Falko-Gunter Falkner v. Inglis ( 2006 )

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, argued 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) designated 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 priority date, and entered judgment against Falkner on the
sole count of the interference. It ordered that Falkner was not entitled to claims 1-19 of
the Falkner ’212 patent. It further 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 affirm the judgment of the Board.
I. BACKGROUND
A. The Invention
Some vaccines against a virus (the “target virus”) incorporate harmless
fragments of the target virus’s genetic material into a second virus, called a “viral
vector.” When a person is vaccinated, the viral vector produces harmless fragments of
the target virus, ultimately conferring immunity 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 inactivating one or more genes responsible for
the vector’s growth and infectiousness. However, because the vaccine is produced by
essentially “growing” the vector virus (accompanied 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 substantially less pathogenic. At the same time,
because the vector virus can still fully reproduce itself, albeit more slowly, the vaccine
can be produced in commercial quantities. However, the traditional approach carried a
disadvantage, namely the risk that the vector virus, though attenuated, could still cause
a harmful infection in the inoculee.
05-1324 2
The inventors discovered a way of making 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 the production problem by growing the vaccines
in cells that were complementarily modified 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 different kinds of vector viruses, e.g.,
adenoviruses, herpesviruses, poxviruses and retroviruses. 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”, meaning that they are
unlikely to enter the cell nucleus. Because a cell’s genes are located in the nucleus,
cytoplasmic viruses such as poxvirus cannot swap genes with the cell genome and
possibly revert to a virulent wild-type virus.
B. Defining the Count and Assigning Priority
The sole count of the interference was either “[a] vaccine according to Claim 1 of
Falkner’s 5,770,212 patent or a vaccine according to Claim 29 of Inglis’ 08/459,040
application.” Claim 29 of the Inglis ’040 application reads:
A vaccine comprising a pharmaceutically 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 3
infectious new virus particles, wherein said mutant virus is able to cause
production of infectious new virus particles in a complementing host cell
gene expressing a gene which complements said essential viral gene, but
is unable to cause production of infectious 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 region of its parental poxvirus, wherein (i) said
defective poxvirus comprises a DNA polynucleotide encoding an antigen
and said DNA polynucleotide is under transcriptional control of a promoter,
and (ii) the function can be complemented 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 claim, directed to poxvirus; and claim 30,
which depends on claim 29, is a poxvirus vaccine for mammalian subjects. Claim 9 is
directed to poxvirus but contains some additional limitations unrelated to the type of
virus used; claim 10 depends on claim 9 and is directed 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 vaccine 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 inventors made their inventions in the chronological order of
their effective filing dates, namely that the senior party invented first, see 37 C.F.R.
§ 1.657(a) (2004), and the junior party bears the burden of proving otherwise, see
§ 1.657(b), such as by proving that she actually reduced the invention to practice before
the constructive filing date (priority date) of the senior party, or that she was first to
conceive and diligently reduced the 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 4
application (filed June 2, 1995) the benefit of several earlier-filed applications, dating
back to September 25, 1990.3 Likewise, the APJ accorded the Falkner ’212 patent
(issued June 23, 1998 from an application filed February 21, 1997) the benefit of earlier-
filed 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 were similar. Although they
focused on herpesvirus vectors, they contained several passages related to poxvirus-
based vaccines. Because Falkner believed 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-related 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 parties’ 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) (applying a new procedural rule if and
only if it did not affect the parties’ reliance interests).
3
The Inglis priority applications were U.S. Application Serial No. 08/384,963
(“the Inglis ’963 application”), filed February 7, 1995; U.S. Application 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 British application”), filed
March 8, 1991; and GB 9020799.4 (“the Inglis 1990 British application”), filed
September 25, 1990. The Inglis ‘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 application. The Inglis PCT application
claimed priority to, and was essentially identical to, the Inglis 1990 and 1991 British
applications.
4
The Falkner priority applications were U.S. Application Serial No.
08/616,313 (“the Falkner ’313 application”) filed March 14, 1996; and U.S. application
Serial No. 08/235,392 (“the Faulkner ’392 application”), filed April 29, 1994.
05-1324 5
In 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) (explaining that “[t]he term ‘burden of proof’ . . . means the
burden to establish the proposition at issue by a preponderance of the evidence”).
