Enzo Biochem, Inc. v. Gen-Probe Inc.

United States Court of Appeals for the Federal Circuit

04-1570

ENZO BIOCHEM, INC.,

Plaintiff-Appellant,

v.

GEN-PROBE INCORPORATED,

Defendant-Appellee,

and

BECTON DICKINSON AND COMPANY,

Defendant-Appellee.

Charles A. Weiss, Kenyon & Kenyon, of New York, New York, argued for
plaintiff-appellant. With him on the brief were Richard L. DeLucia, John R. Kenny and
Patrice P. Jean. Of counsel were Anita Pamintuan Fusco and Henry N. Wixon.

William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston,
Massachusetts, argued for defendants-appellees. With him on the brief for Gen-Probe
Incorporated were William G. McElwain and Nina S. Tallon. Of counsel was Henry N.
Wixon. On the brief for Becton Dickinson and Company were Donald R. Ware, Barbara
A. Fiacco, and Katherine J. Fick, Foley Hoag LLP, of Boston, Massachusetts. Of
counsel were Denise W. DeFranco and Lauren T. Knapp.

Appealed from: United States District Court for the Southern District of New York

Judge Alvin K. Hellerstein
 United States Court of Appeals for the Federal Circuit

04-1570

ENZO BIOCHEM, INC.,

Plaintiff-Appellant,

v.

GEN-PROBE, INCORPORATED,

Defendant-Appellee,

and

BECTON DICKINSON AND COMPANY,

Defendant-Appellee.

___________________________

DECIDED: September 30, 2005
___________________________

Before LOURIE, LINN, and PROST, Circuit Judges.

LOURIE, Circuit Judge.

Enzo Biochem, Inc. (“Enzo”) appeals from the summary judgment of the United

States District Court for the Southern District of New York holding that United States

Patent 4,900,659 is invalid under the on-sale bar of 35 U.S.C. § 102(b). Enzo Biochem,

Inc. v. Gen-Probe, Inc., No. 99 Civ. 3548 (S.D.N.Y. July 27, 2004) (“Order”). Because

the invention claimed in the ’659 patent was the subject of an offer for sale before the

critical date, we conclude that the patent is invalid and we affirm the district court’s

judgment.
 BACKGROUND

Enzo is the assignee of the ’659 patent, which relates to nucleic acid probes that

selectively hybridize with the bacteria that cause gonorrhea, namely, Neisseria

gonorrhoeae, as well as methods for using those probes to detect the bacteria. N.

gonorrhoeae has a high degree of homology with Neisseria meningitidis, making it

difficult to differentiate between the two bacteria. Enzo recognized the need for a

chromosomal DNA probe specific for N. gonorrhoeae, and it derived three such

sequences that preferentially hybridized with six common strains of N. gonorrhoeae

over six common strains of N. meningitidis. ’659 Patent, col. 3, l. 49 to col. 4, l. 14; col.

4, ll. 45-50. Enzo deposited those sequences in the form of a recombinant DNA

molecule within an E. coli bacterial host at the American Type Culture Collection

(“ATCC”). Id., col. 13, ll. 27-31.

Claim 1 of the ’659 patent reads, in pertinent part, as follows:

1. A composition of matter that is specific for Neisseria gonorrhoeae
comprising at least one nucleotide sequence for which the ratio of the
amount of said sequence which hybridizes to chromosomal DNA of
Neisseria gonorrhoeae to the amount of said sequence which
hybridizes to chromosomal DNA of Neisseria meningitidis is greater
than about five, said ratio being obtained by a method comprising the
folllowing steps;

Id., col. 27, ll. 29-36. The method steps that follow are directed to obtaining the claimed

ratio. Id., col. 27, l. 37 to col. 28, l. 26. Claim 4 of the patent is directed to the deposited

probes, referenced by their accession numbers, and variations thereof:

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 4. The composition of claim 1 wherein said nucleotide sequences are
selected from the group consisting of:

a. the Neisseria gonorroheae [sic] DNA insert of ATCC 53409,
ATCC 53410 and ATCC 53411, and discrete nucleotide
subsequences thereof,
b. mutated discrete nucleotide sequences of any of the foregoing
inserts that are within said hybridization ratio and
subsequences thereof; and
c. mixtures thereof.

