Ex Parte Bird et al

Patent Trial and Appeal Board

Nov 30, 2017

13787923 (P.T.A.B. Nov. 30, 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.
13/787,923 03/07/2013 Ian Michael Bird WIS0008US2 3856
97568 7590 12/04/2017
Fantnr Pnlhiirn-WARF
EXAMINER
20 Church Street RODRIGUEZ, RAYNA B
22nd Floor
Hartford, CT 06103-3207 ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
usptopatentmail@cantorcolbum.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IAN MICHAEL BIRD,
MANISH SURESH PATANKAR, DEREK STEVEN BOELDT, and
MIAN MOHAMMED KHURAM SHAHZAD
(APPLICANTS: WISCONSIN ALUMNI RESEARCH FOUNDATION)
Appeal 2017-002218
Application 13/787,9231
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 19, 20, 22, and
23 (App. Br. 2). Examiner entered a rejection under 35 U.S.C. § 102(b).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “the Wisconsin Alumni
Research Foundation” (App. Br. 2).
Appeal 2017-002218
Application 13/787,923
STATEMENT OF THE CASE
Appellants disclose “compositions ... for reducing the risk of pre­
term birth in pregnant women, particularly women at risk of preeclampsia”
(Spec. 13). Claim 19 is representative and reproduced below:
19. A prenatal vitamin oral pharmaceutical composition,
comprising
tl0:cl2 conjugated linoleic acid or a pharmaceutically
acceptable salt, triglyceride or ester thereof,
folic acid, and
a pharmaceutically acceptable excipient,
wherein the prenatal vitamin oral pharmaceutical
composition is suitable for administration to a pregnant human
woman, and wherein the prenatal vitamin oral pharmaceutical
composition is a dietary supplement for pregnant human
women and/or human women planning on becoming pregnant.
(App. Br. 11.)
The claims stand rejected as follows:
Claims 19, 20, 22, and 23 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Bassaganya-Riera.2
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Bassaganya-Riera teaches Appellants’ claimed
invention?
FACTUAL FINDINGS (FF)
FF 1. Bassaganya-Riera teaches pharmaceutical compositions, including
“clinical nutrition products[ and] products adapted for consumption during
2 Bassaganya-Riera, et al., WO 2007/096148 Al, publishes Aug. 30, 2007.
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Application 13/787,923
pregnancy,” for administration to a mammal, preferably a human
(Bassaganya-Riera 14: 21—22; id. at 8: 13—18; id. at 33: 1—9; Ans. 3).
FF 2. Bassaganya-Riera’s “[pharmaceutical compositions will comprise a
pharmaceutically acceptable diluent or carrier” and “are preferably adapted
for administration parenterally (e.g., orally)” (Bassaganya-Riera 14: 28—30;
see generally Ans. 2—3).
FF 3. Bassaganya-Riera teaches pharmaceutical compositions comprising
a “Mineral Mix” that includes “folic acid,” a “Vitamin Mix,” that includes
iron (i.e., ferric citrate), and “at least 50% by weight of the . . . translO, cisl2
isomer of conjugated linoleic acid” (CLA) (Bassaganya-Riera 17: 1—18: 8;
id. at 3: 8—10; see Ans. 2—3).
FF 4. Bassaganya-Riera teaches that “[t]he compositions . . . may contain
0.1-99% by weight of conjugated fatty acid” and that a “unit dosage of
conjugated fatty acid is from lmg to lOOOmg (more preferably from lOOmg
to 750mg)” (Bassaganya-Riera 15: 15—19; Ans. 4).
ANALYSIS
Examiner finds that Bassaganya-Riera teaches Appellants’ claimed
invention (Ans. 2—3; see FF 1—4).
Claim 19:
Appellants’ claim 19 is reproduced above.
