Ex Parte Liu et al

Patent Trial and Appeal Board

Jul 26, 2016

12598138 (P.T.A.B. Jul. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/598, 138 10/29/2009 Fang Liu
22850 7590 07/28/2016
OBLON, MCCLELLAND, MAIER & NEUSTADT, LLP,
1940 DUKE STREET
ALEXANDRIA, VA 22314
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.
349750USOPCT 6534
EXAMINER
ROBINSON, LISBETH C
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/28/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
patentdocket@oblon.com
oblonpat@oblon.com
ahudgens@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FANG LIU, ABDUL W. BASIT, ROSARIO LIZIO,
HANS-ULRICH PETEREIT, CHRISTIAN MEIER,
and MICHAEL DAMM
Appeal2013-007658
Application 12/598,138
Technology Center 1600
Before ERIC B. GRIMES, CHRISTOPHER G. P AULRAJ, and
TA WEN CHANG, Administrative Patent Judges.
P AULRAJ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
pharmaceutical solid dosage form. The Examiner rejected claims 1-11 for
obviousness and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as the EVONIK ROEHM
GmbH (see Appeal Br. 2).
Appeal2013-007658
Application 12/598,138
STATEMENT OF THE CASE
Background
The invention described in the Specification relates generally to an
enteric coated pharmaceutical dosage form designed to remain intact in the
stomach and then to release the active substance in the intestine. Spec. i-f 2.
As noted in the Specification, "[a ]lmost all the currently used enteric
materials are synthetic or modified natural polymers containing ionizable
carboxylic groups," wherein "[i]n the low pH environment of the stomach,
the carboxylic groups remain un-ionized, and the polymer coatings remain
insoluble" and wherein "in the intestine, the pH increases to 5 and above,
allowing the carboxylic groups on the polymeric coating materials to ionize,
and the polymer coatings to disintegrate or dissolve, releasing their
contents." Id. i-f 3. The Specification, however, notes that there is a
discrepancy between in vitro and in vivo performance of enteric coatings.
Id. i-f 5. As a result, "[t]he actual observation is that solid dosage forms
having the enteric coatings of the state of art do not rapidly disintegrate on
entry into the small intestine" and this delay could lead to ineffective drug
therapy. Id. i-f 11.
"Therefore the object of the present invention is to provide solid
dosage forms with enteric coatings where the drug release is faster at lower
pH compared to state of art solid dosage forms." Id. i-f 13.
The Claims
Claims 1-11 are under appeal, and are reproduced in the Claims
Appendix of the Appeal Brief. Independent claim 1 is representative and
reads as follows:
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Application 12/598,138
1. A solid dosage form comprising
an inner coating located between a core containing a
pharmaceutically active ingredient and an outer enteric coating;
wherein said inner coating comprises a partially
neutralized anionic polymeric material, and at least a carboxylic
acid having 2 to 16 carbon atoms, the salts thereof or mixtures
of said acid and its salt;
wherein said outer coating comprises an anionic
polymeric material which is less neutralized than the material of
the inner coating or not at all neutralized.
Appeal Br. 25 (Claims App'x).
The Rejections
The Examiner has rejected the claims as follows:
I. Claims 1-11 under 35 U.S.C. § 103(a) as being unpatentable
over Heese2 in view of Lehmann3.
II. Claims 1-11 on the ground of nonstatutory obviousness-type
double patenting as being unpatentable over claims 1-16 of US
Patent 7,932,258 (the '258 patent)4 in view of Heese and
Lehmann.
DISCUSSION
Obviousness Rejection Based on Heese and Lehmann
The Examiner finds that Heese teaches solid dosage forms comprising
an inner coating containing a partially neutralized anionic polymeric
material with a pH of either 5.5 or 7 and an outer coating containing an
2 U.S. Patent No. 6,623,759 B2, issued September 23, 2003.
3 U.S. Patent No. 4,520,172, issued May 28, 1985.
4 U.S. Patent No. 7,932,258 B2, issued April 26, 2011.
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Application 12/598,138
anionic polymeric non-neutralized material with pH of 2-3. See Final Act. 5
(i-f 15). The Examiner asserts that the teachings of Heese satisfy the
requirements of claim 1 with the exception that Heese "do[ es] not teach a
dosage form having carboxylic acids or inorganic acids or salts thereof, in
the inner layer." Id. at 6 (i-f 21).
