Ex Parte Chow et al

Patent Trial and Appeal Board

Apr 25, 2013

11265918 (P.T.A.B. Apr. 25, 2013)

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.
11/265,918 11/03/2005 San-Laung Chow BIOK/0010 7812
26290 7590 04/25/2013
PATTERSON & SHERIDAN, L.L.P.
3040 Post Oak Blvd.
Suite 1500
Houston, TX 77056
EXAMINER
BREDEFELD, RACHAEL EVA
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
04/25/2013 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 SAN-LAUNG CHOW, DAVID WONG,
and DAMIAN GARCIA
__________

Appeal 2011-010654
Application 11/265,918
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to pharmaceutical compositions comprising bupropion. The
claims have been rejected as obvious, and as failing to comply with the
written description requirement. We have jurisdiction under 35 U.S.C.
§ 6(b).
Appeal 2011-010654
Application 11/265,918

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STATEMENT OF THE CASE
Claims 1, 2, 4, 5, 9-11, 15, 16, 18, 19, 23-25, and 35-43, are pending
and on appeal. Claims 3, 6-8, 12-14, 17, 20-22, 26-34, and 44 have been
canceled (App. Br. 5).
The Examiner relies on the following evidence:
Olsson et al. US 5,952,005 Sep. 14, 1999
Chen et al. WO 00/50010 A1 Aug. 31, 2000
Breitenbach et al. US 6,350,398 B1 Feb. 26, 2002
Chen at el. US 6,485,748 B1 Nov. 26, 2002
Zhou et al. US 2004/0037883 A1 Feb. 26, 2004
The claims stand rejected as follows:
I. Claims 35-42 under 35 U.S.C. § 103(a) as unpatentable over
Zhou and Chen '010 (Ans. 5-7).
II. Claim 43 under 35 U.S.C. § 103(a) as unpatentable over Zhou,
Chen '010, and Olsson (Ans. 7-8).
III. Claims 1, 2, 4, 9, 11, 15, 16, 18, 23, and 25 under 35 U.S.C.
§ 103(a) as unpatentable over Zhou, Breitenbach, and Chen '748 (Ans. 8-
10).
IV. Claims 10 and 24 under 35 U.S.C. § 103(a) as unpatentable
over Zhou, Breitenbach, Chen '748, and Chen '010 (Ans. 10-11).
V. Claims 5 and 19 under 35 U.S.C. § 103(a) as unpatentable over
Zhou, Breitenbach, Chen '748, and Olsson (Ans. 11-13).
VI. Claims 1, 2, 4, 5, 9-11, 15, 16, 18, 19, and 23-25 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement (Ans. 4-5).
Appeal 2011-010654
Application 11/265,918

