Ex Parte Forney et al

Patent Trial and Appeal Board

Oct 16, 2017

12793266 (P.T.A.B. Oct. 16, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/793,266 06/03/2010 LARRY J. FORNEY 531267: UIC-004DV2 6331
12779 7590
Lathrop & Gage LLP
28 State Street
7 th Floor
Boston, MA 02109
EXAMINER
STRZELECKA, TERESA E
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
10/18/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
bostonpatent @ lathropgage. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LARRY J. FORNEY, JAMES FOSTER, CELESTE BROWN,
PAUL JOYCE, ZAID ABDO, AUDRA JOHNSON, and XIA ZHOU
Appeal 2016-002248
Application 12/793,2661
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a solid
support with attached oligonucleotides that hybridize to sequences of genes
from vaginal microorganisms. The Examiner rejected the claims as lacking
adequate descriptive support, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants state that the “real party in interest is the assignee of record, the
Board of Regents of the University of Idaho.” Appeal Br. 3.
Appeal 2016-002248
Application 12/793,266
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 18—21, 25, and 27—30, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 2—5); and
(2) Claims 18—21, 23, 25, and 27—30, under 35 U.S.C. § 103(a), for
obviousness over Burton,2 Burton-2,3 Pavlova,4 Verhelst,5 Ashelford,6
Ferris,7 and Hsu8 (Ans. 5—12).
2 Jeremy P. Burton & Gregor Reid, Evaluation of the Bacterial Vaginal
Flora of 20 Postmenopausal Women by Direct (Nugent Score) and
Molecular (Polymerase Chain Reaction and Denaturing Gradient Gel
Electrophoresis) Techniques, 186 J. Infect. Dis. 1770—1780 (2002).
3 Jeremy P. Burton et al., Detection of Atoyobium vasinae in
Postmenopausal Women by Cultivation-Independent Methods Warrants
Further Investigation, 42 J. Clin. Microbiol. 1829—1831 (2004).
4 S.I. Pavlova et al., Genetic diversity of vaginal lactobacilli from women in
different countries based on 16S rRNA gene sequences, 92 J. Appl.
Microbiol. 451^459 (2002).
5 Rita Verhelst et al., Cloning of 16S rRNA genes amplified from normal and
disturbed vaginal microflora suggests a strong association between
Atoyobium vasinae. Gardnerella vaginalis and bacterial vaginosis, 4 BMC
Microbiol. 1-11 (2004).
6 Kevin E. Ashelford et al., PRIMROSE: a computer program for generating
and estimating the phylogenetic range of 16S rRNA oligonucleotide probes
and primers in conjunction with the RDP-II database, 30 Nucl. Acids Res.
3481-3489 (2002).
7 Michael J. Ferris et al., Use of Species-Directed 16S rRNA Gene PCR
Primers for Detection of Atoyobium vasinae in Patients with Bacterial
Vaginosis, 42 J. Clin. Microbiol. 5892-5894 (2004).
8 US 2004/0010129 Al (published Jan. 15, 2004).
2
Appeal 2016-002248
Application 12/793,266
Claim 18, the only independent claim on appeal, is representative and
reads as follows (Appeal Br. 22):
18. A solid support comprising a set of nucleic acid probes
immobilized to the solid support that detect phylogenetically
informative genes of vaginal microorganisms comprising a
plurality of oligonucleotide probes that specifically hybridize to
phylogenetically informative genes for a plurality of vaginal
microorganisms, wherein the plurality of vaginal
microorganisms comprise species Lactobacillus crispatus,
Lactobacillus iners, Lactobacillus jensenii, Lactobacillus
gasseri, and Atopobium vaginae, wherein the oligonucleotide
probes specifically hybridize to portions of the phylogenetically
informative genes that differ between the species.
WRITTEN DESCRIPTION
The Examiner’s Prima Facie Case
In rejecting claims 18—21, 25, and 27—30 as failing to comply with the
written description requirement, the Examiner found, based on the number
of genes and organisms recited in the rejected claims, that the claims
potentially encompass “an extremely large genus of probe sets” which
number in the “billions.” Ans. 4.
