Ex Parte Upadhyay

Patent Trial and Appeal Board

Nov 14, 2012

09879320 (P.T.A.B. Nov. 14, 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.
09/879,320 06/12/2001 Ajay Hasmukhlal Upadhyay RD 01022 5176
7590 11/15/2012
Rhodia Inc.
CN 7500
8 CEDAR BROOK DRIVE
Cranbury, NJ 08512
EXAMINER
CHANNAVAJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
11/15/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte AJAY HASMUKHLAL UPADHYAY
__________

Appeal 2011-005440
Application 09/879,320
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 09/879,320

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STATEMENT OF CASE
The invention relates to compressible gauifenesin compositions.
(Spec. 1.) The compressible guaifenesin compositions exhibit low capping
(cracking and separation of a part of the dosage form from the body of the
dosage form, if compression forces higher than the critical range are used)
and improved flow properties. (Spec. 2.)

37. A tablet formed by compressing in a tableting press a free flowing
granular composition comprising an agglomerate of guaifensesin and a
binder therefore, said binder comprising from about 1.0 to about 7% by
weight polyvinylpyrrolidone, and from about 0.2 to about 4% by weight of
solubilizer, or distintegrant, or solubilizer and disintegrant; and from about
0.1 to about 2 wt % of a lubricant; wherein the free flowing agglomerate
exhibits a flow rate greater or equal to 6.5 grams per second as measured in
a VanKel flowmeter and direct compression tableted in a tableting press
operating at no more than 2.5 tons, to produce a tablet exhibiting less than
1% friability, a hardness in the range of 10.3 to 17.0 kp, and resistant to
capping, said composition comprising particles having a sieve analysis,
based on the total weight of the components of the composition, wherein 0%
by weight of the particles exhibit a particle size greater than 425
micrometers and greater than about 85% by weight of the particles exhibit a
particle size of greater than about 45 micrometers, and the composition
comprises from about 85% by weight to about 97.5% by weight guaifenesin.

Cited References

Blume et al., US 6,372,252 B1 Apr. 16, 2002
Dansereau et al., US 5,032,406 Jul. 16, 1991
Troy et al., US 3,627,583 Dec. 14, 1971
Wilber et al., US 6,623,756 B1 Sept. 23, 2003
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Grounds of Rejection
Claims 2-4, 8, 33, 34 and 37 are rejected under 35 U.S.C. §103(a) as
being unpatentable over U.S. 6,372,252 to Blume in view of Dansereau,
Troy and Wilber or Blume in view of Dansereau and Wilber.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
3-10.

Discussion
ISSUE
The Examiner concludes that
It would have been obvious for one of an ordinary skill in the
art at the time of the instant invention was made from the
teachings of Troy and Wilbur that particle sizes between 12-325
or 20-200 respectively, are important for free flowing and the
ability for compression such that the drug is released at a
determined rate from the compressed tablet. Troy teaches that
sizing of the granules particles is important for free flowing of
drug, which in turn imparts improved flow characteristics to the
active material and other materials of the blend and also the
ease of tabletting. Wilbur suggests particle size ranges between
75-420 microns for free flowability and suitability for direct
compression. Troy as well as Dansereau recognizes PVP as a
suitable binder for compressible tablets, particularly guaifenesin
(Dansereau). Accordingly, it would have been obvious for one
of an ordinary skill in the art at the time of the instant invention
was made to employ PVP for the processing and preparation of
compressible guaifenesin tablets of Blume because Troy as well
as Dansereau recognize PVP as a suitable binder. Further,
Dansereau (and Blume) recognizes methylcellulose and PVP as
equivalent binders as well as disintegrants in preparing a
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sustained release compressible tablet preparation comprising
guaifenesin.

(Ans. 6.)

Appellant argues that

Blume clearly does not teach an agglomerate of guaifenesin and
polyvinylpyrrolidone, Blume specifically teaches that his
granulation far exceeds the maximum particle size permitted,
i.e. Blume states his granulation has "not more than about 10%
of the resulting granulation is retained on a 10 mesh screen"
(about 2.0mm)-more than 400% larger than that permitted in
the instant claim (see column 8, lines 22-23 of Blume et al.).
While it is stated in Blume that the resulting formulation "may
further be compressed on a tablet compressing machine using
tooling to form tablets” (Blume, column 8, lines 36-37) no
disclosure of the pressure of the tableting press, nor of the
resulting tablet properties as far as hardness, capping and
friability can be found within the four corners of the Blume et
al. reference.

