Ex parte MOROZUMI et al.

Board of Patent Appeals and Interferences

Dec 29, 1998

07833718 (B.P.A.I. Dec. 29, 1998)

Application for patent filed February 11, 1992.1
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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(2) is not binding precedent of the Board.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. 37
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MANAMI MOROZUMI, MASAO KUMAGAI, and
TOYOFUMI YAMAGUCHI
____________
Appeal No. 95-3056
Application 07/833,7181
____________
HEARING: December 10, 1998
____________
Before KIMLIN, GRON, and WARREN, Administrative Patent Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal under 35 U.S.C. § 134 from an
examiner’s rejections of Claims 1-3, 7-13, and 15-28, all
claims pending in this application.
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1. Introduction
Claims 1-3, 7-13, and 15-28 stand rejected under 35
U.S.C.
§ 103 as being unpatentable over the teaching of either
Miyasaka et al. (Miyasaka), U.S. Patent 4,956,345, patented
September 11, 1990, or Matsuda et al. (Matsuda), “Introduction
of Carbon Substituents at C-2 Position of Purine Nucleosides,”
Nucleic Acids Research, Symposium Series No. 12, pp. 5-8
(1983), in view of the teaching of Weygand et al. (Weygand),
Preparative Organic Chemistry (Hilgetag et al., eds., John
Wiley & Sons, New York, pp. 1096-98, 1111-21, and 1127
(1972)). The examiner’s rejection of Claim 23 under 35 U.S.C.
§ 112, fourth paragraph, has been withdrawn (Supplemental
Examiner’s Answer (Supp. Ans.), p. 3,
l. 19-21). The examiner appears also to have withdrawn the
appealed rejections of appellants’ claims under 35 U.S.C. §
103 in view of the teaching of Miyasaka or Matsuda alone and
in view of appellants’ admissions in combination with
Weygand’s teaching (Examiner’s Answer (Ans.), p. 5, l. 15, to
p. 6, l. 20).
All claims stand or fall together with Claim 1. See 37 CFR
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§ 1.192(c)(5)(October 22, 1993). Claim 1 reads:
1. Solid 2-octynyl adenosine having a water content
of not more than 3%.
2. Examiner’s findings
A. The examiner finds that each of Miyasaka and Matsuda
describe 2-octynyl adenosine (Ans., p. 5, l. 19-20).
B. The examiner finds that Weygand describes “processes
commonly used by the practitioner to produce and isolate
compounds which are free from impurities, i.e.,
recrystallization from anhydrous solvents, drying under vacuum
at temperatures above ambient, etc.” (Ans., p. 5, l. 21-24).
C. The examiner finds that Miyasaka and Matsuda
isolated 2-octynyl adenosine as a “hydrate” (Ans., p. 5, l.
27-28).
D. The examiner finds that 2-octynyl adenosine hydrates
are not patentably distinct from anhydrous 2-octynyl adenosine
(Ans., pp. 5-6, bridging sentence).
E. Based on Morozumi’s Declarations Under 37 CFR 1.132,
filed July 6, 1993 (Paper No. 14) and April 13, 1994 (Paper
No. 21 ) and accompanying remarks, the examiner finds that1/2
persons having ordinary skill in the art would have known that
“practical production of 2-octynyladenosine on large scale was
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rendered commercially impractical because [of] the instability
of hydrated 2-octynyladenosine when stored” (Ans., pp. 6-7,
bridging para.).
F. The examiner finds that “it does not defy logic . .
. that a compound of known chemical structure, initially
isolated in hydrated form, should not be patentably
distinguishable from the identical compound rendered anhydrous
by one or more conventional purification steps” (Ans., p. 6,
l. 9-13).
G. The examiner finds that applicants have solved “a
very simple problem quickly understood by any ordinary
practitioner using commonly available analytical techniques .
. . and quickly soluble [sic] using routine purification
techniques” (Ans., p. 7, l. 6-10).
H. The examiner finds that “pharmaceuticals are
routinely tested for activity as a function of storage
conditions to determine how they must be processed in
preparation for storage” (Ans., p. 7, l. 13-15).
