Tsu-I Wang et al.

Patent Trials and Appeals Board

Mar 20, 2020

14011552 - (D) (P.T.A.B. Mar. 20, 2020)

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.
14/011,552 08/27/2013 Tsu-I Catherine Wang 47658/15-227 4893
135404 7590 03/20/2020
GableGotwals
1100 ONEOK Plaza, 100 West 5th Street
Tulsa, OK 74103-4217
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
03/20/2020 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 TSU-I CATHERINE WANG and BRUCE VINCENT BIUNDO
____________

Appeal 2019-006685
Application 14/011,552
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JAMIE T. WISZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 6, 7, 9, and 11–20 (see Final Act.2 1). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Professional
Compounding Centers of America (100%)” (Appellant’s January 30, 2019
Appeal Brief (Appeal Br.) 2). Because Appellant’s Appeal Brief is not
paginated, all reference to a page numbers refer to this document as if it
were numbered consecutively starting with the first page.
2 Examiner’s May 29, 2018 Final Office Action.
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STATEMENT OF THE CASE
Appellant’s “disclosure relates in general to transdermal delivery of
pharmaceutical active ingredients, and more particularly to compositions and
methods for anastrozole transdermal compositions” (Spec.3 ¶ 3).
Appellant’s claims 6 and 17 are reproduced below:
6. A method of increasing hormone levels consisting of:
administering to the skin of a patient a pharmaceutical
composition consisting of anastrozole and a permeation
enhancer.
(Appeal Br. 13.)
17. The method according to claim 6, wherein the
pharmaceutical composition is formulated as an ointment,
cream, gel, lotion, solution, or paste.
(Id. at 15.)

Ground of rejection before this Panel for review:
Claims 6, 7, 9, and 11–20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Xi4 and Banov.5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Xi discloses the formulation of “monolithic drug-in-adhesive patches
containing anastrozole and the evaluation of the transdermal site-specific

3 Appellant’s August 27, 2013 Specification.
4 Xi et al., Transdermal patches for site-specific delivery of anastrozole: In
vitro and local tissue disposition evaluation, 391 International Journal of
Pharmaceuticals 73–78 (2010).
5 Banov et al., US 2012/0201871 A1, published Aug. 9, 2012.
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delivery of anastrozole from a transdermal patch system in vitro as well as
local tissue disposition studies,” wherein “[t]he effect of enhancers and the
drug content on anastrozole transport across female rat skin was evaluated”
(Xi § 1; see Ans.6 4).
FF 2. Xi discloses that its
drug-in-adhesive transdermal patches containing anastrozole
were prepared by dissolving anastrozole, [pressure sensitive
adhesives (PSAs)] . . ., and enhancers in ethyl acetate and
mixed thoroughly with a mechanical stirrer to obtain a
homogeneous coating formulation. . . . The resulting
formulation was coated onto a fluoropolymer-treated polyester
release liner. . . . The coated release liner was oven-dried at 60
ºC for 10 min and after removal of the solvent, then it was
laminated with a polyester backing film.
(Xi § 2.3; see generally Ans. 4 (Examiner finds that Xi discloses that “the
drug-in-adhesive design, the simplest form for a transdermal patch system,
as the drug and any excipients are directly loaded or dispersed into the PSA
polymer, the PSA used has a unique influence on this very simple design”
and “the anastrozole, PSAs, and enhancers form a homogenous coating
formulation”).)
FF 3. Examiner finds that Xi does not disclose a “penetration enhancer of
the species election”,7 i.e. pracaxi oil, and relies on Banov to make up for
this deficiency in Xi (see Ans. 4–5).