Falkner brought his first preliminary motion pursuant to 37 C.F.R. § 1.633(a),5
arguing that the claims in Inglis’s involved (’040) application that corresponded to the
count were unpatentable because they failed to meet the written description
requirement of 35 U.S.C. § 112. In support of his argument, he stated, inter alia, that
(1) the specification of Inglis’s ’040 application did not identify any essential genes in
poxvirus or describe the inactivation of such genes, (2) vaccines based on vaccinia (a
type of poxvirus) had not yet been produced, and (3) the bulk of the Inglis specification
was directed not to poxviruses but to herpesviruses. The Board denied Falkner’s
motion, based in part on his failure to address the perceived shortcomings 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 that 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 completed before the new rules took effect. See
Singh v. Brake, 222 F.3d 1362, 1371 (Fed. Cir. 2000) (applying a new procedural rule if
and only if it did not affect the parties’ reliance interests); see also Brown v. Barbacid,
436 F.3d 1376, 1379 n.1 (Fed. Cir. 2006) (holding that the Board did not err in applying
the old rules “under which this case was decided”).
05-1324 6
describe and enable the claims in question.6 Falkner argued that without the benefit of
these applications Inglis would be unable to establish constructive reduction to practice
earlier than Falkner. Falkner would win priority as to the count, and
Inglis’ corresponding claims would be unpatentable. In support of his motion, Falkner
alleged deficiencies in Inglis’ benefit specifications similar to those raised in his first
motion. The Board carefully articulated the 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 compliance 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) (holding that where a “parent
application is relied upon as a prior constructive reduction to practice[,] . . . . the § 112,
first paragraph requirements need only be met for an embodiment within the count”)).
After careful review of the record, the Board held that Falkner had failed to meet his
burden of proof.
Third, Falkner moved for judgment pursuant to 37 C.F.R. § 1.633(a) that the
claims in Inglis’ involved (’040) application that corresponded to the count were
anticipated and therefore unpatentable. He argued that because Inglis’ earlier
applications had failed to adequately describe and enable the full scope of his current
claims, the current claims could not be accorded 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 Falkner ’392 patent, filed in 1994,
would have enabled the subsequent ’963 patent.
05-1324 7
purpose of antedating patent-defeating prior art.7 The Board explained 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. After carefully considering
the written description and enablement issues, the 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 matter 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 arguments 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 designating 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 discuss them. We turn, therefore, to the
central issues in this case: written description and enablement.
Written description is a question of fact, judged from the perspective 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). Enablement 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 own U.S. Pat. No. 5,766,882 (“the ’882
patent’), issued in March 1995, as the patent-defeating prior art.
05-1324 8
1365 (Fed. Cir. 1997); see also In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)
(holding that whether undue experimentation is required is a “conclusion reached by
weighing many factual considerations. . . . includ[ing] (1) the quantity 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 those in the art, (7) the predictability or unpredictability of the
art, and (8) the breadth of the claims.”).
This court applies the standards of the Administrative 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 arbitrary, 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 factual findings). We review questions of law
de novo. See Rapoport v. Dement, 254 F.3d 1053, 1058 (Fed. Cir. 2001).
Substantial evidence is defined 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 detracts from an agency’s opinion. See In re Gartside, 203
F.3d 1305, 1312 (Fed. Cir. 2000). An agency decision can be supported by substantial
evidence, even where the record will support several reasonable but contradictory
conclusions. See id.; see also In re Jolley, 308 F.3d 1317, 1320 (Fed. Cir. 2002).
05-1324 9
II. 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 poxvirus family.
Conceptually, poxviruses are a “subgenus” of viruses that includes the “species”
vaccinia. All of the prior Falkner applications 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 discussed the poxvirus invention and specifically
mentioned “vaccinia virus.”8 For example, after introducing the concept of vaccine
vectors, the specification states 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 vector genomes, noting that the “invention can
8
We recognize that the Inglis applications 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 the 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 unnecessary 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 Inglis 1990 British application.
05-1324 10
be applied to any virus where one or more essential gene(s) can be identified and
deleted from or inactivated within the virus genome” (emphasis added). Moreover, it
provides that “the virus may comprise an orthopox virus, for example, vaccinia virus,
which may comprise a heterologous sequence encoding an immunogen derived from a
pathogen.” Finally, it reads:
For example vaccinia virus, a poxvirus, can carry and express genes from
various pathogens, and it has been demonstrated that these form effective
vaccines when used in animal experimental 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 vaccine 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 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.
