deference to that of the

district court. Id. at 979, 34 USPQ2d at 1329 ("Because

claim construction is a matter of law, the construction given

the claims is reviewed de novo on appeal.") In construing

the claims we look to the language of the claims, the

specification, and the prosecution history. Id. Extrinsic

evidence may also be considered, if needed to assist in

determining the meaning or scope of technical terms in the

claims. Id. at 980, 34 USPQ2d at 1330.

At trial both sides presented support for their

conflicting positions concerning the term "skinless." Pall

presented data showing "bubble point," "flow time,” and

"KL curve" measurements of the membranes in suit. These

measurements were described in the Pall patent

specification as tests for determining the presence or

absence of a skin on a membrane. The bubble point test

measures the pressure applied to a membrane whose pores

7a

are filled with water in order to force the water through the

pores; the larger the bubble point value, the smaller the

pores in the membrane. Flow time is the time required for

a certain amount of water to pass through a given area of

membrane; the smaller the pores the longer the flow time.

The KL curve depicts the flow of water through a

membrane at constant pressure; skinless membranes

characteristically show an initially level KL curve followed

by a sharp rise in the curve as flow commences, whereas

KL curves for skinned membranes show a gradual upward-

sloping curve. These are generally accepted tests of

whether a membrane is skinned or skinless, for a non-

porous skin impedes the passage of water through the

membrane, and is detected by all three tests. The district

court defined "skinless" as a performance characteristic in

accordance with the parameters of these tests. We too

conclude, based on the specification and the data in

evidence, that "skinless" is properly construed as a

performance characteristic, and that a surface that does not

impede flow is "skinless" as that term is used in the art of

filtration membranes.

The district court then applied the construed claims

to MSI's membranes. The court found that the MSI

. membranes had bubble points, flow times, and KL curves

characteristic of skinless membranes. The court also

observed that MSI's product literature described its

membranes as of uniform pore size or having precise

porosity, which the court found were necessary

characteristics of skinless membranes. The court thus

found, on the totality of the evidence, that the MSI

membranes did not have a barrier layer that blocked fluid

flow, and that the MSI membranes were skinless as the Pall

patent used that term. We discern no clear error in this

finding.

8a

Literal infringement is found when every limitation

of a claim is met in the accused structure. Applying its

interpretation of the term "skinless," which we have

confirmed, the district court found that the MSI nylon 66

membranes literally infringed the Pall patent. The

judgment of infringement by MSI's nylon 66 membranes is

affirmed.

Nylon 46 Membranes

Three years after Pall filed this suit, MSI converted

most of its membrane manufacture from nylon 66 to nylon

46. Nylon 46 is made not from hexamethylenediamine and

adipic acid, but from tetramethylenediamine and adipic

acid. Claim 34, quoted supra, does not name

polytetramethylene adipamide (nylon 46). However, claim

116 of the Pall patent describes the polyamide resins in

terms of their methylene to amide ratio:

116. A hydrophilic skinless alcohol-

insoluble polyamide resin membrane sheet

of alcohol-insoluble hydrophobic polyamide

resin having a ratio CH,:NHCO of

methylene CH, to amide NHCO groups

capable when completely immersed in water

of being wetted through within no more than

one second, and reverting when heated to a

temperature just below the softening

temperature of the membrane to a

hydrophobic material which is no longer

wetted by water. [Emphasis added. ]

Nylon 66 has a ratio of methylene to amide groups

of 5:1. Nylon 46 has a ratio of 4:1. Pall asserts that the

9a

term "about 5:1 to about 7:1 " is infringed by the ratio of

4:1, either literally or by the doctrine of equivalents.

A. Literal Infringement

The district court, construing the term “about 5:1 to

about 7:1," observed that the word "about" does not have a

universal meaning in patent claims, and that the meaning

depends on the technological facts of the particular case.

We have so held. Eg. Andrew Corp, vy. Gabriel

Electronics, Inc., 847 F.2d 819, 821-22, 6 USPQ2d 2010,

2013 (Fed. Cir.), cert. denied, 488 U.S. 427 (1988); W.L.

Gore & Assoc, Inc, v. Garlock, Inc,, 842 F.2d 1275, 1280,

6 USPQ2d 1277, 1282 (Fed. Cir. 1988).

The determination of whether the literal meaning or

scope of "about 5:1 to about 7:1” includes 4:1 is a matter of

claim construction, a question of law for decision de novo

by this court. The use of the word "about," avoids a strict

numerical boundary to the specified parameter. Its range

must be interpreted in its technologic and stylistic context.

We thus consider how the term "about 5:1 to about 7:1"

was used in the patent specification, the prosecution

history, and other claims. It is appropriate to consider the

effects of varying that parameter, for the inventor's intended

meaning is relevant. Extrinsic evidence of meaning and

usage in the art may be helpful in determining the criticality

of the parameter, and may be received from the inventor

and others skilled in the field of the invention. See

Markman, 52 F.3d at 980, 34 USPQ2d at 1330 ("The court

may, in its discretion, receive extrinsic evidence in order to

aid the court in coming to a correct conclusion’ as to the

‘true meaning of the language employed’ in the patent.")

(quoting Seymour v. Osbome, 78 U.S. (11 Wall.) 516, 546,

(1871)).

10a

Dr. Pall, the inventor, explained his usage of "about

5:1 to about 7:1 " as deriving from his tests of the

performance of various nylon resin membranes. He

explained that the ratios change in half integers, ¢. ¢.., WH,

6.5:1, 6:1, etc., depending on the total number of methylene

groups in the acid and amine components of the polymer.

For example, each recurring unit of nylon 66 contains 10

methylene groups and 2 amide groups, for a ratio of 10:2,

which reduces to 5:1. Each recurring unit of nylon 46

contains 8 methylene groups and 2 amide groups, for a ratio

of 4:1. The Pall patent also illustrated a mixture having the

ratio of 5.3:1.

Dr. Pall testified that he conducted experiments

with several commercially available nylon resins. He

found that a nylon resin having a methylene:amide ratio

higher than 7:1 produced membranes that were less readily

wettable, such that use of a wetting agent was required for

optimum results. He therefore placed the upper limit of

"about 7:1 " in the claims. Dr. Pall stated that the only

commercially available nylon resin with a ratio lower than

5:1 was a nylon with the ratio of 3:1, and that he made a

membrane of the 3:1 nylon and found it to be soluble in

alcohol and therefore unacceptable. No experiments were

conducted with a nylon between 3:1 and 5:1, he testified,

because none was commercially available. He placed the

lower limit at "about 5:1." The reasons for these claim

limitations also appear in the patent specification.

The district court found that Dr. Pall's use of the

word “about” was “appropriate.” We agree that the

evidence showed that an exact limitation would have been

inappropriate. However, the evidence showed that while a

ratio of 7:1 was satisfactory, higher ratios were not,

suggesting that the upper limit was close to 7:1, and did not

extend to, for example, 8:1. At the lower ratios, although

Dr. Pall conducted no tests with resins between 3:1 and 5:1,

lla

the 3:1 resin was clearly unsatisfactory. Reviewing all the

evidence, the district court held that a literal reading of

“about 5:1 to about 7:1" did not include the ratio of 4:1. On

plenary review we reach the same conclusion.

Since the claim is construed more narrowly than

would literally encompass the ratio of 4:1, the district

court's finding that MSI's nylon 46 membranes do not

literally infringe the Pall patent is affirmed.

B. Infringement by Equivalents

When literal infringement is not established,

infringement may be proved under the doctrine of

equivalents when there is not a substantial difference

between the claimed invention and the accused product.

, 339 US.

605, 85 USPQ 328 (1950); Hi j

Wamer-Jenkinson Co., F.3d_, 35 USPQ2d 1641 (Fed.

Cir. 1995) (en banc). The determination of whether the

accused product is substantially the same as the claimed

invention is a question of fact, and the district court's

determination thereof is reviewed for clear error. ]d. at Po.

35 USPQ2dat_.

The district court found that MSI's nylon 46

membranes had substantially the same chemical and

physical structure, performed the same function in the same

way, and achieved the same result, as Pall's claimed

membranes. The court thus found that claim 116 was

infringed under the doctrine of equivalents.

MSI does not argue on this appeal that the nylon 46

and nylon 66 membranes are not equivalent instead, MSI

argues that Pall is estopped to establish infringement based

on equivalency because during patent prosecution Pal]

voluntarily gave up claim scope that would have literally

included nylon 46. MSI asserts that Pall is estopped from

12a

obtaining that scope under the doctrine of equivalents, even

if the products are in fact equivalent.

Prosecution history estoppel limits infringement by

otherwise equivalent structures, by barring recapture by the

patentee of scope that was surrendered in order to obtain

allowance of the claims. Mannesmann Demag Corp. v.

Engineered Metal Products Co,, 793 F.2d 1279, 1285, 230

USPQ 45, 48 (Fed. Cir. 1986); Thomas and Betts Corp. v.

Litton Sys., Inc., 720 F.2d 1572, 1579, 220 USPQ 1, 6

(Fed. Cir. 1983). Thus, by actions taken during patent

prosecution the patentee can be estopped from reaching

subject matter that otherwise meets the criteria of

equivalency.

Pall states that there is no estoppel with respect to

nylon 46, because no claim scope covering nylon 46 was

yielded due to prior art or based on any requirement of

patent examination. We outline the circumstances: Pall's

initial patent application contained broad claims, wherein

the only limit placed on the nylon polyamide resin was that

it be insoluble in alcohol. These claims stated no upper or

lower limit to the methylene:amide ratio. Dr. Pall testified

that upon continuing his research while his patent

application was pending, he discovered that his view of the

nylon resins usable in his invention was too broad. He

eventually refiled the patent application with additional

data, and claims to nylon resins "within the range of about

5:1 to about 7:1." Dr. Pall stated, and the prosecution

record is in accord, that the refiling was based not on prior

art or any requirement by the patent examiner, but on his

own research.

The examiner for the continuation-in-part

application at first rejected the new ratio claims under 35

U.S.C. §112, stating that the claimed range was too broad

and unsupported by the disclosure. No prior art was cited.

Dr. Pall responded that the claimed range was "actually

l3a

rather narrow" and that the claims "clearly exclude the vast

majority of polyamide resins." MSI relies on this statement

as the basis of estoppel. MSI states that whether polyamide

resins having a ratio below about 5:1 were required by the

€xaminer to be surrendered, or were voluntarily not claimed

by Pall, resins having a 4:1 ratio are excluded by estoppel

because of this response to the examiner. Pall states that

“about 5: 1" was simply descriptive of the inventor's

knowledge at the time the continuation-in-part application

was filed, and that there is no estoppel against the

admittedly equivalent 4:1 resin.

Prosecution history estoppel normally arises when a

change of claim scope is made in order to overcome an

examiner's rejection based on prior art. Estoppel may arise

whether the change is made by amendment of the claims

during prosecution, or by refiling the patent application

with changed claims. Thus a patentee is estopped from

recovering through equivalency that which was deemed

unpatentable in view of the prior art. However, when a

rejection based on prior art did not dictate the claim change

that was made, it is necessary to look at the specific change

and the reason, in ascertaining whether an estoppel has

arisen by virtue of the change. Diversitech Corp. v,

Century Steps, Inc,, 850 F.2d 675, 681, 7 USPQ2d 1315,

1320 (Fed. Cir. 1988). See Bayer Aktienizesellschaft v.

Duphar Int'l Research B.V., 738 F.2d 1237, 1243, 222

USPQ 649, 653 (Fed. Cir. 1984) ("a close examination

must be made as to not only what was surrendered, but also

the reason for such a surrender”); i

United States, 717 F.2d 1351, 1363, 219 USPQ 473, 481

(Fed. Cir. 1983) (an amendment to a claim may “have a

limiting effect within a spectrum ranging from great to

small to zero"). We take note that in the course of patent

examination claims are often amended and rewritten and

added and subtracted. A non-substantive change or a

l4a

change that did not in fact determine patentability does not

create an estoppel. Laitram Corp, v. NEC Corp., 952 F.2d

1357, 1361, 21 USPQ2d 1276, 1279 (Fed. Cir. 1991).

