Ex Parte Dietrich et al

Patent Trial and Appeal Board

Oct 22, 2012

12153585 (P.T.A.B. Oct. 22, 2012)

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.
12/153,585 05/21/2008 Rango Dietrich 27080UYY 7901
34375 7590 10/22/2012
NATH & ASSOCIATES PLLC
112 South West Street
Alexandria, VA 22314
EXAMINER
WAX, ROBERT A
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
10/22/2012 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 RANGO DIETRICH and HARTMUT NEY
__________

Appeal 2010-012503
Application 12/153,585
Technology Center 1600
__________

Before FRANCISCO C. PRATS, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to oral dosage
forms for administering compounds that treat diseases involving excess
gastric acid secretion. The Examiner entered rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 11, 12 and 14-32 stand rejected and appealed (App. Br. 5).
Claim 11, the only independent claim, is representative and reads as follows:
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Application 12/153,585

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11. An oral fixed combination administration form for an
active compound, which is a pyridin-2-ylmethylsulfinyl-1H-
benzimidazole or a pharmaceutically acceptable salt thereof,
wherein said active compound is in a capsule in two different
administration forms which have a different release of the
active compound, wherein one administration form comprises
the active compound together with a tablet disintegrant and
bears a coating film for sustained-release, and an enteric coating
film being absent, and wherein the other administration form
comprises the active compound and which bears an enteric
coating film.

The following rejections are before us for review:
(1) Claims 11, 12, and 14-32, under 35 U.S.C. § 103(a) as obvious
over Dietrich
1
(Ans. 5-8); and
(2) Claims 11, 12, and 14-32, under 35 U.S.C. § 103(a) as obvious
over Chen
2
and Dietrich (Ans. 11-15).
OBVIOUSNESS – DIETRICH
In rejecting the pending claims as obvious over Dietrich alone, the
Examiner summarized Dietrich as teaching “an oral pantoprazole fixed
combination composition in suitable forms, such as tablets, coated tablets,
pellets and microtablets in capsules. The composition provides delayed and
controlled release of the active ingredient. Dietrich et al. teach tablet
disintegrants, film-forming polymers, enteric coatings and various additives”
(Ans. 7).
Based on these teachings, the Examiner concluded that an ordinary
artisan would have considered it prima facie obvious “to use the specific
teachings of Dietrich et al. who teach a varied release pantoprazole

1
WO 97/02020 A1 (published January 23, 1997).
2
U.S. Patent No. 5,260,069 (issued Nov. 9, 1993).
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formulation comprising disintegrants, film-forming polymers, enteric
coatings, additives and the like to provide a beneficial drug formulation.
The expected result would be an effective formulation in the treatment of
various disorders of the stomach” (id. at 7-8).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Ultimately, “[i]n determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
Here, we agree with Appellants that a preponderance of the evidence
does not support the Examiner‟s finding that Dietrich would have suggested
the claimed dosage form.
Specifically, claim 11, the only independent, recites a capsule that
contains the benzimidazole active agent in two different administration
forms which provide different release of the agent. One of the
administration forms includes the active compound with an enteric coating
film.
The other form includes the active agent, a disintegrant, and a
sustained release coating. Claim 11 specifies, however, that the disintegrant-
requiring form may not have an enteric coating.
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We acknowledge that Dietrich describes dosage forms that contain the
active agent in an extended release portion and a rapid release portion:
Rapid release of part of the pantoprazole and extending
release of another part can be achieved, for example, also by
layered tablets or multilayer tablets, in which case part of the
pantoprazole is present in an outer coating in a form without
retarding its release; this is followed by another coating
containing the antimicrobially-active ingredient and then the
core with the pantoprazole, whose release is extended in a
suitable manner.

(Dietrich 5.) However, while the Examiner reasoned that an ordinary artisan
would have modified Dietrich‟s expressly described dosage forms to instead
prepare the capsule of claim 11 “to provide a beneficial drug formulation”
(Ans. 8), the Examiner points to no evidence of record clearly or specifically
suggesting that the claimed combination of elements would have been
viewed as equivalent to, or useful or suitable as, the therapeutic composition
of Dietrich.
Conclusory statements that lack a rational underpinning or evidentiary
support are inadequate to support a conclusion of obviousness. See KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”); see also In
re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000) (“Whether the Board relies
on an express or an implicit showing, it must provide particular findings
related thereto. Broad conclusory statements standing alone are not
„evidence.‟” (Citation omitted)).
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Moreover, as Appellants argue, Dietrich teaches that an enteric
coating should be used to protect the pantoprazole in its formulations from
the acidity in the stomach, due to the compound‟s acid-lability:
Because of a great tendency to decompose in a neutral
and, in particular, acidic environment, which also results in
highly colored decomposition products, for oral compositions,
it is necessary on the one hand to keep pantoprazole in an
alkaline environment and, on the other hand, to protect it from
exposure to acids. It is generally known to coat tablets or
pellets which contain an acid-labile active ingredient with an
enteric coating which, after passage through the stomach,
rapidly dissolves in the alkaline medium in the intestine. In the
case of pantoprazole, which i[s] very acid-labile, it is necessary
to process it in the tablet core or in pellets in the form of its
alkaline salts, for example as sodium salts, or together with
alkaline substances.