The application provides a detailed example of an embodiment that comprised
not a poxvirus, but a herpesvirus, including the identity of the deleted essential
sequences therein. Nevertheless, for the reasons 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 disclosure is judged from the perspective of one of
ordinary skill in the art, we start our review of the Board’s decision 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 creating 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 11
in the scientific literature relating to recombinant virus, including poxvirus.” The Board
agreed with the parties’ stipulation as to level of skill.
The Board did not err in finding Inglis’ claims to be enabled as a matter of law, in
light of its articulated underlying factual findings. In support of its conclusion, it noted
that “there is extensive disclosure of the selection of an essential gene, its deletion or
inactivation and the production of a mutated virus with said deleted or inactivated gene,
albeit for herpesvirus.” Moreover, because the differences between the herpesviruses
and poxviruses were well known, this would have aided the person of ordinary skill in
the art in her application of the 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 applications to be enabling.
Reviewing the Board’s legal conclusion 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” poxvirus genes, as discussed below we note that
there was undisputed testimony that as of the time of filing of the earliest Inglis
application publications in professional journals had disclosed the DNA sequence of the
poxvirus genome along with the locations of the “essential regions.” The person of
ordinary skill in the art would clearly have possessed such knowledge, and given the
ready accessibility of the journals, the absence of incorporation by reference is not
problematic. Indeed, “[a] patent need not teach, and preferably omits, what is well
05-1324 12
known 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 essentially reargues the positions on written
description that he took before the Board. Although the Board erred in its articulation of
the written description standard, that error is harmless. The 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). Nonetheless, we conclude there is
no need for remand because the undisputed testimony supports the Board’s ultimate
conclusion.
As noted above, the Board found several passages in the Inglis ‘040 application
(and in the benefit applications) that were directed 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 length.”). Furthermore, the testimony of Falkner’s expert, Dr.
Boursnell, established that the articles describing essential genes for poxvirus were
well-known in the art. Dr. Boursnell testified that “the skilled person 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.
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The 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 reduction to practice of an invention is absent;
and (3) there is no per se rule that an adequate written description of an invention that
involves a biological macromolecule must contain a recitation of known structure.
1. Examples Are Not Required
First, it is clear that the absence of examples 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 section 112 grounds simply because the
embodiments of the specification 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 spell 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 technology that is sought to be
patented; the requirement serves both to satisfy the inventor’s obligation to disclose the
technologic knowledge upon which the patent is based, and to demonstrate that the
05-1324 14
patentee was in possession of the invention 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 course do not mean to suggest that the
written description requirement can be satisfied 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 with Supreme Court precedent.
In the context of interpreting 35 U.S.C. § 102(b), the Court 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 specifications stated that “[n]o vaccinia 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.
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to practice is necessary in every case.” Id. (emphasis added).12 Thus, to the extent that
written description requires a showing of “possession of the invention,” Capon, 418 F.3d
at 1357 (emphasis added), Pfaff makes clear that an invention 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 specifications do not adequately
describe the poxvirus invention, in light of Eli Lilly, because they do not describe the
“essential regions” of any poxvirus. 119 F.3d 1559. We note, in addition, that Inglis did
not attempt to incorporate by reference any literature that described 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 sequence, 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 carefully 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 specification of what is
reduced to practice, does not serve to describe or identify the invention for purposes of
§ 112, P 1. As with ‘possession,’ proof of a reduction to practice 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.”).
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Enzo 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 invention at issue, and with the scientific and
technologic knowledge already in existence. 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 the 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 state of knowledge in the field and
differences in the predictability 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 between 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 the claimed invention. As we
stated in Capon, “[t]he ‘written description’ requirement states that the patentee must
describe the invention; it does not state that every invention must be described in the
same way. As each field evolves, the balance also evolves between what is known and
what is added by each inventive 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 where, as in this case, accessible literature
sources clearly provided, as of the relevant date, genes and their nucleotide sequences
(here “essential genes”), satisfaction of the written description requirement does not
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require either the recitation or incorporation by reference14 (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 relied 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 incorporation by reference. Where, of
course, certain material that is not present in the specification is deemed nonessential
to the satisfaction of the written description requirement, the issue of proper
incorporation by reference vel non is irrelevant.
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