The estoppel asserted by MSI arose not from prior

art but from Pall's statement to the examiner, in response to

the rejection that the claims were too broad and

unsupported by the disclosure, that the claims were

"actually rather narrow." There were no changes made in

the claims in response to this rejection. A rejection for lack

of support in the specification is deemed a rejection under

35 U.S.C. §112, first paragraph. In re Borkowski, 422 F.2d

904, 909, 164 USPQ 642, 646 (CCPA 1970). Section 112,

first paragraph, states in part:

The specification-shall contain a written

description of the invention, and of the

manner and process of making and using it,

in such full, clear, concise, and exact terms

as to enable any person skilled in the art to

which it pertains, to make and use the same

Whether amendment or argument made in response

to a rejection under §112 produces an estoppel, as does an

amendment made to obtain allowance in view of cited

references, is dependent on the particular facts. There is no

all-encompassing rule that estoppel results from all claim

changes, or all arguments, whatever their cause or purpose.

Laitram v. NEC, 952 F.2d at 1361, 21 USPQ2d at 1280:

Hi-Life Products, Inc. v. American National WaterMattress

Corp., 842 F.2d 323, 325, 6 USPQ2d 1132, 1134 (Fed. Cir.

1988).

As we have observed, a concession made or

position taken to establish patentability in view of prior art

on which the examiner has relied, is a substantive position

15a

on the technology for which a patent is sought, and will

generally generate an estoppel. In contrast, when claim

changes or arguments are made in order to more

particularly point out the applicant's invention, the purpose

is to impart precision, not to overcome prior art. Such

prosecution is not presumed to raise an estoppel, but is

reviewed on its facts, with the guidance of precedent. See,

2 | , 872

F.2d 978, 990, 10 USPQ2d 1338, 1348 (Fed. Cir. 1989)

(rejection for lack of enablement, withdrawn based on the

patentee’s arguments did not serve as a basis for estoppel

“in these events"); Moeller v, Jonetics, Inc., 794 . F.2d 653,

659-60, 229 USPQ 992, 996-97 (Fed. Cir. 1986) ("on this

record" prosecution history estoppel not applicable to

amendment to more particularly point out the invention);

Mannesmann Demag, 793 F.2d at 1285, 230 USPQ at 48

(estoppel not necessarily created, by an amendment

designed only to remove a §112 indefiniteness rejection);

, 714 F.2d 1110,

1115, 219 USPQ 185, 187-88 (Fed. Cir. 1983) (prosecution

history estoppel not found where rejection based on

indefiniteness under 1 12, since prior art did not dictate the

limitation at issue).

MSI argues that even if prosecution history estoppel

does not limit Pall's claims to precisely the 5:1 to 7:1 range,

the doctrine of equivalents can be invoked only for subject

matter that is disclosed and enabled in the patent

specification but not claimed. That is incorrect. The

doctrine serves to guard against "fraud on a patent," Graver

Tank, 339 U.S. at 608, 85 USPQ at 330, by enabling fair

protection of the patentee's contribution. It is not

controlling whether the inventor foresaw and described this

potential equivalent at the time the patent application was

filed. See, eg,,

16a

Nemours & Co., 750 F.2d 1569, 1581, 224 USPQ 409, 417

(Fed. Cir. 1984).

The district court applied these principles. The

court found that Pall had not:surrendered or abandoned

patent protection outside of the 5:1 to 7:1 range, and that

Pall's voluntary restriction of the claims in the continuation-

in-part application, and the response to the examiner's

rejection under §112, did not produce an estoppel with

respect to the 4:1 product. The court found that although

nylon 46 had been known chemically since 1942, nylon 46

was not commercially available at the time of Dr. Pall's

invention. The court stated: "I do not find that nylon 46

was known in the sense that there was any requirement that

Pall experiment with nylon 46 to understand its properties."

Observing the close similarity in chemical structure and the

identity of function, way, and result to the claimed

membranes, the district court found infringement by MSI's

nylon 46 membranes under the doctrine of equivalents.

We discern no reversible error in the application of

the law of estoppel to the facts of this case, or in the court's

finding that the nylon 46 membranes infringed under the

doctrine of equivalents. The judgment of infringement is

affirmed.

The Process Claims

In view of our affirmance of infringement of the product

claims for the nylon 66 and nylon 46 membranes, we need

not reach the process claims. A patent is infringed if any

claim is infringed, Intervet America, Inc, v. Kee-Vet Lab.

Inc., 887 F.2d 1 050, 1055, 12 USPQ2d 1474, 1477-78

(Fed. Cir. 1989), for each claim is a separate statement of

the patented invention. 35 U.S.C. 282: Jones v. Hardy, 727

F.2d 1524, 1528, 220 USPQ 1021, 1024 (Fed. Cir. 1984).

17a

Willfulness

In the context of patent infringement, a distinction

is drawn between infringement that is not deemed "willful"

because the accused infringer had a reasonable basis for

believing that its actions did not infringe the patent, and

infringement that deliberately disregarded the property

rights of the patentee. i j , 716

F.2d 1550, 1565, 219 USPQ 377, 388 (Fed. Cir. 1983).

Willfulness of infringement is a question of fact, for

it includes elements of intent, reasonableness, and belief.

., 868 F.2d 1226, 1250,

9 USPQ2d 1913, 1932 (Fed. Cir. 1988); King Instrument

Corp. v. Otari Corp., 767 F.2d 853, 867, 226 USPQ 402,

412 (Fed. Cir. 1985);

ison- » 717 F.2d 1380, 1390, 219 USPQ

569, 576-77 (Fed. Cir. 1983). The boundary between

unintentional and culpable acts is not always bright, see

jte-Hi Co., 819 F.2d 1120, 1125-26, 2

USPQ2d 1915, 1919 (Fed. Cir. 1987), for the facts often

include subjective as well as objective elements. Thus

willful infringement must be established by clear and

convincing evidence,

ili » 849 F.2d 1430, 1440, 7 USPQ2d

1129, 1137 (Fed. Cir.), cert. denied, 488 U.S. 986 (1988),

for it is a punitive findin , and can have the consequence of

multiplication of damages.

The district court found that MSI's infringement

was not willful at its inception and for several years

thereafter. The court found that although MSI failed to

obtain an infringement opinion of counsel before producing

its nylon 66 membranes. MSI made "significant efforts to

avoid the claims of the patent." Thus the district court

found that MSI's infringing production of nylon 66

membranes from 1983 until October 1989 was not willful.

:

:

18a

The court also found that MSI's production of nylon 46

membranes after October 1989 did not constitute willful

infringement. Pall does not appeal these findings.

In October 1989 MSI shifted most of its production

to nylon 46 membranes. However, MSI continued to

manufacture some membranes using nylon 66. The district

court referred to MSI's shift to nylon 46 as evidence that

MSI knew that it had an alternative to its nylon 66 product,

and found that MSI should have known by that time that its

nylon 66 product infringed the Pall patent. The court stated

that it assumed that MSI had acquired competent patent

counsel, after three years of litigation. On these grounds

the district court found that MSI's failure to shift to nylon

46 for all of its production showed the requisite culpability

to sustain willfulness, from that time forward, with respect

to MSI's continuing nylon 66 membrane production. The

court doubled the damages for MSI’s infringing sales of

nylon 66 after October 1989. MSI appeals these rulings.

MSI argues that the district court violated Federal

Rule of Evidence 407 in finding that MSI's continued

production of nylon 66 membranes after MSI switched to

nylon 46, was willful infringement. Rule 407 bars evidence

of subsequent remedial action in proving culpability for a

prior act or event.’ The policy implemented by Rule 407 is

’ Rule 407. When, after an event, measures are taken which, if

taken previously, would have made the event less likely to

occur, evidence of the subsequent measures is not admissible to

prove negligence or culpable conduct in connection with the

event. This rule does not require the exclusion of evidence of

subsequent measures when offered for another purpose, such as

proving ownership, control, or feasibility of precautionary

measures, if controverted, or impeachment.

19a

to avoid inhibiting post-accident repair, lest additional

injury occur. j :

716 F.2d 1322, 1327 (10th Cir. 1983), cert. denied, 466

U.S. 958 (1984). Here MSI's conversion to nylon 46 was

not relied on as evidence of culpability for the prior

infringement by nylon 66 membranes, and the court

declined to find willfulness for that prior infringement.

Thus by its terms Rule 407 was not violated.

However, patent infringement is a continuing tort,

and an action even if innocently begun does not

automatically retain its purity as circumstances change.

The filing of a lawsuit does not stop the clock insofar as

culpability may arise from continuing disregard of the legal

rights of the patentee. The district court relied on the fact

that MSI switched to an alternative product three years into

the litigation, yet continued to produce some of the nylon

66 membranes.

- Willfulness of infringement after October 1989 is

determined on the totality of the evidence. We do not hold

that because the infringement was found not to be willful

when begun, there is a greater burden on the patentee to

prove willfulness as circumstances change. The

requirement of law-abiding respect for the property of

others is not reduced simply because lesser transgressions

were overlooked. However, upon the ruling that

willfulness was not established for MSI's activities during

the initial six years of infringement, the partial conversion

to the nylon 46 product while continuing some of the nylon

66 production is not probative of willfulness for the nylon

66 continuing production. Attempts to avoid or mitigate

infringement, whether or not successful, do not of

themselves enlarge the culpability of the continuing

activity.

The finding of willful infringement for the

continuing production of nylon 66 is clearly in error.

TSE Oe ee ee,

20a

Absent other grounds for the finding of willfulness, this

ruling and the award of damages attributed thereto are

reversed.

DAMAGES

A

The district court awarded damages measured by

Pall's lost profits on 25% of MSI's infringing sales, and a

royalty of 8% on the remaining 75% of MSI's infringing

sales. The district court relied on the presence in the

marketplace of nylon membranes sold by Cuno

Corporation, with whom Pall had settled worldwide

litigation with respect to the patent here in suit and several

Cuno patents, each having charged the other with

infringement. Pall states that it is entitled to lost profits on

all of MSI's infringing sales, at least until May 9, 1990,

when Pall granted immunity to Cuno under the Pall patent.

In order to recover lost profits damages the patentee

"must show a reasonable probability that, ‘but for' the

infringement, it would have made the sales that were made

by the infringer." Rite-Hite Corp. v. Kelley Co., 56 F.3d

1538, 1545, 35 USPQ2d 1065, 1069 (Fed. Cir. 1995) (en

banc); Yarway Corp, v, Eur-Control USA, Inc., 775 F.2d

268, 275, 227 USPQ 352, 357 (Fed. Cir. 1985); Kiniz

Instrument, 767 F.2d at 863, 226 USPQ at 409. In a market

with only two suppliers, the patentee and the infringer, this

requirement is readily met, for example by applying the

guideline set forth in Panduit Corp. v. Stahlin Bros. Fibre

Works, Inc., 575 F.2d 1152, 1156, 197 USPQ 726, 730 (6th

Cir. 1978). To establish lost profits by applying the

evidentiary guideline of Panduit the patentee must show (1)

that there was a demand for the patented product, (2) the

absence of acceptable noninfringing substitutes, (3) that the

2la

patentee was capable of meeting the demand, and (4) the

amount of profits lost. This guideline facilitates the

determination of damages by stating conditions which

allow the inference that the patentee would reasonably have

made the infringer's sales. See Del Mar Avionics, Inc. v.

‘at Quinton Instrument Co., 836 F.2d 1320, 1327, 5 USPQ2d

1255, 1260 (Fed. Cir. 1987).

The district court, applying this guideline, held that

the Cuno membranes were "acceptable noninfringing

substitutes" for the Pall membranes. Pall states that this is

incorrect, that the Cuno membranes were the subject of

ongoing infringement litigation until May 1990, when they

were licensed. The district court should have recognized

the distinction between the legal and market situation

before and after the licensing of the Cuno products. During

the period before the Cuno products were licensed their

presence in the marketplace did not defeat Pall's entitlement

to lost profits damages for all of MSI's infringing sales, for

the Cuno products were not "noninfringing substitutes."

