Ex Parte Namburi et al

Board of Patent Appeals and Interferences

Jun 22, 2010

11849505 (B.P.A.I. Jun. 22, 2010)

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.
11/849,505 09/04/2007 Ranga R. Namburi ACC-3 DIV1 5831
54630 7590 06/22/2010
ROBERTS & ROBERTS, LLP
ATTORNEYS AT LAW
P.O. BOX 484
PRINCETON, NJ 08542-0484
EXAMINER
POLANSKY, GREGG
ART UNIT PAPER NUMBER
1614
MAIL DATE DELIVERY MODE
06/22/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RANGA R. NAMBURI, RAMA PRASAD KARRI,
RAVI SRIKANTH TALLAPRAGADA, and BUROISE F. PALKHIWALA
__________

Appeal 2010-001018
Application 11/849,505
Technology Center 1600
__________

Decided: June 22, 2010
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an oral
dosage form. The Examiner has rejected the claims as obvious.1 We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The Examiner also provisionally rejected the claims for obviousness-
type double patenting based on claims in U.S. Patent Application
Appeal 2010-001018
Application 11/849,505

2
STATEMENT OF THE CASE
The Specification discloses that “proton pump inhibitors are a class of
anti-secretory compounds used in the management of gastrointestinal
disorders” (Spec. 1). The Specification discloses that proton pump
inhibitors are typically administered orally as delayed-release dosage forms
because they are destroyed by gastric acid (id. at 3).
Claims 16-23 and 35 are on appeal. Claim 16 is representative and
reads as follows:
16. An oral dosage form comprising:
a core tablet of compressed granules, said compressed granules
comprising:
powder particles comprised of a pharmaceutically acceptable material,
said powder particles having coated thereon a composition comprising, in
admixture: an amorphous, salt form of a benzimidazole proton pump
inhibitor produced in situ; and a pharmaceutically acceptable, water-soluble,
hydrophilic polymer having a surfactant functionality;
which core tablet of compressed granules further comprises at least
one pharmaceutically acceptable disintegrating agent;
a pharmaceutically acceptable sub-coating on the core tablet; and
a pharmaceutically acceptable enteric coating on the sub-coating.

Issue
The Examiner has rejected claims 16-23 and 35 under 35 U.S.C.
§ 103(a) as being obvious in view of Namburi2 and Nonomura.3
The Examiner finds that Namburi discloses “a tablet oral dosage form
comprising microcrystalline cellulose particles coated with … an amorphous

11/191,520. However, that application is now abandoned. Thus, we vacate
the provisional obviousness-type double patenting rejection.

2 Namburi et al., US 2004/0052847 A1, published Mar. 18, 2004.
3 Nonomura et al., US 2006/0057195 A1, published Mar. 16, 2006.
Appeal 2010-001018
Application 11/849,505

3
form of a benzimidazole proton pump inhibitor” (Ans. 4-5). The Examiner
also finds that Namburi discloses “tablet formulations of granules of the
above constituents, further comprising disintegrants and … the optional
application of an external coat to the above coated particles” (id. at 5).
The Examiner finds that Nonomura discloses “a coating between an
amorphous benzimidazole proton pump inhibitor compound … and an outer
enteric coating to protect the proton pump inhibitor from degradation by the
acidic enteric coating” (id.). The Examiner concludes that “it would have
been obvious to the artisan to modify whether to coat the granules or to coat
the compressed tablet of uncoated granules based upon the pharmacokinetic,
pharmacodynamic and manufacturing requirements” (id. at 10).
Appellants contend that the “cited art fails to disclose the presence of
a disintegrating agent within a core tablet of compressed granules, and which
formed tablet is has been thereafter coated with a sub-coating and enteric
coating” (Appeal Br. 6). Appellants urge that “the particular combination of
features of the present invention is not shown or suggested in the applied art,
and that a combining of Namburi and Nonomura would still fail to obviate
the present claims” (id. at 9).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the cited references would have suggested a
dosage form having a core tablet comprising active ingredient granules and
coated by a sub-coating and an enteric coating?
Findings of Fact
1. Namburi discloses a method of making an oral dosage form
comprising coating particles of a core material with a solution containing an
Appeal 2010-001018
Application 11/849,505

