Ex parte Bouffard et al.

Board of Patent Appeals and Interferences

Feb 27, 1998

07936558 (B.P.A.I. Feb. 27, 1998)

Application for patent filed September 3, 1992. 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journal and (2) is not binding precedent of the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. 20
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte FRANCES A. BOUFFARD and JAMES F. DROPINSKI and
ROBERT A. ZAMBIAS
____________
Appeal No. 95-0976
Application No. 07/936,5581
____________
HEARD: January 16, 1998
____________
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 1-14. Claims 1 and 13 are illustrative of
the subject matter and they read as follows:
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13. An antibiotic composition comprising therapeutic
amount of a compound of Claim 1 in a pharmaceutically
acceptable carrier.
The references relied upon by the examiner are:
Sandoz (Belgium)
'310 Pat. 851,310 Aug. 10, 1977
Sandoz (Belgium)
'067 Pat. 859,067 Mar. 28, 1978
Schmatz 5,166,135 Nov. 24, 1992
Claim 1 stands rejected under 35 U.S.C. § 112, first
paragraph, as failing to provide an enabling disclosure. We
reverse this rejection.
Claims 1-14 stand rejected under 35 U.S.C. § 103 over
Schmatz or '310 Pat. in combination with '067 Pat. We reverse
this rejection.
Claims 1-14 stand provisionally rejected under the
judicially created doctrine of obviousness-type double
patenting
as lacking patentable distinction over (1) Claims 1-11 and 13
or (2) Claims 1-4 or (3) Claims 3-20 or (4) Claims 4-7 or (5)
Claims 1-13 or (6) Claims 1-10 or (7) Claims 1-9 of copending
applications (1) 07/936,561; (2) 07/963,332; (3) 07/775,774;
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(4) 07/960,983; (5) 08/005,942; (6) 07/936,434; and (7)
07/959,948; respectively. We affirm this rejection.
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BACKGROUND
Claims 1-12 are drawn to compounds which are derivatives
of known cyclohexapeptidyl compounds. These compounds are
known in the art as echinocandins. Claims 13 and 14 are drawn
to antibiotic compositions comprising the compounds of claim
1.
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
Rejection based on 35 U.S.C. § 112
Claim 1 stands rejected under 35 U.S.C. § 112, first
paragraph, as having been based on a non-enabling disclosure.
Although phrased various ways the position of the
examiner is that the single in vivo example of the claimed
antibiotic activity is inadequate to provide the necessary
guidance to one of skill in the art to practice the invention
across the scope of the claim. The claims at issue encompass
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a product claim which is broader than the single compound
whose antimycotic activity is exhibited in the specification.
Assuming arguendo that the examiner had established a
prima facie case to reject this claim, the examiner fails to
adequately rebut the position taken by appellants. The data
presented in the specification on pages 25-29 exhibits
antibiotic activity in vivo against one strain of yeast and
against Pneumocystis carinii. However the antibiotic
activity of one of the claimed compounds against several
strains are shown in vitro in this section of the
specification. Having shown by animal testing the
effectiveness of a compound which exhibited antibiotic
properties both in vitro and in vivo, the appellants' position
is that an adequate correlation between in vitro test data and
in vivo test data has been established. The examiner
reiterates that one example is inadequate to support many but
does not give any reasons why the correlation between in vitro
and in vivo has not been established by the data submitted in
the specification.
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Furthermore, appellants take the position that the single
compound and the two species tested in vivo are adequate
representatives of the respective genera of compounds and
pathogens. The examiner makes no comment, beyond the
statement that the claims cover many species, to controvert
the appellants' position.
The appellants also point to the teachings of the applied
art (specifically the specifications of the two Belgian
patents) for a further showing of the reasonableness of the
claimed scope based on similar exhibitions with representative
compounds. The examiner's response is to note that in these
two publications as well, the in vivo data is limited to the
use of the same species of yeast as is shown in the instant
specification. These patents contain in vitro test data which
indicate the effectiveness of a representative compound
disclosed therein against several genera of mycogenic
pathogens.
The examiner has failed to cite references or give
specific examples from the prior art or provide scientific
reasoning that would counterbalance the reasonableness of the
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position taken by the appellants, and that undue
experimentation would not be required for one skilled in the
art to practice the claimed invention. Thus, the rejection
under 35 U.S.C. § 112, first paragraph is considered to be
effectively rebutted and is reversed.
Rejections based on 35 U.S.C. § 103
Claims 1-14 stand rejected under 35 U.S.C. § 103 over
Schmatz or '310 Pat. in combination with '067 Pat. We first
note
that the Examiner's Answer (Paper # 14) fails to provide an
explanation of the teachings of each reference relied upon in
the obviousness rejection. A previous rejection is not
incorporated by reference. The secondary reference, i.e. '067
Pat., is not mentioned in the Examiner's Answer with the
exception of its inclusion in the list of references on page 3
and the statement of rejection under 35 U.S.C. § 103 on page
6. Pages 6 and 7 of the Examiner's Answer respond to points
raised by appellants in the Brief with respect to the
obviousness rejection. Page 10 of the Examiner's Answer
contains the following sentence under the heading "(11)
Response to argument":
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The issues raised by appellants have been fully
responded to under the GROUNDS OF REJECTION, supra.
