# Petition for Writ of Certiorari — Shandon Inc. v. Miles Laboratories, Inc.

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition for Writ of Certiorari
- **Published:** January 1, 1994
- **Citation:** 510 U.S. 1100

## Text

Bupreme Gourt, WA,
FILED

NOV 24 1993

93-834

f
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| OFFICE OF THE @LERK

-

Case No.

iN THE
Supreme Court of the United States
OCTOBER TERM, 1993

SHANDON INC., et al,
Petitioners,

Vv.

MILES LABORATORIES, INC., et al.,
Respondents.

PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT

PETITION FOR WRIT OF CERTIORARI

Robert D. Yeager

Counsel of Record For Petitioners
Kirkpatrick & Lockhart

1500 Oliver Building

Pittsburgh, Pennsylvania 15222
(412) 355-8605

Christine R. Ethridge

Counsel for Petitioners
Kirkpatrick & Lockhart -
1500 Oliver Building

Pittsburgh, Pennsylvania 15222

November 24, 1993

Balmar Legal Publishing Services, Washington, D.C., (202) 682-9800

i

QUESTION PRESENTED FOR REVIEW

To best serve the Constitutional purpose of promoting the
progress of Science and the useful Arts, should the reach of the
Doctrine of Equivalents be determined only by the subjective
and increasingly inconsistent application of the func-
tion/way/result test, or by an evaluation of the four objective
factors advanced by this Court in Graver Tank as justification
for a finding of infringement under the Doctrine?

ii

PARTIES TO THE PROCEEDING

Pursuant to Supreme Court Rules 14.1.(b) and 29.1., the
parties to the proceedings in the Court of Appeals for the Federal
Circuit were the Petitioners, Shandon Inc. and Shandon South-
ern Products Limited and the Respondents, Miles Laboratories,
Inc. and Triangle Biomedical Equipment, Inc.

The parent companies of the Petitioners are set forth below:

For Shandon Inc.

Parent:-Life Sciences International Inc. which is
wholly owned by Life Sciences International
PLC

All subsidiaries are wholly owned.

For Shandon Southern Products Limited (now by change
of name, Life Sciences international (Europe) Ltd.)

Parent:-Life Sciences International PLC
All subsidiaries are wholly owned.

iii

TABLE OF CONTENTS
Page
QUESTIONS PRESENTED FOR REVIEW _.._. i
PARTIES TOTHE PROCEEDINGS ........ li
TABLE OF AUTHORITIES............. Vv
CP ee ee l
STATEMENT OF GROUNDS FOR
a eee 2
CONSTITUTIONAL PROVISION
ANDSTATUTEINVOLVED............ 2
STATEMENT OF THECASE............ 3
SE ooh etr k ya s,s, tod nee 3
The Accused Device .............. 4
Se ae tae tires phe 5
The Federal Circuit Decision .......... 6
REASONS FOR GRANTING THE WRIT ..... 8

I. The Federal Circuit, Whose Charter Was
To Unify Decisional Patent Law, Has Lost
Touch With The Objective Factors That
Bottomed This Court’s Decision In Graver
Tank And Now Subjectively Applies The
Doctrine Of Equivalents; As A Result,
Uncertainty Abounds ............ 8

Il. Despite The Complete Absence Of
Graver Tank’s Objective Factors —
Imitation, Insubstantial Changes, Known
Interchangeability Between The Accused ~
And Patented Structures — The Federal
Circuit Subjectively Applied The Doctrine
To Petitioner’s Improved Device ...... 12

iv
Page
IIL. In Analyzing The “Result” Branch
Of The Function/Way/Result Test,
The Federal Circuit Looked To The
Result Of The Invalid ’460 Method

Patent, Not The ’073 Apparatus
PatentInIssue....-.-------+-°° 14

‘os bi): re a 15

Vv

TABLE OF AUTHORITIES
Page
Constitution of the United States:
Article I, Section 8, Clause8 .....~2.2.«iw«i«#« 2,9

United States Code: |
Title 28, Section 1254(1) (1993) ..........
Title 35, Section 103 (West Supp. oo, Ce
Title 35, Section 271(a) (1984). ...........
Cases:

Corning Glass Works v. Sumitomo
Electric U.S.A., Inc.,
868 F.2d 1251 (Fed. Cir. 1989)... .._ 9

Graver Tank & Mfg. Co. v.
The Linde Air Products Company,
339 U.S. 605 (1950).............. passim

Hughes Aircraft Co. v. U.S.,
717 F.2d 1351 (Fed. Cir. 1983) ...... .. 9

London v. Carson Pirie Scott & Co..
946 F.2d 1534 (Fed. Cir. 1991) ........ 11

Malta v. Schulmerich Carillons Inc..
952 F.2d 1320 (Fed. Cir. 1991), reh. den..
959 F.2d 923 (Fed. Cir. 1992) cert. denied.
— U.S. __, 112 S.Ct. 2942 (1992) ...... 9,10

Pennwalt Corp. v. Durand-Wayland, Inc.,
833 F.2d 931 (Fed. Cir. 1987), cert. denied,
485 U.S. 961 and 1009(1988) ......._. 9

Nm Ww he

Sanitary Refrigerator Co. v. Winters,
SOP Um. SOUND ns tak ones cnun 8

vi

Schneider (USA), Inc. v. Cordis Corporation,

DC Minn, No. 4-92-1143 (Sept. 9, 1993) . . . 9
Spectra Corp. v. Lutz,

839 F.2d 1579 (Fed. Cir. 1988) ....-.-.-- 9
Wilson Sporting Goods v.

David Geoffrey & Associates,
904 F.2d 677 (Fed. Cir. 1990),
cert. denied, 498 U.S. 992 (1990)... .--- 14

Other:

Adelman, Martin J. and Francione, Gary L..
The Doctrine Of Equivalents In
Patent Law: Questions That Pennwalt

Did Not Answer,
137 U. PA. L. REV. 673 (1989) .....-.-- 1]

Burchfiel, Kenneth J., Patent Misuse and
Antitrust Reform: “Blessed Be The Tie?” ,
4 HARV. J.L. & TECH. 1 (1991). ..--.-.- 12

Moorhead, Sean T., Note, The Doctrine
of Equivalents: Rarely Actionable
Non-Literal Infringement or the
Second Prong of Patent
Infringement Charges’,
53 OHIO ST. LJ. 1421 (1992) ...---.-- 12

Casc No.

IN THE
Supreme Court of the United States
OCTOBER TERM, 1993

SHANDON INC., et al.,
Petitioners,

V.

MILES LABORATORIES, INC., et al.,
Respondents.

PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

PETITION FOR WRIT OF CERTIORARI

Petitioners, Shandon Inc. and Shandon Southern Products
Limited, respectfully pray that a writ of certiorari issue to review
the judgment and opinion of the United States Court of Appeals
for the Federal Circuit entered in its Case Nos. 92-1358, -1387
on June 14, 1993.

OPINIONS BELOW
The opinion of the Court of Appeals for the Federal Circuit
is reported at F.2d 27 USPQ2d (BNA) 1123 (Fed.

Cir. 1993) and is reprinted in the Appendix! beginning at page
A-l.

| References to the Appendix in this booklet are “A” followed by the
page number; thusly “A-1”. References to the Joint Appendix filed in the
Federal Circuit are “JA” followed by the page number.

2

A Petition for Rehearing was denied on Sepiember 1, 1993;
a Suggestion for Rehearing in Banc was also denied September
1, 1993; the order denying the Combined Petition for Rehearing
and the Suggestion for Rehearing in Banc is set forth in the
Appendix at pages A-53, 54.

The Opinion, Memorandum Opinion and Orders of the
District Court entered March 11, 1992, April 14, 1992 and May
8, 1992, respectively, are set forth in the Appendix beginning at
page A-16.

STATEMENT OF GROUNDS
FOR JURISDICTION

The judgment of the Court of Appeals for the Federal
Circuit was entered on June 14, 1993, and issued as a mandate
on July 6, 1993. A petition for rehearing and a suggestion for
rehearing in banc were denied on September 1, 1993. This
Court has jurisdiction under 28 U.S.C. § 1254(1) (1993).

CONSTITUTIONAL PROVISION
AND STATUTE INVOLVED

Constitution of the United States, Article I,
Section 8, Clause 8:

The Congress shall have Power . . . to promote the
Progress of Science and useful Arts, by securing for
limited times to Authors and Inventors the exclusive
Right to their respective Writings and Discover-
ies;. .

Title 35, United States Code, § 271(a):
271. INFRINGEMENT OF PATENT.

(a) Except as otherwise provided in this title, who-
ever without authority makes, uses or sells any pat-
ented invention, within the United States during the
term of the patent therefor, infringes the patent.

ae ee sit

3

STATEMENT OF THE CASE

Background

This petition arises out of an action by Respondents Miles
Laboratories, Inc. (“Miles”) and its licensor against Petitioners
Shandon Inc. (“Shandon”) and its U.K. parent, Shandon South-
ern Products Limited (“Shandon Southern”) alleging that
Shandon’s sales of tissue processors manufactured by Shandon
Southern infringe two patents? exclusively licensed by Miles.
Tissue processors automatically process tissue using a very old,
well-understood procedure that involves the sequential treat-
ment of tissue specimens with a series of chemical solutions
(sometimes called “reagents”)? to prepare the specimens for
viewing under a light microscope to detect, for example, cancer
cells.

Early tissue processing equipment typically consisted of a
rotary carousel of open-topped solution containers into which
the tissue specimens were sequentially dunked. This arrange-
ment allowed noxious fumes from the volatile reagents to per-
vade the laboratory. Later devices, including those involved
here, employ a central processing basin which holds the speci-
mens while the liquid reagents are moved, one-by-one, from
storage bottles into the basin (or chamber) and back.

The ’460 method patent, which was held invalid for obvi-
ousness under 35 U.S.C. § 103, claims a particular method for
moving the liquid reagents solutions within a tissue processor.
The ’073 patent, the subject of this petition, claims a tissue

2 15. Patent No. 4,001,460 (“the '460 patent”) claims a process and U.S.
Patent No. Re. 29,073 (“the 073 patent”) claims an apparatus. The specifi-
cation and drawings are identical, the ’460 patent being a division of the
original of the ’073 patent. See JA-842 through JA-864. Copies of the patents
are lodged with the Clerk of the Supreme Court.

. Exemplary of reagents used in tissue processing are the volatile sub-
stances formalin, xylene and various alcohols.

| |

4

processing apparatus in which the unpatentable method may be
practiced. The Federal Circuit reversed the district court’s
judgment that the claims of the 073 patent are literally infringed
and affirmed the district court’s judgment that the claims of the
’073 patent are not invalid and are infringed under the doctrine
of equivalents.

The Accused Device

In response to a complaint in 1980 received from the
Canadian Health Authority demanding that something be done
to prevent the amount of xylene fumes in the laboratory from
reaching adverse levels, Shandon Southern, in the person of its
senior design engineer, John Gordon, began the design of a new
tissue processor.* Mr. Gordon knew of the two commercially
available tissue processors, one made by Miles called the “VIP”
which purported to use the method of the *460 patent, and
another made by Fisher Scientific. It was known in the industry
that both machines emitted large quantities of fumes.

Mr. Gordon’s efforts produced an automated tissue pro-
cessor called the “Hypercenter’, for which Shandon South-
ern was awarded a patent. The accused Hypercenter
employs Mr. Gordon’s eventual solution to the problem of
noxious fume emission; namely, abandon the conventional
(Miles and Fisher) technique of trying to filter the air emitted by
the tissue processor and adopt a “closed loop” system in which
all liquids and gases are-held captive within the system so that
no fumes of any kind are discharged to atmosphere during
normal operation.

4 Shandon Southern had been a longtime supplier of tissue processing
equipment.

5 USS. Patent No. 4,604,964 (JA-1472-82). During the prosecution of
the application leading to the Gordon patent, the U.S. Patent and Trademark
Office considered U.S. Patent No. 3,892,197, the original of the ’073 reissue
patent in suit, and presumably found Mr. Gordon’ s invention to be patentable
over the teachings of that patent.

Bios CA RRM alee

5

A further dramatic improvement in the Hypercenter was its
modular design. As shown in the Shandon brochure [A-56, 57],
the Hypercenter consists of three separate cabinets: a command
module which houses the controls for operating the Hypercen-
ter, a reaction module which contains the processing chamber
and the paraffin baths, and a fireproof storage module which
houses the volatile reagent storage bottles. Mr. Gordon delib-
erately chose the modular design in order to isolate the flamma-
ble reagents used in tissue processing from any source of
ignition, notably the electrical components. In the Hypercenter,
the back and forth movement of volatile liquids from the storage
module to the reaction module is accomplished by pneumatic
(air) pressure exerted by a pump located in the control module
and transmitted through air lines to the other two modules. Mr.
Gordon thus sacrificed the lower cost and operating conve-
nience associated with housing all components of the Hypercen-
ter within a single cabinet in favor of a more expensive and
complex, but safer design.

The ’073 Patent

The ’073 patent (and its companion, the *460 patent)
discloses the tissue processor that was built for the inventors,
Thomas D. Kinney and John E. P. Pickett, in the early 1970's.
As is evident from FIG. 1 of the ’073 patent [A-55], all of the
components of the Kinney/Pickett tissue processor are con
tained in a single cabinet. Indeed, the 073 patent speaks of “the
many advantages of unifying all the necessary processing and
control apparatus in a common table top mounted cabinet’’®

© ‘The specification states that the controls could be mounted in a separate
cabinet and the claims stafe that the controls are mounted proximate the
cabinet. The clear preference, however, is for unification. More importantly,
every other element recited in the claims, including other electrical compo-
nents and the reagent solution containers, are specifically required to be
positioned in the same cabinet. In contrast, the Hypercenter’s design sepa-
rates all electrical components from the vicinity of the volatile reagents.

