Invitrogen Corp. (Formerly Known as Life Technologies, Inc.) v. Clontech Laboratories, Inc.

United States Court of Appeals for the Federal Circuit

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INVITROGEN CORPORATION
(formerly known as Life Technologies, Inc.),

Plaintiff-Appellant,

CLONTECH LABORATORIES, INC.,

Defendant-Cross Appellant.

Jay I. Alexander, Milbank, Tweed, Hadley & McCloy LLP, of Washington, DC,
argued for plaintiff-appellant. With him on the brief were Robert J. Koch and James
Pooley. Of counsel on the brief were Kevin R. Casey and Harrie R. Samaras,
RatnerPrestia P.C., of Valley Forge, Pennsylvania; and Alan Hammond, Invitrogen
Corporation, of Carlsbad, California.

Marc R. Labgold, Patton Boggs LLP, of McLean, Virginia, argued for defendant-
cross appellant. With him on the brief were Michael J. Schaengold, Richard J. Oparil,
and Kevin M. Bell.

Appealed from: United States District Court for the District of Maryland

Judge Alexander Williams, Jr.
United States Court of Appeals for the Federal Circuit

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INVITROGEN CORPORATION
(formerly known as Life Technologies, Inc.),

Plaintiff-Appellant,

CLONTECH LABORATORIES, INC.,

Defendant-Cross Appellant.

___________________________

DECIDED: November 18, 2005
___________________________

Before MICHEL, Chief Judge,∗ RADER, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.

Invitrogen appeals from the judgment of the United States District Court for the

District of Maryland, invalidating two hundred and twenty-one claims, in three related

Invitrogen patents, as anticipated by § 102(g)(2) prior art. Invitrogen Corp. v. Clontech

Labs., Inc., Nos. AW-96-4080, AW-00-1879 (D. Md. October 17, 2003) (final judgment)

(“Invitrogen”). Invitrogen confessed judgment of invalidity based on the district court’s

underlying ruling that researchers at Columbia University conceived of a similar

∗
Paul R. Michel assumed the position of Chief Judge on December 25,
2004.
invention before, and were diligent in reducing it to practice after, Invitrogen’s first

reduction to practice in 1987. Invitrogen Corp. v. Clontech Labs., Inc., (D. Md. Mar. 18,

2002) (order adopting the Special Master’s Report & Recommendation and granting

partial summary judgment in favor of Clontech on conception); Invitrogen Corp. v.

Clontech Labs., Inc., (D. Md. Jan. 15, 2002) (Special Master’s Report and

Recommendation on cross summary judgment motions regarding conception). On this

appeal, Invitrogen challenges the district court’s partial summary judgment dating

conception by the Columbia researchers.

On cross-appeal Clontech challenges three underlying partial summary

judgments in favor of Invitrogen: (1) that the claims-in-suit are enabled; (2) that the

claims-in-suit satisfy the § 112 written description requirement; and (3) that Clontech’s

products literally infringe claims 3, 4, 12, and 13 of U.S. Patent No. 6,063,608.

We hold that the district court misapplied the law of appreciation when dating

conception by the Columbia researchers and ignored genuine issues of fact precluding

partial summary judgment in favor of Clontech. Thus, the court vacates the invalidity

judgment and the district court’s conception ruling and remands for further proceedings.

Turning to Clontech’s cross-appeal, we affirm the district court’s rulings on enablement

and written description.

Clontech’s remaining cross-appeal challenges the district court's partial summary

judgment of literal infringement for Invitrogen. Because we find no error in the district

court’s claim construction, or its treatment of the facts, we affirm.

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I.

Invitrogen owns U.S. Patent No. 5,244,797 (“the '797 patent”), U.S. Patent No.

5,688,005 (“the '005 patent”), and U.S. Patent No. 6,063,608 (“the '608 patent”) (the

“patents-in-suit”). This appeal involves the '797 patent, claims 1-4; the '005 patent,

claims 8-29; and the '608 patent, claims 1-196 (the “claims-in-suit”). All three patents

issued from continuations of a common parent application, No. 07/143,396 (“the ‘396

application”), filed on January 13, 1988, and share a common written description.1

The patents deal with molecular biology. In particular, the patents disclose a

genetically modified enzyme, reverse transcriptase, involved in DNA replication.

Reverse transcriptase (“RT”) is a naturally occurring enzyme produced by retroviruses,

such as the Moloney-Murine Leukemia Virus (“MMLV”). Invitrogen’s genetic

modifications affect how the modified RT participates in DNA replication.

DNA replication involves a series of discrete steps. The original DNA—a

molecule comprised of two strands of nucleotides forming a double helix—is opened to

expose single strands. Messenger RNA (“mRNA”), comprising a single strand of

nucleotides, forms opposite the exposed DNA strands. The mRNA detaches from the

1
The '797 patent issued on September 14, 1993, from application
No. 07/671,156 (“the ‘156 application”), filed March 18, 1991. The '156 application was
a continuation of the parent '396 application, filed January 13, 1988.
The '005 patent issued September 16, 1997, from application No. 08/614,260
(“the ‘260 application”). The '260 application, filed on March 12, 1996, traces through a
series of continuation applications to a divisional from the '156 application (now issued
as the '797 patent).
The '608 patent issued on May 16, 2000, from application No. 08/798,458, filed
February 10, 1997, as a continuation of the '260 application (now issued as the '005
patent).

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exposed DNA and serves as a template against which a first strand of complementary

DNA (“cDNA”) forms. This is first strand synthesis. The mRNA detaches from the first

cDNA strand, allowing a second, complementary DNA strand to form opposite the first

strand, completing the process. This is second strand synthesis. The completed cDNA

molecule is a copy of the original DNA transcribed by the mRNA. “Reverse

transcription” describes building the cDNA from the mRNA template.

Reverse transcriptase affects at least two steps in this process. First, it facilitates

the formation of cDNA opposite the mRNA template, a step called DNA polymerase

activity. Second, it degrades the mRNA strand of the mRNA / cDNA hybrid molecule so

that the first strand cDNA nucleotides are free to form a second strand and complete the

DNA replication. Degrading or destroying the mRNA template is called RNase H

activity. Until the mRNA template is removed from the first strand cDNA, the second

strand cDNA synthesis cannot occur.

If RNase H activity destroys the mRNA template, as happens with naturally

occurring RT, then it cannot serve as a template for additional cDNA. But if the RNase

H activity of RT is inhibited, and the mRNA is detached from the hybrid mRNA / cDNA

first strand without being destroyed, then scientists can reuse the mRNA to form

additional cDNA. An RT with inhibited RNase H behavior is useful for efficiently cloning

DNA.

As described and claimed in the patents, Invitrogen developed mutant RT with

DNA polymerase, but no RNase H, activity (“RNase H minus”). More particularly,

Invitrogen altered a gene that originally encoded wild or natural RT, resulting in a

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mutant enzyme with the desired properties. Invitrogen reduced this invention to practice

on January 27, 1987.

Invitrogen was not, however, the first to explore the genetics of RT. Beginning in

the early 1980s two scientists at Columbia University, Dr. Stephen P. Goff and his post-

doctoral researcher, Dr. Naoko Tanese, studied the effects of random mutations in the

MMLV gene for RT – an approach called “random mutagenesis.”2 In 1984, Tanese

prepared a panel of roughly 100 mutants. Without sequencing the mutants, Goff did not

know where the MMLV gene had been altered in each mutation. Two mutant genes

created in 1984 were H7 and H8, each encoding enzymes that later proved to lack

RNase H activity.

After creating the mutant MMLV genes, Tanese tested the mutant RT they

encoded for DNA polymerase activity. Roth tested the mutant RT for a different function

called integrase. In late 1984, Tanese also tested the mutant RT for RNase H activity.

But the tests using 1984 assay technology yielded inconclusive results. The mutant RT

under investigation was produced in E. coli bacteria, which naturally produces an

enzyme with RNase H activity. The RNase H activity of the bacterial enzyme

introduced too much background noise to measure, with existing methods, the RNase H

behavior of the mutant RT.

The 1984 assay technology could have been used to measure the mutant RT

RNase H activity if Goff and Tanese first purified the mutant RT for each mutant MMLV

2
Goff was the first person to isolate and clone the wild MMLV gene for RT.
On May 6, 1985, Goff filed a patent application on a plasmid incorporating that MMLV
gene. The application listed Goff, Tanese, and Monica Roth – another researcher in
Goff’s lab – as inventors. It issued on July 24, 1990, as U.S. Patent No. 4,943,531.
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gene – that is, if they had they isolated the mutant RT from the background E. coli

enzymes. Goff concluded that approach was too time consuming for the large number

of mutant MMLV at issue, so he and Tanese developed a new in situ assay. That new

assay was designed to measure the RNase H activity of the mutant RT without first

isolating it from the bacterial enzymes. Not until March 1987, however, did Goff and

Tanese complete the new assay and apply it to their panel of mutants.

Nonetheless, in 1986, before finishing the new assay, Goff sequenced various

mutant RT genes. Among those he sequenced were H7 and H8.

When Goff and Tanese completed the new in situ assay in March 1987, they

rapidly determined which parts of the MMLV RT gene affected which enzyme

properties. By March 7, 1987, they established that H7 and H8 encoded mutant RT

with DNA polymerase activity but no RNase H activity.

Goff and Tanese started publishing their work after March 1987. On January 29,

1988, Goff filed a patent application pertaining to this research. In 1993 the U.S. Patent

and Trademark Office (“PTO”) declared an interference between Goff’s application and

the '260 application that eventually issued as Invitrogen’s '005 patent. (October 18,

1993 notice of interference from PTO). The sole count described a method for

producing a genetically modified RT with DNA polymerase but “having substantially no

RNase H activity.” Goff’s assignee, Columbia University, defaulted and the PTO ruled

in Invitrogen’s favor. As a result, the PTO never reviewed Goff’s research records to

determine priority of invention between Goff and Invitrogen. That priority question is

now central to this appeal.