We are constrained to reverse this rejection in light of
the failure of the examiner to present a rejection based on
prior art that outlines which teachings are being relied upon
to establish the examiner's position that the claims would
have been obvious over the cited prior art.
Despite the failure of the Examiner's Answer to present
an explanation of the grounds for the rejection under 35
U.S.C.
§ 103, we have reviewed the prosecution history and we will
discuss the reasons for rejection which appear at various
sites in the record. The presentation of the rejection in the
first instance appears in Paper #7 and includes the following
points on pages 7 and 8 of that office action:
Each of the compounds of Schmatz or the '310
Pat. differs from the claimed compound in that
the claimed compound is a quarternary (sic)
ammonium salt derivative of eichinocandin (sic).
The Belgian Pat. ('067) however teach (sic) a
quarternary (sic) ammonium salt derivative of
eichinocandin(sic). (Note page 1, formula 1
of the '067 Pat.). Accordingly, it would have
been obvious to one of ordinary skill in the
art at the time the invention was made to
incorporate a quarternary (sic) ammonium salt
to the compound of each of Schmatz or '310
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Belgian Pat. as taught by the '067 Pat. with
a reasonable expectation that said quarternary
(sic) ammonium derivative would exhibit the
same or similar antibiotic effect. The
claimed compound containing an alkylamine
derivative would have been obvious in view
of the teachings of the '067 Pat. which appears
to teach an alkylamine when n is zero.
On page 6 of the Examiner's Answer the following points are
made:
Contrary to appellants' arguments Schmatz teaches
an amine at the Thr position. Note col. 18,
lines 37-38. Even assuming, for the sake of
arguments [sic, argument], that Schmatz does not
teach an amine however, it would be within the
expected skill of a person in the art to replace
the amide i.e., glutamine in the Thr residue of
Schmatz with an amine i.e., a basic residue as
Orn. Gln and Orn residues belong to the same
group of hydrophilic amino acid residues
and would reasonably be expected to exhibit
similar antibiotic activity. Further,
attachment of said amine group in the
cyclohexapeptide echinocandin, albeit at
different position i.e., at the Orn residue
as taught by Schmatz or the Belgian Pat. has
been known to exhibit a similar antibiotic
effect. To therefore merely transpose or
shift a particular substituent to a different
location of the peptide sequence, without
producing new and unexpected result, would
be within the expected skill in the art.
Although appellants urge that the Belgian
('310 ) Pat. discloses only the limited group
-(CH2)16-CH3 for R5 substituent (RI of the
instant application) the said group are (sic)
however, within the purview of the claims on
appeal.
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Appellants argue that the requirement of the claimed
compounds and compositions with respect to the propanolamine
substituent at the Thr position is neither taught nor
suggested by the applied art. We agree with appellants in
this regard. This position being dispositive of the issue of
obviousness for each of the claims we will not reach the other
questions raised by appellants. We note in particular the
issue as to the claimed R position desmethyl variations (set5
forth in claims 2-12 herein) and point out that the
Supplemental Examiner's Answer (Paper #17) refers to
variations of echinocandins obtained from a particular
microbial source. However, appellants did not file any Reply
Brief to address this reasoning. We take no position on this
specific matter.
The examiner bears an initial burden of establishing that
one of ordinary skill in the art would have found the claimed
invention to have been obvious at the time that it was made.
The evidence relied upon must support such a conclusion. As
was set forth in In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d
1438, 1442 (Fed. Cir. 1991):
Where claimed subject matter has been rejected
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as obvious in view of a combination of prior
art references, a proper analysis under § 103
requires, inter alia, consideration of two
factors: (1) whether the prior art would have
suggested to those of ordinary skill in the
art that they should make the claimed composition
or device, or carry out the claimed process; and
(2) whether the prior art would also have
revealed that in so making or carrying out,
those of ordinary skill would have a reasonable
expectation of success.
Considering the rejection at issue, with regard to
modification of the echinocandin antibiotics taught by Schmatz
and '310 Pat. by adding a propanolamine substituent at the Thr
position of the cyclic hexapeptidyl compounds, the examiner
has taken these positions: 1) that the '067 Pat. appears to
teach an alkylamine when n is zero; 2) that Schmatz teaches an
amine at the Thr position at col. 18, lines 37-38; 3) that it
would be well within the expected skill of a person in the art
to replace the amide i.e., glutamine in the Thr residue of
Schmatz with an amine i.e., a basic residue as Orn because Gln
and Orn residues belong to the same group of hydrophilic amino
acid residues and would reasonably be expected to exhibit
similar antibiotic activity; and 4) that attachment of said
amine group in the cyclohexapeptide echinocandin, albeit at
different position
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i.e., at the Orn residue, as taught by Schmatz or the '310
Pat., has been known to exhibit a similar antibiotic effect
and to merely transpose or shift a substituent to a different
location of the peptide sequence, without producing new and
unexpected result would be within the expected skill in the
art.