Id., col. 28, ll. 31-39. Claim 5, upon which Claim 6 depends, is directed to a method of

conducting a hybridization assay with the deposited probes and variations thereof:

5. In a nucleic acid hybridization assay for the detection of Neisseria
gonorrhoeae utilizing a polynucleotide probe, wherein said probe is
contacted with a sample and the amount of any hybridized probe is
detected, the improvement which comprises utilizing as said
nucleotide probe a composition of claim 1, wherein said composition is
labeled with a detectable marker.

Id., col. 28, ll. 40-46.

In June 1982, Enzo and Ortho Diagnostic Systems (“Ortho”), an affiliate of

Cambridge Research Labs, entered into an agreement involving joint funding of

research and development on “any human diagnostic product resulting from the

program of research” (defined elsewhere in the agreement) “whether or not invented or

developed by Enzo prior to the effective date of this agreement.” In August 1983, the

parties executed an amendment that made it clear that a probe for gonorrhea was part

of the agreement. Importantly, paragraph 2.14 of the Enzo-Ortho agreement provided

the following:

ENZO shall supply to ORTHO and ORTHO shall purchase from ENZO for
use in Licensed Products no less than ninety percent (90%) of ORTHO’s
United States requirements or seventy-five percent (75%) of ORTHO’s
worldwide requirements of Active Ingredients; provided, however, that
ENZO shall have this right to supply and ORTHO shall have this obligation
to purchase only with regard to Active Ingredients supplied to ORTHO at

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 prices and time schedules which are reasonably competitive with those of
other sources. . . .

The agreement also contained a paragraph 2.12 reading as follows:

ENZO shall supply ORTHO at ENZO’s fully allocated cost with all
quantities of any Licensed Product reasonably required by ORTHO or any
Affiliate for its own research, development, and test marketing, including
that required to perform all preclinical and clinical studies.

In December 1984, apparently in satisfaction of paragraph 2.12, a key research and

development provision of the agreement, Enzo transferred to Ortho a probe that was

essentially the same as GC155, one of the three probes that Enzo deposited at the

ATCC. Enzo filed a patent application on that subject matter in January 1986, more

than one year after the transfer of the probe and the execution of the agreement, that

eventually issued as the ’659 patent in February 1990. The ATCC accession numbers

were cited in the patent.

Enzo sued the defendants, Gen-Probe, Incorporated and Becton Dickinson and

Company (collectively, “Gen-Probe”), for infringement of the ’659 patent, and Gen-

Probe moved for summary judgment that the claims were invalid for failure to satisfy the

written description requirement of 35 U.S.C. § 112. The district court granted Gen-

Probe’s motion, and Enzo appealed to this court. In 2002, we reversed the district

court’s grant of summary judgment and remanded the case to the district court because

genuine issues of material fact existed regarding the satisfaction of the written

description requirement. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.

Cir. 2002).

On remand, Gen-Probe moved for summary judgment of invalidity on different

grounds, this time contending that all the claims of the ’659 patent were barred by the

04-1570 4
offer to sell contained in Enzo’s agreement with Ortho, in violation of the 35 U.S.C.

§ 102(b) on-sale bar. In a detailed oral hearing conducted on July 27, 2004, the district

court delivered its decision invalidating the ’659 patent for violation of the on-sale bar.

The court first considered whether the material offered for sale was within the scope of

all of the claims. Because Enzo’s success in its suit depended in part on its establishing

that GC155 satisfies all the limitations of the claims for purposes of the enablement and

written description requirements, the court determined that it was appropriate for Gen-

Probe to rely on that contention as if proved for the purpose of Gen-Probe’s own motion

for summary judgment on the on-sale bar.

Second, the court determined that Enzo offered an embodiment of the ’659

patent for sale prior to the critical date. The court found that the material transferred

from Enzo to Ortho in December 1984 was GC155, the same material that was

deposited at the ATCC in January 1986 as an embodiment of the invention. The court

did not agree with Enzo that a genuine issue of material fact existed as to whether the

probe sent to Ortho in December 1984 was identical to that deposited at the ATCC.

Enzo had argued that the probe was still being developed and had only 700 base pairs,

not the 840 base pairs that comprised ATCC 53411. The district court, on the other

hand, relied on evidence in the form of laboratory notebooks and testimony from Enzo

scientists that did not distinguish between various lengths of GC155.

Finally, the court evaluated Enzo’s assertion of experimental use. The court

found that Enzo had asserted that the probe that it delivered to Ortho was its final

product, which it deposited at the ATCC, and thus that it had reduced the invention to

practice. The court reasoned that the policy behind the rule that experimental use

04-1570 5
negates an on-sale bar is to give the inventor the opportunity to reduce an invention to

practice, and thus that what occurs after a reduction to practice cannot be experimental

use; consequently, it concluded that Enzo’s use was not experimental.