6

[JA-850, ’073 patent at Col. 10, lines 36-38] and describes the
apparatus as being “unified in a table mounted cabinet.” [JA-
846, Col. 2, lines 22-23]. The specification provides further that
“[t]he mounting of the air pump 61 and its associated piping and
valves in the cabinet provide a unitary and self-contained pro-
cessing apparatus with obvious advantages.” [JA-850, Col. 10,
lines 27-30]. Ironically, the first prototype tissue processor
made for Kinney and Pickett was destroyed by fire.

The Federal Circuit Decision

The Federal Circuit determined that “the district court
clearly erred in finding that the HYPERCENTERSs (consisting
of three cabinets) literally infringed the single cabinet limitation
of the 073 patent.” A-9. The Federal Circuit observed that
[t]he district court properly construed the term ‘cabinet’ to
mean a single’ enclosure for the various parts of the apparatus.
The claims, specification, and drawings disclose a single cabinet
enclosing the tissue processing apparatus.” A-8.

However, the Federal Circuit affirmed the district court’s
holding with regard to infringement of the asserted claims of the
073 patent under the doctrine of equivalents. Shandon had
argued that the district court did not determine that the accused
Hypercenter achieves substantially the same result as the ’073
patent and that the stated purpose of the single cabinet in the
’073 patent is to unify the various components, whereas the three
modules of the Hypercenter intentionally disperse the compo-
nents. The Federal Circuit acknowledged the three prong func-
tion, way and result test of Graver Tank & Mfg. Co. v. Linde Air
Products Co., 339 U.S. 605, 608 (1950), and said that the
doctrine’s goal is to prevent “the pirating of the patentee’s
invention... when liability is nevertheless warranted.” A-9. The
Federal Circuit, however, seized upon language in the district
court’s opinion that emphasized the process aspects of the

7 Emphasis ours throughout unless otherwise noted.

7

apparatus disclosed in the ’073 patent.® Building upon that
language, the Federal Circuit concluded:

Regardless of separation into modules, Shandon’s
system is still a “completely automatic system for
allowing light microscopy tissue to be processed
under a completely automatic sequence in an entirely
closed system and without requiring substantial
movement of the specimens.” (citations omitted)
Thus, the HYPERCENTERs achieved substantially
the same result as the ’073 patent.

To allow Shandon to escape infringement simply
because it used separate cabinets, as opposed to a
single cabinet, is the exact type of injustice the doc-
trine of equivalents prevents. A-10, 11.

The Federal Circuit thus determined that, notwithstanding
the unpatentability of the process for automatically processing
tissue defined in the claims of the "460 method patent (..e., the
“same result” the Federal Circuit talked about above) and the
lack of literal infringement of the °073 patent, the Hypercenter,
a novel device in its own right, is within the reach of the doctrine
of equivalents.

8 The Federal Circuit’s quotation of the district court reads:

The 073 patent discloses an apparatus for fixing and processing the
tissue specimens. It is an improvement over the prior art because it
represents the first completely automatic system for allowing light
microscopy tissue to be processed under a completely automatic se-
quence in an entirely closed system and without requiring substantial
movement of the specimens. (emphasis in original) A-10, A-19.

8

REASONS FOR GRANTING THE WRIT

I. The Federal Circuit, Whose Charter Was To Unify
Decisional Patent Law, Has Lost Touch With The
Objective Factors That Bottomed This Court’s
Decision In Graver Tank And Now Subjectively
Applies The Doctrine Of Equivalents; As A Result,
Uncertainty Abounds.

The last time this Court addressed the doctrine of equiv-
alents was in its 1950 decision, Graver Tank, 339 U.S. 605
(1950). In that case, the Court upheld a district court deter-
mination that the use of manganese in substitution for mag-
nesium in a claim to a composition for a welding flux
constituted infringement of the claim under the doctrine of
equivalents. Mr. Justice Jackson, on behalf of the majority,
recounted the basis for the doctrine of equivalents:

But courts have also recognized that to permit imita-
tion of a patented invention which does not copy every
literal detail would be to convert the protection of the
patent grant into a hollow and useless thing. Such a
limitation would leave room for - indeed encourage -
the unscrupulous copyist to make unimportant and
insubstantial changes and substitutions in the patent
which, though adding nothing, would be enough to
take the copied matter outside the claim, and hence
outside the reach of law. One who seeks to pirate an
invention, like one who seeks to pirate a copyrighted
book or play, may be expected to introduce minor
variations to conceal and shelter the piracy.

Justice Jackson then quoted earlier Supreme Court decisions in
which it had been said that infringement may be found under
the doctrine of equivalents if the device of another “‘performs
substantially the same function in substantially the same way to
obtain the same result.”” Graver Tank, 339 U.S. at 608, quoting
Sanitary Refrigerator Co. v. Winters, 280 U.S. 30, 42 (1929).

In the last forty-three years, the “function, way and result”
test has become the starting and stopping point in every doctrine
of equivalents analysis, but its application by the Federal Circuit
falls short of the peace of mind and guidance a real framework
for analysis should provide. The just goal of the doctrine, to
prevent piracy by the introduction of insubstantial changes
without loss of the constitutional goal of promoting the useful
arts?, has been lost. The function, way and result test can be
used to support any outcome desired, depending on how broadly
or narrowly the function or the result is defined. Whether to
define it broadly, by applying it to the “invention as a whole”!®,
or narrowly, by applying it on an “element-by-element’”!! basis,
or whether to entertain the issue at all,!2 has been the subject of
considerable controversy in the Federal Circuit and the lower
courts.

Petitioners respectfully call on this Court to provide the
framework and guidance lacking in this area of the law for so
long. The success of the Federal Circuit in bringing conformity
to other issues of patent law has not been duplicated in regard
to the doctrine of equivalents. Ina startling comment on this
failure, Chief Judge Nies of the Federal Circuit observed, “the
interpretation of the doctrine of equivalents, will continue to

9 US. Const art. I, § 8, cl. 8, supra p.2.
10 Hughes Aircraft Co. v. U.S.,717 F.2d 1351 (Fed. Cir. 1983).

1! pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931 (Fed. Cir.
1987); Spectra Corp. v. Lutz, 839 F.2d 1579 (Fed. Cir. 1988); but see, Corning
Glass Works v. Sumitomo Electric USA. Inc., 868 F.2d 1251 (Fed. Cir.
1989) and Malta v. Schulmerich Carillons Inc., 952 F.2d 1320 (Fed. Cir.
1991).

12 Schneider (USA), Inc. v. Cordis Corporation, DC Minn, No. 4-92-
1143, slip op. (Sept. 9, 1993) (where the court granted a motion for summary
judgment, declining to permit the question of infringement under the doctrine
of equivalents to go to the fact finder, and remarked that if the doctrine of
equivalents is applied too broadly it “can eviscerate both the claiming system
and the goal of providing notice to the public of the scope of a patent. ")

a

10

depend on the selection of the panel.” Malta v. Schulmerich
Carillons Inc., 959 F.2d 923 (Fed. Cir. 1992) den 'g reh. of 952
F.2d 1320 (Fed. Cir. 1991).

Consistency in the application of the doctrine of equiva-
lents and conformity in the reach of the patent monopoly is
critical to progress in this country. Business people, particularly
in today’s economic climate, are wont to spend precious re-
sources designing improvements, solving problems in existing
technology and developing new products if the fruits of their
labor and the benefits of their advances can be stripped from
them, without notice, by the sometimes broad and always un-
predictable reach of the doctrine of equivalents in patent in-
fringement actions. This is particularly painful where, as in the
instant case, improvers have been able to avoid the literal scope
of another’s patent; where, as in the instant case, the changes
and improvements made were not unimportant and insubstan-
tial; where, as in the instant case, there has been no piracy, but
rather a good faith effort to correct serious problems in the
conventional technology.

Mr. Justice Black, in a dissenting opinion in Graver Tank,
339 U.S. at 617, foreshadowed the events of today:

Hereafter a manufacturer cannot rely on what the
language of a patent claims. He must be able, at the
peril of heavy infringement damages, to forecast how
far a court relatively unversed in a particular techno-
logical field will expand the claim’s language after
considering the testimony of technical experts in that
field. To burden business enterprises on the assump-
tion that men possess such a prescience bodes ill for
the kind of competitive economy that is our profes-
sional goal.

Mr. Justice Black’s concern for business was not unwar-
ranted. The application of the doctrine of equivalents by the
courts has been inconsistent and haphazard; and there are no

11

signs that the Federal Circuit is headed toward correction of the
problem.!3 Commentators and legal scholars have bemoaned
the negative impact; one observed:

The doctrine of equivalents is the primary (although
not the exclusive) cause of the current uncertainty
surrounding the scope of patent claims. This uncer-
tainty has serious consequences. First, uncertainty
about the scope of patent protection hinders .. -
business decisions, such as the direction that research
and development efforts should take. Second, a pri-
mary purpose of the protection of intellectual property
is to encourage the production of inventions. . . . The
uncertainty generated by the doctrine of equivalents
frustrates and chills the activities of these other inven-
tors, who must be concerned about whether their
j efforts will be met by an infringement suit based on
the amorphous doctrine of equivalents. . . .'4

Another observed:

_..the courts have intentionally fashioned the doctrine
of equivalents into one of the most complex and

13 As almost a lone voice, Circuit Judge Lourie said in 1991:

Application of the doctrine of equivalents is the exception, however,
not the rule, for if the public comes to believe (or fear) that the language
of patent claims can never be relied on, and that the doctrine of
equivalents is simply the second prong of every infringement charge,
regularly available to extend protection beyond the scope of the claims,
then claims will cease to serve their intended purpose. Competitors
will never know whether their actions infringe a granted patent.

' London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).
Circuit Judge Rader, who authored the unanimous opinion in this case, was
a member of the panel in London.

14 Martin J. Adelman and Gary L. Francione, The Doctrine Of Equiva-
j lents In Patent Law: Questions That Pennwalt Did Not Answer, 137 U. PA.
L. REV. 673, 682-83 (1989).

POET ee REY eee se

12

unpredictable factors in patent enforcement. The es-
sentially subjective nature of the standard makes it
difficult to determine whether a device or composition
.. . Will be held to be an equivalent until the case is
decided on appeal.!5

Il. Despite The Complete Absence Of Graver Tank’s
Objective Factors — Imitation, Insubstantial
Changes, Known Interchangeability Between The
Accused And Patented Structures — The Federal
Circuit Subjectively Applied The Doctrine To
Petitioner’s Improved Device.

The confusion and subjectivity in applying the doctrine of
equivalents need not have happened. Graver Tank provides
meaningful, objective benchmarks to be considered in the ap-
plication of the doctrine:

- the presence or absence of unimportant and insubstantial
changes and substitutions in the patents [339 U.S. at 608]

+ whether persons skilled in the art would have known of the
interchangeability of the accused equivalent structure and
the patented structure [/d. at 609]

- whether the accused equivalent structure was developed as
the result of independent research or experiments [/d. at
612]

+ whether there is equivalence in fact between the patented
structure and the accused equivalent structure. [/d. at 608]

[tis only in the assessment of the last benchmark — equivalence
in fact — that the function/way/result test should come into play.
The Federal Circuit has used the test, however, in a subjective

'S Kenneth J. Burchfiel, Patent Misuse and Antitrust Reform: “Blessed
Be The Tie?”, 4 HARV. J.L. & TECH. 1, 93-94 (1991); See also, Sean T.
Moorhead, Note, The Doctrine of Equivalents: Rarely Actionable Non-Lit-
eral Infringement or the Second Prong of Patent Infringement Charges ?, 53
OHIO ST. LJ. 1421, 1428 (1992).

13

vacuum without regard to the other three objective benchmarks
advanced by Graver Tank to justify a finding of infringement
under the doctrine of equivalents. It is important to keep in mind
that the doctrine is applied only after a determination that the
accused device does not include every limitation required by the
claims and, therefore, does not literally infringe the patent. The
doctrine should thus be applied sparingly after consideration of
all four of the Graver Tank objective benchmarks. The reliance
on the function/way/result test to the exclusion of the other
benchmarks and the subjective, inconsistent application of the
tripartite test has permitted it to evolve into nothing more than
a mantra with which to initiate every doctrine of equivalents
analysis. The direction the analysis takes thereafter, as dis-
cussed above, is unpredictable.

The Federal Circuit in this case had no evidence before it

on the first three benchmarks that would favor the application
of the doctrine of equivalents. To the contrary, the record
showed:

- The Hypercenter’s three modules were adopted despite an
increased cost of manufacture compared with a single
cabinet, but the improvement in safety with regard to fire
hazard was worth it.

The ’073 patent contains no suggestion of modularization
to effect the complete segregation of electrical components
from volatile reagents; to the contrary, the patent specifi-
cation speaks of the benefits of unifying all components in
a single cabinet and the claims require the juxtapositioning
of electrical components and solution containers in the
same cabinet.

- The Hypercenter was designed with knowledge of the
existing single cabinet designs and was deemed by the US.
Patent and Trademark Office to be a sufficient advance
over the patented device to warrant a patent itself.

14

Against this factual background, the Federal Circuit im-
mediately seized upon the function/way/result test, proclaiming
that its application “prevents the pirating of the patentee’s
invention in the absence of literal infringement when liability is
nevertheless warranted’. [A-9] How, in this case, is liability
“nevertheless warranted”? Certainly, the objective factors of
Graver do not “warrant” liability. The answer, unfortunately,
is that liability is warranted by the subjective notions of the
court.

So strong were these notions, apparently, that the Federal
Circuit, as we shall see, applied the result of the wrong one of
the two patents in suit to its analysis of the Hypercenter.