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C.

This litigation involves using RNase H minus RT to prepare libraries of cloned

DNA. The defendant and cross-appellant, Clontech, develops and sells products in the

fields of genomics and molecular biology. Clontech has produced cDNA libraries using

genetically modified RTs and has sold kits with RNase H minus RT that may be used to

prepare cDNA libraries.

On December 31, 1996, Invitrogen, formerly Life Technologies, Inc., accused

Clontech of infringing the '797 patent. It later added the '005 patent to the suit. Among

other contentions, Invitrogen accused Clontech of infringing the '797 and '005 patents

by selling two products, SuperScript and SuperScript II, other RTs, and cDNA libraries

prepared using such enzymes. Clontech responded by asserting non-infringement,

invalidity, and unenforceability.

In 1999, following a bench trial, the district court entered judgment of

unenforceability in favor of Clontech on both the '797 and '005 patents. The district

court ruled that Invitrogen had engaged in inequitable conduct by not citing to the

examiner as prior art a presentation by Goff in which he described his work on mutant

MMLV RT to a conference at Stanford. On September 21, 2000, this court reversed

and remanded. Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d 1320 (Fed. Cir.

2000).

On May 16, 2000, while the appeal on the '797 and '005 patents was pending,

the '608 patent issued to Invitrogen. As noted above, the '608 patent claims priority to

the original January 13, 1988, application. On June 22, 2000, Clontech filed a

complaint for declaratory judgment of non-infringement, invalidity, and unenforceability

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of the '608 patent. Invitrogen counterclaimed that Clontech’s PowerScript RT product

infringed the '608 patent. The district court consolidated this set of claims for trial with

the remanded infringement action on the '797 and '005 patents.

There followed a series of pre-trial motions regarding Goff’s conception,

Invitrogen’s enablement, Invitrogen’s written description, and Clontech’s infringement of

the '608 patent. On June 20, 2001, the district court appointed a Special Master, who

reviewed several of those motions.

On January 15, 2002, the Master recommended partial summary judgment in

favor of Clontech under § 102(g)(2), establishing that Goff (1) conceived Invitrogen’s

invention first, and (2) diligently reduced it to practice. On March 18, 2002, the district

court accepted the Master’s report and recommendation (“R&R”) and granted partial

summary judgment in favor of Clontech.3 Invitrogen now challenges this ruling as to

Goff’s conception.

The district court also entered three other interlocutory orders. First, on May 4,

2001, the court granted partial summary judgment for Invitrogen that the claims-in-suit

were enabled. Second, on April 21, 2003, the court granted partial summary judgment

in favor of Invitrogen, holding that two Clontech products literally infringed claims 3, 4,

12, and 13 of the '608 patent. Third, on August 11, 2003, the court granted partial

summary judgment in favor of Invitrogen, ruling that the claims-in-suit satisfied the

written description requirement. On cross-appeal Clontech challenges the following:

(1) the ruling that the claims-in-suit were not invalid for lack of enablement; (2) the ruling

3
As discussed below, the parties cannot agree on the nature of this ruling.

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that the claims-in-suit were not invalid for lacking a written description; and (3) the

partial summary judgment of infringement.

***

Following these rulings and immediately before the scheduled trial, the court

adopted this jury instruction on “Anticipation – Prior Invention by Goff”:

The Court has already determined that Goff et al. invented a mutant [RT]
enzyme that did not have RNase H activity. The enzyme was prepared in
December 1984, and its reduction to practice was confirmed in March
1987. The Court has also found that Goff was diligent and that he did not
abandon, suppress or conceal his invention. Goff’s work is available as
prior art as of December 1984.

Faced with this jury instruction, Invitrogen consented to entry of final judgment of

invalidity under § 102(g) in view of Goff’s work. On October 17, 2003, the district court

entered final judgment in both actions (Invitrogen’s infringement suit and Clontech’s

declaratory judgment action), invalidating several claims under § 102(g)(2) in view of

Goff: (a) '797 patent, claims 1-4; (b) '005 patent, claims 8-29; and (c) '608 patent, claims

1-196.

Both parties timely appealed. The court has jurisdiction under 28 U.S.C.

§ 1295(a)(1).

II.

Section 102(g)(2) provides “[a] person shall be entitled to a patent unless . . .

before such person's invention thereof, the invention was made in this country by

another inventor who had not abandoned, suppressed, or concealed it. In determining

priority of invention under this subsection, there shall be considered not only the

respective dates of conception and reduction to practice of the invention, but also the

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reasonable diligence of one who was first to conceive and last to reduce to practice,

from a time prior to conception by the other.” 35 U.S.C. § 102(g)(2) (2000).

Invitrogen and Clontech filed cross summary judgment motions under this

section concerning Goff’s work at Columbia University. Invitrogen argued that Goff’s

work could not qualify as prior art to the three patents-in-suit. Clontech contended that

Goff’s work anticipated the claims-in-suit. In the alternative Clontech sought a ruling on

the admissibility, or relevance, of Goff’s work as prior art.4

Although the district court denied both parties’ motions, it made several

substantive rulings. First, the court determined that on January 27, 1987, Invitrogen

actually reduced to practice a genetically altered reverse transcriptase with DNA

polymerase activity but no RNase H activity. Second, it held that Goff conceived of a

genetically modified reverse transcriptase with no RNase H activity in December 1984

when he produced the H7 and H8 mutants, or at the latest in January 1986 when he

sequenced the two mutant genes. Third, the court found that Goff actually reduced his

invention to practice in March 1987 when he demonstrated the RNase H minus

behavior of the H7 and H8 mutants with his new in situ assay. Finally, the court found

that Dr. Goff was diligent in reducing his invention to practice, and he did not abandon,

conceal or suppress it. Notwithstanding these rulings, the court refused to find

Dr. Goff’s work anticipatory under § 102(g)(2) on grounds that anticipation posed factual

questions requiring resolution on a claim by claim basis. Thus, the court appeared to

4
As noted below, Clontech relies on a series of documents – primarily
laboratory notebooks kept by Dr. Goff and his assistants throughout the 1984-87 time-
frame – as evidencing Dr. Goff’s prior invention for § 102(g)(2). The district court
entered its invalidity judgment purely on grounds of anticipation; it did not discuss Goff’s
work as a potential 102(g) / 103 prior art reference.

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question – or leave for the jury’s resolution – whether its description of the “inventions”

by Invitrogen and Goff properly coincided, or whether the claims-in-suit accurately

corresponded to the description of Goff’s invention.

As a preliminary matter, Clontech contends the district court’s order was no more

than an evidentiary ruling on the admissibility of Goff’s work at trial. This argument has

no merit. As demonstrated by the jury instruction on anticipation, the order established

facts and removed legal issues from dispute. The rulings define Invitrogen’s invention,

date Invitrogen’s reduction to practice (if not its conception), date Goff’s conception, find

diligence, and date his reduction to practice. These are determinations on less than the

entire case and less than the whole relief sought by the cross summary judgment

motions. The district court expressly premised these rulings on what it viewed as

undisputed facts in the record. Thus, the court’s determinations comprise an order

“specifying the facts that appear without substantial controversy . . . and directing such

further proceedings in the action as are just.” Fed. R. Civ. P. 56(d). Regardless of how

the district court labeled its order, it is a partial summary judgment on Goff’s conception

under § 102(g)(2).

On appeal Invitrogen challenges only the district court’s determination that

Dr. Goff conceived of a genetically engineered reverse transcriptase with no RNase H

before the critical date. As the first step in evaluating Goff’s conception under

§ 102(g)(2), the court must identify two references: (1) the “invention” subject to the

priority contest; and (2) the critical date, or the date of Invitrogen’s conception. Although

the district court appeared to treat its characterization of Dr. Goff’s invention and

Invitrogen’s invention as potentially divergent, Invitrogen effectively concedes two

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critical points by consenting to judgment of invalidity and limiting its appeal to the date of

Goff’s conception. First, this eliminates any doubt that Goff’s invention, whose

conception the district court evaluated, was the same as the Invitrogen invention at

issue.5 Second, this establishes that the court’s statement of the invention captures

subject matter that anticipates all two hundred twenty-one claims at bar.6 Furthermore,

Invitrogen’s failure to challenge the January 27, 1987 critical date effectively establishes

its conception, for § 102(g)(2), as simultaneous with its reduction to practice. As

Invitrogen does not challenge the court’s rulings on diligence, the relevant question on

appeal is whether Goff conceived of the invention before January 27, 1987.

The court must resolve that question using a properly defined invention.

Although the district court described Goff’s invention without mentioning DNA

polymerase activity, the invention at issue plainly requires this additional limitation. The

DNA polymerase activity limitation is manifest in the patent claims, the common written

descriptions of the patents-in-suit, and in the purpose of the invention. In short, the

court is tasked with dating Dr. Goff’s conception of a (1) genetically engineered

(2) reverse transcriptase enzyme (3) with no RNase H activity (4) but having DNA

polymerase activity.

The court reviews de novo a grant of partial summary judgment. Beech Aircraft

Corp. v. Edo Corp., 990 F.2d 1237, 1245 (Fed. Cir. 1993). Although Invitrogen and

5
For the same reasons, it frames the dispute in terms of a single Invitrogen
invention, rather than multiple inventions spread across the three patents-in-suit.
6
The claims-at-bar correspond to the court’s statement of the invention.
The district court’s reasons for deciding priority, but refusing summary judgment, are
somewhat unclear.

