## United States Court of Appeals for the Federal Circuit

05-1324 (Interference No. 105,187)

FALKO-GUNTER FALKNER, GEORG HOLZER, and FRIEDRICH DORNER, Appellants,

v.

STEPHEN C. INGLIS, MICHAEL E.G. BOURSNELL, and ANTHONY C. MINSON, Appellees.

John P. Isacson , Heller Ehrman LLP, of Washington, DC, argu ed for appellants. With him on the brief was Paul M. Booth

. Robert G. McMorrow, Jr. , Connolly Bove Lodge & Hutz LLP, of Wilmington, Delaware, argued for appellee. Appealed from: United States Patent and Trademark Office, Board of Patent Appeals and Interferences

## United States Court of Appeals for the Federal Circuit

05-1324 (Interference No. 105,187) FALKO-GUNTER FALKNER, GEORG HOLZER, and FRIEDRICH DORNER, Appellants,

v. STEPHEN C. INGLIS, MICHAEL E.G. BOURSNELL, and ANTHONY C. MINSON, Appellees.

________________________ DECIDED: May 26, 2006

________________________

Before GAJARSA, Circuit Judge , ARCHER, Senior Circuit Judge and DYK, Circuit Judge

. GAJARSA, Circuit Judge

. This is an appeal from a decision of the Board of Patent Appeals and Interferences (“Board”) in Interference No . 105,187, declared on December 24, 2003, between Falkner et al. , U.S. Patent No. 5,770,212 (“the Falkner ’212 patent”) and Inglis et al. , U.S. Application Serial No. 08/459,040 (“the Inglis ’040 application”). The Administrative Patent Judge (APJ) des ignated Inglis as the senior party. On December 29, 2004, the Board issued a final decision, holding that Falkner could not antedate Inglis’ September 25, 1990 pr iority date, and entered judgm ent against Falkner on thesole count of the interference. It ordered that Falkner was not entitled to claims 1-19 of the Falkner ’212 patent. It furt her ordered that Inglis was entitled to claims 9, 10, 29 and 30 of the ’040 application. Falkner filed a timely notice of appeal. This Court has jurisdiction pursuant to 28 U.S.C. § 1295( a)(4)(A) and 35 U.S.C. §§ 141 and 142. For the reasons discussed below, we a ffirm the judgment of the Board. I. BACKGROUND

A. The Invention Some vaccines against a virus (the “t arget virus”) incorporate harmless fragments of the target virus’s genetic materi al into a second virus, called a “viral vector.” When a person is vaccinated, the vi ral vector produces harmless fragments of the target virus, ultimately conferring immuni ty against it. To prevent the viral vector from itself causing a harmful infection in the inoculee, it must be attenuated. Attenuation is achieved by deleting or inac tivating one or more genes responsible for the vector’s growth and infectiousness. Ho wever, because the vaccine is produced by essentially “growing” the vector virus (acco mpanied by its inserted target virus gene), attenuation makes it difficult to manufacture the vaccine. The traditional solution to this problem has been to inactivate genes known as “inessential” genes. With inessential genes inactivated, the viral vector is subst antially less pathogenic. At the same time, because the vector virus can st ill fully reproduce itself, albeit more slowly, the vaccine can be produced in commercial quantities. Ho wever, the traditional approach carried a disadvantage, namely the risk t hat the vector virus, though attenuated, could still cause a harmful infection in the inoculee.

05-1324 2The inventors discovered a way of ma king vaccines safer by deleting or inactivating an essential , rather than an inessential, gene from the viral vector’s genome, while at the same time solving t he production problem by growing the vaccines in cells that were complementarily modifi ed to produce the absent essential viral gene product “on behalf of” the vector virus. Thus, the modified vector virus could be readily grown in these complementarily-modified cells, but not in other cells , such as those of an inoculee. This approach is applicable to many differ ent kinds of vector viruses, e.g., adenoviruses, herpesviruses, poxviruses and retr oviruses. The subject matter of this interference, however, is directed specifically to vaccines in which the vector virus is a poxvirus . For many vector viruses, there is a risk that vectors that have been attenuated in essential genes can “swap” genes with the host cell genome, thereby reacquiring their deleted genes and reverting to wild-type virus. This risk can be minimized through the use of viruses that are “cytoplasmic”, m eaning that they are unlikely to enter the cell nucleus. Because a cell’s genes are located in the nucleus, cytoplasmic viruses such as poxviru s cannot swap genes wit h the cell genome and possibly revert to a virulent wild-type virus. B. Defining the Count and Assigning Priority The sole count of the interf erence was either “[a] vaccine according to Claim 1 of Falkner’s 5,770,212 patent or a vaccine accord ing to Claim 29 of Inglis’ 08/459,040 application.” Claim 29 of the Inglis ’040 application reads: A vaccine comprising a pharmaceutica lly acceptable excipient and an effective immunizing amount of a mutant virus, wherein said mutant virus is a mutant poxvirus and has a genome which has an inactivating mutation in a viral gene, said viral gene being essential for the production of

