Opposition Brief — Micron Separations, Inc. v. Pall Corp.

Supreme €ourt, U.S.

> le ie PS oe

~ 996

No. 95-1096 |

In The

Supreme Court of the United States

October Term, 1995

+

MICRON SEPARATIONS, INC.,

Petitioner,

PALL CORPORATION,

Respondent.

°

On Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Federal Circuit

6

RESPONDENT'S BRIEF IN OPPOSITION

+

H. MicuHast HartTMane

Counsel of Record

Leypvic, Vorr & Mayer, Lr

Two Prudential Plaza

Suite 4900

Chicago, IL 60601

(312) 616-5600

Attorneys for Respondent

Pall Corporation

COUNTER-STATEMENT OF

QUESTIONS PRESENTED

Respondent Pall Corporation is dissatisfied with peti-

tioner’s statement of questions presented, and, in accor-

dance with Supreme Court Rule 24.2, presents this

counter-statement:

1. In a patent infringement action in which an

accused product is admittedly an equivalent of the pat-

ented product, do statements by the patentee to the pat-

ent examiner that were not made to distinguish the prior

art, and were not accompanied by any amendments to the

patent claims, give rise to an estoppel that bars the appli-

cation of the doctrine of equivalents?

2. Ina patent infringement action where the award

of damages under 35 U.S.C. § 284 must be “adequate to

compensate for the infringement,” did the appellate court

err in holding that a product that was the subject of on-

going infringement litigation was not an acceptable non-

infringing alternative and in awarding lost profits accord-

ingly?

ii

TABLE OF CONTENTS

Page

COUNTER-STATEMENT OF QUESTIONS PRESEN- _

TED ....0cccede resides Anes pueaeebebunsneeerets i

TABLE OF AUTHORITIES .........cccccececcscvees iii

RESPONDENT’S BRIEF IN OPPOSITION........... 1

OPINIONS BELOW. ..,.00sssssacssssvecessceccccces 2

STATUTORY PROVISIONS INVOLVED............. 3

COUNTER-STATEMENT OF THE CASE............ 4

A. The Lower Courts’ Determination Of Infringe-

Ment......csccissndeesbeneey OEne eee aseeb ee 4

B. The Hilton Davis Petition Has No Bearing On

This Caee . .iccisciiuanesden ae eeeeenesaene 7

C. The Law and Evidence Support The Award Of

100% Lost Profits During The Period Of On-

Going Patent Litigation...................44. 9

REASONS FOR DENYING THE WRIT............. il

A. The Lower Courts’ Infringement Determina-

tions Are Coevect..i...:scsssasctsvevesovasses 11

B. This Is Not the Appropriate Case for Recon-

sideration of the Doctrine of Equivalents..... 14

C. There Is No Reason To Tamper With The Doc-

trine of Equivalente .. .sscssscasccsensacec#ss 15

D. The Federal Circuit’s Lost Profits Award Is

Supported By Evidence And Long Established

Precedent And Raises No Issue Worthy Of This

Court’s CompiGeGeiiit sick ccsnaueeeobissedacs 16

CONCLUSION . . 4405454505 eek ee ee 18

eters 2 ime

Rts IN A ee et trac

ili

TABLE OF AUTHORITIES

Page

Cases

Beatrice Foods Co. v. New England Printing and

Lithographing Co., 899 F.2d 1171 (Fed. Cir. 1990) .... 17

Caterpillar Tractor Co. v. Berco, S.p.A., 714 F.2d 1110

PME, GO, BOO co ccc recs cccsccccccssccssccoaceses 13

Datascope Corp. v. SMEC, Inc., 879 F.2d 820 (Fed.

Cir. 1989), cert. denied, 493 U.S. 1024 (1990) ....... 17

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

BE RA: MD CEU occ cccceescccccnscvecccecess 14, 16

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

Mattress Corp., 842 F.2d 323 (Fed. Cir. 1988)....... 13

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

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

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

(U.S. Nov. 6, 1995) (No. 95-728) ............ 7, 8, 15, 16

Laitram Corp. v. NEC Corp., 952 F.2d 1357 (Fed. Cir.

SESS SGU eUe edb es ev eeeVedhesedescacesceddecveces 13

Mannesmann Demag Corp. v. Engineered Metal,Prod-

ucts Co., 793 F.2d 1279 (Fed. Cir. 1986)............ 13

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

(Fed. Cir. 1995) (en banc), cert. granted, 64

U.S.L.W. 3238 (U.S. Sept. 27, 1995) (No. 95-26) .... 16

Micro Motion, Inc. v. Kane Steel Co., 894 F.2d 1318

rs osc h bebe ed beulsscceecdweees 17

Moeller v. lonetics, Inc., 794 F.2d 653 (Fed. Cir.

iv

TABLE OF AUTHORITIES - Continued

Page

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

CRE: DOOR witncknpcdacsatesesDaaubstbeusvaseass vax 15

Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538 (Fed. Cir.

Re ee is oi sk occ ccewes Uk aca eae eseedni 17

State Industries, Inc. v. Mor-Flo Industries, Inc., 883

F.2d 1573 (Fed. Cir. 1989), cert. denied, 493 U.S.

Ce CI es 6 has bake cgibecendkeedsgnsoe ess <i

Sun Studs, Inc. v. ATA Equipment Leasing, Inc., 872

J bo Fi ee. | epee Per rrrry rrr rr 13

STATUTES

Be Bos SE ie 0 beatae cables basalesinaees 6, 12, 13, 15

BE tae | Pree rerrrr err rirTer ri ir risy tL ree 15

SB FISH. FG vin no dncensbcacs cad dvsesiaciecasees i, 4

OTHER REFERENCES

Rule 24.2, Supreme Court Rules................. 2, 3, 4

Rule 29.6, Supreme Court Rules..................+... 2

RESPONDENT'S BRIEF IN OPPOSITION

Respondent Pall Corporation (“Pall”) respectfully

submits that a writ of certiorari should not issue in this

action. Micron Separations, Inc. (“MSI”) has presented no

reason, other than that it was adjudged and affirmed to

be an infringer of a patent, why the Court should exercise

its certiorari jurisdiction in this matter.

This case was before the Court of Appeals for the

Federal Circuit for four years. The court had the appeal

briefed and argued twice, once before a regular panel and

again en banc. It then remanded the matter back to the

original panel which issued its decision unanimously.

MSI cannot possibly complain that the appellate court did

not carefully and at great length consider this appeal.

MSI argues that the principal question presented in

this case concerns the patent law’s doctrine of equiva-

lents. It does not. The issue MSI chose to present to both

of the lower courts, and which the courts ruled upon, was

the applicability of the doctrine of prosecution history

estoppel. MSI had not previously contested that the

adjudged product and process were in fact technologi-

cally and legally equivalent to the patented product and

process. Indeed, it assured the appellate court that it did

“not challenge here on appeal any of the district court’s

underlying findings of fact regarding infringement.”

Supp. App. 94a.'

1 Page references io the appendix attached to petitioner’s

brief are indicated as “Pet. App. __-” Page references to

petitioner’s brief are indicated as “Pet. Br.___” and references to

the supplemental appendix attached hereto are indicated as

“Supp. App. __.”

Petitioner's damages arguments are equally defi-

cient. The appellate court's lost profits award is based on

properly admitted evidence and sound legal precedent

establishing that a third party’s product subject to on-

going infringement litigation cannot be an acceptable

non-infringing alternative

Because no questions worthy of the exercise of the

Court's certiorari jurisdiction have been presented and

because the decisions below are in all respects correct, the

petition should be denied.”

+

OPINIONS BELOW

Pall notes that MSI has failed to comply with

Supreme Court Rule 14.1(i)(i) regarding the requirement

to include in the appendix the lower court opinions

which are sought to be reviewed. Accordingly, under

Supreme Court Rule 24.2, Pall submits the following:

Pall agrees that the Court of Appeals opinion is

reported at 66 F.3d 1211 (Fed. Cir. 1995). Contrary to

MSI's assertion, however, the district court opinion

reviewed by the Court of Appeals is reported at 792

F.Supp. 1298 (D. Mass. 1992), and has not been included

in MSI's appendix.

The opinion reproduced by MSI in its appendix is

only the preliminary decision rendered by the district

court from the bench in June, 1991 immediately following

? Pursuant to Supreme Court Rule 29.6, Pall states that it

does not have any parent companies or subsidiaries other than

wholly owned subsidiaries.

————

3

the trial. At that time, the court specifically reserved the

“option of rendering a full written opinion.” Supp. App.

1a. Such full written opinion was then issued as a slip

opinion in April, 1992 and published shortly thereafter. It

is reproduced in the supplemental appendix attached

hereto. Pall’s cited references in this brief are to the

published opinion and are followed, where appropriate,

with the citation to the preliminary decision included in

MSI's appendix. While the two opinions are substantially

alike, there are some differences in wording, grammar,

organization, and emphasis.

At the time of publication of the district court's full

written opinion, the appellate proceedings were still on-

going. While a first round of briefing and argument had

been completed, the court ordered on November 5, 1993

that the case be heard en banc. Further briefs were filed

and another argument was held. The Court of Appeals

then referred the case back to the original panel which

rendered its decision on September 26, 1995. In that opin-

ion, the court not only referenced the full written pub-

lished district court decision, see Pet. App. 5a (“slip op. at

1”), but also specifically denied MSI's motion to strike the

published opinion, Pet. App. 23a-24a.

.

STATUTORY PROVISIONS INVOLVED

Pall is dissatisfied with MSI's presentation of the

statutory provisions involved in this appeal. Accordingly,

under Supreme Court Rule 24.2, Pall submits that the

following additional statute is involved in this case:

35 U.S.C. § 284 provides in pertinent part:

Upon finding for the claimant the court

shall award the claimant damages adequate to

compensate for the infringement, but in no

event less than a reasonable royalty for the use

made of the invention by the infringer, together

with interest and costs as fixed by the court.

#

COUNTER-STATEMENT OF THE CASE

Pursuant to Supreme Court Rule 24.2, the following

is presented to correct inaccuracies and omissions in the

Statement of the Case by petitioner MSI:

A. The Lower Courts’ Determination of Infringement

The Pall patent in suit is directed to microporous

membranes having certain properties and made of certain

plastic materials, nylons, which contain “methylene” and

“amide” chemical groups. Of greatest significance here

are membranes made from nylons that have methylene to

amide ratios of about 5:1 to about 7:1. The patent also

covers a process for making such membrane. The trial

court found, (Supp. App. 29a, Pet. App. 60a), and the

appellate court acknowledged, (Pet. App. 4a), that the

inventor, Dr. Pall, was a pioneer in the field of nylon

membrane technology.

The trial court also found that in making the infring-

ing products, MSI had “made extraordinarily extensive

use of that [Pall] patent in its own process.” Supp. App.

76a, Pet. App. 93a. MSI made two infringing membranes,

one of a nylon with a methylene to amide ratio of 5:1

(nylon 66), and the other with a ratio of 4:1 (nylon 46).

The district court held that both products and MSI’s

processes for making them infringed the Pall patent.

Supp. App. 50a-51a, 59a, 61a-62a, Pet. App. 77a, 83a-84a,

9'74.

The MSI membrane made from the 5:1 ratio nylon

was held to infringe the Pall patent literally. As to the

membrane made from the 4:1 ratio nylon, the district

court found, and the appellate court affirmed, that there

was infringement under the doctrine of equivalents. The

lower courts agreed that there was no substantial differ-

ence between MSI's 4:1 nylon membrane product and the

patented nylon membrane:

The Court finds that Nylon 46, as used by

MSI, does in fact perform substantially the same

function as nylons in the range of about 5 to 1 to

about 7 to 1 methylene to amide groups. It per-

forms in substantially the same way to achieve

substantially the same result as the claimed

device. Indeed, MSI in its advertising doesn’t

even point out the source of the nylon used, and

claims itself that the two nylons do precisely the

same thing. Supp. App. 61a-62a, Pet. App. 87a.

MSI did not appeal the correctness of these district

court findings, nor has MSI ever contended that

membrane made from the 4:1 nylon is not equivalent to

the claimed membrane. Pet. App. 1la.> Rather, MSI

3 The issue identified by MSI for appellate review was: Did

the district court err as a matter of law when it held that

prosecution history estoppel did not apply to limiting

argued to the Court of Appeals, as it had to the district

court, that a statement made by Pall during the prosecu-

tion of the patent created an estoppel that rendered the

doctrine of equivalents inapplicable. Pet. App. 11a-12a.

Both lower courts rejected the argument based on well-

established legal principles and because the facts simply

did not support the contention.

The district court made extensive findings of fact

regarding the prosecution history of the Pall patent,

Supp. App. 18a-27a, Pet. App. 48a-55a, and the Court of

Appeals reiterated those facts in its opinion, Pet. App.

lla-16a. Regrettably, MSI selected only certain of these

facts for presentation in its petition for certiorari. It

falsely suggests that Pall had amended its ratio claims to

narrow their scope (see, e.g. Pet. Br. 9). In fact, as both of

the lower courts found, the ratio range claims in the Pall

patent were never amended at all. See, e.g., Pet. App.

12a-13a. They were originally submitted to the Patent

Office in the application that became the Pall patent (the

“continuation-in-part application”), and were based on

research done by Dr. Pall. Supp. App. 67a, Pet. App. 92a,

12a. The claims were allowed without change after the

examiner withdrew an initial objection.

The principal ratio claim, No. 116, reads as follows:

A hydrophilic skinless alcohol-insoluble hydro-

phobic polyamide resin membrane sheet

of alcohol-insoluble hydrophobic polyamide

resin having a ratio CH,:NHCO of methylene

35 U.S.C. § 112 enablement rejection. Supp. App. 94a. MSI did

not seek review of the equivalents findings. Pet. App. 11a.

Bs Ban ts te AT ARs Veber SUD CEA PNG TE RN as se

Pee Crate Ce ei eee eto Coed

7

CH, to amide NHCO groups within the range

from about 5:1 to about 7:1;

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 mem-

brane to a hydrophobic material which is no

longer wetted by water.” Pet. App. 8a

Acknowledging that at the time the research was

carried out, nylon 46 was not commercially available or

“known” in the sense that Pall was required to carry out

experiments (Supp. App. 66a-67a, Pet. App. 91a-92a, 16a)

both courts below determined that Pall had not intended

to abandon, nor did in fact abandon his claim to a work-

able nylon which fell outside the range of about 5:1 to

about 7:1, so long as it was “within the penumbra of

methylene to amide combinations which are ‘about’ that

range.” Supp. App. 67a, Pet. App. 92a.

In applying the well-settled law of prosecution his-

tory estoppel to these facts, which stand unchallenged by

MSIL, the district court found that there was no estoppel

as to the ratio range claims. Supp. App. 62a-67a, Pet.

App. 87a-92a. The Federal Circuit Court of Appeals

affirmed these determinations. Pet. App. 16a.

B. The Hilton Davis Petition Has No Bearing On This

Case

The petition for a writ of certiorari in Hilton Davis

Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512 (Fed. Cir.

1995) (en banc), petition for cert. filed, Warner-Jenkinson Co.

v. Hilton Davis Chem. Co., (U.S. Nov. 6, 1995) (No. 95-728),

is not relevant to this case. MSI has gone to great lengths

to discuss alleged “similarities” between the cases in the

Statement of the Case section of its petition. Indeed,

much of MSI’s statement is a word-for-word replication

of the Hilton Davis petition. Two important facts distin-

guish this petition from the Hilton Davis petition, how-

ever. First, in the present case MSI did not contest in the

Court of Appeals the district court’s finding that the

differences between the accused 4:1 ratio nylon mem-

brane an@ the claimed product were “insubstantial”, or

that the 4:1 ratio nylon membrane performs substantially

the same function, in substantially the same way, to

achieve substantially the same result as the claimed prod-

uct. Supp. App. 61a-62a, Pet. App. 87a, 11a. This case, as

presented to the Court of Appeals for review, concerned

the doctrine of prosecution history estoppel, and not the

application of the doctrine of equivalents. Supp. App.