Enzo filed a Notice of Appeal on August 20, 2004. Gen-Probe then moved to

dismiss the appeal, arguing that its counterclaim of unenforceability for inequitable

conduct remained unadjudicated and that the district court’s judgment was thus

nonfinal. We determined that Gen-Probe’s pending counterclaim rendered the district

court’s judgment nonfinal for purposes of appeal, but restated the principle that “a

premature notice of appeal ripens upon subsequent action of the district court.” Enzo

Biochem, Inc. v. Gen-Probe, Inc., No. 99 Civ. 3548, slip op. at 7 (Fed. Cir. July 13,

2005) (quoting Pause Tech. LLC v. TiVo Inc., 401 F.3d 1290, 1295 (Fed. Cir. 2005)).

Hence, we permitted the parties to seek remedial action in the district court and move to

reinstate the appeal from a final judgment.

The parties returned to the district court requesting dismissal of Gen-Probe’s

pending counterclaim. The court agreed to dismiss the counterclaim, and Enzo filed an

unopposed motion to reinstate the appeal. We granted that motion and now turn to the

merits of the case, as the judgment of the district court is final and we have jurisdiction

pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

We review a district court’s grant of summary judgment without deference,

reapplying the same standard used by the district court. Ethicon Endo-Surgery, Inc. v.

U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed. Cir. 1998). Summary judgment is

appropriate “if the pleadings, depositions, answers to interrogatories, and admissions on

04-1570 6
file, together with the affidavits, if any, show that there is no genuine issue as to any

material fact and that the moving party is entitled to a judgment as a matter of law.”

Fed. R. Civ. P. 56(c).

A patent is presumed to be valid, see 35 U.S.C. § 282 (1994), and this

presumption only can be overcome by clear and convincing evidence to the contrary.

See, e.g., WMS Gaming Inc. v. International Game Tech., 184 F.3d 1339, 1355 (Fed.

Cir. 1999). Whether an invention is “on sale” within the meaning of 35 U.S.C. § 102(b)

is a question of law that we review de novo. Monon Corp. v. Stoughton Trailers, Inc.,

239 F.3d 1253, 1257 (Fed. Cir. 2001). We review the district court’s grant of summary

judgment of invalidity by considering whether Gen-Probe established that there were no

material facts in dispute and presented clear and convincing evidence, viewed in a light

most favorable to Enzo, that the invention claimed in the ’659 patent was the subject of

an offer for sale before the critical date. Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339

(Fed. Cir. 2000).

Section 102(b) provides, in relevant part, that “[a] person shall be entitled to a

patent unless . . . the invention was . . . on sale in this country, more than one year prior

to the date of the application for patent in the United States.” 35 U.S.C. § 102(b)

(2000). The Supreme Court has established a two-prong test for the application of the

on-sale bar: “First, the product must be the subject of a commercial offer for sale. . . .

Second, the invention must be ready for patenting.” Pfaff v. Wells Elecs., Inc., 525 U.S.

55, 67 (1998). It is the first aspect of that test that primarily is at issue here.

04-1570 7
A. Commercial Offer For Sale

We first consider, with particular attention to paragraph 2.14, whether part of the

1982 Enzo-Ortho agreement constituted a commercial offer for sale. Enzo argues that

the agreement was solely for research purposes. It maintains that the general nature of

the agreement was primarily research, citing paragraph 2.12, and it asserts that the

parties’ mere hope that a commercial project might result from the collaboration did not

transform the research agreement into a commercial offer for sale. Enzo analogizes its

facts to In re Kollar, 286 F.3d 1326 (Fed. Cir. 2002), in which we held that an agreement

to conduct a broad research and development program was experimental rather than

commercial. Additionally, Enzo asserts that paragraph 2.14 was not an enforceable

offer for sale that occurred before the critical date. Enzo argues that paragraph 2.14

contains vague language, does not specifically require the sale of an embodiment of the

’659 patent, and does not obligate Ortho to buy the “active ingredients” exclusively from

Enzo.

Gen-Probe responds that paragraph 2.14 clearly relates to a commercial

objective different from the research and development intent evident in paragraph 2.12

and other provisions of the agreement. It argues that the language of that paragraph

constitutes a requirements contract that is enforceable, not illusory, because the parties

have a duty to act reasonably and in good faith in setting prices and ordering goods.