It was not necessary for Pall to continue the Cuno

litigation to judicial decision of the issue of infringement,

as MSI argues. The voluntary settlement of litigation does

not retrospectively transform an accused infringing product

into a "noninfringing substitute." See State Indus., Inc. v.

Mor-Flo Indus., Inc., 883 F.2d 1573, 1578, 12 USPQ2d

1026, 1029 (Fed. Cir. 1989) (if the other suppliers “were

likely infringers," State would have been entitled to their

shares of the market in determining damages based on lost

sales), cert. denied, 493 U.S. 1022 (1990); Micro Motion,

Inc. v. Kane Steel Co., 894 F.2d 1318, 1322, 13 USPQ2d

1696, 1699 (Fed. Cir. 1990) (there’is precedent for finding

causation for lost profits damages if the alternative source

of supply is an infringer); Datascope Corp. vy. SNEC, Inc..

879 F.2d 820, 824-25, 11 USPQ2d 1321, 1323-24 (Fed.

Cir. 1989) (the finding that there was an acceptable

22a

noninfringing alternative can not be supported by the

ongoing litigation between Datascope and a third party),

cert. denied, 493 U.S. 1024 (1990).

However, after Pall settled with Cuno, the district

court correctly held that Cuno's presence in the marketplace

could not be ignored, and limited the award of lost profits

to the share of MSI's sales that Pall would reasonably have

made. For the remaining share the court viewed Pall as a

hypothetical willing licensor, and accordingly assessed

damages as an 8% royalty. This holding implements the

reasoning that the purpose of compensatory damages is not

to leas the infringer, but to make the patentee whole.

See Aro Mfg. Co, v. Convertible Top Replacement Co.,

377 U.S. 476, 507, 141 USPQ 681, 694 (1964) (the

question to be asked is "Had the infringer not infringed,

what would the patent holder... have made?"); State

Industries, 883 F.2d at 1577, 12 USPQ2d at 1028 (damages

shall compensate the patentee for its pecuniary loss because

of the infringement). Pall argues that this result provides a

windfall to the infringer, for when there are multiple

infringers the infringement will be profitable to the

remaining infringers as soon as the patentee settles with any

one of them. We doubt that injustice is inevitable, for the

setting of the royalty rate and the discretion to multiply

damages can assist in achieving a just remedy.

In summary, for MSI's sales after Pall settled with

Cuno, we affirm the damages award based on recovery of

Pall's lost profits for 25% of MSI's infringing sales, and a

royalty of 8% for the remaining 75% of MSI's infringing

sales. For the period before the grant of immunity to Cuno,

Pall shall recover damages measured as its lost profits for

ali of MSI's infringing sales. We remand for the

recalculation of damages.

23a

B

The district court selected 45% as the rate of Pall's

lost profits. MSI does not challenge this rate on appeal.

However, Pall appeals this determination, stating that the

court selected an arbitrary rate that was lower than the

actual rate that Pall had proved.

Among its reasons for reducing the rate from that

presented by Pall's accountants, the district court

considered that MSI's prices were lower than Pall's,

concluded that some of MSI's customers would have

shifted to membranes other than nylon, and factored this

into its reduction of Pall's estimated profits. Pall disputes

the presence as well as the significance of asserted price

differentials, and challenges the other premises of the

district court's decision.

In general, an infringer's sales at a lower price do

not defeat the patentee's recovery of its losses at the

patentee's price, for the principle of patent damages is to

return the patentee to the pecuniary position it would have

been in but for the infringement. Aro Manufacturing, 377

U.S. at 507, 141 USPQ at 694. See also Rite-Hite, 56 F.3d

at 1544, 35 USPQ2d at 1068 ("The statute thus mandates

that a claimant receive damages ‘adequate’ to compensate

for infringement.”) However, in view of the complex of

financial factors presented at trial, we discern no clear error

in the district court's finding of the rate of Pall's lost profits.

The district court's ruling on this aspect is affirmed.

Motions

MSI moves to strike the opinion of the district court

that was written on April 14, 1992. That opinion was an

edited form of the court's prior opinion from the bench, the

district court having reserved the right to present a written

24a

opinion. Although MSI objected to Pall's proposed

substitute opinion, and to the transmittal to this court of a

"substitute opinion, of any kind," it made no objection to

that opinion after it was forwarded by the district court and

did not move to strike it until two years after the district

court's edited opinion was issued. MSI offers no

explanation for the delay. The motion is denied.

Pall in turn states that the court should strike MSI's

argument on the merits, raised in MSI's motion to strike the

opinion of the district court. In view of our disposition

herein, the motion is dismissed as moot.

laid

The stay of injunction pending appeal is vacated.

25a

Costs

Each party shall bear its costs.

ps a eit ale

26a

United States Court of Appeals for the Federal Circuit

91-1393, -1394, -1409

PALL CORPORATION,

Plaintiff/Cross-Appellant,

V.

MICRON SEPARATIONS, INC.,

Defendant-Appellant.

MAYER, Circuit Judge, concurring in the judgment.

Claim interpretation demands an objective inquiry

into how one of ordinary skill in the relevant art at the time

of the invention would comprehend the disputed word or

phrase in view of the patent claims, specification, and

prosecution history. A patent, however, is written for a

person of ordinary skill in an art; it is not written for a

court. Because it is beyond argument that "[a] judge is not

usually a person conversant in the particular technical art

involved and is not the hypothetical person skilled in the art

to whom a patent is addressed," Markman v. Westview

Instruments, Inc., 52 F.3d 967, 986, 34 USPQ2d 1321,

1335 (Fed. Cir. 1995), a disputed word or phrase in a patent

claim, as well as the technology disclosed in the

specification and prosecution history, is often far beyond

the court's unaided understanding. “Extrinsic evidence,

therefore, may be necessary to inform the court about the

language in which the patent is written." Id.

27a

In this case, infringement hinged on the definition

of the word "skinless". The patentee and supporting expert

witnesses who were membranologists testified that in light

of the specification and prosecution history, one of ordinary

skill would understand "skinless" in terms of specific pore

size, shape, and resulting way in which fluid flows through

the membrane. Micron's experts countered that "skinless"

refers to a visible physical characteristic of the membrane

that could be viewed with an electron microscope, and

requires that a membrane not visually appear to have a skin.

Both of these interpretations are plausible and are

adequately supported. After a lengthy trial, the district

court found in favor of Pall's definition as a matter of

underlying fact.

On appeal this panel unanimously agreed on an

opinion which held that those findings of fact were not

clearly erroneous. Then Markman intervened and this case

was revisited by direction of the court en banc. Now,

without explanation, where it was prepared to sustain the

interpretation of "skinless" based on the findings of fact,

the court says it is correct as a matter of law. I continue to

believe Markman was wrongly decided, see 52 F.3d at 989,

34 USPQ at 1337, and this case is an example of why. I

see no principled basis on which the court may rest its

conversion of what once was mutable fact into immutable

law. I can sustain the judgment of the district court as not

based on clear error. Otherwise there is little for the

uninitiated to choose between the contending

interpretations. As far as I can see, this court’s action is

based on mere preference, thus illustrating the artificiality

of Markman. How it fosters greater predictability and

consistency in the law or a certainty that a judge will

“arrive at the true and consistent scope of the patent owner's

rights", id. at 978, 34 USPQ3d at 1329, is beyond my

understanding.

28a

Judge Learned Hand put it cogently: "The question

was of how the art understood the term, which was plainly

a question of fact; and unless the finding was ‘clearly

erroneous,’ we are to take this definition as controlling. It

is an issue which we are altogether incompetent to decide

upon the merits; even the terminology is beyond our

acquaintance . . . indeed the very elements themselves are

in dispute among those who have made them their life

study, as the merest smattering of modern physics quickly

discloses to a lay reader. While Congress sees fit to set

before us tasks which are so much beyond our powers,

suitors must be content that we shall resort to the testimony

of experts, though they are concededly advocates with the

inevitable bias that advocacy engenders. " Harries v. Air

King Prods, Co,, 183 F.2d 158, 164 (2d Cir. 1950).

These cases often deal with the interpretation of

complex scientific terms in areas of cutting edge

technology. But science is not absolute, it is dynamic; and

what is “truth” today is often shown to be error tomorrow.

The fact finder may or may not arrive at the "true" meaning

of the claims, but that problem is inherent in any judicial

undertaking because an undisputed knowledge of fact is

largely unobtainable. To suggest that appellate judges,

precious few of whom are trained in science, will always

arrive at the "true" meaning of words embodying complex

concepts endows them with knowledge and enlightenment

far beyond those who have training and experience in the

field. They are in no position to declare the state of

knowledge in the art or that scientific hypotheses are

correct as a matter of law. Those who provide conflicting

testimony and other evidence about scientific or technical

matters should be evaluated as are any other expert

witnesses and the finder of fact should decide what is the

best, most reasonable result in light of the evidence

presented. The trial court is the proper forum for such an

29a

exercise. This court should review according to traditional

standards.

30a

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

PALL CORPORATION, )

)

Plaintiff, ) CIVIL ACTION

) NO. 86-1427-Y

V. )

)

MICRON SEPARATIONS, )

INC., )

)

Defendant. )

MEMORANDUM OF ORDERS

YOUNG, D.J. June 18, 199]

On May 15, 1991, the Court entered the following

injunctive order at the close of the first phase of the liability

case:

... the claim of MSI that the Pall patent is

unenforceable by reason of inequitable

conduct is not proved; that MSI has not

proved that the claims of the patent are

indefinite, invalid due to the 1978

commercialization of the Pall nylon

membrane, invalid by reason of

anticipation by the disclosure of the

Marinaccio patent, invalid by reason of

obviousness over the prior art, invalid by

reason of the work by AMF. The Pall

patent is declared to be valid.

Further, it’s declared that MSI’s

infringed by virtue of its products made

Se ne eer ee ee

7

3la

from Nylon 66. It has infringed the claims

of the Pall patent, and its process for

making membranes out of Nylon 66

infringes the Pall patent. The Court makes

no finding on the state of the record as it

now stands that MSI has willfully infringed

the Pall patent, and it makes no finding that

Pall is entitled to attorneys’ fees.

Accordingly, MSI, its agents,

servants, employees, and all persons acting

in concert with it are hereby enjoined, for

the life of the Pall patent, from engaging in

the process in which they are now engaged

to make nylon membranes out of Nylon 66.

Transcript, pp. 2261-62.

On June 6, 1991, at the close of the liability phase

of the case, the Court immediately made findings and

rulings from the bench, including the following injunctive

order:

Accordingly, the Court finds that

although there is no literal infringement in

this case, given its peculiar facts, the

Doctrine of Equivalents is not trumped or

made inapplicable by the file wrapper

history. Therefore, since Nylon 46 infringes

the Pall patent under the Doctrine of

Equivalents, that patent, even as to Nylon

46, is valid and infringed; and MSI is

forthwith, its agents, servants, and counsel,

and all persons acting in concert therewith,

are enjoined immediately from any further

production or sale of any items involving

Nylon 46 to the same extent that the Court

has already enjoined Nylon 66.

32a

Transcript, p. 2758.

Later that same day, the Court stayed the injunction

as to Nylon 46 upon the following terms:

Accordingly, the injunction as to 46,

not as to 66, but as to 46 just entered, is

stayed pending an appeal on the following

terms: That an appeal bond in the sum of

$1,700,000 is filed with the Court, which

provides that it will increase by a further

$1,700,000 on January 1, 1992, and a further

$1,700,000 on June 30, 1932 (sic), and that

this stay is vacated by it’s own terms if MSI

files for reorganization or bankruptcy or at

the moment -- I guess this goes without

saying -- that an appeal of the Court’s

judgment is dismissed.

