Ex Parte Daggy et al

Board of Patent Appeals and Interferences

Apr 27, 2010

10993272 (B.P.A.I. Apr. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRUCE DAGGY, NARESH I. MEHTA,
and PRIYASHRI NAYAK
__________

Appeal 2009-008390
Application 10/993,272
Technology Center 1600
__________

Decided: April 27, 2010
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a rapidly
disintegrating tablet. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 29-63 are pending and on appeal (App. Br. 2). We will focus
on claims 29 and 46, which read as follows:
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29. A rapidly disintegrating tablet for oral administration comprising:
a methylcellulose;
a diluent; and
a crospovidone,
wherein the ratio of said methylcellulose to said diluent is between
about 2:1 to 4:1.
46. The tablet of Claim [29, further comprising a second diluent that is an
ingredient that is separate from the diluent], wherein the second diluent is
selected from the group consisting of microcrystalline cellulose, corn starch,
pregelatinized starch, and any mixtures thereof.
Claims 29-33, 35-37, 39, 40, and 43-63 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Davis1 in view of Ohno2 (Ans. 3).
Claims 34, 38, 41, and 42 stand rejected under 35 U.S.C. § 103(a) as
obvious over Davis in view of Ohno and Remington3 (Ans. 3).
The Examiner relies on Davis for teaching “a pharmaceutical laxative
composition for peroral administration to a human or animal subject,
comprising a safe and effective amount of bisacodyl in a rapidly dissolving
means” (Ans. 4 (emphasis in original)). The Examiner finds that the
“bisacodyl means comprises solid particulate forms of bisacodyl . . . that can
be compressed into tablets” (id.). The Examiner also finds:
The particulate solids may be blended into various excipients
such as diluents (e.g., lactose, sucrose, starch, calcium sulfate,
dicalcium phosphate, microcrystalline cellulose); binders (e.g.,
methyl cellulose, pregelatinized starch, polyvinylpyrrolidone,
hydroxypropyl methyl cellulose[)]; lubricants like stearic acid[,]
magnesium stearate; disintegrants such as sodium starch

1 Davis et al., US 5,670,158, Sep. 23, 1997.
2 Ohno et al., US 4,017,598, Apr. 12, 1977.
3 Remington’s Pharmaceutical Sciences, 18th ed., pp. 1633-37 (1990).
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glycolate, crosslinked polyvinylpyrrolidone and buffers (see
column 6, lines 33-42).
(Id. (emphasis added.))
The Examiner relies on Ohno for teaching “rapidly disintegrating
tablets for oral administration comprising methylcellulose, a diluent, and
other conventional excipients” (id. at 5). The Examiner finds that Ohno
“further teaches using methylcellulose as the main ingredient” (id.). The
Examiner also finds that Example 1 “depicts the ratio of methyl cellulose to
microcrystalline cellulose (claimed as diluent in instant claim 46) to be
between about 2:1 to 4:1” (id.).
The Examiner concludes that “[o]ne would have been . . . motivated
to add methyl cellulose and diluent [in the formulation of Davis] in a
specific ratio as claimed instantly . . . since Ohno teaches the same ratio as
shown in Table 1 while preparing [a] rapidly disintegrating tablet” (id. at 6).
The Examiner also argues:
[O]ne of ordinary skill would be motivated to manipulate the
amounts of methylcellulose based on the desired formulation
and would modify the amounts of each ingredient to achieve
the desired release profile. . . . [I]t would have been obvious to
modify the percentages and amounts of the ingredients to
optimize the results through routine experimentation.
(Id. at 7.)
The Examiner relies on Remington for disclosing features of
dependent claims (id. at 7-9).
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ISSUE
Does the evidence support the Examiner’s conclusion that it would
have been obvious to include methylcellulose and diluent in a tablet where
the ratio of methylcellulose to diluent is between 2:1 to 4:1?
FINDINGS OF FACT
1. Davis discloses a pharmaceutical composition for peroral
administration to provide laxation, the composition comprising a rapidly-
dissolving bisacodyl means and a delivery means that “prevents the release
of bisacodyl from the dosage form into the lumen of the gastrointestinal tract
during transport of the dosage form through the lumen until the dosage form
is near the junction between the small intestine and the colon or in the
colon” (Davis, Abstract).
2. Davis also discloses that preferred bisacodyl means comprise
solid particulate forms of bisacodyl that are compressed into a tablet (id. at
col. 6, ll. 27-32).
3. In addition, Davis discloses:
Such bisacodyl particulate solids may be blended with various
excipients such as diluents (e.g., lactose, sucrose, glucose,
starch, calcium sulfate, dicalcium phosphate, micro crystalline
cellulose); binders (e.g., polyvinylpyrrolidone, pre-gelatinized
starch, gelatin, hydroxypropyl methylcellulose, methylcellulose,
hydroxyethyl cellulose, hydroxypropyl cellulose); lubricants
(e.g., stearic acid, magnesium stearate); disintegrants (e.g.,
sodium starch glycolate, cross-linked polyvinylpyrrolidone,
cross-linked carboxymethyl cellulose); glidants (e.g., fumed
silica); and buffers.
(Id. at col. 6, ll. 32-42 (emphasis added).)
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4. In Example 1, Davis discloses bisacodyl means compressed
into a tablet comprising the following components:

(id. at col. 10, ll. 5-37). In this example, the ratio of pregelatinized starch to
microcrystalline cellulose is about 0.3:1.
5. Ohno discloses “the preparation of readily-disintegrable tablets
characterized in that granules made from a water-soluble methylcellulose . . .
and [optionally] medically active ingredients are admixed with a
disintegrator and then shaped into tablets” (Ohno, col. 1, ll. 42-61).
6. Ohno also discloses that suitable disintegrators include
microcrystalline cellulose (id. at col. 3, ll. 32-35).
7. In addition, Ohno discloses adding various kinds of additives
including lubricants such as calcium stearate, coloring agents, sweetenings,
and flavorings (id. at col. 3, ll. 61-68).
8. In Example 1, Ohno discloses a formulation comprising
700 parts methylcellulose, 300 parts microcrystalline cellulose, and 3 parts
calcium stearate, which was subjected to tableting and provided tablets that
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rapidly disintegrate (id. at col. 4, ll. 39-67 (formulation no. 4)). In this
example, the ratio of methylcellulose to microcrystalline cellulose is about
2.3:1.
9. The Specification discloses that crospovidone is a disintegrant
(Spec. 7).
PRINCIPLES OF LAW
“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). The relevant
question is “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418. “[W]here
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 re Aller, 220 F.2d 454, 456 (CCPA 1955).
ANALYSIS
Davis discloses a rapidly disintegrating tablet for oral administration
comprising bisacodyl (Findings of Fact (FF) 1-2). Davis also discloses that
the tablet may additionally contain a binder such as methylcellulose, a
diluent, and a disintegrant (FF 3). In Example 1, Davis discloses a tablet
comprising crospovidone, which is a disintegrant, pregelatinized starch,
which is a binder, and microcrystalline cellulose, which is a diluent (FF 3-4
& 9). Davis discloses that both methylcellulose and pregelatinized starch
are examples of binders (FF 3). Thus, it would have been obvious to replace
the pregelatinized starch with methylcellulose in this example. Therefore,
we agree with the Examiner that Davis suggests a rapidly disintegrating
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tablet for oral administration comprising methylcellulose, a diluent, and
crospovidone (Ans. 4-5).
Davis discloses a tablet having a ratio of pregelatinized starch, which
is a binder, to microcrystalline cellulose, which is a diluent, that is about
0.3:1 (FF 3-4). However, we agree with the Examiner that it would have
been obvious to discover the optimum or workable ranges by routine
experimentation (Ans. 7). In addition, Ohno discloses that a rapidly-
disintegrable tablet may be formed by including methylcellulose and a
diluent, microcrystalline cellulose, in a ratio that is between about 2:1 to 4:1
(FF 8). It would have been obvious to combine Ohno with Davis to
determine workable or optimum amounts of methylcellulose. Thus, we
agree with the Examiner that it would have been obvious to include, in
Davis’s tablets, methylcellulose and microcrystalline cellulose in the ratio
recited in claim 29 (Ans. 6).
Appellants argue, however, that “Ohno does not disclose diluents.
Ohno discloses methylcellulose, a disintegrant . . . , and other additives such
as lubricants, coloring agents, sweetenings, and flavorings. . . . Ohno,
therefore, . . . does not disclose any ratio of methylcellulose to diluent.”
(App. Br. 5.) We are not persuaded.
Ohno discloses a tablet having a ratio of methylcellulose to
microcrystalline cellulose of about 2.3:1 (FF 8). We recognize that Ohno
discloses that microcrystalline cellulose is a disintegrant (FF 6). However,
that does not mean that microcrystalline cellulose cannot also be considered
a diluent. In fact, Davis specifically identifies microcrystalline cellulose as a
diluent (FF 3). In addition, as noted by the Examiner, Appellants’ claim 46
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lists microcrystalline cellulose as a diluent (Ans. 15). Although this claim is
directed to a second diluent, it still confirms the teaching in Davis that
microcrystalline cellulose is a diluent.
Appellants also argue:
Davis and Ohno have completely different goals. The dosages
of Davis are meant to be released in the colon, and to avoid
release in the gastrointestinal tract (such as the stomach), while
the tablets of Ohno are purposefully designed to release in the
stomach. For at least this reason, the teachings of Davis and
Ohno can not be combined in the manner advocated by the
Examiner’s Answer.
(Reply Br. 2.) We are not persuaded.
Davis does disclose that its delivery means “prevents the release of
bisacodyl from the dosage form into the lumen of the gastrointestinal tract
during transport of the dosage form through the lumen until the dosage form
is near the junction between the small intestine and the colon or in the
colon” (FF 1). However, like Ohno’s tablets, Davis’s bisacodyl means is
rapidly-dissolving (FF 1, 5, & 8). Thus, we do not agree that Ohno cannot
be properly combined with Davis.
In the Reply Brief, for the first time on appeal, Appellants separately
argue the limitations of claims 31, 32, 46, 52, 53, 56, and 57 (Reply Br. 3-4).
According to 37 C.F.R. § 41.37(c)(1)(vii), in the Appeal Brief:
For each ground of rejection applying to two or more claims,
the claims may be argued separately or as a group. . . .
Notwithstanding any other provision of this paragraph, the
failure of appellant to separately argue claims which appellant
has grouped together shall constitute a waiver of any argument
that the Board must consider the patentability of any grouped
claim separately.
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37 C.F.R. § 41.37(c)(1)(vii). In the Appeal Brief, Appellants argued
claims 29-33, 35-37, 39, 40, and 43-63 as a group and did not present any
separate arguments as to claims 31, 32, 46, 52, 53, 56, and 57. Thus,
Appellants’ arguments in the Reply Brief with respect to the separate
patentability of claims 31, 32, 46, 52, 53, 56, and 57 are untimely and will
not be considered on appeal.
CONCLUSION
The evidence supports the Examiner’s conclusion that it would have
been obvious to include methylcellulose and diluent in a tablet where the
ratio of methylcellulose to diluent is between 2:1 to 4:1. We therefore
affirm the obviousness rejections of claims 29-63.
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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