Ex parte Dow

Board of Patent Appeals and Interferences

Oct 24, 2000

08142284 (B.P.A.I. Oct. 24, 2000)

1
The opinion in support of the decision being entered today was not
written for publication and is not binding precedent of the Board.
Paper No. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ROBERT L. DOW
__________
Appeal No. 1997-1856
Application 08/142,284
__________
ON BRIEF
__________
Before WINTERS, ROBINSON, and ADAMS, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claims 1 through 4,
which are all of the claims in the application.
Claim 1, which is illustrative of the subject matter on appeal, is attached as an
appendix to this opinion.
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Application 08/142,284
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In rejecting the appealed claims on non-prior art grounds, the examiner relies on the
following references:
Kruse et al. (Kruse), “Synthesis and Evaluation of Multisubstrate Inhibitors of an Oncogene-
Encoded Tyrosine-Specific Protein Kinase,” J. Med. Chem., Vol. 31, No. 9, pp. 1768-772
(1988)
Levitzki, “Tyrphostins: tyrosine Kinase blockers as novel antiproliferative agents
and dissectors of signal transduction,” The FASEB Journal, Vol. 6, pp. 3275-282
(Nov. 1992)
The issues presented for review are: (1) whether the examiner erred in rejecting
claims 1 through 4 under 35 U.S.C. § 112, first paragraph, as based on a non-enabling
disclosure; and (2) whether the examiner erred in rejecting claims 1 through 4 under
35 U.S.C. § 112, second paragraph, as indefinite.
On consideration of the record, we reverse the examiner's rejection under
35 U.S.C. § 112, first paragraph. We remand this application to the examiner for
clarification and further proceedings respecting the rejection under 35 U.S.C. § 112,
second paragraph.
35 U.S.C. § 112, FIRST PARAGRAPH
The examiner acknowledges that appellant's specification enables any person
skilled in the art to make the instantly claimed compounds (Examiner's Answer, page 4,
lines 4 and 5). The examiner argues, however, that the specification does not enable any
person skilled in the art to use the claimed compounds (Examiner's Answer, page 4, lines
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6 and 7). Thus, the issue before us centers on the “how to use” requirement of 35 U.S.C. §
112, first paragraph.
Appellant expressly states that the compounds of his invention “are all readily
adapted to therapeutic use as tyrosine kinase inhibitors for the control of tyrosine kinase
dependent diseases in mammals” (specification, page 16, line 30 through page 17, line
1). Appellant amplifies on the meaning of tyrosine kinase dependent diseases, and
provides examples of those diseases (specification, page 17, lines 1 through 7).
Further, appellant sets forth an in vitro assay, useful for demonstrating the tyrosine
kinase inhibitory activity of the present compounds (specification, page 17, lines 8 through
29). With respect to the specifics of “how to use” his compounds, appellant describes
specific modes of administration, dosages, and dosage forms (specification, page 17,
line 30 through page 18, line 14). Furthermore, appellant elaborates on the preparation of
tablets, capsules, and aqueous suspensions and/or elixirs for the purposes of oral
administration (specification, page 18, line 15 through page 19, line 5). Likewise,
appellant describes the preparation of solutions useful for parenteral or topical
administration (specification, page 19, lines 6 through 24). Finally, appellant provides
guidelines for preparing a pharmaceutical composition comprising, as active ingredient, a
claimed compound or pharmaceutically acceptable salt thereof (specification, page 19,
lines 15 through 32).
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Application 08/142,284
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All in all, we believe that the specification imparts ample information enabling any
person skilled in the art to use the claimed compounds throughout their scope without
undue experimentation. Therefore, we disagree with the examiner's conclusion that the
specification does not satisfy the “how to use” requirement of 35 U.S.C. § 112, first
paragraph.
We have carefully reviewed the Examiner's Answer (Paper No. 16) and
Supplemental Answer (Paper No. 18). In our judgment, however, the examiner does not
adequately explain why she doubts the truth or accuracy of any statement in appellant's
supporting disclosure. Nor does the examiner back up assertions of her own with
acceptable evidence or reasoning inconsistent with the contested statement. See In re
Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971). In this regard,
we find that the examiner's reliance on Kruse and Levitzki is misplaced. Those references
relate to compounds structurally distinct from and not analogous to the instantly claimed
compounds. In our judgment, therefore, the discussion of tyrosine kinase inhibiting activity
in Kruse or Levitzki does not constitute reason to doubt the objective truth of statements in
the specification which are relied on by appellant for enabling support. In re Marzocchi,
439 F.2d at 223, 169 USPQ at 369 (CCPA 1971).
To the extent that the examiner would find working examples of “how to use” the
claimed compounds desirable, we agree. As the court cautioned in In re Strahilevitz,
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668 F.2d 1229, 1232, 212 USPQ 561, 563 (CCPA 1982), however, working examples
are not required to satisfy section 112, first paragraph.
The rejection of claims 1 through 4 under 35 U.S.C. § 112, first paragraph, is
reversed.
35 U.S.C. § 112, SECOND PARAGRAPH
In the Examiner's Answer, section (10), the examiner entered a new ground of
rejection of claims 1 through 4 under 35 U.S.C. § 112, second paragraph, as indefinite.
According to the examiner, claims 1 through 4 are indefinite in view of the recitation
“[a] compound ... and the pharmaceutically-acceptable cationic salts and prodrugs thereof”
(emphasis added). The examiner argued that it is unclear whether these claims “read on”
a combination of a compound and its pharmaceutically acceptable cationic salts and
prodrugs. To resolve this issue, the examiner recommended that the claims be amended
using the language “a compound ... or a pharmaceutically-acceptable cationic salt or a
prodrug thereof” (Examiner's Answer, page 7, section (10)).
In the Reply Brief (Paper No. 17), appellant proffered an amendment designed to
overcome the examiner's new ground of rejection. In the Supplemental Examiner's Answer
(Paper No. 18), however, the examiner does not indicate whether the proffered
amendment has been entered; nor does the examiner repeat or refer to the rejection under
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Application 08/142,284
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35 U.S.C. § 112, second paragraph. This is confusing, and leads us to conclude that the
rejection for indefiniteness is not ready for review.
Under these circumstances, we remand this application to the examiner to clarify
the status of the rejection under 35 U.S.C. § 112, second paragraph. On return of this
application to the examining corps, the examiner should review appellant's Reply Brief and
expressly state whether the proffered amendment, designed to overcome the new ground
of rejection, has been entered. Assuming that the amendment has not been entered, and
further assuming that the examiner adheres to the rejection, we would recommend to both
appellant and the examiner that every effort be made to resolve this issue at the examining
group level.
Accordingly, this application is remanded to afford appellant and the examiner the
opportunity to review and resolve the issue arising under 35 U.S.C. § 112, second
paragraph.
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This application, by virtue of its “special” status, requires an immediate action.
Manual of Patent Examining Procedure (MPEP) § 708.01(d)(7th ed., July 1998).
REVERSED and REMANDED
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Douglas W. Robinson )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Donald E. Adams )
Administrative Patent Judge )
Appeal No. 1997-1856
Application 08/142,284
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Appeal No. 1997-1856
Application 08/142,284
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Gregg C. Benson
Pfizer Inc.
Eastern Point Road
Groton, CT 06340
SDW/cam