Since this is an increasing bond,

there has to be another provision. I expect

that MSI will seek expedited hearing from

the Court of Appeals of the Federal Circuit,

and the increase which is to take place on

January 1 and on June 30, 1991, is of no

force and effect should Pall object to any

advancement of the appeal, accelerated

briefing schedule, or other accelerated

appellate determination of the matter. Pall

has to press just as hard to hang on to its

judgment as Micron is pressing to have the

judgment reversed. That’s the only way the

bond stays in effect.

Transcript, p. 2777.

On June 10, 1991, after hearing, the Court modified

the stay order just quoted by 1.) reducing the initial sum of

aa

33a

the bond from $1,700,000 to $1,000,000; 2.) permitting the

stay to take effect if the reduced bond were filed on or

before Noon, Tuesday, June 11, 1991; and 3.) omitting

from the stay order any reference to its being vacated

should MSI seek the protection of the bankruptcy laws.

Transcript, pp. 2918-19.

There the matter presently stands as the Court

concludes the damages phase of the trial.

/s/

WILLIAM G. YOUNG

UNITED STATES DISTRICT JUDGE

34a

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

PALL CORPORATION,

CIVIL ACTION

NO. 86-1427-Y

Plaintiff,

v.

MICRON SEPARATIONS,

INC.,

Defendant.

ORDER OF JUDGMENT

In accordance with the findings and rulings

announced in open court on May 15, 1991, June 5, 1991,

June 6, 1991, and June 20, 1991, it is hereby ORDERED:

1) that the judgment be entered for the plaintiff,

Pall Corporation, in the amount of $4,434,291 .00;

2) — that defendant, Micron Separations, Inc., its

officers, agents, servants, employees, and attorneys and all

persons acting in concert with them are permanently

ENJOINED for the life of United States Letters Patent No.

4,340,479 from infringing any asserted claim of said patent

by the manufacture, use or sale of nylon microporous

membrane products from nylon 4-6 or nylon 6-6; and

3) that the foregoing injunction with respect to

nylon 4-6 microporous membrane products only is

STAYED pending appeal of this judgment, provided that

defendant, Micron Separations, Inc., has filed and

maintains in the custody of the Clerk of this Court a bond

35a

or cash deposit in the following increasing total amount:

$1,000,000 on and after June 11, 1991; $3,400,000 on and

after January 1, 1992; and $5,100,000 on and after July 1,

1992.

/s/

WILLIAM G. YOUNG

June 24, 1991 UNITED STATES DISTRICT JUDGE

228 NO REE ISAS i

CORTE SINR OE SRR NET MPR

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36a

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

Civil Action

No. 86-1427-Y

KEKE KREKKEKEEEKERSES

PALL CORPORATION, ¢

.

Plaintiff, * DAILY TRIAL

* TRANSCRIPT

Vv. : .

*

MICRON SEPARATIONS, *

INC., *

a

Defendant. *

KKREKEEEKEEKEEAKEREE SE EK EEE

BEFORE: The Honorable William G. Young,

District Judge

June 5, 6, and 20, 1991

37a

THE CLERK: Calling Case no. 86-1427-Y,

Pall Corporation v. Micron Separations, Incorporated.

Court is in session. Please be seated.

THE COURT: Good morning, everyone.

COUNSEL: Good morning, your Honor.

THE COURT: Give me just a second to set

my papers up here, and as I’m doing it let me explain how

we’re going to proceed.

I’m going to deliver my findings and rulings

on the, on all aspects of the liability portion of the case

from the bench. I reserve the right to take the bench

opinion and revise it grammatically. I reserve the right to

find additional subsidiary facts consistent with the facts as I

describe them from the bench, as I have found them. I

reserve the right to make additional and more detailed

exposition of the law.

To that end, you are invited, once you

review the transcript of my findings and rulings, to submit

transcript and exhibit citations which any of you believe

support the findings made herein. You're not precluded

from moving for consideration, reconsideration obviously

to point out what you think are inconsistencies and the like,

but I invite you to point out those specific transcript and

exhibit references in this lengthy case that you think

support the findings and rulings.

This is a patent case which involves United

States Patent 4,340,479 issued July 20, 1982 to the Pall

Corporation involving a process for preparing hydrophilic

polyamide membrane filtered media and product. The

plaintiff Pall Corporation is a New York corporation having

a principal place of business in Glen Cove, New York, and

offices on Route 25A in Roslyn, New York. It was

founded by Dr. David B. Pall of Roslyn Estates, New York,

in the late 1940’s. Dr. Pall is designated as the inventor of

the patent-in-suit.

38a

The action is brought against the defendant

Micron Separations, Incorporated, which I'll call MSI, a

Massachusetts corporation having a principal place of

business in Westboro, Massachusetts. The company was

formed, MSI was formed in 1981 when certain employees

of a filtration company known as Millipore, named James

S. Johnson and John M. Greenwood left that company and

along with Edward J. Ackley decided to start their own

company with, decided to start their own company and

enter into competition with Pall, Millipore and others in the

microporous filtration industry.

The compleint in this action was filed on

May 7, 1986. It seeks a judgment that MSI has willfully

infringed the patent. I'll sometimes refer to the patent as

the Pall patent. It also seeks damages for past infringement

and an injunction against future infringement.

Analysis starts not with the Pall patent but

with the prior art, more specifically, a patent referred to in

this lawsuit as the Marinaccio patent.

Pall J. Marinaccio was hired as a research

chemist by AMF Company to make reverse osmosis

membranes and serendipitously embarked upon

microporous membrane research after it occurred to him

that microporous membranes -- strike that -- after it

occurred to him by looking at his polystyrene coffee cup

that it might be possible to make microporous membranes

out of related materials.

Marinaccio devised a process which he

believed was a breakthrough in that it -allowed the

manufacture of microporous membranes rapidly, far more

rapidly than was then the case. Marinaccio knew that at the

time in the late 1960’s and early 1970’s when he was

performing these experiments that no one else in the

industry had such a process.

39a

One of AMF’s subsidiaries is a company

known as Cuno. Cuno, within the AMF Corporation, a

large corporation with 80 divisions, one of which is Cuno,

research and development was largely centered in AMF

itself. Cuno sought to have the AMF research chemists

develop a microfiltration fiber filter and Mr. Marinaccio

and others commenced work on such a project. They

abandoned this work and instead devoted their efforts to the

development of a microporous membrane. Mr. Marinaccio

believed that the key to the process as he developed it were

devices which prevented any air contact during the quench

process, an aspect of his claimed invention which he called

zero quench. I should say generally, at this point, that the

general steps, the general mechanical steps for making

microporous membranes were, by the time of the early

1970’s, largely known to those skilled in the art of making

such membranes. To the extent there are developments,

they are developments in particular materials used and the

manner of their use. But the developments are not in the

mechanical aspects of the membrane process.

Marinaccio sought, and received, United

States Patent 3,876,738 dated April 8, 1975. I°ll call this

_ the Marinaccio patent. The Marinaccio patent described

this so-called zero quench process for the continuous

formation deposit of membrane so as to form large sheets

of microporous membranes.

Now, while Marinaccio had obtained a patent on his

invention, a patent presumed to be valid, he had a number

of problems within his company. Marinaccio believed that

his patented process had significant commercial viability.

But, as is the plaint of investors everywhere, he considered

himself starved for money and that that the business leaders

at AMF didn't adequately support his research efforts.

He testified, and I credit, that at AMF they were

literally holding the machines together with wire and tape.

AE SAR 22 GASTRO ER LTT PET REN IS EIN

£

4

40a

Marinaccio's concept of commercialization of his process

was to make an idiot-proof membrane; that is, he constantly

sought for a simple, readily understandable, generally

applicable approach. Marinaccio, through the use of his

invention, was able to manufacture, albeit not commercially

for sale, but was able to manufacture sheets of microporous

membrane which looked, as I will say all these sheets in

this case look like typewriter paper, they all look to the

naked eye identical. On the materials that he manufactured

he ran bubble point tests and flow tests and came to believe

that the material manufactured pursuant to his process was

as good for microfiltration purposes as anything then

commercially available.

A gentleman named Ostricher at Cuno was very

enthusiastic about the samples which Marinaccio had

produced, was evaluating those membrane samples against

standard Cuno product with the result that the Marinaccio

samples were thought to be by Marinaccio and Ostricher

considerably better.

The trouble came in the commercialization of the

Marinaccio process. The chief executive officer of Cuno

was one Ray Tritten. Cuno, at that time, made only

unsophisticated paint filters. Tritten's idea of

commercialization of microporous filters was a process

which resulted in long runs of membrane sheets. While

certain of his subordinates thought that the sheets prepared

by the Marinaccio process were good enough for

commercial application, Tritten said no. Tritten was

concerned in tests that Cuno ran with tap water that the

filters prepared by the Marinaccio process had only a very

short life. Marinaccio believed that the short life showed

nothing more than the remarkable benefits to be derived

from his filter inasmuch as it filtered everything out of the

tap water retaining it on the filter face and quickly clogging

the filter.

4la

The rejection by Cuno of, really by Tritten, and then

confirmed by AMF, the rejection of Marinaccio's efforts to

commercialize the Marinaccio process as set forth in his

patent did not daunt Marinaccio. He went right on testing it

in an underground fashion. He, though no one had asked

him, he kept on testing it.

The zero quench process that is referred to in the

Marinaccio patent was assisted in the development thereof

by one Rodney A. Knight who's also listed as an inventor

thereof. That process was able to make short runs of .2

micron material. Long runs were not made in Marinaccio's

view because he did not have the money to develop the

machinery sufficiently to actually make long runs, though

he believed, and indeed still believes, that he could have

made long runs by his process had he only been adequately

supported.

Marinaccio believed that his only failure was the

equipment limitation failure. His process involved the

dissolving of pellets of Nylon 66 -- strike that. Strike that.

His process involved the dissolving of nylon pellets in

formic acid. Marinaccio, however, recognized the

problems with the long-term reproducibility of the

materials formed by his process. He further recognized that

the most critical test for microporous membrane is the

bacteria retention test and that in ways that he was never

satisfactorily able to explain various of his prototype

production runs failed to meet the bacteria challenge test.

Cuno did not sell any of the rolls of membranes material

developed by, or developed pursuant to the Marinaccio

patent.

The Marinaccio patent does not contain any

indication that the products obtained by its process are

hydrophilic, as that term is used in the Pall patent, and

skinless. Marinaccio does not claim, the Marinaccio patent

does not claim that the products produced are inherently

——_

42a

hydrophilic as that term is used in the Pall patent, and

further teaches that the products produced should be

“treated with a wetting agent." The Marinaccio patent is

silent with respect to skinlessness. It comments only that a

person of ordinary skill in the art may, ought recognize that

a skin may result on the casting solution and therefore is

likely on the final product after quenching. The Marinaccio

produced at or near room temperature. In fact, temperature

plays an important role in the preparation and casting of a

pore size control but not, thought Knight, absolutely

__ essential to the preparation of the microporous membrane

itself. The Marinaccio patent does not disclose that control

of the esterification reaction resulting from the order in

which the reagents are added to form the casting solution is

silent regarding the manner in which the membrane film

that's produced is dried. It makes no mention of controlled

nucleation.

Now, wholly apart from the claim anticipation of

the Pall patent by the Marinaccio patent, MSI here claims

43a

concealed by not being made public. So, a brief analysis

need be made of this issue.

If a prior invention is made public or is used

commercially it has not been abandoned. Friction Division

Products v. E.I. DuPont de Nemours, 658 F.Supp. 998,

1014, District of Delaware (1987). The law does not

require any disclosure of the actual invention to the public

nor any commercial use for an invention to qualify as prior

art. Hazeltine Research v. Brenner, 382 U.S. 252 at 254-

256 (1965). Nor does 35 U.S.C., Section 102(g) carry a

"personal knowledge. requirement" on the part of the

infringer. E.I. DuPont De Nemours and Co. v. Phillips

Petroleum, 649 F.2d 1430, 1437, Federal Circuit (1988).

