Ex Parte Berger

Patent Trial and Appeal Board

Jun 26, 2014

10052961 (P.T.A.B. Jun. 26, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/052,961 01/18/2002 Joseph R. Berger 44657-AAA-PCT-US/JPW 3958
23432 7590 06/27/2014
COOPER & DUNHAM, LLP
30 Rockefeller Plaza
20th Floor
NEW YORK, NY 10112
EXAMINER
WANG, SHENGJUN
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
06/27/2014 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 JOSEPH R. BERGER1
__________

Appeal 2012-004370
Application 10/052,961
Technology Center 1600
__________

Before ERIC B. GRIMES, ULRIKE W. JENKS, and ZHENYU YANG,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a unit
dosage form of oxandrolone, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 According to Appellant, the real party in interest is Savient
Pharmaceuticals, Inc. (App. Br. 5).
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STATEMENT OF THE CASE
“Oxandrolone (17-hydroxy-17-methyl-2-oxaandrostan-3-one) is a
known compound that is commercially available” (Spec. 3:21-23).
“Oxandrolone dispositi n [sic] and metabolism in man has been studied
following oral administration of a 10 milligram dose” (id. at 4:3-5).
The Specification states that “[t]he present invention provides a
method which employs oxandrolone (an anabolic steroid with weak
androgenic activity) as an alternative approach to the clinical management of
HIV-associated myopathy/muscle weakness/muscle wasting” (id. at 2:27-
31).
Claims 88-105 are on appeal. Claim 88 is illustrative and reads as
follows:
88. A solid pharmaceutical composition in unit dosage form comprising a
pharmaceutically acceptable carrier and 10 mg of oxandrolone per
unit dosage form.

DISCUSSION
Issue
The Examiner has rejected claims 88-105 under 35 U.S.C. § 103(a) as
obvious based on Metcalf,2 ANAVAR®,3 and Babu4 (Ans. 5). The
Examiner finds that Metcalf teaches a “method of using oxandrolone for
nitrogen retention wherein the daily [ ] amounts of oxandrolone are from
5 mg, 10 mg, 20 mg, and up to 150 mg. Oxandrolone [was] taken as single