94a. In Hilton Davis, on the other hand, the issue of

equivalency between the accused product and the

claimed product was hotly contested in the Court of

Appeals, and precipitated an opinion directed to that issue.

Second, in Hilton Davis the claims at issue were in fact

narrowed by amendment to distinguish them from what

other inventors had done earlier. Hilton Davis, 62 F.3d at

1515-16. Only then did the Patent Office allow them. The

legal effect of such an amendment to overcome prior art is

quite different from that of an argument that demonstrated to

a patent examiner’s satisfaction that the invention had been

adequately described in the application papers. The sim-

ilarities MSI sees between this case and the Hilton Davis case

are strictly conjured up in an attempt to create substance for

the petition where there really is none.

C. The Law and Evidence Support the Award of 100%

Lost Profits During The Period Of On-Going Patent

Litigation

MSI finally contends that the appellate court should

not have modified the damages award pursuant to Pall’s

cross-appeal. It takes issue with the appellate court's

determination that Pall was entitled not just to 25% but to

100% of its lost profits prior to the availability of a non-

infringing substitute. MSI wrongly contends that there

was no factual record upon which the modified award

may be based. It further misapprehends the applicable

law.

The trial court had before it ample evidence of the

unavailability of a non-infringing substitute. That evi-

dence, testimonial and documentary, established the fol-

lowing:

1. Pall had accused the only even arguably

similar membrane, made by Cuno, as an

infringement. Supp. App. 95a.

2. From 1987 until May, 1990, Pall prosecuted

its U.S. infringement claim in a civil action

against Cuno. Supp. App. 95a.

3. Corresponding infringement suits had also

been brought in foreign countries. One such

action, in England, had progressed through a

four week trial and a full determination of

infringement. Supp. App. 96a-97a.

4. In May, 1990, Pall and Cuno settled their

world-wide patent dispute. Under the settle-

ment, Cuno obtained from Pall a covenant not to

sue. Supp. App. 95a.

10

Contrary to MSI’s representations in its petition,

none of this evidence was excluded at trial. MSI had

ample opportunity to rebut any or all of it, and to offer its

own evidence that the Cuno membrane was an acceptable

and available alternative. MSI presented no such evi-

dence.

Refusing to formally adjudicate the infringement of

the Cuno membrane when Cuno was not before the court,

the district court, with MSI’s support, excluded further

evidence proffered by Pall establishing that the Cuno

membrane in fact infringed. The court then awarded Pall

its lost profits on only 25% of the infringing sales prior to

the Settlement Agreement. Supp. App. 73a, Pet. App.

107a.

The Court of Appeals held that under the applicable

law the presence of the accused Cuno membrane in the

marketplace “did not defeat Pall’s entitlement to lost

profit damages,” and that Pall was not required “to con-

tinue the Cuno litigation to judicial decision.” Pet. App.

21a. It properly applied the law to the uncontested facts

and awarded Pall all of its lost profits damages for the

period prior to the Cuno settlement. Pet. App. 20a-22a.

Still misapprehending the law, MSI now argues that

it should have been permitted to attempt to prove the

non-infringement of the Cuno membranes. It wishes to

ignore the fact that it itself objected to the presentation of

trial evidence on the issue of the actual infringement. The

Court of Appeals decision was in all respects correct.

¢

11

REASONS FOR DENYING THE WRIT

This case exemplifies the correct application of relatively

plain and long-settled principles of patent law. The petition

for certiorari should be denied because the decisions below

are correct, because this is not an appropriate case to address

the doctrine of equivalents, and because no extraordinary

issues of law or public policy have been raised.

A. The Lower Courts’ Infringement Determinations

Are Correct

MSI conceded that the specific factual determinations

and conclusions of law by the lower courts regarding

infringement are correct. Supp. App. 94a. It does not

dispute that the district court construed the claims as a

matter of law, applied those claims to the accused prod-

uct and method, and found the literal presence of each

claimed element, save only the “about 5:1” ratio element.

The question then became whether in the context of a

membrane having all of the other required attributes of

the patent claim (see claim 116, supra, p. 6), a nylon 46

material having a ratio of 4:1 was equivalent to a nylon

material having a ratio of “about 5:1.” The district court

applied the long-standing tripartite test of Graver Tank

and held that the differences were “insubstantial” and

that the two products were “substantially the same.”

Supp. App. 61a-62a, Pet. App. 87a. MSI’s own documents

supported that finding and MSI did not challenge it on

appeal. The district court properly concluded that, absent

prosecution history estoppel, there was infringement.

Supp. App. 62a, 67a, Pet. App. 87a, 92a.

12

The trial court held that there was no such estoppel.

Supp. App. 67a, Pet. App. 92a. It found that the inclusion

in the description in the patent claims of nylon resins

“within the range of about 5:1 to 7:1” was not based upon

prior art or any requirement by the patent examiner,

Supp. App. 26a, Pet. App. 55a, and that in response to a

§ 112 rejection, the applicant pointed out, without amend-

ing the claims, that they were “actually rather narrow.”

Pet. App. 156a. This statement was based upon the scien-

tific knowledge at the time relating to the limited number

of “known” nylons which produced membranes with the

properties claimed in the patent. See, Supp. App. 66a-67a,

Pet. App. 92a.

MSI has not alleged error by either the district court

or the Court of Appeals regarding the factual findings

relating to prosecution history estoppel. According to its

own appellate brief:

MSI does not challenge here on appeal any of

the district court’s underlying findings of fact

regarding infringement. Therefore, . . . it is

unnecessary for this Court to set aside any pro-

bative findings of fact found by the district

court or to engage in any reweighing of the

evidence in this case. Supp. App. 94a.

Nor did it “argue .. . that the nylon 46 and nylon 66

membranes are not equivalent.” Pet. App. lla. Only now

does it contend that the claims were somehow “nar-

rowed” by claimant’s comment (Pet. Br. 9, 11), and that

the claims were then improperly enlarged under the doc-

trine of equivalents (Pet. Br. 15). However, the law is

well-settled, that, as the Federal Circuit stated:

13

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 depen-

dent 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 Corp. v. NEC Corp.,

952 F.2d 1357, 1361 (Fed. Cir. 1991); Hi-Life Prod-

ucts, Inc. v. American National Water-Mattress

Corp., 842 F.2d 323, 325 (Fed. Cir. 1988).

Pet. App. 14a. Each case must be reviewed on the specific

facts surrounding the argument. See, Sun Studs, Inc. v.

ATA Equipment Leasing, Inc., 872 F.2d 978, 987 (Fed. Cir.

1989); Moeller v. Ionetics, Inc., 794 F.2d 653, 659-60 (Fed.

Cir. 1986); Mannesmann Demag Corp. v. Engineered Metal

Products Co., 793 F.2d 1279, 1285 (Fed. Cir. 1986); Caterpil-

lar Tractor Co. v. Berco, S.p.A., 714 F.2d 1110, 1115 (Fed.

Cir. 1983). Pet. App. 15a.

Under the undisputed facts in this case, the lower

courts properly concluded that applicant’s argument did

not create an estoppel. MSI has failed to present a single

fact or single case which even challenges, much less

contradicts, any of the determinations below. Its broad

allegations of “violation of statutory policy” and

“improper exercise of judicial power”, Pet. Br. at 15, 16,

are simply unjustified. The petition for certiorari should

be denied.

14

B. This Is Not the Appropriate Case for Reconsidera-

tion of the Doctrine of Equivalents

Even though this is plainly not a doctrine of equiva-

lents case, MSI urges that the Court seize upon this case

to rewrite or eliminate more than 100 years of doctrine of

equivalents law, including the almost 50 years of clear

precedent in Graver Tank & Mfg. Co. v. Linde Air Products

Co., 339 U.S. 605 (1950). Its submission is essentially an

amicus brief supporting the petition for certiorari in

Warner Jenkinson Co. v. Hilton Davis Chem. Co., No. 95-728,

filed Nov. 6, 1995. It is not an attempt to seek review of

specific rulings actually made by the lower courts in this

case.

This is plainly not the right case for a reexamination

of the doctrine of equivalents. At no time in the proceed-

ings below did MSI put forward any evidence or argu-

ment in support of its present proposition that the

doctrine of equivalents be eliminated, at least as we know

it presently. At no time did MSI even seriously argue, let

alone present any evidence, that the infringing membrane

was not equivalent to the patented membrane. MSI

wishes to have this Court convert the case from the

prosecution history estoppel case that it was throughout

the lower court proceedings to a doctrine of equivalents

case that it never was and, under the present state of the

record, can never be. This Court would be poorly served

by the record in this case were it to undertake a reex-

amination of the doctrine of equivalents. MSI's petition

should be denied for this reason alone.

Wal Si a oh

15

C. There Is No Reason to Tamper with the Doctrine of

Equivalents

Perhaps most importantly, this Court should deny

MSI’s petition for certiorari because the doctrine of

equivalents needs no overhaul in any event. It has served

inventors, industry and society as a whole with great

distinction for more than 100 years. And it is not, as MSI

seems to suggest, suddenly gone out of control.

The doctrine is in fact necessary to effectively protect

intellectual property rights and foster innovation and

technological advance. Courts have applied it repeatedly

for more than a century and Congress has wisely never

intervened. “[T]he greater complexity of today’s patented

high technology inventions,” Hilton Davis, 62 F.3d at 1549

n.3 (Lourie, J., dissenting), renders the doctrine not obso-

lete, but of even greater importance than ever before.

Inventors must be protected against unscrupulous

infringers.

At the same time, Pall fully accepts that there must

be limitations and predictability in the scope of a patent

and the application of the doctrine of equivalents. And

there is. Both Congress and the courts have put in place

numerous restrictions against the indiscriminate broaden-

ing of patents. For example, 35 U.S.C. § 112 requires that

patent claims be definite and supported in a patent's

specification, and the reissue provision of the Patent Act,

35 U.S.C. § 251, permits the broadening of patent claims

only within two years of the issuance of the patent.

Similarly, courts have ruled that reexamined claims can-

not be broader than the original claims, Quantum Corp. v.

Rodime, PLC, 65 F.3d 1577 (Fed. Cir. 1995), and, as yet

16

subject to review by this Court, that the meaning of

patent claims is a question of law not to be left to pre-

sumably unpredictable juries, Markman v. Westview

Instruments, Inc., 52 F.3d 967 (Fed. Cir.) (en banc), cert.

granted, 64 U.S.L.W. 3238 (U.S. Sept. 27, 1995) (No. 95-26).

The doctrine of equivalents does not clash with these

policies and objectives. It also is narrowly circumscribed.

Under Graver Tank, supra, and its progeny such as Hilton

Davis, supra, only in those rare instances where the differ-

ence between an accused and a patented product is

“insubstantial,” and only in the absence of prosecution

history estoppel, does the doctrine operate to result in

infringement. That has been the law for decades, and MSI

has failed to show any reason why this Court should

revisit the matter.

D. The Federal Circuit’s Lost Profits Award Is Sup-

ported by Evidence And Long Established Prece-

dent And Raises No Issue Worthy of This Court’s

Consideration

MSI asks that this Court review the appellate court's

recalculation of damages. It contends that the lower court

was without evidence and legal authority to do so. No

other reason for a grant of certiorari is offered. MSI's

request should be denied because it is unsupported by

law or fact. The lower court in fact had sufficient evi-

dence and ample legal support for its actions.

MSI argues that an express adjudication of infringe-

ment is required in order to establish the absence of

acceptable non-infringing alternatives for a lost profits

17

award. Pet. Br. 16. As the trial court excluded certain

evidence of actual infringement of the Cuno membrane,

MSI contends that there is no evidence to support the

appellate court’s award. MSI does not contest that Pall

established all other requirements for the award of lost

profits, as well as the facts of the prior charge of infringe-

ment against the Cuno membrane, extended infringement

litigation between Pall and Cuno involving that mem-

brane, and the ultimate settlement of that litigation and

Pall’s grant of a covenant not to sue Cuno.

Under prevailing law, that evidence is in fact suffi-

cient to support an award of lost profit damages. Pall

needed only to show a reasonable probability that, but for

the infringement, it would have made the sales that were

made by MSI. Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538,

1545 (Fed. Cir. 1995) (en banc); Beatrice Foods Co. v. New

England Printing and Lithographing Co., 899 F.2d 1171, 1173

(Fed. Cir. 1990) (Pet. App. 103a, 20a).

It is clear that a “likely infringer” cannot provide an

acceptable non-infringing alternative, State Industries, Inc.

v. Mor-Flo Industries, Inc., 883 F.2d 1573, 1578 (Fed. Cir.

1989), cert. denied, 493 U.S. 1022 (1990); Micro Motion, Inc.

v. Kane Steel Co., 894 F.2d 1318, 1322 (Fed. Cir. 1990).

Similarly, courts have held that on-going litigation cannot

support a finding of an acceptable non-infringing alterna-

tive. Datascope Corp. v. SMEC, Inc., 879 F.2d 820, 824-25

(Fed. Cir. 1989), cert. denied, 493 U.S. 1024 (1990). Pet.

App. 21a-22a.

The Court of Appeals did have ample evidence to

support its judgment, i.e. the existence of the infringe-

ment charge, on-going litigation, and the settlement

18

agreement, establishing the likely infringement by the

Cuno membrane. The fact that MSI chose not to introduce

any rebuttal evidence simply reflects the irrefutable

nature of Pall’s evidence, and was in any event a decision

made by MSI. It should not now be heard to protest that

it never had a reason or an opportunity to introduce

rebuttal evidence. Pet. Br. 16.

MSI seeks a remand requiring the district court to do

that which case law expressly does not require. The Court

of Appeals had adequate facts and correctly applied well-

established and uncontroversial law in modifying the lost

profits award. There is no reason why MSI's petition for a

writ of certiorari should be granted.

*

CONCLUSION

For the reasons stated above, respondent Pall Corpo-

ration, respectfully requests that MSI's Petition for a Writ

of Certiorari be denied.

Respectfully submitted,

Dated: February 9, 1996 H. MicHast HARTMANN

Counsel of Record

Leyrpic, Vorr & Mayer, Ltp.

Two Prudential Plaza

Suite 4900

Chicago, IL 60601

(312) 616-5600

Attorneys for Respondent

Pall Corporation

INDEX TO SUPPLEMENTAL APPENDIX

Page

A. Memorandum of Decision of the United States

District Court for the District of Massachusetts,

Se POE Ss ON kc ik csc ows BEE vee dks la

B. Extract of Brief of Appellant, Micron Separations,

Inc. filed in the Court of Appeals for the Federal

Circuit, Appeal Nos. 91-1393, -1394, -1409....... 93a

C. Extract of Settlement Agreement Between Pall

95a

Corporation and Cuno, Inc.....................

la

UNITED STATES DISTRICT COURT FOR THE

DISTRICT OF MASSACHUSETTS

PALL CORPORATION, )

Plaintiff, )

Ts ) CIVIL ACTION

v. ) No. 86-1427-Y

MICRON SEPARATIONS, INC.,

Defendant. )

MEMORANDUM OF DECISION!

YOUNG, D,J. April 24, 1992, Decided

This case involves United States Patent 4,340,479 (the

“Pall patent”) covering a process for preparing hydro-

philic polyamide membrane filtered media and product,

which issued on July 20, 1982 to the plaintiff Pall Corpo-

ration (“Pall”). Pall 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. Pall was

founded in the late 1940’s by Dr. David B. Pall of Roslyn

Estates, New York. Dr. Pall is designated as the inventor

of the patent-in-suit.

The action is brought against the defendant Micron

Separations, Inc. (“MSI”), a Massachusetts corporation

having a principal place of business in Westborough,

Massachusetts. MSI was formed in 1981 when certain

employees of a filtration company known as Millipore,

specifically James S. Johnson and John M. Greenwood,

1 The Court rendered its decision in this case from the

bench on June 5 and June 20, 1991, reserving the option of

rendering a full written opinion. This is that opinion.