Bassaganya-Riera teaches a pharmaceutical composition for
administration to mammals, including a human, during pregnancy that
comprises folic acid and tl0:cl2 CLA (FF 1—4). Therefore, we are not
persuaded by Appellants’ contention that Bassaganya-Riera fails to
exemplify the administration of such a composition to a human (App. Br. 4—
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6 and 7—8; Reply Br. 4—8; see id. 4 (“Bassaganya-Riera describes a diet for
mice and not an oral pharmaceutical composition for human consumption. . .
. Clearly animal feeds and pharmaceutical compositions are different types
of compositions as described in Bassaganya-Riera”)). In addition,
Bassaganya-Riera discloses a composition for administration to pregnant
mammals, which includes humans and mice. Therefore, we are not
persuaded by Appellants’ contention that Examiner “pieced together
separate parts of Bassaganya-Riera to make” a prima facie case of
anticipation (App. Br. 7; see id. at 3; Reply Br. 3 and 10).
We are not persuaded by Appellants’ contention that Bassaganya-
Riera fails to teach Appellants’ claimed invention, because Bassaganya-
Riera does not identity its pharmaceutical composition as “a prenatal
vitamin” (App. Br. 5; Reply Br. 8). Identical language between the prior art
and claims is not required to sustain a prior-art rejection. In re Skoner, 517
F.2d 947, 950 (CCPA 1975) (“Any other result would permit the allowance
of claims drawn to unpatentable subject matter merely through the
employment of descriptive language not chosen by the prior art”).
Bassaganya-Riera teaches pharmaceutical compositions “adapted for
consumption during pregnancy,” for administration to a human (FF 1).
Therefore, we are not persuaded by Appellants’ contention that Bassaganya-
Riera fails to teach a “prenatal vitamin” as defined by Newman3 (App. Br. 6
(citing Newman (“The term prenatal vitamin means a vitamin supplement
for administration during pregnancy,” which “include folic acid as well as
3 Vicky Newman et al., Evaluation of prenatal vitamin—mineral
supplements, 6 Clinical Pharmacy 770-77 (1987).
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Application 13/787,923
other nutrients that are critical for prenatal care”) see also Reply Br. 8; cf. FF
1-5).
Appellants’ claimed invention does not require elemental iron, a
particular amount of folic acid, or any of the numerous ingredients Newman
recommends that a prenatal supplement contain (see App. Br. 6—7; Reply Br.
8—9; cf. App. Br. 11). Appellants have also not established that the term
“prenatal” as recited in the claims would be understood by the ordinary
skilled worker as necessarily requiring such ingredients. Therefore, we are
not persuaded by Appellants’ reliance on Newman to support a finding that
the term “prenatal vitamin,” as that term is used in Appellants’ claimed
invention, necessarily means that Appellants’ prenatal vitamin includes all
the ingredients recommended by Newman, at the concentrations
recommended by Newman (see App. Br. 6—7; Reply Br. 8—9). If the
foregoing were true, the folic acid requirement in Appellants’ claimed
prenatal vitamin oral pharmaceutical composition is redundant. Further,
notwithstanding Appellants’ contentions, Appellants define the term
“prenatal vitamin ... as a dietary supplement typically recommended for
pregnant women and/or women planning on becoming pregnant. Prenatal
vitamins include vitamins and minerals such as iron, and folic acid, for
example” (Spec. 128). Bassaganya-Riera teaches a composition for
administration to a pregnant human that comprises, inter alia, folic acid and
iron (ferric citrate) (see FF 1—5). Therefore, we are not persuaded by
Appellants’ contentions relating to the requirements of a prenatal vitamin
within the scope of their claimed invention.
Appellants contend that Bassaganya-Riera teaches a composition
comprising CLA, “states that 100% of either tl0:cl2 or c9:tl 1 [CLA] can be
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Application 13/787,923
used,” and does not “teach[] or suggest[] that one isomer is preferred over
the other” (App. Br. 8; Reply Br. 10). We find that Appellants’ contention
supports Examiner’s anticipation rejection.