Ill. In Analyzing The “Result” Branch Of The
Function/W ay/Result Test, The Federal Circuit
Looked To The Result Of The Invalid ’460 Method
Patent, Not The ’073 Apparatus Patent In Issue.

The Federal Circuit has always stated that the scope of
equivalence cannot expand the patentee’s right to exclude to
cover things in the prior art for which patent protection would
not have been granted. Wilson Sporting Goods v. David Geof-
frey & Associates, 904 F.2d 677 (Fed. Cir. 1990). In the instant
case, however, the Federal Circuit has opened the door.

The Federal Circuit’s opinion attributes to the claimed
apparatus a function and result found to be within the skill of
the art. The method for automatically processing tissue speci-
mens at a single location, the processing chamber, as defined in
the claims of the 460 patent, was determined to have been
obvious to those of ordinary skill in the art. Those claims are
invalid and do not benefit from the patent monopoly. Thus,
anyone should have been able to practice that process, in an
apparatus not covered by the 073 patent, without liability for
patent infringement. To borrow Justice Douglas’ words, we end
with a strange anomaly: the monopoly on the process of the ’460
patent lives on.'°

16 Graver Tank, 339 U.S. at 618.

15

The Federal Circuit’s analysis under the docirine of equiv-
alents did not focus on the result which the specification of the
'073 patent attributes to the structural limitations of the claims
— unification. Instead, the Federal Circuit focused on the
process to be performed by the tissue processing apparatus as a
whole. But that process is unpatentable and cannot be allowed
to form the basis of a test for equivalence. Decisions to reject
claims of a patent application made by the Patent and Trademark
Office and decisions to invalidate patent claims made by courts
are rendered meaningless if the thing declared to be unpatentable
can be used, in the name of the doctrine of equivalents, to extend
the patent monopoly of the valid claiins of a companion patent.

If the Federal Circuit had focused on the result of the
structural elements set forth in the claim, the panel would have
considered the patent’s stated goal of unification discussed
above. When the result is defined as unification, three modules
that separate the elements and remove all electrical components
from the vicinity of the solution containers for fire protection
cannot be construed as being equivalent to a single cabinet that
unifies the elements and deliberately positions the electrical
elements in the same cabinet as the volatile, flammable reagents.

CONCLUSION

The extension of the patent monopoly under the doctrine
of equivalents as applied by the Federal Circuit is inconsistent,
unpredictable and often in direct contradiction to the constitu-
tional goals to be served by the patent laws. The outcome iS
based not on any objective standard, but on judicial fiat.

This Court’s decision in Graver Tank applied the doctrine
of equivalents to prevent a fraud on a patent by the clever pirate
who makes insignificant and insubstantial changes to a claimed
invention to escape the literal language of the claims. In the
years since Graver Tank was decided, the subjective and some-
times sweeping application of the function/way/result test has

16

allowed the doctrine of equivalents to become a great pirate in
its own right, stealing, without fair warning, the fruits of those
who develop improvements in a field in total disregard to
whether the changes are substantial and significant.

We do not propose abandoning the doctrine of equivalents
in its entirety. There are still unscrupulous pirates that should
be enjoined from stealing another’s invention. We do propose
that this Court set down clear guidelines which the Federal
Circuit can follow to render consistent decisions under the
doctrine of equivalents and which the business and scientific
communities can follow to make reasonable determinations
regarding the future of research and development.

For the reasons expressed herein, Petitioners respectfully
request this Court to grant this Petition for Writ of Certiorari to

consider the application of the doctrine of equivalents.

Respectfully submitted,

Robert D. Yeager
Counsel of Record
Kirkpatrick & Lockhart
1500 Oliver Building
Pittsburgh, PA 15222
(412) 355-8605
Christine R. Ethridge
Counsel for Petitioners
Kirkpatrick & Lockhart
1500 Oliver Building
Pittsburgh, PA 15222

November 24, 1993

CK

cree ne

Case No.

IN THE
Supreme Court of the United States

OCTOBER TERM, 1993

SHANDON INC., et al.,

Petitioners,

We

MILES LABORATORIES, INC., et al.,
Respondents.

PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT

APPENDIX

Robert D. Yeager

Counsel of Record For Petitioners
Kirkpatrick & Lockhart

1500 Oliver Building
Pittsburgh, Pennsylvania 15222
(412) 355-8605

Christine R. Ethridge

Counsel for Petitioners
Kirkpatrick & Lockhart

1500 Oliver Building
Pittsburgh, Pennsylvania 15222

Balmar Legal Publisiing Services, Washington, D.C., (202) 682-9800

FN NNR BREE Gs 8 RAR a REE A

A-i

APPENDIX
TABLE OF CONTENTS

Page
Opinion of June 14, 1993 of the
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Order of March 11, 1992 of the
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Opinion of March 11, 1992 of the
RPM aw Sk tb ete aiwre nn A-17
Order of April 14, 1992 of the
I a A-45
Memorandum Opinion of April 14, 1992
ofthe DistrictCourt............... A-47
Order of May 8, 1992 of the ;
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Order of September 1, 1993 of the
Federal Circuit denying Request
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Fig. 1 of U.S. Patent No. Re. 29,073 ...... A-55

HypercenterBrochure.............. A-56

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A-l

United States Court of Appeals
for the Federal Circuit

MILES LABORATORIES, INC. and
TRIANGLE BIOMEDICAL EQUIPMENT, INC..,
Plaintiffs/Cross-Appellants,

V.

SHANDON INC. and SHANDON SOUTHERN
PRODUCTS LIMITED,
Defendants-Appellants.

92-1358,-1387

Arnold Sprung, Sprung Horm Kramer & Woods, of Tarry-
town, New York, argued for plaintiffs/cross-appellants. With
him on the brief was Nathaniel D. Kramer.

Robert D. Yeager, Kirkpatrick & Lockhart, of Pittsburgh,
Pennsylvania, argued for defendants-appellants. With him on
the brief were Christine R. Ethridge and Melvin C. Snyder, III.

Appealed from: U.S. District Court for the
Western District of Pennsylvania

Judge Diamond

A-2

United States Court of Appeals
for the Federal Circuit

MILES LABORATORIES, INC. and
TRIANGLE BIOMEDICAL EQUIPMENT, INC.,
Plaintiffs/Cross-Appellants,

V.

SHANDON INC. and SHANDON SOUTHERN
PRODUCTS LIMITED,
Defendants-Appellants.

92-1358,-1387

DECIDED: June 14, 1993

Before PLAGER, Circuit Judge, SMITH, Senior Circuit Judge,
and RADER, Circuit Judge.

RADER, Circuit Judge.

Miles Laboratories, Inc. and Triangle Biomedical Equip-
ment, Inc. sued Shandon Inc. and Shandon Southern Products
Limited, for infringement of U.S. Patent Reissue No. 29,073,
entitled “Light Microscopy Processing Apparatus” (’073),* and
U.S. Patent No. 4,001,460, entitled “Light Microscopy Process-
ing Method” (460). The United States District Court for the
Western District of Pennsylvania held claims 1, 2, and 4-7 of
the ’460 patent invalid for obviousness, sustained the validity of
the 073 patent, and found infringement of both patents. Miles
Lab., Inc. v. Shandon, Inc., No. 86-2404 (W.D. Pa. Mar. 11,
1992) (Miles I); Miles Lab., Inc. v. Shandon, Inc., No. 86-2404
(W.D. Pa. Apr. 14, 1992) (Miles IT). Because the record ade-
quately supports the district court’s decision, this court affirms.

*

U.S. Patent Reissue No. 29,073 issued on December 14, 1976 as a
reissue of U.S. Patent No. 3,892,197, which was issued on July 1, 1975.

A-3

BACKGROUND

Tissue processing is the treatment of tissue specimens to
facilitate viewing them under a microscope. The process ex-
poses the tissue specimens to a series of chemical solutions
(reagents) in sequence. The ’460 patent claims a method and
the ’073 patent an apparatus for tissue processing. Except for
the claims, the two patents have identical specifications. _

Under the method accomplished by the apparatus, a central
processing chamber confines the tissue specimens under a
sealed cover where they remain fixed during treatment with
various fluids and paraffin. Once embedded in paraffin, the
specimens can be sliced into very thin sections for microscopic
viewing. The treatment takes place when a vacuum draws the
fluids and paraffin into the central chamber. After proper expo-
sure, pressure in the central chamber expels the fluids back to
their storage containers. Thus, the entire processing occurs
without tampering with the tissue specimens.

In 1986, Miles sued Shandon for infringement of both
patents. The district court held a bench trial in 1988. The
district court determined that the doctrine of laches did not bar
this action and that claim 1 of the ’460 patent was invalid under
35 U.S.C. § 103. Miles I, slip op. at 30. The district court also
upheld the validity of the 073 patent and found infringement of
both patents. Jd. |

Later, the district court clarified its earlier decision and
added the *460 patent’s dependent claims 2 and 4-7 to its
obviousness ruling. Miles II, slip op. at 1. In addition, the district
court enjoined Shandon from further infringement of the ’073
patent. Jd. Shandon appeals the validity determination on the
’073 patent and the infringement rulings. Miles cross-appeals
the invalidity determination on the ’460 patent.

A-4
DISCUSSION

Standard of Review

This court reviews the district court’s fact finding under the
“clearly erroneous” standard of Rule 52(a):

Findings of fact, whether based on oral or documen-
tary evidence, shall not be set aside unless clearly
erroneous, and due regard shall be given to the oppor-
tunity of the trial court to judge of the credibility of
the witnesses.

Fed. R. Civ. P. 52(a) (1988); see Heisig v. United States, 719
F.2d 1153, 1158 (Fed. Cir. 1983). This court accepts the legal
conclusions of the district court unless incorrect as a matter of
law. Id.

‘This court does not review de novo proceedings of the
district court. Medtronic, Inc. v. Daig Corp. , 789 F.2d 903, 904,
229 USPQ 664, 666 (Fed. Cir.), cert. denied, 479 U.S. 931
(1986). To win reversal, a party must show that the district court
committed reversible legal error or relied upon factual findings
which were clearly erroneous in light of the trial record. Jd. at
904-05. In addition, the “clearly erroneous” standard does not
entitle this court to reverse the district court’s finding simply
because it would have decided the case differently. Hybritech
Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375, 231
USPQ 81,87 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987).
Where the fact-finder’s account of the evidence is plausible in
light of the entire record or where it chooses one of two permis-
sible views of the evidence, it has committed no clear error. /d.

The ’073 Patent

On the last day of trial, Shandon moved to introduce an
infringement defense that the ’073 patent was invalid for indef-
initeness under 35 U.S.C. § 112,42 (1988). The district court,
however, upheld the validity of the °073 patent. On appeal,

A-5

Shandon alleges the claims of the 073 patent omit the require-
ment for “vented” solution containers and therefore do not
distinctly claim the disclosed invention.

Validity

Shandon challenged the claims of the ’073 patent as indef-
inite under § 112,49 2. Compliance with § 112, 4 2 is a question
of law. Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d
1565, 1576, 1 USPQ2d 1081, 1088 (Fed. Cir. 1986). Section
112, paragraph 2, states:

The specification shall conclude with one or more

claims particularly pointing out and distinctly claim-

ing the subject matter which the applicant regards as

his invention.
35 U.S.C. § 112, 4 2. The “distinctly claiming” requirement
means that the claims must have a clear and definite meaning
when construed in the light of the complete patent document.
Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 452,
227 USPQ 293, 296 (Fed. Cir. 1985). Section 112 thus ensures
definiteness of claim language. See In re Zletz, 893 F.2d 319,
322, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).

The test for definiteness is whether one skilled in the art
would understand the bounds of the claim when read in light of
the specification. Orthokinetics, 806 F.2d at 1576. If the claims
read in light of the specification reasonably apprise those skilled
in the art of the scope of the invention, § 112 demands no more.
Hybritech, 802 F.2d at 1385. The degree of precision necessary
for adequate claims is a function of the nature of the subject
matter. Id.

At trial, a Miles expert, Mr. Kocsis, stated:

Q Now, reading these claims [of the ’073 patent),
which we have just discussed, did you see any

A-6

mention in any of these claims of vented contain-
ers or reagent bottles, or anything like that?

A No, I did not.

Q_ Now, that single machine, as described in the
°460 and ’073 patents, requires that a vent to
atmosphere be present in each solution container
in order for the machine to transfer solutions
from a solution container to a processing cham-
ber and back, is that correct?

A That’scorrect.

Relying on these isolated statements, Shandon contends
that the claims do not specify vented solution containers. With-
out vented containers, Shandon contends, the claims do not
describe a workable invention. Without vents, Shandon asserts,
the invention cannot change pressure to draw fluids into and out
of the central treatment chamber.

Shandon’s argument is irrelevant to definiteness under §
112,42. The invention’s operability may say nothing about a
skilled artisan’s understanding of the bounds of the claim.
Shandon’s argument is possibly relevant, however, to the en-
ablement requirement of § 112, { 1, or to utility under § 101.

Construed as a challenge to utility or enablement,
Shandon’s argument nevertheless fails. Mr. Kocsis testified that |
the claimed tissue processors would operate with or without
vents in the solution containers. Without vents, collapsible
solution containers could permit the transfer of fluids by pres-
sure changes. The district court correctly concluded that “the
record shows that even unvented containers would be opera-
tive.” Miles II, slip op. at 4. Thus Shandon did not show a lack
of utility, even if the claims cover only unvented containers.

Tneaennenscnemameasamennimaaaaiaamamaa

A-7

The trial court also determined that the claims, read in light
of the specification, covered both unvented containers and
vented containers. In fact, the preferred embodiment described
in the specification discloses “vented” solution containers:

Referring again to FIG 3, the previously referred to
solution containers 15 (with operating numbers 1
through 10) have respective caps 55 for refilling the
containers. Suitable air vents 56, indicated by dashed
lines, are provided in each cap 55, but are preferably
kept extremely small so as to limit any admission of
moisture.

