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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 1997
- **Citation:** 520 U.S. 1115

## Text

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 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

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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386007_1520%3A2. Public record. Not legal advice.
