Ex Parte Morris

Patent Trial and Appeal Board

Nov 22, 2016

13439192 (P.T.A.B. Nov. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/439, 192 04/04/2012
24353 7590 11/25/2016
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
1900 UNIVERSITY A VENUE
SUITE 200
EAST PALO ALTO, CA 94303
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-029DIV 2554
EXAMINER
MACAULEY, SHERIDAN R
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/25/2016 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 1
Appeal2015-005962
Application 13/439,192
Technology Center 1600
Before MELANIE L. McCOLLUM, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to method of
treating apraxia and/or autism spectrum disorder. The Examiner has rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
STATEMENT OF THE CASE
Claims 18, 19, 22, 27, 29, and 30 are on appeal (Br. 1).2 Claim 18 is
representative and reads as follows:
1 Appellant identifies the real party in interest as Children's Hospital &
Research Center at Oakland (Br. 3).
2 Claims 20, 21, 26, 28, and 31 are also pending but have been withdrawn
from consideration (Final Act. 1 ).
Appeal2015-005962
Application 13/439,192
18. A method of treating apraxia and/or autism spectrum disorder, the
method comprising orally administering to an individual in need thereof an
effective amount of a formulation comprising:
a) eicosapentaenoic acid (EPA);
b) docosohexaenoic acid (DHA);
c) a-tocopherol;
d) y-tocopherol;
wherein the ratio of EPA to DHA is in a range of from about 1.5:1 to
about 5:1,
wherein the a-tocopherol is present in an amount of from about
500 mg to about 3000 mg per unit dose,
wherein the y-tocopherol is present in an amount of from about
200 mg to about 1000 mg per unit dose,
wherein the EPA is present in an amount of from about 500 mg to
about 3000 mg per unit dose,
wherein the DHA is present in an amount of from about 100 mg to
about 400 mg per unit dose.
(Br. 16 (Claims Appendix).) Claim 2 7 depends from claim 18 and recites
that "the formulation further comprises vitamin K in an amount of from
about l 00 µg to about 2 mg per unit dose" (id. at 16-17).
Claims 18, 19, 22, 29, and 30 stand rejected under 35 U.S.C. § 103(a)
as obvious over Murphy et al. (US 2005/0249823 Al, Nov. 10, 2005) in
view of Miller et al. (US 6,426,362 Bl, July 30, 2002) (Final Act. 3).
Claims 18, 19, 22, 27, 29, and 30 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Murphy in view of Miller and Manning et al.
(US 2006/0088574 Al, Apr. 27, 2006) (Final Act. 5).
PRINCIPLES OF LAW
A claim "composed of several elements is not proved obvious merely
by demonstrating that each of its elements was, independently, known in the
prior art." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The
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Application 13/439,192
relevant question is "whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue." Id.
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
I
The Examiner relies on Murphy for teaching "methods for the
treatment of an individual with a neurological condition such as autism
comprising orally administering to the individual an effective amount of a
composition comprising EPA, DHA and tocopherols (vitamin E ... )" (Final
Act. 3). The Examiner finds: Murphy "teaches that the composition may
comprise, for example, 1200-2000 mg EPA and 300-500 mg DHA ....
Thus, the reference teaches that the ratio of EPA to DHA may be, for
example, 4:1(e.g.,1200 mg EPA to 300 mg EPA)." (Id.) However, the
Examiner finds that "Murphy does not teach that the composition comprises
the specific tocopherols recited in the claims in the concentrations recited in
the claims" (id. at 4).
The Examiner relies on Miller for teaching "tocopherol compositions
comprising alpha- and gamma-tocopherols" (id.). The Examiner finds that
Miller "teaches that the compositions may comprise up to 1000 mg of
tocopherols as a mixture of alpha- and gamma-tocopherols" and "that the
compositions may be useful for treating an individual, such as one with a
vitamin E deficiency" (id.). The Examiner concludes:
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Application 13/439,192
One of ordinary skill in the art would have been motivated to
combine the teachings of Murphy and Miller to arrive at the
claimed invention because Murphy teaches that the compositions
contain tocopherols (vitamin E) because some neurological
conditions may be caused by a vitamin E deficiency, and Miller
teaches improved compositions comprising tocopherols that are
useful for the treatment of vitamin E deficiency. . . . Since
[Miller] teaches the use of 1000 mg of a mixture of alpha- and
gamma-tocopherols, one of ordinary skill in the art would have
been motivated to use, for example, 500 mg of alpha-tocopherol
and 500 mg of gamma-tocopherol, and would therefore have
arrived at a composition comprising the claimed amounts of
tocopherols based on the teachings of the prior art.
(Id. at 4--5.)
Analysis
Appellant argues that "Murphy does not disclose or suggest the
amounts of a-tocopherol and y-tocopherol recited in instant claim 18"
(Br. 5). Appellant also argues that, "[b ]ecause an individual with [autism
spectrum disorder] would not necessarily have been considered to have a
'vitamin E deficiency,' it could not have been obvious to treat such
individuals with a formulation as recited in claim 18" (id. at 10-11). We
conclude that the Examiner has not set forth a prima facie case of
obviousness.
In particular, Murphy is directed to "nutritional supplements that are
specifically tailored to treat and/or prevent neurological, neurogenetic, or
psychiatric diseases, disorders, conditions, or distress in both adult and
