Ex Parte Neu

Board of Patent Appeals and Interferences

Jun 30, 2010

10704936 (B.P.A.I. Jun. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOSEF NEU
__________

Appeal 2009-0111391
Application 10/704,936
Technology Center 1600
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Decided: June 30, 2010
__________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1, 4, 5, and 17, directed to a formulation for enteral administration to a
human. The claims have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).

1 Heard June 23, 2010.
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Application 10/704,936

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STATEMENT OF THE CASE
Claims 1, 4, 5, and 17 are pending and on appeal,2 and stand rejected
under 35 U.S.C. § 103(a) as unpatentable over Eisenbach-Schwartz (U.S.
Patent 6,126,939, issued October 3, 2000).3
The claims on appeal are as follows:
1. A formulation for enteral administration to a human wherein said
formulation has no free amino acids and wherein said formulation comprises
an arginyl-glutamine dipeptide wherein the arginine residue is the amino
terminus of said dipeptide and the glutamine residue is the carboxy terminus
of said dipeptide and wherein the dipeptide is present in said formulation at a
concentration of about 0.1% to about 25% by weight of said formulation;
wherein said formulation additionally comprises at least one ingredient
selected from fats and vitamins.

4. The formulation, according to claim 1, wherein said formulation
further comprises an additive selected from the group consisting of minerals,
trace elements, monosaccharides and oligosaccharides.

5. The formulation, according to claim 4, wherein said monosaccharide
is glucose.

17. The formulation, according to claim 1, which is a total nutritional
formulation.

2 Claims 2, 3, and 6-16 have been canceled.
3 The rejection of claims 1, 4, 5, and 17 under 35 U.S.C. § 102(e) as
anticipated by Eisenbach-Schwartz has been withdrawn by the Examiner
(Ans. 2).
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ISSUES
The issues raised by this rejection are:
Is the evidence of record sufficient to establish that it would have been
obvious to combine the dipeptide Arg-Glu with oil in a formulation acceptable
for enteral administration, as required by claim 1, and further, with glucose, as
required by claims 4 and 5?
Is the evidence of record sufficient to establish that it would have been
obvious to include the dipeptide Arg-Glu in a total nutritional formulation, as
required by claim 17?
FINDINGS OF FACT
FF1 According to the present Specification, the dipeptide Arg-Glu
“promotes healthy muscle tissue and an advantageous immune response”
(Spec. 3: 24). Thus, “compositions containing the dipeptide of the subject
invention can be used to maintain muscle mass in inactive patients while
having the added benefit of reducing susceptibility to hospital acquired
infections” (id. at 5: 13-16).
FF2 The Specification discloses that the dipeptide can be added to
enteral or parenteral aqueous clinical nutrient compositions “of either
complete or incomplete nutritional content” (Spec. 5: 17-20). “[T]he clinical
nutritional solution can contain, for example, dextrose, liquid emulsions,
vitamins, minerals and trace elements” (id. at 23-25) and “a total nutritional
formulation which contains dipeptides as one component among many . . .
[is] contemplated by this invention” (id. at 5: 27-29).

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FF3 According to the Specification, “[t]he concentration of the
dipeptide in the aqueous solution can be, for example, from about 0.1 to
about 25.0 percent by weight” (Spec. 5: 22-23), but no specific volumes or
dosages are disclosed.
FF4 Eisenbach-Schwartz discloses anti-inflammatory, immuno-
suppresive dipeptides and tripeptides (Eisenbach-Schwartz, col. 2, ll. 38-49)
selected from the group consisting of:
(i) a peptide of the amino acid sequence: Xaa-Yaa-Arg wherein
either Xaa is any amino acid residue and Yaa is Glu or Xaa is
absent and Yaa is any amino acid residue with the exception of
Pro; (ii) a peptide of the amino acid sequence: Arg-Yaa-Xaa
wherein either Xaa is any amino acid residue and Yaa is Glu or
Xaa is absent and Yaa is any amino acid residue with the
exception of Asn; (iii) a peptide of the amino acid sequence:
Xaa-Arg-Yaa wherein Xaa is any amino acid residue and Yaa is
Glu; (iv) a peptide of the amino acid sequence: Yaa-Arg-Xaa
wherein Xaa is any amino acid residue and Yaa is Glu; [etc.]

(id. at col. 2, l. 64 to col. 3, l. 7.)
FF5 Eisenbach-Schwartz’s type (ii) dipeptides explicitly include
Arg-Glu (Eisenbach-Schwartz, col. 3, l. 38).
FF6 Eisenbach-Schwartz teaches that pharmaceutical compositions
containing the dipeptides and tripeptides “can be administered systemically
by e.g., intravenous or intramuscular injection.” In addition, “[t]he
pharmaceutical compositions . . . can be introduced to a site which is a joint
by any suitable route including intravenously, sub-cutaneously, orally, trans-
cutaneously, topically, intramuscularly, intraarticularly, retrobulbarly,
subconjuntivally, etc.” (Eisenbach-Schwartz, col. 13, ll. 48-55.)

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FF7 Eisenbach-Schwartz teaches that the peptides can be combined
with a pharmaceutically acceptable carrier:
The term “carrier” refers to a diluent, adjuvant, excipient, or
vehicle with which the peptide is administered. Such
pharmaceutical carriers can be sterile liquids, such as water and
oils, including those of petroleum oil such as mineral oil,
vegetable oil such as peanut oil, soybean oil, and sesame oil,
animal oil, or oil of synthetic origin. . . .
Suitable pharmaceutical excipients include starch,
glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica
gel, sodium stearate, glycerol monostearate, talc, sodium
chloride, dried skim milk, glycerol, propylene, glycol, water,
ethanol, and the like.

(Eisenbach-Schwartz, col. 14, ll. 45-61.)
FF8 According to Eisenbach-Schwartz, “[t]he formulation should
suit the mode of administration” (Eisenbach-Schwartz, col. 15, ll. 6-7). In
addition,
The amount of the therapeutic or pharmaceutical
composition . . . which is effective in the treatment of a
particular disease, condition, or disorder will depend on the
nature of the disease, condition, or disorder and can be
determined by standard clinical techniques. In general, the
dosage ranges from about 0.001 mg/kg to about 2 mg/kg.

(id. at col. 15, ll. 38-43.)
PRINCIPLES OF LAW
“[T]he Examiner bears the burden of establishing a prima facie case
of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265
(Fed. Cir. 1992).
[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was,
independently, known in the prior art. Although common sense
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directs one to look with care at a patent application that claims
as innovation the combination of two known devices according
to their established functions, it can be important to identify a
reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the
claimed new invention does.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In other words,
“there must be some articulated reasoning with some rational underpinning
to support the legal conclusion of obviousness.” Id. (quoting In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006)).
ANALYSIS
Claims 1, 4, and 5
Appellant contends “without the hindsight benefit of the Appellant’s
disclosure there would be no reason to modify the Eisenbach-Schwartz et al.
parenteral anti-inflammation composition” (App. Br. 5). That is, “there
would be no reason to select various essentially random aspects of the broad
Eisenbach-Schwartz et al. disclosure to arrive at the Appellant’s
formulations” (id. at 4).
Nevertheless, we agree with the Examiner’s conclusion that it would
have been obvious to formulate any of Eisenbach-Schwartz’s peptides -
including the explicitly disclosed dipeptide Arg-Glu - with oil and glucose,
given Eisenbach-Schwartz’s teaching that pharmaceutical formulations
containing the disclosed peptides can be administered orally (FF6), that the
formulations should be suited to the mode of administration (FF8), and that
suitable carriers and excipients include various edible oils and glucose
(FF7).
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Appellant further contends that Eisenbach-Schwartz “is silent
regarding the concentration of the dipeptide and the absence of free amino
acids” (App. Br. 5).
Appellant’s argument is not persuasive. Claim 1 recites that the
dipeptide is present in the formulation at a concentration of about 0.1% to
about 25% by weight of the formulation, but doesn’t specify a volume or
dosage. As noted by the Examiner, Eisenbach-Schwartz teaches that the
formulation should suit the mode of administration, and that an effective
amount of the pharmaceutical composition depends on the disease,
condition, or disorder being treated (Ans. 7; FF8). We agree with the
Examiner that it would have been obvious for one of skill in the art to adjust
the concentration of Eisenbach-Schwartz’s anti-inflammatory formulations
to provide an appropriate dosage in a given pharmaceutical carrier, and “the
ranges claimed would be . . . expected,” depending on the volume of the
carrier (Ans. 7).
As for the assertion that Eisenbach-Schwartz is silent regarding “the
absence of free amino acids,” Appellant has not pointed to anything in the
reference to suggest that free amino acids are present.
Claim 17
Appellant contends that formulations containing the dipeptide Arg-
Glu “are useful for treating muscle wasting” (App. Br. 6), while “Eisenbach-
Schwartz et al. disclose anti-inflammatory compounds” (id.). Appellant
contends there is no “reason to expect [that] any of the Eisenbach-Schwartz
et al. compounds would be useful for treating muscle wasting” (id.).
Appellant further contends that “[t]he Answer provides no rational
explanation as to why the skilled artisan would select the Appellant’s
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specific dipeptide and formulate it into . . . a total nutritional formulation as
recited in Appellant’s claim 17” (Reply Br. 3).
We agree with Appellant that the Examiner has not adequately
explained why Eisenbach-Schwartz’s disclosure of oral formulations of
dipeptides would have suggested including them in a “total nutritional
formulation,” given the reference’s exclusive focus on using the peptides as
anti-inflammatory, immunosuppressive agents - “a purpose for which there
would be no reason to utilize a total nutritional formulation as claimed” (id.).
CONCLUSIONS OF LAW
The evidence of record is sufficient to establish that it would have been
obvious to combine the dipeptide Arg-Glu with oil and glucose in a
formulation acceptable for enteral administration, as required by claims 1, 4,
and 5.
However, the Examiner has not adequately explained why the evidence
of record is sufficient to establish that it would have been obvious to include
the dipeptide Arg-Glu in a total nutritional formulation, as required by claim
17.
Accordingly, the rejection of claims 1, 4, 5, and 17 as unpatentable over
Eisenbach-Schwartz is affirmed with respect to claims 1, 4, and 5, and reversed
with respect to claim 17.
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)(1)(iv)(2006).

AFFIRMED-IN-PART

Appeal 2009-011139
Application 10/704,936

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