2a

left that company and, along with Edward J. Ackley,

decided to start their own company and enter into com-

petition with Pall, Millipore, and others in the micro-

porous filtration industry.

The complaint in this action was filed on May 7, 1986.

It seeks a judgment that MSI has willfully infringed the

Pall patent. The complaint also seeks damages for past

infringement and an injunction against future infringe-

ment.

I. Prior Art

A. The general setting.

At this juncture it’s helpful to put some matters in

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 membranes are made from a chemical

material that has many thousands of repeating units, a

polymer. 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.

3a

Prior to the development of the Pall nylon mem-

brane, 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 micro-

filtration.

Typical filtration applications include use by phar-

maceutical companies to assure that the drugs they make

are free of bacteria contamination, use by electronic com-

panies to purify 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 diag-

nostics to detect the presence of antibodies and the so-

called transfer membranes for identification of genetic

characteristics.

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 pro-

cesses microfiltration, for example, the complete absence

of any skin is necessary.

Microfiltration is one of the most common applica-

tions for polymeric membranes at this time. It is, how-

ever, by no means the only application. Membranes are

also used in reverse osmosis, electrophoresis, dialysis,

electrodialysis, gas separation, and immobilization and

4a

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 pore size that gives the highest flow

rates and throughputs consistent with the retention of the

approximate .3 micron Pseudomonas diminutia bacteria

which is the criterion for a pore size rating equivalent to

sterilization. Today commercially acceptable microfiltra-

tion membranes are skinless and macrovoid-free and

have a narrow pore size distribution which maximizes

their efficiency at removing bacteria, and other particu-

late matter of equivalent size, from fluids.

Other uses for microfiltration membranes are now

found more and more in the biotechnology area. Poly-

meric 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:

Polymer Application

Cellulose acetate and nitrate Electrophoresis

including mixtures Microfiltration

Ultrafiltration

Reverse Osmosis

Gas Separation

Cellulose triacetate Microfiltration

Ultrafiltration

Reverse Osmosis

5a

Cellulose acetate/triacetate blends Reverse Osmosis

Polyacrylonitrile Ultrafiltration

Polyacrylonitrile-polyvinyl- Microfiltration

chloride copolymer

Polyamide (incl. various nylons) Microfiltration

Ultrafiltration

Reverse Osmosis

Immobilizing

Medium

Polyaryl Sulfone Ultrafiltration

Polycarbonate Microfiltration

Reverse Osmosis

Electrophoresis

Polyester Microfiltration

Polyether Sulfone Ultrafiltration

Polyimide Ultrafiltration

Reverse Osmosis

Microfiltration

Polypropylene

Polysulfone Microfiltration

Ultrafiltration

Polytetrafluoroethylene (PTFE) Microfiltration

Polyvinylchloride Microfiltration

Polyvinylidenefluoride (PVFD) Microfiltration

Ultrafiltration

Dr. Kesting Direct Testimony at 7.

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

6a

atmosphere; casting from a polymer solution into 2 non-

solvent 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.

In 1978, the leading manufacturers of microfiltration

media were Pall with its fibrous potassium titanate prod-

uct, 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 pro-

cess that involved casting from a solution followed by

evaporation or quenching in a liquid.

Pre-1978 filter media, fibrous and non-fibrous, suf-

fered from one or another of the following deficiencies:

brittleness, unless highly plasticized they could not be

pleated and incorporated into a cartridge; marginal ther-

mal stability, the membrane shrank excessively while

being sterilized with steam; high extractables, the surfact-

ants employed to render the membranes hydrophilic so

that they could be used with acqueous fluids and the

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 flow-

rate, the amount of liquid per unit time capable of flow-

ing 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

7a

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 many

avenues of reaching that goal. All such attempts had

failed.

B. The efforts of Paul J. Marinaccio.

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.

Paul J. Marinaccio was hired as a research chemist by

AMF Corporation (“AMF”) to make reverse osmosis

membranes. AMF is a large corporation. It has 80 divi-

sions, but has largely centered research and development

within AMF itself. Cuno, a subsidiary of AMF, sought to

have the AMF research chemists develop a microfiltration

fiber filter. Marinaccio and others commenced work on

this project, but Marinaccio serendipitously embarked

upon microporous membrane research when it occurred

to him as he looked at his polystyrene coffee cup that it

might be possible to make microporous membranes out

of related materials.

Marinaccio thereupon devised an experimental pro-

cess involving the dissolving of nylon pellets in formic

acid which he believed was a breakthrough in that it

allowed the rapid manufacture of microporous mem-

branes. In the late 1960’s and early 1970’s when he was

8a

performing these experiments, Marinaccio knew that no

one else in the industry had such a rapid commercial

process.

Abandoning their work on the microfiltration fiber

filter, Marinaccio and his colleagues instead devoted their

efforts to the development of a microporous membrane.

Marinaccio believed that the key to the development of

microporous membranes was a device which prevented

any air contact during the quench process. He called this

aspect of his claimed invention zero quench. The general

steps for making microporous membranes were, by the

early 1970’s, well known to those skilled in the art of

making such membranes. To the extent that Marinaccio’s

process incorporates new developments in the art of mak-

ing microporous membranes, they are developments in

the particular materials used and the manner of their use

rather than in the mechanical aspects of the membrane

process.

Marinaccio sought, and received, United States Pat-

ent 3,876,738 (the “Marinaccio patent”) dated April 8,

1975. The Marinaccio patent described the so-called zero

quench process for the continuous formation deposit of

membrane so as to form large sheets of microporous

membranes.

Although Marinaccio had obtained a patent on his

invention, he had a number of problems within his com-

pany. Marinaccio believed that his patented process had

significant commercial viability but, as is the pliant of

inventors everywhere, he considered himself starved for

money and thought that the business leaders at AMF did

9a

not support his research efforts adequately. He charac-

terized the microporous membrane research laboratory at

AMF as filled with equipment literally held together with

wire and tape. Marinaccio, through the use of his inven-

tion, was able to manufacture sheets of microporous

membrane which looked identical to the naked eye. That

process was able to make short runs of .2 micron

material. Marinaccio claims that long runs were not made

because he did not have the money to develop the

machinery capable of making long runs. Marinaccio

believed and indeed still believes, that he could have

made long runs by his process had he adequately been

supported. ‘

Marinaccio believed that his only failure was the

equipment limitation failure. Marinaccio, however, recog-

nized the problems with the long-term reproducibility of

the materials formed by his process. He further recog-

nized that the most critical test for microporous mem-

brane 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

retention test. Marinaccio ran bubble point tests and flow

tests on these materials that he had manufactured and,

from those tests, he came to believe that microporous

membrane manufactured pursuant to his process was as

good for microfiltration purposes as anything then com-

mercially available.

A gentleman named Ostricher at Cuno was very

enthusiastic about the samples which Marinaccio had

produced. Ostricher compared those membrane samples

with the standard Cuno counterpart and concluded that

the Marinaccio samples were considerably better.

10a

The trouble came in the commercialization of the

Marinaccio process. Marinaccio’s concept for the com-

mercialization of his process was to design an idiot-proof

process for making membranes; that is, he constantly

sought a simple, readily understandable, generally appli-

cable approach. Cuno, at that time, made only unsophisti-

cated paint filters. The chief executive officer of Cuno

was one Ray Tritten. Tritten’s idea of commercialization

of microporous filters was a process that resulted in long

runs of membrane sheets. While certain of his subordi-

nates thought that the sheets prepared by the Marinaccio

process were good enough for commercial application,

Tritten disagreed. The results of tests conducted with tap

water made Tritten concerned that the filters prepared by

the Marinaccio process had a very short life. Marinaccio

believed that the short life showed nothing more than the

remarkable benefits to be derived from his filter inas-

much as it filtered everything out of the tap water retain-

ing it on the filter face and quickly clogging the filter.

Tritten’s rejection of Marinaccio’s efforts to commer-

cialize the Marinaccio process as set forth in the patent

and AMP's confirmation of that rejection did not daunt

Marinaccio. He continued testing it covertly. Cuno did

not sell any of the rolls of the membrane material devel-

oped pursuant to the Marinaccio patent.

C. The Marinaccio patent.

The Marinaccio patent does not contain any indica-

tion that the products obtained by its process are skinless

or hydrophilic, as that term is used in the Pall patent. The

Marinaccio patent is silent with respect to skinlessness. It

lla

comments only that a person of ordinary skill in the art

ought to recognize that a skin may result on the casting

solution and therefore is likely on the final product after

quenching. Not only does the Marinaccio patent not

claim that the products produced are inherently hydro-

philic as that term is used in the Pall patent, it further

teaches that the products produced should be “treated

with a wetting agent.” The Marinaccio patent teaches that

the process does not require special conditions of tem-

perature. The films can conveniently be produced at or

near room temperature. In fact, temperature plays an

important role in the preparation and casting of a resin to

form a membrane. Because of this, Rodney A. Knight, an

inventor who assisted Marinaccio in the development of

the zero quench process that is referred to in the Marinac-

cio patent, later came to think temperature was a signifi-

cant variable in getting exact 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 important and affects the

resulting product. The Marinaccio patent does not indi-

cate any importance in the mixing conditions employed

in making the casting resin. The Marinaccio patent

teaches that increased porosity is obtained by increasing

the polymer concentration to the solution and by increas-

ing the nonsolvent concentration causing the polymer to

aggregate. The Marinaccio patent is silent regarding the

manner in which the membrane film that is produced is

dried. It makes no mention of controlled nucleation.

12a

Marinaccio’s patent claims polystyrene as a workable

substance. In fact, polystyrene can never be made into a

membrane with a zero contact angle which meets the

definition of hydrophilic, as the term is used in the Pall

patent. Marinaccio did not distinguish between amor-

phous and crystalline polymers.

D. Abandonment by Cuno.

Wholly apart from the claimed anticipation of the

Pall patent by the Marinaccio patent, MSI here claims that

the invention of the Pall patent, the microporous mem-

brane itself, had been reduced to practice by virtue of the

rolls of microporous material which Marinaccio produced

for Cuno. Pall disagrees, claiming that the Marinaccio

efforts were abandoned, suppressed or concealed by not

being made public. A brief analysis need be made of this

issue.

If a prior invention is made public or is used com-

mercially it has not been abandoned. Friction Div. Prod.,

Inc. v. E.I. DuPont de Nemours & Co., 658 F. Supp. 998, 1014

(D. Del. 1987, 3 U.S.P.Q.2D (BNA) 1775), aff'd, 883 F.2d

1027 (Fed. Cir. 1989). The law does not require any dis-

closure of the actual invention to the public nor any

commercial use for an invention to qualify as prior art.

Hazeltine Research, Inc. v. Brenner, 382 U.S. 252, 254-56, 15

L. Ed. 2d 304, 86 S. Ct. 335, 147 U.S.P.Q. (BNA) 429 (1965).

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

must be reduced to practice. Friction Div. Prod., Inc., 658 F.

Supp. at 1013-14. Reduction to practice means something

less than commercialization, but requires an exposure of

the benefits to the public. Id. An invention is deemed

13a

publicly known if the public enjoys the benefits or use of

the prior invention. Id.; see also Schreiber Mfg. Co., Inc. v.

Saft America, Inc., 704 F. Supp. 759, 762 (E.D. Mich. 1989)

(“ ‘[P]ublic use’ of an invention under sec. 102[b] is any

nonexperimental use by an inventor or by an individu-

al. ... 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 circumstances”).

In the circumstances of this case, the Court finds that

the rolls of material made by Marinaccio for Cuno were

experimental only, never benefited the public, were never

disclosed publicly, and were never in use.

Cuno restarted its membrane program in 1978 after

seeing a Pall sample.

II. The Pall Patent

A. The Invention and Patent Application.

Turning to the Pall patent, even before Marinaccio’s

experiments, Dr. Pall was conducting research on micro-

porous filters made from polymeric materials, including

nylon, in the mid- to late-1960’s. He set aside that project

in 1969 because he believed developments in other areas

were more promising. In mid-1974, Dr. Pall reactivated

his research program in microporous polymeric mem-

branes. By November, 1974, he made a promising micro-

porous membrane from Nylon 11 and Nylon 612. It’s

clear to this Court that in 1975 Dr. Pall tried to design

around the Marinaccio patent, just as MSI later tried to

14a

design around the Pall patent. Indeed, Pall focused heavy

resources on designing around the Marinaccio patent.

Unlike MSI, however, Dr. Pall did it successfully. By

September 1975 he made a pliant, alcohol-insoluble, skin-

less microporous membrane from Nylon 66. By Novem-

ber 1975 he had repeated this result on a larger scale.

The cases make clear that a patent applicant can be

his own lexicographer.? Dr. Pall’s patent application

reveals that Dr. Pall considered the membrane that he had

developed to be naturally hydrophilic, but it is important

to remember what Dr. Pall means when he uses the word

hydrophilic. Use of the word hydrophilic in the mechani-

cal sciences and in chemistry differs from Dr. Pall’s use of

the word. In those industries, 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.

The qualities of hydrophilicity — attractiveness to water,

and hydrophobicity — repelling water, are confirmed by a

variety of formulae and tests involving capillary action of

the material and water.

A substance is naturally hydrophilic if it is attractive

to water without the addition of wetting agents. It is very

important to a microporous membrane that it be naturally

hydrophilic — the more hydrophilic the better. This is so

2 See, e.g., ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d

1576, 1580 (Fed. Cir. 1988); W.L. Gore & Assoc., Inc. v. Garlock,

Inc., 721 F.2d 1540, 1558 (Fed. Cir. 1983), cert. denied, 469 U.S. 851

(1984); Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1569

(Fed. Cir. 1983).

15a

because otherwise the wetting agents themselves may

interact with the material being passed through the mem-

brane and make the membrane not commercially usable.

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’s use of the term hydrophilic is quite differ-

ent. Dr. Pall considers a material 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. One can understand that

definition, but confusion results because he defines

everything else as hydrophobic, whereas in fact certain

nylon blocks, pellets, solid materials, and, most important

as we will see further on, Nylon 46, in their natural states

have contact angles of less than 90 degrees.

The term skinlessness should also be examined. It is

clear that Pall makes no claim to skinned membranes in

this patent. Figure 8 in the patent-in-suit shows a skinned

membrane, which is outside the claims of the patent. Dr.

Pall emphasizes that the membranes produced through

the Pall patent are skinless. Skinlessness is never speci-

fically defined in the Pall patent but clearly it is a signifi-

cant parameter and it is 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

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

the through pores of the membrane. Under

l6a

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.

Ex. 500.

Column 26 of the Pall patent, starting at Line 33,

explains:

Skinned membranes behave very differ-

ently; when water wetted and their air flow-

pressure drop relationship is determined, the

[KL] 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 FIG. 3 [in the patent],

a sloping line is obtained, reflecting a wide pore

size range. Such membranes are poorly suited to

obtain sterile filtrates when challenged by bacte-

ria; 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.

Ex. 500.

|

17a

Stated another way, the skinlessness of the mem-

branes was important for filtration applications because it

assured a good flow rate and acceptable pressure drops

and avoided functional imperfections typically associated

with skinned membranes which rendered such mem-

branes 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 used in bio-

technological applications.

Dr. Pall found the immediate zero contact angle

aspect of the nylon membranes produced by the process

which he had invented unexpected since he considered

the source material, that is, the pellet form of the starting

nylon resins, each to have a contact 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 con-

taminate the filtered fluids when they shed off to one

degree or another.

A pliancy of the material produced by the Pall pro-

cess likewise was important to facilitate handling, includ-

ing pleating into high surface area cartridges.

The alcohol-insolubility of the membrane produced

by the Pall process is important to permit the use of nylon

membranes with a wide variety of liquids.

