Ex Parte Shah et al

Patent Trial and Appeal Board

Mar 8, 2017

10671138 (P.T.A.B. Mar. 8, 2017)

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.
10/671,138 09/23/2003 Indukumar G. Shah MCP-5013 7577
27777 7590 03/10/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
03/10/2017 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte INDUKUMAR G. SHAH, CHRISTOPHER E. SZYMCZAK,
ANTHONY A. OSEI, and KARL J. PRUSS1
Appeal 2016-004774
Application 10/671,138
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition comprising caffeine and a cephalagic, which
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification describes a solid pharmaceutical composition
comprising caffeine and a cephalagic such as an analgesic or a non-steroidal
anti-inflammatory drug. Spec. 1. The caffeine is uncoated and has a particle
1 Appellants identify the Real Party-in-Interest as McNeil-PPC, Inc. Br. 2.
Appeal 2016-004774
Application 10/671,138
size of from 70 to 600 microns. Id. The resulting composition provides for
fast dissolution of the caffeine. Id.
Claims 1—6 and 14—17 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A solid pharmaceutical dosage form comprising about 5 mg to about
400 mg caffeine, a disintegrant selected from the group consisting of
sodium starch glycolate, crosslinked carboxymethylcellulose, and
mixtures thereof, and a cephalagic, wherein said caffeine is in the
form of uncoated ungranulated particles having a granular
morphology and an average particle size of about 70 to 600 microns,
and wherein at least 86% of said caffeine dissolves within 5 minutes,
when measured by USP, Type II Apparatus (Paddles) set at 50 rpm.
Claims 1—6 and 14—17 have been rejected under35 U.S.C. 103(a) as
unpatentable over Tencza2 in view of Schroeder3 and Remington4.
DISCUSSION
Issue
The issue with respect to this rejection is whether the evidence of
record supports the Examiner’s conclusion that the claims would have been
obvious over Tencza combined with Schroeder and Remington.
The Examiner finds that Tencza teaches a solid composition
comprising caffeine, ibuprofen, acetaminophen and disintegrants. Final Act.
4. The Examiner finds that Tencza teaches using caffeine in amounts of
from 30 mg to 130mg. Id. The examiner finds that Tencza teaches caffeine
having a particle size of from 20 to 100 mesh which is equivalent to 841 to
2 Tencza et al., CA 1,336,687, issued Aug. 15, 1995 (“Tencza”).
3 Schroeder et al., US 6,602,520 Bl, issued Aug. 5, 2003 (“Schroeder”).
4 Remington’s Pharmaceutical Sci. 18th ed. 1637 (1990) (“Remington”).
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159 microns. Final Act 5. The Examiner finds that the caffeine granules in
Tencza may be uncoated and Tencza teaches that 80% of the active
ingredients in the tablets dissolve within 5 minutes. Final Act. 6. The
Examiner acknowledges that Tencza does not teach the specific disintegrants
sodium starch glycolate and cross-linked carboxymethylcellulose or
mixtures thereof. Final Act. 7. The Examiner relies on Schroederand
Remington for this teaching.
The Examiner finds that Schroeder teaches the use of
carboxymethylcellulose as a disintegrant and that Remington teaches the use
of sodium starch glycolate as a disintegrant. Final Act. 6. The Examiner
finds that Schroeder teaches “rapidly disintegrating preparations containing
at least one active pharmaceutical ingredient and at least one excipient” and
that it specifically teaches ibuprofen, caffeine and [a] disintegrating agents
cross-linked carboxymethylcellulose.” Id.
The Examiner concludes that
[i]t would have been obvious to one skilled in the art at the time
the invention was made to prepare additional beneficial solid
pharmaceutical compositionshaving good dissolution rate
containing active and useful drugs such as acetaminophen
(elected) in combination with caffeine and a disintegrant
because amount of caffeine and particle size overlaps with the
prior art. Regarding the limitation of 86% and 95% dissolution
in less than 5 minutes in present claim 1, Tencza et al. teach
80% of the caffeine in their caffeine composition tablet
dissolves within 5 minutes using aUSP paddle apparatus,
known as Apparatus 2, rotated at 50 rpm (figure 1 and pages
20-21). Since the dissolution rate depends upon the particle
size, and amounts of caffeine along with amounts of
disintegrant, the drug and various other factors, it would have
been obvious to one skilled art to adjust the rate as needed.
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Application 10/671,138
Applicants specification does not show any example of claimed
invention where amount of acetaminophen.
Final Act. 7.
Appellants contend that Tencza teaches a composition where the
caffeine particles are granulated as opposed to the present invention where
the caffeine particle are not granulated. Br. 5—6. Appellants argue that the