Indeed, the invention need only benefit the public, that is, it

must be reduced to practice. Friction Division, supra, at

1013 and 14. Reduction to practice means something less

than commercialization, 1013, but requires an exposure of

‘the benefits to the public, 1014. An invention is deemed

publicly known if the public enjoys the benefits or use of

the prior invention. Friction Division again at 1013-1014;

see also Schreiber Manufacturing Co., Incorporated v. Saft

America, 704 F.Supp. 759, 762, Eastern District of

Michigan (1989). "Public use of an invention under

Section 102(b) is any nonexperimental use by an inventor

or by an individual. A commercial use by the inventor will

bar a patent, even if that commercial use is kept secret. The

determination of whether a ‘public use’ has occurred can

only be made upon consideration of all surrounding

circumstance."

In the circumstance of this case the Court finds that

the rolls of material made by Mr. Marinaccio for Cuno

were experimental only, never benefited the public, never

were disclosed publicly, never were in use, and in fact did

not anticipate the patent-in~suit, the Pall patent, as any sort

of prior art.

a

44a

Now let's turn to the Pall patent. Coincident, and

indeed even earlier than Marinaccio, Pall was -- and now

I'm referring to Dr. Pall and that's how I'll distinguish him

from Pall Corporation; when I'm talking about the

individual I'll refer to him as Dr. Pall-- Dr. Pall was

conducting research on microporous filters made from

polymeric materials, including nylon, in the mid- to late-

1960's. He set aside that project in 1969 because

developments in other areas were believed to be more

promising. In mid-1974, Dr. Pall reactivated his research

program in microporous polymeric membranes. By

November '74 he made a promising microporous membrane

from Nylon 11 and Nylon 612. By September 1975 he

made a pliant, alcohol-insoluble, skinless microporous

membrane from Nylon 66. And by November 1975 he had

repeated this result on a larger scale.

Now, Dr. Pall considered the membrane that he had

developed to be naturally hydrophilic. At least that's what

he says in his patent application and that's what he defines

in his patent. Now, a patent applicant, as the cases make

clear, can be his own lexicographer, but it's important to

pause for a moment and discuss what Dr. Pall says when he

uses the word hydrophilic.

The general use of the word in industries beyond

this industry is in a manner different from the way Dr. Pall

uses it. Generally, a material is thought to be hydrophilic if

the contact angle of a drop of water with the surface of the

material is less than 90 degrees, and hydrophobic if the

contact angle of the drop of water with the surface of the

material is greater than 90 degrees. And these concepts of

hydrophilicity, attractiveness to water, hydrophobicity,

repelling water, are confirmed by a variety of formulas and

tests involving capillary action of the material and water.

Now, it's very important to a microporous membrane that it

be naturally hydrophilic and the more hydrophilic the

AT PR er

45a

better. Naturally hydrophilic, that is, attractive to water

itself without the addition of wetting agents, because the

wetting agents themselves may interact with the material

being passed through the membrane and make the

membrane not commercially usable. So, natural

hydrophilicity is desirable. And the more hydrophilic a

material is, the better it is for microporous membrane

filtration in view of the need, of course, to pass the water

through the material filtering out whatever is sought to be

filtered out.

Dr. Pall uses the term, and the patent I find uses the

term in a readily understandable fashion, but his use of the

term hydrophilic is different than that term is used

generally in the mechanical sciences and in chemistry. For

Dr. Pall, at least by the time his patent is issued, a matter

we will come back to, a material is naturally hydrophilic

only if it is so readily wetted with water that no contact

angle at all can be measured between the material and the

drop of water because the water has gone into the material

in less than one second. Now, one can understand that

definition, but arguable confusion results since he defines

everything else as hydrophobic, whereas in fact certain

nylon blocks, pellets, solid materials, most important, as we

will see further on, Nylon 46, have contact angles, in their

natural states have contact angles of less than 90 degrees.

This aspect of skinlessness should also be

mentioned. When he comes to obtain the patent-in-suit he

makes an important point of claiming that the membranes

produced through the Pall patent are skinless.

Now, skinlessness is never specifically defined in

the Pali patent but it clearly is a significant parameter and

it's discussed at some length, as follows, reading from

Column 9 of the patent: The conditions under which the

polyamide resin is precipitated determine the skinless

nature of the membrane, as well as its physical

|

46a |

characteristics, i.e., the size, length and shape of the

through pores of the membrane. Under certain conditions a

membrane is formed which has through pores extending

from surface to surface that are substantially uniform in

shape and size. Under other conditions, the through pores

are tapered, being wider at one surface and narrowing

towards the other surface of the membrane.

Under conditions outside the scope of the invention,

still another form of the membrane is obtained, having a

dense skin penetrated by pores of smaller diameter than the

pores in the remainder of the sheet. This skin is normally |

on one side of the membrane sheet, but it can be on both

sides of the membrane sheet. Such skinned membranes are

conventional in the art, exhibit relatively higher pressure

drop and other poor filtration characteristics, and are

undesirable.

Then in Column 26 of the patent, starting at

Line 34, it says: Skinned membranes behave very

differently; when water wetted and their air flow-pressure

drop relationship is determined, the curve is not flat -- and

the curve that is referred to here, I'm interpolating, is what's

called a KL curve used in the industry -- and now going

back to the quote: -- the curve is not flat initially, but slopes

upward, indicating presence of large pores; transition to a

more nearly vertical line is slow, with a large radius, and in

the vertical area, instead of the sharp rise of Figure 3 -- the

reference is to Figure 3 in the patent -- going back to the

quote: a sloping line is obtained, reflecting a wide pore

size range. Such membranes are poorly suited to obtain

sterile filtrates when challenged by bacteria; either a

nonsterile fluid is obtained, or, if sterility is gotten, it is at

the cost of very high pressure drop to achieve a low

throughput rate.

Stated another way, the skinlessness of the

membranes was important for filtration applications

47a

because it assured a good flow rate and acceptable pressure

drops and avoided functional imperfections typically

associated with skinned membranes which rendered such

membranes unsuitable for use in critical filtration

applications where absolute removal of all particles larger

than a predetermined size must be assured. Skinlessness is

also an important attribute of nylon membranes in

biotechnological applications.

Dr. Pall found the immediate zero contact angle

aspect of the nylon membranes produced by the process

with which he was working, which he had invented, to be

unexpected since he considered the source material, that is,

the pellet form of the starting nylon resins, each to have a

contract angle much greater than zero. This immediate

natural zero contact angle occurring within one second,

which Dr. Pall defines in his patent as natural

hydrophilicity, was .a tremendous advantage over most

known commercial filtration materials which had to be

treated with a surfactant to make them hydrophilic. Such

surfactants invariably contaminated the filtered fluids when

they shed off to one degree or another.

A pliancy of the material produced by Pall process

likewise was important to facilitate handling, including

pleating into high surface area cartridges.

The alcohol-insolubility is important to permit the

~use of nylon membranes with a wide variety of liquids.

Between 1976 and 1977 Dr. Pall developed a

manufacturing process for making commercial quantities of

nylon membrane. On May 15, 1978, Dr. Pall filed a parent

patent application covering the products and the process for

making the nylon membrane. The parent application was

drafted broadly enough to encompass all alcohol-insoluble

nylons which produced hydrophilic, that is, Dr. Pall defines

it, skinless microporous membranes.

48a

At the same time, Dr. Pall prepared and filed a

related application which ultimately matured into United

States Patent 4,340,480, not at issue herein, directed to the

range of nylon which he considered useful for making

liquophilic membranes, that is, those which, though not

wettable by water, were wettable by certain organic liquids.

Reference must now be had to the file wrapper.

My reference is to Page 112 of Exhibit 545, the date of

which I know we discussed in the transcript but I don’t

have it before me right now.

The examiner -- and the principal examiner

throughout was one Frank A. Spear, Jr. -- initially took the

position that Claims 1 through 97, which were the claims in

the initial application, were all subject to certain restrictions

which he listed. In response to his direction that the claims

be restricted, on May 15, 1978, a document entitled

“Amendment” was filed seeking reconsideration of the

requirement for a restriction in which Pall claimed that the

claims of Group Roman numerals I, II and III are drawn to

one indivisible invention based on the process which is

defined in Claims 1 to 31, 56 to 66, 96 and 97. As a result

of this process it has been found possible to prepare a

skinless, hydrophilic, alcohol-insoluble polyamide

membrane, which itself is new and patentable because it

was never before made available, and indeed no process

was known for preparing it. The words skinless,

hydrophilic, alcohol-insoluble are underlined for emphasis.

And, indeed, that is the thrust of the patent applicant, that

he had, and his concern with restriction that what had been

invented here was this skinless, hydrophilic, alcohol-

insoluble polyamide membrane.

Nevertheless, in an action mailed on June 4th, 1979,

Claims | through 86 and 96 and 97 were rejected by the

patent examiner, Claims 87 through 95 having been

withdrawn. The ground of the rejection is significant. The

49a

examiner took issue with the use of the word “hydrophilic”

in the original application, quoting now, quote, because it

has no absolute meaning, close quote. Well, stop the close

quote. Because it has no absolute meaning. It is a relative

term, close quote. In this the examiner was precisely

correct and indeed focused on the point that Dr. Pall, as a

patent applicant, was defining hydrophilic in a manner

somewhat different than it had generally been understood.

Other claims were rejected because the use of the support

for the membrane had already been revealed in the prior art,

including the Marinaccio patent. Claims 3 and 4 were

rejected as unpatentable over Marinaccio with respect to the

manner in which Marinaccio had filtered the casting dope.

Claims 56 through 66 were rejected as unpatentable over

Marinaccio and others on the ground that it was obvious to

use multiple layers in a membrane and that had been shown

in Marinaccio as modified by other patents. Claims 75

through 86 were rejected on the ground that it, that, quote,

it would be obvious to use a solution ready to precipitate in

Marinaccio, close quote, and reference is made to other

patents.

Well, that did not slow Dr. Pall down. He came

back requesting in a document entitled “Amendment” and

in response to the action of June 4, 1979, he states, at

Page 129 of Exhibit 545, that the applicant agrees that the

term hydrophilic is perhaps susceptible of being

misunderstood because it is not precise. And then he goes

on to explain exactly what he means, saying, in relevant

part, on Page 129 of the exhibit, a very high angle of

contact indicates very poor wetting, while a zero angle of

contact defines complete or perfect wetting. While the

polyamide resins from which the membranes of this

invention are made have a high angle of contact and are not

wetted by water, the membranes of the invention have a

substantially zero contact angle because they are readily

50a

wetted by water, and an amendment is made to Claim 27

accordingly.

It’s pointed out that all claims, including the claims

objected to by the examiner, which use the term

hydrophilic have now been further amended so as to

indicate either that the membrane has a substantially zero

angle of contact with water or that the membrane is readily

wetted by water. This defines hydrophilicity in a precise

way and also distinguishes the applicant’s membranes from

the membranes of the prior art. The fact is that the

polyamide resins from which the membranes of this

invention are made have a high angle of contact with water

and are not wetted by water.

At this stage in the application process, Dr. Pall

then goes on, at Page 130, to make the statement, however,

when in dealing with the examiner’s concern as to which

nylons are, and whether particular types of nylons are

critical elements of the process, goes onto say, quote,

However, there is nothing critical in the polyamide resin

apart from its being alcohol-insoluble. The applicant

believes that the invention is applicable to any alcohol-

insoluble polyamide resin, and has said so, not only in the

broad claims but also in the broad statements of the

invention at Pages 15 to 21. Throughout this portion of the

specification, the term “polyamide resin” is used

generically to encompass the entire class of alcohol-

insoluble hydrophobic polyamide resins. The word

hydrophobic is used there, I infer, in the sense of being

opposite to the way Dr. Pall has defined hydrophilic.

And, on Page 131 he says: This being so, and there

being no prior art requiring a narrowing of the claims in

this respect, the applicant proposes to maintain the present

scope of polyamide in the claims.

