Ex Parte Burke et al

Patent Trial and Appeal Board

Feb 25, 2016

12598476 (P.T.A.B. Feb. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/598,476 11102/2009
22186 7590 02/25/2016
MENDELSOHN DUNLEAVY, P.C.
1500 JOHN F. KENNEDY BL VD., SUITE 312
PHILADELPHIA, PA 19102
FIRST NAMED INVENTOR
Matthew D. Burke
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PU62936 1645
EXAMINER
DEVITO, ALEX T
ART UNIT PAPER NUMBER
2855
MAILDATE DELIVERY MODE
02/25/2016 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 MATTHEW D. BURKE, LIDA KALANTZI, and
ALAN FRANK PARR
Appeal2014-004344
Application 12/598,476 1
Technology Center 2800
Before BEYERL YA. FRANKLIN, MICHAEL P. COLAIANNI, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
COLAIANNI, Administrative Patent Judge.
DECISION ON APPEAL
1 According to Appellants, the real party in interest is Glaxo Group Limited.
Br. 3.
Appeal2014-004344
Application 12/598,476
Appellants appeal under 35 U.S.C. § 134 the final rejection of claims
13-15, 17-26, and 28. We have jurisdiction over the appeal pursuant to
35 U.S.C. § 6(b).
We AFFIRM.
Appellants' invention is directed to a method and an apparatus for
analyzing and/or predicting the release of active agents in pharmaceutical
and pharmaceutical-like products (Spec. 1:10-13).
Claim 13 is illustrative:
13. A method of analyzing the release of an active agent
from a dosage form in a GI tract, the method comprising:
positioning the dosage form in a medium;
circulating the medium;
applying at least one of multiple compression forces
and/ or compression angles to the dosage form to simulate
conditions in the GI tract; and
collecting data representative of the release of the active
agent from the dosage form.
Appellants appeal the following rejections:
1. Claims 13-15 and 17 are rejected under 35 U.S.C. § 102(b) as
unpatentable over Sinnreich et al. (US 5,827 ,984 issued Oct. 27, 1998
(hereinafter "Sinnreich") ).
2. Claims 20-26 and 28 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Sinnreich.
3. Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Sinnreich in view of Hu (US 5,807,115 issued Sept.
15, 1998).
2
Appeal2014-004344
Application 12/598,476
Appellants' arguments focus on the subject matter of claim 13 (Br. 12).
Regarding rejections (2) and (3), Appellants rely on the same arguments
made regarding claim 13 (id. at 13-14). Accordingly, claims 14, 15, 17-26,
and 28 will stand or fall with our analysis of the rejection of claim 13.
FINDINGS OF FACT & ANALYSIS
Appellants argue that Sinnreich fails to teach applying at least one of
multiple compression forces and/or compression angles in a dissolution
device to analyze the release of an active agent from a dosage form (Br. 12).
Appellants contend that Sinnreich cannot anticipate the subject matter of
claim 13 because not all limitations are taught by Sinnreich (id.).
Contrary to Appellants' argument, the Examiner finds that Sinnreich
teaches, at column 6, lines 55-59 and column 7, lines 1-5, applying multiple
compressions to a dosage form to analyze the release of active agent from
the dosage form (Final Act. 2; Ans. 2). Appellants do not specifically
challenge or otherwise show reversible error with the Examiner's findings
regarding Sinnreich's columns 6 and 7 disclosures teaching the use of
multiple compressions on a dosage form to assess its release of active agent
(Br. 12; No Reply Br.). Based upon our review of Sinnreich's column 6 and
7 disclosures, we find that Sinnreich teaches that the agitator 23 can be
moved into and back out of beaker 21 periodically, preferably vertically, as
indicated by double arrow V in Figure 2. By moving the agitator 23 into and
out of the beaker 21, the piston-shaped head portion 24 applies compression
forces on dosage form Din and via test medium P (col. 6, 11. 50-67; col. 7,
11. 1-5). The flow patterns formed in the test medium P by agitator 23 apply
a compression force to the dosage form D to simulate pressure and kneading
3
Appeal2014-004344
Application 12/598,476
forces in the gastrointestinal tract on the dosage form. Id. ivioreover,
Sinnreich discloses that the piston 24 may contact the dosage form to exert a
compression force on the dosage (col. 8, 11. 39-48).
For these reasons and on this record, we affirm the Examiner's§ 102
and § 103 rejection over Sinnreich, and the § 103 rejection over Sinnreich in
view of Hu.
DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
ORDER
AFFIRMED
4