Col. 6, lines 3-9. Therefore, the claims read in light of the
specification reasonably apprise those skilled in the art of the
claimed invention. Moreover, the record shows that the patent
disclosed adequate information to enable a skilled artisan to
make and use the claimed invention. Northern Telecom, Inc. v.
Datapoint Corp., 908 F.2d 931, 941, 15 USPQ2d 1321, 1329
(Fed. Cir.), cert. denied, 498 U.S. 920 (1990).

Appellant incorrectly characterized its validity challenge
as a Claim definiteness issue — a characterization which the
district court followed, at least in name. Nonetheless, the district
court made proper findings and correctly concluded that appel-
lant did not rebut the presumed validity of the claims.

Infringement

The district court determined that the accused devices,
known as the HYPERCENTER and the HYPERCENTER 2,
infringed the ’073 patent literally, or in the alternative, under the
doctrine of equivalents. Miles I, slip op. at 28-30. On appeal,
Shandon argues that the district court misconstrued the “cabi-
net” limitation of the claims.

This court reviews a trial court’s infringement findings
under the “clearly erroneous” standard. Charles Greiner & Co.
v. Mari-Med Mfg., Inc., 962 F.2d 1031, 1034, 22 USPQ2d 1526,

A-8

1528 (Fed. Cir. 1992); Insta-Foam Prods., Inc. v. Universal
Foam Sys., Inc., 906 F.2d 698, 702, 15 USPQ2d 1295, 1297
(Fed. Cir. 1990). Claim interpretation is the first step in the
two-part infringement determination. Greiner, 962 F.2d at
1034. Claim interpretation proceeds as a question of law. /d.
When a trial court, however, resolves factual disputes underly-
ing the meaning of claim terms, this court reviews these findings
under the clearly erroneous standard. Jd. In interpreting dis-
puted-claim terms, the trial court considers the specification and
the prosecution history. Jd. After interpreting the claim, the
final step of the infringement analysis determines whether the
accused device is within the scope of the claim. Jd. To infringe,
an accused device must embody exactly each claim limitation
or its equivalent. Jd.

The district court determined that the HYPERCENTERs
contained every limitation set forth in claim 1 of the ’073 patent.
Miles I, slip op. at 28. In reaching this conclusion, the district
court construed the cabinet limitation of claim 1 to define an
enclosure for the various elements of the processing apparatus.
Id. The court also determined that the HYPERCENTERs con-
sisted of three modules: a module which housed the operating
controls, a module which housed the reagent storage bottles, and
a module which contained the central processing chamber and
the paraffin baths. The district court concluded that the separate
modules of the HYPERCENTER collectively formed a cabinet.
Id.

The district court properly construed the term “cabinet” to
mean a single enclosure for the various parts of the apparatus.
The claims, specification, and drawings disclose a single cabinet
enclosing the tissue processing apparatus. The embodiment
illustrated in the patent specification disclosed a single cabinet
comprised of a number of sections, including numerous reagent
bottles, a processing chamber, paraffin containers, and a control
module. Moreover, Webster’s defines “cabinet” as “1 a case or’

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A-9

cupboard with drawers or shelves for holding or storing things
... 2a boxlike enclosure.” Webster’s New World Dictionary,
193 (3d col. ed. 1988).

The HY PERCENTERSs, however, consist of three modules
as opposed to one. “Module” is defined as “any of a set of units,
as cabinets, designed to be arranged or joined in a variety of
ways.” Webster’s at 872. Because three does not equal one, the
district court clearly erred in finding that the HYPERCENTERs
(consisting of three cabinets) literally infringed the single cabi-
net limitation of the ’073 patent.

This court, however, concludes that the district court did
not err in determining that the HYPERCENTERs infringed the
"073 patent under the doctrine of equivalents. Infringement
under the doctrine of equivalents requires a showing that the
accused device performs substantially the same function, in
substantially the same way, to achieve substantially the same
result as the claimed device. Malta v. Schulmerich Carillons,
Inc., 952 F.2d 1320, 1325, 21 USPQ2d 1161, 1165 (Fed. Cir.
1991), cert. denied, 112 S. Ct. 2942 (1992) (citing Graver Tank
& Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950)).

The doctrine of equivalents prevents the pirating of the
patentee’s invention in the absence of literal infringement when
liability is nevertheless warranted. Hormone Research Found,
Inc. v. Genentech, Inc., 904 F.2d 1558, 1564, 15 USPQ2d 1039,
1044 (Fed. Cir. 1990). The doctrine of equivalents thus prevenis
the risk of injustice that may result from a limited focus on words
alone. Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d
855, 856-57, 9 USPQ2d 1289, 1291 (Fed. Cir. 1988), cert.
denied, 490 U.S. 1068 (1989).

Shandon argues that the district court did not determine that
the HYPERCENTERs achieved “substantially the same result”
as the 073 patent. Shandon contends that the intended result of
the ’073 patent is unification of the various components.

A-10

Shandon alleges that HYPERCENTERs achieve safety and
operational advantages by separating the components.

The ’073 patent achieves an enclosed tissue processing
system. The district court stated:

The ’073 patent discloses an apparatus for fixing and
processing the tissue specimens. It is an improvement
over the prior art because it represents the first com-
pletely automatic system for allowing light micros-
copy tissue to be processed under a completely
automatic sequence in an entirely closed system and
without requiring substantial movement of the speci-
mens.

Miles I, slip op. at 3-4 (citation omitted). This result does not
change merely because Shandon separated certain components
of the system into discrete modules.

In addition, the ’073 patent does not specify that the cabinet
contains all components of the invention. Rather, claim 1
specifies an “air pump means . . . mounted proximate said
cabinet.”” The ’073 patent, col. 11, lines 17-19. Claim 1 also
claims “electrical control means . . . mounted proximate said
chamber.” Jd. col. 12, lines 1-3. Therefore, although claim 1
may have a cabinet limitation, not all components of the tissue
processor must be within the cabinet. Indeed, the specification
states that “the controls could be mounted in a separate cabinet.”
Id. col. 10, lines 34-35.

The limitations and functions of the invention in the claims,
not the elements or functions of the accused device, establish
the reference point for the doctrine of equivalents. Insta-Foam,
906 F.2d at 702. Infringement under the doctrine does not
vanish merely because the accused device performs functions in
addition to those performed by the claimed device. Jd. Regard-
less of separation into modules, Shandon’s system is still a
“completely automatic system for allowing light microscopy

A-11

tissue to be processed under a completely automatic sequence
in an entirely closed system and without requiring substantial
movement of the specimens.” See Miles I, slip op. at 3-4. Thus,
the HYPERCENTERs achieved substantially the same result as
the ’073 patent.

To allow Shandon to escape infringement simply because
it used separate cabinets, as opposed to a single cabinet, is the
exact type of injustice the doctrine of equivalents prevents. See
Laitram Corp., 863 F.2d at 856-57. This court discerns no clear
error in the district court’s finding of infringement under the
doctrine of equivalents.

The ’460 Patent

The district court held claim 1 of the ’460 patent invalid
for obviousness under 35 U.S.C. § 103 (1988). Miles I, slip op.
at 16-17. The district court later held the dependent claims of
the 460 patent (claims 2, 4-7) invalid by virtue of claim 1’s
invalidity. Miles IT, slip op. at 2.

35 U.S.C. § 103 - Obviousness

The ultimate legal conclusion of obviousness is a question
of law. Specialty Composites v. Cabot Corp., 845 F.2d 981, 989,
6 USPQ2d 1601, 1606 (Fed. Cir. 1988). The analysis of obvi-
ousness, however, rests on several factual inquiries: (1) the
scope and content of the prior art; (2) the differences between
the prior art and the claims; (3) the level of ordinary skill in the
art at the time of invention; and (4) objective evidence of
nonobviousness. Jd. (citing Graham v. John Deere Co., 383
U.S. 1, 17-18, 148 USPQ 459, 467 (1960)). This court reviews
these factual underpinnings for the legal conclusion of obvious-
ness under the “clearly erroneous” standard. Specialty Compos-
ites, 845 F.2d at 989. The facts stated herein are based on district
court findings not found to be clearly erroneous or otherwise not
in dispute.

A-12

The prior art in this instance included U.S. Patent No.
3,526,203 (the ’203 patent), U.S. Patent No. 3,227,130 (the
Weiskopf patent), and the Lipshaw Manufacturing
Corporation’s “Fluid X Changer.” The ’203 patent covers an
electron microscopy tissue processor. Electron microscopy dif-
fers from light microscopy in that the former requires only very
small tissue specimens. With small tissue specimens, electron
microscopy does not need to reuse processing reagents. None-
theless, the specification of the ’203 patent provides: “‘it will be
apparent that the processor of the invention may be used for
processing the larger sized tissue particles which are intended
for light microscopy examination.” Miles I, slip op. at 10
(quoting U.S. Patent No. 3,526,203, col. 8, lines 5-8). The
Claims of the ’203 patent disclose the vacuum component of the
460 patent. Furthermore, the ’203 patent suggests a solution to
the problem resolved by claim 1 of the ’460 patent, namely, a
means of reusing a solution by returning unused quantities to
the storage container with pressure.

The specification of the ’203 patent provides:

In this regard it should be noted that the practice in

electron microscopy work is not to reuse the solutions

and in the system of the invention only fresh solution

is transferred through the lines and valves connecting

the containers with the processing chamber. If the

particular solutions are required to be pumped back to

the containers after use appropriate pumping and

switching controls would have to be provided.
U.S. Patent No. 3,526,203, col. 8, lines 12-19. Although elec-
tron microscopy does not reuse solutions, the ’203 patent sug-
gests to a skilled artisan the reuse of solutions by pumping them
back to their storage containers.

The “Fluid X Changer” (a device used for staining slides
bearing tissue specimens) also suggests transfer of solutions by
pressure. Moreover, the Weiskopf patent discloses a tissue

A-13

processor which transfers solutions by pressure controls. Thus,
the prior art of histological equipment taught the flow of liquids
in tissue processing apparatuses from one location to another
with vacuum-pressure.

The differences between the prior art and claim 1 of the
_ ’406 patent were minor and achievable by simple modification.
Moreover, the prior art references collectively suggest the engi-
neering necessary to achieve these modifications. Simply put,
the ’203 patent discloses a tissue processor which does not reuse
fluids but instead discharges them into a waste tank after pro-
cessing. By running a line from the processing chamber back
to the fluid storage containers (rather than to the waste tank), the
°203 patent would anticipate the ’460 patent.

The level of ordinary skill in the art suggests as well a
thorough knowledge of the principles of fluid transfer using
pressure-vacuum pumps, valves, and conduits at the time of the
’460 patent’s development. Finally, Miles did not show objec-
tive indicia of non-obviousness. Such evidence, if present,
would weigh in favor of non-obviousness, although the lack of
such evidence does not weigh in favor of obviousness. See, e.g.,
Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d
955, 1 USPQ2d 1196, 1199 (Fed. Cir. 1986). Miles presented
no evidence, for instance, that its device represented a substan-
tial share of any definable market. Miles also did not offer
evidence on factors such as long-felt need or teaching away in
the prior art.

In sum, the district court concluded:

On the basis of the Graham test, therefore, we con-
clude that claim 1 of the ’460 patent is invalid under
35 U.S.C. § 103 because the subject matter of claim
1 as a whole would have been obvious at the time the
invention was made to a person having ordinary skill
in the art to which the subject matter pertains.

A-14

Miles I, slip op. at 16-17. This court finds no error (and certainly
no Clear error) with the district court’s obviousness findings and
conclusion. Therefore, this court affirms the district court’s
determination of invalidity of claim 1 of the ’460 patent.

In its later opinion, the district court clarified its earlier
decision and also held dependent claims (2 and 4-7) of the ’460
patent invalid. Miles II, slip op. at 1-2. Section 282 requires an
independent analysis of the validity of each claim. 35 U.S.C. §
282 (1988); Ortho Pharmaceutical Corp. v. Smith, 959 F.2d
936, 942, 22 USPQ2d 1119, 1124 (Fed. Cir. 1992). A party
challenging the validity of a claim, absent a pretrial agreement
or Stipulation, must submit evidence supporting a conclusion of
invalidity for each contested claim. Jd. Where the parties
stipulate to “representative” claims, however, a validity resolu-
tion for the representative claims applies to the other claims as
well. See Panduit Corp. v. Dennison Mfg. Co., 836 F.2d 1329,
1330-31, 5 USPQ2d 1266, 1267-68 (Fed. Cir. 1987).

In an April 1988 pretrial “Stipulation of Agreed Fact, Law
of the Case and Questions of Law,” the parties agreed:

The ’460 patent contains seven claims. Claim | is the
only independent claim. Claims 2 through 7 depend
directly or indirectly from claim 1. Consequently,
Claim 1 is the broadest claim and can be considered to
be representative of the claims in this patent.

Miles II, slip op. at 2 n.l. This stipulation of the parties made
claim 1 a representative for the other claims in the patent. Thus,
the parties, their counsel, and the trial court understood that the
result the court reached for claim 1 would bind all other claims.
Therefore, this court affirms the district court’s invalidation of
the dependent claims of the ’460 patent.

The district court also determined that the accused device
infringed the ’460 patent. Because it affirms the district court’s
invalidity findings, this court need not reach the district court’s

i all aie

A-15

infringement determination. See Dana Corp. v. IPC Ltd. Part-
nership, 860 F.2d 415, 417, 8 USPQ2d 1692, 1694 (Fed. Cir.
1988), cert. denied, 490 U.S. 1067 (1989).