We agree with Gen-Probe that paragraph 2.14 of the Enzo-Ortho agreement

created the necessary contractual obligations on the parties to constitute a commercial

offer for sale. See generally Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041,

1046-48 (Fed. Cir. 2001) (discussing principles useful to determine whether a

04-1570 8
communication or series of communications rises to the level of a commercial offer for

sale). While it is true that the agreement states throughout its text that the parties are

interested in cooperating in certain experimental work, the language of paragraph 2.14,

unlike paragraph 2.12 and other provisions that explicitly refer to research and

development efforts, does not purport to be for such preliminary production of the probe.

Instead, paragraph 2.14 is distinctly different from those earlier sections because it

relates specifically to supply of Ortho’s worldwide requirements for what are clearly

commercial purposes. Supply of worldwide requirements at reasonable times and

prices surely means commercial supply, and the provision constitutes an offer to sell

that has been accepted.

Enzo’s reliance upon our decision in Kollar is misplaced. In that case, the

research and development agreement at issue contained language that conveyed to the

licensee an exclusive license under any issued patent “to design, engineer, construct,

and operate a pilot plant and one or more commercial plants, to sell the resultant

products, and to sublicense others.” 286 F.3d at 1330. The agreement language was

held to provide the “right to commercialize” the invention at issue and was essentially a

license, not a sale, because it only contemplated that “resultant products” could

potentially be sold, and did not offer to sell products of the claimed process. A key fact

in that case was the fact that the involved invention was a process rather than a tangible

item or product; we acknowledged that “[a] process is . . . not sold in the same sense as

is a tangible item” because only the mere transfer of the know-how to carry out a given

process has taken place and “the process has not been carried out or performed as a

result of the transaction.” Id. at 1332. An offer to sell a claimed product in being is quite

04-1570 9
different from a license to an undeveloped claimed process. Accordingly, we concluded

that the agreement was not a sale of the claimed invention and therefore was

insufficient to raise a § 102(b) on-sale bar. Id. at 1331.

Here, in contrast, paragraph 2.14 of the Enzo-Ortho agreement cannot be

considered to be only a research and development provision relating to an undeveloped

process. Unlike the invention in Kollar, Enzo’s claimed invention, the polynucleotide

probe, is a tangible item or product that can be sold or offered for sale. The language of

that provision clearly imposes upon Enzo the obligation to sell and on Ortho the

obligation to purchase a significant percentage of its U.S. and worldwide requirements

of the product labeled “Active Ingredients.” There is no doubt that paragraph 2.14

constitutes a binding commitment by the parties to enter into a commercial sale and

purchase relationship. Enzo’s arguments to the contrary, citing the surrounding context

of the agreement and the actual transfer of material between the parties, do little to alter

the plain language of that provision in the agreement.

We have cautioned before that “[i]n any given circumstance, who is the offeror,

and what constitutes a definite offer, requires looking closely at the language of the

proposal itself. . . . Differing phrases are evidence of differing intent, but no one phrase

is necessarily controlling.” Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041,

1048 (Fed. Cir. 2001) (citing Restatement (Second) of Contracts §§ 24, 26 (1981)).

Here, the district court carefully considered the language of paragraph 2.14, and we

discern no error in its legal interpretation or clear error in its factual findings. We thus

agree with the district court that a binding contract was formed between Enzo and Ortho

04-1570 10
and that the resulting commercial offer for sale, more than one year before the

application for patent, ran afoul of the § 102(b) on-sale bar.

B. Identity of Material Shipped to Ortho

We next examine whether the sample that Enzo transferred to Ortho in

December 1984 pursuant to the 1982 agreement was in fact the same material that

Enzo deposited as ATCC 53411. Although the agreement lacked any explicit

references to the ’659 patent, the GC155 probe, or ATCC 53411, the district court

concluded that Gen-Probe established that Enzo shipped GC155 pursuant to its

obligations under that agreement, that GC155 was the same material as ATCC 53411,

which was cited in the patent to support the patent’s validity, and consequently that

paragraph 2.14’s offer for sale relates to an embodiment of the ’659 patent.

Enzo argues that the polynucleotide allegedly sold or offered for sale before the

critical date was not the subject matter of the ’659 claims. It asserts that the

polynucleotide delivered to Ortho consisted of “approximately 700 base pairs,”

according to shipping documents and laboratory notebooks, and thus differed from

ATCC 53411, which contained 840 base pairs. Enzo also alleges that the district court

erred as a matter of law by shifting the burden of production of evidence to Enzo to

prove that the sample sent to Ortho was not the same as ATCC 53411, when it was

Gen-Probe who bore the burden of establishing that there was a commercial sale of an

embodiment of the claims of the ’659 patent before the critical date.