Well, then on a date that has been discussed in the

transcript, but I can’t figure it out from this particular

5la

exhibit, on Page 165, of Exhibit545, the examiner

nevertheless rejects all the claims and he’s somewhat more,

his rejection is in somewhat more detail.

Now, one of the key elements of Dr. Pall’s claimed

invention is what he calls, and what has been called in this

trial, controlled nucleation. But the examiner, at least at

this stage of the application, rejects the claims, stating that

it would be obvious, putting, aside support now -- strike

that. He rejects them on Page 166, saying it would be

obvious to use the support of Brown and others in

Marinaccio, and by support I infer he means there the

polyester support for the membrane sheet. But now he goes

on, the examiner does, it is submitted that there is some

nucleation in Marinaccio and others. For instance, during

the addition of small amounts of nonsolvent there would

come a time when a small amount of precipitate would

form temporarily and immediately redissolve. In fact, the

applicant’s specification, Pages 43 to 44, suggests there is

some nucleation in Marinaccio. Then, he continues to

believe that it would be obvious to filter the casting dope

and that’s not an advance over Marinaccio. It would be

obvious to use multiple layers. Not an advance over

Marinaccio and others. He makes reference to the Sharp

membrane being hydrophilic in the sense that they have

produced membranes, and so has Marinaccio, which are

“more readily wettable than prior art films.” And he makes

the statement one would obviously expect a very thin, very

porous film to be completely wettable throughout as

claimed. He, the examiner, anyway, obviously didn’t think

there was very much to this invention, at least at this time.

The rejection for multilayers is maintained. And then,

again significantly, the examiner rejects the application,

saying it would be obvious to use a solution ready to

precipitate in Marinaccio as shown by Lovell, and to filter

it as shown by Jamison.

52a

Well, that didn’t stop Pall and his people, either.

And on an examiner interview dated May 2nd, 1980, it’s

indicated that all claims were discussed, Marinaccio,

Brown, Sharp, identified as prior art, and the examiner then

says, he’s received what he terms a, quote, impressive

demonstration, close quote. Examiner, quote, examiner

will consider 132 declarations in detail while reflecting on

the demonstration. Check examples for support of 6-10,

and I can’t make out the next word, but I assume, I infer

that that has to do with -- oh, 6-10 carbon atoms. And then

he quotes, Markush looks promising, close quote.

Now, it appears that they had discussed at this

interview a new approach to defining what it was that’s

claimed. Because in a document entitled “Amendment”

dated May 5, 1980, three days after the interview to which

reference was just had, the initial claim is amended, as

follows. And I'll highlight the amendment. It’s claimed

that, the invention is in Claim 1, a process for preparing

skinless, hydrophilic, alcohol-insoluble polyamide

membranes that are readily wetted by water which

comprises preparing a solution of an alcohol-insoluble

polyamide resin, and now I’m adding the amendment,

selected form the group consisting of polyhexamethylene

adipamide, polyhexamethylene sebacate, and poly-e-

caprolactam -- that’s the addition -- in a polyamide and

then add the word resin solvent, inducing nucleation of the

solution by controlled addition to the solution of a

nonsolvent for the polyamide resin, et cetera. And these

same limitations, selected for the group that I just read,

follow on. Then in the remarks section, reading from

Page 178 of Trial Exhibit 545, it is stated that: As

indicated at the interview, Claims 1, 32, 56, 67, 75,

although not rejected on the grounds of undue breadth, are

amended because on the basis of research done since this

application was filed, the applicant now considers that the

53a

process described and claimed herein is actually applicable

only to polyamide resins which are polymers of

hexamethylene diamine and aliphatic saturated dicarboxylic

acids having from six to ten carbon atoms. As indicated at

Page 22, Lines 12 to 14, the preferred polyamide resins

now recited in these claims in a Markush group are

polyhexamethylene adipamide, Nylon 66, poly-e-

caprolactam, Nylon 6, and polyhexamethylene sebacamide,

Nylon 610. These embrace the limits of the class of

saturated aliphatic dicarboxylic acids having from six

adipic to ten sebacic carbon atoms.

Then, with respect to the rejection for, with

reference to nucleation in the Marinaccio patent, over on

Page 213, the applicant states, omitting -- well, no, I won’t

omit anything. These claims, Claims 75 to 86, the

reference is to, are directed to a casting resin solution for

forming hydrophilic skinless microporous polyamide

membranes that have a visible precipitate of polyamide

resin formed during the addition of the nonsolvent, and that

is nucleated by virtue of the addition of the nonsolvent

under controlled conditions of solvent, of nonsolvent, and

of resin concentration, temperature, mixing intensity,

addition time, and system geometry, resulting in this visible

precipitate. This rejection is accordingly answered by the

discussion above of the phenomenon of nucleation vis-a-vis

the disclosure of the Marinaccio patent in connection with

the rejection of Claim 1 on Marinaccio. The Marinaccio

disclosure clearly teaches one not, underline the not, to use

a solution which contains a visible precipitate. The

solution with nonsolvent cannot proceed this far, but only

up to the point of incipient precipitation of the nylon. This

is before a visible precipitate is formed, not after. Note

Column 6, Line 6 to 9 of the reference. Thus, to use a_

solution that contains a visible precipitate is to proceed

contrary to the Marinaccio disclosure as noted above.

54a

Now, there matters stood until a continuation-in-

part was filed on a date I can’t quite figure out, but I’m sure

it’s not in dispute and you can supply it. And in the

continuation-in-part the full abstract of the disclosure is

discussed. My reference now is to trial Exhibit 544 of the

continuing application. Oh, here it is. Filed October 20,

1980. So the last reference I had was in May, now here in

October the continuation is filed. And the continuation-in-

part now goes on to define the invention, or redefine it, get

at it in a different way, by what we have called in this

litigation the ratio claims. And I read from Page 123 of

Exhibit 544.

The application Serial No. 905,698, has been refiled

to provide basis for a narrow subclass of polyamide resins

disclosed in Serial No. 905,698 that forms such skinless

hydrophilic membranes. All members of this class have a

ratio CH2 to NHCO of methylene, CH2 to amide NHCO

groups within the range from about five to one to about

seven to one, including polyhexamethylene adipamide,

Nylon 66, poly-e-caprolacatam, Nylon 6,

polyhexametehylene sebacamide, Nylon610, poly-7-

aminoheptanoamide, Nylon 7, polyhexamethylene

azeleamide, Nylon 69, and mixtures of two or more thereof,

as well as mixtures thereof with higher polyamide

homologues such as polyhexamethylene dodecandiamide,

Nylon 612, in portions such that the mixture has an average

of CH2 to NHCO ratio within the stated range. The first

three polyamides, Nylon 66, Nylon 6 and Nylon 610, are

preferred.

The other polyamides disclosed in _ Serial

No. 905,698 have been found not to form hydrophilic

skinless membranes. Such of them, those that have a ratio

CH2 to NHCO of methylene CH2 to amide NHCO groups

within the range from about seven to one to about twelve to

55a

one, form skinless liquophilic hydrophilic membranes. The

others form hydrophobic skinned membranes.

Now, then, on August24, 1981, the examiner

allows Claims 1 through 76, 111 through 115; rejects

claims 77 through 110, 116 through 172. He makes the

following note at Page 168: The broadly recited amide

having the claimed ratio of CH2 to NHCO groups in

unwarranted in view of the disclosure. The various

mixtures in that range are particularly unsupported. Only

one mixture appears in the examples, Exhibit 68. Most of

the examples involve only Nylon 66. The interview of the,

the summary record of the examiner interview shows that

all the rejected claims were discussed, that there was no

rejection based on prior art, and then he says amide looks

promising. No strike that. Amendment looks promising.

Discussed three options. All would clear up Claim 87.

And the amendment to which exhibit, to which reference is

made is the amendment that follows on Page 172, and the

most significant language therein is under remarks and it

reads, as follows. Well, I’m going to save time by not

reading it but simply by inserting in the opinion the last

three liens of Page 173 down through the entire Page 174.

The patent issues on July 20, 1982.

And I think this is a good time to take a recess and

we’ll recess for about, we'll recess until 11:30, and we'll go

on until 1:00 if I’m not done prior to 1:00. We'll recess.

(Recess.)

THE COURT: Now, at this juncture it’s helpful to

put these matters in some perspective.

Polymeric membranes are thin, sheet like materials

with very small interconnected pores. The pores usually

range in size from about one-tenth of a micron to ten

microns. The members are made from a chemical material

that has many thousands of repeating units, a polymer.

56a

There are many such materials, many methods for making

them into membranes, and many uses for such membranes.

Polymeric membranes, in the strictest sense of the

word, may be fibrous or non-fibrous. Usually, however,

when the term polymeric membrane is employed, the non-

fibrous type is meant. Non-fibrous membranes are usually

made directly from a solution or melt of the polymer.

Fibrous polymeric membranes are made by first converting

the polymer into fibers, and then making a thin web from

those fibers. Potassium titanate is a good example of a

fibrous polymeric membrane.

Prior to the development of the Pall nylon

membrane, fibrous filter media, made, for example, from

potassium titanate or asbestos, were commonly employed

as filtration medium. At the present time, the two most

commonly used microfiltration membranes are Pall’s nylon

membrane and Millipore’s PVDF membrane, both made

from non-fibrous polymers. They are employed mainly in

the filtration of liquids to remove very small particles,

including bacteria, a process known as microfiltration.

Depending upon their use, polymeric membranes

may have a skin on them, or they may be without a skin.

Certain processes, reverse osmosis, for example, require the

presence of a continuous~skin, while in other processes

microfiltration, for example, the complete absence of any

skin is necessary. ;

Microfiltration is one of the most common

applications for polymeric membranes at this time. It is,

however, by no means the only application. Membranes

are also used in reverse osmosis, electrophoresis, dialysis,

electrodialysis, gas separation, and immobilization and

transfer of substances.

Microfiltration is the regime with pores between

about one-tenth of a micron and 10 microns. The most

important pore size is .2 microns because this is the largest

ania RR” RRR aa be

aT «ia ai

57a

pore and hence gives the highest flow rates and throughputs

consistent with the retention of the approximately .3 micron

Pseudomonas diminutia bacteria which is the criterion for

sterilizing pore size rating. | Today microfiltration

membranes are skinless and macrovoid-free and have a

narrow pore size distribution which maximize their

efficiency at removing bacteria, and other particulate matter

of equivalent size, from fluids.

I’m going to amend that sentence simply to add the

words commercially acceptable today microfiltration

membranes, and then the rest of the sentence.

Other uses for microfiltration membranes are now

found more and more in the biotechnology area. Polymeric

membranes are there employed, for example, to hold

certain substances such as antibodies, antigens or other

proteins while blood or other body fluids are passed

through the membrane.

Over the years, many different polymers have been

investigated as possible membrane media in a number of

different applications. By the late 1970’s, the list included

the following, without any attempt to be exhaustive, and

here I’m inserting Page7 of the direct testimony of

Dr. Kesting.

By 1978, many methods had been investigated for

making the polymers mentioned above, and many other

polymers not here mentioned in porous membranes. They

included: casting membranes from a melt of the polymer,

casting from a polymer solution into an evaporative

atmosphere; casting from a polymer solution into a

nonsolvent liquid; stretching semi-crystalline films; thermal

gelling by decreasing the temperature of the polymer

solution; inducing porosity by irradiation of polyester

and/or polycarbonate films, binding the polymer into a thin

sheet structure by sintering.

58a

In 1978, the leading manufacturers of

microfiltration media were Pall with its fibrous potassium

titanate product, and Millipore with its membrane made of

a mixture of cellulose nitrate and cellulose acetate. Several

other membrane products were on the market, but none had

any significant market share. Most, if not all, of the

polymeric non-fibrous membranes were made by a process

that involved casting from a solution following by

evaporation or quenching in a liquid.

Pre-1978 filter media, fibrous and non-fibrous,

suffered from one or another of a number of deficiencies, as

follows: Brittleness. Unless highly plasticized, they could

not be pleated and incorporated into a cartridge.