6 Examiner’s July 10, 2019 Answer.
7 See Examiner’s April 14, 2015 Office Action, Appellant’s April 17, 2015
Response to Restriction Requirement, and Examiner’s June 16, 2015 Office
Action 2 (Examiner finds that Appellant elected the penetration enhancer
“pracaxi oil”).
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CLAIM INTERPRETATION
The method of Appellant’s claim 6 consists of administering a
pharmaceutical composition to the skin of a patient (Appeal Br. 13).
Appellant’s claim 6 defines the pharmaceutical composition as “consisting
of anastrozole and a permeation enhancer” (id.)
As Appellant’s claim 17 makes clear, however, the pharmaceutical
composition of Appellant’s claim 6 may be “formulated” into a suitable
pharmaceutical preparation, such “as an ointment, cream, gel, lotion,
solution, or paste” (see id. at 15; see also Spec. ¶ 40 (“[T]ransdermal
anastrozole may be applied on the body surface as ointments, creams, gels,
lotions, solutions, and pastes, among other suitable pharmaceutical
preparations”)).
ANALYSIS
On this record, Examiner finds that Xi discloses a method consisting
of administering a pharmaceutical composition to skin (see FF 1–2). In this
regard, Xi discloses that its pharmaceutical composition consists of
anastrozole and a permeation enhancer that is formulated as a drug-in-
adhesive transdermal patch, i.e. a suitable pharmaceutical preparation (see
FF 1–2). In addition, Appellant does not dispute Examiner’s finding that
Banov makes obvious Appellant’s elected penetration enhancer, pracaxi oil,
or that a person of ordinary skill in this art, at the time of Appellant’s
claimed invention, would have found it prima facie obvious to utilize
Banov’s pracaxi oil as the penetration enhancer in Xi’s composition (FF 3;
cf. Appeal Br. 1–10).
Therefore, we find no error in Examiner’s conclusion that, at the time
Appellant’s invention was made, it would have been prima facie obvious to
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use Banov’s pracaxi oil as the penetration enhancer in Xi’s pharmaceutical
composition consisting of anastrozole and a penetration enhancer (see Ans.
5–6).
As discussed above, the pharmaceutical composition set forth in
Appellant’s claim 6, which consists of anastrozole and a penetration
enhancer, may be formulated into a suitable pharmaceutical preparation.
The evidence on this record supports a conclusion that a drug-in-adhesive
transdermal patch is a suitable pharmaceutical preparation (see FF 1–2).
Therefore, we are not persuaded by Appellant’s contention that Xi “does not
read upon Appellant’s method where the treatment consists of application of
anastrozole and a permeation enhancer,” because “Xi’s treatment method
requires a . . . [drug-in-adhesive transdermal patch]” (Appeal Br. 6; see
Reply Br.8 2 (Appellant contends that “Xi teaches only treatment methods
that require an adhesive patch and therefore it does not read upon
Applicant’s claimed method where the treatment consists of application of
anastrozole and a permeation enhancer”)). For the foregoing reasons, we are
not persuaded by Appellant’s contention that its “method requires treatment
without patches and adhesives” (Appeal Br. 7; Reply Br. 2 (“Applicant’s
claim structure would exclude use of a patch or an adhesive from the
method,” because “[c]laim 6 is in closed form such that other claim elements
(e.g., a patch and an adhesive) are excluded”); see generally Appeal Br. 7–
8).
To be clear, the combination of Xi and Banov discloses a method that
consists of administering, to skin, a pharmaceutical composition consisting

8 Appellant’s September 9, 2019 Reply Brief.
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of anastrozole and a penetration enhancer, which is formulated with, inter
alia, PSAs to prepare a drug-in-adhesive transdermal patch (see FF 1–2).
Because the pharmaceutical composition set forth in Appellant’s claim 6
may be formulated into a suitable pharmaceutical preparation (see dependent
claim 17, which depends from claim 6), we are not persuaded by Appellant’s
contention that Xi’s disclosure of PSA or transdermal patches are excluded
from the scope of the claim (see Appeal Br. 6–9; Reply Br. 2–3).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claims 6, 7, 9, and 11–20 under
35 U.S.C. § 103(a) as unpatentable over the combination of Xi and Banov is
affirmed. Claims 7, 9, and 11–20 are not separately argued and fall with
claim 6.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
6, 7, 9,
11–20
103 Xi, Banov 6, 7, 9, 11–
20

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