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Clontech filed cross summary judgment motions, each motion “must be independently

assessed on its own merits.” California v. United States, 271 F.3d 1377, 1380 (Fed. Cir.

2001). Moreover, on summary judgment, the court holds the parties to the same

evidentiary burden they would have faced at trial. Apple Computer, Inc. v. Articulate

Sys., Inc., 234 F.3d 14, 20 (Fed. Cir. 2000).

Conception is a legal conclusion premised on various underlying facts. Singh v.

Brake, 222 F.3d 1362, 1367 (Fed. Cir. 2000); Cooper v. Goldfarb, 154 F.3d 1321, 1327

(Fed. Cir. 1998); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376

(Fed. Cir. 1986). As the partial summary judgment ruling arose in the context of

Clontech’s motion for summary judgment of invalidity, Clontech was required to identify

clear and convincing evidence of the factual underpinnings for Goff’s conception. See

Apotex USA, Inc. v. Merck & Co., Inc., 254 F.3d 1031, 1036 (Fed. Cir. 2001) (requiring

the party asserting invalidity to prove by clear and convincing evidence that the

invention was not abandoned, suppressed, or concealed under § 102(g)); cf.

Lindemann Machinenfabrik GmbH v. Am. Hoist and Derrick Co., 730 F.2d 1452, 1459

(Fed. Cir. 1984).

In sum, the court must affirm the district court’s partial summary judgment on

conception in favor of Clontech if, in view of the heightened evidentiary burden at trial

and drawing all reasonable factual inferences most favorably to Invitrogen, it finds no

disputed issue of material fact underlying the conception analysis, and Clontech was

entitled to the determination that Goff’s conception preceded Invitrogen’s. Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).

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C.

Conception defines the legally operative moment of invention under § 102(g). It

is the “formation in the mind of the inventor, of a definite and permanent idea of the

complete and operative invention, as it is hereafter to be applied in practice.” Hybritech,

802 F.2d at 1376. An idea is sufficiently definite and permanent for conception if it

provides one skilled in the art with enough guidance to “understand the invention,” that

is, “when the inventor has a specific, settled idea, a particular solution to the problem at

hand, not just a general goal or research plan he hopes to pursue.” Burroughs

Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). The inventor

must be able to “describe his invention with particularity.” Id. This requires both (1) the

idea of the invention’s structure and (2) possession of an operative method of making it.

Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991). Thus, with

regard to a claimed chemical compound, conception requires that the inventor “be able

to define” the compound “so as to distinguish it from other materials, and to describe

how to obtain it.” Id.

This description, and the “definite and permanent idea of the complete and

operative invention” for conception, require more than unrecognized accidental creation.

“[A]n accidental and unappreciated duplication of an invention does not defeat the

patent right of one who, though later in time, was the first to recognize that which

constitutes the inventive subject matter.” Silvestri v. Grant, 496 F.2d 593, 597 (CCPA

1974). Thus, “[t]he date of conception of a prior inventor’s invention is the date the

inventor first appreciated the fact of what he made.” Dow Chem. Co. v. Astro-Valcour,

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Inc., 267 F.3d 1334, 1341 (Fed. Cir. 2001). In other words, conception requires that the

inventor appreciate that which he has invented.

The invalidity judgment depends on when Goff appreciated that H7 and H8 were

RNase H minus, but retained DNA polymerase activity.7 Invitrogen contends that the

district court misread the facts and misapplied the law to award Goff priority of invention.

Under a correct application of law, Invitrogen argues, Goff did not conceive of the

invention until March 1987, when he perfected his in situ assay and established that the

H7 and H8 mutants were RNase H minus. Invitrogen contends that until that moment,

Goff never recognized that his accidental creations, the H7 and H8 mutants, had the

inventive features at issue. Clontech disagrees, and asks the court to affirm the district

court’s ruling.

Although such conscious problem solving suggests conception comes first, under

some conditions conception is delayed until a reduction to practice. See Burroughs, 40

F.3d at 1229; Amgen, 927 F.2d at 1206; Alpert v. Slatin, 305 F.2d 891, 894 (CCPA

1962).8 Such delayed conception is often described by the rule against nunc pro tunc

conception. That is, a reduction to practice at time A necessarily requires the inventor

7
The district court did not discuss the DNA polymerase activity of H7 and
H8. On appeal, Invitrogen does not separately challenge Goff’s timely appreciation of
this behavior. Clontech argues that the record demonstrates Goff’s recognition of H7
and H8 DNA polymerase activity in 1984. For purposes of this analysis the court
assumes that timely appreciation of DNA polymerase activity is not disputed. The
parties and the trial court can revisit this issue, as necessary, on remand.
8
“A conception is not complete if the subsequent course of
experimentation, especially experimental failures, reveals uncertainty that so
undermines the specificity of the inventor’s idea that it is not yet a definite and
permanent reflection of the complete idea as it will be used in practice.” Burroughs,
40 F.3d at 1229.

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to possess the knowledge about the invention to show a conception. However, the law

will not sanction the inference that reduction to practice at time A implies conception at

earlier time B.

With unrecognized accidental duplication, the invention exists but remains

unrecognized. The priority determination requires evidence that the inventor actually

first made the invention, and that he understood his creation to have the features that,

comprise the inventive subject matter at bar. Thus, the court must identify when, during

an emerging recognition that a particular invention includes something new, the

inventor’s understanding reaches the level needed for appreciation. In the appreciation

analysis, the relevant uncertainty relates to the emerging recognition of something new.

That analysis requires objective corroboration of the inventor’s subjective beliefs.

Heard v. Burton illustrates the importance of the inventor’s actual knowledge or beliefs.

333 F.2d 239, 243 (C.C.P.A. 1964). In Heard, a priority contest arose in an interference

proceeding. The “essence of the invention” was “using eta-aluminum, a specific type of

hydrated aluminum oxide, as support material for platinum” in a reforming process in

which the platinum-alumina combination served as a catalyst. Id. at 240. The record

showed that the compound could only be identified by its x-ray diffraction pattern. Id. at

241 n.1. The critical date was April 23, 1952, when Burton filed a patent application on

the invention.

Although Heard actually made the novel compound in 1949 and 1950, the record

showed that he never recognized it. Only in 1954 did the successor to Heard’s work,

the Standard Oil Company, confirm by x-ray diffraction analysis that the 1949

compound contained the novel catalyst; only in 1961 did Standard Oil Company – again

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by x-ray diffraction – establish that the new catalyst was also present in the 1950

compound. Id. at 242. As the court observed, “we consider it fatal to [Heard’s] case

that not until after the [critical date] did Heard recognize that his ‘ammonia-aged’

catalyst . . . ‘contained any different form of alumina at all.’” Id. at 243. The fact that

Heard “relegated the spent catalysts to storage cages” rather than further develop them

confirmed the lack of recognition. In short, the inventor – Heard – never suspected

what he had created, and the context – a novel compound whose existence is shown by

inspecting its x-ray diffraction pattern – required the most specific of objective evidence,

which was missing. Heard was an easy case.

While Heard made clear the importance of an inventor’s subjective beliefs about

his invention, objective evidence is also an important part of the appreciation inquiry.

Indeed, because of the danger in post-hoc rationales by an inventor claiming priority,

the court requires objective evidence to corroborate an inventor’s testimony concerning

his understanding of the invention. See Jolley, 308 F.3d at 1321 (“Because conception

is a mental act, ‘it must be proven by evidence showing what the inventor has disclosed

to others and what that disclosure means to one of ordinary skill in the art.’”) (quoting

Spero v. Ringold, 377 F.2d 652, 660 (CCPA 1967)). Thus, it is not enough that a party

adduce evidence that objective test results comport with an inventor’s testimony

concerning his state of mind. Rather, there must also be evidence that the junior party

timely interpreted or evaluated the results, and understood them to show the existence

the invention. See Langer v. Kaufman, 465 F.2d 915, 919 (CCPA 1972).

In Langer, the court extended Heard to provide that where there is an objective

basis for identifying the novel features of an invention, there must be evidence that the

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inventor timely considered it. The facts of the Langer interference were essentially

identical to those in Heard: the invention called for a catalyst using a particular

crystalline compound,9 and as defined in the count the new compound was identified by

a characteristic x-ray diffraction pattern. Id. at 917-18. But in contrast to Heard, Langer

photographed x-ray diffraction patterns of the new compound two years before the

critical date. Id. at 919. Reviewing those photos roughly eleven years after the critical

date, Langer’s co-inventor identified evidence of the new catalyst. Id. The problem was

that nothing showed, before the critical date, that anyone had either looked at the

photos or understood what they meant. Quoting the opinion below, the court observed

that there was “no evidence of any contemporaneous interpretation or evaluation of the

patterns” by the inventors or anyone working with them. Id.

In Silvestri v. Grant, 496 F.2d 593, 597 (CCPA 1974), the court applied these

principles to a priority contest in view of a record showing uncertainty in interpreting the

test results corroborating the inventor testimony on appreciation. Notwithstanding that

uncertainty, the court tested the evidence against the junior party’s burden at the

interference, and concluded that the record showed appreciation. In short, Silvestri

requires an objective basis corroborating the inventor’s belief to show, consistent with

9
Specifically, it required the gamma form of crystallized titanium trichloride
(TiCl3) as a co-catalyst component. Langer, 465 F.2d at 917.

04-1039, -1040
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the appropriate burden at trial, that persons skilled in the art at the time of the

recognition would have recognized the existence of the relevant inventive features.10

The rule in Silvestri has direct application to the genetically engineered RT

claimed here. Clontech must show by clear and convincing evidence that Goff formed a

timely belief that his H7 and H8 RT were RNase H minus. Once Goff’s belief is

established, the court must further determine that whatever test results Goff cites, and

Clontech relies upon, show by clear and convincing evidence to one of skill in the art at

the time that the H7 and H8 mutant RT were RNase H minus.

