Ex parte JAO et al.

Board of Patent Appeals and Interferences

Sep 8, 1999

08036648 (B.P.A.I. Sep. 8, 1999)

Application for patent filed March 24, 1993. Said 1
Application a continuation of U.S. Application Serial
Numbers 07/971,011, filed on November 2, 1992, now U.S.
Patent Number 5,252,338, issued on October 12, 1993;
said application a continuation of U.S. Serial Number
07/799,451, filed on November 26, 1991, now
U.S. Patent Number 5,190,765, issued on March 2,
1993; which is a continuation-in-part of
U.S. Application Serial Number 07/722,622, filed
on June 27, 1991, now U.S. Patent Number
5,160,744, issued November 3, 1992.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the
Board.
Paper No. 18
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte FRANK JAO, PATRICK S. L. WONG,
HOA T. HUYNH, KATHY McCHESNEY
and PAMELA K. WAT
________________
Appeal No. 95-2244
Application 08/036,6481
________________
ON BRIEF
________________
Before METZ, GARRIS and WALTZ, Administrative Patent Judges.
METZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal No. 95-2244
Application 08/036,648
2
This is an appeal under 35 U.S.C. § 134 from the
examiner's refusal to allow claims 19 through 26, all the
claims remaining in this application.
THE INVENTION
The appealed subject matter is directed to a "dosage
form" for administering drugs which is specially configured
for delayed delivery of a drug. The "dosage form" includes
(1) a drug composition comprising a dose of a particular type
of drug and a polymer having particular viscosity properties
which polymer permits or prevents the delayed release of the
drug and (2) a drug-delayed delivery composition comprising a
polymer of a particular molecular weight which forms part of
the wall material of the "dosage form" and aids in delaying
the rate of passage of fluid through the wall material. The
appealed subject matter also includes a method of delayed
delivery of a drug to a patient by giving the patient the
above-described "dosage form".
Claim 19 is adequately representative of the appealed
subject matter and is reproduced below for a more facile
understanding of the appealed subject matter.
Claim 19. A dosage form for the delayed-delivery of
Appeal No. 95-2244
Application 08/036,648
3
a drug to a fluid environment of use, wherein the
dosage form comprises:

(a) a drug composition comprising a
dose of 0.05 ng to 1.5 g of a calcium channel
blocker drug, and a polymer comprising a molecular
weight up to 1,000,000 and a rate of hydration in
the presence of fluid that contacts the dosage form
to change from a non-dispensable phase to a
dispensable phase; and,
Appeal No. 95-2244
Application 08/036,648
4