In contrast, the Examiner found that Appellants were “not in
possession of even a single set of claimed probes. The only ‘probes’
Applicant presented in the disclosure are primers listed in Table 4 . . . .” Id.
at 5. In particular, the Examiner found that Appellants “did not show any
species-specific primers for amplification of Lactobacillus crispatus,
Lactobacillus jensenii and Lactobacillus gasseri.” Id.
The Examiner concluded, therefore, that Appellants were “not in
possession of the claimed genus of sets of probes.” Id.
3
Appeal 2016-002248
Application 12/793,266
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a prima
facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
We select claim 18 as representative of the claims subject to this
ground of rejection. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s prima facie case of lack of written
description as to claim 18.
“The written description requirement. . . ensures that when a patent
claims a genus by its function or result, the specification recites sufficient
materials to accomplish that function—a problem that is particularly acute in
the biological arts.” AriadPharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336,
1352-1353 (Fed. Cir. 2010) (enbanc).
Thus, a “sufficient description of a genus . . . requires the disclosure
of either a representative number of species falling within the scope of the
genus or structural features common to the members of the genus so that one
of skill in the art can ‘visualize or recognize’ the members of the genus.” Id.
at 1350 (quoting Regents of the Univ. of California v. Eli Lilly & Co., 119
F.3d 1559, 1568-1569 (Fed. Cir. 1997)).
Accordingly, “merely drawing a fence around the outer limits of a
purported genus is not an adequate substitute for describing a variety of
materials constituting the genus and showing that one has invented a genus
and not just a species.” Id.
4
Appeal 2016-002248
Application 12/793,266
Ultimately, the “test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. at 1351.
In the instant case, representative claim 18 recites a solid support.
Appeal Br. 22. A set of oligonucleotide probes is immobilized to the solid
support. Id. The probes must be capable of detecting phylogenetically
informative genes of the vaginal microorganisms Lactobacillus crispatus,
Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, and
Atopobium vaginae. Id.
As to the genus found by the Examiner as lacking descriptive support,
claim 18 requires the oligonucleotide probes to “specifically hybridize to
portions of the phylogenetically informative genes that differ between the
species.” Id. Consistent with claim 18, as explained in Appellants’
Specification, “a ‘phylogenetically informative gene[]’ . . . is[] a functional
genetic element that differs between species.” Spec. 1 50.
Thus, as to the disputed genus, claim 18 requires a set of probes that
includes oligonucleotides which hybridize specifically to gene sequences in
one of Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii,
Lactobacillus gasseri, ox Atopobium vaginae, but which do not hybridize to
gene sequences in any of the other species. That is, the claimed set of
probes must include at least one oligonucleotide that hybridizes to a gene
sequence from one of the claimed microorganisms, but which does not
hybridize to any gene sequence from any of the other organisms. In other
words, the set of probes recited in claim 18 must include at least five
oligonucleotides, each one of which hybridizes specifically to a gene
5
Appeal 2016-002248
Application 12/793,266
sequence from one of the five claimed microorganisms, but which does not
hybridize to any gene sequence from any of the other claimed organisms.
Appellants do not persuade us that the Examiner erred in finding that
Appellants’ Specification does not describe a representative number of
oligonucleotide probe sets that fall within the claimed genus. Appellants do
not identify in their Specification the sequences of oligonucleotide probes
which hybridize specifically to a gene sequence in one of Lactobacillus
crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri,
or Atopobium vaginae, but which do not hybridize to gene sequences in any
of the other species, as required by claim 18.
Appellants, moreover, do not assert error in the Examiner’s
calculation (Ans. 4—5) that claim 18, in view of its dependent claims,
encompasses “about 2.1 x 1010” probe sets (id. at 5). Nor do Appellants
assert error in the Examiner’s finding that, as to the organisms recited in
claim 18, Appellants “did not show any species-specific primers for
amplification of Lactobacillus crispatus, Lactobacillus jensenii and
Lactobacillus gasseri.'” Id. Appellants do not persuade us, therefore, that
the Specification includes even a single representative example of a set of
probes encompassed by claim 18.
