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

Supreme Court brief1994

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Bupreme Gourt, WA,

FILED

NOV 24 1993

93-834

| 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

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?

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

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

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

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,

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.

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

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.

| |

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

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’’®

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.

[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.

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.

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. ")

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

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

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).

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.

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.

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

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

cree ne

Case No.

IN THE

Supreme Court of the United States

OCTOBER TERM, 1993

SHANDON INC., et al.,

Petitioners,

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

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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,

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,

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’

mie eh ona 4B MAN WO Ltn Couiils Ge

;

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,

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-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.

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

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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.

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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 which are

“kept extremely small so as to limit any admission of moisture.”

Col. 6, line 3. Thus, claim 1 of the ’073 patent is not invalid

under §112 2, because, reading the claim’s language literally,

the modifier “closed” pertains only to the term “solution”, not

air. In short, it is defendants who would have us “read in”

modifiers into claim 1 of the 073 patent by adding the terms

“absolutely” closed or “hermetically” closed. This we decline

to do. Finally, the language relating to a “closed processing

system” is directed towards a self-enclosed system for process-

ing tissues as distinct from one which relies on manual interac-

tions with the tissues and fluid.

An appropriate order will follow.

/s/Gustave Diamond

United States District Judge

Date: April 14, 1992

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

A-51

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

ORDER OF COURT

AND NOW, this 8th day of May, 1992:

The parties to the above-captioned action have filed a joint

motion to amend paragraph 3 of this court’s April 14, 1992,

order enjoining defendants from infringing plaintiff's valid

patent.

Accordingly, IT IS ORDERED that the joint motion to

amend paragraph 3 of this court’s April 14, 1992, order (Docket

No. 68) be, and the same hereby is, granted; and,

IT IS FURTHER ORDERED that paragraph 3 of the April

14, 1992, order (Docket No. 67) be, and the same hereby is,

amended to read as follows:

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 received actual notice of this

order by personal service or otherwise, are permanently en-

joined from infringing the ’073 patent by manufacturing, using,

A-52

or selling the Hypercenter and Hypercenter 2 or otherwise

infringing said patent.

/s/Gustave Diamond

United States District Judge

cc: Lynn J. Alstadt, Esq.

Buchanan Ingersoll, P.C.

58th Floor, USX Tower

Pittsburgh, PA 15219

Robert D. Yeager, Esq.

Kirkpatrick & Lockhart

1500 Oliver Building

Pittsburgh, PA 15222

A-53

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

MILES LABORATORIES, INC. and

TRIANGLE BIOMEDICAL EQUIPMENT, INC.,

Plaintiffs-Appellees,

SHANDON INC. AND SHANDON SOUTHERN

PRODUCTS LIMITED,

Defendants-Appellants.

92-1358

ORDER

A-54

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

ORDER

A combined petition for rehearing and suggestion for re-

hearing in banc having been filed by the APPELLANT, and a

response thereto having been invited by the court and filed by

the CROSS-APPELLANT, and the petition for rehearing hav-

ing been referred to the panel that heard the appeal, and there-

after the suggestion for rehearing in banc and response having

been referred to the circuit judges who are in regular active

service,

UPON CONSIDERATION THEREOF, it is

ORDERED that the petition for rehearing be, and the same

hereby is, DENIED, and it is further

ORDERED that the suggestion for rehearing in banc be,

and the same hereby is, DECLINED

For The Court,

Francis X. Gindhart, Clerk

Dated: September 1, 1993

By/s/Diane M. Frye

Diane M. Frye

Chief Deputy Clerk

cc: ROBERT D. YEAGER

ARNOLD SPRUNG

MILES LAB INC V SHANDON INC, 92-1358

(DCT - 86-2404)

Note: Pursuant to Fed. Cir. R. 47.6, this order is not citable as precedent. It

is a public record.

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This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.