CONCLUSION

For the above stated reasons, this court affirms the district
court’s finding of infringement of the 073 patent and the
upholding of its validity. This court also affirms the district
court’s holding that claims 1, 2, and 4-7 of the ’460 patent are
invalid due to obviousness.

COSTS

Each party shall bear its own costs for this appeal.
AFFIRMED

A-16

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA

MILES LABORATORIES, INC.,
and TRIANGLE BIOMEDICAL
EQUIPMENT, INC.,
Plaintiffs,

V.

SHANDON, INC., and SHANDON
SOUTHERN PRODUCTS LIMITED,
Defendants.

Civil Action No. 86-2404

ORDER OF COURT

AND NOW, this 11th day of March, 1992, for the reasons
set forth in the opinion filed this day, IT IS ORDERED that
pursuant to 35 U.S.C. §103 (1984), claim 1 of United States
Letters Patent No. 4,001,460 (’460 patent) be, and the same
hereby is, declared invalid; and,

IT IS FURTHER ORDERED that claim | of United States
Letters Patent No. Re. 29,073 (’073 patent) be, and the same
hereby is, declared valid, and found not to be lacking the
specification particularity required by the second paragraph of
35 U.S.C. §112 (1984); and,

IT IS FURTHER ORDERED that pursuant to 35 U.S.C.
§271 (1991 Supp.), defendants be, and they hereby are, found

to be infringing claims 1, 2, and 4-7 of the ’460 patent and claims
1, 4-6, 9, 11, and 13 of the ’073 patent.

/s/Gustave Diamond
United States District Judge

a

A-17

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA

MILES LABORATORIES, INC.,
and TRIANGLE BIOMEDICAL
EQUIPMENT, INC.,
Plaintiffs,

¥..

SHANDON, INC., and SHANDON
SOUTHERN PRODUCTS LIMITED,
Defendants.

Civil Action No. 86-2404

OPINION
DIAMOND, J.

This is an action for patent infringement under 28 U.S.C.
§1338. Plaintiffs, Miles Laboratories and Triangle Biomedical
Equipment (“Miles”), seek to enforce two patents relating to a
method and an apparatus directed to the art of processing and
treating tissue specimens in preparation for examination under
a microscope. The patents in suit are United States Letters
Patent No. Re. 29,073 (“the ’073 patent”) (see Appendix A)
' which discloses and claims a LIGHT MICROSCOPY PRO-
CESSING APPARATUS issued on December 14, 1976, as a
reissue of United States Letters Patent No. 3,892,197 issued on
July 1, 1975, and United States Letters Patent No. 4,001,460
(“the ’460 patent”) (see Appendix B) which discloses and claims
a LIGHT MICROSCOPY PROCESSING METHOD, issued on
January 4, 1977. Plaintiffs contend that defendants have in-
fringed claims 1, 4-6,9, 11, and 13 of the ’073 patent and claims
1, 2, and 4-7 of the ’460 patent. The other claims of the patents
are not at issue. i

A-18

Plaintiffs seek injunctive relief to prevent defendants from
further infringing the patents at issue and damages for past
infringement. See 35 U.S.C. §§283, 284 (1984). Defendants
Shandon, Inc., et al. (“Shandon’’) assert a number of defenses:
they invoke the doctrine of laches; they deny infringement; they
maintain that the ’460 patent is invalid and therefore unenforce-
able because it is obvious in light of the prior art; and they argue
that the ’073 patent is invalid because it fails to claim distinctly
the disclosed invention as required by the second paragraph of
35 U.S.C. §112.

For the reasons which follow, the court concludes that
(1) this action is not barred by the doctrine of laches; (2) claim 1
of the °460 patent is invalid; (3) claim 1 of the ’073 patent is
valid; and (4) both patents have been infringed.

I. Procedural and Factual Background

This action was reassigned to this member of the court
subsequent to a bench trial held before the Honorable Louis A.
Rosenberg.** The trial was limited to the issue of liability, in
accordance with the parties’ agreement to bifurcate. Although
the reassignment occurred prior to the issuance of any findings
of fact or conclusions of law, the parties agreed to have the case
decided on the basis of the existing record and any other sub-
missions requested by this court.***

The ’073 and °460 patents were issued to Dr. Thomas D.
Kinney and Mr. John E. P. Pickett. Both patents were assigned
to plaintiff Triangle Biomedical Equipment, Inc. (“Triangle’’),
which in turn entered into a licensing agreement with Miles on

The reassignment followed Judge Rosenberg’ s retirement from active
senior status after serving for twenty-nine years on this court.

*** This opinion shall constitute this court’s findings of fact and con-
clusions of law in accordance with Fed.R.Civ.P. 52(a). The parties have filed
post-trial proposed findings of fact and conclusions of law along with
memoranda of law.

A-19

March 20, 1975, making Miles the exclusive licensee of the ’073
and °460 patents. Plaintiff Miles has its principal place of
business in Elkhart, Indiana, and plaintiff Triangle is a North
Carolina corporation.

The ’460 patent discloses a method of treating tissue spec-
imens before the specimens are examined by a light microscope.
The tissue specimens are confined in a central processing cham-
ber under sealed cover and they remain fixed while they are
treated with various fluids and paraffin. The fluids are drawn
from their containers into the processing chamber by vacuum
and the fluids are expelled from the chamber back to their
containers by pressure which is applied to the chamber. See
Appendix B; Defendants’ Ex. 1. The 073 patent discloses an
apparatus for fixing and processing the tissue specimens. It is
an improvement over the prior art because it represents the first
completely automatic system for allowing light microscopy
tissue to be processed under a completely automatic sequence
in an entirely closed system and without requiring substantial
movement of the specimens. See Appendix A; Defendants’ Ex.
3

Defendant Shandon Southern is a limited liability company
with its principal place of business in Runcorn, England, and it
manufactures the accused devices known as HYPERCENTER
and HYPERCENTER 2. Defendant Shandon is a Pennsylvania
corporation, and its principal place of business is Pittsburgh,
Pennsylvania. Shandon is responsible for the nationwide distri-
bution of the Hypercenter and Hypercenter 2 (collectively
“Hypercenter’”). Plaintiffs allege that the manufacture, use and
sale of the Hypercenter 2 infringe the 073 and °460 patents.

The parties have stipulated that for the purposes of this
litigation, there are no material differences between the
Hypercenter and Hypercenter 2. The Hypercenter 2 is operated
by the purchasers of that product, and defendants have admitted
that should the fina] judgment conclude that the operation of the

A-20

Hypercenter 2 in a normal and tendered manner infringes the
460 patent, the purchasers of the Hypercenter operate it in such
a manner as well.

II. The Defense of Laches

Defendants argue that plaintiffs’ claim for damages is
barred by the doctrine of laches. Although patent infringement
actions are not subject to a statute of limitations, the equitable
doctrine of laches establishes a rebuttable presumption that a
delay in filing suit is prejudicial and unexcusable if the suit is
filed more than six years from the time the plaintiff knew or in
the exercise of reasonable diligence should have known of the
alleged infringement. See Bott v. Four Star Corp., 807 F.2d
1567, 1575 (Fed.Cir. 1986).

In order to evaluate a laches defense, the court must ascer-
tain “the time at which the plaintiff knew or, in the exercise of
reasonable diligence, should have known of the defendants’
alleged infringing action.” Studiengesellschaft Kohle mbH v.
Eastman Kodak Co., 616 F.2d 1315, 1326 (Sth Cir.), cert.
denied, 449 U.S. 1014 (1980). If the trier of fact finds that a
plainuff unnecessarily and unexcusably delayed filing its law-
suit, the plaintiff-patentee will be denied damages accrued up to
the date of the complaint. See, e g., Bott v. Four Star Corp., 807
F.2d 1567, 1575 (Fed.Cir. 1986); Chisum, Patents 19.05[2] at
19-164-165.

A finding of laches is dependent upon the particular facts
of each case. As the Federal Circuit has put it, laches “is a
question primarily addressed to the discretion of the trial court.”
Bott, 807 F.2d at 1576.

Defendants insist that “Miles slept on its rights and allowed
Shandon to (i) continue its promotion of the Hypercenter in
virtual side-by-side relationship with Miles VIP and (ii) improve
the Hypercenter to yield a new product, the Hypercenter 2.”
Defendants’ Proposed Findings of Fact and Conclusions of Law

A-21

at {130. Defendants maintain that as early as November, 1981,
plaintiffs became aware of the Hypercenter at the annual meet-
ing of the National Society of Histology (“NSH”) held in Salt
Lake City. (Tr. 321-322). Defendants also point out that in
September of 1982, the Hypercenter was displayed by Shandon
at the NSH show in Boston where Miles was present as an
exhibitor, and that two Miles salesmen visited the Shandon
booth. (Tr. 326). Defendants further claim that plaintiffs had
ample exposure to the Hypercenter in the fall of 1983 at the NSH
show in Anaheim, California. (Tr. 292).

Notwithstanding these and other anecdotal incidents cited
by defendant, we find that defendant has failed to establish that
plaintiff unreasonably delayed in filing suit. The record reveals
that defendants periodically altered their advertising literature
and that these alterations created a degree of uncertainty in the
mind of plaintiffs as to what elements constituted the Hypercen-
ter. Compare Defendants’ Ex. 23 and 74. Indeed, the record
indicates that it was not until 1986 that Miles learned that
Shandon was marketing a unit for processing tissue which
operated with a vacuum-pressure cycle. (Tr. 285-286;
Defendants’ Ex. 74).

Moreover, even if we assume, as defendants’ experts opine,
that the six-year period was triggered as early as November
1981, when a reasonable person should have known about the
operation of the Hypercenter, Bott, 807 F.2d at 1575, any delay
by plaintiffs in filing suit was not unreasonable in view of the
fact that they filed this suit on November 12, 1986, five (not six)
years later. Therefore, we find that the circumstances of this case
do not indicate that there was any unreasonable or unexcusable
delay in filing of this suit, nor does the evidence suggest that
plaintiffs failed to exercise reasonable diligence in acquiring
knowledge of defendants’ alleged infringing action.

A-22

Ill. The Validity of the ’460 Patent

Each claim in a patent is afforded a presumption of validity
pursuant to 35 U.S.C. §282 (1984) and that presumption can
only be refuted by clear and convincing evidence.**** Medtro-
nic, Inc. v. Cardiac Pacemakers, Inc., 721 F.2d 1563, 1567
(Fed.Cir. 1983) (citations omitted).

Defendants maintain that claim 1 of the ’460 patent
invalid by virtue of the doctrine of obviousness, which requires
a court to declare a patent invalid if the court determines that:

Et is

[t]he differences between the subject matter sought to
be patented and the prior art are such that the subject
matter as a whole would have been obvious at the time
the invention was made to a person having ordinary
skill in the art to which said subject matter pertains.
Patentability shall not be negatived by the manner in
which the invention was made.

35 U.S.C. §103 (1984). In the seminal case of Graham v. John
Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 694 (1966), the
Supreme Court set forth a four-part inquiry which courts are to
follow in deciding whether a patent is invalid because its subject
matter is obvious in light of the prior art. First, the scope and
content of the prior art are to be determined; second, the differ-
ences between the prior art and the claims at issue are to be
ascertained; third, the level of ordinary skill in the pertinent art
is to be assessed; and fourth, additional evidence may be con-
sidered such as the commercial success of the allegedly invalid

ett

35 U.S.C. §282 provides in pertinent part:

A patent shall be presumed valid. Each claim of a patent (whether in
independent or dependent form) shall be presumed valid independently of
the validity of other claims; dependent claims shall be presumed valid even
though dependent upon a valid claim. The burden of establishing invalidity
of a patent or any claim thereof shall rest on the party asserting it.

Set

Our analysis of the validity of the ‘460 patent is limited to claim
1, because that was the only claim contested.

A-23

patent’s embodiments. See also Leinoff v. Louis Milona & Sons,
Inc., 726 F.2d 734, 739 (Fed.Cir. 1984); Gardner v. TEC Sys-
tems, Inc., 725 F.2d 1338, 1344 (Fed.Cir.), cert. denied, 469
U.S. 830 (1984).

In applying the Graham test, courts are admonished against
succumbing to the temptation of hindsight. Thus, a patent may
be invalidated only if the invention would have been obvious to
those who knew only about the prior art, and the court must
examine the prior art without reading into it the patent’s teach-
ings. See Carella v. Starlight Archery and Pro Line Co., 804
F.2d 135, 140 (Fed. Cir. 1986). In short, the question is whether
that which is claimed in the patent would have been obvious to
one of ordinary skill attempting to solve the inventor’s problem;
that is, whether “there is something in the prior art as a whole
to suggest the desirability and thus the obviousness, of making
the combination (set forth in the instant claim).” Custom Acces-
sories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 959 (Fed.
Cir. 1986) (citations omitted and emphasis added).

A. The Scope and Content of the Prior Art:

As noted above, the appropriate starting point for consid-
eration of obviousness is the scope and content of the prior art.
The prior art in this case incudes that considered by the Patent
and Trademark Office in examining the application for the 460
patent. In 1968, the inventors of the ’460 patent, Kinney and
Pickett, filed a patent application on an electron microscopy
tissue processor and the application issued as U.S. Patent No.
3,526,203 (“the ’203 patent”), which is stipulated to be prior art
against both patents in suit. See Stipulation of Agreed Facts.