Appellants assert that their Specification, nonetheless, provides
adequate descriptive support for the set of probes recited in claim 18 because
they are “only required to provide ‘reasonable detail... in order to enable
members of the public to understand and carry out the invention.’” Appeal
Br. 5 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366
(Fed. Cir. 1997) (emphasis added)); see also id. (“Appellants have]
provided enough detail that a person with skill in the art would be able to
6
Appeal 2016-002248
Application 12/793,266
determine the oligonucleotides and phylogenetically informative genes for
carrying out the determination of the vaginal flora of a subject”) (emphasis
added); id. at 8 (“reiterating] that the skilled person given the common
knowledge and teachings of the instant specification, would have known how
to make and use the nucleic acid probes as claimed'''’) (emphasis added); see
also Reply Br. 4 (“[0]ne of ordinary skill in the art, knowing the genomic
sequences of the claimed species and molecular biology techniques known
at the time of filing the instant application, could generate any number of
probes that would specifically hybridize to phylogenetically informative
genes that differ between the species”) (emphasis added).
That a skilled artisan, based on disclosures in Appellants’
Specification, might have been able to determine, generate, make, and use,
probe sets encompassed by claim 18, does not demonstrate that the
Specification adequately describes the set of oligonucleotide probes recited
in claim 18. As explained in Amgen, Inc. v. Hoechst Marion Roussel, Inc.,
314 F.3d 1313, 1334 (Fed. Cir. 2003):
The enablement requirement is often more indulgent than
the written description requirement. The specification need not
explicitly teach those in the art to make and use the invention;
the [enablement] requirement is satisfied if, given what they
already know, the specification teaches those in the art enough
that they can make and use the invention without “undue
experimentation. ”
Thus, that Appellants’ Specification might have enabled a skilled
artisan, based on the knowledge in the art, to practice the subject matter
recited in claim 18, does not demonstrate that the Specification adequately
described, for the purposes of § 112, first paragraph, the probe set recited in
claim 18. SeeAriad v. Lilly, 598 F.3d at 1340 (“We now reaffirm that § 112,
7
Appeal 2016-002248
Application 12/793,266
first paragraph, contains a written description requirement separate from
enablement. . .”) (emphasis added).
We acknowledge, as Appellants contend (see Reply Br. 4), that the
Examiner appears to concede that, given the teachings in the Specification
and the knowledge in the art, a skilled artisan would have considered it an
obvious matter to generate a probe set encompassed by claim 18 (see Ans.
18).
As the court pointed out in Ariad, however, “a description that merely
renders the invention obvious does not satisfy the requirement.” Ariad v.
Lilly, 598 F.3d at 1352; see also Univ. of Rochester v. G.D. Searle & Co.,
Inc., 358 F.3d 916, 927—928 (Fed. Cir. 2004) (although claims specified a
broad category of drugs (NSAIDS) that an ordinary artisan could readily
envision and test, court found lack of written description in view of the
patentees’ failure to provide any specific examples of embodiments that met
the desired functional property recited in the claims). Thus, as the Examiner
explains:
[E]ven though the bacteria and genes were known in the art, the
issue does not lie in the fact that one of skill in the art would have
been able to design probes for these bacteria from the claimed
genes, but in the fact that [Appellants] did not describe a
representative number of species of the claimed genus.
Ans. 18.
In sum, Appellants do not persuade us, for the reasons discussed, that
a preponderance of the evidence does not support the Examiner’s prima
facie case of lack of written description as to claim 18. We, therefore, affirm
the Examiner’s rejection of that claim, as well as claims 19-21, 25, and 27—
30, which were not argued separately. See 37 C.F.R. § 41.37(c)(l)(iv).