Appellants’ claimed invention is not directed to a “tl0:cl2 isomer of
CLA [that] inhibits ERK and Src signaling in uterine artery cells,” “the
treatment of women with pregnancy-induced hypertension, including
preeclampsia or risk of preeclampsia,” or “restoring/preserving vascular
endothelial function” (see App. Br. 11; Reply Br. 10; cf. id. at 8). Therefore,
we are not persuaded by Appellants’ contention that because Bassaganya-
Riera does not teach the foregoing effects of the administration of a
composition comprising tl0:cl2 CLA, a person of ordinary skill in this art
would not have selected tl0:cl2 CLA from the two CLA isomers disclosed
in Bassaganya-Riera for inclusion in a composition for administration to
pregnant humans (see App. Br. 8). To the contrary, we find that a person of
ordinary skill in this art would have formulated compositions within the
scope of Bassaganya-Riera that contain, as Appellants’ recognize (App. Br.
8; Reply Br. 10), 100% tl0:cl2 CLA, as well as, compositions that contain
100% c9:tl 1, for administration to pregnant mammals, including humans.
Thus, Bassaganya-Riera anticipates Appellants’ claim 19.
Claim 22\
Appellants’ claim 22 depends from and further limits the prenatal
vitamin oral pharmaceutical composition of Appellants’ claim 19 to require
that the CLA in the composition is greater than 98% tl0:cl2 (App. Br. 11).
As discussed above, Appellants’ concede that Bassaganya-Riera
teaches a composition comprising 100% tl0:cl2 CLA (see App. Br. 8).
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Application 13/787,923
Therefore, we are not persuaded by Appellants’ contentions regarding the
amount of tl0:cl2 CLA contained in Bassaganya-Riera’s composition (id. at
8—9; Reply Br. 11).
For the foregoing reasons, we are not persuaded by Appellants’
contention that they “found specifically that tl0:cl2 CLA isomer is active in
preventing pregnancy-induced hypertension” or the preferential selection of
a tl0:cl2 over a c9:tl 1 CLA for treatment of pregnancy-induced
hypertension (App. Br. 8—9; Reply Br. 11).
Claim 23:
Appellants’ claim 23 depends from and further limits the amount of
tl0:cl2 CLA present in the prenatal vitamin oral pharmaceutical
composition of Appellants’ claim 19 to an amount sufficient to provide a
blood level of tl0:cl2 CLA of 0.1 pM to 50 pM in a woman’s bloodstream.
Examiner finds that Bassaganya-Riera teaches a composition within
the scope of Appellants’ claimed invention that comprises 100—750 mg of
tl0:cl2 CLA (Ans. 4; FF 4; cf. Spec. 33 (“when taken orally, the tl0:cl2
[CLA] is administered in an amount of 10 mg to 40 g per day”)). Examiner
finds that absent evidence to the contrary, the administration of the
composition taught by Bassaganya-Riera that comprises 100—750 mg of
tl0:cl2 CLA will provide a blood level of tl0:cl2 CLA of 0.1 pM to 50 pM
in a woman’s bloodstream (Ans. 4—5). See In re King, 801 F.2d 1324, 1326-
28 (Fed. Cir. 1986).
For the foregoing reasons, we are not persuaded by Appellants’
contention that “[w]hile certain concentrations of tl0:cl2 [CLA] as
disclosed in the extremely broad ranges of Bassaganya-Riera may by
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Application 13/787,923
happenstance provide the claimed blood levels, Bassaganya-Riera provides
no suggestion or motivation for the importance of such blood levels in the
context of a prenatal vitamin” (App. Br. 9; Reply Br. 12).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Bassaganya-Riera teaches Appellants’ claimed invention. The
rejection of claims 19, 22, and 23 under 35 U.S.C. § 102(b) as anticipated by
Bassaganya-Riera is affirmed. Claim 20 is not separately argued and fall
with claim 19.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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