Ex Parte Wilm

Board of Patent Appeals and Interferences

Nov 19, 2009

10239572 (B.P.A.I. Nov. 19, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CLAUDIA WILM
__________

Appeal 2009-013268
Application 10/239,572
Technology Center 1600
__________

Decided: November 20, 2009
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to
calcineurin B subunit beta polypeptides, polynucleotides, vectors, host cells
and a method for producing the polypeptides. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

Appeal 2009-013268
Application 10/239,572

2
Statement of the Case
Background
“Calcineurin is a calcium-dependent phosphatase regulated by
calmodulins. Calcineurin is composed of a catalytic subunit, calcineurin A,
and a Ca(2+)-binding regulatory subunit, calcineurin B” (Spec. 3, ll. 13-15).
According to the Specification, “[c]alcineurin may be involved in human
heart failure in which chronic increases in intracellular calcium activate
phosphatase-mediated signaling” (Spec. 3, ll. 30-32).
The Claims
Claims 1-9 and 12-16 are on appeal1. Claims 1 and 3 are
representative and read as follows:
1. An isolated polypeptide selected from the group
consisting of:
(a) a polypeptide encoded by a polynucleotide
comprising the sequence of SEQ ID NO:1;
(b) a polypeptide comprising a polypeptide
sequence comprising at least 95% identity along its entire
length to the polypeptide sequence of SEQ ID NO:2 and
which hybridizes[2] to the complement of SEQ ID NO:1
under hybridization conditions comprising overnight
incubation at 42°C in a solution comprising: 50%
formamide, 5xSSC (150mM NaCl, 15mM trisodium citrate),

1 We note that the Examiner, in a Notice of Non-Entry of Reply
Brief mailed 7/14/2008, denied entry of Appellant’s amendment
filed with the Reply Brief on 4/6/07. Therefore, we do not address
the amended claims or new claims 17-20 added in the Reply Brief.
2 We note that polypeptides typically do not “hybridize” to one
another, and that the “hybridizing” language in the claim would
more reasonably refer to the nucleic acids which encode the
polypeptides. Appellant’s amendment filed April 6, 2007 which
was denied entry by the Examiner would correct this error.
Appeal 2009-013268
Application 10/239,572

3
50 mM sodium phosphate (pH 7.6), 5x Denhardt's solution,
10% dextran sulfate, and 20 microgram/ml denatured,
sheared salmon sperm DNA; followed by washing the filters
in 0.1x SSC at 65°C;
(c) a polypeptide comprising at least 95% identity
along is [sic] entire length to the polypeptide sequence of
SEQ ID NO:2 and which hybridizes to the complement of
SEQ ID NO:1 under hybridization conditions comprising
overnight incubation at 42°C in a solution comprising: 50%
formamide, 5xSSC (150mM NaCl, 15mM trisodium citrate),
50 mM sodium phosphate (pH 7.6), 5x Denhardt's solution,
10% dextran sulfate, and 20 microgram/ml denatured,
sheared salmon sperm DNA; followed by washing the filters
in 0.1x SSC at 65°C;
(d) the polypeptide sequence consisting of SEQ ID
NO:2; and
(e) fragments of such polypeptides in (a) to (e),
wherein said polypeptide of (a) to (e) has calcium binding
activity and/or the ability to associate with the calcineurin
catalytic subunit A.

3. The isolated polypeptide of claim 1 consisting of
polypeptide sequence of SEQ ID NO:2.

The prior art

The Examiner relies on the following prior art references to show
unpatentability:

Rosen (PgPUB) US 2004/0018969 A1 Jan. 29, 2004

Rosen (Provisional) 60/179,065 Jan. 31, 2000
Appeal 2009-013268
Application 10/239,572

4
The issues
The rejections as presented by the Examiner are as follows:
A. The Examiner rejected claims 1-6, 12, 15, and 16 under
35 U.S.C. § 102(e) as anticipated by Rosen (PgPUB) (Ans. 3-5).
B. The Examiner rejected claims 1, 6-9 and 12-14 under
35 U.S.C. § 103(a) as being obvious over Rosen (PgPUB) (Ans. 6-7).
The Examiner finds that
Rosen et al. teach[es] SEQ ID NO: 845, which is a 187
amino acid polypeptide. Amino acid residues 18-187 of SEQ
ID NO: 845 are identical to instant SEQ ID NO: 2.
Therefore, Rosen et al.'s SEQ ID NO: 845 has at least 95%
identity to SEQ ID NO: 2 (Claims 1 (a), (b), (c)), at least
99% identity of SEQ ID NO: 2 (Claim 15), and comprises
SEQ ID NO: 2 (Claim 2).