To the extent the district court may, inter alia, have considered appreciation in

reaching its conception ruling, its analysis was inadequate. At most, the court seemed

to find it undisputed that Goff intended to create RNase H minus RT in 1984 and that by

the time he sequenced the H7 and H8 in 1986, Goff completed his conception (and

appreciation).

10
The invention was “a new form of an otherwise old composition” of
ampicillin. Silvestri, 496 F.2d at 597. The interfering subject matter, as defined in the
count, called for an anhydrous form of ampicillin having improved storage stability and a
particular infrared spectrograph. Id. at 595-96.
Although Silvestri framed the issue as “whether the evidence establishes beyond
a reasonable doubt that, prior to [the critical date], Silvestri not only actually prepared
[the new form of ampicillin], but also appreciated that a new form of ampicillin had been
obtained,” id. at 597 (emphasis added), that high standard does not apply to this case,
see Horwath v. Lee, 564 F.2d 948, 949 n.2 (CCPA 1977), and has been replaced by
clear and convincing evidence. See Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir.
1993) (“The board erred . . . by requiring Price to prove derivation and priority beyond a
reasonable doubt rather than by clear and convincing evidence.”). The fact that Silvestri
could satisfy this high burden, even with ambiguity in the evidence showing the
presence of the new compound, demonstrates that appreciation does not require
conclusive or unassailable evidence showing existence of a new compound’s novel
features.

04-1039, -1040
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As a matter of law, the court’s conclusion is unsustainable. Langer and Silvestri

require some connection between the physical result (the invention) and the belief (by

the inventor). Here, the district court never identified corroborating evidence of Goff’s

purported belief, nor identified how it could determine that Goff had reviewed such

evidence and understood its import. There is no evidence that merely sequencing the

mutant RT gene could, in 1986, establish the corresponding enzyme’s properties.

More fundamentally, the record is inconsistent with the district court’s notion that

Goff set out to create RNase H minus RT, or that he recognized his invention in 1984. It

shows, instead, that this action fits squarely within the unrecognized, accidental

duplication cases. First, Goff’s research was general in nature. The random

mutagenesis involved a panel of 100 randomly mutated MMLV RT genes. At his

deposition, Goff testified that Tanese’s 1984 experiments “[were] focused on

understanding what the consequences of those mutations were for the virus.” He

explained that his “main grant and the main focus of [his] whole lab was to look at the

[MMLV] mutants . . . and to look at the [effects] of those mutations on the virus.”

Second, it was unknown at the time whether it was even possible to make an RNase H

minus RT with DNA polymerase activity. Not until his March 1987 assay, Goff

explained, had anyone shown that RNase H activity involved a separate area of the RT

gene from the sequence responsible for DNA polymerase. The publications at the time

were conflicting, and it was unclear “whether it would be possible to express [the two

functions] separately because there are many multi function enzymes, but frequently

[their] multiple activities are interconnected so intimately, that [it is] very hard to

separate them.” Finally, asked to identify the time when he “decided” to create an

04-1039, -1040
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RNase H minus mutant RT, Goff testified that “the belief was that we had them, but I

didn’t know how to characterize them. I mean, it wasn’t that we wanted one. There was

no reason to have one in our minds.” (emphasis added) Even assuming the district

court had assessed an objective basis for appreciation – which it did not – on these

facts the partial summary judgment of conception for Clontech is unsustainable.

Although the district court’s conception analysis misapplied the law to the facts,

this court must examine whether correctly applying the law of appreciation to this record

would dictate a different result. See Litton Indus. Prods., Inc. v. Solid State Sys. Corp.,

755 F.2d 158, 164 (Fed. Cir. 1985). As shown below, we cannot affirm the invalidity

judgment under a correct application of the law.

Although initially (as shown above) Goff explained that he had no reason to

believe that H7 and H8 were RNase H minus, by late 1986 he had formed a suspicion.

Asked whether he suspected this behavior in H7 and H8 RT before March 1987, Goff

replied:

“Sure. I mean, in the course of all those failed assays, you know, there
were hints of things [RNase H] working badly. So that you do develop a
feel for what’s likely to be the result later . . . . But, you know, for
publications of quality you’ve got to convince people. So we needed – it
took that long [until March 1987] to get reliable assays.” Goff dated his
suspicion regarding H8 to “the end of ’86 or something because they really
weren’t working very well for quite a while.”

This testimony plainly excludes the district court’s dates of Goff’s conception,

December 1984 or January 1986. But Clontech may still show that Goff’s conception

took place before January 27, 1987. Put differently, a reasonable fact-finder presented

with Goff’s testimony could conclude that while Goff appreciated the RNase H minus
04-1039, -1040
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features of the H7 and H8 RT by March 1987, the evidence preceding the March 1987

test results might also suffice, by clear and convincing evidence, to corroborate Goff’s

timely suspicions about the H7 and H8 mutants. The question becomes whether, as a

matter of law, the trial court ignored a genuine issue of fact that should have been given

to a jury.11

The court thus turns to the objective evidence that might corroborate Goff’s

suspicion. Clontech urges the court to find Goff’s appreciation shown, without any

genuine dispute, by a collection of laboratory notebook entries spanning the years 1984

to 1987. On close inspection, however, Clontech’s evidence fails to carry its summary

judgment burden.

Clontech relies on several notebook entries whose meanings are factually

disputed. For example, Clontech argues that entries from December 1984 and May

1985 show Goff was “focused” on testing H7 and H8 as early as December 19, 1984. It

further argues that this “focus” demonstrates Goff’s understanding that the mutants

were RNase H minus. But on inspection neither the December 1984 entry, nor the May

11
Relying on Goff’s statement concerning the need for academic certainty
before he would publish his suspicions, Invitrogen argues that Goff has admitted he did
not appreciate the RNase H behavior of the H7 or H8 RT before March 1987. We
disagree. The appreciation analysis is objective and depends on the record evidence
Clontech adduces or cites in support of its conception argument. The legal test does
not depend on subjective factors like an inventor’s readiness to publish, art-specific
factors like journal publication requirements, career pressure to publish in an academic
environment, or grant requirements. Such variable factors are poor proxies for how a
person skilled in the relevant art would interpret objective evidence corroborating a
purported recognition, and we do not believe the law should depend on such malleable
parameters. If it did, the law would create a perverse incentive to rush to publication, in
order to preserve a conception claim against a potential later priority date. Goff’s
testimony about wanting more conclusive data, in short, does not prevent a finding of
appreciation and conception before the January 27, 1987 critical date.

04-1039, -1040
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1985 entry, indicates the alleged “focus” on H7 or H8. Each recites a list of several

mutants under examination, and Goff’s paper concerning this research discusses forty-

two mutants.

Other Clontech contentions squarely conflict with inventor testimony interpreting

the same underlying notebook entries. For example, Clontech contends that a

December 1984 entry provides undisputed evidence that Goff recognized that the H7

and H8 mutants were RNase H minus.12 But Invitrogen specifically asked Goff, at his

deposition, to comment on the entry, and he testified that it was not relevant to the H7

or H8 RT RNase H minus behavior.13

Overshadowing all of Clontech’s arguments are defects in the expert testimony.

Clontech nowhere provides the court with expert testimony that properly explains the

technical notebook entries advanced in support of its conception arguments. The

declaration from Clontech’s expert, Joseph O. Falkinham, III, gives the court no

substantive factual guidance. Falkinham states, “Based on my review, Goff, et. al.

conceived of the claimed invention, RNase H-deficient mutant [MMLV RT] in 1984 . . . .

It is clear from his testimony and his lab records that he conceived of the invention in

1984.” (Falkinham Decl. ¶ 4). Citing various notebook entries, Falkinham asserts

“[t]hese representative entries demonstrate Goff’s conception, diligence and reduction

to practice.” (id. ¶ 5). But such wholly conclusory assertions on a legal issue cannot

carry Clontech’s burden on summary judgment. See Biotec Biologische

12
The December 21 and 22 entry reads “clone H7 & H8 (weakly positive on
RT assay – 12/17/84 Should amplify the signal).”
13
Goff responded, “that’s cell culture work, so this is not relevant. . . .
[T]here are many distinct issues of function from the bacterial enzyme.”

04-1039, -1040
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Naturverpackungen GmbH & Co. KG v. Biocorp, Inc., 249 F.3d 1341, 1353 (Fed. Cir.

2001).

Although Clontech responds to that evidentiary problem with extensive attorney

argument regarding multiple notebook entries, the argument is insufficient. See id.; Am.

Airlines, Inc. v. United States, 204 F.3d 1103, 1112 (Fed. Cir. 2000); Glaverbel Societe

Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1562 (Fed. Cir. 1995)

(“There must be sufficient substance, other than attorney argument, to show that the

issue requires trial.”). Unsubstantiated attorney argument regarding the meaning of

technical evidence is no substitute for competent, substantiated expert testimony. It

does not, and cannot, support Clontech’s burden on summary judgment.

Perhaps Clontech’s strongest factual argument concerns January 1987

laboratory notebook entries by Roth, working in Goff’s laboratory. The entries record

various experiments or “product analyses” or RT assays involving H7, during which

Roth added RNase H to various batches under inspection. Essentially, Clontech argues

that Roth would not have added RNase H unless the H7 mutant lacked RNase H

activity. Thus, Clontech concludes, these entries demonstrate to a person skilled in the

art that the H7 RT was RNase H minus. As with its other record citations, however, the

problem lies in Clontech’s attempt to substitute attorney argument for expert testimony.

Nowhere does Clontech point to expert testimony explaining what Roth’s notebook

entries mean. Even if Clontech were correct about their meaning, nothing indicates that

they amount to clear and convincing evidence that H7 and H8 were RNase H minus,

nor that Goff drew that conclusion from them.

04-1039, -1040
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Indeed, the record compels an inference that he did not. At his deposition, Goff

testified that Roth’s work was directed to testing for integrase activity—an unrelated

property of the mutant RT.14 Insofar as Goff’s testimony goes to his subjective

recognition of the test results, the issue is similar to that recognized in Langer. Goff’s

testimony demands the inference, on this partial summary judgment, that he did not

understand Roth’s entries to show that H7 and H8 RT were RNase H minus.

In short, as the factual inferences must be drawn adverse to Clontech, the district

court erred in granting partial summary judgment establishing Goff’s conception before

January 27, 1987.

Finally, Invitrogen argues that the court should reverse the district court’s partial

summary judgment on conception, rather than merely vacate it. This argument in effect

challenges the district court’s denial of Invitrogen’s motion for partial summary judgment

on conception. We review the denial of a motion for partial summary judgment for

abuse of discretion. See Pickholtz v. Rainbow Techs., Inc., 284 F.3d 1365, 1371 (Fed.

Cir. 2002). In view of the foregoing factual discussion, on this record the district court

did not abuse its discretion in refusing to grant partial summary judgment for Invitrogen.

III.

Clontech’s cross-appeal challenges three interlocutory orders by the trial court in

favor of Invitrogen. Two were partial summary judgments that the claims-in-suit were

14
Invitrogen argues that Goff’s testimony forecloses the court from finding
appreciation based on these January 1987 notebook entries by Roth. Contrary to
Invitrogen’s contention, neither its argument nor the record precludes finding timely
recognition by Goff. Goff was not responding to a question specifically addressing
these notebook entries, and his testimony is too general either to join issue with
Clontech’s conception argument, or to explain away Roth’s entries.

04-1039, -1040
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not invalid, either for failing enablement or the written description requirements of § 112.

The last determined that Clontech infringed four claims of the '608 patent. “As a general

proposition, when a trial court disposes finally of a case, any interlocutory rulings

‘merge’ with the final judgment. Thus both the order finally disposing of the case and

the interlocutory orders are reviewable on appeal.” Hendler v. United States, 952 F.2d

1364, 1368 (Fed. Cir. 1991). The court turns first to the validity rulings.

The court begins with Clontech’s enablement arguments. The claims-in-suit

describe genetically engineered RT without regard for the method used to mutate the

genes. It is undisputed that by 1988 those skilled in the art knew several techniques for

altering genetic sequences, including deletion and point mutations. The written

description for the patents-in-suit describes how to implement the claimed invention by

deletion mutation; the parties disagree as to whether it also teaches how to implement

the claimed invention by point mutation. Clontech made at least one accused product,

its PowerScript RT, by point mutation rather than deletion mutation.

Enablement is a question of law, and the court reviews the judgment de novo.

See Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1149 (Fed. Cir. 2004);

Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1194

(Fed. Cir. 1999).

Clontech argues the district court erred, as a matter of law, in concluding that

Invitrogen’s claims are enabled. The contention rests on Invitrogen’s failure to explain

in the written description how to achieve RNase H minus RT with DNA polymerase

using point mutation. Because the law requires the inventor to enable claims

04-1039, -1040
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throughout their full scope without requiring undue experimentation by those having

ordinary skill in the art, Clontech argues Invitrogen’s written description fails to enable

claims encompassing point-mutated RT.15 Recognizing that the claims-in-suit do not

exclude point-mutated RT, Clontech concludes that the claims must be invalid for lack

of enablement.

This argument mistakes the purpose of the enablement requirement. Section

112 requires that the patent specification enable “those skilled in the art to make and

use the full scope of the claimed invention without ‘undue experimentation’” in order to

extract meaningful disclosure of the invention and, by this disclosure, advance the

technical arts.16 Koito Mfg., 381 F.3d at 1155 (quoting Genentech, Inc. v. Novo Nordisk

A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (citation omitted)). Because such a

disclosure simultaneously puts those skilled in the art on notice of the enforceable

boundary of the commercial patent right, the law further makes the enabling disclosure

operational as a limitation on claim validity. “The scope of [patent] claims must be less

than or equal to the scope of the enablement. The scope of enablement, in turn, is that
15
Invitrogen’s arguments that the written description satisfies the
enablement requirement, because it teaches point mutated RT, are without merit.
Although the common written description explains that “a single amino acid change at a
position 12 residues from the carboxy end of E. coli RNase H produces a 10-fold
reduction in RNase H specific activity,” ’608 patent, col. 17, ll. 11-13, as explained infra
with respect to the infringement judgment, the claims at issue are drawn to a complete
absence of RNase H activity. Nothing in the record suggests that a “10-fold reduction”
satisfies the “complete absence” limitation. This disclosure does not itself teach an
enabling point mutation, nor does the record support a contention that the disclosure,
coupled with the knowledge of those skilled in the art at in January 1987, enabled a
point mutation.
16
The enablement requirement provides that “[t]he specification shall
contain a written description . . . of the manner and process of making and using [the
invention] . . . in such full, clear, concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with which it is most nearly connected, to make
and use the same. . . .” 35 U.S.C. § 112 (2000).

04-1039, -1040
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which is disclosed in the specification plus the scope of what would be known to one of

ordinary skill in the art without undue experimentation.” Nat’l Recovery, 166 F.3d at

1196; see also In re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (“[T]he specification

must teach those of skill in the art ‘how to make and how to use the invention as broadly

as it is claimed’.”); In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (“[T]he scope of the

claims must bear a reasonable correlation to the scope of enablement provided by the

specification to persons of ordinary skill in the art.”).

Although Clontech’s validity argument might have force had Invitrogen limited its

claims to modified RT by reference to point mutation, Clontech overlooks the fact that

the claims are not limited by the method of achieving the mutation. As the district court

noted, “[t]he enablement requirement is met if the description enables any mode of

making and using the invention.” Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342,

1361 (Fed. Cir. 1998); accord Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d

1313, 1335 (Fed. Cir. 2003); Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533

(Fed. Cir. 1991). In this case Invitrogen’s teaching regarding deletion mutation is

sufficient to satisfy its part of the patent bargain, as it fully teaches a mode of making

the claimed invention.

Clontech mistakenly relies on our decision in National Recovery to support its

nonenablement argument. In National Recovery the court affirmed judgment that a

patent claim was invalid for lack of enablement. 166 F.3d at 1198. The claim was to a

method, not a compound. The claimed method called for selecting certain signals for

processing, yet the written description failed to teach one of ordinary skill in the art how

to select among various candidate signals. Id. at 1196. A person of ordinary skill,

04-1039, -1040
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reading the patent, would have been required to engage in undue experimentation

before reaching a means of practicing the claimed method. In short, the National

Recovery enablement problem concerned a failure to disclose any way to practice the

claimed method. In this case, by contrast, Invitrogen fully described an operable

method for achieving the claimed mutation.

Enablement does not require the inventor to foresee every means of

implementing an invention at pains of losing his patent franchise. Were it otherwise,

claimed inventions would not include improved modes of practicing those inventions.

Such narrow patent rights would rapidly become worthless as new modes of practicing

the invention developed, and the inventor would lose the benefit of the patent bargain.

The court therefore affirms the district court’s judgment that the claims at bar are

not invalid for lack of an enabling disclosure on point mutation.

The court turns to Clontech’s written description argument.17 The three patents-

in-suit each claim a genetically modified RT in terms of its RNase H and DNA

polymerase behavior. Claim 1 of the '608 patent is representative. It provides

17
Section 112 requires that “[t]he specification shall contain a written
description of the invention. . . .” 35 U.S.C. § 112, ¶ 1 (2000) (emphasis added). This
“written description” requirement is distinct from the enablement requirement, as
discussed in the previous section. Univ. of Rochester v. G.D. Searle & Co., Inc., 358
F.3d 916, 920 (Fed. Cir. 2004); Enzo Biochem Inc. v. Gen-Probe, Inc., 323 F.3d 956,
963 (Fed. Cir. 2002).

04-1039, -1040
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nucleotide sequence is derived from an organism selected from the group
consisting of a retrovirus, yeast, Neurospora, Drosophila, primates and
rodents.

'608 patent, col. 19, lines 26-34 (claim 1) (emphases added). With these patents

Invitrogen thereby claims a compound (the polypeptide or genetically engineered RT) in

terms of biological functions (DNA polymerase and RNase H activity).

Clontech filed for summary judgment, arguing that this fashion of claiming the

modified RT fails the § 112 written description requirement and renders the claims-in-

suit invalid.18 Invitrogen opposed and filed a cross-motion that the claims were not

invalid on this ground.

The district court tested the common written description of the patents-in-suit

against the PTO guidelines. The guidelines state that the written description

requirement of 35 U.S.C. § 112, ¶ 1, can be met by

show[ing] that an invention is complete by disclosure of
sufficiently detailed, relevant identifying characteristics . . .
i.e., complete or partial structure, other physical and/or
chemical properties, functional characteristics when coupled
with a known or disclosed correlation between function and
structure, or some combination of such characteristics.

Guidelines for Examination of Patent Applications under 35 U.S.C. § 112, first

paragraph, “Written Description” Requirement, 66 Fed. Reg. 1099, 1106 (Jan. 5,

2001).19 The court adopted this standard in Enzo Biochem Inc. v. Gen-Probe, Inc., 323

F.3d at 964.

18
Claims 3 and 4 of the '797 patent do not follow the compound-by-biologic-
function model exemplified in the '608 patent, claim 1. Clontech excluded these two
claims from this written description challenge.
19
In University of Rochester the court reaffirmed its approval of Enzo’s use of the
PTO written description guidelines. 358 F.3d at 925.

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The district court ruled that (1) the common written description, (2) testimony

from Invitrogen’s expert, Dr. Champoux, and (3) an article by Johnson et al., 83 Proc.

Nat’l Acad. Sci. USA 7648-52, 7651 (1986), established a sufficiently known correlation

between RNase H activity in RT (function) and the RT gene made by deletion mutation

(structure) to satisfy the PTO test for written description. The court concluded that the

undisputed evidence was entirely one sided in favor of Invitrogen, and granted partial

summary judgment, ruling that the claims at issue were not invalid for lack of written

description.

Unlike conception and enablement, compliance with the written description

requirement is a question of fact. Enzo Biochem, 323 F.3d at 962-63; Vas-Cath Inc. v.

Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). Like the facts underlying conception

and enablement, invalidating a claim requires a showing by clear and convincing

evidence that the written description requirement has not been satisfied. Enzo

Biochem, 323 F.3d at 962. In response to Invitrogen’s partial summary judgment

motion, the law required Clontech to come forward with evidence raising at least a

genuine issue of fact regarding whether the patents failed the written description

requirement. Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir.

2001).

Clontech argues that University of California v. Eli Lilly & Co., 119 F.3d 1559

(Fed. Cir. 1997) compels the conclusion that the claims-in-suit fail the written description

requirement. In Eli Lilly, this court found a claim to mammalian DNA for insulin

04-1039, -1040
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unsupported by a written description reciting only the nucleotide sequence of rat cDNA

for insulin. Id. at 1567-68. Clontech maintains that it was error not to determine, as a

matter of law, that all but two claims in the patents-in-suit fail the written description

requirement of § 112, ¶ 1 because they “do not recite the DNA or protein sequences as

required” by Eli Lilly, id. at 1566-69, and Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir.

1993). Thus, according to Clontech, the district court erred in finding sufficient structure

in the DNA sequence recited in the common specification, and within the knowledge of

one of ordinary skill in the art, because the claims at issue “are not limited to sequences

recited in the specification and do not recite DNA or protein sequences.”

This argument is misplaced. First, the district court found it undisputed that in

addition to the sequence recited in the specification at bar, “at the time of the invention,

the sequences of RT genes were known and members of the RT gene family shared

significant homologies from one species of RT to another.” The written description

teaches that the invention can be applied to RT genes of other retroviruses including

HTLV-1, BLV, RSV, and HIV. See, e.g., '608 patent, col. 9, ll. 34-54. As Invitrogen’s

expert explained, the specification cites references providing the known nucleotide

sequences of these RT genes. Id., col. 9, ll. 47-54; January 24, 2002 Champoux Decl.

¶ 4. Finally, Champoux’s declaration established that the sequences for these and

other representative RT genes were known in the art by January 1988. Id. ¶¶ 4-7.

Clontech has not adduced contrary evidence establishing a genuine issue of fact, and

we discern no error in the district court’s analysis. Clontech’s written description

challenge, in short, proceeds from a factual premise contrary to the record.

04-1039, -1040
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Second, Clontech’s appeal to Eli Lilly and Fiers is misplaced. In those cases, the

patent specifications at issue did not identify the sequence (structure) of any

embodiment of DNA claimed therein. See Eli Lilly, 119 F.3d at 1567-68 (affirming a

judgment that the claim requiring cDNA encoding human insulin was invalid for failing to

provide an adequate written description where the specification described the human

insulin A and B chain amino acid sequences encoded by the cDNA, but did not provide

the nucleotide sequence for the cDNA itself); Fiers, 984 F.2d at 1167-68, 1170-71

(finding the written description insufficient where the patent claimed purified DNA

encoding human fibroblast interferon-beta polypeptide, but the specification only

disclosed a bare reference to DNA and suggested a process to sequence it). In

contrast, the shared written description for the patents-in-issue recites both the DNA

and amino acid sequences of a representative embodiment of the claimed RT enzyme.

The specification also discloses test data that the enzyme produced by the listed

sequence has the claimed features – DNA polymerase activity without RNase H activity.

Under both the Eli Lilly and Fiers analysis, the specification at bar is sufficient.

In short, there is no error in the district court’s ruling that the claims in the

patents-in-suit satisfy the written description requirement of § 112.

***

In sum, the district court erred in granting judgment of invalidity under

§ 102(g)(2). Clontech's challenges to the court's partial summary judgments on written

description and enablement are misplaced and fail to support the invalidity judgment.

Accordingly, the court vacates the judgment of invalidity and the conception ruling on

partial summary judgment, and remands for further proceedings.

04-1039, -1040
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On remand, we remind the district court that the material factual dispute we

perceive regarding appreciation affects not only the proper date of conception, but also

the date of reduction to practice. “It is now well settled that in [an accidental creation]

there is no conception or reduction to practice where there has been no recognition or

appreciation of the existence of the new form.” Silvestri, 496 F.2d at 597. Because we

reserve the question of appreciation for the jury, its determination on this issue will

decide the date of conception (as well as reduction to practice).

IV.

Finally, Clontech cross-appeals the district court’s partial summary judgment that

the PowerScript RT infringes claims 3, 4, 12, and 13 of the '608 patent.

Each claim at issue depends from claim 1 of the '608 patent. As noted in the

preceding discussion, independent claim 1 provides:

1. An isolated polypeptide having DNA polymerase activity and
substantially reduced RNase H activity, wherein said polypeptide is
encoded by a modified reverse transcriptase nucleotide sequence that
encodes a modified amino acid sequence resulting in said polypeptide
having substantially reduced RNase H activity, and wherein said
nucleotide sequence is derived from an organism selected from the group
consisting of a retrovirus, yeast, Neurospora, Drosophila, primates and
rodents.

'608 patent, col. 19, ll. 26-34 (claim 1) (emphases added).

In 2001, the trial court determined that 178 claims in the '608 patent, reciting the

limitation “substantially reduced RNase H activity,” were invalid as indefinite under

§ 112. See Invitrogen, slip op. (D. Md. May 4, 2001) (opinion and order granting partial

summary judgment of invalidity) (“May 4 PSJ Order”); Invitrogen Corp. v. Clontech

04-1039, -1040
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Labs., Inc., slip op. (D. Md. Aug. 8, 2001) (R&R recommending clarifications to May 4

PSJ Order); Invitrogen Corp. v. Clontech Labs., Inc., slip op. (D. Md. Oct. 4, 2001)

(order adopting the Aug. 8, 2001 R&R on validity). Although the district court

invalidated independent claim 1, eighteen other claims in the '608 patent – including

dependent claims 3, 4, 12, and 13 – survived Clontech’s challenge.

Dependent claims 3 and 4 provide:

3. The polypeptide of claim 1, wherein said polypeptide has no detectable
RNase H activity.

4. The polypeptide of claim 1, wherein said polypeptide lacks RNase H
activity.

'608 patent, col. 19, ll. 38-41 (emphases added). In the May 4 PSJ Order, the court

ruled that “no detectable RNase H activity” and “lacks RNase H activity” had “sufficient

clarity to alert those of ordinary skill in the art of the metes and bounds of the invention,”

and thus were not invalid for indefiniteness. See May 4 PSJ Order at 16.

Claims 12 and 13 further provide:

12. The polypeptide of claim 1, wherein said polypeptide allows an mRNA
template to remain intact during cDNA synthesis as shown in FIG. 5.

13. The polypeptide of claim 1, wherein said polypeptide allows an mRNA
template to remain intact during a one minute cDNA synthesis reaction as
shown in FIG. 5.

'608 patent, col. 19, ll. 62-67. Figure 5 of the '608 patent, as recited in claims 12 and

13, reprints a photograph of a gel assay. The specification describes that gel assay as

confirming that a plasmid with the claimed, modified RT gene, encoded RT that

“completely lacked RNase H activity.” '608 patent, Fig. 5 & col. 16, ll. 33-49.

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The limitation “substantially reduced RNase H activity” in claim 1 of the '608

patent resembles the limitation “substantially no RNase H activity” in independent claim

1 of the earlier '005 patent. That claim reads in full:

1. An isolated DNA molecule comprising a nucleotide sequence encoding
a polypeptide having DNA polymerase activity and substantially no RNase
H activity, wherein said nucleotide sequence is derived from a Moloney
murine leukemia virus (M-MLV) nucleotide sequence.

'005 patent, col. 19, ll. 2-6 (claim 1) (emphasis added). The same “substantially no

RNase H activity” limitation appears in the '797 patent claims. See, e.g., '797 patent,

col. 19, ll. 17-25 (claim 1).

After the district court adjudged the '797 and '005 patents unenforceable in 1999,

Clontech set about developing a competing product. In a July 18, 1999 laboratory

notebook entry, Clontech’s scientist Dr. Steven Hendricks wrote he would “now focus on

generating an RNase H minus form of the MMLV RT.” The entry identified “D524N” as

one “potential mutant already cloned” and predicted that the changes to it “should

completely inactivate the RNase H activity.”

Testing the D524N-encoded RT by the solubilization assay described in the

patents-in-suit, on August 3, 1999, Hendricks wrote in his laboratory notebook, “NO

SIGNIFICANT RNase H activity detected in the preparation of the D524N mutant!!!”

The D524N mutant RT became the basis of Clontech’s PowerScript RT. Numerous

Clontech internal documents and marketing materials, including their website, further

touted the PowerScript RT as “lacking” in or that it “eliminates” RNase H activity.

Invitrogen sought partial summary judgment that Clontech’s PowerScript RT

infringed claims 3, 4, 12, and 13 of the '608 patent. On February 21, 2003, the Special

Master recommended granting Invitrogen’s motion in part and finding literal

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infringement. Invitrogen, (D. Md. Feb. 21, 2003) (R&R regarding Invitrogen’s

infringement motion) (“Infringement R&R”). On April 21, 2003, after reviewing the record

de novo, the district court adopted the recommendation over Clontech’s objection and

granted partial summary judgment of literal infringement on all four claims. Clontech

appeals.

