Ex parte Hegde

Board of Patent Appeals and Interferences

Feb 18, 1998

07747456 (B.P.A.I. Feb. 18, 1998)

Application for patent filed August 12, 1991. According 1
to applicants, this application is a continuation of Application
07/590,315, filed September 28, 1990, now abandoned; which is a
continuation of Application 07/227,968, 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(2) is not binding precedent of the Board.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. 35
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte VINOD R. HEGDE, ANN C. HORAN,
MAHESH G. PATEL and INGRID-AGNETA GUNNARSSON
____________
Appeal No. 94-1046
Application 07/747,4561
____________
ON BRIEF
____________
Before CAROFF, WILLIAM F. SMITH, and GRON, Administrative Patent
Judges
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
Appeal No 94-1046
Application 07/747,456
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This is an appeal from an examiner’s rejections of
Claims 1-9, all claims pending in this application.
1. The claimed subject matter
Claim 1 is representative of the claimed macrolactam
monosaccharide antimicrobial compound and is reproduced in the
attached Appendix. All claims stand or fall together (Brief on
Appeal, p. 4).
The claims are directed to a macrolactam monosaccharide
antimicrobial compound in substantially pure form, its
pharmaceutically acceptable salts, pharmaceutical compositions
comprising the pure compound or its salts, and methods for their
administration to hosts having a susceptible microbial infection.
“The compound is isolated from an antimicrobial complex 517 which
is produced in fermentation under controlled conditions using a
biologically pure culture of the microorganism, Actinomadura
vulgaris subsp. vulgaris SCC 1776, ATCC 53748" (Specification
(Spec.), p. 1, introductory paragraph). The microorganism was
isolated from soil collected in Borneo (Spec., p. 3, last
paragraph).
2. The rejections
A. Claims 1-9 stand rejected under 35 U.S.C. § 112, first
paragraph, purportedly because the specification, as originally
filed, did not describe the compound of formula 1 of Claim 1.
Appeal No 94-1046
Application 07/747,456
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B. Claims 1-9 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.
C. Claims 1-9 stand provisionally rejected for
obviousness-type double patenting of Claims 1-12 of commonly
assigned copending Application 07/746,050.
D. Claims 1-9 stand provisionally rejected for
obviousness-type double patenting of Claims 1-9 and 11 of
commonly assigned Application 07/746,059.
3. Discussion
A. Description requirement of Section 112
We reverse the rejection of the claimed subject matter for
noncompliance with the description requirement of the first
paragraph of 35 U.S.C. § 112. The examiner’s doubts that the
specification, as originally filed, describes the compound of
formula 1 of Claim 1, have not been adequately explained.
Compliance with the description requirement of 35 U.S.C.
§ 112, first paragraph, is a question of fact. Vas-Cath Inc. V.
Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116 (Fed. Cir.
1991). To satisfy the description requirement, the specification
as originally filed must convey to persons skilled in the art
that applicants invented the subject matter claimed. In re
Wilder, 736 F.2d 1516, 1520, 222 USPQ 369, 372 (Fed. Cir. 1984);
Appeal No 94-1046
Application 07/747,456
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In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir.
1983). However, compliance with the description requirement does
not require that the invention be described ipsis verbis in the
specification. In re Lukach, 442 F.2d 967, 969, 169 USPQ 795,
796 (CCPA 1971). The first paragraph of Section 112 only
requires that the description in the specification would have
clearly allowed persons skilled in the art to recognize that
applicants invented the subject matter claimed. In re Gosteli,
872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989).
The examiner has the initial burden to explain why persons
skilled in the art would not have recognized a description of the
compound defined by formula 1 of Claim 1 in the specification.
In re Gosteli, supra; In re Wertheim, 541 F.2d 257, 263, 265,
191 USPQ 90, 97, 98 (CCPA 1976). Thus, faced with the
qualitative data in the specification and identical limitations
in Claim 1, including the NMR and IR spectroscopy and optical
rotation information presented in Table II at page 14 of the
specification, the argument by the examiner that formula 1 of
Claim 1 is not drawn in precisely the same manner as formula 1
on page 2 of the specification does not itself satisfy the
examiner’s burden to explain why applicants’ specification would
not have described the compound presently claimed to persons
skilled in the art. This is especially true when, as here,
Appeal No 94-1046
Application 07/747,456
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Mohindar S. Puar, a person with much experience interpreting NMR
and IR data, declares that the compound spectroscopically
described in Table II on page 14 of the specification is the same
compound represented by the formula now appearing in Claim 1
based on his review of the NMR, IR, and optical rotation data in
the specification (pages 2-3, bridging paragraph, of the
Declaration of Mohindar S. Puar, Paper No. 26, filed March 26,
1992). In essence, Puar declares that the data in the
specification necessarily describes the inventive compound
appellants now claimed. It is not clear why, but the examiner is
not satisfied.
The examiner does not contradict the Puar Declaration.
Rather, the examiner appears to be arguing that appellants have
not proven that formula 1 of Claim 1 is the “necessary and only
reasonable” formula to be given to the compound spectroscopically
described on page 14 of the specification. What is the problem?
The examiner answers that Puar’s declaration is not persuasive
“because appellants have not presented any objective evidence
showing that the said physicochemical data is not consistent with
the structural formula presented in the specification, as
originally filed” (Examiner’s Answer, paragraph bridging
pages 5-6). We are confused by these remarks.
Appeal No 94-1046
Application 07/747,456
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The examiner does not explain why the data on page 14 of
the specification does not represent the structural formula
depicted in Claim 1 as Puar declares and does not constitute