Between 1976 and 1977 Dr. Pall developed a manu-

facturing process for making commercial quantities of

18a

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, as

Dr. Pall defines it, skinless microporous membranes.

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 liq-

uids.

The examiner — and the principal examiner through-

out was one Frank A. Spear, Jr. — initially, on February 5,

1979, took the position that the initial application Claims

1 through 97 were all subject to certain restrictions which

he listed. Ex. 545 at 112-13. In response to his direction

that the claims be restricted, on March 5, 1979, a docu-

ment entitled “Amendment” was filed seeking recon-

sideration of the requirement for a restriction in which

Pall claimed,

[t]he claims of Groups 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 pro-

cess was known for preparing it.

19a

Ex. 545 at 114 (emphasis in original). The patent applicant

wanted to emphasize that what had been invented here

was this skinless, hydrophilic, alcohol-insoluble poly-

amide membrane.

Nevertheless, in an action mailed in June, 1979,

Claims 1 through 86 and 96 and 97 were rejected by the

patent examiner, Claims 87 through 95 having been with-

drawn. Ex. 545 at 120. The ground of the rejection is

significant. The examiner took issue with the use of the

word “hydrophilic” in the original application, “because

it has no absolute meaning. It is a relative term.” Ex. 545

at 121. 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 some-

what different than the term had heretofore 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.

Ex. 545 at 121. Claims 3 and 4 were rejected as unpatent-

able over Marinaccio with respect to the manner in which

Marinaccio had filtered the casting dope. Ex. 545 at 121.

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. Ex.

545 at 121. Claims 75 through 86 were rejected on the

ground that “[i]t_would be obvious to use a solution

ready to precipitate in Marinaccio,” and reference is

made to other patents. Ex. 545 at 122.

That did not slow down Dr. Pall. In response to the

action of June 4, 1979, Pall stated in a document entitled

“Amendment” that “[t]he applicant agrees that the term

20a

‘hydrophilic’ is perhaps susceptible of being misun-

derstood, because it is not precise.” Ex. 545 at 129. He

then goes on to explain exactly what he means:

A very high angle of contact indicates very poor

wetting, while a zero angle of contact defines

complete or perfect wetting. While the poly-

amide 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 wetted by water.

Ex. 545 at 129. Dr. Pall then amended Claim 27 accord-

ingly.

All claims, including the claims objected to by the

examiner, which use the term hydrophilic were then fur-

ther 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 distin-

guishes 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

addressed the examiner’s concern as to whether particu-

lar types of nylons are critical elements of the process,

stating:

However, there is nothing critical in the poly-

amide resin, apart from its being alcohol-insolu-

ble. The applicant believes that the invention is

applicable to any alcohol-insoluble polyamide

2la

resin, and has said so, not only jn 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 “poly-

amide resin” is used generically to encompass

the entire class of alcohol-insoluble hydrophobic

polyamide resins.

Ex. 545 at 130. The word hydrophobic is used in this

passage, the Court infers, in a manner directly the oppo-

site of the Pall definition of hydrophilic.

Dr. Pall further stated: “This being so, and there

being no prior art requiring a narrowing of the claims in

this respect, the applicant proposes to maintain the pres-

ent scope of ‘polyamide’ in the claims.” Ex. 545 at 131.

On December 3, 1979, the examiner rejected all the

claims in greater detail. Ex. 545 at 165. At that time, the

examiner rejected one of the key elements of Dr. Pall’s

claimed invention, controlled nucleation. The examiner

stated:

It is submitted that there is some nucleation in

Marinaccio et al. For instance, during the addi-

tion of small amounts of non solvent, there

would come a time when a small amount of

precipitate would form temporarily and imme-

diately redissolve. In fact, applicant’s specifica-

tion (pages 43-44) suggests that there is some

nucleation in Marinaccio et al.

Ex. 545 at 166. The examiner stated that it would be

obvious to use the support of Brown and others in Mari-

naccio — by support the Court infers that the examiner is

referring to the polyester support for the membrane

sheet. The examiner continued to believe that it would be

22a

obvious to filter the casting dope and duing so was not an

advance over Marinaccio et al. Use of multiple layers

would also be obvious and was not an advance over

Marinaccio et al. The examiner made reference to a Sharp

membrane as being hydrophilic in the sense that they

have produced membranes, and so has Marinaccio, which

are “more readily wettable than prior art films.” Ex. 545

at 167. The examiner stated that one would obviously

expect a very thin, very porous film to be completely

wettable throughout as claimed. The examiner did not

think there was very much to Dr. Pall’s invention, at least

at this time. The rejection for multilayers was maintained.

Significantly, the examiner again rejected 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.

That rejection did not deter Dr. Pall and his people,

either. The summary record of the examiner interview on

May 2, 1980 indicates that all claims were discussed and

Marinaccio, Brown, and Sharp were identified as prior

art. Ex. 545 at 172. The examiner noted that he had

received an “impressive demonstration.” Ex. 545 at 172.

He further noted, “examiner will consider 132 declara-

tions in detail while reflecting on the demonstration.

Check examples for support of 6-10 carbon atoms.” Then

the examiner remarked, “Markush looks promising.” Ex.

545 at 172. A Markush claim is a claim which claims a

group of related things of which examples are given.

It is likely that a new approach to defining what was

claimed was also discussed at this interview because the

claim was amended in a document entitled “Amend-

ment” dated May 5, 1980, three days after that interview.

23a

Claim 1, describing the invention, was to be amended as

follows:

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, selected from the group consisting

of polyhexamethylene adipamide, polyhexamethylene

sebacate and poly-e-caprolactam in a polyamide

resin solvent, inducing nucleation of the solution

by controlled addition to the solution of a non-

solvent for the polyamide resin. . .

Ex. 545 at 175 (emphasis in original). The rest of the

claims were also to be amended to incorporate the limita-

tions imposed by the amendment to Claim 1. In the

remarks section of the amendment, it is stated that:

As indicated at the interview, Claims 1, 32, 56,

67, and 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 pro-

cess described and claimed herein is actually

applicable only to polyamide resins which are

polymers of hexamethylene diamine and alipha-

tic 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 polyhex-

: amethylene sebacamide (Nylon 610). These

embrace the limits of the class of saturated

24a

aliphatic dicarboxylic acids having from six

(adipic) to ten (sebacic) carbon atoms.

Ex. 545 at 178.

With reference to nucleation in the Marinaccio pat-

ent, the applicant stated:

[Claims 75 to 86] are directed to a casting resin

solution for forming hydrophilic skinless micro-

porous polyamide membranes that have a visi-

ble 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 sol-

vent, of nonsolvent, and of resin concentration,

temperature, mixing intensity, addition time,

and system geometry, resulting in this visible

precipitate. This rejection is arcordingly

answered by the discussion above of the phe-

nomenon of nucleation vis-a-vis the disclosure

ofthe Marinaccio et al. patent, in connection

with the rejection of Claim 1 on Marinaccio et al.

The Marinaccio et al. disclosure clearly teaches

one not to use a solution which contains a visi-

ble precipitate. Dilution 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, Lines 6 to 9 of the reference.

Thus, to use a solution that contains a visible

precipitate is to proceed contrary to the Mari-

naccio et al. disclosure, as noted above.

Ex. 545 at 213 (emphasis in original).

On October 20, 1980, a continuation-in-part was filed

which discusses the full abstract of the disclosure. Ex.

544. The continuation-in-part redefines the invention by

25a

what has been referred to in this litigation “the ratio

claims”:

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 form such skinless hydrophilic membranes.

All members of this class have a ratio

CH,:NHCO of methylene CH, to amide NHCO

groups within the range from about 5:1 to about

7:1, including polyhexamethylene adipamide

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

polyhexamethylene sebacamide (Nylon 610),

poly-7-aminoheptanoamide (Nylon 7), polyhex-

amethylene azeleamide (Nylon 69), and mix-

tures 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 CH,: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 hydro-

philic skinless membranes. Some of them, those

that have a ratio CH,:NHCO of methylene CH,

to amide NHCO groups within the range from

about 7:1 to about 12:1, form skinless liquophilic

membranes. The others form hydrophobic

skinned membranes.

Ex. 544 at 123 (emphasis in original).

On August 24, 1981, the examiner allowed Claims 1

through 76, and 111 through 115 and rejected Claims 77

through 110 and 116 through 172. He made the following

note: “The broadly recited amide having the claimed ratio

26a

of CH, to NHCO groups is unwarranted in view of the

disclosure. The various mixtures in that range are partic-

ularly unsupported. Only one mixture appears in the

examples. (Ex. 68). Most of the examples involve only

Nylon 66.” Ex. 544 at 168. In the summary record of the

examiner interview, the examiner wrote that all the

rejected claims were discussed, that there was no rejec-

tion based on prior art, and that the amendment looks

promising. Ex. 544 at 170. He wrote that three options

were discussed, all of which would clear up Claim 87.

The amendment to which reference is made by the exam-

iner is that which follows on page 172 of Exhibit 544. The

most significant language therein is contained in the

remarks section and it reads:

The range of CH,:NHCO ratios within the range

from about 5:1 to about 7:1 is actually rather

narrow, and it is moreover well supported in the

disclosure. The ratio of 5:1 requires there to be

five CH, to one NHCO group, and the ratio of

7:1 requires there be seven CH, groups to one

NHCO group. These limits constrain a rather

narrow range of CH,:NHCO ratios, and clearly

exclude the vast majority of polyamide resins,

all of which can of course be prepared from

diamines and dicarboxylic acids or aminocar-

boxylic acids having virtually infinite number of

carbon atoms, in virtually infinite permutations.

The specification at the bottom of page 22

lists a number of commercially available poly-

amide resins that fall within the limits of the

ratio range, and these are as follows:

——— Ee

27a

Nylon 6 [(CH,);CONH}],, 5:1

Nylon 66 [(CH,),NHCO(CH,),CONH],, 5:1

Nylon 610 [(CH,),NHCO(CH;),CONH],, 7:1

Nylon 7 [(CH,);CONH],, 6:1

Nylon 69 [(CH,),NHCO(CH,),CONH],, 6.5:1

Mixtures of these with each other or with

polyamides outside the range but with an aver-

age ratio within the limits as well as other poly-

amides within the range can of course be

conceived, but the above should make it clear

that those listed are virtually all of the permuta-

tions based on hexamethylene diamine, or on

aminocarboxylic acids, of which only Nylon 8

[((CH,),CONH],, is not specified.

Ex. 544 at 173-74.

The Pall patent issued on July 20, 1982. Although

Nylon 6 is included within the patent claims of the Pall

patent, Pall does not manufacture anything commercially

using Nylon 6.

B. The Advance Over the Prior Art.

Dr. Pall invented the first naturally and instan-

taneously wettable, completely skinless, and alcohol-

insoluble polymeric membrane and a process for making

it. The membrane was suitable for service in severe sol-

vent environments and for sterile filtration. It was strong

and pleatable so that without plasticizers it could be

made into a cartridge. It met all of the criteria the indus-

try had long sought. And remarkably, it was made of

28a

- nylon, a material that had been investigated several times

before without success.

The process invented by Dr. Pall to prepare the mem-

brane, and described in his patent, involved the prepara-

tion 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 those skilled in the art had known

how to prepare membranes by casting solutions of poly-

mers, the step of precisely controlling the nucleation of

the solution prior to casting, thereby achieving 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 recog-

nized 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 impor-

tance to the theoretical aspects of microfiltration and

helped move microfiltration from an art to a science. Dr.

Pall’s papers described the first studies which addressed

the theory of microfiltration in a thoroughly scientific and

| |

29a

at the same time practical manner. Dr. Pall and his associ-

ates 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 as an

integrity test rather than the bubble point were intro-

duced by Dr. Pall.

To a person of ordinary skill in the art, setting out in

1974 to develop a new polymeric membrane free of all the

then-existing disadvantages, there was little guidance as

to what polymers and what methods for membrane for-

mation should be pursued. A great number of polymers

and casting methods had been tried without success.

Such a person faced initially two broad choices. One was

to 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 cellulosics 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 properties could be transferred at least in

part 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.

30a

The controlled nucleation in the Pall process is criti-

cally 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 wet-

tability 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 instan-

taneously wettable. The restraint of the membrane during

drying ensures that the pores remain open and that 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 66 was known to be very sensitive to

oxidation by, for example, sodium hypochlorite (chlorine)

solutions. Since most membranologists entered the micro-

filtration membrane field via reversion osmosis where

chlorine resistance was an important desideratum, it ten-

ded to be dismissed out of hand. The fact that chlorine

was not typically encountered in microfiltration was not

considered. Nylon 66 was known to be somewhat polar,

but many indices suggested that it was less so than the

eR a ee a ee API rosie

eet oon

rer

3la

cellulosics which did yield spontaneously wettable mem-

branes without surfactants. There was little understand-

ing 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 an adequate microporous membrane polymer. Mari-

naccio’s patent was known after 1975 and it was also

known there was no corresponding commercial micro-

filtration product. The industry therefore concluded that

Nylon 6, the Marinaccio preferred embodiment, was, for

some unknown reason, not an adequate membrane poly-

mer.

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 con-

structed, suggested that the Marinaccio patent was sim-

ply a closeout of a failed product.

Likewise, the use of formic acid as the casting solvent

was original. Formic acid is not a pleasant casting sol-

vent. 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 could have predicted

the properties of the final membrane product, partic-

ularly its natural and instantaneous wettability and the

absence of any skinning.

Hydrophilicity, defined by the Pall patent as the com-

plete and very rapid penetration of water through the

32a

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 domain, 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

filtration. The user would have no choice but to dis-

assemble his filtration system and replace the membranes

or membrane cartridge. This would have adverse eco-

nomic consequences to the user — labor, cartridge replace-

ment, cost, and to the membrane producer - loss of

credibility. Therefore, instantaneous and complete mem-

brane wettability is a practical product property neces-

sity. 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 proper-

ties. Any prediction of complete wettability within one

second or two seconds through the entire thickness of a

porous membrane is impossible by extrapolation from the

bulk properties of nylon polymers.

The presence of skinning on microfiltration mem-

brane greatly reduces the concentration of accessible

33a

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 commer-

cial application since wettability with no surfactants was

an extraordinarily desirable result. Scientists in the area,

however, continued to express doubt that Nylon 66 could

be used to form a sufficiently hydrophilic membrane to

be spontaneously wettable in the membrane form with-

out 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

immobilization media in biotechnological applications. To

date, Pall alone has sold about $400 million worth of its

nylon membrane products in the aggregate.

Ill. The Validity of the Pall Patent

A. Standard of Proof.

Ot course, it is unquestioned that in accordance with

35 U.S.C. § 282 the Pall patent is presumed valid. Roper

Corp. v. Litton Sys., Inc., 757 F.2d 1266, 1270 (Fed. Cir.

1985). MSI has the burden of proving all of its allegations

of invalidity and unenforceability by clear and convinc-

ing evidence. American Hoist & Derrick Co. v. Sowa & Sons,

Inc., 725 F.2d 1350, 1358-60 (Fed. Cir.), cert. denied, 469

U.S. 821 (1984). The Federal Circuit defines clear and

convincing evidence as “an abiding conviction that the

truth of [the] factual contentions are ‘highly probable.’ ”

34a

Buildex, Inc. v. Kason Indus., Inc. 849 F.2d 1461, 1463

(Fed. Cir. 1988) (quoting Colorado v. New Mexico, 467 U.S.

310, 316 [1984]) (alteration in original).

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 Corp. v.

Eastman Kodak Co., 789 F.2d 1556, 1560 (Fed. Cir.), cert.

denied, 479 U.S. 850 (1986).

B. Anticipation by Pall’s Sale of the Membrane

Product.