4
active agent (among other things), drying the particles, and forming the dried
particles into an oral dosage form (Namburi, 1: ¶¶ 0010-0015).
2. Namburi discloses that “an external coat may be applied to the
active agent coated particles, typically after the drying step” (id. at 1:
¶ 0016).
3. Namburi discloses that the “pellets of the invention can be
formulated into various pharmaceutical dosage forms, including capsules
and tablets. … The tablets are preferably formed from a composition
comprising the particles described herein distributed in a mixture of a
disintegrant and a diluent or filler.” (Id. at 5: ¶ 0078.)
4. Nonomura discloses a solid dosage form comprising
benzimidazole proton pump inhibitor, made
by blending with a non-toxic base, preferably a basic inorganic
salt, furthermore by forming an enteric coating layer and/or a
controlled release coating layer on the core particle containing
these active ingredients, and if necessary, by forming an
intermediate coating layer in order to prevent a direct contact of
the particles with these coating layer.
(Nonomura 2: ¶ 41.)
5. Nonomura discloses that “[i]n the case of intestine disintegrative
dosage form, the granules… [are] preferably prepared as granules having
active ingredients layer…, an intermediate coating layer formed on said
active ingredient layer, and an enteric coating layer or controlled release
coating layer formed on said intermediate coating layer” (id. at 7: ¶ 0103).
6. Nonomura discloses that “granules or fine granules having large
surface area and easy to disintegrate or dissolve quickly is preferred. If
desired, these granules or fine granules may be fomulated as tablets, or
capsules by filling in capsules.” (Id. at 6: ¶ 0098.)
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Application 11/849,505

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7. Nonomura discloses that “in case of capsules or tablets, granules or
fine granules are prepared in advance for the purpose of improving stability
and the like, with which may be formulated into the tablets or capsules” (id.
at 8: ¶ 0121).
Analysis
Claim 16 is directed to an oral dosage form comprising a core tablet
made of compressed granules that are coated with a composition comprising
a benzimidazole proton pump inhibitor, among other things, the core tablet
being coated with a sub-coating and, on that, an enteric coating.
Appellants contend that the “cited art fails to disclose the presence of
a disintegrating agent within a core tablet of compressed granules, and which
formed tablet is has been [sic] thereafter coated with a sub-coating and
enteric coating” (Appeal Br. 6). Appellants argue that, “[i]n contrast, the
cited references individually coat their particles with an intermediate coating
or an enteric coating prior to formulation into a capsule or tablet form” (id.).
Appellants’ arguments are persuasive. The Examiner states that “[i]t
is not uncommon to externally coat tablets” (Ans. 9). The Examiner,
however, has not provided evidence showing that this is the case with
respect to tablets containing benzimidizole proton pump inhibitors: both
Namburi and Nonomura disclose that the particles or granules are coated
before they are formed into a tablet. The Examiner has not pointed to any
reference that discloses coating of the core tablet formed from particles or
granules. Nor has the Examiner adequately explained what
“pharmacokinetic, pharmacodynamic and manufacturing requirements”
(Ans. 6) would have prompted one of ordinary skill in the art to modify the
procedures disclosed in Namburi and Nonomura to coat the tablets, instead
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Application 11/849,505

6
of or in addition to coating the particles or granules. Thus, the rejection of
claim 16, and dependent claims 17-23 and 35, as being obvious in view of
Namburi and Nonomura is reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the cited references would have suggested a dosage form having a core
tablet comprising active ingredient granules and coated by a sub-coating and
an enteric coating.
SUMMARY
We reverse the rejection of claims 16-23 and 35 under 35 U.S.C.
§ 103(a).

REVERSED

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