8
Appeal 2016-002248
Application 12/793,266
OBVIOUSNESS
The Examiner’s Prima Facie Case
In rejecting claims 18—21, 23, 25, and 27—30 for obviousness, the
Examiner cited Burton as disclosing a study that used nucleotide sequencing
to identify the species of organisms present in the vaginal microflora of a
number of women. Ans. 6—7. The Examiner noted that Burton identified a
number of the organisms recited in Appellants’ claims, including L.
crispatus, L.jensenii, and L. gasseri. Id. at 7.
The Examiner also noted that Burton differed from the rejected claims
in that Burton did not describe probes specific for L. iners, L. crispatus, L.
jensenii, L. gasseri, and A. vaginae. Id.
The Examiner found, however, that Burton-2 described species-
specific primers, directed to 16S rRNA sequences, useful for detecting A.
vaginae in vaginal microflora. Id. at 8.
The Examiner concluded that an ordinary artisan would have
considered it obvious to use species-specific primers, like that described in
Burton-2, “for the detection of specific Lactobacilli in vaginal samples from
women.” Id.
As evidence that an ordinary artisan would have been motivated to
identify the species of Lactobacilli present in the vaginal microflora of
different individuals, the Examiner cited Pavlova’s disclosure that such
information “may help guide future development of bacterial replacement
therapy to control vaginal infections.” Id. at 9 (quoting Pavlova 458).
The Examiner also cited Verhelst as providing motivation for
detecting L. iners and A. vaginae in vaginal samples, finding in particular
that the presence of those organisms was associated with bacterial vaginosis
9
Appeal 2016-002248
Application 12/793,266
(BV). Ans. 9—10. The Examiner noted also that Ferris described primers for
detecting different vaginal organisms. Id. at 11.
The Examiner cited Ashelford as describing a computer program,
PRIMROSE, capable of identifying species-specific primers and probes
from 16S rRNA sequences, the primers/probes being useful for identifying
organisms at the species level. Ans. 10—11.
Based on the teachings outlined above, the Examiner reasoned as
follows:
[Considering the fact that the sequences of 16S rRNA genes of
Lactobacillus species, A. vaginae and other bacteria constituting
vaginal microflora were known in the art at the time of the
invention, as evidenced by Table 1 of Verhelst et al., for
example, and the availability of the software which designed
primers based on 16S rRNA genes, one of ordinary skill in the
art would have a reasonable expectation of success in designing
species-specific primers or probes for the claimed species and
genera of bacteria. This reasonable expectation of success is
substantiated by Ferris et al., who designed species-specific
primers for A. vaginae using the PRIMROSE software (page
5892, fifth paragraph).
Id. at 11.
The Examiner cited Hsu as evidence that it was known in the art to
attach multiple species-specific probes to a solid support, such as a chip, in
order to detect, identify, and diagnose disorders caused by microbial
pathogens. Ans. 11—12. The Examiner noted in particular Hsu’s teaching
that its chip tremendously improves the efficiency of diagnosis, providing
speedy detection, simple operation, and lower cost. Id. at 12. The Examiner
reasoned, therefore, that an ordinary artisan would have considered it
10
Appeal 2016-002248
Application 12/793,266
obvious to immobilize, to a solid support, species-specific probes capable of
detecting the different microorganisms present in a vaginal sample. Id-
Analysis
We again select claim 18 as representative of the claims subject to this
ground of rejection. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s prima facie case of obviousness as to claim
18.
As seen above, claim 18 recites a solid support having immobilized
thereto species-specific probes capable of detecting L. crispatus, L. iners, L.
jensenii, L. gasseri, and A. vaginae. See Appeal Br. 22.
As the Examiner found, Hsu describes a solid support having species-
specific probes capable of detecting 20 different species of microorganisms.
Hsu, abstract (describing “nucleic acid kit for bacterial pathogen diagnosis”
which “can be utilized as probes to be conjugated on polymers as diagnostic
chips for bacterial pathogens (for example, the meningitis chip)”).
As the Examiner found, Hsu discloses that its chip has distinct
diagnostic advantages, including “provid[ing] users with speedy detection,
simple operation and lower cost, thus improving the efficiency tremendously
and . . . improving] upon the quality of medical detection regarding
bacterial pathogens.” Id. 112.