2 William Metcalf et al., A Quantitative Expression for Nitrogen Retention
with Anabolic Steroids, 14 METABOLISM 59 (1965).
3 SEARLE, ANAVAR® (1962).
4 US 5,073,380 issued Dec. 17, 1991.
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dosage daily. See, particularly, Method at page 60.” (Id.) The Examiner
finds that ANAVAR® discloses that the “daily dosage of oxandrolone may
be up to 20 mg/day” (id.).
The Examiner finds that “Anavar® disclosed an oxandrolone tablet,
wherein the inactive ingredients include corn starch, lactose, magnesium
stearate and methylcellulose” (id.) and Babu discloses that hydroxypropyl
methylcellulose is a typical excipient for tablets (id.). The Examiner
concludes that it would have been obvious “to make a dosage composition
comprising 10 mg of oxandrolone, and the particular excipients herein as the
excipients herein are well-known pharmaceutical excipients” (id.) and that
the “10 mg dosage would have been obvious in view the fact that it has been
used in the amount of 10 mg, 20 mg, and up to 150 mg daily” (id. at 6).
Appellant contends that the claimed 10 mg unit dosage form reduces
pill burden and patient compliance problems for AIDS patients (App. Br. 17-
18) but “[p]rior to appellant’s discovery of the use of oxandrolone in treating
AIDS patients, and thus prior to identification of a specific pill burden issue
with respect to oxandrolone, there existed no motivation to make a unit dose
form comprising 10 mg oxandrolone” (id. at 18). Appellant also contends
that his position is supported by declaratory evidence (id. at 19-20).
The issue presented is whether the Examiner has identified a reason,
based on the cited references or the knowledge of those skilled in the art, to
make a 10 mg unit dosage form of oxandrolone.
Findings of Fact
1. Metcalf states that a “series of trials was carried out with
Oxandrolone” (Metcalfe 59).
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2. Metcalf states that “[t]he drug was given orally each morning. It
was first given to a series of 7 patients at a dose of 30 mg./day. Subsequently,
trials were made at 2.5, 5, 10, 20, 40, 80 and 150 mg./day.” (Id. at 60.)
3. Metcalf states that “[a]t doses from 30 to 150 mg. the compound
was maximally effective in nitrogen retention and progressively less
effective at doses from 30 to 2.5 mg./day” (id. at 59 (abstract)).
4. ANAVAR® describes Searle’s ANAVAR® brand of oxandrolone,
which is in the form of tablets containing 2.5 mg of oxandrolone
(ANAVAR® 1).
5. ANAVAR® states that the “average adult dose of Anavar is one
2.5 mg. tablet twice daily. It is emphasized, however, that the requirements
for any anabolic agent vary considerably between patients and satisfactory
effect may indicate the administration of daily doses between 2.5 and 10 mg.
In rare cases, daily doses of 15 to 20 mg. may be required.” (Id. at 6.)
6. The Examiner finds that the ANAVAR® tablets described in
ANAVAR® include pharmaceutically acceptable carriers (Ans. 5).
Appellant does not dispute this finding.
7. Babu discloses that hydroxypropyl methylcellulose is an outer
surface smoothness enhancer for tablet dosage forms (Babu, col. 2, ll. 4-7,
15).
Principles of Law
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007).
“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
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patentee controls. . . . [A]ny need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” Id. at 419-20.
Analysis
ANAVAR® describes tablets containing 2.5 mg of oxandrolone
(FF 4). There is no dispute that the ANAVAR® tablets also include a
pharmaceutically acceptable carrier (FF 6) and, in any event, Babu discloses
that hydroxypropyl methylcellulose is a known excipient for tablet dosage
forms (FF 7).
Metcalf discloses administration of oxandrolone at several dosages
that are multiples of 10 mg: 10, 20, 30, 40, 80, and 150 mg (FF 2), and
concludes that “[a]t doses from 30 to 150 mg. the compound was maximally
effective in nitrogen retention” (FF 3). In addition, ANAVAR® indicates
that daily doses of up to 10 mg, and in rare cases up to 20 mg, may be
required to produce a satisfactory result (FF 5).
We agree with the Examiner that these teachings would have made
obvious the claimed 10 mg dosage form of oxandrolone for those uses
requiring more than 10 mg/day (Ans. 6). Specifically, modifying
ANAVAR®’s 2.5 mg unit dosage to include 10 mg of oxandrolone would
make it more convenient for patients to take a prescribed dosage of 10 mg or
more per day; e.g., for a 20 mg dose, a 10 mg unit dosage form would
require swallowing only two tablets instead of the eight tablets that would be
required with ANAVAR®’s 2.5 mg unit dosage form.
Appellant argues, however, that “[p]rior to appellant’s discovery of
the use of oxandrolone in treating AIDS patients, and thus prior to
identification of a specific pill burden issue with respect to oxandrolone,
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there existed no motivation to make a unit dose form comprising 10 mg
oxandrolone” (App. Br. 18).
This argument is unpersuasive. As discussed above, both Metcalf and
ANAVAR® disclose administering oxandrolone at doses of, for example, 20
or 30 mg/day. These disclosures would have provided sufficient reason for a
person of ordinary skill in the art to make a 10 mg unit dosage form of
oxandrolone. The fact that the prior art does not suggest Appellant’s reason
for modifying the known dosage form is immaterial to the question of
whether that dosage form would have been obvious to a skilled worker. See
KSR, 550 U.S. at 419-20 (“ [A]ny need or problem known in the field of
endeavor at the time of invention and addressed by the patent can provide a
reason for combining the elements in the manner claimed.”).
Appellant also argues that “Metcalf et al. teach that the optimal
combined daily amount is 25-30 mg per day (see Metcalf et al. page 63)”
(App. Br. 19), and argues that this teaching would not suggest a 10 mg unit
dosage form (id.). Appellant points to the Ottery Declaration5 as support for
this position. Dr. Ottery declared that “Metcalf and the cited combination of
prior art can be reasonably only interpreted to suggest a 25-30mg unit
dosage form for oxandrolone” (Ottery Decl., ¶ 6). Dr. Ottery reasons that
“pill-burden” issues occur in chronic conditions, such as treatment of HIV,
and “[c]onsequently, those in the art are motivated to formulate treatments
that minimize the number of tablets a patient needs to take each day” (id. at
¶ 7). Dr. Ottery concludes that “one of skill in the art aware of the art-
recognized issues of pill-burden and patient-compliance would understand

5 Declaration under 37 C.F.R. § 1.132 of Faith Ottery, filed May 20, 2008.
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Metcalf to suggest unit dosage forms of 25-30mg of oxandrolone” (id. at
¶ 8).
This argument is also unpersuasive. Although Metcalf states that
“[t]he optimum dose for maximum sparing with Oxandrolone may [ ] be
taken as 25 to 30 mg./day” (Metcalf 63), it also states that “[a]t doses from
30 to 150 mg. the compound was maximally effective in nitrogen retention”
(FF3). In addition, ANAVAR® states that a 10 mg daily dose of
oxandrolone is within the normal range, and that 20 mg daily is required in
some cases (FF5). A skilled worker would recognize that a 10 mg unit dose
of oxandrolone would be convenient to deliver any daily dosage of
oxandrolone that is a multiple of 10 mg; e.g., 20 mg or 30 mg.
Although Appellant again relies on his purpose of decreasing the pill
burden on HIV patients as the reason he made the claimed dosage form,
none of the cited references suggest making oxandrolone dosage forms for
the treatment of HIV patients. Metcalf lists the diagnoses of the patients in
its study (Metcalf 60, Table 1) and ANAVAR® lists thirteen conditions in
which the use of oxandrolone is indicated (ANAVAR®, pages 3-4).
Appellant has pointed to no evidence to show that, for any of the disorders
disclosed in the prior art as treatable with oxandrolone, problems related to
pill burden or patient compliance would have discouraged a skilled worker
from making a 10 mg unit dosage form of oxandrolone.
Conclusion of Law
The Examiner has identified a reason, based on the cited references or
the knowledge of those skilled in the art, to make a 10 mg unit dosage form
of oxandrolone. The rejection of claim 88 as obvious based on Metcalf,
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ANAVAR®, and Babu is affirmed. Claims 89-105 have not been argued
separately and therefore fall with claim 88. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the rejection of claims 88-105 under 35 U.S.C. § 103(a)
based on Metcalf, ANAVAR®, and Babu.
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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