Defendants maintain that the ’203 patent renders obvious
the method of treating tissue specimens disclosed by claim 1 of
’460 patent, which relies on vacuum-pressure cycles alternately
to draw and expel reagent solutions to and from the processing
chamber. (Tr. 347-51, 368; Defendant’s Ex. 28, 101-104,
Defendant’s Ex. 90A at 61-62). Claim 4 of the ’203 patent

A-24

discloses the vacuum component of the ’460 patent (see also
Summary of Invention at{2, Defendants’ Ex. 13), and it suggests
a solution to the problem resolved by claim 1 of the ’460 patent:
that, in order to reuse a solution, pressure would have to be
applied to the processing chamber, thereby returning the solu-
tion to its container. Defendants therefore contend that claim 1
is obvious, even though electron microscopy differs from light
microscopy in that the former requires only very small tissue
specimens because of the high magnification achievable with
electron microscopy and even though electron microscopy re-
quires small volumes of treating reagents, meaning that the
reagents may be discarded after a single use rather than being
reused as in light microscopy tissue processing.

The ’203 patent provides:

While the invention is primarily intended to provide
a means for processing minute size particles for sub-
sequent electron microscopy examination it will be
apparent that the processor of the invention may be
used for processing the larger sized tissue particles
which are intended for light microscopy examination.
In either case, the required aqueous and nonaqueous
organic vexation, dehydration and cleaning solutions
may be installed in the respective solution containers
and introduced as required for the particular type of
microscopy examination. In this regard, it should be
noted that the practice in electron microscopy work is
not to reuse solutions in the system of the invention.
Only fresh solution is transferred through the lines in
vials connecting the containers with the processing
chamber. /f the particular solutions are required to
be pumped back to the containers after use appropri-
ate pumping and switching controls would have to be
provided.

A-25

Defendants’ Ex. 13, Col. 8, lines 3-19 (emphasis added). Thus,
although solutions are not reused for electron microscopy, the
’203 patent “suggest{s] to one skilled in the art” that the solu-
tions may be reused by pumping them back to their containers
from the processing chamber. W.L. Gore & Associates, Inc. v.
Garlock, Inc., 721 F.2d 1540, 1551 (Fed. Cir. 1983), cert.
denied, 469 U.S. 851 (1984). (citations omitted).

The prior art also includes the Lipshaw Manufacturing
Company’s “Fluid X Changer” and it too suggests that solutions
may be transferred by using pressure. This device was used for
staining slides bearing tissue specimens in which the treating
reagents were brought to a central basin for contact with the
specimens and were then returned to their respective storage
bottles. See Defendants’ Ex. 17. This method of moving fluids
was an innovation over the previous manual technique of trans-
ferring specimens or slides from the various reagent containers.
The Lipshaw method for moving the reagents to the central basin
and back is described thus:

AIR PRESSURE is the method used to transfer the
staining solutions from the storage bottle to the stain-
ing basin. Then, at a pre-set time ... the solution is
withdrawn from the basin with vacuum, and returned
to the storage Container.

Defendants’ Ex. 17 (emphasis added). In order for a pressure
differential to be deveioped between the bottle and the basin,
which is subject to atmospheric pressure, the reagent storage
bottles must be completely closed. Defendant’s Ex. 17 at F-10.
Similarly, in order to return the reagent to the storage bottle, a
vacuum pump acting on the interior of the closed bottle evacu-
ates air from the bottle to reduce its pressure below the atmo-
spheric pressure acting on the central basin. /d., Defendants Ex.
19 at F-8. During the trial, plaintiffs conceded that the Lipshaw
machine describes the use of a vacuum-pressure cycle for titrat-
ing staining solutions. (Tr. 75, 78, 134-35).

A-26

Finally, the “Weiskopf Patent” (U.S. Patent No.
3,227,130), which was cited during the prosecution of the ’460
patent, discloses a tissue processor and contains the following
teachings relative to the use of pressure control as a means of
transferring solutions:

... [t]he flow of the various liquids to the chamber for
treating the tissue is controlled by a programming
device so that the liquids are transmitted to the inlet
of the chambers seriatim, whereby the tissue is treated
separately by each of the liquids. To improve and
accelerate the infiltration of the tissue by the various
processing liquids, the pressure in the chamber is
reduced to below atmosphere, the liquids are heated
and means are provided for stirring the liquids in
relation to tissue specimens. The programming in-
cludes means of predetermining the length of periods
during which each of the liquids is in the chamber for
treating the tissue. The apparatus also includes means
of separately collecting the various liquids after the
treatment of the tissue therewith, so that the liquids
may be used repeated, if so desired.

Thus, we find from the record that in the early 1970s it was
known in the art of histological equipment that liquids could be
caused to flow in tissue processing apparatus from one location
to another within the machine by the application of air pressure
alone and by the application of vacuum alone or both applied
alternately at a single location in the apparatus.

B. Differences Between the Prior Art and the Claimed
Invention.

Defendants maintain, and we agree, that the differences
between the ’203 patent and claim 1 of the ’460 patent are
revealed by the simple modifications which may be applied to
the ’203 patent in order to reach the system of the ’460 patent.
These modifications were acknowledged by Pickett and were

RD 8 PONTE FV Ea ee

FREE DS oe REN ME Bh Sone PLL SS Ay BAIR vec INS ts a HN

A-27

confirmed at trial by the testimony of defendants’ expert, Abe
Gordon, and these modifications are suggested by the °203
patent. (Tr. at 344; 353-56; 363-69; 370-71; Defendants’ Ex.
90B at 169). See also In re Mills, 916 F.2d 680, 682
(Fed.Cir. 1990). The modifications to the ’203 patent include (1)
adding a clamp to the already airtight cover of the central
processing chamber, allowing it to be pressurized; (ii) running
a drain line to the waste tank back to the liquid storage container
and eliminating the waste tank as being unnecessary; (iii) pro-
viding controls to switch the existing vacuum line to the central
processing chamber to a pressure line for pumping liquid back
to the storage container.

Mr. Gordon’s testimony (Tr. 353-56) is consistent with the
doctrine of obviousness, which depends not only on what the
references expressly teach, but also on what they would collec-
tively suggest to one of ordinary skill in the art. See Leinoff, 726
F.2d at 739. This statement by the Federal Circuit in Leinoff is
apposite to the instant case as the prior art references collectively
suggest the engineering necessary to achieve a reagent transfer
system of the sort set forth in claim 1 of the ’460 patent. (See
Tr. at 363-71).

Although plaintiffs do not bear the burden of proof on the
issue of invalidity, they counter the foregoing arguments by
stating that the prior art evinced a prejudice against applying
pressure to tissue, as is the case with the °460 patent when
pressure is applied to the processing chamber. However, this

_ argument was raised for the first time at trial and there is no

reference to it in the ’460 patent or in the patent’s prosecution
history. Moreover, defendants’ expert, John Ryan of Yale
University, disputed the existence of this alleged prejudice. (Tr.
at 613, 626-27).

A-28

C. The Level of Ordinary Skill and the Pertinent Art.

In ascertaining the level of ordinary skill in the art of
transferring liquids in histology apparatus, we may consider the
educational level of the inventor, the problems encountered in
the art, prior art solutions to those problems, the rapidity with
which innovations are made in the field, the sophistication of
the technology, and the educational level of active workers in
the field. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan
Indus., Inc., 807 F.2d 955 (Fed.Cir. 1986); Orthopedic Equip.
Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381-82
(Fed.Cir. 1983). Not all factors may be present in every case,
one or more of them may predominate, and the education of the
actual inventor is not dispositive on the question of ordinary
skill. However, the inventor’s admissions may be important in
this inquiry. Custom Accessories, Inc., supra.; Constant v.
Advanced Micro-Devices, Inc., 848 F.2d 1560 (Fed. Cir.), cert.
denied, 488 U.S. 892 (1988).

With regard to the educational level of the inventor, Pickett
was the supervisor of the histology laboratory at Duke Univer-
sity Hospital, and Kinney, the deceased co-inventor, was an
M.D. and specialized in pathology. Pickett acknowledged that
he was mainly self-taught and he did not have a college degree.
Defendant Ex. 90A at 48. Neither Kinney nor Pickett had
engineering expertise, and they relied on outside help in the
actual construction of prototypes. (Tr. at 42-43, 77-79, 85-87).
With regard to problems encountered in the field and prior art
solutions to those problems, the record supports the conclusion
that the principles of fluid transfer, such as pressure-vacuum
pumps, valves and conduits, were well-known to engineers at
the time Kinney and Pickett collaborated in the development of
their automated tissue processor. (Tr. at 27, 341-42, 395).
Indeed, Pickett admitted that prior to his work on the ’460 patent,
the concept of moving treating solution from a storage container
to a processing vessel and returning the solution to its container

Oe Eee FITS SENT Oe oo eS DP des a is Sir Gee ol ns ne EE sh EOE o

A Ek ee OF

A-29

by the alternate application of pressure and vacuum was well-
known to the public. Defendant’s Ex. 90A at 103-04; 202-03.

D. Additional Factors on the Issue of Obviousness.

The final factor to be considered before reaching a conclu-
sion of obviousness is the commercial success which is attrib-
utable to the claimed invention. Demaco Corp. v. F. Von
Langsdorff Lic., Ltd., 851 F.2d 1387 (Fed.Cir.), cert. denied,
488 U.S. 956 (1988). Asa general matter, evidence of commer-
cial success in terms of sales volume is less probative where
there is no showing that the sales represent a substantial share
of any definable market or that the profitability attributable to
the patent exceeds the industry standard. Cable Elec. Prods.,
Inc.v. Genmark, Inc., 770 F.2d 1015 (Fed.Cir. 1985). With the
preceding caveat in mind, we conclude that plaintiffs’ evidence
on the commercial success of their invention is inconclusive
because there has been no showing that the sales represented a
substantial share of any definable market. See Plaintiffs’ Ex. W;
Tr. at 725-37. Rather, plaintiffs have simply documented the
total United States and foreign sales by units, without indicating
the market share they represent.

On the basis of the Graham test, therefore, we conclude
that claim 1 of the ’460 patent is invalid under 35 U.S.C. $103
because the subject matter of claim 1 as a whole would have
been obvious at the time the invention was made to a person
having ordinary skill in the art to which the subject matter
pertains. Moreover, plaintiffs have not rebutted defendants’
prima facie case of obviousness by offering evidence on such
factors as long-felt need or teaching away in the prior art.
Orthopedic Equipment Co., 702 F.2d at 1013. In accordance
with 35 U.S.C. §282, however, our conclusion of the invalidity
of claim 1 has no impact on the other claims of the ’460 patent.

A-30

IV. The Validity of ’073 Patent

Defendants attack the validity of claims 1, 4-6, 9, 11 and
13 of the ’073 patent as being invalid for failing to comply with
paragraph 2 of 35 U.S.C. §112, which states:

The specification shall conclude with one or more
claims particularly pointing and distinctly claiming
the subject matter which the applicant regards as his
invention.

Specifically, defendants argue that claim 1 of the ’073
patent does not comply with §112 because it fails to indicate that
the solution containers described by the ’073 patent must be
vented, and thus, the dependant claims of the ’073 patent are
invalid.****** Claim 1 of the ’073 patent states:

d. Aplurality of closed solution containers mounted
in predetermined order in a storage compartment in
said cabinet approximate said paraffin container, each
solution container containing a particular tissue pro-
cessing solution with said melted paraffin container
collectively containing all of the said tissue solutions
in which said specimens are processed.

Claim 1, subparagraph k, recites in detail the purpose of the
tissue processing system.

said solutions ... are successfully, selectively and
independently drawn from said solution ... contain-
ers ... and admitted to said solution under a vacuum
condition in a predetermined volume ... and at the

SSeas

In accordance with Fed.R.Civ.P. 15(b), defendants moved at trial
to amend their answer to include the §112 defense. Plaintiffs opposed the
motion, and it was not ruled on at trial. We will grant defendants’ rule 15(b)
motion, because of the well-established rule that motions to amend should
liberally be granted and because we find that under all the circumstances
plaintiffs would not have been prejudiced unfairly even if we were to have
ruled differently on the defense asserted by one amendment.

A-31

end of each processing step being forced back to a
respective said solution ... container by pressure
from said pump ....

Plaintiffs’ Ex. A, Col. 12, Lines 8-17. Defendants argue that
because the preceding language does not indicate that the con-
tainers must be vented, this means that the claimed invention is
inoperative and therefore invalid under §112. See Defendants’
Post-Trial Br. at 26-27; Tr. at 70; 184-185.

We disagree with defendants that the language in claim 1
of the ’073 patent does not read with the specificity which would
reasonably apprise those skilled in the art both of the utilization
and scope of the invention. Fromson v. Advance Offset Plate,
Inc., 720 F.2d 1565 (Fed.Cir. 1983). Rather, the apparatus
described by claim 1 of the ’073 patent is adequately described
because one skilled in the art would understand all of the
language in the claims when they are read in light of the
specification, as they must be. Andrew Corp. v. Gabriel Elec-
tronics, Inc., 847 F.2d 819, 822 (Fed.Cir.) cert. denied, 488 U.S.
927 (1988); Hybritech, Inc. v. Monoclonal Antibodies, Inc. , 802
F.2d 1367, 1385 (Fed.Cir. 1986), cert. denied, 480 U.S. 947
(1987).

V. Infringement of the 460 Patent

When testing for infringement, courts must interpret the
patent’s claims, giving the claims their ordinary meaning unless
they have been given a different meaning in view of their
prosecution in the United States Patent and Trademark office.
Specialty Composites v. Cabot Corp., 845 F.2d 981, 987
(Fed.Cir.1988); SRI Int’l v. Matsushita Electric Corp., 775 F.2d
1107, 1121 n.14 (Fed.Cir. 1985). Once the patent claims are
interpreted, infringement is determined by comparing these
claims with the accused process or device. Infringement will be
found if “every limitation of the patent claims asserted to be
infringed is found in the accused device, either literally or by an
equivalent.” Smithkline Diagnostics, Inc. v. Helena Labora-

A-32

tories, Corp., 859 F.2d 878, 889 (Fed.Cir. 1988). See also
Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S.
605, 70 S.Ct. 854 (1950); SRI International, supra at 1118. As
the following discussion indicates, we find that the ’460 and
073 patents have been literally infringed or, in the alternative,
we find there is infringement under the doctrine of equivalents
because the Hypercenter performs substantially the same func-
tion in substantially the same way to obtain substantially the
same result as the claimed invention. Graver Tank & Mfg. Co.,
supra at 607; Pennwalt Corp. v. Durand-Wayland, Inc., 833
F.2d 931, 934-37 (Fed.Cir. 1987), cert. denied, 485 U.S. 961
(1988).