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OBVIOUSNESS
Principles of Law
A rejection on the ground of obviousness must include “articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
[An invention] composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. . . . [I]t can be important
to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in
the way the claimed new invention does.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
REJECTIONS I & II
Claims 35-42 stand rejected as unpatentable over Zhou and Chen '010,
while claim 43, which depends from independent claim 35, stands rejected
over Zhou, Chen '010, and Olsson.
Independent claim 35 is as follows:
35. An extended release pharmaceutical composition, comprising:
a tablet core of a pharmaceutical mixture comprising bupropion;
a first coating layer surrounding the tablet core, the first coating layer
comprising:
a pharmaceutically acceptable pH-independent polymer; and
sodium lauryl sulfate; and
a second coating layer surrounding the first coating layer, the second
coating layer comprising:
a pharmaceutically acceptable coating mixture, wherein the coating
mixture comprises at least one of an enteric polymer, a pharmaceutically
acceptable salt, disintegrants, a colorant, a plasticizer, a water-soluble
polymer, a water-insoluble polymer, a dye, a pigment, a rapid-disintegrating
coating material, excipients, fillers, binders, blending agents, or
combinations thereof.
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Findings of Fact
1. Zhou discloses a “monolithic stable controlled release coating
for use in coating oral pharmaceutical dosage forms” (Zhou ¶ 16), including
oral dosage forms of bupropion (id., Example 2).
2. Zhou’s controlled release coating comprises an aqueous
dispersion of a neutral ester polyester copolymer without any functional
groups, e.g., Eudragit® NE30D; a poly glycol; and one or more
pharmaceutically acceptable excipients, e.g., sodium laurel sulfate (Zhou ¶¶
17, 39, 42). Water soluble polymers such as hydroxypropyl methylcellulose
(HPMC), “may also be included in the coat to promote wetting of the coat
when in contact with gastrointestinal fluids” (id. at ¶ 39).
3. Zhou teaches that Eudragit® NE30D is “insoluble over the
entire physiological pH range but will . . . swell in water and give permeable
membranes . . . and is thus suitable for the development of pH-independent
modified-release oral dosage forms” (Zhou ¶ 5).
4. Chen '010 discloses a controlled release formulation of
bupropion hydrochloride comprising a combination of pellet A “having a
core which comprises bupropion hydrochloride and hydroxypropyl
methylcellulose . . . and a coating which comprises a mixture of an acrylic
resin which is soluble in acidic media and ethyl cellulose” (Chen '010 1: 34 -
2: 1), and pellet B “having a core which comprises bupropion hydrochloride
and hydroxypropyl methylcellulose . . . ; an inner coating which comprises a
mixture of an acrylic resin which is soluble in acidic media and a water
insoluble polymer and an outer coating which comprises an enteric coating
polymer” (id. at 2: 3-8). Pellets A and B are blended together and placed in
a gelatin capsule or compressed into a tablet (id. at 5: 7-20).
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Discussion
The Examiner finds, in relevant part, that Zhou discloses a bupropion
HCl tablet that meets the limitations of independent claim 35, except that
Zhou’s tablet lacks “a second coating comprising enteric polymers” (Ans.
6). The Examiner finds that Chen '010 discloses “a controlled release
dosage form . . . which comprises a core containing bupropion hydrochloride
. . . and an enteric coating” (id.).
The Examiner concludes that it would have been obvious “to add
enteric polymers, such as cellulose acetate phthalate or methacrylic acid
polymers, in a second coating to the bupropion HCL tablets of Zhou . . . in
order to control the location in the digestive system where bupropion is
absorbed” (id. at 6-7), specifically, “to prevent release of the bupropion
before it reaches the small intestine” (id. at 6).
We agree with Appellants that the Examiner has not established that
one of ordinary skill in the art would have had reason “to add the enteric
coating of Chen ['010] to the monolithic stable controlled release coating of
Zhou” (Reply Br. 5), particularly as Zhou’s coating is so different from Chen
'010’s inner coating. That is, Chen '010’s enteric coating is applied to an
“inner coating which comprises a mixture of an acrylic resin which is
soluble in acidic media and a water insoluble polymer” (FF4), while Zhou
“achieves its stated goal of controlled or sustained release” (Reply Br. 5) by
coating a bupropion tablet core with a water-swellable, pH-independent
polymer, which coating may further comprise sodium laurel sulfate and a
water soluble polymer (FFs 2, 3).
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The rejection of claims 35-42 as unpatentable over Zhou and Chen
'010 is reversed, as is the rejection of claim 43 over Zhou, Chen '010, and
Olsson.
REJECTIONS III-V
Claims 1, 2, 4, 9, 11, 15, 16, 18, 23, and 25 stand rejected as
unpatentable over Zhou, Breitenbach, and Chen '748. In addition, claims 10
and 24 stand rejected as unpatentable over Zhou, Breitenbach, Chen '748,
and Chen '010, while claims 5 and 19 stand rejected as unpatentable over
Zhou, Breitenbach, Chen '748, and Olsson.
Claims 1 and 15, the only independent claims involved in rejections
III-V, are representative:
1. A pharmaceutical composition, comprising:
a tablet core comprising bupropion; and
two coatings surrounding the tablet core, the coatings comprising a
pharmaceutically acceptable pH-independent polymer, sodium lauryl sulfate,