05-1324 3infectious new virus particles, wherein said mutant virus is able to cause production of infectious new virus par ticles in a complementing host cell gene expressing a gene which complements said essential viral gene, but is unable to cause production of infect ious new virus particles when said mutant virus infects a host cell other than a complementing host cell; for prophylactic or therapeutic use in generating an immune response in a subject. (emphasis added) Claim 1 of the Falkner ’212 patent reads: A vaccine comprising (a) a defective poxvirus that lacks a function imparted by an essential r egion of its parental poxvirus, wherein (i) said defective poxvirus comprises a DNA polynucleotide encoding an antigen and said DNA polynucleotide is under tr anscriptional control of a promoter, and (ii) the function can be complem ented by a complementing source; and (b) a pharmaceutically acceptable carrier. The Administrative Patent Judge (APJ) designated claims 1-19 of the Falkner ‘212 patent and claims 9,10, 29, and 30 of the Inglis ’040 application as corresponding to the interference count. 1 Both parties sought the benefit of earlier-filed applications to establish dates of constructive reduction to practice. 2 The ALJ accorded the Inglis ’040

1 Inglis’s claim 29 is his broadest clai m, directed to poxvi rus; and claim 30, which depends on claim 29, is a poxvirus vacci ne for mammalian subjects. Claim 9 is directed to poxvirus but contains some additi onal limitations unrelat ed to the type of virus used; claim 10 depends on claim 9 and is di rected to a single species of poxvirus, namely vaccinia virus. Falkner’s claims 2-10 depend on claim 1. Falkner claim 10 is directed to a method of producing the vacci ne of claim 1, and the remaining method claims depend thereon. 2 Priority in an interference goes to the first to invent, but a rebuttable presumption exists that the in ventors made their inventions in the chronological order of their effective filing dates, namely t hat the senior party invented first, see 37 C.F.R. § 1.657(a) (2004), and the j unior party bears the burden of proving otherwise, see § 1.657(b), such as by proving that she act ually reduced the invention to practice before the constructive filing date (pri ority date) of the senior party , or that she was first to conceive and diligently reduced t he invention to practice, starting from a date prior to reduction to practice by the senior party. See 35 U.S.C. § 112(g) (2000). Falkner sought to rely, in part, on an alleged date of conception and beginning of reasonable diligence: April 27, 1994.

05-1324 4application (filed June 2, 1995) the benefit of several earlie r-filed applications, dating back to September 25, 1990. 3 Likewise, the APJ acco rded the Falkner ’212 patent (issued June 23, 1998 from an app lication filed February 21, 1997) the benefit of earlierfiled applications, but these dated back only to April 29, 1994. 4 Consequently, the APJ designated Inglis as the senior party. C. Board Decision The specifications of all of Inglis’ earlier applications we re similar. Although they focused on herpesvirus vectors, they contained several passages related to poxvirusbased vaccines. Because Falkner believ ed that these passages did not adequately describe and enable the poxvirus invention, he challenged both Inglis’ entitlement to priority as to the count and the patentability of Inglis’ corresponding claims. Falkner brought these challenges in three closely-rela ted preliminary motions before the Board.