combined references do not teach a solid pharmaceutical product where the
caffeine is ungranulated and uncoated. Id. Appellants argue that the
composition resulting from the combined references would not exhibit a
dissolution rate of at least 86% of the caffeine within 5 minutes. Br. 6.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF1. Tencza discloses solid pharmaceutical compositions
comprising ibuprofen, acetaminophen and caffeine. Tencza Abstract.
FF2. Tencza discloses a formulation comprising 100 mg ibuprofen,
250 mg acetaminophen, 65 mg caffeine and micro crystalline cellulose
wherein the caffeine is uncoated and can be a powder or granular with a
particle size of from 20 mesh to 100 mesh. Tencza 23.
FF3. Tencza teaches that the caffeine dissolution rate for the above
formulation is 80% within 5 minutes. Tencza 6A, Figure 2.
FF4. Schroeder teaches the preparation of rapidly disintegrating
pharmaceutical compositions containing at least one active ingredient.
S chro eder Ab strac t.
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Application 10/671,138
FF5. The active ingredients in Schroeder include analgesics such as
ibuprofen and caffeine. Schroeder col. 3,11. 25—30 and col.4,1. 1.
FF6. Schroeder teaches the use of “so-called superdisintegrants”
including crosslinked carboxymethylcellulose. Schroeder col. 5,11. 3—13.
FF7. Remington teaches that sodium starch glycolate is a “super
disintegrant” for use in pharmaceutical compositions. Remington 1637.
Principles of Law
“The test of obviousness vel non is statutory. It requires that one
compare the claim’s ‘subject matter as a whole’ with the prior art ‘to which
said subject matter pertains.’” In re Ochiai, 71 F.3d 1565, 1569 (Fed. Cir.
1995) (quoting 35 U.S.C. § 103).
“[Wjhere the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation.” In reAller, 220 F.2d 454, 456 (CCPA 1955).
Analysis
Claim 1 is representative or the rejected claims and is directed to a
solid pharmaceutical composition comprising caffeine, a cephalagic and a
disintegrant.
We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one skilled in the art at the time the invention was
made. Tencza discloses a solid pharmaceutical comprising ibuprofen,
acetaminophen and caffeine. FF1. The amounts and particle sizes of
caffeine taught in Tencza overlap with the amounts and sizes recited in
claim 1. FF2. The caffeine in Tencza is uncoated and is in either powder or
granular form. FF2. The dissolution rate for the caffeine used in Tencza is
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Application 10/671,138
86% within 5 minutes. FF3. Schroederand Remington teach the use of
“super disintegrants” which include crosslinked carboxymethylcellulose and
sodium starch glycolate. FF6 and 7. We agree with the Examiner that one
skilled in the art would have been motivated to combine the teachings of the
references to improve the dissolution of caffeine. Ans. 11.
Appellants argue that the references do not teach achieving the recited
dissolution rate. Br. 6. We are unpersuaded. As the Examiner points out,
adjusting the dissolution rate would have been a matter of routine
optimization. Final Act. 7.
Appellants also argue that the references do not teach ungranulated
uncoated caffeine. We remain unpersuaded. Tencza specifically teaches
using caffeine in an ungranulated form (powder or granular) and which is
uncoated. FF2.
Turning to the Declaration of Mr. Szymczak5, the declaration is
unpersuasive as it only addresses the issue of granulated versus granular
particles. As discussed above, Tencza discloses granular caffeine particles,
i.e. particles that are not formed through compression or wetting, that meet
the claimed size limitations. Tencza recognizes the difference “between a
granulation form and a granular form of an ingredient that is to be
compressed into a tablet.” Tencza 7, see also 6A (“IBU, APAP and caffeine
were used in the form of powders or granules as distinguished from a
granulation form”). The declaration does not persuade us that Tencza’s
granular form of caffeine is not meet the claimed “uncoated ungranualted
5 Declaration under 37 C.F.R. § 1.132, filed May 13, 2015 (“Decl.”).
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particles” as claimed. Because the declaration does not present evidence of
unexpected results, we agree with the Examiner that declaration is
insufficient to overcome the prima facie case of obviousness presented. See
Ans. 11.
Conclusion of Law
We conclude that the evidence of record supports the Examiner’s
conclusion that claim 1 would have been obvious over Tencza combined
with Schroederand Remington under 35 U.S.C. § 103(a).
Claims 2-6 and 14—17 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
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
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