pediatric patients" (Murphy, i-f 15). Murphy discloses that "the present
invention provides compositions containing vitamins B6 and E, magnesium
oxide, Essential Fatty Acids ... , and folate" and that "[ c ]ontemplated
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Application 13/439,192
dosage ranges for compositions of the invention include the following: in
pediatric use, ... vitamin E at a range of 150-250 Iu, ... Essential Fatty
Acids at ranges of 600-1000 mg EPA and 150-250 mg DHA" (id. i-f 16).
Murphy also discloses that "[ s ]pecific pediatric conditions that can be
prevented and/or treated by administering the formulations of the present
invention include ... autism" (id. i-f 3 8). However, it is undisputed that
Murphy does not teach the claimed amounts oftocopherols (Ans. 4).
Miller is directed to "compositions or formulations for amelioration of
disruption of energy metabolism secondary to stress comprising a tocopherol
selected from the group consisting of alpha-, delta- and gamma-tocopherol
and combinations or derivatives thereof' (Miller, col. 4, 11. 31-37). In
particular, Miller discloses "a mixture of alpha and gamma tocopherol
ranging from about 10-1000 mg, preferably about 50-600 mg" (id. at
col. 15, 11. 2-3). In addition, Miller discloses that "[ c ]ertain concentrations
of ( +/-) alpha tocopherol and gamma-tocopherol exhibited synergistic
effects" and that "[ o ]ther concentration combinations provided optimized
concentrations, where the effects were additive or slightly better than
additive" (id. at col. 47, 11. 32--41). However, we agree with Appellant that
the Examiner does not adequately explain why it would have been obvious
to include the claimed amounts of alpha- and gamma-tocopherols in a
composition for the treatment of autism.
The Examiner concludes:
One of ordinary skill in the art would have been motivated to
combine the teachings of Murphy and Miller to arrive at the
claimed invention because Murphy teaches that the compositions
contain tocopherols (vitamin E) because some neurological
conditions may be caused by a vitamin E deficiency, and Miller
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Application 13/439,192
teaches improved compositions comprising tocopherols that are
useful for the treatment of vitamin E deficiency.
(Final Act. 4.) Miller, however, describes alpha- and gamma-tocopherols
use to counteract disruptions of normal energy metabolism secondary to
stress, meaning "injury(ies) to cells, organs or organisms associated with,
resulting in or caused by alterations in oxidative metabolism or respiration"
(Miller, col. 4, 11. 32-35, & col. 12, 11. 9-13), wherein reactive oxygen
species, e.g., free radicals, are produced (see, e.g., col. 1, 1. 66, to col. 3,
1. 38). The stresses described do not refer to a vitamin deficiency, but rather,
things like hypothermia, drug toxicity, physical exertion, and aging (id. at
col. 12, 1. 28, to col. 13, 1. 23).
Moreover, even if one were to conclude that Miller describes the use
of alpha- and gamma-tocopherols to ameliorate neurological conditions, the
question in this appeal is not whether it would have been obvious to include
the claimed amounts of tocopherols for arzy' neurological condition. Instead,
given that claim 18 is directed to a method for treating specific disorders, the
question is whether it would have been obvious to include the claimed
amounts of tocopherols in a formulation for use in the treatment of apraxia
and/or autism spectrum disorder. The Examiner does not adequately explain
why this would have been obvious.
Conclusion
The Examiner has not set forth a prima facie case that Murphy and
Miller suggest the method of claim 18. We therefore reverse the
obviousness rejection over Murphy and Miller of claim 18 and of claims 19,
22, 29, and 30, which depend from claim 18.
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Application 13/439,192
II
In the second rejection, the Examiner relies on Murphy and Miller as
discussed above (Final Act. 5). However, the Examiner finds that "neither
of the references specifically teaches the administration of a formulation
comprising the specific amount of vitamin K" (id. at 6).
The Examiner relies on Manning for teaching "recommended daily
values for vitamins" (id.). In particular, the Examiner finds that Manning
"teaches that the recommended daily value for vitamin K for individuals
4 years or older is 80 micrograms" (id.). The Examiner concludes:
(Id.)
One of ordinary skill in the art would have been motivated to use
the amount of vitamin K disclosed by Manning in the method of
Murphy and Miller because Murphy discloses that the
composition should comprise vitamin K, but does not disclose a
specific amount. One would therefore have been motivated to
consult the dietary recommendations for this nutrient and would
have arrived at a recommended dosage, such as that taught by
l\.1anning, in the course of routine experimentation.
Analysis
For the reasons discussed above, we conclude that the Examiner has
not set forth a prima facie case that Murphy and Miller suggest the method
of claim 18. In addition, we agree with Appellant that the Examiner has not
adequately shown that Manning cures the deficiencies of Murphy and Miller
(Br. 14).
Conclusion
The Examiner has not set forth a prima facie case that Murphy, Miller,
and Manning suggest the method of claim 18. We therefore reverse the
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Application 13/439,192
obviousness rejection over Murphy, Miller, and Manning of claim 18 and of
claims 19, 22, 27, 29, and 30, which depend from claim 18.
REVERSED
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