On September 13, 2004, the “ 600” rules expired in favor of new rules found at 37 C.F.R. § 41.100 et seq. However, the Board correctly chose to decide the matter under the old rules, given the parti es’ reliance on them in filing all motions, oppositions, and replies in the case, which were completed before the new rules took effect. See Singh v. Brake , 222 F.3d 1362, 1371 (Fed. Cir. 2000) (applyi ng a new procedural rule if and only if it did not affect the parties’ reliance interests). 3 The Inglis priority applications we re U.S. Application Serial No. 08/384,963 (“the Inglis ’963 application”), filed Februar y 7, 1995; U.S. App lication Serial No. 08/030,073 (“the Inglis ’073 application”), filed May 20, 1993; WO/92/05263, PCT/GB91/01632 (“the Inglis PCT application”), filed September 23, 1991, published in English on April 2, 1992; GB 9104903.1 (“the Inglis 1991 Brit ish application”), filed March 8, 1991; and GB 9020799.4 (“the Inglis 1990 British application”), filed September 25, 1990. The Ing lis ‘040 application is a continuation in part of the ’963 application, which was in turn a continuation of the Inglis ’073 application. The ’073 application corresponded to the Inglis PCT app lication. The Ing lis PCT application claimed priority to, and was essentially identical to, the I nglis 1990 and 1991 British applications. 4 The Falkner priority applications were U.S. Application Serial No. 08/616,313 (“the Falkner ’313 applic ation”) filed March 14, 1996; and U.S. application Serial No. 08/235,392 (“the Faulkner ’392 application”), filed April 29, 1994.

05-1324 5In each, as the moving party, Falkner carried the burden of proof by a preponderance of the evidence. See 37 C.F.R. § 1.637(a); see also Kubota v. Shibuya , 999 F.2d 517, 520 n.2 (Fed. Cir. 1993) (ex p lain ing that “[t]he term ‘burden of proof’

. . . means the burden to establish the proposition at iss ue by a preponderance of the evidence”). Falkner brought his first preliminary mo tion pursuant to 37 C.F.R. § 1.633(a), 5 arguing that the claims in Inglis’s invo lved (’040) application t hat corresponded to the count were unpatentable because they fail ed to meet the wr itten description requirement of 35 U.S.C. § 112. In support of his argument, he stated, inter alia , that (1) the specification of Ing lis’s ’040 application did not i dentify any essential genes in poxvirus or describe the inactivation of su ch genes, (2) vaccines based on vaccinia (a type of poxvirus) had not yet been produced, and (3 ) the bulk of the I nglis specification was directed not to poxviruses but to her pesviruses. The Board denied Falkner’s motion, based in part on his failure to addre ss the perceived shortcom ings of the ’040 claims in light of the specification. Second, Falkner moved pursuant to 37 C. F.R. §§ 1.633(g) & 1.637(g) to deny Inglis the priority benefit of his earlier applications, arguing t hat they did not sufficiently

5 On September 13, 2004, the “600” rules expired in favor of new rules found at 37 C.F.R. § 41. 100 et seq. However, the Board correctly decided the matter under the old rules, given the parties’ reliance on them in filing all motions, oppositions, and replies in the case, which were comple ted before the new rules took effect. See Singh v. Brake , 222 F.3d 1362, 1371 (Fed. Cir. 2000) (appl ying a new procedural rule if and only if it did not affect t he parties’ reliance interests); see also Brown v. Barbacid , 436 F.3d 1376, 1379 n.1 (Fed. Cir. 2006) (holding that the Boar d did not err in applying the old rules “under which this case was decided”).

05-1324 6describe and enable the claims in question. 6 Falkner argued that wit hout the benefit of these applications Inglis would be unable to est ablish constructive reduction to practice earlier than Falkner. Falkner would win priority as to the count, and Inglis’ corresponding claims would be unpatentabl e. In support of his motion, Falkner alleged deficiencies in Inglis’ benefit specifications similar to those raised in his first motion. The Board carefully articulated t he legal standard, correctly explaining that “benefit with respect to priority in an interference is granted with respect to counts not claims ” and that “[a]ll that is necessary for a party to be entitled to benefit of an earlier filed application for priority purposes is co mpliance with 35 U.S.C. § 112 with respect to at least one embodiment within the scope of the count.” Board Op. at 7 (citing Hunt v. Treppschuh , 523 F.2d 1386, 1389 (CCPA 1975) (hol ding that where a “parent application is relied upon as a prior constructive reduction to practice[,]

. . . . the § 112, first paragraph requirements need only be met fo r an embodiment within the count”)). After careful review of the record, the B oard held that Falkner had failed to meet his burden of proof. Third, Falkner moved for judgment purs uant to 37 C.F.R. § 1.633(a) that the claims in Inglis’ involved (’040) applicat ion that corresponded to the count were anticipated and therefore unpat entable. He argued that because Inglis’ earlier applications had failed to adequately descri be and enable the full scope of his current claims, the current claims could not be acco rded the benefit of 35 U.S.C. § 120 for the

6 Falkner did not argue lack of enablement with respect to the Inglis ‘963 patent because he believed that the teachings of the Falkne r ’392 patent, filed in 1994, would have enabled the subsequent ’963 patent.

