Ex Parte Dharmadhikari et al

Patent Trial and Appeal Board

Dec 17, 2012

11790356 (P.T.A.B. Dec. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte NITIN BHALACHANDRA DHARMADHIKARI and
YASHORAJ RUPSINH ZALA
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Appeal 2012-000848
Application 11/790,356
Technology Center 1600
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Before ERIC GRIMES, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge FRANKLIN.

Opinion Dissenting filed by Administrative Patent Judge PRATS.

FRANKLIN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of alleviating signs and symptoms of spasticity in human patients
comprising orally administering a once-a-day controlled drug delivery
system comprising baclofen or its pharmaceutically acceptable salt. The
Patent Examiner rejected the claims as anticipated and obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
Claims 1-4 are on appeal. Claim 1 is representative and reads as
follows:
1. A method of alleviating signs and symptoms of spasticity in human
patients, said method comprising orally administering to said human patients
an once-a-day controlled drug delivery system comprising an effective daily
dose of baclofen or its pharmaceutically acceptable salt,
wherein the controlled drug delivery system produces a level of
sedation lower than a sedation produced by three times a day immediate
release tablets,
wherein a total daily dosage of the controlled release tablets and a
total daily dosage of the three times a day immediate release tablets remain
the same.

The Examiner rejected the claims as follows:
• claims 1 and 2 under 35 U.S.C. §102(b) as anticipated by Khanna;
1

• claims 3 and 4 under 35 U.S.C. § 103(a) as unpatentable over
Khanna and Dudhara.
2

ANTICIPATION/OBVIOUSNESS
The Examiner relies on Khanna as teaching all of the elements of
independent claim 1 with respect to the anticipation rejection of claims 1 and
2, as well as the obviousness rejection of claims 3 and 4. Therefore, we
consider these rejections together. The Examiner found that Khanna taught
a pharmaceutical composition comprising baclofen in a tablet formulation

1
US Patent No. 5,091,184 issued to Satish C. Khanna, Feb. 25, 1992.
2
Patent Application Publication No. WO 03/011255 A1 by Kamlesh
Mohanlal Dudhara et al., published Feb. 13, 2003.

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for therapeutic use as a spasmolytic. (Ans. 4.) The Examiner found that
Khanna taught that treatment with commercially available dosage forms
caused side-effects including daytime sedation. (Id.) Additionally, the
Examiner found that Khanna taught that “the object of [its invention was] to
provide an improved dosage form for the administration of baclofen, which
permits uniform administration at the commencement, as well as the course,
of therapy at constant intervals. The improved dosage form will also reduce
the number of daily doses administered, preferably to one to two doses a
day….” (Id. at 5.)
Appellants contend that that Khanna does not specifically disclose all
elements of claim 1. (App. Br. 8.) In particular, Appellants assert that
Khanna “fails to specifically disclose orally administering a once-a-day
controlled drug delivery system” (Id. (emphasis removed).) According to
Appellants, Khanna’s disclosed dosage form is meant for adhesion to
mucosa of the oral cavity, i.e., applied to the palate, buccally, lingually, or
sublingually, which is different from oral administration. (Id. at 9.) In
support of this position, Appellants refer to Remington’s Pharmaceutical
Sciences,
3
which describes buccal, sublingual and topical application to the
skin or mucous membranes as “non-oral” routes of administration. (Id.)
The Examiner responds by referring to Dorland’s Illustrated Medical
Dictionary
4
as evidence that the term “oral” means “pertaining to the mouth,
taken through or applied in the mouth.” (Ans. 7-8.) According to the

3
REMINGTON’S PHARMACEUTICAL SCIENCES 764 (17th ed. 1985).
4
DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 187 (28th ed. 1994).