(Ans. 4). The Examiner notes that “[t]hose pages of the relied upon priority
application Serial Number 60/179,065 is attached hereto for the convenience
of the Board” (Ans. 8).
Appellant argues that “[i]n order to establish anticipation with respect
to this priority application, it is the PTO's burden to show where all the
sequence limitations recited in the rejected claims are found in this priority
document. To date, such information has not been provided, and therefore
the rejection cannot be sustained” (App. Br. 6). Appellant also argues that
“the priority document is not an enabling reference because it does not ‘give
possession of the invention to the person of ordinary skill’” (App. Br. 7).
In view of these conflicting positions, we frame the issues before us as
follows:
Appeal 2009-013268
Application 10/239,572

5
(i) Has Appellant demonstrated that the Examiner erred in finding
that Rosen is an anticipatory reference for claim 1 under
35 U.S.C. § 102(e) based upon the priority claim to provisional
60/179,065?
(ii) Has Appellant demonstrated that the Examiner erred in finding
that Rosen is an anticipatory reference for claim 3 under
35 U.S.C. § 102(e) based upon the priority claim to provisional
60/179,065?
Findings of Fact (FF)
1. Rosen (PgPUB) claims priority to U.S. provisional application
60/179,065, filed January 31, 2000 (see Rosen (PgPUB), Related U.S.
Application data).
2. The Code of Federal Regulations states that:
(1) Records associated with patent applications (see
paragraph (g) for international applications) may be
available in the following situations . . .

(iv) Unpublished abandoned applications (including
provisional applications) that are identified or relied upon.
The file contents of an unpublished, abandoned application
may be made available to the public if the application is
identified in a . . . U.S. patent application publication . . . A
copy of the application-as-filed, the file contents of the
application, or a specific document in the file of the
application may be provided to any person upon written
request, and payment of the appropriate fee (§ 1.19(b)).

37 C.F.R. § 1.14(a)(1)(iv).
3. It is undisputed that Rosen (PgPUB) teaches a SEQ ID NO: 845
which comprises the claimed SEQ ID NO: 2, where “Rosen’s SEQ ID NO:
Appeal 2009-013268
Application 10/239,572

6
845 is 17 amino acid residues longer than the instantly claimed polypeptide
of SEQ ID NO: 2” (Reply Br. 3).
4. The Rosen 60/179,065 [hereinafter ‘065] provisional discloses
SEQ ID NO: 129396 which is reproduced below with the Examiner’s
notations regarding the location of the instantly claimed SEQ ID NO: 2:

The figure shows the amino acid sequence of SEQ ID NO: 129396 as shown
in the sequence listing of provisional application 60/179,065 (Attachment to
Ans.).

Appeal 2009-013268
Application 10/239,572

7
5. The Examiner aligned the sequence of the Rosen ‘065
provisional SEQ ID NO: 129396 with SEQ ID NO: 845 of the Rosen
(PgPUB) as shown below:

The alignment shows that SEQ ID NO: 129396 includes two additional N-
terminal amino acids relative to SEQ ID NO: 845, but is otherwise identical
to SEQ ID NO: 845 (Attachment to Ans.).
Appeal 2009-013268
Application 10/239,572

8
6. A portion of Table 2 at page 103 of Rosen (PgPUB) showing
the heading and the calcineurin alignment is reproduced below:

Rosen (PgPUB) teaches that “Table 2 further characterizes certain encoded
polypeptides of the invention, by providing the results of comparisons to
protein and protein family databases” (Rosen (PgPUB) 112 ¶ 0049). Rosen
(PgPUB) teaches that the sequence was analyzed with blastx.14 as shown in
the portion of Table 2 reproduced above.
7. The calcineurin alignment is from nucleotides 53 to 562 of SEQ
ID NO: 247 (see FF 5)
8. The Examiner finds that Rosen (PgPUB) “predicts nucleotides
53-562 of SEQ ID NO: 247 as encoding calcineurin. These nucleotides
encode amino acid residues 18-187 of Rosen et al. SEQ ID NO: 845, which
is identical to instant SEQ ID NO: 2” (Ans. 4).
9. The Examiner concludes that “Rosen et al. recognized that the
first 17 amino acids of SEQ ID NO: 845 did not encode the active or
relevant region of SEQ ID NO: 845 and therefore teach the polypeptide
consisting of SEQ ID NO: 2” (Ans. 4).
10. Rosen (PgPUB) teaches that in Table 2 “[c]olumns 8 and 9
delineate the polynucleotides of SEQ ID NO: X which encode the
polypeptide sequence which show a significant match to a PFAM protein
family” (Rosen (PgPUB) ¶ 0051).
Appeal 2009-013268
Application 10/239,572