In 1978, at a time following the initial filing of its

patent application but prior to the filing of its continua-

tion-in-part, Pall sold its membrane product commer-

cially. 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

_

3 On the comparison between proof by clear and

convincing evidence and proof by a fair preponderance of the

evidence, see Barry Wright Corp. v. I1°* Grinnell Corp., 724 F.2d

227, 233 (1st Cir. 1983) (clear and convincing requires showing

that it’s highly probably true); Bose Corp. v. Consumers Union of

United States, Inc., 692 F.2d 189, 195 (1st Cir. 1982) (clear and

convincing means more than a preponderance, but less than a

reasonable doubt), aff’d, 466 U.S. 485 (1984). But see New England

Elec. Sys. v. Securities & Exchange Comm'n, 376 F.2d 107, 112 n.3

(1st Cir. 1967) (“all courts that we know of consistently

recognize what to us seems self-apparent, that there is a

significant difference” between the standards of clear and

convincing evidence and fair preponderance of the evidence),

rev'd on other grounds, 390 U.S. 207 (1968).

35a

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 clea:

and convincing evidence that the ratio claims are not

entitled to the filing date of the parent application

Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570

1573-74 (Fed. Cir. 1985); Pennwalt Corp. v. Akzona, Inc., 740

F.2d 1573, 1578 (Fed. Cir. 1984). The ratio claims are

entitled to the filing date of the parent application under

35 U.S.C. § 120 if the disclosure of the parent application

complies with the enablement description and best mode

requirements of Section 112. DeGeorge v. Bernier, 768 F.2d

1318, 1320 n.1 (Fed. Cir. 1985); Pennwalt Corp., 740 F.2d at

1577, 1580 n.13; Hughes Aircraft Co. v. United States, 717

F.2d 1351, 1358-59 (Fed. Cir. 1983). Compliance with the

best mode enablement requirement is not contested in

this case. The enablement description requirement is met

if the disclosure of the parent application would have

reasonably conveyed to an artisan of ordinary skill that

Dr. Pall had invented the subject matter of the ratio

claims when he filed the patent. Utter v. Hiraga, 845 F.2d

993, 999 (Fed. Cir. 1988); Application of Smith, 481 F.2d 910,

914 (Cust. & Pat. App. 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 continua-

tion-in-part application did not constitute new matter.

36a

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 enable-

ment description requirement is satisfied. Kennecott Corp.

v. Kyocera Int'l, Inc., 835 F.2d 1419, 1421-23 (Fed. Cir.

1987), cert. denied, 486 U.S. 1008 (1988).

Accordingly, MSI has failed to prove by clear and

convincing evidence that the ratio claims are not entitled

to the filing date of the parent application, and since the

filing date of the parent application is prior to the

allegedly invalidating sales of membranes, the assertion

of invalidity under section 102(b) fails.

C. Anticipation of the Pall Patent by Marinaccio.

The Court addressed in Part I, supra, the disclosure

under 102(g) of Marinaccio’s prior invention. Now the

Court will address 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 of that claim must be found either expressly

or inherently in that single reference. Akzo N.V. v. United

States Int'l Trade Comm'n, 808 F.2d 1471, 1479 (Fed. Cir.

1986), cert. denied, 482 U.S. 909, 96 L. Ed. 2d 382, 107 S. Ct.

2490 (1987); Tyler Refrigeration v. Kysor Indus. Corp., 777

F.2d 687, 689 (Fed. Cir. 1985); In Re Donohue, 766 F.2d 531,

534 (Fed. Cir. 1985); W.L. Gore and Assocs., Inc., 721 F.2d at

1554. Second, that single reference must enable one

skilled in the art to practice the claimed invention with-

out undue experimentation. Akzo, 808 F.2d at 1479;

37a

Titanium Metals Corp. of America v. Banner, 778 F.2d 775,

781-82 (Fed. Cir. 1985). See Hybritech, Inc. v. Monoclonal

Antibodies, Inc., 802 F.2d 1367, 1379 (Fed. Cir. 1986), cert.

denied, 480 U.S. 947 (1987). For a process to anticipate a

product the process must consistently reproduce the

product. W.L. Gore and Assocs., 721 F.2d at 1554.

In this case, the Court finds that the Marinaccio pat-

ent, 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 dis-

close 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,

and the inherent wettability. 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 tempera-

ture of the product. Therefore the Court rules that the

Marinaccio patent is not an anticipatory reference such as

to invalidate the Pall patent. United States v. Adams, 383

U.S. 39 (1966).

Likewise, the Court is not convinced that there was

any public disclosure of the work that Dr. Johnson did on

Nylon 66 while at Millipore, or commercial embodiment

thereof, or that, in fact, was there any invention in that

work which would anticipate the Pall patent.

D. Obviousness.

MSI claims that the Pall patent fails because it is

obvious. The issue with respect to obviousness is whether

MSI has established by clear and convincing evidence

38a

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 claims. 35 U.S.C. § 103.

Obviousness is a question of law. It is based on factual

inquiries and factual evidence. Graham v. John Deere Co.,

383 U.S. 1, 17-18 (1966); Stevenson v. Int'l Trade Comm’n,

612 F.2d 546, 549 (C.C.P.A. 1979).

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. Bausch & Lomb, Inc. v. Barnes-Hind/Hydro-

curve, Inc., 796 F.2d 443, 447 (Fed. Cir. 1986), cert. denied,

484 U.S. 823 (1987).

The issue of obviousness is determined entirely with

reference to a hypothetical person having ordinary skill

in the art. Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d

448, 454 (Fed. Cir. 1985). Factors that may be considered

in determining the level of ordinary skill in 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 edu-

cational level of active workers in the field. Environmental

Designs Ltd. v. Union Oil Co., 713 F.2d 693, 696-97 (Fed.

Cir. 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, 774 F.2d at 454.

39a

The Court has made the findings relevant on this

issue above, with one exception — the objective evidence

of nonobviousness. Objective evidence of nonobviousness

may well be the most pertinent probative and revealing

evidence available to aid in reaching a conclusion with

respect to this issue. Demaco Corp. v. F. Von Langsdorff

Licensing Ltd., 851 F.2d 1387, 1391-92 (Fed. Cir.), cert.

denied, 488 U.S. 956 (1988).

Both the Pall and the MSI product literature emphas-

ize that the sales of nylon membranes by both of them‘

are directly attributable to the advantages offered by the

invention of the Pall patent, including its natural wet-

tability, uniform porosity, and skinlessness. Indeed, MSI

considered Pall’s nylon membrane to be revolutionary in

the art. MSI’s marketing information characterized its

own Nylon 66 product as, “the first innovative product to

be introduced to this market in 20 years. The nylon

membrane has no extractables because of its natural wet-

tability and is virtually indestructible.” 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 *epresented a major breakthrough in the

filtration industry. Dr. Pall was the first person to work

4 MSI has some $17 million worth of such sales.

40a

with a highly crystalline material and wind up with a

reproducible membrane of uniform pore size. As recited

above, AMF/Cuno had abandoned its nylon membrane

project because of technical problems. Other investigators

and scientists in the 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 pres-

ence of surfactants for many years. Commercial success is

a strong factor favoring non-obviousness. Akzo, 808 F.2d

at 1481.

MSI has failed to prove by fair and clear and convinc-

ing evidence that any of the claims in issue in the Pall

patent would have been obvious in light of the prior art.

E. Definiteness.

Claims are sufficiently definite if, when read in light

of the specifications, they 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.

Hybritech, Inc., 802 F.2d at 1385. The use of the term

“about” “does not impart invalidity to the claims [of a

patent], but is to be considered in determination of

infringement.” Andrew Corp. v. Gabriel Elec., Inc., 847 F.2d

819, 822 (Fed. Cir.), cert. denied, 488 U.S. 927 (1988). See

also, W.L. Gore & Assocs., 842 F.2d at 1280; Hybritech, Inc.,

802 F.2d at 1385; but see Amgen, Inc. v. Chugai Pharmaceuti-

cal Co., Ltd., 927 F.2d 1200, 1217-18 (Fed. Cir.), cert. denied

sub nom., Genetics Institute v. Amgen, Inc., 112 S. Ct. 169

(1991).

The Court noted above that there are many cases that

confirm that every patentee may be his own lexicogra-

pher. See, e.g., Hormone Research Found. v. Genentech, Inc.,

4la

904 F.2d 1558, 1563 (Fed. Cir. 1990), cert. dismissed, 111 S.

Ct. 1434 (1991); Jonsson v. Stanley Works, 903 F.2d 812, 821

(Fed. Cir. 1990); W.L. Gore & Assocs., 721 F.2d at 1558. This

means that a patentee can choose his own terms and use

them as he wishes so long as he remains consistent in

their use and makes their meaning reasonably clear.

Ellipse Corp. v. Ford Motor Co., 452 F.2d 163, 167 (7th Cir.

1971), cert. denied, 406 U.S. 948 (1972). See also Constant v.

Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed.

Cir.), cert. denied, 488 U.S. 892 (1988) (patentee may be his

own lexicographer provided that the patent specification

supports his asserted definition). With respect to the chal-

lenges raised in this case, the use of the terms “about,”

“hydrophilic” and “skinless” do not impart invalidity to

the claims of the patent but the meaning of those terms is

to be considered in determining infringement.

F. Summary of Conclusions Regarding Validity.

As there was no new matter in the continuation-in-

part application, the claim of fraud on the Patent Office is

inappropriate and that claim fails. Likewise, the Court

rules that the Pall patent 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

likewise had no disclosure or benefit to the public; the

Pall patert was not obvious in light of the prior art that

was known, given the commercial success of the Pall

patent, the surprise and recognition of the industry, and

42a

the failure by others; and the Pall patent is adequately

definite.

IV. Infringement

A. Nylon 66.

1. The Product Claims

The specific claims Pall alleges are infringed by MSI

with respect to its manufacture and sale of microporous

membrane made from Nylon 66 are set forth in Appendix

A to this opinion.

a. Hydrophilicity

MSI’s Nylon 66 membranes are capable when com-

pletely immersed in water of being wetted through

within no more than one second.

Under the definition of hydrophilicity as that term is

used in the Pall patent, MSI’s Nylon 66 membranes are

hydrophilic as matter of fact.

b. Skinlessness

The matter of skinlessness is a matter of significant

import here. If one looks with the naked eye at the Pall

membrane and the MSI membrane, they look and feel

identical. In the MSI membranes, however, there is more

crystallinity on the surface than in the interior. Thus, if

one magnifies the cross-sectional view of a Pall

membrane and an MSI membrane thousands of times by

a scanning electron microscope, or similarly magnifies a

top down or bottom up view of both those membranes,

43a

they look substantially different. The Pall membrane

appears of uniform porosity throughout. Under a scan-

ning electron microscope magnification of thousands of

times, however, at least one surface of the MSI membrane

frequently has, when compared to the interior of that

membrane, a surface where the pore size looks signifi-

cantly different. Many of the MSI membranes look like

they have a skin, as that word is used to refer to the

epidermis of the human body, in that the membranes

have a coating that appears to be of substantially less

porosity than the interior.

The photographic evidence reveals that at 2,000,

5,000, and 10,000 times magnification the MSI membranes

do not look like the Pall membranes. Moreover, there are

voids that appear to be bubbles in the interior of the MSI

membranes. Sometimes these bubbles appear on the sur-

face of the membrane. In an MSI membrane that is sup-

posedly rated .2 microns, voids or bubbles appear that

are as big as ten microns.

Although scanning electron microscope examples of

a Pall membrane are included in the Pall patent, the

definition of skinlessness as used in the Pall patent is one

which. does not depend on visual inspection. Whether a

membrane is skinless depends in part on whether the

membrane has pores which are substantially uniform in

size and shape. Whether the membrane is skinless further

depends on whether it has the characteristics which allow

the passage of water through the membrane in specific

fashion as measured by the KL curve, all, in this Court’s

judgment, adequately defined in the patent.

44a

Pall contends here that the actual functioning of the

MSI membrane is the same as that of the Pall membrane.

Pall is correct at least insofar as that functioning helps

define skinlessness. The MSI membranes perform as rela-

tively adequate skinless membranes. The Pall patent

speaks of skinned membranes exhibiting relatively higher

pressure drop and other poor filtration characteristics.

MSI membranes lack these defective characteristics.

There is no evidence that persuades this Court of any

fluid-blocking layer on MSI’s membranes, nor of pinholes

or other defects rendering them incapable of performing

as microporous membranes. Indeed, the MSI product lit-

erature indicates that MSI’s membranes have uniform

pore structures and are thus skinless within the meaning

of the Pall patent. MSI’s own descriptions of its mem-

branes include “highly uniform membrane,” “uniform

pore size,” “highly porous,” “precise porosity,” and

“superior bubble point uniformity.” MSI’s own docu-

ments further suggest that a porous structure and a uni-

form pore structure indicate the absence of skinning.

These functional aspects can be explicated further. A

bubble point is the pressure that has to be applied to a

membrane whose pores have been filled with water in

order to force the water through the largest pore. The

bubble point is an indication of the largest pore present in

a membrane, as that pore releases the water within it

before the smaller pores do. Thus, the larger the bubble

point the smalier the pores in the membrane.

MSI also employs flow time to.rate its membranes.

Flow time is the time required for a certain amount of

water to pass through a given area of membrane. The

smaller the pores in the membrane the longer or higher

45a

the flow time. Very high flow times for particular bubble

points indicate skinned membranes. The relationship

between pore size, bubble point and flow time for MSI

membranes is as follows:

Pore Size Bubble Point Flowtime

0.2 microns 40-50 psi 200-350 sec

0.4 microns 30 psi about 110 sec

5.0 microns 12 psi less than 50 sec

The bubble points of Pall membranes made in accor-

dance with the patent-in-suit are similar to those of the

MSI membranes for similar pore sizes. MSI membranes,

interestingly, have flow times that frequently are compa-

rable and sometimes even better than skinless Pall mem-

branes as the following data indicates.

Type Flowtimes in seconds for predetermined

Membrane amount of water to pass through mem-

brane

MSI5 Pall

40-50 psi bubble

point membrane 200-350 190-455°

30 psi bubble

point membrane about 110 46-1607

12 psi bubble

point membrane “ass than 50 228

5 The flowtime data for the MSI membrane was elicited

from Dr. Johnson at Tr. 1996 and was recorded on

Demonstrative TX-32.

6 The Pall data is found in an MSI notebook, TX-122 at 481.

7 The Pall data is found in an MSI notebook, TX-94 at 69.

8 The Pall data is found in an MSI notebook, TX-122 at 462.

46a

Moreover, the KL curves of the MSI membranes

tested are similar to the KL curves of the Pall membrane.

The similarity is especially great where, under constant

pressure, there is an abrupt curve upward rather than a

gradual curve upward. This shape of the KL curves is

explained by the fact that the through pores, the pores

that go from one side of the membrane to the other, are

all substantially the same size.

Because of these characteristics, the Court finds that

the MSI membranes are skinless. It does appear that

MSI's practice of the art is less perfect than that of Pall,

but an infringer cannot take refuge in the fact that he has

a sloppy product. Laitram Corp. v. Cambridge Wire Cloth

Co., 863 F.2d 855, 859 (Fed. Cir. 1988), cert. denied, 490 U.S.

1068-(1989) (“inefficient infringement is still infringe-

ment”); Johns Manville Corp. v. Guardian Indus. Corp., 586

F. Supp. 1034, 1066 (E.D.Mich. 1983), aff'd, 770 F.2d 178

(Fed. Cir. 1985) (“imperfect infringement’ is infringement

nevertheless”). This sloppiness, after all, is visible only to

one who has a scanning electron microscope which he

can turn up to a magnification of a thousand times. The

MSI product serves the same goal as the Pall product and

serves it in the same way. Though there is no doubt that it

looks different under extreme magnification, the MSI

product is functionly skinless in the manner of the Pall

product. Indeed, the MSI membrane with its surface con-

figuration, which the Court has held is not skinned in

light of the Pall patent claims, appears to work better

than the Pall patent for those DNA transfers involving

blotting. This is because there’s more polymer at the

surface to hold the DNA.

