Ex parte Cooper et al.

Board of Patent Appeals and Interferences

Feb 18, 1998

07746050 (B.P.A.I. Feb. 18, 1998)

Application for patent filed August 12, 1991. 1
According
to applicants, this application is a continuation of
Application 07/590,570, filed September 28, 1990, now
abandoned; which is a continuation of Application 07/227,964,
filed August 3, 1988,
now abandoned.
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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(2) is not binding precedent of the Board.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. 36
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte RAYMOND COOPER, ANN C. HORAN,
MAHESH G. PATEL and IMBI TRUUMEES
____________
Appeal No. 94-1146
Application 07/746,0501
____________
ON BRIEF
____________
Before CAROFF, WILLIAM F. SMITH, and GRON, Administrative
Patent Judges
GRON, Administrative Patent Judge.
And Appeal No 94-1146
Application 07/746,050
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DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal from an examiner’s rejections of
Claims 1-12, all claims pending in this application.
1. The claimed subject matter
Claim 1 is representative of the claimed macrolactam
monosaccharide antimicrobial compounds and is reproduced in
the attached Appendix. All claims stand or fall together
(Brief on Appeal, p. 4).
The claims are directed to macrolactam monosaccharide
antimicrobial compounds in substantially pure form, their
pharmaceutically acceptable salts, pharmaceutical compositions
comprising the pure compounds or their salts, and methods for
treating a bacterial infection in a host comprising
administering the compounds to the infected host. “The
compounds are
isolated from an antimicrobial complex 510 which is produced
in fermentation under controlled conditions using a
biologically pure culture of the microorganism, Actinomadura
fulva subsp. uruguayensis SCC 1778, ATCC 53713" (Specification
(Spec.), p. 1, introductory paragraph). The microorganism was
And Appeal No 94-1146
Application 07/746,050
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isolated from soil collected in Uruguay (Spec., p. 3, last
paragraph).
2. The rejections
A. Claims 1-12 stand rejected under 35 U.S.C. § 103 as
being unpatentable in view of antibiotic AB-85 disclosed in
Japanese Patent Publication 59-18035, published April 25,
1984.
B. Claims 1-12 stand provisionally rejected for
obviousness-type double patenting of Claims 1-9 of commonly
assigned copending Application 07/747,456.
C. Claims 1-12 stand provisionally rejected for
obviousness-type double patenting of Claims 1-9 and 11 of
commonly assigned Application 07/746,059.
3. Discussion
A. Obviousness under Section 103
The examiner has the initial burden of making out a case
for obviousness under 35 U.S.C. § 103. Here, the examiner’s
case for obviousness is supported by the following arguments
(Examiner’s Answer, pp. 3-4):
The Japanese patent discloses an antibiotic
having molecular formula C H N O . Appellants on 25 28 2 5
page 13 of the specification state that the macrolactam
monosaccharide of formal [sic, formula] 2 and having
the molecular formula as given, is disclosed by the
And Appeal No 94-1146
Application 07/746,050
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Japanese patent. The only difference between known
compound and the claimed compound is at the 9, 5 or 13
positions, i.e [sic] the known compound contains ethyl
groups at the said positions while the claimed compound
contains at least one methyl group at the said positions.
Since methyl is a next lower homologue of ethyl, it would
have been obvious to a person having ordinary skill in
the art at the time of the instant invention to
substitute
methyl group for ethyl on the compound of formula 2 with
an expected result. The instant compounds, compositions
and methods are deemed obvious over the Japanese patent.
The two-part test for holding that a claimed compound
would have been obvious under Section 103 over the disclosure
of a structurally similar compound in the prior art is set out
in
In re Payne, 606 F.2d 303, 314-15, 203 USPQ 245, 254-255 (CCPA
1979). First, we must ask whether the undisclosed structure
of the AB-85 antibiotic described by Japan would have been
understood by persons having ordinary skill in the art to be
so similar to formula 1 of appellants’ Claim 1 that they
reasonably would have been led to make and use the compounds
of formula 1 of Claim 1 as an antibiotic with reasonable
expectation of success. Id. at 313, 203 USPQ at 254. Second,
we must ask whether the prior art would have enabled persons
skilled in the art to make and use the claimed compounds,
i.e., would it have placed the claimed compounds in the
And Appeal No 94-1146
Application 07/746,050
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possession of the public. In re Payne, 606 F.2d at 314-15,
203 USPQ at 255. On considering the second part of the two-
part test, we find that the examiner has not supported his
allegation that the claimed antibiotic compounds would have
been obvious with evidence sufficient to justify a conclusion
that the prior art would have enabled one skilled in the art
to make and use appellants’ antibiotic compounds without
appellants’ disclosure.
In his declaration filed March 26, 1992 (Declaration of
Min Chu (Chu), Paper No. 26), Chu declares (Chu, pp. 2-3):
THAT, the structural formula of the antibiotic
AB-85 . . . of the Japanese patent . . . [has] the
formula 2 on page 15 of the US Patent Application Serial
No. 07/747,456, filed 08/12/91 . . .[; and]
THAT, based on information and belief and my
expertise in synthetic organic chemistry, I am aware of
no synthetic method as of August 3, 1988 of
selectively activating and removing one, two or three
of the CH groups at C-5', C-9' and C-13' of AB-85 to 2
form any of the aglycone of the compounds of this
invention of formula 1. . .[;]
THAT, based on information and belief and my
expertise in synthetic organic chemistry, I am aware
of no chemical method in existence as of August 3,
1988 of synthesizing the compounds of this invention
except by the fermentation of Actinomadura fulva subsp