(Dietrich 6; see also id. at 9-14 (working examples of Dietrich consistently
use an enteric outer coating).)
Thus, reading the reference as a whole, we agree with Appellants that
Dietrich would not have prompted an ordinary artisan to prepare a
pantoprazole dosage form without an enteric coating, as claim 11 expressly
requires. Rather, as Appellants argue, an ordinary artisan would have
protected the acid-labile pantoprazole from degradation in the acidic
environment of the stomach by providing an enteric coating.
In sum, we are not persuaded, for the reasons discussed, that a
preponderance of the evidence supports the Examiner‟s prima facie case that
claim 11 would have been obvious to an ordinary artisan in view of Dietrich.
We therefore reverse the Examiner‟s obviousness rejection of that claim, and
its dependents, over Dietrich.

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OBVIOUSNESS – CHEN AND DIETRICH
In rejecting claims 11, 12, and 14-32 as obvious over Chen and
Dietrich, the Examiner cited Chen as disclosing a drug dosage form in which
“a plurality of populations of pellets is provided within a unit dosage form
such as a capsule or tablet” (Ans. 11). The Examiner noted that, due to the
use of coatings containing different ingredients, Chen‟s “dosage units are
readily adaptable to a variety of timing intervals” (id.).
The Examiner further noted that Chen described using enteric
coatings with its dosage forms, and also noted Chen‟s teaching that its
dosage forms could be used to deliver a number of different categories of
drugs (id. at 12). The Examiner conceded, however, that Chen did not teach
delivering the claimed benzimidazoles in its dosage forms (id.).
Nonetheless, the Examiner concluded that “[i]t is deemed obvious to
one of ordinary skill in the art to employ any particular active ingredient,
based on the intended or desired purpose” (id.). The Examiner also reasoned
that, in view of Dietrich‟s teaching of delivering pantoprazole with a varying
release rate, an ordinary artisan would have considered it obvious “to use the
combined teachings of Dietrich et al. with[] Chen to obtain suitable
formulations of a benzimidazole, particularly pantoprazole for treating
gastric acid conditions. The expected result would be a highly effective
pantoprazole composition, which is beneficial for treating disorders of the
stomach, as similarly desired by Applicants” (id. at 13).
While this rejection arguably presents a close case, we again agree
with Appellants that a preponderance of the evidence does not support the
Examiner‟s conclusion of prima facie obviousness.
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We acknowledge that, unlike Dietrich, Chen teaches a dosage form
that includes distinct populations of drug-containing pellets having different
release characteristics (see Chen, abstract). We also acknowledge Chen‟s
disclosure of two strategies for controlling release rate, one of which
includes the use of an enteric coating (see id. at col. 2, ll. 13-31), as well as a
“second means for altering release of the drug compris[ing] the
incorporation into the coating of material which reduces the permeability of
the coating” (id. at col. 2, ll. 33-35). Thus, in one embodiment Chen
describes an aggregate of five distinct types of pellets having a spectrum of
release characteristics allowing extended release of a drug over time (see id.
at col. 5, ll. 32-65).
Accordingly, it might be true that Chen suggests formulations that
include a plurality of pellets, some of which have an enteric coating and
some of which do not, and that a variety of drugs can be delivered using that
approach. Nonetheless, as noted above, Dietrich consistently teaches that
when preparing therapeutic pantoprazole compositions, the dosage form
should include an enteric coating (see Dietrich 6; also, id. at 9-14 (working
examples of Dietrich all use an enteric outer coating)).
We are not persuaded that an ordinary artisan would have been
prompted by Chen‟s generic disclosure of suitable drug dosage forms to
diverge from Dietrich‟s specific teaching that the drug used in its
formulations requires protection by an enteric coating due to its acid lability.
We are, therefore, also unpersuaded that an ordinary artisan would have
considered it obvious, even in light of Chen‟s teachings, to prepare
Dietrich‟s pantoprazole in a dosage form lacking an enteric coating, as
required by Appellants‟ claim 11.
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As we are not convinced, for the reasons discussed, that a
preponderance of the evidence supports the Examiner‟s conclusion that
Chen and Dietrich would have rendered claim 11 prima facie obvious to an
ordinary artisan, we reverse the Examiner‟s rejection of that claim, and its
dependents, over those references.
SUMMARY
We reverse the Examiner‟s obviousness rejection of claims 11, 12,
and 14-32 over Dietrich.
We also reverse the Examiner‟s obviousness rejection of claims 11,
12, and 14-32 over Chen and Dietrich.

REVERSED

cdc