(Br. 5.)

Appellant argues that the Examiner miscomprehends Wilber and all
that Wilber et al. teach is the rheology modifying polymer or copolymer
having the described particle size identified at column 4, line 48 to column
5, line 10. While the Examiner believes that she was citing particle sizes of
an agglomerate of a guaifenesin and binder, all that she was citing was the
particle size of the binder absent the guaifenesin. (Br. 6-7.)
The issue is: Does the cited prior art support the Examiner’s
conclusion that the pending claims are obvious in view of the prior art?

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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
One cannot show nonobviousness by attacking references individually
where the rejections are based on combinations of references. See In re
Keller, 642 F.2d 413 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed.
Cir. 1986).
“[W]hen a prima facie case is made, the burden shifts to the applicant
to come forward with evidence and/or argument supporting patentability.”
In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). Rebuttal evidence is
“merely a showing of facts supporting the opposite conclusion.” In re
Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984).
To show criticality of the claimed range, “‘it is not inventive to
discover the optimum or workable ranges by routine experimentation.’ Only
if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent
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be obtained for the claimed critical range. ” In re Geisler, 116 F.3d 1465,
1469 (Fed. Cir. 1997) (internal citations omitted).
“[T]he discovery of an optimum value of a variable in a known
process is normally obvious.” Exceptions to this rule include (1) the results
of optimizing a variable were unexpectedly good and (2) the parameter
optimized was not recognized in the prior art as one which would affect the
results. In re Antonie, 559 F.2d 618, 620 (CCPA 1977).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“Any arguments or authorities not included in the brief or a reply brief ...
will be refused consideration by the Board, unless good cause is shown.”).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment.
In proceedings before the Patent and Trademark Office, the Examiner
bears the burden of establishing a prima facie case of obviousness based
upon the prior art. On appeal to this Board, Appellant must show that the
Examiner has not sustained the required burden. Only if the burden of the
Examiner is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
According to the Examiner, Blume discloses an agglomerated mixture
of guaifenesin and methocel that is granulated and sized through a mesh
screen to form a tablet. (See Ans. 3.) Troy and Dansereau disclose the use
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of PVP binder in compressible tablets, with Dansereau particularly
disclosing PVP and guaifenesin. (See Ans. 6.) Troy and Wilber are cited by
the Examiner to show that “particle sizes between 12-325 or 20-200
respectively, are important for free flowability and the ability for
compression such that the drug is released at a determined rate from the
compressed tablet.” (Ans. 6.) “Further, Dansereau (and Blume) recognizes
methylcellulose and PVP as equivalent binders as well as disintegrants in
preparing a sustained release compressible tablet preparation comprising
guaifenesin.” (Id.). Based on the evidence before us, we find that the
Examiner has established a prima facie case of obviousness, showing that it
was well known in the art to prepare compressible tablets of guaifenesien,
including PVP, and that one of ordinary skill in the art would have known
that the claimed particle sizes are an important, result-effective variables for
free flowability of a tablet and the ability for compression such that the drug
is released at a determined rate from the compressed tablet.
On the record and Brief before us, the Appellant has come forth with
insufficient evidence to rebut the Examiner’s prima facie case of
obviousness. Appellant has not shown that one of ordinary skill in the art
would not have expected that sized binder associated with drug would have
different flowability from granulated and sized binder alone.
Appellant has come forth with no evidence of secondary
considerations or unexpected results on this record. We agree with the
Examiner that
Appellants [sic] have not shown that the tablets resulting from
the teachings of Blume, having a particle within the claimed
size range based on the teachings of Wilbur and Troy do not
posses the claimed hardness, friability and resistance to
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capping. With respect to the results in tablets [sic, tables] 2A-
2G [of the Specification], it is observed that while compositions
of the instant invention do not exhibit capping at any
compression force applied, comparative examples 1 and 3 also
do not exhibit capping at the highest compression force. For
the friability, comparative examples do provide low friability
(<1 %) even at highest force applied. Thus, it is not clear if the
instant compositions provide any unexpected advantage over
the comparative compositions.

(Ans. 12.)
Appellant has failed to rebut the Examiner’s prima facie case of
obviousness and the rejections are affirmed.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections.
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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