In reply, Gen-Probe asserts that there is no real dispute that the Enzo-Ortho

agreement related to the claimed invention. To link the patent to the agreement, and

thus to the invalidating commercial offer for sale, Gen-Probe argues that the ’659 patent

04-1570 11
cites ATCC 53411 as a preferred embodiment, and that the GC155 probe and the probe

deposited in the ATCC as sample 53411 are undisputedly identical. As for whether it

was GC155 that Enzo delivered in December 1984 to Ortho pursuant to the 1982

agreement, Gen-Probe relies on laboratory notebooks and shipping documents

accompanying the transferred material, as well as the testimony of Enzo’s own

scientists, to prove that the material was in fact GC155. The district court’s burden-

shifting, Gen-Probe argues, was proper because, following Gen-Probe’s presentation of

clear and convincing evidence that the probe delivered to Ortho was GC155, Enzo

presented no evidence that the probe was not GC155, and that Enzo’s mere arguments

contesting the identity of the shipped material are insufficient to satisfy its burden of

coming forward with evidence, so that summary judgment was proper.

We agree with the district court that there was no genuine issue of material fact

as to whether the material that Enzo shipped to Ortho in December 1984 was GC155.

Gen-Probe refers to several documents, including contemporaneous documents such

as the shipping invoice and accompanying letters, that overwhelmingly refer to the

material as “GC155” or simply “155.” For example, the district court relied on a letter

from Dr. Engelhardt, an Enzo employee, to his counterpart at Ortho stating that a probe

specific to gonorrhea was being delivered pursuant to the 1982 agreement. It also cited

laboratory notebooks describing a “155” insert as follows: “Works very nicely. Very

clean. Sent three micrograms to Raritan [location of Ortho’s New Jersey facilities].”

The evidence also included Enzo quarterly reports from early 1984 that described

Enzo’s contractual obligation to deliver a GC probe to Ortho and that indicated that “the

most promising” candidate was one designated “155-1.” In short, Gen-Probe put forth a

04-1570 12
great deal of evidence before the district court to establish that Enzo transferred GC155

to Ortho in satisfaction of the 1982 agreement.

Under Anderson v. Liberty Lobby, 477 U.S. 242 (1986), Enzo had the burden of

showing that there was a genuine issue of material fact as to whether GC155 was

shipped to Ortho. Id. at 250 (“Rule 56(e) provides that, when a properly supported

motion for summary judgment is made, the adverse party ‘must set forth specific facts

showing that there is a genuine issue for trial.’” (footnote omitted)). We agree with the

district court that Enzo’s argument that the material was not GC155 because of an

alleged discrepancy in the length of the base pairs failed to meet that burden. Since

GC155 was transferred pursuant to the agreement, and that material has been shown

to be the same as the ATCC deposit made to support the ’659 patent, there was no

genuine issue of material fact disputing that the subject matter of the agreement was

the same as that of the patent.

We also reject Enzo’s contention that the district court erred by shifting the

burden of production to Enzo, the non-movant, and by calling upon Enzo to come

forward with evidence to show that the question of the distinction between 700 and 840

base pairs was a genuine issue of material fact sufficient to defeat summary judgment.

The Supreme Court stated in Anderson that “in ruling on a motion for summary

judgment, the judge must view the evidence presented through the prism of the

substantive evidentiary burden.” 477 U.S. at 254. Although the ultimate burden of proof

remained on Gen-Probe, once it came forward with evidence to establish that the

material shipped to Ortho in December 1984 was GC155, it was proper for the district

court to shift the burden of production of evidence to refute Gen-Probe’s evidence to

04-1570 13
Enzo. While it is true that a court must draw all reasonable inferences in favor of the

nonmoving party, Enzo presented no evidence to the district court disputing the identity

of the Ortho delivery. Instead, the court was faced only with Enzo’s arguments and

perhaps a suggestion of what Enzo might present at trial; that alone is insufficient to

meet its burden of production. Attorney argument is no substitute for evidence.