Marginal Thermal Stability. The membrane shrank

excessively while being sterilized with steam.

High Extractables. The surfactants employed to

render the membranes hydrophilic so that they could be

used with aqueous fluids and plasticizers required to permit

the membranes to be made into useful products leached out

of the membrane while in use.

Poor Solvent Resistance. The membranes softened

or dissolved when used in certain solvents.

Limited Flowrate. The amount of liquid per unit

time capable of flowing across the membranes was limited.

Limited Throughput. The membranes clogged

easily and thus had to be exchanged frequently.

Limited Sterilizing Ability. The membranes could

not consistently produce bacteria-free fluids.

Poor Dimensional Stability. The membranes

swelled in water.

Danger of Fiber Sloughing into the Permeate.

Unless specially treated, fibrous materials tend to slough

off fibers into the permeate.

By 1978, the industry had recognized the

desirability for a new type of membrane and had pursued

59a

many avenues of reaching that goal. All such attempts had

failed.

Dr. Pall invented the first naturally and

instantaneously wettable, completely skinless, and alcohol-

insoluble polymeric membrane and a process for making it.

The membrane was suitable for service in severe solvent

environments and for sterile filtration. It was strong and

pleatable so that within plasticizers it could be made into a

cartridge. It met all of the criteria the industry had long

sought. And remarkably, it was made of nylon, a material

that had been investigated several times before without

success.

The process invented by Dr. Pall, and described in

his patent,’ to prepare the membrane involved the

preparation of a precisely nucleated casting solution made

up of solvent, nonsolvent and nylon, casting that solution

into a film and quenching the film in a bath containing

solvent and nonsolvent. While it had been know to prepare

membranes by casting solutions of polymers, the step of

precisely controlling the nucleation of the solution prior to

casting thereby to achieve certain properties such as

particular pore sizes, or skinlessness, was altogether new

and represented a breakthrough in the art.

Dr. Pall was the first to recognize the connection

between true skinlessness, pore size distribution, and the

titre reduction of bacteria passage. This is now recognized

to be one of the main advantages of skinlessness in

microfiltration membranes. Prior to Dr. Pall’s invention, a

titre reduction of 7 was the standard, and few besides

Dr. Pall strove to increase the titre reduction. Millipore, for

example, spoke in terms of such erroneous concepts as

absolute retention and pore sizes of .22 microns.

Clearly the understanding of microfiltration at that

time was vastly less sophisticated than it is now. The

efforts of Dr. Pall and his colleagues were of great

60a

importance to the theoretical aspects of microfiltration and

helped moved microfiltration from an art to a science.

Pall’s papers described the first studies which addressed the | §

theory of microfiltration in a thoroughly scientific and at | 4

the same time practical manner. Pall and his associates )

were pioneers both in the invention, development and

commercialization of functional nylon microfiltration

membranes and in the theory of microfiltration. Such

practices as the determination of the KL curve rather than

the bubble point as an integrity test were introduced by

Pall.

To a person of ordinary skill in the art, setting out in

1974 to development a new polymeric membrane free of all

the then-existing disadvantages, there was little guidance as

to what polymers and that methods for membrane

formation should be pursued. A great number of polymers

and casting methods had been tried without success. Such

a person faced initially two broad choices:

Either improve the properties of the conventional

membrane polymers especially those of the cellulosics and

mixed cellulosics. This approach was a good one in that

the materials were already accepted by the market place and

the processing characteristics of these materials was well

‘ understood.

The other general approach was to look to polymers

other than cellulocics which had intrinsic properties

superior to those of the cellulosics. It was a reasonable

assumption -- but by no means a certainty -- that superior

bulk polymer property could be transferred at least in part 4

to the high porosity, high surface area bodies which

constitute microfiltration membranes.

A worker skilled in the field in 1974 could not have

predicted what processing steps would be required to

achieve the Pall membrane, or even how the various

required processing steps would affect the starting material.

™

6la

The controlled nucleation in the Pall process is

critically important to the pore size and pore size

distribution of the resultant membranes. The composition

of the gel bath will determine the rate of gelation and the

presence or absence of skinning which in turn can influence

wettability as much as the intrinsic polarity of the nylon

material itself.

In the Pall process, the rate of nucleation and of

crystallite growth is precisely regulated. The end effect is

to provide for sufficient surface area and hence non-

polymer-to-polymer-hydrogen-bonded amorphous amide

(CONH) groups which are free to hydrogen-bond with

water molecules and hence render the membrane

instantaneously wettable. The restraint of the membrane

during drying ensures that the pores remain open and the

concentration of non-polymer-to-polymer-hydrogen-

bonded to amorphous amide groups remains high enough to

ensure spontaneous wetting.

Nylon was not considered as a candidate by most

membranologists in the mid 1970’s for a number of

reasons. Nylon 6,6 was known to be very sensitive to

oxidation by, for example, sodium hypochlorite (chlorine)

solutions.. Since most membranologists entered the

microfiltration membrane field via reversion osmosis where

chlorine resistance was an important desideratum, it tended

to be dismissed out of hand. The fact that chlorine was not

typically encountered in microfiltration was not considered.

Nylon 6, 6 was known to be somewhat polar, but many

indices suggested that it was less so than the cellulosics

which did yield spontaneously wettable membranes without

surfactants. There was little understanding of how to

control the dope formulating, casting and quenching

processes for nylon membranes.

Marinaccio, of course, was one of the individuals

who appreciated at least in part the potentiality of nylon as

62a

a use, aS a membrane product. Marinaccio’s patent was

known after 1975 and it was also known there was no

corresponding commercial microfiltration product. It was,

therefore, concluded that Nylon 6, the Marinaccio referred

embodiment, was, for some unknown reason, not an

adequate membrane polymer.

The very poor quality of the Marinaccio disclosure

and the inclusion therein of polystyrene, a substance which

may have led him down the right track but for which no

membrane could possibly ultimately be constructed,

suggested that the Marinaccio patent was simply a closeout

of a failed product.

Formic acid is not a pleasant casting solvent. It has

a highly acrid odor and is corrosive. It also leads to

scarring of skin tissue and, therefore, must be handled

carefully. At that time, more innocuous solvents such as

acetone were employed.

There was no way a worker in the field in 1974 or

later -- well, I'll say 1974. Strike that. -- could have

predicted the properties of the final membrane product,

particularly its natural and instantaneous wettability and the

absence of any skinning.

The hydrohilicity of the Pall patent, defined as the

. complete and very rapid penetration of water to the entire

thickness of the membrane, is a property of great

importance to the membrane user because the membrane

filtration system must be subjected to an integrity test,

either a KL or bubble point test, prior to filtration to

guarantee the sterility of the filtrate. The presence of even

a single small unwetted portion of the membrane will

permit the flow of air through this demain, and lower the

apparent KL curve or bubble point of the membrane

element. Thus a membrane with an actual bubble point of

50 psi, which would suffice for sterile filtration, may only

exhibit a value of 30 psi, which is inadequate for sterile

i

63a

filtration. The user would have no choice but to dissemble

his filtration system and replace the membranes or

membrane cartridge. This would have adverse economic

consequences to the user - labor, cartridge replacement,

cost, and to the membrane producer - loss of credibility.

Therefore, instantaneous and complete membrane

wettability is a practical product property necessity. It is

also essential that wettability be a permanent property

which will not change with the storage time at ambient

conditions, temperature and relative humidity within the

range normally encountered during storage and transport.

It was not possible in 1978, or even in 1989 for that

matter, to predict wettability of a nylon microfiltration

membrane of a given pore size from its intrinsic properties.

Any prediction of complete wettability within one

second through the, or two seconds through the entire

thickness of a porouc membrane is impossible by

extrapolation from the bulk properties of nylon polymers.

The presence of skinning on microfiltration

membrane greatly reduces the concentration of accessible

surface area and hence the concentration of accessible

CONH groups. This in turn retards spontaneous and instant

wettability.

The microporous filtration industry reacted very

favorably to the claims of the Pall patent and its

commercial application since wettability with no

surfactants was an extraordinarily desirable result.

Scientists in the area, however, continue to express doubt

that Nylon 66 could be used to form a sufficiently

hydrophilic membrane to be spontaneously wettable in the

membrane form without a surfactant. This is an example of

the advance of the Pall patent over the prior art.

The nylon membranes covered by the Pall patent

have numerous applications, primarily in filtration and as

‘mmobilization media in biotechnological applications. To

64a

date, Pall alone has sold about $400 million worth of its

nylon membrane products in the aggregate.

Typical filtration applications include use by

pharmaceutical companies to assure that drugs, that the

drugs they make are free of bacteria contamination, use by

electronic companies which require highly purified water

for chip manufacture, and use by hospitals to assure that the

fluids administered to patients are free from bacteria and

other contaminants. Typical biotechnological applications

include use in diagnostics to detect the presence of

antibodies and the so-called transfer membranes for

identification of genetic characteristics.

In 1978 Pall, at a time following the initial filing of

its patent application, but prior to the filing of its

continuation-in-part, Pall sold its membrane product

commercially. It is claimed that this commercial sale of the

membrane product produced by the process for which Pall

later was issued a patent is an anticipation violative of

Section 102(b) in that the ratio claims of the patent added in

the continuation-in-part are not entitled to the filing date of

the parent application and, therefore, are invalid under

Section 102(b) due to Pall’s earlier sales of nylon

membranes.

MSI, to support that conclusion, must prove by

clear and convincing evidence that the ratio claims are not

entitled to the filing date of the parent application. Ralston

Purina Company v. Far-Mar-Co., Inc., 772 F.2d, 1579,

1573, 74, Federal Circuit (1985). The ratio claims are

entitled to the filing date of the parent application under

35 U.S.C., Section 120 if the disclosure of the parent

application complies with the enablement description and

best mode requirements of Section 112. Compliance with

the best mode enablement requirements are not contested in

this case. The description requirement is met if the

disclosure of the parent application would have reasonably

65a

conveyed to one of ordinary skill that Dr. Pall had invented

the subject matter of the ratio claims when he filed the

patent. In re Smith, 481 F.2d 910-914, Court of Claims and

Patent Appeals (1973). The methylene to amide ratio was

well-recognized as an inherent property of nylons at the

time of the original application in 1978. Accordingly, the

Court finds that the methylene to amide ratio was impliedly

disclosed in the parent application and the addition of the

express language in the continuation-in-part application did

not constitute new matter. Since the ratio claims recite an

inherent property of the group of nylons disclosed and

claimed in the parent application, for use in membrane

manufacture, the description requirement is satisfied.

Kennecott Corporation v. Kyocera International, Inc.,

835 F.2d 1419, 1421-23, Fed. Cir. (1987), cert. denied 446

U.S. 1008 (1988).

Accordingly, MSI has failed to prove by clear and

convincing evidence that the ration claims are not entitled

to the filing date of the parent application, and since the

filing date of the parent applicaticn is prior to the alleged

invalidating sales of membranes the assertion of invalidity

under Section 102(b) fails.

I’ve already spoken about the prior invention

disclosure under 102(g). Let’s talk about the anticipation

of the Pall patent by Marinaccio.

In order for a prior art reference to anticipate a

claim of the Pall patent, two conditions must be met. First,

all of the elements that claim must be found either

expressly or inherently in that single reference. Second,

that single reference must enable one skilled in the art to

practice the claimed invention without undue

experimentation. Akzo v. United States International Trade

Commission, 808 F.2d 1471, 1479, Federal Circuit (1986),

cert. denied, 482 U.S. 909 (1987).

66a

For a process to anticipate a product the process

must consistently reproduce the product. W.L. Gore and

Associates, Incorporated v. Garlock 842 F.2d 1275. Strike

that. W.L. Gore and Associates, Incorporated v. Garlock,

Incorporated, 721 F.2d 1540, at 1554, Federal Circuit

(1983), cert. denied, 469 U.S. 851 (1984).

