Ex Parte Porubek et al

Board of Patent Appeals and Interferences

Feb 25, 2003

08932834 (B.P.A.I. Feb. 25, 2003)

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for publication and is not binding precedent of the Board.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. 49
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte DAVID PORUBEK,
ANIL M. KUMAR, and
CHARLES R. BREDL
___________
Appeal No. 2001-1101
Application No. 08/932,834
__________
ON BRIEF
__________
Before WINTERS, WILLIAM F. SMITH, and GREEN, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claims 1, 2, 4, 6, 7,
9, 10, 12 through 16, 18 through 21, and 23 through 27, which are all of the claims
remaining in the application.
The Invention
The invention relates to compounds that form the hydroxy-substituted zanthine,
lisofylline, in vivo. These compounds, or prodrugs, are said to possess a primary,
characteristic benefit, viz., selective enantiomeric stability coupled with varying
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resistance to hydrolysis (Specification, paragraph bridging pages 5 and 6).
Claim 1, which is illustrative of the subject matter on appeal, reads as follows:
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Prior Art
In rejecting the appealed claims under 35 U.S.C. § 112, first and second
paragraphs, the examiner does not rely on any prior art references (Examiner's Answer,
Paper No. 43, Section (9)).
The Rejections
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Application No. 08/932,834
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Claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21, and 23 through 27
stand rejected under 35 U.S.C. § 112, second paragraph, as not particularly pointing
out and distinctly claiming the subject matter which applicants regard as their invention.
Claims 1, 2, 4, 6, 7, 9, 10, 12 through 16, 18 through 21, and 23 through 27
stand rejected under 35 U.S.C. § 112, first paragraph, as based on a specification
which does not adequately teach any person skilled in the art how to use the claimed
invention.
Deliberations
Our deliberations in this matter have included evaluation and review of the
following materials: (1) the instant specification, including Figures 1 through 10 and all
of the claims on appeal; (2) the amended Appeal Brief (Paper No. 42); (3) the
Examiner's Answer (Paper No. 43); and (4) the Paradise Declaration, filed under the
provisions of 37 CFR § 1.132, executed June 17, 1999 (Paper No. 32).
On consideration of the record, including the above-listed materials, we affirm
the examiner's rejection of claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21, and
23 through 27 under 35 U.S.C. § 112, second paragraph. We reverse the rejection of
claim 14 under 35 U.S.C. § 112, first paragraph, and we do not reach the rejection of
the remaining claims under that statutory provision.
Preliminary Matter
As a preliminary matter, we refer to section VII of the amended Appeal Brief
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entitled "GROUPING OF THE CLAIMS." Applicants ask that we consider two groups of
claims separately, stating that "[c]ompound claims 1, 2, 4, 6, 7, 9, 10, and 12-14 are
patentable regardless of whether pharmaceutical composition claims 15, 18-21 and 23-
27 are patentable" (Paper No. 42, Section VII). That section of the Appeal Brief,
however, makes little sense. First, applicants have not set forth a grouping of claims
"for each ground of rejection which appellant contests" as required by 37 CFR §
1.192(c)(7) (1999). Second, applicants have omitted claim 16 from their grouping of
claims. Third, applicants' statement to the contrary, notwithstanding, claims 20, 21, and
23 through 27 are drawn to compounds, not pharmaceutical compositions.
Nonetheless, applicants' error in grouping claims for purposes of this appeal may
be viewed as "harmless error" in view of our disposition of each ground of rejection
discussed infra.
35 U.S.C. § 112, Second Paragraph
As stated in In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir.
1989): "An essential purpose of patent examination is to fashion claims that are pre-
cise, clear, correct, and unambiguous. Only in this way can uncertainties of claim
scope be removed, as much as possible, during the administrative process." In the
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Answer (Paper No. 43), the examiner points to several aspects of the appealed claims
which are incorrect, indefinite, ambiguous, or simply make no sense. We shall not
belabor the record on this point, because we agree substantially with the examiner's
analysis. For reasons ably set forth by the examiner in the Answer, we affirm the
rejection of claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21, and 23 through 27
under 35 U.S.C. § 112, second paragraph, as not particularly pointing out and distinctly
claiming the subject matter which applicants regard as their invention.
We here note that the examiner rejected all claims in the application, except
claim 14, under 35 U.S.C. § 112, second paragraph. Our affirmance of that rejection
constitutes a disposition of the appeal with respect to all claims except claim 14.
35 U.S.C. § 112, First Paragraph
The remaining issue is whether the examiner erred in rejecting all of the
