Ex parte BOUFFARD et al.

Board of Patent Appeals and Interferences

Feb 27, 1998

08005942 (B.P.A.I. Feb. 27, 1998)

Application for patent filed January 15, 1993. 1
According to the appellants, the application is a
continuation-in-part of Application No. 07/775,774, filed
October 17, 1991, now Patent No. 5,430,019, issued July 4,
1995, which is a continuation-in-part of Application No.
07/960,983, filed October 16, 1992, now abandoned.
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journal and (2) is not binding precedent of the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. 15
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte FRANCES A. BOUFFARD and JAMES F. DROPINSKI
___________
Appeal No. 95-3387
Application No. 08/005,9421
____________
ON BRIEF
____________
Before WINTERS, WEIFFENBACH and WEIMAR, Administrative Patent
Judges.
WEIMAR, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner's decision finally
rejecting claims 1-15. Claims 1 and 12 are illustrative of
the subject matter on appeal and they read as follows:
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The references relied upon by the examiner are:
Schmatz 5,166,135 Nov. 24, 1992
Sandoz (Belgium)
'310 Pat. 851,310 Aug. 10, 1977
Sandoz (Belgium)
'067 Pat. 859,067 Mar. 28, 1978
Michel (German)
'130 Pat. 2,065,130 June 24, 1981
Claims 1-15 stand provisionally rejected under the
judicially created doctrine of obviousness-type double
patenting
as lacking patentable distinction over (1) Claims 1-17 or
(2) Claims 1-4 or (3) Claims 3-20 or (4) Claims 4-7 or (5)
Claims 1-11 and 13 or (6) Claims 1-10 or (7) Claims 1-9 of
copending applications (1) 07/936,558; (2) 07/963,332; (3)
07/775,774; (4) 07/960,983; (5) 07/936,531; (6) 07/936,434;
and (7) 07/959,948; respectively. We affirm this rejection.
Claims 1-15 stand rejected under 35 U.S.C. § 103 over
Schmatz alone or in the alternative over '310 Pat. or '067
Pat. in combination with Michel. We reverse this rejection.
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BACKGROUND
Claims 1-9 and 13-15 are drawn to compounds which are
derivatives of known cyclohexapeptidyl compounds. These
compounds are known in the art as echinocandins. Claims 10
and 11 are drawn to antibiotic compositions comprising the
compounds of claim 1. Claim 12 is drawn to a method of
administering a therapeutic amount of a compound set forth in
claim 1 to a mammal to control microbial infection.
The compounds that were starting materials for the
production of the claimed compounds are echinocandin
hexapeptidyl compounds extracted from microbial fermentates.
These parent compounds and their antibiotic activity were
known prior to the filing date of this application.
DISCUSSION
Obviousness-type Double Patenting
Claims 1-15 stand provisionally rejected under the
judicially created doctrine of obviousness-type double
patenting
as lacking patentable distinction over (1) Claims 1-17 or (2)
Claims 1-4 or (3) Claims 3-20 or (4) Claims 4-7 or (5) Claims
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1-11 and 13 or (6) Claims 1-10 or (7) Claims 1-9 of copending
applications (1) 07/936,558; (2) 07/963,332; (3) 07/775,774;
(4) 07/960,983; (5) 07/936,531; (6) 07/936,434; and (7)
07/959,948; respectively.
With respect to application Serial Number 07/960,983 this
rejection is now moot in that this application has been
abandoned. With respect to application Serial Number
07/775,774 and application Serial Number 07/936,434 this
rejection is no longer provisional in that these applications
have issued as U.S. Patent # 5,430,018 and U.S. Patent #
5,348,940, respectively.
The Appeal Brief acknowledges this rejection on page 4,
however no argument is presented with respect to the merits of
this rejection. In that no arguments have been presented by
appellants as to why the examiner's rejection is erroneous, we
summarily affirm this rejection.
In the Appeal Brief on page 4, appellants "requested that
the Examiner hold any rejection on these grounds in abeyance
until there is an indication of allowable subject matter."
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Appellants should note that an examiner does not have the
authority to grant such a request. As explained in the Manual
of Patent Examining Procedure, MPEP (6th edition, Rev. 3, July
1997) Section 1206, page 1200-8:
Appellants must traverse every ground of
rejection set forth in the final rejection. Oral
argument at the hearing will not remedy such a
deficiency in the brief. Ignoring or acquiescing
in any rejection, even one based upon formal matters
which could be cured by subsequent amendment, will
invite a dismissal of the appeal as to the claims
affected. If this involves all of the claims, the
proceedings in the case are considered terminated
as of the date of the dismissal. Accordingly, any
application filed thereafter will not be copending
with the application on appeal.
