Ex Parte Smithey et al

Patent Trial and Appeal Board

Apr 17, 2014

10596876 (P.T.A.B. Apr. 17, 2014)

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.
10/596,876 11/28/2006 Daniel Tod Smithey 0003.0551/PC32026A 1776
152 7590 04/17/2014
CHERNOFF, VILHAUER, MCCLUNG & STENZEL, LLP
601 SW Second Avenue
Suite 1600
PORTLAND, OR 97204-3157
EXAMINER
FUBARA, BLESSING M
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
04/17/2014 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 DANIEL TOD SMITHEY, DWAYNE THOMAS FRIESEN,
WARREN KENYON MILLER, and WALTER CHRISTIAN BABCOCK
____________

Appeal 2012-001040
Application1 10/596,876
Technology Center 1600
____________

Before LORA M. GREEN, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
pharmaceutical composition comprising a low-solubility drug. The
Examiner has rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 Appellants identify Bend Research, Inc. as the Real Party in Interest (App.
Br. 1).
Appeal 2012-001040
Application 10/596,876

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STATEMENT OF THE CASE
Claims 45, 46, and 53-62 are on appeal,2 and can be found in the
Claims Appendix of the Appeal Brief. Claim 45 is representative of the
claims on appeal, and reads as follows:
45. A pharmaceutical composition comprising a mixture that
is not a molecular dispersion of the following components:
(1) at least 50 wt% of particles, said particles comprising
a low-solubility drug and a poloxamer, wherein at least 75 wt%
of said drug is amorphous; and
(2) a concentration-enhancing polymer.
The Examiner has rejected claims 45, 46, and 53-62 under 35 U.S.C.
§ 103(a) as unpatentable over Hoover3 in view of Babcock.4

Does the preponderance of the evidence of record support the
Examiner’s conclusion that the claimed pharmaceutical composition is
obvious?

Findings of Fact
1. We adopt the Examiner’s findings and analysis concerning the
scope and content of the prior art (Ans. 5-9). The following facts are
repeated for reference convenience.
2. Hoover disclosed formulating a glycogen phosphorylase
inhibitor (GPI) with a concentration enhancing polymer (Hoover 3: ¶ 0016;
see also Ans. 5).

2 The Examiner acknowledged that claim 53 was inadvertently omitted in
the Final Office Action (Ans. 5), Appellants contend that claim 53 is not
obvious for the same reasons set out for independent claim 45 (App. Br. 4).
3 Dennis J. Hoover et al., US 2001/0053778 A1, published Dec. 20, 2001.
4 Walter C. Babcock et al., US 2001/0053791 A1, published Dec. 20, 2001.
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Application 10/596,876

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3. Hoover disclosed producing layered tablets that contain
amorphous GPI and one or more layers of a concentration enhancing
polymer (Hoover 15: ¶ 0193; see also Ans. 5).
4. Hoover’s disclosed “[e]xamples of matrix materials, fillers, or
diluents include lactose, mannitol, xylitol, microcrystalline cellulose,
calcium diphosphate, and starch.” (Hoover 16: ¶ 0200; see also Ans. 6.)
5. Babcock disclosed
Examples of other matrix materials, fillers, or diluents
include lactose, mannitol, xylitol, dextrose, sucrose, sorbitol,
compressible sugar, microcrystalline cellulose, powdered
cellulose, starch, pregelatinized starch, dextrates, dextran,
dextrin, dextrose, maltodextrin, calcium carbonate, dibasic
calcium phosphate, tribasic calcium phosphate, calcium sulfate,
magnesium carbonate, magnesium oxide, poloxamers such as
polyethylene oxide, and hydroxypropyl methyl cellulose.
(Babcock 12: ¶ 0126 (emphasis added); see also Ans. 6.)

Analysis
Appellants contend that there is no motivation to combine a
poloxamer with the composition of Hoover or Babcock (see App. Br. 4).
We are not persuaded by Appellants’ contention. As acknowledged
by the Examiner, Hoover’s dosage form of GPI and concentration enhancing
polymer does not include the use of a poloxamer (Ans. 6; see also FFs 2-4).
The Examiner concludes that a person of ordinary skill at the time of the
invention, nevertheless, would have been motivated to combine a poloxamer
with a GPI composition containing a concentration enhancing polymer
because poloxamers are listed as one of the possible diluents in Babcock
(Ans. 7; see also FF 5). Specifically, the Examiner reasons that “because
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Application 10/596,876

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Babcock lists poloxamers, lactose, mannitol, xylitol, microcrystalline
cellulose, calcium diphosphate, and starch as diluents, which are also the
diluents listed by Hoover except for poloxamer, it flows any of these
customary diluents can be used with the GPI composition” (id.).
The Examiner explained that:
Babcock has recognized poloxamer as being equivalent to or
interchangeable with the same customary diluents disclosed for
use with GPI in Hoover. A person of ordinary skill in the art
would have recognized the interchangeability of the
“customary” diluents, poloxamer, lactose, mannitol, xylitol,
microcrystalline cellulose, calcium diphosphate, and starch with
the expectation that poloxamer or any of the other
interchangeable diluents would not adversely harm the GPI
composition as taught by Babcock and as recognized by
appellant. Therefore, interchanging poloxamer for any of the
other diluents in Hoover does not play substantially different
role other than diluent. The goal and expectation would be
sustained enhancement of aqueous concentration and
bioavailability of GPI.
(Ans. 8; see also FFs 2-6.)
We agree with the Examiner’s findings and reasoning. “Express
suggestion to substitute one equivalent for another need not be present to
render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA
1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997). “The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Accordingly, we conclude that the preponderance of the evidence of
record supports a prima facie case of obviousness with respect to claim 45,
and Appellants have not provided sufficient evidence of secondary
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Application 10/596,876

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considerations or rebuttal that outweighs the evidence supporting the prima
facie case. As claims 46 and 53-62 have not been argued separately, they
fall with claim 45 as acknowledged by the Appellants (App. Br. 4).
37 C.F.R. § 41.37(c)(1).

SUMMARY
The rejection of the Examiner is affirmed.

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

cdc