Claim | of the 460 patent, in its preamble, calls for:

A method for processing a plurality of individual
specimens of tissue to be separately contained while
being simultaneously bathed for varying lengths of
time in successive selected tissue solutions including
melted paraffin so as to fix, dehydrate and clear the
specimens preparatory to embedding, ....

Defendants have admitted that the Hypercenter is a system
Or apparatus for processing a plurality of individual tissue
specimens. (Tr. at 227). Moreover, the record indicates that
steps la to lc of the ’460 patent are carried out in the operation
of the Hypercenter because tissue specimens are installed by
groups, having at least one specimen per group in tissue cas-
settes, which are then installed in the processing chamber of the
Hypercenter. This processing chamber is temperature con-
trolled and electrically heated, having a pressure-sealable top.
(Tr. at 40-43; 227-228). In the normal operation of the
Hypercenter, the temperature in the processing chamber is main-
tained at a lower temperature for all solutions except paraffin.
(Plaintiff's Ex. H, Sec. 2.3; Tr. at 56, 65-67).

Step d of claim 1 discloses the processing chamber posi-
tioned “in proximity to a plurality of closed vented containers,

A-33

each containing a particular tissue processing solution ....” See
Appendix B (emphasis added). ‘The features disclosed by claim
1d appear in the Hypercenter, although defendants maintain that
the containers used in the Hypercenter for the individual pro-
cessing solutions are not “vented” containers. (Tr. at 43-45,
228, 229).

Along with the requirement concerning temperature, vol-
ume and time, which the record indicates the Hypercenter
embodies, claim 1 of the ’460 patent calls for the application of
pressure and vacuum cycles for each of the processing solutions,
including paraffin, with the particular solution being drawn into
the processing chamber during the vacuum cycle and returned
to its container during the pressure cycle. The record indicates
that the Hypercenter operates with these vacuum-pressure Cy-
cles applied to the processing chamber. (Tr. at 43-44, 53-54,
229-32).

However, defendants advance two arguments in order to
avoid a finding of infringement of the ’460 patent: (1) that the
solution containers in the Hypercenter 2 are not “vented” con-
tainers, or the equivalent thereof, as called for in the claim; and
(2) that the transfer of the processing solutions to and from the
processing chamber is not caused solely by vacuum and pressure
in the processing chamber, but additionally, the solutions are
transferred by pressure and vacuum applied to the individual
solution containers.

A) The Hypercenter 2 and “Vented” Containers:

It is well-established that in claim interpretation words are
given their ordinary and accustomed meaning unless it appears
that the inventors have intended to apply a different meaning,
acting as their own lexicographers. Loctite Corp. v. Ultraseal,
Ltd., 781 F.2d 861, 867 (Fed.Cir. 1985). The term “vent” has
been defined as “an opening for the escape of a gas or liquid or
for the relief of pressure” and there is nothing in the °460 patent
to suggest that the inventors meant something other than this in

A-34

using the term “vented” containers. See Webster’s 7th New
Collegiate Dictionary. Plaintiffs’ expert testimony concerning
the patent’s use of the word “vented” is consistent with this
definition. (Tr. at 50, 178, 211-212, 214-15).

Defendants argue that the term as used in the ’460 patent
should be read as requiring the gases to be “vented to the
atmosphere”’. (Tr. at 546). However, the claims themselves use
the broader, generic term “vented”, and we see no justification
for narrowing the language used by claim 1 of the ’460 patent.
Specialty Composites, 845 F.2d at 987. Thus, claim 1 covers
both containers which are vented to the atmosphere and those
vented containers which do not release to the atmosphere.

The storage containers in the Hypercenter are “vented
containers” as called for by the ’460 patent claims. The opening
at the upper portion of each Hypercenter storage container is a
vent because it is used as an outlet for gas from the container
when liquid is pumped to that container. Plaintiffs Ex. 2; Tr. at
46-50, 215, 671. Indeed, plaintiffs’ witness John Gordon, who
developed the Hypercenter, conceded that the solution container
of the Hypercenter was a vented container. (Tr. at 547). Both
the accused device and the ’460 patent are provided with tubes
which connect the bottom of the container which holds the
treating solutions with the processing chamber so that the treat-
ing solutions may be transferred from the container to the
processing chamber and then returned from the processing
chamber to the container. And both devices are provided with
Outlet openings on the upper portions through which gas can
exit, displaced by the returning liquid, or through which gas can
enter as the solution is transferred to the processing chamber.
(Tr. at 214-15, 671-72, 47-50).

A-35

B) The Vacuum-Pressure Cycle and The Solution
Containers:

Plaintiffs have shown that the operation of the Hypercenter
utilizes the teaching of the ’460 patent, by pressurizing the
processing chamber. However, defendants seek to avoid a
finding of infringement by asserting that there has been no
showing that pressure acting on the processing chamber was the
sole mechanism for moving liquids within the accused device.
In other words, defendants maintain that plaintiffs may not claim
infringement if pressure is applied to the various solution con-
tainers. (Tr. at 417).

However, where each element recited in any one claim is
found in the accused device or process, there is infringement,
and infringement cannot be avoided merely because the defen-
dants have added further elements or steps to the accused device
or process. Mannesmann Demag Corp. v. Engineered Metal
Products Co., 793 F.2d 1279, 1282-83 (Fed.Cir. 1986); Amstar
Corp. v. Envirotech Corp., 730 F.2d 1476, 1484 (Fed.Cir.), cert.
denied, 469 U.S. 924 (1984). The testimony of Mr. White and
the evidence before the court indicates that plaintiffs did not
limit the scope of claim 1 by prohibiting the use of pressure or
vacuum on the reagent bottles, simply because the prior art
utilized pressure only on the reagent containers. (Tr. at 432,
438-42, 444-45).

Rather, when plaintiffs pointed out the distinctions be-
tween the Astle (Defendants’ Ex. 9) and ’460 patents to the
Patent and Trademark office examiner, they noted that to use
the invention disclosed by the ’460 patent: (1) there must be a
reaction chamber which can be and is pressurized (the prior art
reaction chamber had no such capability); (2) the ’460 patent
had advantages over the Astle patent because in the former, only
one compartment (i.e.: the processing chamber) had to be pres-
surized, whereas in the Astle patent each container had to be
pressurized; and (3) the user of the invention of the ’460 patent

A-36

in suit had an option; he was not required to apply pressure to
the reagent container while the user of the prior art was required
to doso. (Tr. at 445-49; Defendants’ Ex. 1 at 55-56). Moreover,
insofar as defendants make this argument under the guise of file
wrapper estoppel, as Mr. White conceded, in cases of literal
infringement, the doctrine of file history estoppel is irrelevant.
(Tr. at 431-32).

Plaintiffs also have assailed the assertion that pressure is
actually applied to the Hypercenter’s storage containers. Testi-
mony at trial regarding tests run by plaintiffs indicates that no
change of pressure could be noted in the lines connected to the
individual solution containers during the operation of the
Hypercenter. (Tr. 72-73, 196-97, 673; Ex. 81). During the
pressure cycle in the Hypercenter’s processing chamber, the gas
exiting from the solution container is recycled through the pump
to the processing chamber, with any excess gas being collected
in the air bag at about atmospheric pressure. (Tr. 650-61; see
Plaintiffs’ Ex. N). If the bag is filled, the excess gas is released
through a safety valve to the atmosphere. Thus, the degree to
which the individual solution containers are pressurized is re-
vealed by the degree to which the air bag is filled. Plaintiffs’
expert testified that the air bag in the Hypercenter ensures that
during operation the pressure in the individual solution contain-
ers remains at about atmospheric pressure. (Tr. at 72-73, 196-
208, 650-53, 660-61; Ex. 81). The defendants ran only an
aborted test at trial and refused to disclose the results of prior
tests. (Tr. at 510, 561-62, 570-71).

In light of the foregoing, the evidence before us does not
support defendants’ reverse equivalents defense. The doctrine
of reverse equivalents applies when a court finds that although
the accused product literally infringes the claims of the patent
at issue, the process utilized by the accused product performs
the functions of the claims invention in a substantially different

A-37

way. SRI International v. Matsushita Elec. Corp., 775 F.2d
1107, 1123-24 (Fed.Cir. 1985).

The manner in which the Hypercenter recycles gases is the
ostensible improvement provided by the Hypercenter. How-
ever, this improvement does not change in a substantially dif-
ferent way the principles of operation as set forth in claim | of
the ’460 patent, and the improvement will not avoid infringe-
ment even if it is separately patentable. See Texas Instruments,
Inc. v. United States Int’! Trade Com., 805 F.2d 1558, 1568
(Fed.Cir. 1986); Rolls-Royce, Ltd. v. GTE Valeron Corp., 800
F.2d 1101, 1110 n.9 (Fed.Cir. 1986); (Tr. at 73, 665-66). Claim
1 of the ’460 patent is infringed.

C) Infringement of Other Claims of The ’460 Patent:

The evidence before us supports a finding that claim 2 is
infringed. Claim 2 calls for maintaining the paraffin:

in a melted state in two separate, heated-controlled
containers in immediate proximity to the [processing]
chamber, and during each sequence the melted paraf-
fin in a first operative step is drawn from the first of
said paraffin containers and in a second, later opera-
tive step, from the second of such containers.

As is apparent from the discussion of the infringement of the
073 patent, infra, defendants admit that the Hypercenter utilizes
two paraffin containers which operate in the manner called for
in claim 2. However, defendants maintain that they avoid the
“immediate proximity” limitation set forth in claim 2, because
the paraffin containers in the Hypercenter do not touch the
processing chamber. As the discussion of the infringement of
claim 1 of the ’073 patent indicates, defendants’ argument fails
to exonerate it from literally infringing claim 2 of the ’460 patent
and claim of 1 of the ’073 patent. Claim 2 of the ’460 patent is
infringed.

A-38

Claim 4 calls for subjecting the processing chamber to “an
alternating pressure/vacuum cycle to effect agitation of the
solution” during the period that the specimens are being treated
with a particular solution. The evidence before us indicates that
during the operation of the Hypercenter, the processing chamber
is subject to pressure/vacuum cycles during tidal agitation. See
Plaintiffs’ Ex. J; Tr. at 53-54, 204. Claim 4 of the ’460 patent
is infringed.

Defendants do not contest infringement of claims 5 and 6.
Because claim 1 is found to be infringed, claims 5 and 6 of the
460 patent, as dependent claims, are infringed as well.

Claim 7 calls for maintaining the temperature in the pro-
cessing chamber at a lower temperature for all solutions except
paraffin. The Hypercenter 2 operates in the manner as called
for in claim 7. (Tr. at 56). Claim 7 of the ’460 patent is
infringed.

VI. Infringement of the ’073 Patent

Plaintiffs have established that the Hypercenter meets
every element of claim 1 of the ’073 patent. (Tr. at 58-69).
Defendants seek to avoid a finding of infringement by arguing
(1) that the Hypercenter’s cabinet is composed of sections or
modules and is thus not a single cabinet as called for in claim 1,
and (2) that the melted paraffin container of the Hypercenter
does not have an end wall “immediately adjacent’ to the end
wall of the processing chamber as called for in the ’073 patent.

The cabinet recitation in claim 1 merely defines an enclo-
sure for the various elements. In the embodiment illustrated in
the patent, the enclosure is comprised of a number of sections
(including the reagent bottles, the processing chamber, the
paraffin containers, and the control module). The modules of
the Hypercenter collectively form a cabinet.

Even under an alternative finding that the modules of the
Hypercenter do not collectively form a single cabinet infringe-

A-39

ment would lie under the doctrine of equivalents, since the
Hypercenter modules perform the same function, in the same
manner as the cabinet in the instant patent because they represent
an enclosure containing the various elements of the device. (Tr.
56-58, 145, 315). Graver Tank & Mfg. Co., 339 U.S. at 607;
Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 934-37
(Fed.Cir. 1987), cert. denied, 485 U.S. 961 (1988).

As alluded to in the discussion of infringement of claim 2
of the ’460 patent, defendants’ arguments concerning the “im-
mediately adjacent” limitation on the location of the melted
paraffin container is an erroneous interpretation of the claim,
because the language “immediately adjacent” does not mean
that the paraffin container and the processing chamber must be
“in contact with” one another. Indeed, the specification indi-
cates that the paraffin container can be separated from the
processing chamber. See Plaintiffs’ Ex. A. Col. 10, lines 48-49.
The evidence before us also indicates, and defendants have
failed to refute this indication, that the Hypercenter functions as
called for in Subpart k of claim 1. (Tr. at 68-69). Claim 1 of
the ’073 patent is infringed.

The Hypercenter 2 has a remotely electrically controllable
rotary/type valve, as called for in claim 4 of the ’073 patent. (Tr.
at 62-65, 69). Additionally, the Hypercenter has a two-stage
control for obiaining different degrees of heat in the processing
chamber, relative to various time sequences, as calls for in claim
5. (Tr. at 65-67, 70). Claim 6 of the ’073 patent calls for a
combination of the elements of claims 4 and 5 which are present
in the Hypercenter. (Tr. at 65-67, 70). Claim 9 calls for “control
means includ{ing] circuitry connected to cycle the application
of vacuum and pressure conditions [in the processing chamber]”
and this element is found in the Hypercenter. (Tr. at 55-70).
The Hypercenter also embodies the adjustable timing device as
set forth in claim 11. Jd. Finally, claim 13 calls for the control
means mounted on the cabinet, air pump means (i.e. an electri-

A-40

cally operated pump mounted in the cabinet), and intercon-
nected pumping means including an outlet pipe in which the
pressure and vacuum conditions may be selectively produced,
the outlet pipe being connected to the chamber. All of these
elements are present in the Hypercenter. (Tr. at 55, 57, 59, 70).
Claims 4, 5, 6, 9, 11, and 13 of the ’073 patent are infringed.