In this application we consider appellants' comments to be an
acquiescence on the merits. We are loathe to dismiss the
appeal given the particular facts of this case, specifically
the examiner's handling of the issue. The examiner failed to
alert appellants to the consequences of an acquiescence in a
rejection and to extend the opportunity to submit a complete
Appeal Brief, and the comments made in the Examiner's Answer
in this regard, which would give the impression that no more
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need be said by appellants in relation to the obviousness-type
double patenting rejection at this stage of prosecution.
Rejections based on 35 U.S.C. § 103
Claims 1-15 stand rejected under 35 U.S.C. § 103 over
Schmatz alone or in the alternative over '310 Pat. or '067
Pat. in combination with Michel.
The examiner's grounds of rejection are set forth on
pages
4 and 5 of the Examiner's Answer to which we refer for the
examiner's presentation of the reasons for rejection.
Schmatz discloses a genus of compounds which is inclusive
of a number of species contained within the genus of claim 1
herein, with the exception of the hydroxyproline residue.
Schmatz discloses a 3-hydroxy-4-methylproline, while the
instantly claimed compounds do not contain a methyl group on
the 4th carbon of the proline residue. Appellants pointed to
this distinction in response to the first action and submitted
two declarations pursuant to 37 CFR § 1.132. The declarations
address properties of hexapeptidyl echinocandin derivatives
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which compare an echinocandin derivative with 4-methyl-3-
hydroxyproline as the sixth residue against 19 compounds which
are echinocandin derivatives with 3-hydroxyproline residues as
the sixth residue. The examiner responded in the Final
Rejection (Paper #9, pages 2 and 3) taking the position that
the use of a broken line, in association with the methyl group
of the hydroxyproline residue at columns 33 and 34 of Schmatz,
suggested that the methyl can be a leaving group or that it
can be cleaved. The examiner also stated at page 3 of the
Final rejection that:
Further, it is well established in the art
that a hydroxyproline residue containing
a methyl or a hydrogen atom (i.e., desmethyl)
are known to be functionally equivalent.
...Thus, applicants' arguments, the
declarations of Mr. Bartizal, Jr. and
Balkovec are of no probative value
and are insufficient to overcome the 103
rejection since the comparison is not done
with the disclosure identical (not similar)
to that of the reference.
The examiner takes the same position with respect to '310
Pat., '067 Pat. and Michel, because these publications also
depict dotted lines in association with the methyl group on
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the hydroxyproline residue of the hexapeptidyl compounds that
they each disclose.
In the Appeal Brief, at page 3, appellants urge that the
references depict tapered dashed lines from the pyrrolidine
ring to the methyl group so as to indicate the stereochemistry
of the compound and not any potential cleavage of the methyl
group in question. The examiner does not controvert this in
the Examiner's Answer.
The question is then raised as to whether the cited art
is enabling for a method of making compounds which do not have
a
4-methyl-3-hydroxyproline residue. Appellants state on page 4
of the Appeal Brief that “the art cited against the instant
application ... does not teach a method of selectively
removing the methyl group.”
In the response to arguments, on pages 6 and 7 of
the Examiner's Answer, reference is made to Schwartz, U.S.
Patent 5,202,309. The Schwartz patent referred to was
submitted by appellants in an Information Disclosure Statement
filed after the Appeal Brief. In the paragraph bridging pages
6 and 7 of the Examiner's Answer the examiner states:
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Schwartz... teaches that both of these
compounds are natural products of the
same organism wherein the individual
components of the natural product are
separated from one another by methods
commonly employed in the art such as
fractionation, chromatography, etc.
Therefore, one having ordinary skill
in the art, at the time of the invention,
would therefore be apprised of how to
make a compound from a natural product
containing either a non-methylated
hydroxy Pro or methylated hydroxy Pro
by employing procedures clearly known
in the art of separating individual
components from antibiotics of the type
presently claimed.