This court reviews de novo the district court’s partial summary judgment of

infringement. See Sandisk Corp. v. Memorex Products, Inc., 415 F.3d 1278, 1283

(Fed. Cir. 2005); Hilgraeve Corp. v. McAfee Assocs., Inc., 224 F.3d 1349, 1352 (Fed.

Cir. 2000). The trial court’s claim construction is a legal issue that we review de novo.

See Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc).

The court’s comparison of the properly construed claims to the accused products is a

factual matter, Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1323 (Fed. Cir.

2002), and in reviewing the trial court’s partial summary judgment this court ascertains,

as a matter of law, whether the trial court overlooked genuine issues of fact weighing

against infringement.

A material factual dispute must be genuine. “[T]he mere existence of some

alleged factual dispute between the parties will not defeat an otherwise properly

supported motion for summary judgment.” Anderson, 477 U.S. at 247-48. A genuine

dispute requires evidence “such that a reasonable jury could return a verdict for the

non-moving party.” Id. at 248. Evidence that is “merely colorable,” or is “not

significantly probative,” will not prevent summary judgment. Id. at 249-50. Of course, in

assessing a putative dispute “the judge’s function is not himself to weigh the evidence

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and determine the truth of the matter but to determine whether there is a genuine issue

for trial.” Id. at 249.

Clontech challenges the district court’s claim construction, defining claims 3, 4,

12, and 13 by reference to gel assay results. Instead, Clontech argues, under a proper

construction each claim must be limited to the results of a solubilization assay. We

disagree.

Claim construction requires the court to determine the meaning of disputed claim

terms to one of ordinary skill in the art at the time of the invention. See 35 U.S.C. § 112;

Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc); Metabolite

Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004);

Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1332 (Fed. Cir.

2001). The court determines this meaning by examining the claim language, as it

relates to the invention set forth in the written description, the drawings, and where

relevant the prosecution history. See Phillips, 415 F.3d at 1313-17; Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

The court necessarily begins with the language of the asserted claims. See

Phillips, 415 F.3d at 1312; Bell Commc’ns Research, Inc. v. Vitalink Commc’ns Corp.,

55 F.3d 615, 619-20 (Fed. Cir. 1995). Clontech does not challenge the trial court’s

conclusion that “no detectable RNase H activity” and “lacks RNase H activity” mean “a

complete absence of RNase H activity” to one of skill in the art. Although Invitrogen

suggests, inter alia, that “no detectable” and “lacks” might have different meanings,

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Invitrogen does not provide any cogent argument explaining why there is error in this

trial court ruling. Thus, notwithstanding the presumption that “no detectable” in claim 3

and “lacks” in claim 4 have different scopes, see Comark Commc’ns, Inc. v. Harris

Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998), we take the parties as conceding claims 3

and 4 both mean “a complete absence of RNase H activity.”

Focusing on the terms “no detectable” and “lacks,” neither can be understood

without reference to the written description because each limitation begs the question of

how one of skill in the art would understand the patent specification as describing how

to measure RNase H activity for claims 3 and 4. See Phillips, 415 F.3d 1182, 1187.

Although the '608 patent specification does not expressly define either term, it

unmistakably teaches how one skilled in the art would determine that a mutant RT

“completely lacks” RNase H activity. See '608 patent, col. 16, ll. 33-49.

The specification explains that “[t]o confirm” that a claimed mutant RT

“completely lacked” RNase H activity, the inventors undertook a specific gel assay. The

specification describes the assay in detail, and provides the results in Fig. 5. Id., ll. 33-

45. Fig. 5 compares the RNase H activity of the mutant RT (Fig. 5A) to unaltered

MMLV RT (Fig. 5B).20 The written description further notes that, “[i]n addition,” the same

mutant RT showed no RNase H activity under a solubilization assay. Id., col. 16, ll. 45-

49. With this primacy placed on the gel assay results, the patent unmistakably instructs

one skilled in the art to measure RNase H activity, for purposes of claims 3 and 4, by

20
See '608 patent, col. 12, ll. 50-60 (describing pRT601 as encoding MMLV
RT); id., col. 15, l. 29 – col. 16, l. 32 (describing creation of deletion plasmid
pRTdEcoRV-C from pRT601); id., col. 16, ll. 33-45 (explaining comparison, shown in
Fig. 5, of RNase H activity from mutated RT and wild RT).

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using a gel assay. This establishes the gel assay as being both necessary and

sufficient to measure RNase H activity for claims 3 and 4.

Although the written description might teach a different mix of gel assay and

solubilization results as sufficient to show different levels of RNase H activity, as

explained above the parties concede that the claims speak only to a “complete

absence” of such activity. This points the court directly to the passage discussed

above, and establishes the gel assay as determinative of the claimed behavior.

For the same reasons, the specification even more strongly indicates that the gel

assay is the proper means for determining compliance with claims 12 and 13, each of

which expressly references Fig. 5 in the patent and points the person of skill in the art to

this discussion in the specification.21 Clontech’s contrary reading simply cannot be

squared with either the plain language of claims 12 or 13, or the relevant portions of the

’608 patent specification.

Clontech’s arguments to the contrary are without merit. Clontech attempts to link

the meaning of “no detectable” and “lacks” to the stipulated definition of “substantially no

21
In its opening brief to this court, Clontech did not set forth a separate argument
for reading claims 12 or 13 to require a solubilization assay, to the exclusion of a gel
assay. Instead, Clontech lumps claims 12 and 13 into the argument discussed above
with regard to claims 3 and 4. In its reply, Clontech raises a new argument in support of
its contention that a gel assay was foreclosed by the stipulated definition of
“substantially no RNase H activity.”
This reply argument renews Clontech’s earlier argument to the Special Master,
with specific reference to claims 12 and 13. Invitrogen did not seek permission to file a
supplemental brief responding to this new contention, and the issue was not reached at
oral argument. Nevertheless, we view this belated argument by Clontech as improper
and do not consider it. See Novosteel SA v. United States, 284 F.3d 1261, 1274 (Fed.
Cir. 2002) (litigant waives argument not presented in opening brief). Clontech waived
this argument by failing to raise it in its opening brief on the cross-appeal.

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RNase H activity”.22 Clontech argues that these terms must mean less RNase H activity

than the amount satisfying the stipulated definition of “substantially no RNase H activity”

in the '797 and '005 patents. We disagree.

First, Clontech points to the '608 patent prosecution history. The court examines

the prosecution history, when pointed out and placed in evidence, to ascertain if a

proffered claim construction has been disclaimed. See 415 F.3d 1303, 1317; 415 F.3d

1278, 1286-87; Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir.

2005) (“We cannot look at the ordinary meaning of the term . . . in a vacuum. Rather,

we must look at the ordinary meaning in the context of the written description and the

prosecution history.”); Vitronics, 90 F.3d at 1582. Clontech argues that claim 1 of the

'608 patent (and thus the dependent claims 3 and 4), as originally filed, required

“substantially no” instead of “substantially reduced” RNase H activity. But as Clontech

further notes, Invitrogen cancelled those originally-filed claims and added new claims

drawn to the “substantially reduced RNase H activity” limitation in the issued claim 1.

Indeed, as Invitrogen observes, it cancelled those original limitations by preliminary

22
On June 22, 1999, the district court signed a stipulated order, defining an
RT with “substantially no RNase H activity” as
a reverse transcriptase purified to near homogeneity and having an
RNase H activity of less than 0.001 pmoles [3H](A)n solubilized in 20
minutes per µg protein in a reaction volume of 50 µl wherein the [3H](A)n is
solubilized from a [3H](A)n ● (dT)n substrate in which the [3H](A)n has a
specific radioactivity of 2,200 cpm/pmole.

Life Techs., Inc. v. Clontech Labs., Inc., slip op., No. AW-96-4080 (D. Md. June 22,
1999) (stipulation and order). The parties agree that by its terms, testing RT RNase H
activity against this stipulated definition requires using a solubilization assay.
This stipulated definition corresponds, not surprisingly, verbatim to the definition
of “substantially no RNase H activity” in the common written description of the patents-
in-suit. See, e.g., '608 patent, col. 9, ll. 21-26.

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amendment with its continuation application, meaning the “substantially no RNase H

activity” limitation was never presented to the PTO for examination as part of the '608

patent. Nonetheless, because Invitrogen sought, in the prosecution, to distinguish prior

art having “reduced” RNase H activity, Clontech concludes “substantially reduced” must

mean less RNase H activity than the failed “substantially no” limitation in the original

claim.

To the extent that this represents a prosecution disclaimer or prosecution history

estoppel argument, it falters on the principle that the prosecution of one claim term in a

parent application will generally not limit different claim language in a continuation

application. See ResQNet.com, Inc. v. Lansa, Inc., 346 F.3d 1374, 1383 (Fed. Cir.

2003); Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1322 (Fed. Cir. 1999); cf. Biogen,

Inc. v. Berlex Labs., Inc., 318 F.3d 1132, 1141 (Fed. Cir. 2003) (“When an applicant is

seeking different claims in a divisional application, estoppel generally does not arise

from the prosecution of the parent.”). Although the court recognizes an exception where

an amendment to a related limitation in the parent application distinguishes prior art and

thereby specifically disclaims a later (though differently worded) limitation in the

continuation application, see, e.g., Elkay Mfg. Co. v. EBCO Mfg. Co., 192 F.3d 973,

978-79 (Fed. Cir. 1999), Clontech nowhere explains how that exception would apply in

this case. Nor does Clontech explain how any prior art distinguished in the '797, '005,

or '608 patent prosecutions operates to disclaim use of a gel assay to show “complete

absence” of RNase H activity in claims 3 and 4 of the '608 patent. The prosecution

history presented to the court does not impose such a limtiation. The fact that the

parties stipulated to a definition of “substantially no RNase H activity,” drawn verbatim

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from the wording of an express definition in the written description, does not mandate

that the different limitations at issue here be given the same construction. To the

contrary, the use of the distinct terms “substantially reduced” and “no detectable” and

“lacks” canonically suggests that these limitations be given a different scope than the

limitation to which the parties stipulated. See Comark, 156 F.3d at 1187.