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Examiner, there is “no other way[] to place the Khanna composition in the
oral mucosal cavity without using the oral route.” (Id. at 8.)
While we agree with the Examiner that the term “oral” means
“pertaining to the mouth, taken through or applied in the mouth,” we do not
agree that this definition refers to or describes a route of administering a
drug. The claimed invention specifically recites “orally administering”
baclofen. As described by Appellants’ evidence, such oral administration
specifically excludes buccal, sublingual and topical application of a drug to
the skin or mucous membranes. (See Remington’s Pharmaceutical Sciences
at 764.) Thus, we find that Khanna’s teaching to apply baclofen in the form
of an adhesive tablet to the mucosa in the oral cavity did not teach or suggest
a method comprising orally administering baclofen to a patient, as required
by the claimed invention.
Because the Examiner has not shown that a method meeting all of the
limitations of the claimed invention was disclosed or would have been
suggested based upon the cited prior art, we reverse both the anticipation and
obviousness rejections.
REVERSED

cdc
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PRATS, Administrative Patent Judge, dissenting.
I respectfully dissent.
I would affirm the Examiner’s rejections.
As to the second issue Appellants raise (see App. Br. 15-17), because
an ordinary artisan would have reasoned that Khanna’s single daily
sustained release administration of baclofen would avoid the undesired
peaks and valleys of drug plasma concentration in the same way as
Appellants single daily sustained release formulation, I agree with the
Examiner that there was a reasonable evidentiary basis to find that Khanna’s
method inherently met claim 1’s limitation regarding sedation level. See In
re Best, 562 F.2d 1252, 1254-1255 (CCPA 1977) (quoting In re Swinehart,
439 F.2d 210, 213 (CCPA 1971):
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.

As to the issue of whether the recitation “orally administering” in
claim 1 excludes the buccal/sublingual absorption described by Khanna,
while Appellants argue that the term “designates a means of administering
when the system is swallowed by the patient and the drug is absorbed upon
its release in the gastrointestinal tract” (App. Br. 10), claim 1 does not
include any language limiting the claimed process to swallowing or
gastrointestinal absorption, and Appellants point to no clear or specific
definition in the Specification of the term at issue.

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The description, advanced by Appellants, of buccal and sublingual
administration as being “non-oral routes” of drug administration is
acknowledged (Remington’s Pharmaceutical Sciences 764). The Examiner,
however, has advanced evidence supporting the position that “an oral
medication” is one that is simply “taken through . . . the mouth” (Dorland
Medical Dictionary 187).
It is well settled that, during examination, the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
However, “[a]bsent claim language carrying a narrow meaning, the
PTO should only limit the claim based on the specification or prosecution
history when those sources expressly disclaim the broader definition.” In re
Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Thus, “while it is true that
claims are to be interpreted in light of the specification and with a view to
ascertaining the invention, it does not follow that limitations from the
specification may be read into the claims.” Sjolund v. Musland, 847 F.2d
1573, 1581 (Fed. Cir. 1988).
As the court explained in In re Zletz, 893 F.2d 319, 321 (Fed. Cir.
1989), the rationale for this approach to claim interpretation is that “during
patent prosecution when claims can be amended, ambiguities should be
recognized, scope and breadth of language explored, and clarification
imposed.”
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In my view, by asking us to adopt the narrower of two undisputedly
reasonable interpretations of the claim term at issue, without any amendment
of the claim reflecting the narrower claim scope advanced, I am convinced
that Appellants are asking us to interpret claim 1 in a manner contrary to that
directed by our reviewing court.
Thus, I agree with the Examiner that, on this record, the broadest
reasonable interpretation of “orally administering” baclofen simply requires
the practitioner to place the drug into a patient’s mouth. I also agree with
the Examiner that Khanna’s buccal/sublingual administration of baclofen is
encompassed by that interpretation. I further agree that the Examiner
advanced sufficient evidence to support a finding that Khanna’s daily
sustained release would accomplish the same sedation level as that required
by claim 1, absent evidence to the contrary.
I would therefore affirm the Examiner’s rejections.