47a

Within the Pall patent itself, the significant references

to skinlessness are found in Column 2 at Lines 10 through

24. Ex. 500. It is suggested there that the skin to avoid is

an “exceedingly thin but relatively dense barrier layer or

‘skin’ from about 0.1 to 5.0 microns thickness of a micro-

porous polymer in which an average pore diameter is in

the millimicron range, for example, from 1.0 to 1000

millimicrons, i.e., about one-tenth to one-hundredth the

thickness of the skin.” Admittedly, the MSI membranes

have this exceedingly thin surface layer. However, the

Court does not find that it is relatively dense, but rather

that it is permeated by millions of tiny pores roughly the

same size as the pores in the rest of the membrane.

Skinned membranes, as defined in the Pall Patent in

Column 1 at Lines 49 through 53, have smaller surface

pores. While the density of the surface micropores in the

MSI membrane is less per micron than in the interior, the

surface micropores themselves are of substantially the

same diameter as the micropores in the remainder of the

membrane.

Likewise, in Column 2, Lines 32 through 34 of the

Pall patent, there is a reference to an abrupt transition

from skin to support layer. Although there is a transition

in the MSI membrane from the surface to the interior

support layer, there are pores on the MSI membranes that

are substantially the same size as the interior support

layer and act as pores which go from one side of the

membrane to the other.

The conclusion that MSI’s nylon membranes are skin-

less is supported further by the following facts. MSI's

nylon membranes compete with Pall’s in many areas that

48a

require skinless membranes, such as filtration and micro-

filtration and biotechnical applications. MSI advertised

their product as a skinless membrane. Finally, numerous

references in MSI’s notebooks relating to its laboratory

work on membranes indicate that MSI considered

skinned membranes to have undesirable performance

qualities, as exemplified as follows: “Membrane all skin.

Flow 10 min.”, TX-117 at 734; “Second was all skin, no

flow time,” TX-117 at 745; “Skinned and very weak -

tears coming off of plate.” TX-598 at M5420; “very fragile

- skinned,” TX-598, p. M5482; “doesn’t rewet - too

skinned,” TX-KM, p. M5366. The Court finds, as fact, that

MSI’s membranes are skinless within the meaning of the

Pall patent and its claims.

c. Alcohol insolubility

MSI’s Nylon 66 membranes are alcohol-insoluble as

are the resins from which they are made.

d. Hydrophobic polyamide resin

Nylon 66 has a contact angle of between 70 and 80

degrees. Nylon 46 has a contact angle of 45 degrees.

Under the general definition of hydrophilicity, Nylon 46

is more hydrophilic than Nylon 66. However, under the

Pall definition, which the Court has found to be suffi-

ciently definite, both nylons are hydrophobic.

e. Methylene to amide ratio

There is no dispute that MSI originally employed

Nylon 66 and presently employs Nylon 46, and for some

49a

applications continues to employ Nylon 66 as the resins

from which it makes its membranes. Nylon 66 has a

methylene to amide ratio of five, Nylon 46 has a meth-

ylene to amide ratio of four.

f. Reversion to hydrophobicity when

heated

Whether MSI’s Nylon 66 exhibits the reversion fea-

ture which is part of the claims of the Pall patent is in

dispute. This Court concludes that MSI’s Nylon 66, when

heated to slightly below its melting point, reverts such

that thereafter at least part of the membrane surface is

not capable of being wetted within one second. In that

sense, MSI’s Nylon 66 membrane is directly infringing.

Because the chemical analysis which explains this aspect

of the properties of both the Pall and the MSI Nylon 66

membrane is not well understood, the Court can make no

particular scientific findings thereon. The membranes

react sufficiently similarly that the Court finds that MSI

infringes Pall with respect to the reversion feature. With

respect to this feature, however, the behavior of the Pall

and the MSI membranes is not completely congruent. The

data suggest that when heated close to its melting point a

Pall membrane is no longer hydrophilic as Pall defines it

throughout much or all of its surface, whereas it appears

the MSI membrane may remain wettable throughout part

of the surface but not wettable throughout all of it. The

point is a close one, but the Court rules that the MSI

Nylon 66 membrane in fact infringes in this regard.

50a

g- Particle removal rating

MSI’s product literature indicates - and the Court

finds - that most of the MSI membranes have absolute

particle removal ratings of .1 to .20 microns. The term

absolute particle removal rating as used in the patent

claims is synonymous with MSI's pore size rating used in

its trade literature.

h. Membrane thickness

MSI’s membranes are about one-tenth of a micron to

two-tenths of a micron thick and its nylon membrane

product literature indicates thicknesses from 80 to 125

microns. That is .08 to .125 millimicron. MSI’s membranes

thus meet all the elements of Claims 48 and 132 of the

Pall patent in suit.

i. The filter claims

Dealing with the filter element, it’s clear from the

development plan of MSI that from the very beginning

MSI planned to compete with the Pall 66 cartridge, but to

undercut it by price. Pall’s products were considered.

Competition with Pall was one of the goals of MSI from

the very beginning. In light of that goal, MSI made the

corporate decision to manufacture a microporous mem-

brane from Nylon 66 that would be readily wettable.

MSI's cartridge elements contain membrane formed in a

tubular configuration. The tube is sealed to the end caps.

One of the end caps of the filter element has an opening

or a central aperture which gives access to the interior of

5la

the filter element, and all seals are sealed tight. MSI

advertises membranes to fit the Pall housing with fin and

bayonet lock, and expressly makes seals that will fit the

Pall housing.

MSI’s product literature indicates that its filter car-

tridges are fluid type when it states that its cartridges are

integrity tested, because only fluid-type cartridges can be

integrity tested with water. MSI's filter cartridges, con-

taining nylon membrane, meet all the elements of claims

49 and 133 of the Pall patent-in-suit. MSI's filter elements,

the cartridges, contain corrugated nylon membrane

sheets. Filter elements containing corrugated nylon mem-

branes are important to the filtration industry because

they permit increased amounts of membrane to be

enclosed in the cartridge. MSI's filter elements, contain-

ing nylon membrane, meet all the elements of Claims 50

and 134 of the Pall patent. The end caps in MSI's filter

elements are made from the polyester, polybutylene ter-

ephtalate, also known as polybutylene glycol terephta-

late, or PBT. MSI first started using PBT end caps in 1983

or early 1984. The MSI filter elements, containing nylon

membrane, including the end caps, are hydrophilic, as

that term is used in the Pall patent, and rapidly wetted by

water, and are, therefore, integrity testable. MSI’s filter

elements, containing nylon membrane, meet all the ele-

ments of claims 55 and 56, and 139 and 140.

2. The Process Claims

Turning to the process claims, the Court finds that

the MSI process is in various respects different from that

set out in the Pall patent, even recognizing that the Pall

52a

patent does not describe a commercial process but rather,

in patent terms, describes the claims to a process. It is

necessary, therefore, to describe the process as used by

MSI, so that a comparison can be made to the Pall process

claims.

MSI's process involves, first, adding water and then

adding powdered citric acid in a tank and mixing it, and

then pouring off a bucket of this material into a mixer.

Then certain carefully premeasured amounts of water,

hydrochloric acid, and Nylon 66 pellets or powder are

added and the resultant solution is mixed five hours or

more and held overnight. Zytel 101, the commercial

source of Nylon 66 as used by MSI, is hydrophobic, as

that term is used in the Pall patent. That is, it does not

have a zero contact angle; it’s not readily wettable by |

water in approxigiately a second. The resultant mixture, “ys

which may be ca! 8 lacquer, is n“poured into

lacquer holding*taink Which is movable which

held from zero to 24 hours

More specifically, the formulation of the lacquer con-

tains a mixture of solvents and a nonsolvent at a ratio of

nylon - 12 percent, hydrochloric acid - 8 percent, citric

acid - 60 percent, and water - 20 percent. The solvént-¢»

action of the hydrochloric acid is boosted by the citric

acid. During a portion of the period in which it has been

in production, MSI has employed formic acid as the sol-

vent for certain applications. Formic acid is the solvent

preferred in the Pall patent. Water is the nonsolvent in

the casting resin. In comparison, the Pall patent examples

employ 13 percent nylon in a solvent of between 66 and

71 percent formic acid and between 16 and 21 percent

nonsolvent water.

aa

e

53a

The lacquer holding tank is then pumped at 4 ounces

per minute through a heater tube, one half-inch in diame-

ter by four feet, and it passes then through a clear plastic

pipe through a 75 micron filter? and then into a static

mixer. The lacquer is then delivered onto the support

web, which is rolled off a roll through a coating mecha-

nism, referred to as a knife box, into a nonsolvent immer-

sion bath, then into a water rinse and, finally, at a rate of

two to four feet per minute, into a drier where it’s

exposed to drying at 350 degrees Fahrenheit of hot air.

The finished filter is then wrapped onto a spool.

The Court finds that MSI nucleates its nylon lacquer

solution by controlling the initial mixing measurement,

the concentration of the reagents, and, subsequently, the

lacquer temperature and degree of agitation. Because the

solvent used in the MSI formulation is hydrochloric acid,

however, the lacquer does not gel anywhere near as fast

as the comparable lacquer solution used by Pall. Indeed,

the MSI lacquer can be maintained in commercially

acceptable fashion overnight. MSI controls the mixing

regimen for the initial solution by setting the mixing

speed at 90 rpm. MSI has come to understand that tem-

perature is a significant variable and the temperature of

the nylon solution is initially controlled at a set tempera-

ture of 35 degrees centigrade. After mixing, the lacquer is

pumped through a heat exchanger, which heats it to a

particular temperature between 30 degrees and 70

degrees centigrade.

° Originally the lacquer passed through a 25 micron filter,

though that is no longer used.

54a

In the MSI process, the pore size is controlled by

varying the concentration of the solvent to nonsolvent

components in the lacquer by minute amounts, fractions

of a percent. The pore size is further controlled by heat-

ing the lacquer after it has been initially mixed and then

further mixing it in a static mixer while it is being trans-

ferred to the casting box. The fact that MSI prepares

membranes of different pore size by changing the tem-

perature of the lacquer and without changing the compo-

sition indicates that the lacquer is nucleated, as that term

is used in the Pall patent.

The Pall method of nucleation is one of the keys to its

patent. Controlled nucleation is vital for commercial rep-

etition of quality microporous membranes. It’s equally

clear that if the nucleation is done differently, the Pall

patent is not infringed.

While MSI recognized the importance of the nuclea-

tion, as that term is used in the Pall patent, of its casting

resin on the pore structure of a membrane as early as

October, 1982, —- a concept taken from the Pall patent — the

appearance of a visible precipitate is not a significant

parameter in the MSI process. It is true that independent

testing of the MSI lacquer solution by Pall results in a

visible precipitate temporarily appearing when drops of

nonsolvent and water are added to an MSI nylon lacquer,

which precipitate then redissolves in the solution. This is

an indication that the solution has been properly nucle-

ated, but that test does not indicate that there is any

visible precipitate in the process as employed by MSI or

any need or concern about a visible precipitate in that

process. This is a crucial difference between the Pall and

the MSI processes.

55a

MSI employs filters to filter out undissolved nylon

particles and other debris before spreading the casting

solution on the support membrane. The MSI process can-

not operate successfully without these filters.

The Pall patent examples disclose heating the casting

resin solution between 35 degrees and 70 degrees centi-

grade, in order to control the lacquer viscosity. The MSI

process depends in part on the heating of the lacquer,

which is employed to control the viscosity of the resin.

After the casting solution is prepared, a distribution

tube spreads the casting solution on the polyester sup-

port which is fed through a knife box to insure that a

thin, even, predetermined thickness of lacquer is spread

on the porous support. The Pall patent teaches that 40 to

50 percent solvent in the quench bath is necessary to slow

down the reaction and temper the reaction to prevent

skin formation. The MSI support, saturated with the

nylon lacquer, is immersed in a nonsolvent quench bath

of 40 percent citric acid and 60 percent water, where the

nylon precipitates into a solid membrane. The citric acid

makes the quench bath a less strong nonsolvent. It

reduces the nonsolvent properties of the water and acts to

temper the interaction between the lacquer film and the

quench bath, thereby causing precipitation in a uniform

consistent manner. The membrane is then immersed into

a wash bath which removes the remaining solvent and

nonsolvent. The membrane is then dried and rolled up.’°

10 Additional facts explanatory of the MSI process but not

bearing directly on the issue of infringement are: The viscosity

of MSI’s Nylon 66 resin solution is in the range of 1,000 to 3,000

centipoises. The casting and precipitating temperatures of MSI’s

56a

Since all the Pall process claims at issue depend on

process claim 77 and, more specifically, since it is no part

of the MSI process to seek, as is claimed by the Pall

patent, “to obtain a visible precipitate of polyamide resin

particles,” there can be no direct infringement by MSI of

the process claims of the Pall patent. That, however, does

not end the analysis, because a claim may be infringed

under the doctrine of equivalents if the alleged infringing

product “performs substantially the same function in

substantially the same way to obtain substantially the

same result.” Graver Tank & Mfg. Co., Inc. v. Linde Air Prod.

Co., 339 U.S. 605 (1950) (quoting Sanitary Refrigerator Co.

v. Winters, 280 U.S. 30, 42 [1929]). The court determines

the “equivalent” nature of the products by comparing: (1)

the result obtained; (2) the means of attaining that result;

and (3) the manner in which the different parts cooperate

to produce the result. Johnson & Johnson v. W.L. Gore &

Assocs., 436 F. Supp. 704, 729 (D. Del. 1977) (citing Farm-

hand, Inc. v. Craven, 455 F.2d 609 [8th Cir. 1972]); see also

Carter-Wallace, Inc. v. Gillette Co., 531 F. Supp. 840, 873 (D.

Mass. 1981), aff'd in part, rev'd in part, 675 F.2d 10 (1st Cir.

1982).

MSI very well knew the commercial success of the

Pall patent and appreciated the substantial advance it

made in the art. MSI was at all material times familiar

process are within the range of about 10 degrees centigrade to

the boiling temperature of the lowest boiling solvent or

nonsolvent component present. The MSI polyester support is

not stripped from the membrane before drying, ard after drying

remains attached to the membrane. In the MSI product, the

polyester web makes up about 75 percent of the membrane

thickness. It’s melting point is 270 degrees centigrade.

57a

with the Pall patent and intentionally sought to design

around that patent. Designing around a patent does not

constitute infringement. See Seattle Box Co., Inc. v. Indus.

Crating & Packing, Inc., 756 F.2d 1574, 1580 (Fed. Cir.

1985). The decision of the Court of Appeals for the Fed-

eral Circuit, in Slim Fold Mfg., Inc. v. Kinkead Indus. Inc.,

932 F.2d 1453 (Fed. Cir. 1991), is pertinent on this point.

As Judge Rich said there:

Intentional “designing around” the claims of a

patent is not by itself a wrong which must be

compensated by invocation of the doctrine of

equivalents. Designing around patents is, in

fact, one of the ways in which the patent system

works to the advantage of the public in promot-

ing progress in the useful arts, its constitutional

purpose.

Id. at 1457.

Judge Rich goes on to say that “[i]t is only when the

changes are so insubstantial as to result in ‘a fraud on the

patent’ that application of the equitable doctrine of equiv-

alents becomes desirable.” Id. (citations omitted). Follow-

ing the analysis in Slim Fold, “the first question which

must be asked is ‘has a substantial change been made?’

Only if the answer to that question is ‘no’ should an

accused infringer be liable for improperly trying to

appropriate the claimed invention.” Id. According to

Judge Rich, this is the point at which the Graver Tank

tripartite test should be applied:

[T]he differences between an accused device

and a claimed device are considered to be insub-

stantial only when the accused device performs

substantially the same function in substantially

58a

the same way to achieve substantially the same

result as the claimed device. The determination

of whether an accused device meets this strict

test is one of fact.

Id. (emphasis added) (citation omitted).

From a careful review of the MSI lab notebooks, the

Court finds that MSI has set up a measurements regime

that embodies the heart of the learning of the Pall patent.