uruguayensis of this invention; and
Conclusion
In summary, (1) I am aware of no synthetic
And Appeal No 94-1146
Application 07/746,050
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technique to selectively activate and remove the one,
two or three of the -CH - groups at C-5', C-9' and/or 2
C-13' of the macrolactam aglycone of AB-85 to form the
compounds of this invention and (2) there is no synthetic
organic chemical method of making the compounds of this
invention and (3) only by fermentation of the A. fulva
subsp uruguayensis of this invention are the compounds
of this invention available.
In short, Min Chu declares that he is not aware of any
synthetic organic chemical method of preparing antibiotics
including the macrolactam aglycone of this invention with a
methyl radical at the C-5, C-9 and/or C-13 position from
antibiotics including the macrolactam aglycone of AB-85 with
an ethyl radical at the C-5, C-9 and/or C-13 position.
Faced with Chu’s declaration, the examiner responded as
follows (Examiner’s Answer, pp. 5-6):
. . . [T]he Declaration by Dr. Min Chu stating that Dr.
Min Chu is not aware of any synthetic technique to
selectively activate and remove the one, two, or three of
the -CH - groups at the 5, 9 and 10-13 [sic, 13] position2
of the
compound disclosed by the Japanese patent, [the]
same Declaration . . . [has] not been found persuasive
because the removal of the methyl group from the
reference’s compound can be not selective but random
resulting in a mixture of compounds being formed which are
subsequently separated.
However, Chu also said that he was “aware of no chemical
method in existence as of August 3, 1988 of synthesizing the
compounds of this invention except by the fermentation of
And Appeal No 94-1146
Application 07/746,050
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Actinomadura fulva subsp uruguayenis of this invention” (Chu,
p. 3; emphasis added). While Chu’s declaration of
unobviousness is itself supported by no more evidence than is
the examiner’s allegation of obviousness, it is the examiner
who has the initial burden to sustain his case. In our view,
the examiner’s case of obviousness under 35 U.S.C. § 103 in
view of the teaching of Japan 59-18035 is based on pure
speculation. Whether or not the motivation to synthesize
organic compounds is apparent from the prior art applied
against the claims in this case or debatable, the examiner
must also make the inquiries necessary to prima facie
establish that it would have been within the ordinary skill in
the art to synthesize the compounds sought without undue
experimentation, e.g., determine the unpredictability, level
of skill, and suitability of conventional methodology in the
art. The examiner has discussed none of the factors relevant
to the outcome-determinative issue in this case. In short,
the examiner appears to have rested his case of obviousness on
recognizing some motivation to synthesize the claimed
compounds. We repeat, standing alone motivation to synthesize
structurally similar compounds is not enough to sustain a case
of obviousness under
And Appeal No 94-1146
Application 07/746,050
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35 U.S.C. § 103. The prior art must place the claimed
compounds in the possession of the public. In re Payne, 606
F.2d at 314, 203 USPQ at 255. The examiner has not satisfied
his burden to establish that the prior art would have enabled
persons skilled in the art to make the claimed compounds
without undue experimentation. Accordingly, we reverse the
examiner’s rejection.
B. Obviousness-type double patenting
The provisional obviousness-type double patenting
rejection of Claims 1-12 in view of the subject matter of
Claims 1-9 and 11 of Application 07/746,059 is hereby
reversed. The rejection is moot because the application
appears to have been abandoned.
We also reverse the examiner’s provisional obviousness-
type double patent rejection of Claims 1-12 in view of the
subject matter of Claims 1-9 of commonly assigned, copending
Application 07/747,456. The examiner finds (Examiner’s
Answer, p. 3, first full paragraph):
. . . [T]he conflicting claims are not identical . . .
because the difference between the claimed compounds
and the compound of the copending application is at
the 5, 9 or 13 position i.e. the compound of the
copending application has ethyl groups at the 5, 9
and 13 position [sic] while the claimed compound has
a methyl group at the 5, 9 or 13 positions [sic].
And Appeal No 94-1146
Application 07/746,050
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Since methyl is a next higher homologue of ethyl,
the claimed compounds are obvious variants of the
compound claimed in the copending application.
The examiner’s finding is clearly erroneous. The difference
between the claimed compounds and the compound of the
copending application lies not only at the 5, 9, or 13
position of macrolactam aglycone ring of the claimed
antibiotics but also in the difference between the 3-amino-
3,6-dideoxymannopyranose isomer which is attached to C-6 of
the macrolactam aglycone ring of the compound claimed in this
application and the 3-amino-
3,6-dideoxytalopyranose isomer which is attached to C-6 of the
macrolactam aglycone ring of the compound claimed in the
copending application. In addition to the previously stated
reasons for reversing the examiner’s rejection of Claims 1-12
under 35 U.S.C. § 103 in view of the teaching of Japan 59-
18035, the examiner also has not established that a disclosure
of one isomer would have enabled persons skilled in the art to
make and use the other.
4. Conclusions
We reverse all the examiner’s rejections.
REVERSED
And Appeal No 94-1146
Application 07/746,050
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Marc L. Caroff )
Administrative Patent Judge )
)
)
)
William F. Smith ) BOARD OF
PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Teddy S. Gron )
Administrative Patent Judge )

And Appeal No 94-1146
Application 07/746,050
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Thomas D. Hoffman
Schering-Plough Corporation
One Giralda Farms
Madison, NJ 07940-1000