It is clear from the examiner's discussion of this publication
that it forms part of the evidence in support of a holding
that
any or all of the claims would have been obvious. As the
court
stated in In re Hoch, 428 F.2d 1341, 1342 n.3, 166 USPQ 406,
407 n.3 (CCPA 1970):
Appellant complains that although neither of
[the newly cited references] is mentioned in
the statement of either of the appealed
rejections and although this fact was pointed
out in appellant's brief below, the board
approved of their use by the examiner "as
suggesting that [appellant's] compounds would
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exert herbicidal action" and characterizing
this as a use in a "minor capacity" (emphasis
added) to "further support the rejection."
Appellant's complaint seems to be justified,
and if we did not find the rejections based
solely on Molotsky and the French patent to
be sound, we might well feel constrained to
reverse the decision of the board. Where a
reference is relied on to support a rejection,
whether or not in a "minor capacity," there
would appear to be no excuse for not positively
including the reference in the statement of the
rejection.
We do not consider the Schwartz reference to have been cited
in the rejection before us, particularly since the examiner
failed to indicate inclusion of the reference in the rejection
and specifically indicated on page 3 of the Examiner's Answer
that no “new prior art has been applied in this examiner's
answer.” Thus, we consider the issue of whether any of
Schmatz, '310 Pat., '067 Pat. or Michel enable a method of
making a compound which lacks a methyl at the fourth carbon of
the hydroxyproline residue of the hexapeptidyl compounds
disclosed by the references. Each of these references
disclose obtaining the core cyclic hexapeptidyl compounds from
microbial fermentates. In these references there is no
discussion of culturing the exemplified microorganisms or
other strains so as to obtain mixtures of cyclic hexapeptidyl
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compounds which include variants which lack the methyl group
in the hydroxyproline residue. While there is a statement in
Michel, at page 1, lines 21-22 to the effect that the starting
fermentates are mixtures of variant compounds there is no
indication that the desmethyl variant is one of those known to
be present in the microbial fermentate. The exemplified
variants in Michel do not include the desmethyl variant.
There is no teaching of removal of this methyl group either.
Thus, we conclude that the cited references fail to provide
any evidence that one of ordinary skill in the art would have
been enabled to prepare the compounds of the cited prior art
without a methyl on the fourth carbon of the hydroxyproline
residue. Thus, the rejections presented under 35 U.S.C. § 103
are reversed.
Other Issues
We make note of a potential rejection under 35 U.S.C. §
103 based on the disclosure of Schmatz of echinocandin
derivatives that are so closely related to the claimed
compounds as to differ only in the lack of a methyl group in
the hydroxyproline residue, coupled with the disclosure of the
Schwartz reference discussed above, as to the existence of
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variants in echinocandin-containing fermentates of
microorganisms of the species Zalerion arboricola, as well as
methods of enriching the fermentate with respect to desmethyl
variants and means of separating the variants from each other.
While provisions exist for the presentation of such a
rejection by this panel, we decline to make the necessary
findings of fact in this case and consider that it is more
prudent for the examiner to do so in the first instance. The
examiner should conduct a claim-by-claim analysis of the
differences between the claims and the prior art, should
consider the level of skill of the ordinary artisan at the
time of the invention and decide whether a prima facie case of
obviousness exists. We also note the declarations of Dr.
James Balkovec and Dr. Kenneth F. Bartizal, Jr. filed
previously in this record as Paper Nos. 7 and 8, respectively.
This evidence appears to be relevant and may well provide an
adequate rebuttal, at least with respect to some of the
claimed compounds, to any consideration as to whether the
claimed compounds, compositions and method are obvious in view
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of the prior art. The examiner should carefully review this
evidence.
Conclusion
The decision of the examiner refusing to allow claims 1-
15 under the judicially created doctrine of obviousness-type
double patenting is affirmed.
The decision of the examiner refusing to allow claims 1-
15 under 35 U.S.C. § 103 is reversed.
No time period for taking subsequent action in connection
with this appeal may be extended under 37 CFR § 1.136(a).
AFFIRMED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
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) BOARD OF PATENT
CAMERON WEIFFENBACH ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ELIZABETH C. WEIMAR )
Administrative Patent Judge )
Appeal No. 95-3387
Application No. 08/005,942
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Alice O. Robertson
Patent Dept.
Merck & Co., Inc.
P.O. Box 2000
Rahway, NJ 07065-09071
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ECW/jrg
APPEAL NO. 95-3387 - JUDGE WEIMAR
APPLICATION NO. 08/005,942
APJ WEIMAR
APJ WINTERS
APJ WEIFFENBACH
DECISION: AFFIRMED
Typed By: Jenine Gillis
DRAFT TYPED: 14 Jul 99
FINAL TYPED: