Ex Parte Brewer et al

Patent Trial and Appeal Board

Mar 8, 2017

12782584 (P.T.A.B. Mar. 8, 2017)

United States Patent and Trademark Office
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.
12/782,584 05/18/2010 Francesca Mary Brewer 001255/0006 4944
26610 7590 03/10/2017
STROOCK & STROOCK & LA VAN LLP
180 MAIDEN LANE
NEW YORK, NY 10038
EXAMINER
DRAPER, LESLIE A ROYDS
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
03/10/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
u spatents @ stroock. com
jmann @ stroock.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCESCA MARY BREWER, EDWARD STEWART
JOHNSON, and ANTHONY CLARKE1
Appeal 2016-004620
Application 12/782,584
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to an oral
solid dosage form. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellants, the real party in interest is Catalent Pharma
Solutions. (Appeal Br. 3.)
Appeal 2016-004620
Application 12/782,584
STATEMENT OF THE CASE
Claims on Appeal
Claims 1, 6—12, 16, 18—24, 28, and 35 are on appeal.2 (Claims
Appendix, Appeal Br. 21—24.) Claims 1 and 35, the only independent
claims on appeal, are illustrative and read as follows:
1. A fast disintegrating oral solid dosage form formulated for pre-gastric
absorption, the dosage form consisting essentially of selegiline as the active
ingredient and comprising selegiline and a carrier in a freeze-dried form
having a porous network structure.
(Id. at 21.)
35. A fast disintegrating oral solid dosage form for the treatment of a
subject having Parkinson’s disease consisting essentially of selegiline or a
salt thereof or a combination thereof as the active ingredient, and one or
more matrix forming agents, in a freeze dried form having a porous network
structure, whereby the selegiline is absorbed through the pre-gastric mucosa
of the subject when the solid dosage form is placed into the oral cavity.
(Id. at 23-24.)
Examiner’s Rejections
1. Claims 1, 6—12, 16, 18—24, 28, and 35 stand rejected under 35 U.S.C.
§ 112 (b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as indefinite.
(Ans. 2-3.)
2. Claims 1, 6—12, 16, 18—24, 28, and 35 stand rejected under pre-AIA
35 U.S.C. § 103(a) as unpatentable over Chiesi,3 citing to the Merck Index4
to show a fact, and Gregory.5 (Id. at 4—9.)
2 Claims 17, 27, and 29—34 are withdrawn from consideration. (Non-Final
Act. dated Oct. 19, 2013, at 2.)
3 Chiesi, US 5,017,607, issued May 21, 1991 (“Chiesi”).
4 The Merck Index, Monograph 2893 (11th ed.), 458 (1989) (“Merck
Index”).
5 Gregory et al., US 4,371,516, issued Feb. 1, 1983 (“Gregory”).
2
Appeal 2016-004620
Application 12/782,584
DISCUSSION
We begin with claim construction. See In re Hiniker, 150 F.3d. 1362,
1369 (Fed. Cir. 1998) (“the name of the game is the claim”). Here, we
construe claim 1 as directed to an oral solid dosage form comprising an
active ingredient and a carrier in a freeze-dried form having a porous
network structure, wherein the active ingredient consists essentially of
selegiline. Similarly, we construe claim 35 as directed to an oral solid
dosage form comprising an active ingredient and one or more matrix
forming agents, in a freeze dried form having a porous network structure,
wherein the active ingredient consists essentially of selegiline or a salt
thereof or a combination thereof. Moreover, consistent with claim
construction principles, the active ingredient in the claims is limited to
selegiline (claim 1), or selegiline or a salt thereof or a combination thereof
(claim 35), “and those [e.g. ingredients] that do not materially affect the
basic and novel characteristic(s)” of the claimed invention. In re Herz, 537
F.2d 549, 551-52 (CCPA 1976).
Issue—112
Whether a preponderance of the evidence of record supports the
Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 fail to
comply with 35 U.S.C. § 112 as indefinite.
Analysis
The Examiner rejects (a) claim 1 as indefinite because selegiline is
recited twice, and therefor redundant, and because conflicting transitional
language is used (“consisting essentially of selegiline” and “comprising
selegiline”), and (b) claims 1 and 35 as indefinite because the claims imply
that the carrier is presumably not considered “active,” and because there is
3
Appeal 2016-004620
Application 12/782,584
insufficient antecedent basis for the term “the active ingredient.” (Ans. 2—
3.) Appellants argue that one of ordinary skill in the art would understand
what is claimed. (Appeal Br. 10-13; Reply Br. 1—6.)
Based on our construction of claims 1 and 35, we find that the claim
language is sufficiently clear. See In re Packard, 751 F.3d 1307, 1313 (Fed.
Cir. 2014) (“[H]ow much clarity is required necessarily invokes some
standard of reasonable precision in the use of language in the context of the
circumstances.”). Accordingly, we reverse the Examiner’s rejection under
35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph.
Conclusion
A preponderance of the evidence of record fails to support the
Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 fail to
comply with 35 U.S.C. § 112 as indefinite.
Issue — Obviousness
Whether a preponderance of the evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
The Examiner relies on Chiesi for its teachings of compositions for
treating Parkinson’s disease comprising levodopa methyl ester (LDME) in
combination with deprenyl (selegiline),6 that the compositions can be
administered via oral, buccal or sublingual routes, and that the compositions
may be formulated for immediate release of active principles. (Ans. 4—5.)
6 The Merck Index is relied upon for teaching that deprenyl is synonymous
with selegiline. (Ans. 5.)
4
Appeal 2016-004620
Application 12/782,584
The Examiner relies on Gregory for teaching the claimed carrier and matrix
forming agent.7 (Ans. 6—7.)
Appellants argue that Chiesi “always include [s] LDME” and “does
not teach or suggest a dosage form consisting essentially of selegiline as
the active ingredient.” (Appeal Br. 14.) Appellants further argue that the
claimed invention uses selegiline “alone, without the co-administration of
a second or other active ingredient.” (Id., citing Spec. 17,11. 4—10,
emphasis added.) Moreover, according to Appellants, one of ordinary skill
in the art would understand that LDME “is an active principle [in Chiesi] for
treatment of Parkinson’s disease” that would “certainly materially affect the
basic and novel characteristic(s) of a composition having a different active
ingredient.” (Reply Br. 8.)
We find that Appellants have the better position. Chiesi describes the
combination of LDME and “other active principles,” such as selegiline, as
“improve [ing] the therapeutic action” and otherwise interacting in a manner
that achieves results from the combination of LDME and selegiline. (Chiesi
col. 3,11. 4—18.) From this description, we find that LDME would materially
affect the basic and novel characteristics of the claimed invention.
Accordingly, the rejection for obviousness is reversed.
Conclusion of Law
A preponderance of the evidence of record fails to support the
Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 are
obvious under 35 U.S.C. § 103(a).
7 Appellants acknowledge that “Gregory is the U.S. counterpart of UK
Patent No. 1,548,022, which is described in Appellants’] specification as a
particularly preferred dosage form.” (Appeal Br. 15.)
5
Appeal 2016-004620
Application 12/782,584
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
6