I. The examiner finds that “[i]nstability in the
presence of retained solvent, i.e. herein water of hydration,
is not unheard of and . . . readily soluble [sic] in several
different ways without undue expense” (Ans., p. 7, l. 16-18).
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J. The examiner finds that the claimed “purified”
product would have been within the ordinary skill of the
practitioner “seeking to optimize storage conditions for 2-
octynyladenosine” (Ans., p. 7, l. 19-21).
3. Examiner’s conclusions
Based on the aforementioned findings, the examiner holds
that appellants’ claimed “[s]olid 2-octynyl adenosine having a
water content of not more than 3%” would have been obvious to
a person having ordinary skill in the art in view of the
combined teachings of Miyasaka and Weygand and/or Matsuda and
Weygand. Accordingly, the subject matter of Claims 1-3, 7-13,
and 15-28 on appeal stands rejected as unpatentable under 35
U.S.C. § 103.
Discussion
We hold that the examiner’s case for unpatentability is
based on clearly erroneous findings and improper criterion for
obviousness under 35 U.S.C. § 103. Accordingly, we reverse
the examiner’s holding that the subject matter appellants
claim is unpatentable under 35 U.S.C. § 103 in view of the
combined prior art teachings.
First, we hold that the examiner’s finding that 2-octynyl
adenosine hydrates are not patentably distinct from anhydrous
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2-octynyl adenosine is clearly erroneous. See the examples in
the specification and Morozumi’s Declaration Under 37 CFR
1.132 filed July 6, 1993 (Paper No. 14), which establish by
elemental and stability analysis that 2-octynyl adenosine
monohydrate
(4.6% water) has markedly different properties from 2-octynyl
adenosines with a water content ranging from 3.14 to 0.93%.
Compare In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51
(CCPA 1963):
From the standpoint of patent law, a compound and
all of its properties are inseparable; they are one and
the same thing.
Based on the comparative properties of the compounds, we find
that solid 2-octynyl adenosine monohydrate (4.6% water) is
patentably distinct from solid 2-octynyl adenosines with a
water content of not more than 3%. While it may “not defy
logic . . . that a compound of known chemical structure,
initially isolated in hydrate form, should not be patentably
distinguishable from the identical compound rendered
anhydrous” (Ans., p. 6, l. 9-12), the greater weight of
evidence of record in this case reasonably suggests the
contrary.
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Second, whether or not applicants solved “a very simple
problem” (Ans., p. 7, l. 6-7) “is not inimical to
patentability.” In re Oetiker, 977 F.2d 1443, 1447, 24 USPQ2d
1443, 1446 (Fed. Cir. 1992). Oetiker also instructs at 1447,
25 USPQ2d at 1446:
See Goodyear Tire & Rubber Co. v. Ray-O-Vac Co., 321 U.S.
275, 279, [60 USPQ 386, 388] (1944)(simplicity of itself
does not negate invention); Panduit Corp. v. Dennison
Mfg Co., 810 F.2d 1561, 1572, 1 USPQ2d 1593, 1600
(Fed. Cir.)(the patent system is not foreclosed to
those who make simple inventions), cert. denied, 481 U.S.
1052 (1987).
Third, In re Sponnoble, 405 F.2d 578, 160 USPQ 237 (CCPA
1969), teaches at 585, 160 USPQ at 243:
. . . [A] patentable invention may lie in the discovery
of the source of a problem even though the remedy may be
obvious once the source of the problem is identified.
This is part of the “subject matter as a whole” which
should always be considered in determining the
obviousness
of an invention under 35 U.S.C. § 103.
Here, the examiner finds, based on applicants’ own disclosure
and declaratory evidence, that (1) the 2-octynyl adenosines
which Miyasaka and Matsuda isolated are both hydrates (Ans.,
p. 5,
l. 27-28), and (2) practical production of 2-octynyl adenosine
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on large scale was commercially impractical because [of] the
instability of hydrated 2-octynyl adenosine when stored (Supp.
Ans., p. 2, l. 15-18). We agree with the examiner that the
evidence of record, as a whole, strongly suggests that
Miyasaka and Matsuda both isolated a hydrate of 2-octynyl
adenosine.