The Examiner relies upon Lehmann to cure this deficiency of Heese.
Specifically, the Examiner relies upon Lehmann's teaching that "suitable
alkaline substances include hydroxides but also salts of organic acids such as
trisodium citrate (i.e., an alkali metal salt ... )." Id. (i-f 23) (citing Lehmann,
4:55---60). The Examiner asserts that
it would have been obvious to one of ordinary skill in the art at
the time the invention was made to modify the solid dosage
forms of Example 6 in Heese ... by substituting trisodium
citrate for the alkaline substance because Lehmann ...
teach[ es] that these salts are suitable for use neutralizing
anionic polymers,
and "[ m ]oreover, a skilled artisan reading Heese ... would be motivated to
select a salt of a weak acid for its capacity to more readily buffer the inner
layer closer to the preferred pH of 5.5 than sodium hydroxide." Id. at 7 (i-f
24).
Appellants argue that "Heese teaches the ordinary artisan that ( 1)
alkali metal hydroxides should be used to partially neutralize the anionic
polymer material and (2) salts of strong bases and weak acids should not be
used to partially neutralize the anionic polymer material." Appeal Br. 11
(citing Heese, 2:50---62). More specifically, Appellants assert that Heese
teaches away from the claimed invention because the use of an alkali metal
salt of an organic acid such as sodium acetate or trisodium citrate to partially
neutralize the anionic polymer material of the intermediate layer of its
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Application 12/598,138
dosage form will "increase[] the acidity of the intermediate layer to a level
below a pH of 5.5, and are likely to promote the destruction [of] the drugs
Omeprazole, Lansoprazole, and Pantoprazole which Heese seeks to deliver
from a stabile [sic] pharmaceutical delivery form to the intestines of
patient[s] in need." Id. at 13. Appellants also argue that "persons having
ordinary skill in the art would have had no incentive, motivation, or other
reason to replace Lehmann's preferred NaOH and ammonia with trisodium
citrate for Reese's purposes." Id. at 18.
We find that Appellants have the better position. The Examiner's
rationale for including trisodium citrate in the intermediate layer of Heese' s
formulation is that Lehmann teaches that sodium hydroxide and trisodium
citrate are equivalent for neutralizing acid groups. Ans. 7. Lehmann,
however, does not suggest that sodium hydroxide and trisodium citrate are
equivalent for all formulations, or even for the partially neutralized
intermediate layer in the formulation taught by Heese. To the contrary, we
agree with Appellants that Heese indicates that not all alkalizing or
neutralizing agents are suitable for its intermediate layer. See, e.g., Heese,
5: 51-54 ("Buffering and/ or alkalizing additives in the intermediate layer as
proposed in EP 0 24 7 983 are no longer necessary and can even be
damaging because they increase solubility of the intermediate layer and
reduce its protective function."). Contrary to the Examiner's reasoning,
Heese does not merely teach that the use of certain alkalizing or buffering
agents "may be somewhat inferior." Ans. 8. Rather, Heese plainly
discourages the use of the solution claimed by suggesting that buffering
and/or alkalizing additives "can even be damaging." See In re Fulton, 391
F.3d 1195, 1201 (Fed. Cir. 2004). The Examiner has, therefore, not
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Application 12/598,138
demonstrated by a preponderance of the evidence that the skilled artisan
would have considered trisodium citrate to be a suitable alkalizing additive
for the partially neutralized polymer in the intermediate layer of Heese.
We determine that the Examiner has not made a prima facie showing
of obviousness based on the combination of Heese and Lehmann.
Obviousness-Type Double Patenting Rejection
The Examiner's obviousness-type double patenting rejection relies
upon the same teachings of Heese and Lehmann, and the same rationale that
we found insufficient to sustain the obviousness rejection. See Final Act.
12-13. Accordingly, for the reasons discussed above, we also determine
that the Examiner has not made a prima facie showing for the obviousness-
type double patenting rejection.
DECISION
We reverse the obviousness rejection under 35 U.S.C. § 103.
We reverse the obviousness-type double patenting rejection.
REVERSED
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