Vil. Summary

We have concluded that claim 1 of the *460 patent is
invalid because its subject matter is obvious in light of the prior
art. We have upheld the validity of claim 1 of the ’073 patent
and rejected defendants’ contention that it is invalid for lack of
the specificity required by paragraph 2 of 35 U.S.C. §112. Fi-
nally, we have concluded that claims 1, 2, and 4-7 of the *460
patent and claims 1, 4-6, 9, 11 and 13 of the ’073 patent have
been infringed literally, or in the alternative, by application of
the doctrine of equivalents.

An appropriate order will follow.

/s/Gustave Diamond
United States District Judge

Date: March 11, 1992

A-41
APPENDIX A

7073 PATENT
’073 patent reads as follows:

1. A closed processing system enabling a plurality of
individual specimens of tissue to be separately contained while
being bathed simultaneously for varying lengths of time in
successive selected tissue solution including melted paraffin so
as to fix, dehydrate and clear the specimens preparatory to
embedding, comprising:

a. a plurality of uniform tissue receptacles each

being adapted to contain and physically isolate a

group of tissue specimens having at least one speci-

men per group, each receptacle having a body portion

defining an open cavity adapted to receive and retain

specimens and closure means removably received by

said body to enclose said cavity, the material forming

said receptacles being inert to all of said solutions and

having for each said solutions at least some portion

through which each of said solutions may be transferred;

b. acabinet;
c. an electrically heated, temperature controlled
container mounted in said cabinet and having a mov-

able cover and being adapted for melting and holding
melted paraffin;

d. aplurality of closed solution containers mounted
in predetermined order in a storage compartment in
said cabinet proximate said paraffin container, each
solution container containing a particular tissue pro-
cessing solution and with said melted paraffin con-
tainer collectively containing all of said tissue
solutions in which said specimens are processed;

e. air pump means having associated remotely elec-
trically controllable first valve means mounted prox-

A-42

imate said cabinet and associated interconnected pip-
ing means, said pump means providing a pressure and
vacuum source and said first valve means being se-
lectively operable to connect said source whereby to
produce a selected pressure or vacuum condition in
said piping means;

f. aprocessing chamber mounted in said cabinet and
having an end wall immediately adjacent an end wall
of said melted paraffin container, said chamber hav-
ing a pressure sealable top cover and being adapted to
receive and process therein selected numbers of said
receptacles simultaneously, said chamber being tem-
perature controlled and electrically heated and being
connected to said piping means thereby enabling the
corresponding selected pressure and vacuum condi-
tion in said piping means to e produced in said chamber;
g. asecond remotely electrically controllable valve
means mounted in said cabinet and having on one side
a fluid connection to said chamber and on the other
side a fluid connection to said paraffin container
enabling the paraffin contents thereof to be exchanged
between the chamber and said paraffin container, said
fluid connections for said second valve means being
of minimal length and being electrically heated and
maintained at a temperature above the melting point
of said paraffin;

h. a third remotely electrically controllable valve
means mounted in said cabinet and having on one side
a fluid connection of minimal length to said chamber
and on the other side a port for transfer of solutions
therethrough;

i. fourth remotely electrically controllable transfer
means positioned in said cabinet between said pro-
cessing chamber and said storage compartment, said

A-43

fourth valve means being fluid connected on one side
of said third valve transfer port and on the other side
having separate fluid connections to each of said
solution containers and being remotely electrically
controllable for enabling each solution container con-
nection on the one side of the fourth valve means to
be selectively and independently connected to said
transfer port for a predetermined time while all other
solution container connections are isolated therefrom
and at other times to isolate all of said solution con-
tainer connections from said transfer port,

j. an electrical source; and

k. remotely operable electrical control means con-
nected to said power source and mounted proximate
said chamber for remotely powering and electrically
operating each of said valve means and temperature
controls in a predetermined time sequence program
whereby with a selected number of said receptacles
installed in said chamber and said cover sealed oni said
chamber, said solutions and said paraffin containers,
are measured by timing the withdrawal and admitted
to said chamber under a vacuum condition in a prede-
termined volume, retained for predetermined times at
predetermined pressure and at the end of each pro-
cessing step being forced back to a respective said
solution and paraffin container by pressure from said
pump means source in a corresponding processing
sequence such that selected of said solutions and said
melted paraffin are separately and independently ex-
changed with each said greup of specimens while
maintaining said system closed, said paraffin trans-
ferred a minimal distance, and each said group phys-
ically isolated.

A-H
APPENDIX B

°460 PATENT
460 patent reads as follows:

1. Amethod for processing a plurality of individual spec-
imens of tissue to be separately contained while being simulta-
neously bathed for varying lengths of time in successive selected
tissue solutions including melted paraffin so as to fix, dehydrate
and clear the specimens preparatory to embedding, comprising:

a. separating the specimens to be processed into
groups;

b. installing and physically isolating each group
having at least one specimen per group in a respective
uniform tissue receptacle which is porous to the extent
of having for each of said solutions at least some
portion through which the solution may be trans-
ferred;

c. installing a plurality of such receptacles in a tem-
perature controlled and electrically heated processing
chamber having a pressure sealable top cover and then
sealing the cover;

d. with the receptacles installed, the cover sealed
and with the chamber positioned in proximity to a
plurality of closed vented containers, each containing
a particular tissue processing solution, including
melted paraffin in a heated temperature controlled
State, selectively and independently connecting each
container to the chamber to bring the solutions includ-
ing the paraffin, with the paraffin being the last solu-
tion, in a predetermined sequence to the chamber and
for each such solution in the sequence:

A-45

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA

MILES LABORATORIES, INC.,
and TRIANGLE BIOMEDICAL
EQUIPMENT, INC.,

Plaintiffs,
i 23
SHANDON, INC., and SHANDON
SOUTHERN PRODUCTS LIMITED,
Defendants.

Civil Action No. 86-2404

ORDER OF COURT

AND NOW, this 14th day of April, 1992, for the reasons
set forth in the memorandum opinion filed this day, IT IS
ORDERED that claims 2, 4-7 of the ’460 patent be, and the same
hereby are, declared invalid consistent with our March 11, 1992,
opinion; and,

IT IS FURTHER ORDERED that defendants’ motion to
amend judgment by declaring the ’073 patent be invalid by
virtue of 35 U.S.C.§112 {2 be, and the same hereby is, denied;
and,

IT IS FURTHER ORDERED that defendants Shandon,
Inc. and Shandon Southern Products, Ltd., their officers, ser-
vants and employees and those persons in active concert or
participation with them who have receive actual notice of this
order by personal service or otherwise, are permanently en-
joined from manufacturing, using, or selling the Hypercenter
and Hypercenter 2 or otherwise infringing the patents identified
in our March 11, 1992, opinion and order; and,

A-46

IT IS FURTHER ORDERED that an accounting is ordered
to resolve the remaining issues in this case; the parties may take
appropriate discovery as to the damages issue.

/s/Gustave Diamond
United States District Judge

cc: Lynn J. Alstadt, Esq.
Buchanan Ingersoll, P.C.
58th Fl., USX Tower
Pittsburgh, PA 15219

Robert D. Yeager, Esq.
Kirkpatrick & Lockhart
1500 Oliver Building
Pittsburgh, PA 15222

A447

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA

MILES LABORATORIES, INC.,
and TRIANGLE BIOMEDICAL
EQUIPMENT, INC.,
Plaintiffs,

Vv.

SHANDON, INC., and SHANDON
SOUTHERN PRODUCTS LIMITED,
Defendants.

Civil Action No. 86-2404

MEMORANDUM OPINION
DIAMOND, J.

Subsequent to this court’s March 11, 1992, opinion and
order, defendants have moved pursuant to Fed.R.Civ.P. 59(e)
and 52(b) to amend our opinion and plaintiffs have filed a
motion for entry of injunction in accordance with 35 U.S.C.
§154. As we explained below, we will grant defendants’ motion
to amend the judgment insofar as it requests clarification that
the dependent claims in ’460 patent (claims 2, 4-7) are invalid
by virtue of our March 11, 1992, opinion that claim 1 of the °460
patent is invalid. However, we will deny defendants’ motion to
amend the judgment on the basis that the ’073 patent is invalid
pursuant to 35 U.S.C. § 112 {2. We will therefore grant
plaintiffs’ motion for an injunction against further infringement
by defendants and an accounting is ordered to resolve the
remaining issues in this case; the parties may take appropriate
discovery as to damages.

We agree with defendants that our March 16, 1992, opinion
and order should be clarified to include a finding that the
dependent claims of the °460 patent are invalid by virtue of claim

ia eaa timc ileal camel

A-48

1’s invalidity.! It is well settled that where the parties have, as
here, set forth representative claims, dependent claims which
are not argued separately from the independent claim do not
survive a finding the independent claim is invalid. See Gardner
v. TEC Sys., Inc., 725 F.2d 1338, 1350 (Fed.Cir.) (en banc), cert.
denied, 469 U.S. 830 (1984) (dependent claim not separately
argued is invalid along with the independent claim). See also
Panduit Corp. v. Denison Mfg. Co., Inc., 836 F.2d 1329, 1330
n.l (Fed.Cir. 1987).

Defendants also ask this court to amend its judgment on
the basis of its §112 {2 argument that because the 073 patent
does not disclose “a vent,” it does “not fulfill the statutory
requirements of the second paragraph of 35 U.S.C. §112.”
Defendants’ Memorandum in Support of its Motion to Amend
Judgment at 8. Contrary to defendants’ presumption, this court
did not “miss the point of defendants’ argument.” Jd. Rather,
the court believes that it accurately perceived and applied the
doctrine embodied in the second paragraph of §112. It is well
understood that to be valid a claim must recite a structure that is
capable of performing its purported function. General Electric
Co. v. United States, 572 F.2d 745, 755 (Ct.Cl. 1978)(en banc).
Plaintiffs refer us to Mr. Kocsis’s testimony at trial (Tr. at
184-85) which we considered in our March 11, 1992, opinion
and which we deemed insufficient to make out a §112 claim as
a matter of law in view of other evidence in the record.

Indeed, defendants’ argument proves too much when they
write that:

! The April, 1988 pretrial “Stipulation of Agreed Fact, Law of the Case
and Questions of Law,” reads in pertinent part:
The '460 patent contains seven claims. Claim 1 is the only independent
claim. Claims 2 through 7 depend directly or indirectly from claim }.
Consequently, claim 1 is the broadest claim and can be considerea to
be representative of the claims in this patent.

Id. at 4 (emphasis added).

A+9

Mr. Kocsis was merely stating a well known physical
principle. For example, it is well known that it is
difficult to pour liquid from an old-fashioned tin can
unless a second hole is punched opposite the pouring
hole. Any dispute of that principal defies common
sense.

Defendants’ Memorandum at 10. Taking this proposition as
true, we do not find that the ’073 patent fails to satisfy the
standard of §112 92, simply because a vent is not recited in the
claim and we are not “reading in” a vent into the claims. Rather,
we are taking note of the well known doctrine, which is recog-
nized by the case defendants attached to their motion, that “‘it is
not necessary that a claimant cite each and every element needed
for the practical utilization of the claimed subject matter.” Carl
Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 1181 (Fed.Cir.
1991). See also Spectra-Physics, Inc. v. Coherent, Inc., 827
F.2d 1524, 1533-34 (Fed.Cir.), cert. denied, 484 U.S. 954
(1987) (under §112, “a patent need not teach, and preferably
omits, what is well known in the art’) (citing Hybritech, Inc. v.
Monoclonal Antibodies, Inc., 802 F.2 1367, 1384 (Fed.Cir.
1986), cert. denied, 480 U.S. 947 (1987)).

Moreover, in weighing the evidence, we find that defen-
dants have not shown total inoperativeness, assuming that their
argument as a matter of law is correct, which we do not. The
claimed invention utilizes “a plurality of closed solution con-
tainers” and, as plaintiffs have pointed out, there are at least two
kinds of such closed containers: closed vented containers and
closed unvented containers. The preferred embodiment de-
scribes containers closed with caps having vents in them. Col.
6, line 3, et seq. Indeed, the record shows that even unvented
containers would be operative, and we find that defendants have not
carried their burden on this claim. (See Tr. at 647, 701-76, 7 12).2

2 If defendants were proceeding under a 35 U.S.C. §101 theory that the
invention, by failing to disclose “a vent” would be “scientifically impossible,”
they would have to muster clear and convincing evidence and this they have
not done. See, e.g., Tol-O-Matic v. Proma Produkt-Und Marketing, 945 F.2d
1546, 1552-53 (Fed.Cir. 1991).

A-50

Defendants argue that “claim 1, as written, recites a ‘closed
processing system”, and that this language cannot be reconciled
with the finding of “‘a vent’, because a vent implies an opening.
Defendants’ Memorandum at 11. We reject this reasoning.
Whether a unit is “closed” depends on what the unit disclosed
in the claim see’: to “enclose” — solution or air? Indeed, as
noted above, the description of the preferred embodiment points
out that the solution containers are closed with respect to solu-
tion (which is, after all, what they were designed to contain) but
that their vents, if any, pertain to the flow of air and wh

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386003_0825%3A1. Public record. Not legal advice.
