Ex Parte Deutz et al

Patent Trial and Appeal Board

Jan 28, 2013

12293283 (P.T.A.B. Jan. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte NICOLAAS EMILE DEUTZ,
NORMAN ALAN GREENBERG, KALA MARIE KASPAR,
CANDIS KVAMME, and YVETTE CHARLOTTE LUIKING
__________

Appeal 2012-001546
Application 12/293,283
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and JACQUELINE
WRIGHT BONILLA, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treating, reducing, or inhibiting satiety and/or dyspepsia. The Examiner
has rejected the claims as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
Appeal 2012-001546
Application 12/293,283

2
STATEMENT OF THE CASE
Claims 1, 2, 4-6, and 9-15 are on appeal (App. Br. 4).1 The claims
have not been argued separately and therefore stand or fall together. 37
C.F.R. § 41.37(c)(1)(iv). Claim 1 is representative and reads as follows:
1. A method for treating, reducing, or inhibiting, at least one of
satiety and dyspepsia in a mammal, the method comprising:
increasing a concentration of nitric oxide (NO) in the mammal’s cells
by administering to the mammal an orally-administrable nutritional
supplement having a quantity of L-citrulline and at least one of a protein, a
soluble fiber, an insoluble fiber, a fatty acid, a vitamin, a mineral, a
carbohydrate, a flavor agent, a medicament, and a therapeutic agent, wherein
the increased concentration of NO results in a relaxation of smooth muscles
of the stomach.
Claims 1, 2, 4-6, and 9-15 stand rejected under 35 U.S.C. § 103(a) as
obvious over Bandarage2 as evidenced by Yu3 and in view of Cha4 and
Osowska-Vincent5 (Ans. 4).
The Examiner relies on Bandarage for teaching “treating dyspepsia
. . . by administering nitrosylated compounds such as citrulline” (id. at 5).
The Examiner finds that “[i]ntrinsically Bandarage’s administration of
citrulline increases concentration of NO necessarily results in a relaxation of
smooth muscles of the stomach and in the mammal’s cells” (id.). The

1 Claims 16-45 are also pending but have been withdrawn from
consideration (App. Br. 4).
2 Bandarage et al., US 6,593,347 B2, Jul. 15, 2003.
3 Yu et al., Quantitative aspects of interorgan relationships among arginine
and citrulline metabolism, 271 Am. J. Physiol. Endocrinol. Metab. E1098-
E1109 (1996) (Abstract only).
4 Cha et al., WO 2006/002096 A2, Jan. 5, 2006.
5 Osowska-Vincent et al., US 2005/0239891 A1, Oct. 27, 2005.
Appeal 2012-001546
Application 12/293,283

3
Examiner also finds that it “is reasonable that the citrulline will further
necessarily be a L- citrulline because it’s a precursor of L- arginine” (id.).
The Examiner relies on Yu as evidence that the “conversion of
L-citrulline to arginine is an inherent property of the compound” (id.).
The Examiner relies on Cha for teaching “treating a number of
disease[s] wherein L-citrulline is administered as dietary supplements
comprising vitamins and at least one sugar . . . which thereby increases
arginine levels in the treatment of diseases that benefit from an increase in
NO” (id. at 6).
The Examiner relies on Osowska-Vincent for teaching features of
dependent claims, specifically for teaching “treating intestinal insufficiency
by administering L-citrulline in mammals suffering of malnutrition . . . that
have had re-sectioning of the intestine (gastric bypass . . . )” (id.).
The Examiner concludes:
One of ordinary skill in the art would have been motivated to
expand the treatment method of Bandarage to include the
methods of Cha et al. and Osowska-Vincent et al. to treat
patients with satiety and dyspepsia with a nutritional
supplement that is administered orally because both Cha et al.
and Osowska-Vincent et al. teach that L-citrulline may be
administered orally.
(Id.)
ISSUE
Does the evidence support the Examiner’s conclusion that it would
have been obvious to treat, reduce, or inhibit dyspepsia by administering
L-citrulline in a nutritional supplement that also comprises at least one of a
Appeal 2012-001546
Application 12/293,283

4
protein, a soluble fiber, an insoluble fiber, a fatty acid, a vitamin, a mineral,
a carbohydrate, a flavor agent, a medicament, and a therapeutic agent?
ANALYSIS
For at least the reasons stated in the Answer, we agree with the
Examiner that it would have been obvious to treat, reduce, or inhibit
dyspepsia by administering L-citrulline in a nutritional supplement that also
comprises at least one of a protein, a soluble fiber, an insoluble fiber, a fatty
acid, a vitamin, a mineral, a carbohydrate, a flavor agent, a medicament, and
a therapeutic agent.
In particular, Bandarage specifically teaches
methods for decreasing and/or preventing gastrointestinal
disorders by administering to the patient in need thereof a
therapeutically effective amount of . . . at least one nitrosated
and/or nitrosylated NSAID, and, optionally, at least one
compound that donates, transfers or releases nitric oxide, or
elevates levels of endogenous [endothelium-derived relaxing
factor] or nitric oxide, or is a substrate for nitric oxide synthase.
(Bandarage, col. 30, l. 60, to col. 31, l. 2.) Bandarage also discloses that the
gastrointestinal disorders include dyspepsia (id. at col. 31, ll. 4-7) and that
“compounds that stimulate endogenous NO or elevate levels of endogenous
endothelium-derived relaxing factor (EDRF) in vivo or are substrates for
nitric oxide synthase” include citrulline (id. at col. 30, ll. 11-23). Given the
“comprising” language, claim 1 is clearly open to administering at least one
nitrosated and/or nitrosylated NSAID and, in fact, specifically recites that a
medicament and/or a therapeutic agent may be included.
The Examiner relies on Cha for teaching administering L-citrulline in
a dietary supplement (Ans. 6 (citing Cha 7: 7-20)). We agree with the
Appeal 2012-001546
Application 12/293,283

5
Examiner that it would have been obvious to administer L-citrulline in the
form of a dietary supplement, as described in Cha, in order to decrease
and/or prevent dyspepsia, as described in Bandarage. For the reasons stated
by the Examiner (Ans. 8-10), Appellants do not persuade us that “the skilled
artisan would have no reason to combine the cited references to arrive at the
present claims” (App. Br. 8, 10-12).
CONCLUSION
The evidence supports the Examiner’s conclusion that it would have
been obvious to treat, reduce, or inhibit dyspepsia by administering
L-citrulline in a nutritional supplement that also comprises at least one of a
protein, a soluble fiber, an insoluble fiber, a fatty acid, a vitamin, a mineral,
a carbohydrate, a flavor agent, a medicament, and a therapeutic agent. We
therefore affirm the obviousness rejection.
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

lp