Second, Clontech argues that the district court’s “complete absence” definition,

by its plain meaning, requires construing claims 3 and 4 consistent with the stipulated

definition of “substantially no RNase H activity” in the '797 and '005 patents. Nothing in

the notion of “complete absence of RNase H activity” in the '608 patent requires

consideration in view of the “substantially no RNase H activity” limitation set forth in the

'797 and '005 patents and defined by the stipulated order. Nor is it proper to read

provisions in the '608 patent written description, pertaining to the “substantially no

RNase H activity” limitation in the parent applications, into the meaning of claims 3 and

4 in the '608 patent. See id., 156 F.3d at 1186-87 (discussing the prohibition against

reading limitations from the specification into the claims). These are not, as Clontech

presupposes, isolated terms with abstract meanings amenable to easy comparison

such as by referencing a thesaurus; rather, these are claim terms with defined

meanings rooted in the particular context of different patents and patent claims.

Thus, the court finds no error in the district court’s analysis, under which the

complete absence of RNase H activity for claims 3, 4, 12, and 13 must be shown by the

gel assay as set forth in the written description of the ‘608 patent.

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D.

Finally, Clontech contends the district court erred in failing to credit factual

disputes precluding partial summary judgment of literal infringement. First, it argues

that the district court ignored the disagreement between Dr. Falkinham, its expert, and

Dr. Champoux, Invitrogen’s expert, regarding how to interpret gel assays measuring the

PowerScript RT RNase H activity. Second, Clontech maintains that gel assay results

from 1993, in an article by Blain and Goff regarding the D524N mutant RT, proved that

the RT had measurable RNase H activity and thus could not infringe the claims at

issue.23 We disagree.

Although Falkinham and Champoux disagreed regarding how to interpret

Invitrogen’s gel assay evidence, measuring the PowerScript RT RNase H activity, the

district court correctly determined that Falkinham’s disagreement did not create a

genuine dispute for infringement. Champoux explained that a gel assay works by

separating molecules according to their size. Similarly sized fragments move to the

same location on the gel. The RT, by its RNase H activity, cuts mRNA into fragments.

As Champoux explained, the resulting fragments should have a random size

distribution, because the RT cuts the mRNA at random points. This appears on a gel

assay as a visual “smear,” since the differently sized fragments will sort to different

positions in the gel assay lane. But without RNase H activity, the mRNA will remain

intact. All similarly sized mRNA molecules migrate to the same location in the gel

23
Stacy W. Blain & Stephen P. Goff, Nuclease Activities of Moloney Murine
Leukemia Virus Reverse Transcriptase: Mutants with Altered Substrate Specificities,
268 J. Biological Chemistry 23585 (1993) (“Blain & Goff 1993”). In that article Blain and
Goff explain D524N comprises a point mutation to the wild-type MMLV RT gene. Id. at
23586-87. The article concludes that the D524N mutant RT had between 10 and 25%
the RNase H activity of wild-type MMLV RT.

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assay, manifested visually as a band at a particular location. The district court found

this explanation consistent with both the ‘608 patent specification, as it discusses gel

assay,24 and the usage in a 1996 article by Blain and Goff.25

Falkinham offered a very different view of how gel assay works. He opined that

Invitrogen’s gel assay experiments must be understood by evaluating the area of the

bands representing the mRNA fragments left after exposure to the PowerScript RT.

Claiming that Invitrogen’s test results showed the ‘band area’ to be decreasing with

incubation time, Falkinham concluded that this could only be explained by the presence

of RNase H activity. He explained that the fragments produced by such activity could

not be seen because they would have “small size.” Nowhere did Falkinham explain why

the PowerScript RT would only create small sized fragments with its RNase H activity,

nor reference any theory explaining—or evidence confirming—this behavior.

24
The '608 patent specifically calls for using a gel assay to assess “the effect
of cDNA synthesis upon the integrity of the template RNA.” '608 patent, col. 14, ll. 6-7.
It describes Fig. 5 – a gel assay result – as demonstrating pRT601 (a wild-type MMLV
RT) “totally degraded” a 2.3 kilobase mRNA template after five minutes of synthesis.
'608 patent, col. 16, ll. 36-38. As Champoux explained, Fig. 5b shows a “smear” or
distribution of fragment sizes in the five minute lane of the gel assay. By comparison,
gel assay confirming the claimed mutant RT “completely lack[ed]” RNase H activity
shows a clear band at 2.3 kilobases. See '608 patent, Fig. 5a & col. 16, ll. 33-40.
25
Stacy W. Blain & Stephen P. Goff, Differential Effects of Moloney Murine
Leukemia Virus Reverse Transcriptase Mutations on RNase H Activity in Mg2+ and
Mn2+, 271 J. Biological Chemistry 1448 (1996) (“Blain & Goff 1996”).
Neither side disputed that Blain and Goff were persons of ordinary skill in the art.
In the 1996 article, Blain and Goff used gel assays to measure the RNase H activity of
various RT samples. Consistent with Champoux’s explanation, Blain and Goff relied on
the proposition that identically sized fragments should migrate to the same position, and
form a band, in a gel assay lane. See Blain & Goff 1996, supra at 1449-51. Moreover,
discussing a “smear” in one gel assay, id. at 1450, fig. 2, lane 7, they explained it
“presumably corresponded to a heterogenous population of DNA with various sized
RNA species still annealed.” Id. at 1451. E.g., a “smear” indicates – as Champoux
explained – a mixture of differently sized molecular fragments.

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The district court correctly concluded that “Dr. Falkinham’s assertions do not rise

to the level of genuine issues of fact[.]” Infringement R&R at 6. Given that there is no

dispute that Blain and Goff were persons of ordinary skill in the art, and given the

accord between Blain and Goff, the '608 patent, and Champoux on how to read a gel

assay, no reasonable juror could find for Clontech based on Falkinham’s speculative

difference of opinion.26 A party does not manufacture more than a merely colorable

dispute simply by submitting an expert declaration asserting that something is black

when the moving party’s expert says it is white; there must be some foundation or basis

for the opinion. See Anderson, 477 U.S. at 247-48 (“[T]he mere existence of some

alleged factual dispute between the parties will not defeat an otherwise properly

supported motion for summary judgment.”). Had Falkinham cited some basis for his

opinion that the RNase H would yield “small sized” mRNA fragments, Clontech may

have identified a genuine issue. But he did not, and this portion of his declaration does

not prevent partial summary judgment. See Anderson, 477 U.S. at 249-50 (holding that

insufficiently probative evidence will not prevent summary judgment).

The district court also correctly determined that Blain and Goff’s 1993 results did

not create a genuine issue. Although the 1993 paper reported some measurable

RNase H activity in the D524N mutant RT, from which Clontech derived its PowerScript

RT, the 1996 paper reveals error in that 1993 measurement. The 1993 article

26
Clontech argues that the district court made improper credibility
determinations in concluding Falkinham failed to raise a genuine issue, compelling
vacatur. Although the Special Master did write “the credible evidence overwhelmingly
supports Dr. Champoux,” Invitrogen R&R at 8, we do not read the court’s opinion as
relying on a credibility determination. Elsewhere, the Master specifically explained
Falkinham’s assertions failed to create a genuine issue; and, moreover, the Master
follows the “credible evidence” statement with detailed discussion of the competing
evidence.

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described results from a gel assay that was comparable to neither the one described in

the patent, as conducted by Champoux, nor the one discussed in the 1996 article by

Blain and Goff. In the 1996 article they explained why their 1993 result was anomalous

and showed that the D524N mutant had no RNase H activity. The 1996 paper was

motivated by, and directed at, explaining why the 1993 test results were wrong.

Nonetheless, Clontech argues that “if anything is to be drawn from the 1996 Blain and

Goff article, it is the finding that PowerScript (D524N) has measured RNase H activity . .

. and thus cannot infringe as a matter of law.” We disagree.

As Invitrogen observes, the 1996 article reports that—when problems with the

gel assay substrate from 1993 are corrected, and using gels corresponding to those

described in the ’608 patent specification and used in Invitrogen’s assay—D524N

showed no RNase H activity. Noting this fact, and noting the 1993 gel assay did not

correlate to the gel assay described in the '608 patent, the district court correctly

determined that the 1993 results were not relevant to the infringement analysis.

Infringement R&R at 12. Thus, nothing in these articles creates a genuine dispute that

would prevent partial summary judgment of infringement.

Because Clontech shows no error in the partial summary judgment that its

PowerScript RT literally infringes claims 3, 4, 12, and 13 of the '608 patent, we affirm.

We hold as follows. First, we vacate the judgment of invalidity and the district

court’s partial summary judgment on Goff’s conception. Second, we affirm the partial

summary judgments that the claims-in-suit are enabled, and that they satisfy the written

description requirement of § 112. Finally, we affirm the partial summary judgment that

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Clontech’s PowerScript RT literally infringes claims 3, 4, 12, and 13 of the '608 patent.

We remand for further proceedings consistent with this opinion.

AFFIRMED-IN-PART, VACATED-IN-PART, REMANDED.

COSTS

No costs.

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Invitrogen Corp. (Formerly Known as Life Technologies, Inc.) v. Clontech Laboratories, Inc.

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