appealed claims under 35 U.S.C. § 112, first paragraph, as based on a specification
which does not adequately teach any person skilled in the art how to use the claimed
invention. Under the circumstances, however, we shall not reach the merits of the "how
to use" rejection with respect to claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21,
and 23 through 27. Again, those claims are indefinite within the meaning of 35 U.S.C.
§ 112, second paragraph; they are not precise, clear, correct, and unambiguous. We
think it imperative to understand the metes and bounds of the claims before proceeding
to a resolution of an examiner's rejection under 35 U.S.C. § 112, first paragraph. Cf.
In re Steele, 305 F.2d 859, 862, 134 USPQ 292, 295 (CCPA 1962)(Before deciding a
rejection under 35 U.S.C. § 103, "it is essential to know what the claims do in fact
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cover").
We now turn to a consideration of claim 14, cast in Markush format and reciting,
in the alternative, 15 prodrugs of lisofylline. The examiner argues that it would require
undue experimentation "to get lisofylline to actually work" (Paper No. 43, page 7, line 7).
It follows, according to the examiner, that applicants' specification does not teach any
person skilled in the art how to use the prodrugs recited in claim 14 without undue
experimentation. In other words, the examiner's argument centers on lisofylline. If
persons skilled in the art know how to use lisofylline, within the meaning of 35 U.S.C.
§ 112, first paragraph, the examiner would not deny that such persons would also know
how to use the 15 prodrugs recited in claim 14.
It is uncontroverted on this record that "lisofylline is the subject [of] FDA-
sanctioned Phase II and Phase III clinical trials." See the Paradise Declaration, filed
under the provisions of 37 CFR § 1.132, executed June 17, 1999, paragraph 3 and
Appendix E. As stated in In re Brana, 51 F.3d 1560, 1568, 34 USPQ2d 1436, 1442-43
(Fed. Cir. 1995), in the context of a PTO rejection under 35 U.S.C. § 112, first
paragraph,
Were we to require Phase II testing [FDA-sanctioned Phase II trials] in
order to prove utility, the associated costs would prevent many companies
from obtaining patent protection on promising new inventions, thereby
eliminating an incentive to pursue, through research and development,
potential cures in many crucial areas such as the treatment of cancer.
A fortiori, that lisofylline is the subject of FDA-sanctioned Phase II and Phase III clinical
trials establishes, on this record, that any person skilled in the art knows how to use
lisofylline within the meaning of 35 U.S.C. § 112, first paragraph. As stated in the
Paradise Declaration, paragraph 3., "[m]erely getting such trials approved require [sic]
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substantial indications of therapeutic efficacy." Accordingly, the premise of the
examiner's rejection is incorrect and the rejection cannot be sustained.
Further, the examiner argues that applicants' specification does not provide
useful daily dosage information (Paper No. 43, page 10, last full paragraph; and
paragraph bridging pages 10 and 11). We would agree that there is room for
improvement in applicants' description of a dosage regimen at page 9, first full
paragraph of the specification. That passage, standing alone, is somewhat unclear.
This does not, however, end the inquiry. Rather, the specification must be considered
in its entirety taking into account the level of skill in the art. The following passage
appears in the specification, page 9, second full paragraph:
While dosage values will vary, therapeutic compounds of the invention
may be administered to a human subject requiring such treatment as an
effective oral dose of about 50 mg to about 5000 mg per day, depending
upon the weight of the patient. For any particular subject, specific dosage
regimens should be adjusted to the individual's need and to the
professional judgment of the person administering or supervising the
administration of the inventive compounds.
In our judgment, the above-quoted passage adequately conveys to any person skilled
in the art useful daily dosage information for the claimed compounds.
The examiner's rejection of claim 14 under 35 U.S.C. § 112, first paragraph, is
reversed.
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Conclusion
In conclusion, for reasons set forth in the body of this opinion, we sustain the
examiner's rejection of claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21, and 23
through 27 under 35 U.S.C. § 112, second paragraph.
We do not reach the merits of the "how to use" rejection under 35 U.S.C. § 112,
first paragraph, with respect to claims 1, 2, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18 through 21,
and 23 through 27.
We do not sustain the examiner's rejection of claim 14 under 35 U.S.C. § 112,
first paragraph.
The examiner's decision is affirmed-in-part.
No time period for taking any subsequent action in connection with this appeal
may be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
Lora M. Green )
Administrative Patent Judge )
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Application No. 08/932,834
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