Ex Parte Morris

Patent Trial and Appeal Board

Nov 1, 2018

12033431 (P.T.A.B. Nov. 1, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/033,431 02/19/2008
24353 7590 11/05/2018
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
FIRST NAMED INVENTOR
Claudia R. Morris
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CHOR-029 6322
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/05/2018 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLAUDIA R. MORRIS
Appeal2017-006461
Application 12/033,431 1
Technology Center 1600
Before: DONALD E. ADAMS, FRANCISCO C. PRATS and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a dietary
formulation. The Examiner rejected the claims on appeal under 35 U.S.C.
§ 103(a) as obvious.
We REVERSE.
1 According to Appellants, the real party in interest is Children's Hospital &
Research Center at Oakland. App. Br. 3.
Appeal2017-006461
Application 12/033,431
STATEMENT OF THE CASE
The Specification discloses that "[ a Jpraxia of speech is a
neurologically based motor planning disorder of unknown etiology." Spec.
,r 2. "Standard treatment generally involves speech therapy with a speech
pathologist knowledgeable in apraxia." Id. However, there remains "a need
in the art for alternative approaches to treatment of apraxia." Id. ,r 3.
The Specification discloses "dietary formulations comprising
polyunsaturated fatty acids (PUP A) and vitamin E" (id. ,r 18) that "provide
for treatment of ... various categories of disorders ... , including, e.g.,
apraxia." Id. ,r 19.
Claims 1, 3, 4, 7-9, 11-17, and 26-32 are on appeal. Claim 1, the
only independent claim on appeal, is illustrative and reads as follows:
1. A dietary formulation suitable for treating an autism
spectrum disorder and/or apraxia, the formulation comprising:
a) eicosapentaenoic acid (EPA);
b) docosohexaenoic acid (DHA);
c) a-tocopherol;
d) y-tocopherol;
e) vitamin Kl;
f) vitamin K2; and
g) y-linolenic acid (GLA),
wherein the ratio of EPA to DHA is in a range of from
1. 5: 1 to 5: 1,
wherein the a-tocopherol is present in an amount of from
300 mg to 3000 mg per unit dose,
wherein the y-tocopherol is present in an amount of from
200 mg to 1000 mg per unit dose,
wherein the EPA is present in an amount of from 500 mg
to 3000 mg per unit dose,
wherein the DHA is present in an amount of from 100
mg to 400 mg per unit dose,
wherein the vitamin Kl is present in an amount of from
100 µg to 10 mg,
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Application 12/033,431
wherein the vitamin K2 is present in an amount of from
100 µg to 2 mg; and
wherein the GLA is present in an amount of from 50 mg
to 75 mg.
App. Br. 17, Claims Appendix.
The claims stand rejected as follows.
Claims 1, 3, 4, 7-9, 11-13, 17, 26-29, 31, and 32 were rejected under
35 U.S.C. § I03(a) as obvious over the combination ofErnest,2 Dreon, 3 and
Shapiro. 4
Claims 1, 3, 4, 7-9, 11-13, 15-17, and 26-32 were rejected under 35
U.S.C. § I03(a) as obvious over the combination of Ernest, Dreon, Shapiro,
and Chilton. 5
Claims 1, 3, 4, 7-9, 11-14, 17, 26-29, 31, and 32 were rejected under
35 U.S.C. § I03(a) as obvious over the combination of Ernest, Dreon,
Shapiro, and Girsh. 6
ANALYSIS
The same issue is dispositive with respect to all three rejections.
Accordingly, we address all three rejections together.
Ernest discloses formulations designed to "meet the nutritional needs
of patients suffering from a number of metabolic challenges" (Ernest ,r 12)
2 Ernest, US Patent Publication No. 2005/0070498 Al, published Mar. 31,
2005 ("Ernest").
3 Dreon et al., US Patent Publication No. 2004/0048919 Al, published Mar.
11, 2004 ("Dreon").
4 Shapiro, US Patent No. 6,444,221 Bl, issued Sep. 3, 2002 ("Shapiro").
5 Chilton et al., US Patent Publication No. 2006/0052446 Al, published
Mar. 9, 2006 ("Chilton").
6 Girsh, US Patent Publication No. 2005/0260181 Al, published Nov. 24,
2005 ("Girsh").
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Appeal2017-006461
Application 12/033,431
comprising "GLA/DGLA at a range of0.1-to about 4.0 gm, preferably
about 0.7 -to about 1.2 gm, most preferably about 0.85 gm of
GLA/DGLA." Id. ,r 16. In finding claim 1 obvious over the cited art, the
Examiner acknowledged that the amounts of GLA disclosed in Ernest do not
meet the requirement of claim 1 for 50 - 7 5 mg of GLA. Final Act. 5. 7 The
Examiner found, however, that the claimed amount of GLA would have
been obvious because "Ernest teaches that the amount of GLA in the
composition can vary depending upon the lipid blend that is used." Id. at 6.
From this, the Examiner concluded that "[ o ]ne of ordinary skill in the art
would therefore recognize that the amount of GLA included in the
composition of Ernest could have been modified from 100 mg to 7 5 mg in
the course of preparing the composition using available lipid blends, and
could have arrived at the amount of GLA recited in the claims in the course
of routine experimentation, and with a reasonable expectation of success."
Id.
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
ofunpatentability." Appellant has persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
The low end of the range of suitable GLA concentrations disclosed in
Ernest (100 mg - 4,000 mg) is significantly higher than the high end of the
claimed range (50- 75 mg). Ernest ,r 16; see also Ans. 10. Although the
Examiner is correct that the "composition of Ernest could have been
modified from 100 mg to 7 5 mg," the Examiner has not explained why the
7 Office Action mailed October 7, 2015 ("Final Act.").
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Appeal2017-006461
Application 12/033,431
skilled artisan would modify the GLA content in the formulation disclosed
in Ernest to fall within the claimed range rather than within the range
disclosed in Ernest. Ans. 10; see also Final Act. 5. The Examiner invokes
"routine experimentation" as a rationale for finding the claimed range
obvious. Id. However, the claimed range does not overlap with the range
disclosed in Ernest and the Examiner has not explained why the skilled
artisan would have arrived at the claimed invention through routine
optimization. In re Stepan Company, 868 F.3d 1342, 1346 (Fed. Cir. 2017)
( explaining that there must be "some rational underpinning explaining why a
person of ordinary skill in the art would have arrived at the claimed
invention through routine optimization").
In addition, the formulations disclosed in Ernest are not disclosed for
treatment of apraxia (see Ernest ,r 12) and the Examiner does not provide
evidence that the optimal GLA content for the treatments disclosed in Ernest
is the same as the optimal GLA content for a composition which the
Specification teaches treats apraxia. See Ans. 10; see also Final Act. 5;
Ernest ,r 12; and Spec. ,r 19. Thus, even if the skilled artisan were to
optimize Ernest's GLA content, it is not clear that they would arrive at an
amount within the claimed range. Accordingly, we reverse the Examiner's
rejection of claims 1, 3, 4, 7-9, 11-17, and 26-32 as obvious over the cited
art.
SUMMARY
In summary, we reverse the Examiner's rejection of claims 1, 3, 4, 7-9,
11-13, 17, 26-29, 31, and 32 under 35 U.S.C. § 103(a) as obvious over the
combination of Ernest, Dreon, and Shapiro.
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Appeal2017-006461
Application 12/033,431
We reverse the Examiner's rejection of claims 1, 3, 4, 7-9, 11-13,
15-17, and 26-32 under 35 U.S.C. § 103(a) as obvious over the combination
of Ernest, Dreon, Shapiro, and Chilton.
We reverse the Examiner's rejection of claims 1, 3, 4, 7-9, 11-14, 17,
26-29, 31, and 32 under 35 U.S.C. § 103(a) as obvious over the combination
of Ernest, Dreon, Shapiro, and Girsh.
REVERSED
6