Although, as Enzo correctly stated at oral argument, a nonmoving party can defeat a

motion for summary judgment by explaining why a party (Gen-Probe) with the burden of

proof cannot meet its summary judgment standard, Enzo is mistaken that Gen-Probe

has not met that hurdle. Once the district court determined that Gen-Probe satisfied its

burden, and we agree that it did, it was incumbent upon Enzo, as the nonmoving party,

to produce some evidence refuting Gen-Probe’s claim. We find no error in the district

court’s reasoning, and we agree that Enzo failed to establish the existence of a genuine

issue of material fact sufficient to avoid summary judgment.

C. Ready for Patenting

Regarding the second prong of the Pfaff test, Enzo argues that the district court

erred in finding that the invention was ready for patenting. It asserts that Claim 1 of the

patent recites an N. gonorrhoeae to N. meningitidis hybridization ratio of “greater than

about five,” and that because Enzo scientists were uncertain whether the probe that

they shipped to Ortho would meet that ratio, the invention had not been fully reduced to

practice. Gen-Probe responds that GC155 is a composition of matter and, according to

Pfaff, is reduced to practice and hence ready for patenting when it is completely

composed. It asserts that GC155 was a nucleotide sequence that fell within the claims,

and had been isolated. Moreover, according to Gen-Probe, GC155 demonstrated

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preferential hybridization with N. gonorrhoeae even before the December 1984

shipment, thereby satisfying the ratio requirements of the claims. Thus, Gen-Probe

argues, GC155 was reduced to practice and ready for patenting.

We agree with Gen-Probe that GC155 was reduced to practice and therefore

ready for patenting. We have held that reduction to practice is one way an invention

may satisfy the ready for patenting condition. Sparton Corp. v. United States, 399 F.3d

1321, 1323 (Fed. Cir. 2005) (quoting Pfaff, 525 U.S. at 67-68). We reject Enzo’s

arguments that there was insufficient knowledge here about the probe to render it ready

for patenting. The fact that Enzo scientists had shown that it did not cross-react with N.

meningitides (thereby necessarily showing recognition of the specificity requirements

set out by the ratios in the claims), and recognized its utility as a probe for N.

gonorrhoeae, supports the conclusion that the probe that had been delivered to Ortho

pursuant to the 1982 agreement had been reduced to practice. Moreover, the fact that

CG155 was shown to be the same as an ATCC deposit made for the purpose of

supporting the patent application also indicates that it was ready for patenting. We

accordingly conclude that the district court properly found that the probe that Enzo

delivered to Ortho was ready for patenting and thus satisfied the second prong of the

Pfaff test.

D. Method Claims

Finally, Enzo argues that the district court erred by invalidating claims 5 and 6 of

the ’659 patent, which are characterized as “method” claims, by adopting a “gist of the

invention” analysis. It alleges that the court improperly grouped those claims with

product claims 1-4 and incorrectly invalidated all the claims together. Enzo asserts that

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Gen-Probe did not prove that the offer to sell GC155 to Ortho could possibly invalidate

claims 5 and 6. Gen-Probe responds that claims 5 and 6 were drafted in Jepson format

and thus were an acknowledgement that they were patentable only insofar as they

incorporate purportedly novel compositions for use in the hybridization test. Gen-Probe

argues that because the compositions themselves were subject to a statutory bar, the

so-called method claims 5 and 6 must also be unpatentable for the same reason.

We agree with Gen-Probe that the district court did not err in holding claims 5

and 6 invalid. The shipment to Ortho consisted not only of the GC155 probe, but also

accompanying instructions as to how to use the probe in the hybridization assay.

Moreover, given that the composition claims read on probes that hybridize with N.

gonorrhoeae, carrying out such a hybridization assay is inseparable from the

compositions themselves. Effectively, the offer to sell the compositions invalidates

claims 5 and 6 based on those same probes. See generally In re King, 801 F.2d 1324,

1326 (Fed. Cir. 1986) (determining that an article of manufacture in the prior art can be

used to support an anticipation rejection of method claims that, in essence, simply

define what happens when that article of manufacture is placed in the environment in

which the article will be used). Finally, Enzo has failed to meet its burden of coming

forward with evidence tending to show that the detectable marker label was not present

in the probe shipped to Ortho, and hence was not inherent in the offer to sell.

CONCLUSION

We have considered Enzo’s remaining arguments and find them unpersuasive.

Because Enzo offered for sale an embodiment of its claimed invention more than one

year before the critical date of its ’659 patent, the district court properly held that the

04-1570 16
patent was invalid under the on-sale bar of 35 U.S.C. § 102(b). Accordingly, we affirm

the court’s judgment.

AFFIRMED

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