Ex Parte Kolterman et al

Patent Trial and Appeal Board

Jun 20, 2013

10337979 (P.T.A.B. Jun. 20, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ORVILLE G. KOLTERMAN, CHRISTIAN MEYER,
DAVID G. MAGGS, and MARK FINEMAN1
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Appeal 2011-012079
Application 10/337,979
Technology Center 1600
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Before TONI R. SCHEINER, ERIC GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
treatment, which have been rejected for anticipation. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

1 Appellants state that the Real Party in Interest is Amylin Pharmaceuticals,
Inc. (Appeal Br. 4).
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STATEMENT OF THE CASE
The Specification states that “patients with type II diabetes mellitus
frequently have elevated fasting triglycerides, often on the order of 250-500
mg/dl. Following a meal, circulating triglyceride levels in these patients can
rise above 1000 mg/dl, well above the normal range.” (Spec. 4:1-3.) The
Specification discloses that “amylin and amylin agonists are effective
acutely and/or chronically to maintain or reduce fasting lipid levels, and
reduce post-prandial lipid (particularly triglyceride) excursions” (id. at
4:9-11). “A particularly preferred amylin agonist is pramlintide” (id. at 6:3).
Claims 11-20 and 65-69 are on appeal. Claims 11 and 65 are the only
independent claims and read as follows:
11. A method of reducing post-prandial triglyceride excursions in a
patient in need of reducing post-prandial triglyceride excursions comprising
administering to said patient an amount of an amylin or amylin agonist
effective to reduce said patient’s post-prandial triglyceride excursions.

65. A method of reducing post-prandial triglyceride excursions in a
patient in need of reducing post-prandial triglyceride excursions comprising
administering to said patient an amount of pramlintide effective to reduce
said patient’s post-prandial triglyceride excursions.

The claims stand rejected as follows:
• Claims 11-20 and 65-69 under 35 U.S.C. § 102(b) as anticipated by
Duft,2 with evidence provided by Kolterman3 (Answer 4) and

2 Duft et al., WO 98/55144, December 10, 1998.
3 Kolterman et al., US 2003/0130177 A1, July 10, 2003. Kolterman is the
published version of the application on appeal. Thus, a citation to
Kolterman is equivalent to a citation to the Specification.
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• Claims 11-18, 65, 68, and 69 as anticipated by Thompson,4 with
evidence provided by Kolterman (Answer 6).
Issue
Both rejections are based on substantially the same disclosures in Duft
and Thompson. The Examiner finds that both Duft and Thompson disclose
administration of pramlintide to patients with type 2 diabetes at a dosage of
either 30 µg or 60 µg, three times per day (“TID”) or four times per day
(“QID”) (Answer 4, 6). The Examiner finds that the instant Specification
(i.e., Kolterman) provides evidence showing that carrying out the method
described in the prior art would inherently result in reducing post-prandial
triglyceride excursions in a patient in need thereof, and therefore Duft and
Thompson anticipate the claims on appeal (id. at 5, 6-7).
Appellants contend that Duft’s patients are not “necessarily” in need
of reducing post-prandial triglyceride excursions, as required for inherent
anticipation (Appeal Br. 6-7), because only about 20% of patients with type
2 diabetes have hypertriglyceridemia (id. at 9, 12). Appellants also contend
that the Examiner’s reliance on Kolterman is improper because Kolterman is
the present application (id. at 10-11).
The issue with respect to both rejections is: Does the evidence of
record support the Examiner’s findings that both Duft and Thompson
disclose treatment methods meeting the limitations of claims 11 and 65?

4 Robert G. Thompson et al., Pramlintide, a Synthetic Analog of Human
Amylin, Improves the Metabolic Profile of Patients with Type 2 Diabetes
Using Insulin, 21(6) DIABETES CARE 987-993 (1998).
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Findings of Fact
1. Duft discloses “methods for treating or preventing obesity in
humans comprising the administration of an amylin or an amylin agonist”
(Duft 12:10-12).
2. In a working example, Duft describes treating patients “with a
history of Type II diabetes mellitus” (id. at 28:27) with pramlintide (id. at
29:5). Patients self-administered pramlintide at a dosage of 60 µg three
times per day, 30 µg four times per day, or 60 µg four times per day, within
15 minutes before each meal and before evening snack (id. at 29:6-11).
3. Thompson describes administration of pramlintide to patients with
type 2 diabetes, at the same dosages described in Duft’s working example,
also by injection within 15 minutes before meals and evening snack
(Thompson 988, left col.).
4. The Specification states that “[i]n a preferred embodiment a patient
suffering from type II diabetes . . . is given a dose of about 20.0 to about
360.0 µg/dose, or about 90.0 to about 240.0 µg/dose, or preferably about
50.0 to about 120.0 µg/dose” (Spec. 8:11-13).
5. The Specification states that “[p]referred times for administration
are around any bout of eating, . . . more preferably – 15 min before to about
15 minutes after the meal” (id. at 8:13-17).
6. The Specification states that “[a]ny means of administration known
in the art may be employed to deliver the amylin or amylin agonist of the
invention. For example, injection . . . may be used.” (Id. at 8:22-25.)
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Analysis
Both Duft and Thompson describe administration of pramlintide, an
amylin agonist, to patients having type 2 diabetes. The dosages, frequency
of administration, and timing of administration (within 15 minutes before
each meal) are all consistent with the administration described in the
Specification as effective for reducing post-prandial triglyceride excursions.
The Specification also provides evidence that patients with type 2
diabetes are among those “in need of reducing post-prandial triglyceride
excursions,” as recited in claims 11 and 65. The Specification states that
“patients with type II diabetes mellitus frequently have elevated fasting
triglycerides, often on the order of 250-500 mg/dl. Following a meal,
circulating triglyceride levels in these patients can rise above 1000 mg/dl,
well above the normal range.” (Spec. 4:1-3.) The Specification also states
that “amylin and amylin agonists are effective . . . to maintain or reduce
fasting lipid levels, and reduce post-prandial lipid (particularly triglyceride)
excursions. This effect is beneficial in reducing cardiac and atherosclerotic
risk in patients at higher risk, e.g., those who are genetically predisposed,
obese, diabetic, etc.” (id. at 4:9-11).
Thus, the Specification itself describes reducing post-prandial
triglyceride excursions as being “beneficial” in patients who are diabetic. It
therefore follows that patients with diabetes are in need of reducing post-
prandial triglyceride excursions.
Appellants argue that not all of the patients treated by Duft and
Thompson were in need of reducing post-prandial triglyceride excursions
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because Laakso5 provides evidence that only about 20% of patients with
type 2 diabetes have hypertriglyceridemia (Appeal Br. 8-9) and therefore “it
is not true that treating [this] class of patient with amylin or an amylin
agonist ‘necessarily’ involves reducing post-prandial hypertriglyceridemia”
(id. at 9).
This argument is not persuasive because the claims are not directed to
a method of treating patients having hypertriglyceridemia, they are directed
to a method of treating patients “in need of reducing post-prandial
triglyceride excursions” (claims 11 and 65). The Specification itself
provides evidence that patients with diabetes benefit from reducing post-
prandial triglyceride excursions, and therefore patients with diabetes are
patients in need of reducing post-prandial triglyceride excursions, as recited
in the claims, whether or not they have been diagnosed with
hypertriglyceridemia.
Appellants also argue that “[n]o legal basis exists for relying on
Applicants’ own disclosure or other intrinsic evidence to form a rejection
under an anticipation analysis” (Appeal Br. 11).
This argument is also unpersuasive. The Specification must be
reviewed to properly interpret the scope of the claim language. See
Renishaw plc v. Marposs Societa per Azioni, 158 F.3d 1243, 1248 (Fed. Cir.
1998) (“[A] claim must be read in view of the specification of which it is a
part.”). Thus, the Specification is properly cited as evidence of the scope of

5 Laakso, Dyslipidemia, Morbidity, and Mortality in Non-Insulin-Dependent
Diabetes Mellitus: Lipoproteins and Coronary Heart Disease in Non-
Insulin-Dependent Diabetes Mellitus, 11 JOURNAL OF DIABETES AND ITS
COMPLICATIONS 137-141 (1997).
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the patients recited in the claims, as well as the amount of amylin or amylin
agonist effective to reduce post-prandial triglyceride excursions. The
Examiner’s citation of evidence provided by Kolterman was not improper.
Conclusion of Law
The evidence of record supports the Examiner’s findings that both
Duft and Thompson disclose treatment methods meeting the limitations of
claims 11 and 65.
Claims 12-20 and 66-69 have not been argued separately and
therefore fall with claims 11 and 65. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm both of the rejections on appeal.
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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