and a pharmaceutically acceptable salt.
15. An extended release pharmaceutical composition, comprising:
a tablet core of a pharmaceutical mixture comprising bupropion; and
one or more coating layers surrounding the tablet core, the one or more
coating layers comprising:
a pharmaceutically acceptable pH-independent polymer;
sodium lauryl sulfate; and
a pharmaceutically acceptable salt.
Additional Findings of Fact
5. Breitenbach discloses “multiply coated solid dosage forms” of
active ingredients in which a core containing the active ingredient is
“treat[ed] with a coating agent . . . followed by application of one or more
other coating agents, which may be identical or different” (Breitenbach, col.
7, ll. 13-16).
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6. Chen '748 discloses a controlled release tablet with a core
comprising an active agent and a membrane coating which may include a
water-soluble channeling agent, e.g., sucrose, lactose, dextrose, sodium
chloride, sorbic acid, potassium chloride, polyethylene glycol, and propylene
glycol, which dissolves in water and “allows water to be imbibed into the
core” (Chen '748, col. 5, ll. 34-43).
Discussion
The Examiner finds that Zhou discloses a bupropion tablet with a
single coating comprising a pH-independent polymer and sodium laurel
sulfate (Ans. 8), while Breitenbach discloses coated solid dosage forms with
multilayer coatings which may be identical or different (id. at 9).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art to add a second coating to Zhou’s coated tablet (Ans.
9), as Breitenbach teaches that it is conventional to coat tablets with
successive layers of the same composition. In any case, we note that
independent claim 15 merely requires a bupropion core with “one or more
coating layers,” which encompasses a core with only a single coating layer.
The Examiner acknowledges that Zhou does not teach that its coating
includes a pharmaceutically acceptable salt (Ans. 9). However, the
Examiner finds that Chen '748 discloses a controlled release tablet with a
core and a coating comprising a water-insoluble polymer in combination
with an enteric polymer and a “water soluble channeling agent,” e.g., a
pharmaceutically acceptable salt such as sodium chloride or potassium
chloride (id. at 10), which “dissolves in water to form a porous polymer shell
that allows water to be imbibed into the core” (id.).
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The Examiner further concludes that it would have been obvious for
one of ordinary skill in the art “to use a salt within the obvious coatings of
Zhou . . . because the salt can affect the release of the dosage form by
controlling the amount of water imbibed into the core as taught by [Chen]
'748” (id.).
Appellants contend that Zhou, Breitenbach, and Chen '748 “fail[] to
teach, show, or suggest . . . a tablet core comprising bupropion, and two
coatings surrounding the tablet core, the coatings comprising a
pharmaceutically acceptable pH-independent polymer, sodium lauryl sulfate,
and a pharmaceutically acceptable salt, as recited in independent claim 1”
(App. Br. 18), and likewise “fail[] to teach, show, or suggest . . . a tablet core
of a pharmaceutical mixture comprising bupropion, and one or more coating
layers surrounding the tablet core, the one or more coating layers comprising
a pharmaceutically acceptable pH-independent polymer, sodium lauryl
sulfate, and a pharmaceutically acceptable salt, as recited in independent
claim 15” (id.).
Nevertheless, the Examiner has provided an explanation in support of
her conclusion that the claimed dosage forms would have been obvious over
the combined teachings of Zhou, Breitenbach, and Chen '748. The bare
assertion that the combined references fail to teach, show, or suggest the
claimed invention does not persuade us that the Examiner’s rationale is
flawed.
Accordingly, the rejection of claims 1 and 15 as unpatentable over
Zhou, Breitenbach, and Chen '748 is affirmed, as is the rejection of the
remaining claims 2, 4, 9, 11, 16, 18, 23, and 25, as they were not separately
argued. See 37 C.F.R. § 51.37(c)(1)(vii).
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In addition, the rejection of dependent claims 10 and 24 over Zhou,
Breitenbach, Chen '748, and Chen '010, and the rejection of dependent
claims 5 and 19 over Zhou, Breitenbach, Chen '748, and Olsson, are
affirmed as well, as Appellants rely on the same arguments made with
respect to claims 1 and 15. These arguments are unpersuasive for the same
reasons discussed above.
WRITTEN DESCRIPTION
VI
Claims 1, 2, 4, 5, 9-11, 15, 16, 18, 19, and 23-25 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We will reverse this rejection for the reasons set forth on page 9 of
Appellants’ Appeal Brief.
SUMMARY
I. The rejection of claims 35-42 under 35 U.S.C. § 103(a) as
unpatentable over Zhou and Chen '010 is reversed.
II. The rejection of claim 43 under 35 U.S.C. § 103(a) as
unpatentable over Zhou, Chen '010, and Olsson is reversed.
III. The rejection of claims 1, 2, 4, 9, 11, 15, 16, 18, 23, and 25
under 35 U.S.C. § 103(a) as unpatentable over Zhou, Breitenbach, and Chen
'748 is affirmed.
IV. The rejection of claims 10 and 24 under 35 U.S.C. § 103(a) as
unpatentable over Zhou, Breitenbach, Chen '748, and Chen '010 is affirmed.
V. The rejection of claims 5 and 19 under 35 U.S.C. § 103(a) as
unpatentable over Zhou, Breitenbach, Chen '748, and Olsson is affirmed.
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VI. The rejection of claims 1, 2, 4, 5, 9-11, 15, 16, 18, 19, and 23-
25 under 35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement is reversed.
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-IN-PART

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