In this case, the Court finds that the Marinaccio

patent, though certainly an advance, fails to disclose to one

skilled in the art all of the elements of any of the claims at

issue in the Pall patent. More specifically, it fails to

disclose in a manner which would allow a person skilled in

the art to practice the aspects of controlled nucleation, the

concern over temperature, the concern over skinlessness,

the inherent wettability, and therefore the Court rules that

the Marinaccio patent is not an anticipatory reference such

as to invalidate the Pall patent. United States v. Adams,

388 U.S. 39, at 50 (1966).

Moreover, the Marinaccio patent is silent with

respect to what, if anything, happens to a product made in

accordance with its processes when heated to a temperature

just below the softening temperature of the product. The

work that Dr. Johnson did on Nylon 66 while at Millipore, I

am not convinced that there was any public disclosure

thereof or commercial embodiment thereof, or that in fact

there was an invention which would anticipate the Pall

patent.

MSI claims that the Pall patent failed because it is

obvious. The issue with respect to obviousness is whether

MSI has established by clear and convincing evidence that

the differences in the asserted claims of the Pall patent over

the prior art would have been obvious to a person of

ordinary skill in the art when Dr. Pall made his invention

embodied in those ciaims. 35U.S.C., Section 103.

Obviousness is a question of law. It’s based on factual

67a

inquiries and factual evidence. Graham v. John Deere

Company, 383 U.S. 1, at 17 (1966).

The issue of obviousness requires inquiry into the

following areas: the scope and content of the prior art; the

differences between the prior art and the patent claims at

issue; the level of ordinary skill in the art at the time the

invention was made; and objective evidence that may

indicate obviousness or non-obviousness. Graham,

383 U.S. at 17-18.

The issue of obviousness is determined entirely

with reference to a hypothetical person having ordinary

skill in the art. Standard Oil Co. v. American Cyanamid

Co., 774 F.2d 448, 454, Federal Circuit (1985).

Factors that may be considered in determining the

level of ordinary skill and the pertinent art include: the

educational level of the inventor; types of problems

encountered in the art; prior art solutions to these problems;

the rapidity with which innovations are made; the

sophistication of the technology; and the educational level

of active workers in the field.

Environmental Designs Limited v. Union Oil

Company 713 F.2d 693, 696, 697, Federal Circuit (1983),

cert. denied, 464 U.S. 1043 (1984).

A person of ordinary skill is presumed to be one

who thinks along the line of conventional wisdom in the art

and is not one who undertakes to innovate. Standard Oil,

supra, at 454.

The Court has made the findings relevant on this

issue with the exception of objective evidence of non-

obviousness and objective evidence of non-obviousness

may well be the most pertinent probative and revealing

evidence available to aid in reaching a conclusion with

respect to this issue. Demaco Corporation v. F. Von

Langsdorff Licensing Limited, 851 F.2d 1387, 1391-92,

Federal Circuit, cert. denied, 488 U.S. 956 (1988).

68a

Both the Pall and the MSI product literature

emphasize the sales of nylon membranes by both of them,

MSI having some $17 million worth of such sales, are

directly attributable to the advantages offered by the

invention of the Pall patent, including its natural

vettability, uniform porosity and skinlessness. MSI indeed

considered Pall’s nylon membrane to be revolutionary in

the art. MSI's marketing information characterized its

Nylon 66 product as, quote, the first innovative product to

be introduced to this market in 20 years. The nylon

membrane has no extractables because of its natural

wettability and is virtually indestructible, close quote. The

introduction of nylon membrane permitted Pall to surpass

Millipore as the leader in microfiltration membranes. The

industry was surprised by Pall’s introduction of a skinless

nylon membrane which was naturally wettable without the

presence of surfactants because others had failed to achieve

such a membrane. The introduction of Pall’s nylon

membrane represented a major breakthrough in the

filtration industry. As recited above, AMF/C had

abandoned its nylon membrane project because of te¢hnical

problems. Other investigators and scientists in field,

including Dr. Kesting, were surprised by Pall’s introduction

of nylon membrane because they had been unsuccessfully

trying to obtain a membrane that was naturally wettable

without the presence of surfactants for many years.

Commercial success is a strong factor favoring

non-obviousness. Akzo, 808 F.2d, supra, at 1481. MSI

has failed to prove by fair and clear and convincing

evidence that any of the claims in issue in the Pall patent

would have been obvious in light of the prior art.

It's claimed that the Pall patent is not sufficiently

definite. Of course, it's unquestioned that in accordance

with 35 U.S.C., Section 282 the Pall patent is presumed

69a

valid. Roper Corporation v. Litton Systems, Incorporated,

757 F.2d 1266, 1270, Federal Circuit (1985.)

MSI has the burden of proving all of its allegations

of invalidity and unenforceability by clear and convincing

evidence. American Hoist and Derrick Company v. Sowa

and Sons, Incorporated, 725 F.2d, 1350, 1358, 1360,

Federal Circuit (1984), cert. denied, 469 U.S. 821 (1984).

The clear and convincing evidence standard is one

that has received a great degree of criticism in the law

generally. This Court has heard it referred to by an

appellate court as well, it's a fe preponderance of the

evidence standard, but we mean it. The Federal Circuit

does somewhat, is sornewhat more precise and defines clear

and convincing evidence in Buildex, Incorporation Vv.

Kason Industries, Incorporated 849 F.2d, 1461 at 1463,

Fed. Circuit (1988) as an abiding conviction that the truth

of the factual assertions are highly probable.

Here, to the extent MSI relies upon prior art that has

previously been considered by the patent office during the

prosecution of the patent application, MSI's burden of

proving invalidity is especially heavy. Polaroid

Corporation v. Eastman Kodak Company, 789 F.2d, 1556,

1560 Federal Cireuit, cert. denied, 479 U.S. 850 (1986).

Now with respect to the definiteness of the Pall

patent. What's required are claims which, when read in

light of the specifications, reasonably apprise those skilled

in the art both of the utilization and scope of the invention

and are as precise as the subject matter permits. Such

claims are not indefinite. Hybritech, Incorporated v.

Monoclonal Antibodies, Incorporated 802 F. 2d 1367,

1384, 1385, Federal Circuit (1986), cert. denied, 480 U.S.

947 (1987).

I mentioned above that there are many cases that

confirm that every patentee may be his own lexicographer

citing W.L. Gore Associates, supra, at 1569. This means

70a

that a patentee can choose his own terms and vse them as

he wishes so long as he remains consistent in their use and

makes their meaning reasonabiy clear. Ellipse Corporation

v. Ford Motor Company, 452 F.2d 163, 171, Seventh

Circuit (1971), cert. denied, 406 U.S. 948 (1972).

With respect to the challenges raised in this case,

the use of the terms about, hydrophilic and skiniess does

not impart invalidity to the claims of the patent but the

meaning of those terms is to be considered in determining

infringement. Andrew Corporation v. Gabriel Electronics,

Incorporated, 847 F.2d 819, 821, 822, Federal Circuit, cert.

denied, 488 U.S. 927 (1988).

Now, I think that takes care of the defenses. What |

said about the, that there was no new matter in the

continuation-in-part means that the claims of fraud on the

paient office is inappropriate and that claim falls, a matter

which was decided earlier in the lawsuit but which I've now

explained.

Likewise, the Court finds that the Pall patent is

adequately definite; that it is not anticipated by virtue of its

own 1978 commercialization of its nylon membrane; the

Marinaccio patent does not anticipate the Pall patent; the

Pall patent is not obvious when tested against the

AMF/Cuno nylon membrane project which was terminated

with no disclosure or benefit to the public, or when tested

with respect to the Millipore Nylon 66 project which is

likewise of, had no disclosure or benefit to the public.

The prior art that was known, the Pall patent was

not obvious in light of that prior art, and I have detailed the

level of skill in the prior art, the commercial success of the

Pall patent, the surprise and recognition of the industry, and

failure by others.

So let's come to the issue of infringement. And

with respect to infringement the first finding, the first series

of findings relate only to the process insofar as it results in

Via

MSI products made, sales of microporous membrane made

by MSI from Nylon 66. And I'll incorporate in the opinion

the specific parallel claims set out in the requested findings

of fact as found in the Pall patent on Pages 6, 7, 8, 9 and

requested finding of fact 22 in Pall’s proposed findings of

fact filed on May 15, 1991 without reciting them here.

Now, all of this is with respect to Nylon 66 only.

Now, I've mentioned the definition of hydrophilicity as that

term is used in the Pall patent. Under that term, MSI's

Nylon 66 membranes are hydrophilic as matter of fact. The

matter of skinlessness is a matter of significant import here.

If you look in the naked eye at the Pall membrane and the

MSI membrane they look and feel identical. If, however,

you blow the -- I guess that's -- I'll strike that. You're not

blowing it up. If you magnify the cross-sectional view of a

Pall membrane and an MSI membrane, or you magnify a

top down or bottom up view of both those membranes,

thousands of times by a scanning electron microscope, they

look substantially different. And if you look at the Pall

membrane it seems clear to this Court that under a

magnification of thousands of times under a scanning

electron microscope the, at least one surface of the MSI

membrane frequently has, has, when compared to the

interior of that membrane, a surface where the pore size

looks significantly different. And I don't intend to strain at

the point. As one would commonly understand the term, if

you look at MSI membranes they look like they have a

skin, or a lot of them look like they have a skin, if skin is 4,

as one takes the analogy from the epidermis of the human

body, a coating that is of substantially, what appears to be

substantially less porosity than the interior.

Now, one would have to sneeze at the, at the

obvious photographic evidence to say that at 2,000, 5,000,

10,000 times magnification the MSI membranes look like

the Pall membranes. They don't. What's more, in the

72a

interior of the MSI membranes, there are voids, what

appear to be bubbles. And sometimes these appear on the

surface. Sometimes the, a bubble captured on the surface

has a, in a membrane that is supposedly rated .2 microns

voids, if you will, that are as big as ten microns, I think the

transcript will support. So they look different.

And as the term is colloquially used, they look

skinned. However, the definition of skinlessness as used in

the Pall patent is one which does not depend on visual

inspection, although scanning electron microscope

examples of a Pall membrane are included in the Pall

patent. The definition, rather, depends upon the

characteristics. And skinlessness is defined -- well, I take

that back. In part, it does depend on how it looks; that is, in

part it's defined as having pores which are substantially

uniform in size and shape. And then in part skinlessness is

defined as the characteristics which allows the passage of

water through the membrane in specific fashion as

measured by the KL curve, all, in my judgment, adequately

defined in the patent.

Now, in this case Pall contends that the actual

functioning of the MSI membrane is the same as the Pall

membrane. And at least insofar as that functioning helps

. define skinlessness, I find that Pall's correct. The KL

curves of the MSI membranes tested, I find, under adequate

and standard scientific fashion, are so sufficiently similar

that the KL curves of the Pall membrane, especially those

portions of the curve that show that the pressure is flat or

some substantially increase in pressure and then abruptly,

abruptly curves upward rather than a gradual curve upward,

which is explained by the fact that the pores of the

membrane itself, that is, the through pores, the pores that go

from one side of the membrane to the other, are all

substantially the same size. I find that these membranes, as

so defined in light of their characteristics, the MSI

73a

membranes are skinless. It does appear that the art as

practiced by MSI is less perfect that Pall, but an infringer

cannot take refuge in the fact that he has a sloppy product.

This sloppiness, after all, is visible only to one who has a

scanning electron microscope which he can turn up to a

thousand time magnification. The MSI product serves the

same goal, serves it in the same way, and in fact, as the

language is used in the Pall patent, it infringes it. It's

skinless. But there's no doubt that it looks different.

With respect to the Pall patent itself, references to

skinlessness which are significant here, skin is mentioned

‘n Column 2 at Lines 10 through 24 and the skin that it's

suggested you're trying to avoid is an exceedingly thin but

relatively dense barrier layer, or, quote, skin, close quote,

from about one-tenth to five microns thickness of a

micropor

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This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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