Ex Parte Vennerstrom et al

Patent Trial and Appeal Board

Feb 8, 2017

13069697 (P.T.A.B. Feb. 8, 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.
13/069,697 03/23/2011 Jonathan L. Vennerstrom 0685-P04131US06/PJH 1605
110 7590 02/08/2017
DANN, DORFMAN, HERRELL & SKILLMAN
1601 MARKET STREET
SUITE 2400
PHILADELPHIA, PA 19103-2307
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
02/08/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHAN L. VENNERSTROM and DONALD W. MILLER
Appeal 2014-008886
Application 13/069,6971
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, 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 food
supplement. The Examiner rejected the claims on appeal as obvious under
35 U.S.C. § 103(a) and on grounds of non-statutory obviousness-type double
patenting.
We affirm.
1 According to Appellants, the real party in interest is the Board of Regents
of the University of Nebraska. App. Br. 2.
Appeal 2014-008886
Application 13/069,697
STATEMENT OF THE CASE
Claims 106—114, 116, 117, and 119 are on appeal. Claim 106 is
illustrative and reads as follows:
106. A food supplement-consisting essentially of a
creatine ester suitable for being modified by an animal to
form creatine, and said creatine ester is at least one of
creatine ethyl ester and a creatine ethyl ester salt.
App. Br. 9.
The claims stand rejected as follows:
Claims 106-114, 116, 117, and 119 under 35 U.S.C. § 103(a) as
unpatentable over Gardiner.2
Claims 106, 107, 112—114, 116, and 117 were provisionally rejected
on the grounds of non-statutory obviousness-type double patenting over
claims 8, 9, and 13 of US Patent Application No. 12/909,377 (now issued as
US Patent No. 8,354,450).
Claims 106, 107, 112—114, 116, and 117 were rejected on the grounds
of non-statutory obviousness-type double patenting over claims 1—17 of US
Patent No. 6,897,334.3
OBVIOUSNESS
Appellants argue claims 106—114, 116, 117, and 119 together as a
group. We designate claim 106 as representative for the group.
2 Gardiner, US Patent No. 6,136,339, issued Oct. 24, 2000 (“Gardiner”).
3 Claims 106, 107, 112—114, 116, and 117 were also provisionally rejected
on the grounds of non-statutory obviousness-type double patenting over
claims 37-42 and 44—50 of US Patent Application No. 12/723,003. The
Examiner withdrew this rejection in an Advisory Action filed after the
commencement of this appeal based upon Appellants’ filing of a terminal
disclaimer. This rejection is thus no longer part of this appeal.
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Application 13/069,697
The Examiner found that Gardiner disclosed a food supplement
comprising lipoic acid, creatine, and dextrose. Final Act. 5. The Examiner
further found that Gardiner taught ester derivatives of creatine, such as
methyl, ethyl, and propyl esters. Id. at 6. The Examiner noted that the lipoic
acid in Gardiner’s composition was employed in an amount sufficient to
increase creatine transport into the muscle cells. Id. at 5—6.
Appellants argue that lipoic acid is essential to the formulation recited
in Gardiner and that claim 106 excludes the presence of lipoic acid because
it uses the transitional phrase “consisting essentially of.” We are not
persuaded.
The phrase “consisting essentially of’ is used to signal a partially
open claim in a patent. PPG Industries v. Guardian Industries Gorp., 156
F.3d 1351, 1354 (Fed. Cir. 1998). A claim using the phrase “consisting
essentially of’ is generally understood to encompass the components that
follow the transitional phrase as well as additional unlisted ingredients that
do not “materially affect the basic and novel properties of the invention.” Id.
Appellants argue that lipoic acid materially affects the basic and novel
properties of the claimed food supplement. Reply Br. 1. We turn to the
Specification for guidance. As an initial matter, the Specification does not
identify any components as being excluded from the claimed supplement nor
does it define what constitutes a “material change” in the properties of the
claimed supplement. See PPG Industries, 156 F.3d at 1355 (noting that the
patentee “could have defined the scope of the phrase ‘consisting essentially
of for purposes of its patent by making clear in its specification what it
regarded as constituting a material change in the basic and novel
characteristics of the invention”).
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Application 13/069,697
The Specification does provide some guidance as to what the
inventors considered to be the novel properties of the claimed invention in
its discussion the problems solved. It teaches that creatine is “poorly soluble
in an aqueous solution,, and “not well absorbed from the gastrointestinal
(GI) tract.” Spec. 3. Therefore, in order to be effective, “current products
require large amounts of creatine to be administered.” Id. These large doses
can cause side effects, such as “bloating, gastrointestinal (GI) distress,
diarrhea, and the like.” Id. Accordingly, the Specification suggests that “it
would be desirable to provide an improved approach for enhancing
absorption of creatine.” Id.
Appellants solved the problems in the art by using creatine esters,
which the Specification teaches are “more readily absorbed in the intestine.”
Id. at 7. The Specification teaches “[c]ompared to creatine monohydrate, the
increased blood levels of creatine obtained with supplements containing the
creatine ester compounds are expected to result in increased responses at the
target tissue (i.e. muscle).” Id. Accordingly, we find that the basic and
novel properties of the claimed supplement are that it is more readily
absorbed and more successfully transported to muscle than creatine and/or
creatine monohydrate.
Having identified the alleged basic and novel properties of
Appellants’ supplement, we next address Appellants’ argument that the
presence of lipoic acid in Gardiner’s supplement affects those properties.
Appellants argue that Gardiner teaches that lipoic acid increases creatine
transport into muscle cells, and that it is therefore necessarily excluded by
the transitional phrase “consisting essentially of.” Reply Br. 1. We
disagree. The issue is not whether lipoic acid and creatine ethyl ester (the
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Appeal 2014-008886
Application 13/069,697
active ingredient in the claimed supplement) have similar properties. The
issue is whether lipoic acid materially affects the properties of creatine ethyl
ester. PPG Industries, 156 F.3d at 1354. Appellants have not directed us to
persuasive evidence that lipoic acid would materially affect the alleged
novel properties that creatine ethyl ester is “readily absorbed in the intestine”
and that it provides “increased responses at the target tissue (i.e. muscle).”
Accordingly, we find that a preponderance of the evidence supports the
Examiner’s position that “lipoic acid would not affect the basic and novel
properties of the food supplement.” Ans. 2.
Appellants contend that the Specification and the Miller Declaration4
demonstrate unexpected results because they show that creatine ethyl ester
has “increased solubility and membrane permeability, therefore providing
greater bioavailability” as compared to creatine monohydrate. App. Br. 5.
We are not persuaded because Gardiner teaches the use of creatine
derivatives including esters. The comparison in the Miller Declaration is
thus of two compositions that were both known in the art. Moreover, given
our conclusion that the claims do not exclude lipoic acid, the record strongly
supports the obviousness of the claimed supplement. The evidence of
unexpected results reflected in the Miller Declaration is insufficient to
overcome this strong showing of obviousness. See Leapfrog Enterprises,
Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (“given the
strength of the prima facie obviousness showing, the evidence on secondary
considerations was inadequate to overcome a final conclusion” of
obviousness).
4 Declaration of Dr. Donald W. Miller, dated Sept. 21, 2011.
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Application 13/069,697
Accordingly we affirm the Examiner’s rejection of claim 106 as
obvious over Gardiner. Because they were not argued separately, claims
107—114, 116, 117, and 119 fall with claim 106.
DOUBLE PATENTING
The Examiner rejected Claims 106, 107, 112—114, 116, and 117 on
the grounds of non-statutory obviousness type double patenting over claims
8, 9, and 13 of US Patent Application No. 12/909,377 (now US Patent No.
8,354,450 (“the ’450 Patent”)) and claims 1—17 US Patent No. 6,897,334
(“the ’334 Patent”). The Examiner reasoned that “[ajlthough the conflicting
claims are not identical, they are not patentably distinct from each other
because both sets of claims recite a food supplement composition
comprising creatine ester.” Final Act. 3.
Appellants contend that the claims at issue are patentably distinct
from those of the ’450 patent because the relevant claims of the ’450 patent
claim creatine ethyl ester and creatine hydrochloride. Appellants, however,
have not directed us to persuasive evidence establishing that creatine
hydrochloride would materially affect the basic and novel properties of
creatine ethyl ester. Accordingly, we affirm the Examiner’s rejection of
claims 106, 107, 112—114, 116, and 117 on the ground of obviousness-type
double patenting over claims 8, 9, and 13 of the ’450 patent.
The claims of the ’334 patent are directed to a method of producing
creatine ethyl ester in the presence of an acid catalyst. Appellants contend
that “[a] double patenting rejection ‘is not sustainable when the product can
be fabricated by processes other than that secured by the issued process
patent.’” App. Br. 7 (quoting Amgen Inc. v. F. Hoffmann-La Roche, Ltd.,
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Application 13/069,697
580 F.3d 1340, 1355 n. 6 (Fed. Cir. 2009). We agree. Because the
Specification reflects that creatine ethyl ester can be manufactured by
processes other than that recited in the ’334 patent, we reverse the
Examiner’s rejection of claims 106, 107, 112—114, 116, and 117 on the
ground of obviousness-type double patenting over claims 1—17 of the ’334
patent.
SUMMARY
For these reasons and those set forth in the Examiner’s Answer, and
the Final Office Action, we affirm the Examiner’s final decision to reject
claims 106—114, 116, 117, and 119 under 35 U.S.C. § 103(a) as unpatentable
over Gardiner and the Examiner’s final decision to reject claims 106, 107,
112—114, 116, and 117 on the grounds of non-statutory obviousness-type
double patenting over claims 8, 9, and 13 of US Patent No. 8,354,450.
We reverse the Examiner’s decision to reject claims 106, 107, 112—
114, 116, and 117 on the grounds of non-statutory obviousness-type double
patenting over claims 1—17 of US Patent No. 6,897,334.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
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