Ex Parte Rabovsky et al

Patent Trial and Appeal Board

Nov 1, 2016

12854944 (P.T.A.B. Nov. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/854,944 08/12/2010 Alexander B. Rabovsky
26191 7590 11/03/2016
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
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.
09143-0037001 8888
EXAMINER
CONSTANTINE, CHARLES Z
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
11/03/2016 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):
P ATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEXANDER B. RABOVSKY and JEREMY IVIE 1
Appeal2015-006014
Application 12/854,944
Technology Center 1600
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
dietary supplement which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The present invention is directed to a dietary supplement which is
"useful in reducing cholesterol and improving overall cardiovascular
health." Spec. 1.
1 Appellants identify the Real Party in Interest as Melaleuca, Inc. Br. 1.
Appeal2015-006014
Application 12/854,944
Claims 1-5, and 7-11 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A dietary supplement, comprising, per daily dosage:
a) from about 1400 mg to about 2800 mg phytosterols;
b) from about 300 mg to about 800 mg omega-3 fatty acids;
c) from about 20 mg to about 40 mg coenzyme Q-1 O;
d) from about 20 mg to about 36 mg alpha lipoic acid; and
e) bromelain.
The claims stand rejected as follows:
Claims 1-5, and 7-11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Cho2 in view of Sabharwal. 3
DISCUSSION
Issue
In rejecting the pending claims, the Examiner finds that Cho teaches a
nutritional supplement which contains "phytosterols, omega-3 fatty acids,
bromelain and antioxidants such as Coenzyme-Q-10." Final Act. 3. The
Examiner finds that while Cho does not teach the use of alpha lipoic acid, it
is known in the art that alpha lipoic acid is an antioxidant, radical scavenger
and reducing agent known to prevent LDL oxidation as taught by
Sabharwal. Final Act. 4. The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the claimed invention was made to combine the instant
ingredients for their known benefit since each is well known in
the art for the same purpose and for the following reasons: Both
2 Cho, US 2005/0032757 Al, published Feb. 10, 2005 ("Cho").
3 Anup K. Sabharwal and James M. May, a-Lipoic acid and ascorbate
prevent LDL oxidation and oxidant stress in endothelial cells, 309 Mol. Cell.
Biochem. 125 (2008) ("Sabharwal").
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Appeal2015-006014
Application 12/854,944
are known to reduce/protect against LDL oxidation. In KSR
lnt'I Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court reaffirmed "the conclusion that when a patent 'simply
arranges old elements with each performing the same function
it had been known to perform' and yields no more than one
would expect from such an arrangement, the combination is
obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S.
273,282 (1976)). The Supreme Court also emphasized a
flexible approach to the obviousness question, stating that the
analysis under 35 U.S.C. § 103 "need not seek out precise
teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would
employ." Id. at 418; see also id. at 421 ("A person of ordinary
skill is ... a person of ordinary creativity, not an automaton.").
The Supreme Court thus implicitly endorsed the principle,
stated in In re Kerkhoven, 626 F.2d 846, 850 (CCP A 1980)
(citations omitted), that: It is prima facie obvious to combine
two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third
composition which is to be used for the very same purpose ....
[T]he idea of combining them flows logically from their having
been individually taught in the prior art.
Final Act. 5.
Appellants contend that, insofar as the skilled in the art would
consider the teachings of Sabharwal with respect to the addition of alpha
lipoic acid, the skilled person would only use the amounts of alpha lipoic
acid recited in Sabharwal, which is above the amounts in the claimed range.
Appeal Br. 3--4. Appellants also contend that there is no reason to combine
the claimed ingredients in the claimed amounts. Appeal Br. 4--5. Appellants
next argue that the Examiner has not given a reason why Cho was used to
select a "lead compound." Appeal Br. 6-8.
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Appeal2015-006014
Application 12/854,944
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 1-3 would have
been obvious over Cho combined with Sabharwal as defined by 35 U.S.C.
§ 103(a).
Findings of Fact
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FF 1. Cho teaches a nutritional supplement comprising a phytosterol,
a fatty acid compound such as an omega-3 fatty acid, a carboxylic acid ester,
a surfactant, and an enzyme or enzyme blend such as bromelain. Cho ,-r 6.
FF2. The supplement of Cho can also contain antioxidants such as
Coezyme-Q-10. Cho ,-r 6 and 96.
FF3. The phytosterol compounds in Cho are present in the
supplement in amounts ranging from 10 to 900 mg. Cho ,-r 64.
FF4. The omega-3 fatty acids in Cho are present in amounts ranging
from about 10 to 55% by weight of the supplement. Cho ,-r 78.
FF5. The enzyme or enzyme blend used in the compositions of Cho is
present in amounts ranging from 0.1 to 5% by weight of the supplement.
Cho i-188.
FF6. The antioxidants used in the supplement of Cho can be present
in amounts ranging from 0.01 to 2% by weight of the supplement. Cho ,-r 96.
FF7. Sabharwal teaches the use of alpha lipoic acid as an antioxidant.
Sabharwal 129-30.
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Appeal2015-006014
Application 12/854,944
Principles of Law
"It is prima facie obvious to combine two composition each of which
is taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose .... [T]he
idea of combining them flows logically from their having been individually
taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ
1069, 1072 (CCPA 1980).
In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness .... We have also
held that a prima facie case of obviousness exists when the
claimed range and the prior art range do not overlap but are
close enough such that one skilled in the art would have
expected them to have the same properties.
In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
To show criticality of a claimed range, "'it is not inventive to discover
the optimum or workable ranges by routine experimentation.' In re Aller,
220 F .2d 454, 456 (CCP A 1955). Only if the 'results of optimizing a
variable' are 'unexpectedly good' can a patent be obtained for the claimed
critical range. In re Antonie, 559 F.2d 618, 620 (CCPA 1977)." In re
Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
Analysis
Claim 1 is representative of the rejected claims and is directed to a
nutritional supplement containing phytosterols, omega-3 fatty acids,
Coenzyme Q-10, alpha lipoic acid and bromelain.
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Appeal2015-006014
Application 12/854,944
We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one skilled in the art at the time the invention was
made. Cho teaches a nutritional supplement containing all of the claimed
components with the exception of alpha lipoic acid. FF 1. The amounts of
the components recited in Cho either overlap or are close to the amounts
recited in the claims. FF2---6. Sabharwal teaches the use of alpha lipoic acid
as an antioxidant. FF7. We agree with the Examiner that it would have
been obvious to one skilled in the art to use alpha lipoic acid as an additional
antioxidant in the supplement of Cho.
Appellants contend that one skilled in the art would have used alpha
lipoic acid in the amounts taught by Sabharwal rather than according to the
amounts of antioxidants recited in Cho. Appeal Br. 3; Reply Br. 2.
Appellants argue that this would result in an amount of alpha lipoic acid well
in excess of the amount recited in the instant claims. We are unpersuaded.
As the Examiner points out, Cho specifically related to a dietary supplement
whereas Sabharwal is directed to the effect of alpha lipoic acid on individual
cells exposed to oxidative stress. Ans. 7. We agree with the Examiner that
one skilled in the art would predictably follow the teachings of Cho in
developing a supplement with appropriate concentrations of antioxidants.
Appellants next argue that there is no reason why one skilled in the art
would use alpha lipoic acid instead of the antioxidants recited in Cho. Reply
Br. 2. Again, we are unpersuaded. "It is primafacie obvious to combine
two composition each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose." In re Kerkhoven, 626 F.2d at. 850. Here
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Appeal2015-006014
Application 12/854,944
Appellants combined two known antioxidants, coenzyme Q-10 and alpha
lipoic acid to form a mixture used as an antioxidant.
Appellants go on to argue that Cho offers no guidance as to the
specific components to use or the amounts of the ingredients. Appeal Br. 4.
We remain unpersuaded. As the Examiner points out, Cho teaches almost
all of the components in the first paragraph of the summary of the invention.
Ans. 9-10. Cho provides specific examples which contain phytosterol,
bromelain, Coenzyme Q-10 and omega-3 fatty acids. Ans. 9; Cho i-fi-f 115
and 123. The amounts of the components recited in Cho overlap with or are
close to those recited in the claims. FF2---6; Ans. 3--4.
Appellants conclude by arguing that the Examiner failed to properly
explain why Cho was selected to determine the lead composition as required
by Daiichi Sankyo Co., Ltd v. Matrix Labs., Ltd, 619 F.3d 1346, 1354 (Fed.
Cir. 2010). We agree with the Examiner that Appellants' reliance on
Daiichi is misplaced. Daiichi addressed the development of a new
compound from a lead compound. Id at 1348. As the Examiner points out,
[t]he rationale and case law to determine the obviousness of a
structure of a compound is entirely different than that of
compositions, and this rational and case law has not been used
in the instant rejection[.] A single chemical change on a
compound can render a drug much improved or useless for its
purpose. The addition or subtraction of a component does not
alter the ability of the composition to serve as a dietary
supplement. Rationale, case law and guidance based on
determining whether or not a composition containing certain
components and claimed ranges is obvious have been used. The
use of all but one component is explicitly taught by Cho, and a
specific reason to add the single component not taught by Cho
has been given through the combination with Sabharwal.
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Application 12/854,944
Further the combination teaches the use of the instantly claimed
ranges.
Ans. 11.
With respect to claims 2 and 3, we agree with the Examiner that the
specific ranges recited in those claims fall within the ranges taught by Cho.
Discovery of the optimum amounts is a matter of routine experimentation.
In re Aller, 220 F .2d at 456.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1-3 would have been obvious over Cho combined
with Sabharwal under 35 U.S.C. § 103(a).
Claims 4, 5, and 7-11 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1-3 under 35 U.S.C. § 103(a).
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).
AFFIRMED
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