Ex Parte Nauck et al

Board of Patent Appeals and Interferences

Jan 23, 2009

10842933 (B.P.A.I. Jan. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MICHAEL A. NAUCK and FRED A. WAGNER
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Appeal 2008-38481
Application 10/842,933
Technology Center 1600
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Decided: January 23, 2009
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Before TONI R. SCHEINER, ERIC GRIMES, and
MELANIE L. MCCOLLUM, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the Examiner’s final
rejection of claims 1, 4, 8-12, 15, 16, 20, 23, and 26. We have jurisdiction
under 35 U.S.C. § 6(b).

1 This appeal was heard January 13, 2009. The real party in interest is
Amylin Pharmaceuticals, Inc.

Appeal 2008-3848
Application 10/842,933

STATEMENT OF THE CASE
“[N]utrition is a fundamental requirement to enable patient healing
and sustenance” (Spec. 2: 7-8), but “[p]atients suffering from a variety of
illnesses often need to take nutrition by a route other than through the
alimentary canal” (id. at 1: 5-6), i.e., parenterally. In order to avoid
hyperglycemia, which has “deleterious effects upon osmolarity, kidney
tissue, retinal tissue, blood vessels, and the cardiovascular system” (id. at 29-
30), parenteral nutrition is typically co-administered with insulin, which has
significant drawbacks (id. at 1: 15 to 2: 6), including the need to constantly
titrate the blood to avoid hyper- or hypoglycemia (Spec. 1: 13-24, 5: 31).
The present invention is directed to a “method for maximal parenteral
nutrition substantially without acute or chronic hyperglycemia . . . enabl[ing]
delivery of requisite nutrients to satisfy the caloric demand of a patient’s
healing tissues while at the same time maintaining an appropriate blood
glucose level” (Spec. 2: 17-21).
Claims 1, 4, 8-12, 15, 16, 20, 23, and 26 are pending and on appeal.2
1 and 20 are representative of the subject matter on appeal:
1. A method for non-alimentary nutrition comprising administering by a
parenteral route to a patient in need of parenteral nutrition;
a nutritively effective amount of nutrient composition comprising
from about 2% to about 50% glucose or the equivalent thereof; and
an insulinotropic peptide or peptides selected from the groups
consisting of GLP-1, an exendin, the deletion sequences thereof, the natural
and non-natural amino acid substitutes thereof, the C-terminus

2 Claims 2, 3, 6, 7, 14, 17, 18, 21, 22, 24, and 25 are also pending but have
been withdrawn from consideration (App. Br. 2). In addition, claims 5, 13,
and 19 are pending, but are no longer subject to any rejection.
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Application 10/842,933

carboxyamides thereof, the C-terminus ketones thereof, the N-terminus
modifications thereof, and any mixture thereof.3

20. A method for non-alimentary nutrition comprising administering by a
parenteral route to a patient in need of parenteral nutrition;
a nutrient composition to provide from about 600g to about 1000g of
glucose or the equivalent thereof per 24 hours; and
an insulinotropic peptide or peptides selected from the group
consisting of GLP-1, an exendin, the deletion sequences thereof, the natural
and non-natural amino acid substitutes thereof, the C-terminus
carboxyamides thereof, the C-terminus ketones thereof, the N-terminus
modifications thereof, and any mixture thereof.

The Examiner rejected claims 1, 4, 8-12, 15, 16, 20, 23, and 26 under
35 U.S.C. § 103(a) as unpatentable over Eng (U.S. Patent 5,424,286, issued
June 13, 1995).4
We reverse.
OBVIOUSNESS
The Examiner finds that Eng describes parenteral administration of
glucose and exendin to a patient, but does not describe the dosages required
by the claims (Ans. 4). However, the Examiner concludes that it would have
been obvious to optimize the amounts of glucose and exendin administered,
depending on the nutritional needs of the patient (id.), because “glucose
provides nutrition for everyone” (id. at 5).

3 Appellants elected the nutrient composition comprising glucose and
exendin in response to a requirement for an election of a species (Response
of June 13, 2005).
4 A rejection of claims 1, 4, 5, 8-13, 15, 16, 19, 20, 23, and 26 under the
doctrine of obviousness-type double patenting has been withdrawn by the
Examiner (Ans. 4).
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Appellants acknowledge that Eng administers glucose and exendin to
test subjects, but contend that Eng’s “glucose administration . . . was to
induce an experimental hyperglycemia and not to provide nutrition” (App.
Br. 5), and Eng’s test subjects were not patients “in need of parenteral
nutrition” (id. at 5 and 6). Appellants contend that one skilled in the art
would have had no reason to vary the amounts of glucose and exendin
administered by Eng, since “Eng is completely silent with regard to . . .
patients in need of parenteral nutrition, or nutrition in any regard” (id. at 5).
ISSUE
The threshold issue raised by this appeal is whether the Examiner has
established that Eng describes parenteral administration of glucose and
exendin to a patient in need of non-alimentary nutrition. If so, the residual
issue is whether it would have been obvious for one skilled in the art to
modify the amount of glucose administered as proposed by the Examiner.
FINDINGS OF FACT
FF1 Appellants claim a method of providing non-alimentary
nutrition to “a patient in need of parenteral nutrition,” by parenterally
administering a nutrient composition comprising the insulinotropic peptide,
exendin, and about 2% to about 50% glucose (claim 1); or a nutrient
composition providing exendin and about 600g to about 1000g of glucose
per 24 hours (claim 20).
FF2 The Examiner finds that Eng describes administration of
glucose and exendin to a patient by a parenteral route, but does not describe
the dosages required by the claims (Ans. 4).
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FF3 According to the Specification, parenteral administration of a
nutritional composition comprising a glucose source and an insulinotropic
peptide (e.g., glucose and exendin) to a patient who cannot receive nutrition
through the alimentary canal, “aims to . . . as rapidly as possible deliver the
nutritional and caloric requirements to the patient while maintaining his
plasma glucose below the so-called renal threshold” (Spec. 10: 16-18),
“without any corresponding side effects from hyper- or hypoglycemia”
(Spec. 5: 30-31).
FF4 The Specification does not explicitly define the term “a patient
in need of parenteral nutrition,” which appears in the preambles of
independent claims 1 and 20. However, the Specification teaches that
patients who “cannot receive nutrition through the alimentary canal” (Spec.
10: 5-6) include:
[S]urgery patients, comatose patients, patients in shock, patients
with gastrointestinal disease, patients with digestive hormone
disease, . . . obese patients, atherosclerotic patients, vascular
disease patients, patients with gestational diabetes, patients with
liver disease such as liver cirrhosis, patients with acromegaly,
patients with glucocorticoid excess such as cortisol treatment or
Cushings disease, patients with activated counterregulatory
hormones such as would occur after trauma, accidents and
surgery . . . patients with hypertriglyceridemia and patients with
chronic pancreatitis.

(Spec. 10: 6-26.)
FF5 Eng describes a series of experiments in which exendin was
administered to dogs maintained “in a clamped, hyperglycemic state” for up
to four hours (Eng, Examples 1-3; col. 6, ll. 30-31), in order to determine
whether exendin elicits a glucose-dependent insulinotropic response.
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FF6 In a hyperglycemic glucose clamp, blood glucose levels are
“clamped,” or held at a pre-determined hyperglycemic level by infusion of
glucose, in order to determine the body’s ability to metabolize glucose (Eng,
Example 2).
FF7 In Eng’s experiments, the dogs were either conscious, or
anesthetized for the duration of the experiments to facilitate infusion of
glucose and exendin through a catheter (Eng, col. 6, ll. 9-11).
PRINCIPLES OF LAW
Preamble language that merely states the purpose or intended use of
an invention is generally not treated as limiting the scope of the claim. See
Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d
1339, 1345 (Fed. Cir. 2003); Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir.
1997). However, terms appearing in a preamble may be deemed limitations
of a claim when they “give meaning to the claim and properly define the
invention.” Gerber Garment Technology, Inc. v. Lectra Sys., Inc., 916 F.2d
683, 688 (Fed. Cir. 1990) (quoting Perkin-Elmer Corp. v. Computervision
Corp., 732 F.2d 888, 896 (Fed. Cir. 1984), cert. denied, 469 U.S. 857
(1984)).
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).

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ANALYSIS
The Examiner finds that Eng describes parenteral administration of
glucose and exendin to a patient, but does not describe the dosages required
by the claims (Ans. 4). However, the Examiner concludes that it would have
been obvious “to determine the optimum dose amount that can be
administered to a patient depending upon individual factors such as age,
total body weight and other mitigating factors” (id.), because “glucose
provides nutrition for everyone” (id. at 5).
Nevertheless, the claims are directed to a method of providing non-
alimentary nutrition to “a patient in need of parenteral nutrition” (FF1). This
phrase, which appears only in the preambles of claims 1 and 20, identifies
(i.e., limits) the patient population encompassed by the claims, and therefore,
gives meaning to the claim and defines the invention.
While we agree with the Examiner that “glucose provides nutrition for
everyone” (Ans. 5), and that parenteral administration of glucose inevitably
provides some degree of nutrition, not everyone is “a patient in need of
parenteral nutrition,” as required by the claims. Although the Specification
does not explicitly define such a patient, it does provide examples of patients
who cannot receive nutrition through the alimentary canal because of some
underlying condition, and therefore must receive it through a parenteral route,
e.g., comatose patients, surgery patients, patients in shock, etc. (FF4).
The Examiner has not established that Eng’s test subjects (conscious
dogs, or dogs anesthetized merely for purposes of experimentation (FF5, 7)),
had any underlying condition that would have prevented them from receiving
nutrition through the alimentary canal. Thus, the Examiner has not established
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that Eng’s test subjects were patients “in need of parenteral nutrition,” or that
one of skill in the art would have had a reason to modify the amounts of
glucose administered by Eng, especially as doing so would defeat the purpose
of “clamping” the dogs’ blood glucose at a pre-determined level (FF6).
CONCLUSION OF LAW
The Examiner has not established that Eng describes or suggests
parenteral administration of a composition comprising glucose and exendin
to a patient in need of non-alimentary nutrition, and therefore has not
established that the art would have suggested modifying the amount of
glucose administered as proposed by the Examiner.
SUMMARY
We reverse the Examiner’s rejection of claims 1, 4, 8-12, 15, 16, 20, 23,
and 26 under 35 U.S.C. § 103(a) as unpatentable over Eng.

REVERSED

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Intellectual Property Department
Amylin Pharmaceuticals, Inc.
9360 Towne Centre Drive
San Diego, CA 92121
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