05-1324 7purpose of antedating patent -defeating prior art. 7 The Board explai ned that 35 U.S.C. §§ 119 & 120 require benefit applications to comply with § 112, first paragraph, with respect to the full scope of what a party now claims, rather than with respect to merely one embodiment within the scope of the interference count. A fter carefully considering the written description and enablement issues, t he Board denied the motion. As a result of the denial of Falkner’s several motions , Inglis remained the senior party, and the Board ordered judgment as to the subject ma tter of the count in favor of Inglis.
D. Issue and Standard of Review On appeal, Falkner essentially reiterates the arguments that he made before the Board. While we recognize that each of these three argum ents is distinct, they are nonetheless all related, and under the facts of this particular case, we need only to resolve the following common issue: whether the Inglis benefit applications adequately describe and enable a poxvirus-based vaccine. Falkner also argues that the Board committed other errors, such as initially desi gnating Inglis as the senior party and failing to afford Falkner an opportunity for briefing prior to making this designation. These arguments lack merit, and we shall not further di scuss them. We turn, therefore, to the central issues in this case: written description and enablement. Written description is a question of fac t, judged from the persp ective of one of ordinary skill in the art as of the relevant filing date. See Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). Enablem ent is a question of law involving underlying factual inquiries. See Genentech, Inc. v. Novo Nordisk A/S , 108 F.3d 1361,

7 Here, Falkner points to his ow n U.S. Pat. No. 5,766,882 (“the ’882 patent’), issued in March 1995, as the patent-defeating prior art.

05-1324 81365 (Fed. Cir. 1997); see also In re Wands , 858 F.2d 731, 737 (Fed. Cir. 1988) (holding that whether undue ex perimentation is required is a “conclusion reached by weighing many factual considerations. . . . includ[ing] (1) the quant ity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of t hose in the art, (7) the predictab ility or unpredictability of the art, and (8) the breadth of the claims.”). This court applies the standards of the Ad ministrative Procedure Act (“APA”) in reviewing decisions of the Board. See Dickinson v. Zurko , 527 U.S. 150, 152 (1999) (holding that 5 U.S.C. § 706 governs our review of PTO appeals). Accordingly, we will set aside actions of the Board if they are ar bitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, and we set aside factual findings that are unsupported by substantial evidence. See In re McDaniel , 293 F.3d 1379, 1382 (Fed. Cir. 2002) (citing 5 U.S.C. § 706); see also In re Sullivan , 362 F.3d 1324, 1326 (Fed. Cir. 2004) (substantial evidence review of fact ual findings). We review questions of law de novo

. See Rapoport v. Dement , 254 F.3d 1053, 1058 (Fed. Cir. 2001). Substantial evidence is def ined as that which a reasonable person might accept as adequate to support a conclusion. See In re Zurko , 258 F.3d 1379, 1384 (Fed. Cir. 2001). It requires an examination of the record as a whole, taking into account both the evidence that justifies and detra cts from an agency’s opinion. See In re Gartside , 203 F.3d 1305, 1312 (Fed. Cir. 2000). An agency dec ision can be supported by substantial evidence, even where the record will suppor t several reasonable but contradictory conclusions. See id. ; see also In re Jolley , 308 F.3d 1317, 1320 (Fed. Cir. 2002).