Due to the Pall patent, MSI could address the problem of

production of microporous nylon membranes using

Nylon 66 far more rapidly with less experimentation and

in a much different fashion than that facing an original

inventor had addressing the problems inherent in micro-

porous membrane manufacture. By carefully measuring

the components used in the process of making these

nylon microporous membranes, MSI developed a process

which depended more on the measurements than it did

on the steps of the Pall patented process.

This Court finds that the only way one could develop

such a measurements regime is through the learning of

the Pall patent. The MSI casting solution performs sub-

stantially the same function in substantially the same way

and obtains substantially the same overall result as to the

casting solution of Pall claims 1 and 77 and the asserted

claims depending thereon. The casting resin which is

finally obtained and used is in all significant respects

equivalent to the nucleated casting solution of the Pall

patent.

The Court finds that MSI intended to design around

the Pall patent. Tested by the Graver Tank standard, all

aspects of the doctrine of equivalents are met here. The

59a

MSI Nylon 66 process infringes by virtue of the doctrine

of equivalents.

In sum, therefore, as to Nylon 66, the Pall patent

stands as valid and infringed - directly infringed as to the

product claims and infringed under the doctrine of equiv-

alents as to the process claims.

B. Nylon 46.

Nylon 46 has been known to chemists and chemical

engineers, at least theoretically, since 1942. The commer-

cial manufacture of Nylon 46 commenced approximately

May 1984, when Dutch State Mines revealed that it was

going to introduce a new commercial polymer, Nylon 46.

There are differences between Nylon 46 and Nylon 66.

Nylon 66 has a melting point of 260 degrees. Nylon 46

has a melting point of 290 degrees. Indeed, Nylon 46 is

more hydrophilic, as the term is generally used, than the

other polymers discussed in this opinion.

By October, 1989, MSI was making a commercially

acceptable microporous membrane through the use of

Nylon 46. MSI uses Nylon 46 presently to make its com-

mercial products. The original composition of Nylon 46 in

its process is a Nylon 46 powder, not the pellets used by

Pall. Nylon 46 has a contact angle of 45 degrees and is,

therefore, under the generally-accepted chemical defini-

tion, more hydrophilic than the nylon polymers used by

Pall. Nylon 46 is, however, hydrophobic as that term is

used in the Pall patent. MSI developed its Nylon 46

membrane largely in response to the instant lawsuit, out

of a desire to avoid the liability it expected to eventuate

60a

from its use of Nylon 66 membrane manufacture. By

MSI's own admission, there are but minor differences in

MSI’s process for making Nylon 46 membranes as com-

pared to its process for making Nylon 66 membranes.

Nylon 46 is known as polytetramethylene adipamide.

It is made from diaminobutane and adipic acid. It is not a

polymer of hexamethylene diaminine aliphatic saturated

dicarboxylic acids having from 6 to 10 carbon atoms, as

required by the invention of the patent-in-suit. Instead,

Nylon 46 has a ratio of methylene to amide groups of 4 to

1. It does not have a ratio of 5 to 1 or 7 to 1, as found in

Nylon 66 and Nylon 610, respectively, nor does it fall

anywhere within the range of 5 to 1 or 7 to 1 methylene to

amide groups. Of course, the patent is not limited to 5 to

1 or 7 to 1, as to its ratio of methylene to amide groups.

The patent speaks of a ratio of “about” 5 to 1 to “about” 7

to 1 methylene to amide groups.

Technical scientific exactitude in the scope of claims

is not required under 35 U.S.C. § 112. Hybritech, Inc., 802

F.2d at 1385. The law imposes no obligation on a patent

applicant to determine what is going on in a technologi-

cal gap between the claimed invention and the prior art

or to set the claim limits at the precise technological edge

of the invention. The claim is not fatally indefinite for

failing specifically to delineate the exact point at which

the claimed physical phenomenon comes into being.

Andrew Corp., 847 F.2d at 822-23.

Moreover, the term “about” is not an arbitrary term

but is a flexible term with a meaning similar to “approxi-

mately.” It is not subject to a precise and universal con-

struction but is, instead, dependent on the facts of a

6la

EEE

oan 2 eae we

particular case. Johnson & Johnson v. W. L. Gore & Assocs.,

842 F.2d 1275, 1280 (Fed. Cir. 1988); Amgen, Inc., 927 F.2d

1200 at 1218. Courts have liberally construed the word

“about” in patent cases to include a range higher and

lower than the specified amounts. See -Kolene Corp. v.

Motor City Metal Treating, Inc., 440 F.2d 77, 82 (6th Cir.),

cert. denied, 404 U.S. 886 (1971); S.C. Johnson & Son, Inc. v.

Carter-Wallace, Inc., 614 F. Supp. 1278, 1298, 1307-8

(S.D.N.Y. 1985). The test is whether “a person skilled in

the art would read the claim of the patent to contemplate

a range which includes the accused product.” Clopay

Corp. v. Blessings Corp., 422 F. Supp. 1312, 1325-26 (D. Del.

1976) (citing Johnson & Johnson v. W.L. Gore & Assocs., Inc.,

377 F. Supp. 1353, 1355 [D. Del. 1974]).

A fair reading of the language used in the Pall patent

is such that it strains credulity to place Nylon 46 within

the range of “about” 5 to 1 to about 7 to 1. Indeed, the 4

to 1 ratio of methylene to amide groups has some chemi-

cal properties that are of marginal difference in compari-

son to the higher ratios. The Court finds that Nylon 46 is

not logically within the range of about 5 to 1 to about 7 to

1. Nylon 46, therefore, does not literally infringe either

the product or the process claims of the Pall patent. Since

there is no literal infringement, here again Pall must

show that the claims of the patent are entitled to the

protection of the doctrine of equivalents before Nylon 46

can be held to infringe the Pall patent.

The Court finds that Nylon 46, as used by MSI, does

in fact perform substantially the same function as nylons

in the range of about 5 to 1 to about 7 to 1 methylene to

amide groups. It performs in substantially the same way

to achieve substantially the same result as the claimed

62a

device. Indeed, MSI in its advertising doesn’t even point

out the source of the nylon used, and claims itself that the

two nylons do precisely the same thing.

The Graver Tank doctrine of equivalents and its tripar-

tite test is thus met. Graver Tank Co., 339 U.S. at 605. The

differences between the accused device and the claimed

device are insubstantial. The answer to the question of

whether a substantial change has been made by switching

to Nylon 46 is “no.”

The Court therefore must go on to consider whether

the Nylon 46, which the Court finds infringes the Pall

patent under the doctrine of equivalents, can be held so

to infringe in light of file wrapper or file history estoppel.

It is very clear that file wrapper estoppel bars recourse to

the doctrine of equivalents in cases where the patentee

attempts to secure through equivalents what has been

rejected by the Patent Office. See, e.g., Exhibit Supply Co. v.

Ace Patents Corp., 315 U.S. 126 (1942); Jonsson, 903 F.2d at

818; Standard Oil Co., 774 F.2d at 452.

“{File wrapper estoppel] prevents application of the

doctrine of equivalents to recapture coverage which the

patentee has surrendered by amendment whether or not

prior art required the amendment.” Carter Products, Inc. v.

Colgate-Palmolive Co., 269 F.2d 299, 304 (4th Cir. 1959). See

also Oregon Saw Chain Corp. v. McCulloch Motors Corp., 323

F.2d 758, 768 (9th Cir. 1963), cert. denied, 377 U.S. 915

(1964). Under the Fourth Circuit view, it is irrelevant

whether the surrendered claim was given up in light of

the prior art or some other reason. This has not been the

view of all the circuits. Specifically, in Bishman Mfg. Co. v.

Stewart Warner Corp., 380 F.2d 336, 340 (7th Cir.), cert.

63a

denied, 389 U.S. 897 (1967), the Court held that “[a] neces-

sary condition for the establishment of a file wrapper

estoppel is that the patentee must have narrowed his

claim in response to an objection by the Patent Office in

order to obtain the patent.” Along the same lines, is the

case of Trio Process Corp. v. L. Goldstein's Sons, Inc., 461

F.2d 66 (3rd Cir.), cert. denied, 409 U.S. 997 (1972). There,

the Court held:

The doctrine [of file wrapper estoppel] is based

on the theory that the prior art is either in the

public domain or already patented, so that the

patentee may not claim it as part of his inven-

tion. By redrafting or abandoning a claim in the

face of a prior art rejection, the patentee is con-

ceding that he has not invented what he thereby

disclaims, and therefore will not be heard to

assert, at a later date, what he disclaimed as his

invention. Accordingly, for “file wrapper estop-

pel” to become operable, it is necessary, at the

least, that a claim have been narrowed to avoid

the prior art.

Here, the claims were redrafted, not

because they trespassed upon the prior art, but

because they were considered misdescriptive in

view of the specification of the patent. The rejec-

tion here was a technical matter based on the

Rules of Practice of the Patent Office, and had

nothing to do with the question of whether the

matter rejected was patentable. In such a situa-

tion, it would not be equitable to deprive a

patentee of the full fruits of his invention

because of a formalistic rule of the Patent Office.

Id. at 75 (citations omitted). Trio Process is frequently cited

and, as will be seen, remains good law. It has been cited

64a

in this district, albeit for a different proposition, in

Polaroid Corp. v. Eastman Kodak Co., 641 F. Supp. 828, 853

(D. Mass. 1985), aff'd 789 F.2d 1556 (1st Cir.), cert. denied,

479 U.S. 850 (1986). See also Johnson & Johnson v. W.L. Gore

& Assocs., 436 F. Supp. 704, 730 (D. Del. 1977).

In the First Circuit, however, the law has been to the

contrary. The First Circuit is aligned with the Fourth and

the Ninth Circuits on this issue. The First Circuit, speak-

ing through Chief Judge Aldrich, a most distinguished

jurist and an expert in patent matters, said, in dictum, in

Borg-Warner Corp. v. Paragon Gear Works, Inc., 355 F.2d

400, 406 (ist Cir. 1965), cert. dismissed, 384 U.S. 935 (1966):

In our opinion the determinative factor [as

to whether file wrapper estoppel ought apply]

should not be the reason why a change was

required by the Patent Office, but what, in fact,

was surrendered. .. . [I]t should make no differ-

ence whether [the] reason was an alleged con-

flict with prior art or alleged insufficient

definiteness. In either event a subsequent party,

examining the file to make sure that his own

device . . . would not infringe, would discover

that so broad a scope had been affirmatively

disclaimed. The patentee, accordingly, should be

estopped to recapture it.

In the usual case, this conflict between the Circuits

would not be germane because this Court would be

bound by the First Circuit approach. The matter at hand,

however, is no longer within the jurisdiction of the First

Circuit or any of the numbered circuits, but rather it is

within the jurisdiction of the Federal Circuit. As a result,

the conflict between Circuits could present a problem.

Fortunately, the Federal Circuit has spoken to the issue in

65a

Bayer Aktiengesellschaft v. Duphar Int’l Research B.V., 738

F.2d 1237, 1241-43 (Fed. Cir. 1984) and earlier in Hughes

Aircraft Company Co., 717 F.2d at 1362.

In Hughes, the Federal Circuit said:

Some Courts have expressed the view that

virtually any amendment of the claims, creates a

“file wrapper estoppel” effective to bar all resort

to the doctrine of equivalents and to confine

patentee “strictly to the letter of the limited

claims granted[.]” We, as has the Supreme

Court, reject that view as a wooden application

of estoppel... .

Amendment of claims is a common practice

in the prosecution of a patent applications. . . .

Amendments may be of different types and may

serve different functions. Depending on the

nature and purpose of an amendment, it may

have a limiting effect within a spectrum ranging

from great to small to zero.

Hughes, 717 F.2d at 1362-63.

Then, in Bayer Aktiengesellschaft, that court said:

Thus, whenever the doctrine of file history

estoppel is invoked, a close examination must

be made as to, not only what was surrendered,

but also the reason for such a surrender. The fact

that claims were narrowed does not always

mean that the doctrine of file history estoppel

completely prohibits a patentee from recaptur-

ing some of what was originally claimed.

Accordingly, limiting the claims because of a

restriction requirement, as occurred here, would

not necessarily invoke file history estoppel.

Bayer Aktiengesellschaft, 717 F.2d at 1243.

66a

These decisions govern the analysis in this case, not-

withstanding the earlier dispute in the Circuits and the

decision of the First Circuit in Borg-Warner. See also

Anchor Plastics Co., Inc. v. Dynex Indus. Plastics Corp., 363

F. Supp. 582, 605 (D. N.J. 1973) (following Borg-Warner),

aff'd, 492 F.2d 1238, 181 U.S.P.Q. (BNA) 611 (3d Cir.), cert.

denied, 417 U.S. 955 (1974).

More precisely, the analysis followed by this Court

here derives in part from that in Johnson & Johnson v. W. L.

Gore & Assocs., 436 F. Supp. 704 (D. Del. 1977). That case

is similar to this case in that the Court there found that

the claims of the patent were not literally infringed and

applied the doctrine of equivalents. That court said:

The fact that the expanded, lower density

tape was unknown at the time of the application

for the patent in suit does not render the doc-

trine of equivalents inapplicable.

For infringement, the equivalent need not

have been known at the time of the inven-

tion. .. . “[A]n inventor is entitled to whatever

merits his invention has, even though they may

be greater than he supposed.”

Id. at 730 (quoting Johnson & Johnson v. W.L. Gore &

Assocs., Inc., 377 F. Supp. 1353, 1355 [D. Del. 1974)}).

In the instant case, the evidence reveals that at the

time of the Pall patent application Nylon 46 was known

to people experienced as chemists in the area of nylon

polymers. Its chemical properties were known. Its meth-

ylene to amide ratio was known. Even so, it was not

commercially available; it was not being produced for

commercial purposes. Pall, of course, did not have to

67a

experiment with every possible methylene to amide com-

bination in order to claim the patented invention. There

was, in short, no requirement that Pall experiment with

Nylon 46 to understand its properties.

This Court concludes that Pall, in limiting its claims

in response to the overbreadth concerns of the patent

examiner, never gave up a claim to Nylon 46. Pall’s own

experiments indicated the expected range of the validity

of its invention, but the use « f the term “about,” which is

an appropriate term, is indi ative that Pall was not sur-

rendering the invention down to the limits of ratios

between 5 to 1 and 7 to 1 methylene to amide groups. As

matter of fact, Pall never intended to abandon and did

not abandon its claim to workable nylon polymers which

fall outside the range of methylene to amide ratios

between 5 to 1 and 7 to 1, so long as the ratio is within the

penumbra of methylene to amide combinations which are

“about” that range. Accordingly, the Court rules that

although there is no literal infringement in this case,

given its peculiar facts, the doctrine of equivalents is not

trumped or rendered inapplicable by the file wrapper

history.

V. Remedies

A. Injunctive Relief.

1. Scope of Injunction

Since the MSI production of microporous membrane

using Nylon 66 and Nylon 46 infringes the Pall patent

under the doctrine of equivalents, and since that patent is

68a

valid, MSI, its agents, servants, and counsel, and all per-

sons acting in concert with any of them, are forthwith

enjoined from any further production or sale of any items

embodying microporous membrane produced using

either Nylon 66 or Nylon 46.

2. Partial Stay of Injunction

A patent holder whose patent is infringed suffers

irreparable injury for every day of the infringement. Such

injury cannot adequately be compensated simply by cal-

culating the lost profits, but rather the victim of infringe-

ment suffers interference with its relationship with

customers and the like, all of which the injunction is

designed to prevent.

Even so, while the legal determinations here with

respect to Nylon 46 are both appropriate and called for

by the applicable law, they are difficult and complex and

worthy of appellate review. Moreover, in the absence of a

stay of so much of the injunction as pertains to Nylon 46,

MSI will go out of business and, in effect, suffer corporate

death.