(b) a drug-delayed delivery composition in the
dosage form comprising a polymer possessing a 8,500
to 4,000,000 molecular weight that delays the
delivery of the drug from the dosage form up to
seven hours.
The examiner has not relied on any prior art in rejecting
the appealed claims but instead has rejected the claims solely
on formal grounds. Specifically, claims 19 through 26 stand
rejected under 35 U.S.C. § 112, first paragraph, on the
grounds that the claims are not "enabled" by appellants'
disclosure. We reverse.
OPINION
It appears to be the examiner's position that appellants
may not claim a "dosage form" without reciting that the dosage
form includes a body member comprising a wall surrounding an
internal structure and having an exit port. The examiner
reasons that the claims before us claim only part of the
internal structure of what appellants have defined as a
"dosage form" in their disclosure. Thus, the examiner urges
that the claims are not supported by appellants' disclosure
because appellants' disclosure does not disclose that
components "(a)" and "(b)", alone, constitute a "dosage form".
Appeal No. 95-2244
Application 08/036,648
5
The examiner concludes that the claims before us are directed
to drug compositions not "dosage forms".
Appeal No. 95-2244
Application 08/036,648
6
We find that the examiner's position is founded on an
unreasonable interpretation of the claims before us. The
actual claim language recites that appellants claim "[a]
dosage form" which "comprises" components "(a)" and "(b)".
Under fundamental rules of claim interpretation, the term
"comprises" does not exclude any other features, either
disclosed features or features not disclosed or even
contemplated. Accordingly, we interpret the claims on appeal
to embrace the internal structure of appellants' "dosage form"
and, implicitly embrace, the other unrecited features which
are necessary to constitute appellants' "dosage form". We
remind the examiner that it is the function of the
specification, not that of the claims, to set forth the
practical limits of operation of an invention. In re Johnson,
558 F.2d 1008, 1017, 194 USPQ 187, 195 (CCPA 1977).
It is also incumbent upon the examiner in making a
rejection under the first paragraph of 35 U.S.C. § 112, to
make out a prima facie case of lack of enablement. In re
Strahilevitz, 668 F.2d 1229, 1232, 212 USPQ 561, 563 (CCPA
1982); In re Armbruster, 512 F.2d 676, 677, 678, 185 USPQ 152,
153 (CCPA 1975); In re Marzocchi, 439 F.2d 220, 224, 169 USPQ
Appeal No. 95-2244
Application 08/036,648
7
367, 370 (CCPA 1971). Moreover, in determining whether or not
a disclosure is enabling, it has been consistently held that
the enablement requirement of
Appeal No. 95-2244
Application 08/036,648
8
the first paragraph of 35 U.S.C. § 112 requires nothing more
than objective enablement. In re Marzocchi, 439 F.2d at 223,
169 USPQ at 369. How such a teaching is set forth, whether by
the use of illustrative examples or by broad descriptive
terminology, is of no importance since a specification which
teaches how to make and use the invention in terms which
correspond in scope to the claims must be taken as complying
with the first paragraph of 35 U.S.C. § 112 unless there is
reason to doubt the objective truth of the statements relied
upon therein for enabling support. Id.
In the instant case, mere resort to appellants'
disclosure cited by the examiner in her Answer establishes
that appellants' disclosure satisfies the enablement
requirement of 35 U.S.C.
§ 112, first paragraph. Specifically, appellants' disclosure
provides: a narrative description of useful materials; amounts
of materials to be used; an exhaustive listing of exemplary
materials; specific examples of the invention; comparative
examples and more. Nothing in this record provides any
evidence for why there is any reason to doubt the objective
truth of appellants' statements.
Appeal No. 95-2244
Application 08/036,648
9
Finally, we observe the examiner's comment on page 4 of
her Answer wherein she states that she:
does not doubt that the composition comprises drug
and polymer, but remains of the opinion that the
dosage form is encompassed by drug and polymer, as
defined in independent claims, and said drug and
polymer being contained within a wall, compartment
etc as disclosed throughout the specification.
We consider this statement to constitute an expression by the
examiner of a failure by appellants to claim that which they
believe to be their invention under the second paragraph of 35
U.S.C. § 112 rather than an enablement question arising under
the first paragraph. Suffice it to say that, absent evidence
to the contrary, the subject matter set forth in the claims
must be presumed to be "that which the applicant regards as
his invention." In re Moore, 439 F.2d 1232, 1235, 169 USPQ
236, 238 (CCPA 1971). The examiner has not rejected the
claims under the second paragraph of 35 U.S.C. § 112 and, in
any event, neither has the examiner provided the necessary
"evidence to the contrary."
Appeal No. 95-2244
Application 08/036,648
10
SUMMARY
Accordingly, for all the reasons stated above, the
decision of the examiner rejecting claims 16 through 29 as
unpatentable under 35 U.S.C. § 112, first paragraph, is
REVERSED.
REVERSED
ANDREW H. METZ )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
BRADLEY R. GARRIS ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
THOMAS A. WALTZ )
Administrative Patent Judge )
Appeal No. 95-2244
Application 08/036,648
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AHM/dal
Appeal No. 95-2244
Application 08/036,648
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PAUL L. SABATINE
ALZA CORPORATION
P.O. BOX 10950
PALO ALTO, CA 94303-0802