05-1324 9II. DISCUSSION A. Contents of the Inglis Priority Applications The claims that correspond to the count of the interference are directed to a novel type of vaccine that is comprised of a “vector virus” in the pox virus family. Conceptually, poxviruses are a “subgenus” of viruses that includes the “species” vaccinia. All of the prior Falkner applic ations described poxvirus vaccine vectors in detail, and to the exclusion of other types of vaccine vectors (e.g., herpesvirus vaccine vectors). These applications provided five detailed working examples regarding the preparation and use of vaccines from defective poxviruses. They also described the use of a particular species of poxvirus vaccine vector, namely vaccinia virus. In contrast, the Inglis applications described vaccine vectors in general, and then focused on the subgenus of herpesviruses, for which they provided a detailed example. Nevertheless, at least three passages discu ssed the poxvirus invention and specifically mentioned “vaccinia virus.” 8 For example, after introd ucing the concept of vaccine vectors, the specification stat es that “[t]ypically members of the pox virus family, e.g. vaccinia virus, are used as vaccine vectors.” 9 The specification later discusses the deletion of essential genes from vaccine vect or genomes, noting that the “invention can

8 We recognize that the Inglis app lications do not describe any actual reduction to practice of a poxvirus vaccine. See Carroll Declaration (stating that the ‘040 application did not contain any discussion of the “actual creation of the recited ‘mutant poxvirus’” and that t he application in fact stated “that a vaccinia virus with a deletion in an essential gene had not been produced.”). As we discuss below, however, an actual reduction to practice is unnecessa ry to satisfy the written description requirement. 9 Because of the substantial similarity in the specifications of all of the Inglis benefit applications, we shall refer in this opinion to representative passages from the earliest of the applications, the I nglis 1990 British application.

05-1324 10be applied to any virus where one or more essentia l gene(s) can be identified and deleted from or inactivated within the virus genome” (em phasis added). Moreover, it provides that “the virus may comprise an or thopox virus, for exam ple, vaccinia virus, which may comprise a heterologous s equence encoding an immunogen derived from a pathogen.” Finally, it reads: For example vaccinia virus, a poxviru s, can carry and express genes from various pathogens, and it has been demonstr ated that these form effective vaccines when used in animal experiment al systems. The potential for use in humans is vast, but because of the known side effects associated with the widespread use of vaccinia as a vaccine against smallpox, there is reluctance to use an unmodified va ccine in humans. There have been attempts to attenuate vaccinia virus by deleting non-essential genes such as the vaccinia growth factor gene. . . However, such attenuated viruses can still replicate in vivo, albeit at a reduced level. No vaccinia virus with a deletion in an essential gene has ye t been produced, but such a virus, deleted in an essential gene as descr ibed above, with its complementing cell for growth, would provide a safer version of this vaccine. The application provides a detailed exam ple of an embodiment that comprised not a poxvirus, but a herpesvirus , including the identity of the deleted essential sequences therein. Nevertheless, for the r easons discussed below, we find no error in the Board’s determinations on the adequacy of written description and enablement in the various Inglis disclosures. B. Enablement Because the adequacy of the di sclosure is judged from t he perspective of one of ordinary skill in the art, we start our review of the Board’s decisi on by noting that the parties stipulated to a high level of skill in the art. They defined the skilled artisan as having 5-10 years experience cr eating recombinant poxvirus, as being familiar with the poxvirus literature, the use of poxvirus as a vector for the expression of heterologous genes, and having the “needed technical skill to practice the experimentation described

05-1324 11in the scientific literature re lating to recombinant virus, including poxvirus.” The Board agreed with the parties’ stipulati on as to level of skill. The Board did not err in finding Inglis’ clai ms to be enabled as a matter of law, in light of its articulated underlying factual findi ngs. In support of its conclusion, it noted that “there is extensive disclos ure of the selecti on of an essential gene, its deletion or inactivation and the production of a mutated viru s with said deleted or inactivated gene, albeit for herpesvirus.” Moreover, because the differences between the herpesviruses and poxviruses were well known, this woul d have aided the person of ordinary skill in the art in her application of t he lessons of the herpesvirus example in the construction of poxvirus vaccines. The Board observed that “the mere fact that the experimentation may have been difficult and time consuming does not mandate a conclusion that such experimentation would have been considered to be ‘undue’ in this art. Indeed, great expenditures of time and effort were ordinary in the field of vaccine preparation.” Thus, the Board found the Inglis app lications to be enabling. Reviewing the Board’s legal conclu sion of enablement, as based on its underlying findings of fact, we cannot say that the Board erred. With respect to a skilled artisan’s ability to identify “essential” poxvi rus genes, as discussed below we note that there was undisputed testimony t hat as of the time of f iling of the earliest Inglis application publications in professional j ournals had disclosed the DNA sequence of the poxvirus genome along with the lo cations of the “essential regions.” The person of ordinary skill in the art would clearly hav e possessed such knowledge, and given the ready accessibility of the jour nals, the absence of incorporation by reference is not problematic. Indeed, “[a] pat ent need not teach, and prefer ably omits, what is well