Hsu’s chip differs from claim 18’s solid support in that Hsu’s chip
does not have attached probes specific for the organisms recited in claim 18.
As the Examiner found, however, at least two of the cited references,
Burton and Pavlova, teach the desirability of identifying the species present
in an individual’s microflora. See Burton 1770 (“To prevent recurrences of
11
Appeal 2016-002248
Application 12/793,266
urogenital infections, attempts have been made to modify the vaginal
microflora of susceptible women by instillation of exogenous lactobacilli
.... However, to determine the impact of these and other treatments,
methods that reliably monitor the vaginal microflora should be used'')
(emphasis added); Pavlova 451 (“Knowledge of vaginal Lactobacillus
species richness and distribution in women worldwide may lead to the
design of better probiotic products as bacterial replacement therapy”).
Pavlova teaches, in particular:
Because lactobacilli are critical to women’s vaginal health, the
results from this study provide important information for our
understanding of the vaginal colonization of lactobacilli and their
species richness, relative abundance, geographical distributions
and phylogenetic relationships. This knowledge may help guide
future development of bacterial replacement therapy to control
vaginal infections.
Id. at 458 (emphasis added).
Given the teachings in Burton and Pavlova of the importance of
reliably monitoring individuals’ vaginal microflora, in particular the
Lactobacillus species identified therein, taken alongside Hsu’s teaching of
the advantages of its chip in identifying different species of microorganisms
in biological samples, we agree with the Examiner that an ordinary artisan
had ample reason to immobilize, to Hsu’s chip, probes capable of reliably
detecting the species of microorganisms present in a vaginal sample.
As evidenced by Burton, Burton-2, Pavlova, Verhelst, and Ferris, each
of the organisms recited in claim 18 was known in the art to be among
vaginal microflora repeatedly identified in studies of vaginal samples, and
sometimes were associated with bacterial vaginosis. See Burton 1771, 1777
(detecting L. crispatus, L. iners, L.jensenii, L. gasseri in study of
12
Appeal 2016-002248
Application 12/793,266
postmenopausal women); Burton-2 1829 (species-specific 16S rRNA
primers detecting A. vaginae in postmenopausal women, potential
association with bacterial vaginosis); Pavlova 451 (study of vaginal
microflora of women from different countries detecting, among other
species, L. crispatus, L.jensenii, and L. gasseri); Verhelst 3, 7—8 (detecting
L. crispatus, L. iners, L.jensenii, L. gasseri, and A. vaginae in study of
vaginal microflora, potential association of L. iners and A. vaginae with
bacterial vaginosis); Ferris 5892 (species-specific 16S rRNA primers
detecting A. vaginae in women, potential association with bacterial
vaginosis).
Because the cited prior art teaches that it was desirable to reliably
monitor the species of the organisms present in an individual’s vaginal
microflora, and because L. crispatus, L. iners, L.jensenii, L. gasseri, and A.
vaginae were known in the art to be among organisms repeatedly identified
in studies of vaginal microflora, we agree with the Examiner that an ordinary
artisan had ample reason to immobilize, to a solid support such as that taught
by Hsu, species-specific probes capable of detecting L. crispatus, L. iners, L.
jensenii, L. gasseri, and A. vaginae. Given Ashelford’s teaching of the
desirability of obtaining species-specific probes from 16S rRNA sequences,
moreover, we also agree with the Examiner that an ordinary artisan had a
reasonable expectation of success in preparing a solid substrate having
species-specific probes capable of detecting L. crispatus, L. iners, L.
jensenii, L. gasseri, and A. vaginae. Accordingly, we agree with the
Examiner that the solid support recited in claim 18 would have been prima
facie obvious to an ordinary artisan.
Appellants do not persuade us to the contrary.
13
Appeal 2016-002248
Application 12/793,266
Appellants contend that, absent the disclosures in Appellants’
Specification, “or some rationale why these five species should be detected
together instead of others, a solid support or kit with probes to detect L.
crispatus, L. iners, L.jensenii, L. gasseri, and A. vaginae is non-obvious.”
Appeal Br. 10; Reply Br. 6—9. In particular, Appellants contend that none of
the cited references provides a teaching that suggests a solid support having
probes specific for the particular five organisms recited in claim 18. Appeal
Br. 10-15.
We are not persuaded. We acknowledge that, in addition to the five
organisms recited in claim 18, the cited prior art discloses that upwards of 20
to 30 other species of microorganism were repeatedly detected in vaginal
samples. See Burton 1771; Pavlova 454-457; Verhelst 3.
We acknowledge also that, given the cited prior art’s teaching that it
was desirable to reliably monitor the species of organisms present in an
individual’s vaginal microflora, an ordinary artisan had good reason to
attach, to a solid substrate, species-specific probes capable of detecting all,
or at least a substantial majority of, organisms expected to be present in
vaginal samples, as opposed to only those recited in claim 18. Indeed,
Appellants effectively concede the point, stating that “the prior art suggests
identifying members of the genus Lactobacillus and A. vaginae . . . .” Reply
Br. 6.
To that end, however, claim 18 encompasses a solid substrate having
species-specific probes capable of detecting all organisms expected to be
present in vaginal samples, including those expressly recited in the claim.
Specifically, claim 18 recites that the claimed solid support “compris[es]” a
set of species-specific probes capable of detecting L. crispatus, L. iners, L.
14
Appeal 2016-002248
Application 12/793,266
jensenii, L. gasseri, and A. vaginae. Appeal Br. 22. Claim 18, therefore,
does not exclude the presence of probes capable of detecting
microorganisms expected to be in vaginal isolates other than L. crispatus, L.
iners, L. jensenii, L. gasseri, and A. vaginae.
Thus, it might be true that the prior art suggests including, on a solid
substrate, probes capable of detecting all, or at least a substantial majority of,
microorganisms expected to be present in vaginal samples, rather than only
the organisms recited in claim 18. That fact, however, does not demonstrate
that an ordinary artisan lacked a good reason to make a solid support having
probes capable of detecting L. crispatus, L. iners, L. jensenii, L. gasseri, and
A. vaginae attached thereto. Put more simply, claim 18 encompasses the
solid support suggested by the prior art.
In sum, because the cited prior art teaches that it was desirable to
reliably monitor the species of the organisms present in an individual’s
vaginal micro flora, and because L. crispatus, L. iners, L. jensenii, L. gasseri,
and A. vaginae were known in the art to be among organisms repeatedly
identified in studies of vaginal microflora, Appellants do not persuade us
that the Examiner erred in finding that an ordinary artisan had adequate
motivation to immobilize, to a solid support such as that taught by Hsu,
species-specific probes capable of detecting L. crispatus, L. iners, L.
jensenii, L. gasseri, and A. vaginae, as recited in claim 18.
Appellants contend that a set of probes encompassed by claim 18 can
distinguish between women with different vaginal microbiota. Appeal Br.
18—19 (citing Spec. 25—26)). Appellants do not explain adequately,
however, how the capacity to distinguish between different vaginal
microbiota undercuts the Examiner’s prima facie case, discussed above, nor
15
Appeal 2016-002248
Application 12/793,266
do Appellants advance evidence suggesting that capacity would have been
unexpected. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007) (“[A]ny superior property must be unexpected to be considered as
evidence of non-obviousness”).
In sum, Appellants do not persuade us, for the reasons discussed, that
a preponderance of the evidence does not support the Examiner’s prima
facie case of obviousness as to claim 18. Because Appellants do not
advance objective evidence of nonobviousness sufficient to outweigh the
evidence of prima facie obviousness advanced by the Examiner, we affirm
the Examiner’s rejection under § 103(a) of that claim, as well as claims 19—
21, 23, 25, and 27—30, which were not argued separately. See 37 C.F.R. §
41.37(c)(l)(iv).
SUMMARY
For the reasons discussed, we affirm both of the Examiner’s
rejections.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
16