Ex parte FLYNN et al.

Board of Patent Appeals and Interferences

Jul 22, 1998

07919679 (B.P.A.I. Jul. 22, 1998)

Application for patent filed July 27, 1992.1
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for publication in a law journal and (2) is not binding precedent of the Board.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. 19
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte DANIEL L. FLYNN
and ROBERT L. SHONE
_____________
Appeal No. 94-3351
Application 07/919,6791
______________
ON BRIEF
_______________
Before JOHN D. SMITH, WARREN and WALTZ, Administrative Patent
Judges.
JOHN D. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal pursuant to 35 USC § 134 from the final
rejection of claims 1 through 16. Claim 1 is representative and
is reproduced below:
Appeal No. 94-3351
Application 07/919,679
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The references of record relied upon by the examiner are:
Watts 4,816,453 Mar. 28, 1989
King 4,853,376 Aug. 1, 1989
Buchheit 4,910,193 Mar. 20, 1990
Claims 1 through 5 and 9 through 13 stand rejected under 35
USC § 112, first paragraph, enablement requirement.
Additionally, all appealed claims stand rejected under 35 USC
§ 103 over Watts in view of King and Buchheit.
THE REJECTION UNDER 35 USC § 112, FIRST PARAGRAPH
According to the examiner, the ?how to make and use
requirement? of 35 USC § 112, first paragraph requires an
enabling disclosure commensurate in scope with the protection
sought by the claims. The examiner further alleges that
appellants, ?it appears,? have not enabled and disclosed ?how to
make, test and use? the compounds claimed in the generic scope
for the presently claimed invention. See the Answer at page 3.
We reverse.
It is well settled law that the examiner has the ?burden of
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giving reasons, supported by the record as whole, why the
specification is not enabling....Showing that the disclosure
entails undue experimentation is part of the PTO’s initial
burden....? In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219
(CCPA 1976). In determining whether a disclosure would require
undue experimentation to make and use claimed subject matter, the
examiner must consider not only the breadth of the claims but
also other factors such as the predictability or unpredictability
of the art in question, the relative skill of those in the art,
the state of the prior art, the nature of the invention, the
presence or absence of working examples, the amount of direction
or guidance presented, and the quantity of experimentation
necessary. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404
(Fed. Cir. 1988), citing with approval Ex parte Forman, 230 USPQ
546, 547 (Bd. Pat. App. & Int. 1986). The examiner has failed to
adequately address any of the above considerations.
In neither his statement of rejection, nor his response to
appellants’ arguments, has the examiner provided a single
persuasive reason as to why the specification fails to enable one
skilled in the art to disclose how to make and use the compounds
claimed ?in the generic scope?. Indeed, the examiner
acknowledges that the cited prior art shows that the activity
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(utility) of the type of compounds claimed is predictable.
Moreover, it is apparent that the examiner has given no weight to
the statements in the Flynn declaration (paragraphs 2.1 through
2.8) regarding the question of undue experimentation.
Accordingly, the examiner’s rejection under 35 USC § 112, first
paragraph, is reversed.
THE REJECTION UNDER 35 USC § 103
The subject matter on appeal is directed to a certain class
of pharmaceutical compounds referred to as serotonergic agents as
defined by the generic formula in appealed claim 1 (and
compositions) which act as 5-HT agonists or antagonists and/or4
5-HT antagonists in mammals. As set forth in the specification3
at page 9, the compounds of the claimed invention are said to be
useful in treating conditions such as gastrointestinal motility
disorders, emesis, anxiety, cognitive and other CNS disorders.
Gastrointestinal motility disorders said to be responsive to
treatment with 5-HT agonists include reflux esophagitis, non-4
ulcer dyspepsia, gastroparesis, ileus, irritable bowel syndrome
(constipation predominant), constipation, and the like.
Gastrointestinal motility disorders said to be responsive to
treatment with 5-HT antagonists include diarrhea, irritable4
bowel syndrome (diarrhea predominant) and the like. Disorders
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responsive to 5-HT antagonist include emesis due to either3
cancer chemotherapy or post-operative, anxiety, cognitive
disorders, drug abuse (either cravings or withdrawal syndrome),
irritable bowel syndrome (diarrhea predominant) and the like.