9
11. Rosen (PgPUB) teaches that “[a]s mentioned, columns 8 and 9
in Table 2 ‘NT From’ and ‘NT To’, delineate the polynucleotides of ‘SEQ
ID NO:X’ that encode a polypeptide having a significant match to the
PFAM/NR database as disclosed in the fifth column” (Rosen (PgPUB) 113 ¶
0052).
12. Rosen (PgPUB) teaches that “[i]n one embodiment, the
invention provides a protein comprising, or alternatively consisting of, a
polypeptide encoded by the polynucleotides of SEQ ID NO:X delineated in
columns 8 and 9 of Table 2” (Rosen (PgPUB) 113 ¶ 0052).
13. The Examiner finds that “SEQ ID NO: 845 is encoded by SEQ
ID NO: 59,829 of 60/179,065. These sequences are listed in a table on page
5,738 and can be found on page 78,841 and 37,422, respectively” (Ans. 3).
14. The Examiner, in an Interview Summary, identified the
sequence as SEQ ID NO: 845 and noted that “[i]t is listed in a table on page
5,738 and the sequence itself can be found on page 78,841” (Interview
Summary, August 18, 2005, mailed August 24, 2005; FF 13).
15. The Background of the Specification teaches that “[f]unctional
genomics relies heavily on high-throughput DNA sequencing technologies
and the various tools of bioinformatics to identify gene sequences of
potential interest from the many molecular biology databases now available”
(Spec. 1, ll. 20-23).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
Appeal 2009-013268
Application 10/239,572

10
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
“[T]he test for sufficiency of support in a parent application is
whether the disclosure of the application relied upon ‘reasonably conveys to
the artisan that the inventor had possession at that time of the later claimed
subject matter.’” Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570,
1575 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir.
1983)). In other words, “the earlier application need not describe the
claimed subject matter in precisely the same terms as found in the claims at
issue.” Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1331 (Fed.
Cir. 2008).
In addition, “[i]n order to gain the benefit of the filing date of an
earlier application under 35 U.S.C. § 120, each application in the chain
leading back to the earlier application must comply with the written
description requirement of 35 U.S.C. § 112.” Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). Disclosure of an amino
acid sequence effectively puts those of skill in the art in possession of the
entire genus of DNA sequences that encode the amino acid sequence. See In
re Wallach, 378 F.3d 1330, 1333 (Fed. Cir. 2004). Whether the written
description requirement is met is a question of fact. Wang Labs., Inc. v.
Toshiba Corp., 993 F.2d 858, 865 (Fed. Cir. 1993).
“To anticipate, the reference must also enable one of skill in the art to
make and use the claimed invention.” Bristol-Myers Squibb Co. v. Ben
Venue Labs., Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001). A patent claim
“cannot be anticipated by a prior art reference if the allegedly anticipatory
Appeal 2009-013268
Application 10/239,572

11
disclosures cited as prior art are not enabled.” Elan Pharm., Inc. v. Mayo
Found. for Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003).
“The standard for what constitutes proper enablement of a prior art reference
for purposes of anticipation under section 102, however, differs from the
enablement standard under section 112. In re Hafner, 410 F.2d 1403 (CCPA
1969).” Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325
(Fed. Cir. 2005). “[S]ection 112 ‘provides that the specification must enable
one skilled in the art to ‘use’ the invention whereas [section] 102 makes no
such requirement as to an anticipatory disclosure.' Hafner, 410 F.2d at
1405.” Id. at 1325. Thus, “proof of efficacy is not required for a prior art
reference to be enabling for purposes of anticipation. . . . [T]he proper issue
is whether the [prior art] is enabling in the sense that it describes the claimed
invention sufficiently to enable a person of ordinary skill in the art to carry
out the invention.” [Emphasis added.] Impax Labs., Inc. v. Aventis Pharms.
Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006). A prior art reference is
anticipatory under 35 U.S.C. §102(b) if it discloses each and every element
of the claimed invention, either explicitly or inherently, and if it enables
person of ordinary skill in art to make invention without undue
experimentation. In re Gleave, 560 F.3d 1331, 1337-8 (Fed. Cir. 2009).

Analysis
Claim 1
It is undisputed that Rosen (PgPUB) teaches a SEQ ID NO: 845
which comprises the claimed SEQ ID NO: 2, where “Rosen’s SEQ ID NO:
845 is 17 amino acid residues longer than the instantly claimed polypeptide
Appeal 2009-013268
Application 10/239,572

12
of SEQ ID NO: 2” (Reply Br. 3; FF 3). Thus, the Rosen (PgPub) anticipates
claim 1, as discussed by the Examiner (see Ans. 4), because it comprises a
polypeptide sequence comprising at least 95% identity along its entire length
to the polypeptide sequence of SEQ ID NO:2.

Descriptive Support in Priority Document
However, the filing date of the Rosen (PgPUB) on January 17, 2001 is
subsequent to the filing date of Appellant’s foreign priority document on
March 30, 2000. Therefore, in order for Rosen (PgPUB) to anticipate under
35 U.S.C. § 102(e), Rosen (PgPUB) must find support, or a description of,
the subject matter at issue in the parent provisional 60/179,065 (Rosen ‘065)
filed January 31, 2000 to which it claims priority (FF 1).
The Examiner has provided an alignment that shows that SEQ ID NO:
129396 of Rosen ‘065 includes two additional N-terminal amino acids
relative to SEQ ID NO: 845 of Rosen (PgPUB), but is otherwise identical to
it (FF 4-5).
In addition, “[i]n order to gain the benefit of the filing date of an
earlier application under 35 U.S.C. § 120, each application in the chain
leading back to the earlier application must comply with the written
description requirement of 35 U.S.C. § 112.” Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). In Fiers, the court
found that “[a]n adequate written description of a DNA requires more than a
mere statement that it is part of the invention and reference to a potential
method for isolating it; what is required is a description of the DNA itself.”
Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993). Rosen ‘065 satisfies
Appeal 2009-013268
Application 10/239,572

13
this standard of written description by disclosing a specific sequence, SEQ
ID NO: 129396 which is two amino acids larger than SEQ ID NO: 845 and
therefore comprises SEQ ID NO: 845 in the Rosen (PgPUB) (FF 5).
Thus we find that there is descriptive support in the Rosen ‘065
priority application for the anticipatory subject matter of the Rosen
(PgPUB), discussed herein.
We are not persuaded by Appellant’s argument that “[i]n order to
establish anticipation with respect to this priority application, it is the PTO's
burden to show where all the sequence limitations recited in the rejected
claims are found in this priority document. To date, such information has not
been provided, and therefore the rejection cannot be sustained” (App. Br. 6).
In this case, the Examiner has specifically identified the sequences in
the Rosen ‘065 provisional upon which she relies (FF 4, 5, 13, 14) so the
Examiner’s burden has been met.

Anticipatory reference is enabling/accessible
Appellant also argues that “the priority document is not an enabling
reference because it does not ‘give possession of the invention to the person
of ordinary skill’” (App. Br. 7). Appellant argues that there is “no disclosed
method in the provisional application that would enable a person of ordinary
skill to obtain the sequence information from a paper document having over
100,000 sequences and tens of thousands of pages, without using
extraordinary skills.” (App. Br. 8.) Thus, as best we understand Appellant’s
argument, it is that the priority document does not provide an enabling
disclosure, or put one of ordinary skill in the art in possession of the claimed
Appeal 2009-013268
Application 10/239,572

14
sequence because the sequences in the priority application were not publicly
accessible due to the size of the application and the number of sequences in
the application.
We are not persuaded. In Lister, the court was faced with the
contention regarding a prior art reference that “inspecting the manuscript at
the Library of Congress was too burdensome for it to have been considered
publicly accessible.” In re Lister 583 F.3d 1307, 1313 (Fed. Cir. 2009).
Lister found that “we have previously recognized that a reference can be
considered publicly accessible even if gaining access to it might require a
significant amount of travel.” Id.
Applying this logic to the Rosen ‘065 provisional, there is no question
that the provisional was accessible to Appellant since such accessibility is
required by Federal Rule (FF 2). Further, Appellant did not need to sift
through the entire reference to identify the relevant sequences since the
Examiner, in an Interview Summary, identified the sequence as SEQ ID NO:
845 and noted that “[i]t is listed in a table on page 5,738 and the sequence
itself can be found on page 78,841” (Interview Summary, August 18, 2005,
mailed August 24, 2005; FF 14). Therefore, given that the Examiner
identified the specific page numbers of interest and the specific provisional
application number, it would not reasonably have been unduly burdensome
for Appellant to find and review the relevant pages of provisional
60/179,065.
We therefore conclude with respect to claim 1, that the Rosen ‘065
provisional priority document was accessible and put one of ordinary skill in
the art in possession of the claimed subject matter and is therefore an
Appeal 2009-013268
Application 10/239,572

15
enabling reference for the claimed subject matter and thus Rosen (PgPUB)
anticipates the isolated polypeptide of claim 1.

Claim 3
Claim 3 is drawn to the “isolated polypeptide of claim 1 consisting of
polypeptide sequence of SEQ ID NO: 2” (Claim 3). The use of the
transitional phrase “consisting of” signals that this claim is in the “closed”
form and that the sequence may not include any additional amino acids. See
CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1361 (Fed. Cir. 2007)
(“It is equally well understood in patent usage that ‘consisting of’ is closed-
ended and conveys limitation and exclusion”).
The Examiner finds that Rosen (PgPUB) “predicts nucleotides 53-562
of SEQ ID NO: 247 as encoding calcineurin. These nucleotides encode
amino acid residues 18-187 of Rosen et al. SEQ ID NO: 845, which is
identical to instant SEQ ID NO: 2” (Ans. 4; FF 7). This disclosure is found
in Table 2 of Rosen (PgPUB) (FF 6, 7, 9-11). The description of Table 2
expressly teaches that “[i]n one embodiment, the invention provides a
protein comprising, or alternatively consisting of, a polypeptide encoded by
the polynucleotides of SEQ ID NO:X delineated in columns 8 and 9 of Table
2” (Rosen (PgPUB) ¶ 0052; FF 12).
Therefore, Rosen (PgPUB) teaches a polypeptide which “consists of”
SEQ ID NO: 2 by expressly identifying nucleotides 53-562 of SEQ ID NO:
247 in Table 2, which will only encode a polypeptide identical in sequence
to SEQ ID NO: 2, and by stating that the invention consists of proteins
encoded by SEQ ID NO:s found in Table 2 (FF 6-12).
Appeal 2009-013268
Application 10/239,572

16

Anticipatory reference is enabling/provides descriptive support
Appellant argues that Rosen ‘065 is not an enabling reference because
it does not give possession of the invention to one of ordinary skill. (App.
Br. 7.) Therefore, we must first determine whether Rosen (PgPUB)
receives benefit of priority for a protein which “consists of” SEQ ID NO: 2
based upon the Rosen ‘065 provisional application.
To determine whether a priority reference is enabling and gives
possession of the invention to one of ordinary skill, we determine whether
the Rosen ‘065 provisional application complies with the written description
requirement of 35 U.S.C. § 112. Lockwood v. American Airlines, Inc., 107
F.3d 1565, 1571 (Fed. Cir. 1997).
We acknowledge that the Examiner has not identified a specific
disclosure in Rosen ‘065 analogous to the disclosure in Table 2 of Rosen
(PgPUB) which specifically identifies a sequence which “consists of” the
sequence of the instantly claimed SEQ ID NO: 2. However, Rosen ‘065
teaches a sequence which comprises SEQ ID NO: 2 (FF 12-13), but includes
19 additional N-terminal amino acids relative to SEQ ID NO: 2 (see FF 3-5).
For the purposes of whether they are anticipatory, lists and genera
are often treated differently under our case law. Compare
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed.
Cir. 2005) (rejecting “the notion that [a compound] cannot
anticipate because it appears without special emphasis in a longer
list”) with Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999
(Fed. Cir. 2006) (“It is well established that the disclosure of a
genus in the prior art is not necessarily a disclosure of every
species that is a member of that genus.”). This distinction collapses
when the class of compounds that falls within the genus is so
limited that a person of ordinary skill in the art can “at once
Appeal 2009-013268
Application 10/239,572

17
envisage each member of this limited class.” Eli Lilly, 471 F.3d at
1376. In that limited circumstance, a reference describing the
genus anticipates every species within the genus. See Perricone,
432 F.3d at 1377.

In re Gleave, 550 F3d 1331, 1337-1338 (2009).
In the present case, we find that Rosen ‘065 provides descriptive
support for a polypeptide which comprises a genus of smaller polypeptides,
including SEQ ID NO: 2 (FF 3-5, 12-13). We further find that a person of
ordinary skill in the art aware of the generic polypeptide which comprises
SEQ ID NO: 2 can “at once envisage” other members of the genus,
including the polypeptide of claim 3. Furthermore, Rosen ‘065 SEQ ID
NO:2 enables person of ordinary skill in art to make the sequence of claim 3
without undue experimentation. For example, the Specification recognizes
that it is well known for those of ordinary skill in the art to use “various
tools of bioinformatics to identify gene sequences of potential interest from
the many molecular biology databases now available” (Spec. 1, ll. 21-23; FF
15). Therefore, we find that Rosen (PgPUB) properly receives benefit of
priority to the Rosen ‘065 provisional for the amino acid sequence of the
instantly claimed SEQ ID NO: 2 because, without undue experimentation,
accessible bioinformatics tools such as the Blast x.14 used in Rosen
(PgPUB) (see FF 6) permit ready identification by those of ordinary skill in
the art of the functional open reading frame of the sequences disclosed in the
Rosen ‘065 provisional (FF 12-15), including the amino acid sequence of
SEQ ID NO: 2 of claim 3.
In Falkner, the court considered the issue of whether the claims were
supported by a disclosure in priority applications which complied with the
Appeal 2009-013268
Application 10/239,572

18
written description requirement. This case involved an interference over
poxvirus vaccines which delete an essential gene product. Falko-Gunter
Falkner v. Inglis, 448 F.3d 1357, 1360 (Fed. Cir. 2006). Falkner addressed
the question of whether “the Inglis benefit applications adequately describe .
. . a poxvirus-based vaccine.” Id. at 1363. The court found that the “Inglis
applications described vaccine vectors in general, and then focused on the
subgenus of herpesviruses, for which they provided a detailed example.” Id.
at 1364.
The court found, then analyzed, the standard required to satisfy
written description in this context, finding that “the absence of examples
involving poxviruses in the Inglis applications does not render the written
description inadequate.” Id. at 1366. The court also found that “an actual
reduction to practice is not required for written description.” Id. Lastly, the
court found 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 require either the recitation or incorporation by reference (where
permitted) of such genes and sequences.” Id. at 1368.
Applying Falkner to the instant facts, we find that Rosen ‘065
provides descriptive support for a polypeptide which comprises SEQ ID NO:
2 (FF 3-5, 12-13). Further, the Specification recognizes that it is well known
in the prior art to use “various tools of bioinformatics to identify gene
sequences of potential interest from the many molecular biology databases
now available” (Spec. 1, ll. 21-23; FF 15). Therefore, we find that Rosen
(PgPUB) properly receives benefit of priority to the Rosen ‘065 provisional
Appeal 2009-013268
Application 10/239,572

19
for the amino acid sequence of the instantly claimed SEQ ID NO: 2 because
accessible bioinformatics tools such as the Blast x.14 used in the Rosen
(PgPUB) (see FF 6) permit ready identification by those of ordinary skill in
the art of the functional open reading frame of the sequences disclosed in the
Rosen ‘065 provisional (FF 12-15).
This result is consistent with Amgen, where the court explained that
the written description requirement may be satisfied “if in the knowledge of
the art the disclosed function is sufficiently correlated to a particular, known
structure.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313,
1332 (Fed. Cir. 2003). Similarly, in Capon, the court found that “[i]t is not
necessary that every permutation within a generally operable invention be
effective in order for an inventor to obtain a generic claim, provided that the
effect is sufficiently demonstrated to characterize a generic invention.”
Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005). Just as applicants
receive benefit of priority based, in part, upon the interaction of the priority
disclosure with the knowledge of the prior art, so too the prior art for
anticipation purposes reasonably may rely upon priority where the
knowledge in the prior art reasonably conveys possession of the claimed
invention.
Conclusions of Law
(i) Appellant has not demonstrated that the Examiner erred in finding
that Rosen is an anticipatory reference for claim 1 under 35 U.S.C. § 102(e)
based upon the priority claim to provisional 60/179,065.
Appeal 2009-013268
Application 10/239,572

20
(ii) Appellant has not demonstrated that the Examiner erred in finding
that Rosen is an anticipatory reference for claim 3 under 35 U.S.C. § 102(e)
based upon the priority claim to provisional 60/179,065.

SUMMARY
In summary, we affirm the rejection of claims 1 and 3 under 35
U.S.C. § 102(e) over Rosen (PgPUB). We also affirm the rejection of claim
1 under 35 U.S.C. § 103(a) over Rosen (PgPUB). Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2, 4-9, and
12-16 as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

alw

MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON VA 22201