05-1324 12known in the art.” Spectra-Physics, Inc. v. Coherent, Inc. , 827 F.2d 1524, 1534 (Fed. Cir. 1987). C. Written Description On appeal to this court, Falkner essentia lly reargues the positions on written description that he took before t he Board. Although the Board e rred in its articulation of the written description standard, that error is harmless. T he Board held that “an actual possession standard is not required.” (emphasis added). But our precedent clearly establishes that “[t]he applicant must

. . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). N onetheless, we conclude there is no need for remand because the undisputed test imony supports the Board’s ultimate conclusion. As noted above, the Board found several pa ssages in the Inglis ‘040 application (and in the benefit applications) that were di rected to poxvirus. No length requirement exists for a disclosure to adequately describe an invention. See In re Hayes Microcomputer Prods., Inc. Patent Litig. , 982 F.2d 1527, 1534 (Fed. Cir. 1992) (“[T]he adequacy of the description of an invention depends on its content in relation to the particular invention, not its l ength.”). Furthermore, the test imony of Falkner’s expert, Dr. Boursnell, established that t he articles describing essent ial genes for poxvirus were well-known in the art. Dr. Boursnell testif ied that “the skilled per son would have been readily able to choose an essential vaccinia gene” based on references that have been publicly available since 1990. The testimony of Inglis’ expert, Dr. Carroll, did not refute this claim.

05-1324 13The parties also dispute several aspects of our law of written description, which we now address. We conclude that the Board applied correct law. Specifically, we hold, in accordance with our prior case law, that (1) examples are not necessary to support the adequacy of a written description (2) the written description standard may be met (as it is here) even where actual reduc tion to practice of an invention is absent; and (3) there is no per se rule that an adequate written de scription of an invention that involves a biological macromolecule must c ontain a recitation of known structure.
1. Examples Are Not Required First, it is clear that the absence of exam ples involving poxviruses in the Inglis applications does not render the written description inadequate. As we explained in LizardTech, Inc. v. Earth Resource Mapping, PTY, Inc. : A claim will not be invalidated on sect ion 112 grounds simply because the embodiments of the specif ication do not contain examples explicitly covering the full scope of the claim language. That is because the patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. Placed in that context, it is unnecessary to s pell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention and to enable such a person to make and use the invention without undue experimentation. 424 F.3d 1336, 1345 (Fed. Cir. 2005) (citing Union Oil Co. v. Atl. Richfield Co. , 208 F.3d 989, 997 (Fed. Cir. 2000); In re GPAC Inc. , 57 F.3d 1573, 1579 (Fed. Cir. 1995)).
2. Actual Reduction to Practice Is Not Required As we explained in Capon v. Eshhar , “[t]he ‘written description’ requirement implements the principle that a patent must describe the te chnology that is sought to be patented; the requirement serves both to satisf y the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the

05-1324 14patentee was in possession of the inventi on that is claimed.” 418 F.3d 1349, 1357 (Fed. Cir. 2005). The Board was correct, however, not to view as dispositive that Inglis had not actually produced a poxvirus vaccine, 10 because an actual reduction to practice is not required for written description. 11 See Univ. of Rochester v. G.D. Searle & Co. , 358 F.3d 916, 926 (Fed. Cir. 2004) (“We of c ourse do not mean to suggest that the written description requirement can be satisf ied only by providing a description of an actual reduction to practice. Constructive reduction to practice is an established method of disclosure . . . .”). Rochester , moreover, is consistent wit h Supreme Court precedent. In the contex t of interpre ting 35 U.S.C. § 102(b), the C ourt held that “[t]he word ‘invention’ must refer to a concept that is complete, rather than merely one that is ‘substantially complete.’” Pfaff v. Wells Elecs. , 525 U.S. 55, 66 (1998). It then proceeded to make clear that although “reduction to practice ordinarily provides the best evidence that an invention is complete.

. . . it does not follow that proof of reduction

10 The Inglis specificati ons stated that “[n]o vaccini a virus with a deletion in an essential gene has yet been produced, but such a virus, deleted in an essential gene as described above, with its complementing cell for growth, would provide a safer version of this vaccine.” 11 The Board believed that Falkner’s expert, Dr. Carroll, had premised his opinions on the misunderstanding that actual reduction to practice was required to prove written description, and it discredited his expert opinion.

05-1324 15to practice is necessary in every case.” Id. (emphasis added). 12 Thus, to the extent that written description requires a s howing of “possession of the invention ,” Capon , 418 F.3d at 1357 (emphasis added), Pfaff makes clear that an inventi on can be “complete” even where an actual reduction to practice is absent. 13 The logical predicate of “possession” is, of course, “completeness.”
3. Recitation of Known Structure Is Not Required Falkner argues, inter alia , that the Inglis spec ifications do not adequately describe the poxvirus inv ention, in light of Eli Lilly , because they do not describe the “essential regions” of any poxvi rus. 119 F.3d 1559. We note, in addition, that Inglis did not attempt to incorporate by reference any literature that de scribed the DNA sequence of the poxvirus genome and the locations of the “essential regions.” However, it is the binding precedent of this court that Eli Lilly does not set forth a per se rule that whenever a claim limitation is directed to a macromolecular sequenc e, the specification must always recite the gene or sequence, regardless of whether it is known in the prior
art. See Capon , 418 F.3d at 1357 (“None of the cases to which the Board attributes the requirement of total DNA re-analysis, i.e., Regents v. Lilly , Fiers v. Revel , Amgen , or

12 Similarly, this court has care fully explained the relationship between written description and possession, explaining that a showing of possession is not necessarily sufficient to demonstrate the adequacy of written description. See, e.g. , Enzo Biochem, Inc. v. Gen-Probe Inc. , 296 F.3d 1316, 1330 (Fed. Cir . 2002) (“[P]roof of a reduction to practice, absent an adequate description in the s pecification of what is reduced to practice, does not serve to descri be or identify the inv ention for purposes of § 112, P 1. As with ‘possession, ’ proof of a reduction to prac tice may show priority of invention or allow one to antedate a reference, but it does not by itself provide a written description in the patent specification.”). 13 In contrast to reduction to practice, conception is a prerequisite to an adequate written description. See Fiers v. Sugano , 984 F.2d 1164, 1171 (Fed. Cir. 1993) (“[O]ne cannot describe what one has not conceived.”).

05-1324 16Enzo Biochem , require a re-description of what was already known.”). Thus, “[w]hen the prior art includes the nucleotide information, precedent does not set a per se rule that the information must be determined afresh.” Id. at 1358. Rather, we explained that: The descriptive text needed to meet these requirements varies with the nature and scope of the in vention at issue, and with the scientific and technologic knowledge already in exis tence. The law must be applied to each invention that enters the patent process, for each patented advance is novel in relation to the state of t he science. Since the law is applied to each invention in view of the state of relevant knowledge, its application will vary with differences in the st ate of knowledge in the field and differences in the predi ctability of the science. Id. at 1357. Indeed, a requirement that patentees recite known DNA structures, if one existed, would serve no goal of the written description requirement. It would neither enforce the quid pro quo betw een the patentee and the public by forcing the disclosure of new information, nor would it be necessary to demonstrate to a person of ordinary skill in the art that the patentee was in possession of t he claimed invention. As we stated in Capon , “[t]he ‘written description’ requirem ent states that the patentee must describe the invention; it does not state that every invent ion must be described in the same way. As each field evolves, the balanc e also evolves between what is known and what is added by each inv entive contribution.” Id. at 1358. Indeed, the forced recitation of known sequences in patent disclosures would only add unnecessary bulk to the specification. Accordingly we hold that w here, as in this case, accessible literature sources clearly provided, as of the relevant date, genes and their nucleotide sequences (here “essential genes”), satisfaction of t he written description requirement does not

05-1324 17require either the recitation or incorporation by reference 14 (where permitted) of such genes and sequences. In conclusion, having reviewed the decision of the Board, we can discern no error in its conclusion that the disclosures re lied upon by Inglis for priority purposes adequately described and enabled the invention directed to poxvirus, there being substantial evidence to support these findings . Consequently, we hold that the Board’s award of priority to Inglis was proper.

AFFIRMED No costs.

14 Here, the patentee did not attempt inco rporation by reference. Where, of course, certain material that is not present in the spec ification is deemed nonessential to the satisfaction of the written descr iption requirement, the issue of proper incorporation by reference vel non is irrelevant.

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