Most important, the public interest in this calculus

favors a partial stay of this injunction so that there not be

an interruption in the supply to third parties who buy

these materials of the various important scientific and

medical applications presently served by the more eco-

nomical MSI products. Balancing the harms, the harm to

MSI from granting the injunction significantly outweighs

the harm to Pall from partially staying the injunction.

69a

Accordingly, the injunction as to MSI microporous

membrane produced from Nylon 46, not as to MSI prod-

uct using Nylon 66, is stayed pending 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, 1992. This stay is

vacated by its own terms if MSI’s appeal of this Court’s

judgment is dismissed.

Since this is an increasing bond, there has to be

another provision. The Court expects that MSI will seek

an expedited hearing from the Court of Appeals of the

Federal Circuit, and the increases which are to take place

on January 1 and on June 30, 1992, are of no force and

effect should Pall object to any advancement of the

appeal, accelerated briefing schedule, or other acceler-

ated appellate determination of the matter. Pall has to

press just as hard to hang on to its judgment as MSI is

pressing to have the judgment reversed. That’s the only

way the bond stays in effect.

B. Damages.

Chapter 35 of the United States Code, section 284,

provides that, in the case of infringement, the patent

owner, in this case Pall, is entitled to an award of dam-

ages adequate to compensate for the infringement but in

no event less than a reasonable royalty for the manufac-

ture, use, and sale made of the invention by the infringer,

here MSI. Pall is entitled to interest and costs as fixed by

the Court. A spread sheet setting forth each of the ele-

ments of damages calculated in this case, exclusive of

70a

interest and costs, is set forth as Appendix B to this

opinion. The text sets out the Court’s analysis and speci-

fic factual findings as to damages. The period of time

material to the instant case includes the fiscal years set

forth in the first column of the spread sheet, 1983-1990.

Moreover, MSI had $ 2,786,572 in infringing sales through

June 19, 1991. The total MSI infringing microporous mem-

brane sales, including both Nylon 66 and Nylon 46, from

the year 1983 through June 19, 1991, are $ 17,897,479 in

the aggregate.

1. Lost Profits

Pall may recover damages for lost profits if it can

show a reasonable probability that, but for the infringe-

ment, it would have made the sales that were made by

MSI. Kaufman Co., Inc. v. Lantech, Inc., 926 F.2d 1136, 1141

(Fed. Cir. 1991); Beatrice Foods ¥. New England Printing, 899

F.2d 1171, 1173 (Fed. Cir. 1990); State Indus. v. Mor-Flo

Indus., Inc., 883 F.2d 1573, 1577 (Fed. Cir. 1989), cert.

denied, 493 U.S. 1022 (1990). To recover lost profits Pall

need not negate all possibility that a purchaser might

have bought a different product or might have foregone

the purchase altogether. Del Mar Avionics, Inc. v. Quinton

Instrument, Co., 836 F.2d 1320, 1326 (Fed. Cir. 1987); King

Instrument Corp. v. Otari Corp., 767 F.2d 853, 864 (Fed. Cir.

1985), cert. denied, 475 U.S. 1016 (1986); Paper Converting

Mach. Co. v. Magna-Graphics Corp., 745 F.2d 11, 21 (Fed.

Cir. 1984).

In order to recover lost profits Pall must show: (1) a

demand for the patented product; (2) the absence of accept-

able noninfringing substitutes; (3) the manufacturing and

7la

marketing capability to exploit the demand; and (4) the

amount of profit it would have made. Panduit Corp. v. Stahlin

Bros. Fibre Works, Inc., 575 F.2d 1152, 1156 (6th Cir. 1978). This

method of proof, also called the Panduit test, has been

accepted by the Court of Appeals for the Federal Circuit. Bio-

Rad Lab. Labs., Inc. v. Nicolet Instrument Corp., 739 F.2d 604,

616 (Fed. Cir.), cert. denied, 469 U.S. 1038 (1984). See also State

Indus., 883 F.2d at 1577 (approving modified version of Pan-

duit test).

As part of the lost profits analysis courts rely on what

has become known as the incremental income approach.

Paper Converting Mach. Co., 745 F.2d at 22. That approach

has been adopted in this district by my colleague, Judge

Harrington, in King Instrument Corp. v. Perego, 737 F.

Supp. 1227, 1242 (D. Mass. 1990). This Court is not bound

to follow the analysis of another judge in the district but

the Court is not inclined to reinvent the wheel, either, and

where there is a persuasive analysis of a point by one’s

colleague in the same district, matters of comity and

equality among litigants —- as Judge Wyzanski put it -

strongly incline the Court toward following the same

analysis, and this Court does so. Wyzanski, “The Essen-

tial Qualities of a Judge,” from The New Meaning of

Justice (1956), reprinted in Handbook for Judges 96

(American Judicature Society 1975).

At the close of Pall’s case on damages, this Court

opined that 25 percent of the total MSI nylon sales market

appeared to be an accurate calculus, for purposes of

damages, of the lost sales that Pall would have made. On

reflection, this calculus seemed overly generous to Pall

because it instantaneously awarded 25 percent of the MSI

72a

sales to that competitor. It then seemed that an appropri-

ate analysis, consistently drawing appropriate and fair

inferences from the facts, would have been to start with a

Pall penetration of the MSI market at approximately five

percent per year, five percent in ’83, ten percent in ’84, 15

percent in ‘85, 20 percent in ‘86, stabilizing at 25 percent

thereafter.

Ultimately, however, this Court has come to believe

that this incremental approach is too crabbed a construc-

tion of the market share that Pall would have attained in

the absence of infringement. The Court has in mind speci-

fically that the MSI cartridges did not meet the require-

ments of the pharmaceutical industry. MSI has published

various advertising materials in advance of the actual

development of certain membranes. In certain instances

the MSI materials could not pass the pharmaceutical tests

and thus MSI has not made significant sales to the phar-

maceutical industry, notwithstanding advertisements

which represent that the applicable tests were passed. It

seems likely, therefore, that Pall is, and was at all material

times, positioned to garner the bulk of that market. Like-

wise, Cuno was not in the disk market at all.

On the other hand, two critical points tend to limit

Pall’s market share, even in the absence of infringement.

They are these. First, there is a significant price differen-

tial between the prices of Pall’s items and the prices of

MSI's items. Some of Pall’s items are fifty percent higher

in price than the corresponding MSI item. The Court

infers that with such a price differential some people will

refuse to buy from Pall at all, even if it is the only

supplier, and they will no longer be part of the market.

73a

Others will look for a less workable but perhaps accept-

able substitute. Second, as one comes to dominate a mar-

ket more completely, as it appears Pall dominates the

cartridge and disk markets for nylon materials, a party

who is capable of entering that market like Cuno, is more

inclined to do so if they can undercut Pall’s price at all.

Due to Pall’s efforts, such a producer knows there is a

market for that item. As owner of the Marinaccio patent,

Cuno, having settled with Pall, knows it can go forward

without fear of a patent suit, if it can produce the item at

a lesser price.

The incremental income analysis is an appropriate

method for calculating lost profits. See Paper Converting

Mach. Co., 745 F.2d at 22; King Instrument Corp., 737 F.

Supp. at 1242. In arriving at a figure for lost profits, the

Court rejects Pall’s suggestion that its average prof-

itability is 67.2 percent. With respect to the transfer mem-

brane market, Pall would have to tool up to meet the bulk

of what MSI was doing. Pall has failed to meet its burden

of proving that its research and development costs would

be as small as were testified to, and that its direct mate-

rial costs would not be greater than was testified to.

Taking these matters into account, the Court finds that

the incremental profitability of Pall’s items is 45 percent.

This, therefore, leads the Court to conclude that lost

sales of 25 percent for each year, starting in 1983, is an

appropriate and reasonable inference, having in mind the

various variables just discussed. When coupled with an

incremental profitability of 45 percent, Pall’s lost profits

are calculated at $ 2,013,466 as set forth in the third

column in this spreadsheet, Appendix B.

74a

2. Royalty Damages

In calculating a reasonable royalty, the Court follows

the criteria set forth in Georgia-Pacific Corp. v. U.S. Ply-

wood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970), modified, 446

F.2d 295 (2d Cir.), cert. denied, 404 U.S. 870 (1971). The

fifteen factors relevant to a determination of a reasonable

royalty have all been considered by the Court here."

11 As stated by the court in Georgia-Pacific, those factors are

as follows:

The royalties received by the patentee for the

licensing of the patent in suit . . . [,] [t]he rates paid by

the licensee for the use of other patents comparable to

the patent in suit[,] [t]he nature and scope of the

license, as exclusive or non-exclusive; or as restricted

or non-restricted in terms of territory or with respect

to whom the manufactured product may be sold[,]

[t]he licensor’s established policy and marketing

program to maintain his patent monopoly .. . [,] [t]he

commercial relationship between the licensor and

licensee . . . [,] [t]he effect of selling the patented

specialty in promoting sales of other products of the

licensee . . . [,] [t]he duration of the patent and the

term of the license[,] [t]he established profitability of

the product made under the patent; its commercial

success; and its current popularity[,] [t]he utility and

advantages or the patent property over the old modes

or devices, if any, that had been used for working out

similar results[,] [t]he nature of the patented

invention; the character of the commercial

embodiment of it as owned and produced by the

licensor; and the benefits to those who have used the

invention[,] [t]he extent to which the infringer has

made use of the invention; and any evidence

probative of the value of that use[,] [t]he portion of

the profit or of the selling price that may be

customary in the particular business or in comparable

75a

Application of the 15 part test of Georgia-Pacific, 318 F.

Supp. at 1120, indicates that a royalty of eight percent is

appropriate. The Court accordingly makes the findings in

column four of the spreadsheet, Appendix B. Royalty

damages thus aggregate $ 1,073,849.

3. Prejudgment Interest

With respect to prejudgment interest, the Court rules

that, “absent some justification for withholding such an

award,” prejudgment interest should be awarded both on

the lost profits and reasonable royalty portions of the

damage award. General Motors Corp. v. Devex Corp., 461

U.S. 648, 657 (1983). Setting prejudgment interest at the

prime rate, the Court makes the findings set forth in the

fifth column of the spreadsheet, Appendix B. Prejudg-

ment interest thus aggregates $ 848,955.

4. Willfulness

Willfulness must be proved by clear and convincing

evidence in order to justify increased damages under 35

U.S.C. § 284 (1988). E.I. Du Pont de Nemours & Co. v.

businesses to allow for the use of the invention or

analogous inventions[,] the portion of the realizable

profit that should be credited to the invention . . . [,]

[t]he opinion testimony of qualified experts{,] [t]he

amount that a licensor (such as the patentee) and a

licensee (such as the infringer) would have agreed

upon (at the time the infringement began) if both had

been reasonably and voluntarily trying to reach an

agreement{.]

Georgia-Pacific, 318 F. Supp. at 1120.

76a

Phillips Petroleum Co., 849 F.2d 1430, 1440 (Fed. Cir.), cert.

denied, 488 U.S. 986 (1988). This determination is to be

made on the basis of the totality of the circumstances. It

must be shown that the “infringer had no reasonable

basis for believing it had a right to do the acts.” Stickle v.

Heublein, Inc., 716 F.2d 1550, 1565 (Fed. Cir. 1983); See also,

State Indus., Inc. v. A.O. Smith Corp., 751 F.2d 1226, 1237

(Fed. Cir. 1985); American Original Corp. v. Jenkins Food

Corp., 774 F.2d 459, 465 (Fed. Cir. 1985).

Here recognizing that MSI has intentionally sought to

design around the Pall patent but has, in fact, made

extraordinarily extensive use of that patent in its own

process, and having in mind that counsel was not consul-

ted to give an opinion about the infringement or lack

thereof, this case would appear to be a candidate for

increased damages based on willfulness. Nevertheless,

the Court rules that, in the main, there ought not be any

increased damages for willfulness here. The Court

reaches that result through the following analysis.

Failure to consult counsel is but one factor that may

be considered in determining willfulness. American Origi-

nal, 774 F.2d at 465; Ryco, Inc. v. Ag-Bag Food Corp., 857

F.2d 1418, 1428 (Fed. Cir. 1988). In this case, the failure to

consult counsel is not terribly troublesome. The Court

sees no reason that counsel ought monopolize knowledge

about these matters. Inventors ought not be penalized

simply because they don’t go to counsel. Here MSI's

people are experienced in the industry. They made signif-

icant efforts to avoid the claims of the patent. They have

avoided the process claims in the case of Nylon 66, and

both the product and process claims so far as Nylon 46

77a

goes. MSI is liable here only through the application of

Doctrine of Equivalents.

What’s more, the application of the Doctrine of

Equivalents here is not free from doubt as to the process

claims, both as to Nylon 66 and Nylon 46. The matter is a

complex one to which the Court has given a great deal of

thought. Taking all these aspects into account, the Court

does not find, in the main, that there should be any

increased damages with respect to willfulness.

There is this one exception. In October, 1989, MSI

began producing its product line, primarily using Nylon

46, a product which the Court has already found MSI

utilized to avoid the Pall patent. What’s more, it switched

to Nylon 46 during the course of vigorous and active

litigation in this case, during a period when it’s clear that

it was advised by competent and knowledgeable patent

counsel. Even after it switched to Nylon 46, however, on

occasion it continued to manufacture items using Nylon

66.

It must have been apparent to MSI by October, 1989,

given its extensive research efforts and the involvement

of its patent counsel, that Nylon 66 infringed the product

claims of the patent-in-suit. To that extent - the manufac-

ture by MSI after October, 1989, of microporous mem-

brane using Nylon 66 - the damages that stem from such

manufacture are declared to be willful.

In cases where willfulness is found, it is a separate

and distinct determination whether increased damages

should be awarded. Modine Mfg. Co. v. Allen Group, Inc.,

917 F.2d 538, 543 (Fed. Cir. 1990), cert. denied, 111 S. Ct.

2017 (1991); Ryco, Inc., 857 F.2d at 1429; Kloster Speedsteel

78a

AB v. Crucible, Inc., 793 F.2d 1565, 1580 (Fed. Cir. 1986),

cert. denied, 479 U.S. 1034 (1987). Here, having heard the

damages evidence, the Court doubles, but does not tre-

ble, the damages with respect to the willful infringement

of the Pall patent by the use of Nylon 66 in the manufac-

ture of microporous membranes through the 1990 fiscal

year and the 1991 fiscal year to April 2nd, 1991. The

additional damages resulting from the willful infringe-

ment come to $ 198,021. ns

5. Attorneys Fees

The award of attorneys’ fees under the patent law is

reserved for those exceptional cases where there has been

conduct so egregious that as an equitable matter, the

award of attorneys’ fees is appropriate. 35 U.S.C. § 285

(1988). While the matter is within the discretion of the

Court, such discretion may be exercised only upon a

specific finding of exceptional circumstances. Beckman

Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551

(Fed. Cir. 1989). Such circumstances include inequitable

conduct in the manner of conducting the litigation. See,

e.g., Bayer Aktiengesellschaft, 738 F.2d at 1242; Hughes v.

Novi American, Inc., 724 F.2d 122, 124-25 (Fed. Cir. 1984).

This case is such an exceptional case because, when

faced by clear requests for discovery of the use of Nylon

46, MSI, nevertheless, refused to make discovery and

instead concealed its refusal by making discovery which

did not go so far as to disclose the use of Nylon 46

although MSI well knew it was using Nylon 46 in its

manufacturing process and must have understood the

79a

reach of the discovery requests. MSI wrongfully arro-

gated to itself the determination of relevance.

That being so, Pall is awarded so much of its attor-

neys’ fees as are addressed solely to the prosecution of

the case as to the use of Nylon 46.

First, the Court is satisfied that under the patent laws

the attorneys’ fees portion of an award can include the

actual costs for testifying expert witnesses and their par-

ticipation in preparation, testing, and testifying with

respect to the case.

Here, the Court excludes from the calculus any sum

having to do with Mr. Petran simply because his work

was really done and

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