In rejecting the appealed claims over the cited prior art
references, the examiner indicates in the Answer at page 8 that
Clearly, the cited prior art compounds and
the instant compounds are vastly structurally
similar or identical.
As an initial matter, we have independently reviewed each of
the relied upon prior art references. However, we have been
unable to discover any compounds described in these prior art
references which are ?identical? to the claimed compounds.
Accordingly, this application is remanded to the examiner to
point out where in the relied upon references such identical
compounds are disclosed. Further, if identical compounds are
disclosed in the prior art, the examiner should reject the
relevant claims as anticipated (35 USC § 102) by the prior art.
We agree with the examiner that there is a adequate factual
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basis to support the contention that the cited prior art
compounds are structurally similar to the instantly claimed
compounds. However, statements by the examiner that the claimed
serotonergic agents act as 5-HT antagonists or agonist ?are not4
germane to any issue at hand? (Answer, page 8) and the statement
that the methods of using the claimed compounds (the utility of a
compound is based on its properties) are not under consideration
(Answer, page 5) are inconsistent with legal theories of
structural obviousness. In this regard, we point out to the
examiner that an obviousness rejection based on similarity in
chemical structure and function entails the motivation of one
skilled in the art to make a claimed compound in the expectation
that compounds similar in structure will have similar properties.
In re Gyurik, 596 F.2d 1012, 1018, 201 USPQ 552, 557 (CCPA 1979);
In re May, 574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA 1978); In
re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970).
Thus, the expectation that compounds similar in structure will
have similar properties leads one to the conclusion that the
compounds will have similar utilities.
In the case before us, the relied upon prior art references
to Watts and King describe their compounds as having multiple
identical utilities (see Watts at column 4, lines 47 through 56
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and King at column 7, lines 38 through 54), albeit neither Watts
nor King specifically indicates that these prior art compounds
exhibit 5-HT agonist activity, as possessed by some of the4
compounds covered by the appealed claims. In this regard, on
remand, the examiner should indicate why appellants’ finding at
paragraphs 4.6 and 4.7 of the Flynn declaration that a compound
covered by the appealed claims exhibits approximately 3.5 times
more 5-HT agonist activity than the preferred compound of Watts4
would not have been unexpected to a person of ordinary skill in
this art. Compare In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437,
1439, (Fed. Cir. 1987) wherein the court held that evidence that
a compound is unexpectedly superior in one of a spectrum of
common properties can be enough to rebut a prima facie case of
obviousness.
The examiner should also consider, on remand, whether or not
the comparative showing in the Flynn declaration, which is
limited to a single compound covered by the claims (a salt having
0.4 H O), is reasonably commensurate in scope with any claim2
presented on appeal.
On remand to the examiner, the examiner should consider
whether there is any factual support for rejection of the
appealed claims based on the relied upon prior art references
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under 35 USC § 102. The examiner should also reevaluate the
prima facie case of obviousness based on structural obviousness
legal theories giving appropriate consideration to the properties
and uses of the claimed compounds and the prior art compounds.
Finally, the examiner should reevaluate the evidence of record
and specifically the evidence in the Flynn declaration as to
whether or not any prima facie case of obviousness has been
adequately rebutted and particularly whether such evidence is
reasonably commensurate in scope with any claim on appeal.
Accordingly, in summary, the examiner’s rejection of certain
appealed claims under 35 USC § 112, first paragraph, is reversed.
With respect to the examiner’s obviousness rejection of the
appealed claims, this application is remanded to the examiner for
further consideration.
REVERSED & REMANDED
)
Appeal No. 94-3351
Application 07/919,679
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JOHN D. SMITH )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
CHARLES F. WARREN )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
THOMAS WALTZ )
Administrative Patent Judge )
Corporate Patent Law Dept.
ATTN: G.D. Searle & Co.
P.O. Box 5110
Chicago, IL 60680-9889