We also agree with the examiner that the evidence of record,
as a whole, suggests that large scale commercial production of
the 2-octynyl adenosine isolated by Miyasaka and Matsuda would
have been impractical because of its storage instability.
However, aside from the teaching in this specification and
declarations of record, we find no evidence of record that
persons having ordinary skill in the art would have known that
Miyasaka and Matsuda isolated a hydrate of 2-octynyl adenosine
rather than it anhydrous form. Moreover, even if persons
having ordinary skill in the art reasonably would have known
that Miyasaka and Matsuda isolated an unstable hydrate of 2-
octynyl adenosine, there is no evidence in this record other
than that found in applicants’ own specification which
reasonably would have suggested to persons having ordinary
skill in the art that the water content of the 2-octynyl
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adenosine hydrate was responsible for the agent’s storage
instability.
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The examiner argues (Supp. Ans., p. 2, l. 27, to p. 3,
l. 9):
. . . [P]harmaceuticals are routinely tested for activity
as a function of storage conditions to determine how they
must be processed in preparation for storage (shelf-life
determination). Instability in the presence of retained
solvent, i.e. herein water of hydration, is not unheard
of and as noted in Weygand, readily soluble in several
different ways without undue expense. Therefore, the
instant “purified” product is deemed to have been well
within the perview [sic] of the ordinary practitioner
seeking to optimize storage conditions for
2-octynyladenosine.
We certainly agree that it would have been well within
the ordinary skill of the artisan to optimize a result
effective variable. In re Boesch, 617 F.2d 272, 276, 205 USPQ
215, 219 (CCPA 1980). Moreover, we see no clear error in the
examiner’s finding that purity is considered a result
effective variable for most drugs. However, we do not see
that persons skilled in the art would have necessarily
considered water of hydration to be
an impurity. To the contrary, persons having ordinary skill
in the art reasonably would have been justified in presuming
that Miyasaka and Matsuda had purified their 2-octynyl
adenosine sufficiently for effective use as an
antihypertensive agent and optimum pharmaceutical activity.
Furthermore, the evidence presented in Morozumi’s Declaration
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Under 37 CFR 1.132 filed April 13, 1994 (Paper No. 21 ),1/2
evidence which contradicts the examiner’s optimization theory
with water as the result effective impurity for 2-octynyl
adenosine, indicates that the 2-octynyl adenosine prepared by
Miyasaka and Matsuda becomes more stable as its water content
increases.
In re Dow Chemical Co., 837 F.2d 469, 5 USPQ2d 1529 (Fed.
Cir. 1988), teaches at 473, 5 USPQ2d at 1531:
The consistent criterion for determination
of obviousness is whether the prior art would have
suggested to one of ordinary skill in the art that
this process should be carried out and would have a
reasonable likelihood of success, viewed in light
of the prior art. . . . Both the suggestion and the
expectation of success must be founded in the prior
art, not in applicant’s disclosure.
The prior art here cited against the claims on appeal would
not have suggested to persons having ordinary skill in the art
to reduce the water content of 2-octynyl adenosine to 3% or
less to improve the storage stability of the known
antihypertensive agent or for any other apparent reason. The
examiner here, as did the PTO in Dow Chemical Co., at 473, 5
USPQ2d at 1532:
. . . presents an “obvious to experiment” standard
for obviousness. However, selective hindsight is no more
applicable to the design of experiments than it is to the
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combination of prior art teachings. There must be a
reason
or suggestion in the art for selecting the procedure
used,
other than the knowledge learned from the applicant’s
disclosure.
Accordingly, we reverse the examiner’s holding of
unpatentability under 35 U.S.C. § 103.
Conclusion
We reverse the examiner’s rejection of Claims 1-3, 7-13,
and 15-28 under 35 U.S.C. § 103 as being unpatentable over the
teaching of either Miyasaka or Matsuda in view the teaching of
Weygand.
REVERSED
EDWARD C. KIMLIN )
Administrative Patent Judge)
)
)
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)
TEDDY S. GRON ) BOARD OF PATENT
Administrative Patent Judge) APPEALS AND
) INTERFERENCES
)
)
CHARLES F. WARREN )
Administrative Patent Judge)
bae
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