objective evidence that appellants invented the subject matter of
Claim 1 at the time their application was originally filed. We
can speculate why the examiner maintained the rejection, but we
decline to do so.
Decisions by the Board are based on sound reasoning
supported by evidence. Absent some reasonable explanation by the
examiner as to why the data on page 14, especially data which the
art of qualitative analysis recognizes as being capable of
distinguishing isomers (compare the data reported in Tables II
and III of the specification, pp. 14 and 16 respectively, and
Table IV, p. 17), does not correspond to formula 1 of Claim 1,
we reverse the examiner’s rejection.
B. Obviousness under Section 103
The examiner has the initial burden of making out a case
for obviousness under 35 U.S.C. § 103. The examiner’s case for
obviousness is supported by the following arguments (Examiner’s
Answer, p. 4):
The Japanese patent discloses a closely analogous
antibiotic having the molecular formula of C H N O . 25 28 2 5
The only difference between the claimed compound and
the reference’s compound is a position of a hydroxy
group at the 4'-position. Since the claimed compound
is a position isomer of the reference’s compound and
Appeal No 94-1046
Application 07/747,456
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since a person having ordinary skill in the art at the
time the instant invention was made would have expected
the claimed compound to have biological activity similar
to that of the reference’s compound, the claimed compound,
composition containing the same and methods of treatment
would have been prima facie obvious to a person having
ordinary skill in the art at the time the instant
invention was made.
The two-part criteria 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, 313-15, 203 USPQ 245, 254-255 (CCPA
1979) and is particularly applicable to this case. First, would
the undisclosed structure of the AB-85 antibiotic described by
Japan be 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 compound of
formula 1 of Claim 1 for its antibiotic function with reasonable
expectation of success. Id. at 313, 203 USPQ at 254. Second,
would the prior art have enabled persons skilled in the art to
make and use the claimed compounds, i.e., would it have placed
the claimed compound in the possession of the public. In re
Payne, 606 F.2d at 314-15, 203 USPQ at 255. We need not dwell on
the first criteria, because the examiner has not supported his
allegation that the claimed antibiotic compound 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
Appeal No 94-1046
Application 07/747,456
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use appellants’ antibiotic compound 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 of this Application . . .[; and]
THAT, based on information and belief and my
expertise in synthetic organic chemistry, I am aware of
no synthetic chemical method in existence as of August 3,
1988 of synthesizing the compound of this invention . . .
except by the fermentation of Actinomadura vulgaris subsp
vulgaris of this invention . . . .
In short, Min Chu declares that he knows of no method of
preparing antibiotics including the 3-amino-3,6-dideoxytalo-
pyranose radical which is attached as the talopyranoside to C-6
of the macrolactam aglycone of this invention from antibiotics
including the 3-amino-3,6-dideoxymannopyranose radical which is
attached as the mannopyranoside to C-6 of the macrolactam
aglycone AB-85 (Chu, page 3).
Faced with Chu’s declaration, the examiner responded as
follows (Examiner’s Answer, pp. 6-7):
Even though the Japanese patent does not disclose the
structural formula of antibiotic AB-85, it would have
been within the ordinary skill in the art at the time
the instant invention was made to determine the same using
conventional techniques for structural analysis. As
shown on page 3 of the Declaration by Dr. Puar, the
only difference between the claimed compound and the
reference’s compound is the position of hydroxy group
at the 4'-position on a sugar moiety. . . .
Appeal No 94-1046
Application 07/747,456
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With respect to the synthesizing of the claimed
compound, note that the instant claims are not directed
to the process claims but to product claims. Further,
it would have been obvious to a person having ordinary
skill in the art at the time the instant invention was
made to prepare the claimed compound by removing the
sugar moiety of the reference’s compound by acid
hydrolysis and by reacting the resulting aglycone
with the desired sugar moiety.
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 purely speculative. Accordingly, we reverse
the rejection.
C. Obviousness-type double patenting
The provisional obviousness-type double patenting rejection
of Claims 1-9 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 reverse the examiner’s provisional obviousness-type
double patent rejection of Claims 1-9 in view of the subject
matter of Claims 1-12 of commonly assigned, copending Application
07/746,050. The examiner finds (Examiner’s Answer, p. 3, first
full paragraph):
. . . [T]he conflicting claims are not identical . . .
because the difference between the claimed compound and
Appeal No 94-1046
Application 07/747,456
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the compound of the copending application is at the 5,
9, or 13 positions. The compound of the copending
application has a methyl group at the 5, 9, or 13
position instead of ethyl. Since ethyl is a next
higher homologue of methyl, the claimed compound is
an obvious variant of the compound claimed in the
copending application.
The examiner’s finding is clearly erroneous. The difference
between the claimed compound 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-dideoxytalopyranose 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-
dideoxymannopyranose isomer which is attached to C-6 of the
macrolactam aglycone ring of the compound claimed in the
copending application. As we indicated with respect to the
examiner’s rejection of Claims 1-9 under 35 U.S.C. § 103 in view
of the teaching of Japan 59-18035, the examiner 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
Appeal No 94-1046
Application 07/747,456
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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 )

Appeal No 94-1046
Application 07/747,456
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Thomas D. Hoffman
Schering-Plough Corp.
One Giralda Farms
Madison, NJ 07940-1000