With respect to reason 1), '067 Pat. does not teach an
amine substituent at the Thr position when n is zero.
With respect to reason 2), Schmatz teaches at column 18,
lines 36-45 that the variable at the Thr position designated
R by Schmatz is CH not an amine. The alkyl amine referred toV 3
by Schmatz at column 18, lines 36-45, is substituent R whichIII
corresponds to R in the compounds claimed herein.3
With respect to reason 3), Schmatz does not teach a
glutamine in the Thr position. Thus, any thought to replace a
glutamine with an ornithine is of no moment. Moreover, such
replacement would still fail to create the claimed compounds
which retain the hydroxy from the threonine.
With respect to reason 4), the transposition or shifting
of a substituent from a specific Orn to a specific Thr in a
cyclic hexapeptide does not constitute a variation that is
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obvious on its face. Moreover, to meet the claimed structure
one would not be "shifting" the substituent, but duplicating
it since the claimed compounds retain alkyl ether amine
substituents at the Orn position. Even if one of ordinary
skill in the art were to duplicate the substituent at the Orn
position it is an ether amine while the claimed substituent
alkyl amines at the Thr position are not ethers.
A fundamental flaw in the examiner's reasoning that led
to the examiner's conclusion of obviousness is the examiner's
reliance on a proposition that making a change is "within the
expected skill in the art." As explained by the Federal
Circuit in In re Vaeck, supra, the obviousness of a claimed
compound must be based on the teachings of the prior art and
not on whether an artisan of ordinary skill could produce the
claimed compounds from compounds known in the prior art. In
this case the prior art contains no suggestion that one should
make the claimed compounds.
It is well-established that hindsight shall not form
the basis of a conclusion of obviousness under 35 U.S.C. §
103. “Both the suggestion and the expectation of success must
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be founded in the prior art, not in the applicant’s
disclosure.”
In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531
(Fed. Cir. 1988). As the Federal Circuit stated in Sensonics,
Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570, 38 USPQ2d 1551,
1554 (Fed. Cir. 1996):
To draw on hindsight knowledge of the
patented invention, when the prior art
does not contain or suggest that knowledge,
is to use the invention as a template for
its own reconstruction - an illogical and
inappropriate process by which to determine
patentability. . . . The invention must be
viewed not after the blueprint has been
drawn by the inventor, but as it would have
been perceived in the state of the art that
existed at the time the invention was made.
[citations omitted]
For the reasons stated above we fail to find a prima
facie case of obviousness with respect to claims 1-14 based on
the art before us.
Obviousness-type Double Patenting
Claims 1-14 stand provisionally rejected under the
judicially created doctrine of obviousness-type double
patenting
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as lacking patentable distinction over (1) Claims 1-11 and 13
or (2) Claims 1-4 or (3) Claims 3-20 or (4) Claims 4-7 or (5)
Claims 1-13 or (6) Claims 1-10 or (7) Claims 1-9 of copending
applications (1) 07/936,561; (2) 07/963,332; (3) 07/775,774;
(4) 07/960,983; (5) 08/005,942; (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 in the
paragraph bridging pages 6 and 7, 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 7, Appellants "request that
the Examiner hold any rejection on these grounds in abeyance
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until there is an indication of allowable subject matter."
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:
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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
need be said by appellants in relation to the obviousness-type
double patenting rejection at this stage of prosecution.
We explicitly state that claims 1-14 are allowable upon
the timely filing of a proper Terminal Disclaimer inclusive of
all necessary statements with respect to each of the
applications and or patents indicated above. Should such
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Terminal Disclaimer(s) be filed the issuance of this
application is binding upon the examiner in the absence of new
references or other new grounds of rejection. Compare 37 CFR
§ 1.196(c).
CONCLUSION
The decision of the examiner refusing to allow claims 1-
14 under the judicially created doctrine of obviousness-type
double patenting is affirmed.
The decision of the examiner refusing to allow claim 1
under 35 U.S.C. § 112, first paragraph, is reversed.
The decision of the examiner refusing to allow claims 1-
14 under 35 U.S.C. § 103 is reversed.
The time period in which appellants may file a proper
Terminal Disclaimer(s) as noted above is hereby set to expire
TWO MONTHS FROM THE DATE OF THIS DECISION.
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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 )
)
)
)
) BOARD OF PATENT
CAMERON WEIFFENBACH ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ELIZABETH C. WEIMAR )
Administrative Patent Judge )
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Alice O. Robertson
Patent Department
Merck & Co., Inc.
P.O. Box 2000
Rahway, NJ 07065-09071
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ECW/jrg
APPEAL NO. 95-0976 - JUDGE WEIMAR
APPLICATION NO. 07/936,558
APJ WEIMAR
APJ WINTERS
APJ WEIFFENBACH
DECISION: AFFIRMED
Typed By: Jenine Gillis
DRAFT TYPED: 14 Mar 00
FINAL TYPED: