Ex parte Capon et al.

Board of Patent Appeals and Interferences

Sep 2, 1998

07949327 (B.P.A.I. Sep. 2, 1998)

Application for patent filed September 21, 1992. According 1
to applicants, this application is a continuation of Application
07/749,371, filed August 23, 1991, now abandoned; which is a
continuation of Application 07/104,461, filed October 2, 1987,
now abandoned; which is a continuation-in-part of Application
06/438,128, filed November 1, 1982, now abandoned; which is a
continuation-in-part of Application 06/355,298, filed March 8,
1982, 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(2) is not binding precedent of the Board.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. 26
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte DANIEL J. CAPON and DAVID V. GOEDDEL
____________
Appeal No. 94-3676
Application 07/949,3271
____________
HEARING: April 9, 1997
____________
Before GRON, Administrative Patent Judge, McKELVEY, Senior
Administrative Patent Judge, and WEIMAR, Administrative Patent
Judge.
GRON, Administrative Patent Judge.
Appeal No. 94-3676
Application 07/949,327
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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 12-22, 24-28, 32, and 35.
1. Introduction
Claims 12-17, 24-28, and 32 stand rejected under 35
U.S.C.
§ 103 as unpatentable in view of the combined teachings of
Yabrov, “Interferon and Nonspecific Resistance,” Human
Sciences Press, New York, NY, pp. 25-28 (1980), and Goeddel et
al. (Goeddel), “The Structure of Eight Distinct Cloned Human
Leukocyte Interferon cDNAs,” Nature, Vol. 290, pp. 20-26
(1981). Claims 12-22, 24-28, 32, and 35 stand rejected under
35 U.S.C.
§ 103 as unpatentable in view of the combined teachings of
Yabrov, Goeddel, and Nagata et al. (Nagata), “Synthesis in
E. coli of a Polypeptide with Human Leukocyte Interferon
Activity,” Nature, Vol. 284, pp. 316-320 (1980). Claims 12-
22, 24-28, 32, and 35 stand rejected under 35 U.S.C. § 103 as
unpatentable in view of the combined teachings of Yabrov,
Goeddel, and Ptashne et al. (Ptashne), U.S. 4,332,892, which
issued June 1, 1982, from an application filed January 10,
1980.
Appeal No. 94-3676
Application 07/949,327
It is not apparent to this panel that the examiner has 2
expressly determined the metes and bounds of the subject matter of
Claims 19 and 20.
We note that Claims 21 and 27 which are appended to3
Appellants’ Brief have been incorrectly transcribed.
Specifically, Claim 21 should refer to Claim 14, not “Claim 4" as
indicated.
The final word “thereof” in Claim 27 should be --hereof--.
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Claims 29-31, 33, and 34 are also pending in this application
but have been withdrawn from further consideration by the
examiner as drawn to nonelected, restricted inventions.
Because appellants’ brief states that the claims stand or fall
together, we elect to decide the merits of this appeal of the
examiner’s decision to reject the subject matter claimed on
the basis of Claim 12. See 37 CFR § 1.192(c)(7). While all
claims are said to stand or fall together (Appellants’ Brief,
p. 5), Claims 12, 17, 19, 20, and 27 are reproduced below:2 3
12. An essentially purified and isolated DNA
sequence
encoding a polypeptide consisting essentially of the
amino
acid sequence of a non-human mammalian interferon.
17. Plasmid pBoIFN-α1-trp55.
19. A culture of transformant cells capable of
producing non-human mammalian interferon in a form
unaccompanied by the signal peptide or presequence
peptide
that is the immediate product of the translation of the
mRNA
Appeal No. 94-3676
Application 07/949,327
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of said non-human animal interferon.
20. A process which comprises expressing a gene
encoding a non-human mammalian interferon in a form
unaccompanied by the signal peptide or presequence
peptide
that is the immediate product of the translation of the
mRNA
of said non-human animal interferon in a microorganism or
cell culture.
27. An essentially purified and isolated DNA
sequence
encoding a non-human mammalian interferon having the
amino
acid sequence essentially as set forth in Figures 3a-d,
9a-c, 14a-e and 15 hereof.
Our reasons for including Claims 17 and 27 in the body of this
decision should become apparent from the “Other Issues”
portion of our opinion.
2. Discussion
Claim 12 is drawn to essentially purified and isolated
DNAs which encode all amino acid sequences of non-human
mammalian interferons. The examiner relies on Yabrov
essentially for its teaching that “there are reports which
show a high protective activity of bovine, rabbit and rat
interferons for human cells (Babiuk, Rouse, 1977; Filipic et
al., 1977)” (Yabrov, p. 26, first full para.). Goeddel
identifies the structures of eight distinct cloned human
leukocyte interferon cDNAs and, according to the examiner,
Appeal No. 94-3676
Application 07/949,327
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teaches “the genomic cloning of human IFN genes” (Examiner’s
Answer (Ans.), p. 3). The examiner concludes (Ans., p. 3):
It would have been obvious for one of ordinary skill in
the art to clone IFN genes from any non-human species
since the non-human interferons were known (Yabrov) to
be present in specific tissues and cells of animals, and
the cloning methods using the known human DNA sequence to
probe any mammalian library and recover an IFN species
were known. Goeddel et al. uses such a procedure for
other human IFN species and reports eight distinct
species.
Nagata and Ptashne are cited as evidence that processes
for isolating, purifying, cloning and expressing human IFN and
various mammalian genes in a bacterial host were well-known in
the art at the time appellants made their invention. Thus,
the examiner finds that it would have been within the ordinary
skill of the artisan to employ recognized techniques for
isolating, purifying, cloning and expressing any mammalian IFN
gene in a bacterial host in view of Goeddel’s teaching of the
structure of human leukocyte interferon and Yabrov’s
suggestion of some structural homology between heterologous
mammalian interferons (Ans., p. 4).
Appellants argue that (1) the examiner’s holding of
unpatentability of the subject matter claimed herein under
35 U.S.C. § 103 is inconsistent with the precedent set in
Amgen, Inc. v. Chugai Pharmaceuticals Co., Ltd., 927 F.2d
Appeal No. 94-3676
Application 07/949,327
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1200, 18 USPQ 1016 (Fed. Cir. 1991), (2) the prior art cited
by the examiner does not establish a prima facie case of
unpatentability under
35 U.S.C. § 103 for the claimed subject matter, and (3) the
greater weight of all the evidence of record, including the
Declarations of Michael Samuel Neuberger and A. Neil Barclay
under 37 CFR § 1.132 and attached exhibits, favors
patentability. The examiner argues that unpatentability is
evident because
(a) all the means and methods for isolation, purification,
cloning and expression of DNA encoding non-human mammalian
interferons were available to persons having ordinary skill in
the art at the time appellants’ invention was made, (b) the
evidence as a whole provides more than a mere invitation to
try to identify and isolate DNA which encodes non-human
mammalian interferons using probes based on cDNA which encodes
human interferon, e.g., the examiner argues that Yabrov’s
teaching that bovine, rabbit, and rat interferons show
activity on human cells and other corroborative studies of
record (Ans., p. 5, l. 20, to p. 7, l. 7) reasonably would
have suggested to persons having ordinary skill in the art
that a high degree of homology exists between DNA which
Appeal No. 94-3676
Application 07/949,327
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encodes human interferons and DNA which encodes non-human
mammalian interferon, (c) based on the evidence of record as a
whole, persons having ordinary skill in the art reasonably
would have expected success in isolating DNA which encodes
non-human mammalian interferons using probes based on DNA
which encodes human interferons, purifying the isolated DNA,
cloning the non-human mammalian DNA in bacterial hosts, and
expressing the DNA in bacterial hosts to synthesize non-human
mammalian interferons, all without undue experimentation.
Based on the evidence in this record and the precedent of
our reviewing court at the time the issues in this case were
briefed, we reverse the examiner’s holding. Moreover, in
light of the more recent decisions in In re Bell, 991 F.2d
781, 785,
26 USPQ2d 1529, 1532 (Fed. Cir. 1993), and In re Deuel, 51
F.3d 1552, 1559, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995), which
instruct that “a general method of isolating cDNA or DNA
molecules is essentially irrelevant to the question whether
the specific molecules themselves would have been obvious, in
the absence of other prior art that suggests the claimed DNAs”
(Id.), the examiner’s error is apparent.
Appeal No. 94-3676
Application 07/949,327
We note the examiner’s citation of other art. In re4
Hoch, 428 F.2d 1341, 1342 n.3, 166 USPQ 406, 407 n.3 (CCPA 1970):
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.
- 8 -
While appellants do not contest the examiner’s finding
that the prior art of record as a whole shows varying levels
of heterologous activity among bovine, porcine, human, rabbit,
monkey, equine, and canine (Ans., pp. 6-7, bridging para.),4
they argue that the examiner’s finding that “it would be
highly likely bovine and human [DNAs which encode interferon]
are significantly homologous in their primary structure (DNA
and amino acid sequences)” (Ans., p. 7, l. 9-10) is
speculative and contrary to the declaratory evidence of
record. We find that while the evidence to which the examiner
points does suggest some degree of homology between the
interferon amino acid and DNA sequences which likely would
provoke experimentation, we find that it is not sufficient to
have reasonably led persons having ordinary skill in the art
to expect success.
While Yabrov reports that bovine, rabbit and rat
interferons show “a high protective activity . . . for human
Appeal No. 94-3676
Application 07/949,327
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cells,” the evidence of record does not establish that persons
having ordinary skill in the art reasonably would have
expected a high degree of structural homology among DNAs which
encode human and non-human mammalian interferons without some
prior knowledge of the comparative amino acid sequences of the
human and corresponding non-human mammalian interferons.
Absent that knowledge, the use of DNA which encodes human
interferon to probe for DNA which encodes the corresponding
non-human mammalian interferon would have been no more than
“obvious-to-try”. See In re Eli Lilly & Co., 902 F.2d 943,
945, 14 USPQ2d 1741, 1743 (Fed. Cir. 1990):
An “obvious-to-try” situation exists when a general
disclosure may pique the scientist’s curiosity, such that
further investigation might be done as a result of the
disclosure, but the disclosure itself does not contain a
sufficient teaching of how to obtain the desired result,
or that the claimed result would be obtained if certain
directions were pursued.
The examiner cites In re O’Farrell, 853 F.2d 894, 903,
7 USPQ2d 1673, 1681 (Fed. Cir. 1988) for the proposition that
no more than a reasonable expectation of success is required
for a holding of obviousness under 35 U.S.C. § 103 (Ans., p.
7). However, O’Farrell also instructs at 903, 7 USPQ2d 1681,
that a suggestion is “obvious-to-try” when, as here, the
“prior art gave either no indication of which parameters were
Appeal No. 94-3676
Application 07/949,327
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critical or no direction as to which of many possible choices
is likely to be successful” or the “prior art gave only
general guidance as to the particular form of the claimed
invention or how to achieve it” even though it would seem
promising “to explore a new technology or general approach.”
Id.
The examiner appears to justify the holding of
obviousness in this case in-part because appellants are said
to have presented inconsistent arguments in response to
earlier rejections under 35 U.S.C. § 112, first paragraph
(Ans., p. 7, first full para.), now withdrawn. We suspect,
based on statements in Deuel, that the examiner may have
withdrawn the wrong rejection. See In re Deuel, 51 F.3d 1552,
1559, 34 USPQ2d 1210, 1216 (Fed. Cir. 1995):
A general incentive does not make obvious a particular
result, nor does the existence of techniques by which
those efforts can be carried out.
However, at 1560, 34 USPQ2d at 1216, Deuel instructs:
Because Deuel’s patent application does not describe how
to obtain any DNA except the disclosed cDNA molecules,
claims . . . may be considered to be inadequately
supported by the disclosure of the application.
Once the examiner conceded patentability under 35 U.S.C.
Appeal No. 94-3676
Application 07/949,327
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§ 112, first and second paragraphs, we are not surprised that
little weight was given to the declarations of Drs. Neuberger
and Barclay. The declaratory evidence appears to be
inconsistent with the relative scope of enablement provided by
the disclosures in appellants’ prior applications, especially
when comparing the scope of enablement in Application
07/104,461, filed October 2, 1987, to Application 06/438,128,
filed November 1, 1982, in light of the intervening art (e.g.,
Higashi et al. (Higashi), “Structure and Expression of a
Cloned cDNA for Mouse Interferon-β,” J. Biol. Chem., Vol. 258,
pp. 9522-9529 (1983); Leung et al. (Leung), “The Structure and
Bacterial Expression of Three Distinct Bovine Interferon-β
Genes,” Bio/Technology, Vol. 2, pp. 458-464 (1984); and Capon
et al. (Capon), “Two Distinct Families of Human and Bovine
Interferon-α Genes Are Coordinately Expressed and Encode
Functional Polypeptides,” Molecular and Cellular Biology, Vol.
5, No. 4, pp. 768-779 (Apr. 1985)).
No evidence of record indicates that an amino acid
sequence for any known non-human mammalian interferon had been
determined let alone compared to that of human interferon
before November 1, 1982, the filing date of Application
Appeal No. 94-3676
Application 07/949,327
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06/438,128. Accordingly, because there is no prior teaching
of an amino acid sequence for any known non-human mammalian
interferon in the cited references, there can be no suggestion
of the probable structure of DNA likely to encode non-human
mammalian interferon. Therefore, at best, persons having
ordinary skill in the art may have been able to successfully
probe for DNA which encodes non-human mammalian interferon
with human leukocyte interferon cDNA with enough
experimentation. Without providing guidance or direction, the
prior art merely invites such experimentation.
Unpatentability under 35 U.S.C. § 103 requires more
information.
The examiner has the initial burden to establish a prima
facie case of obviousness under 35 U.S.C. § 103. See In re
Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir.
1988):
The PTO has the burden under section 103 to establish a
prima facie case of obviousness. . . . It can satisfy
this
burden only by showing some objective teaching in the
prior
art or that knowledge generally available to one of
ordinary
skill in the art would lead that individual to combine
the
relevant teachings of the references.
Appeal No. 94-3676
Application 07/949,327
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Even assuming a significant degree of homology between DNA
which encodes human interferon and DNA which encodes non-human
mammalian interferon, the evidence in this record reasonably
would not have led persons having ordinary skill in the art to
expect success without undue experimentation.
The examiner correctly states that absolute
predictability of success is not required for obviousness.
The prior art need not ensure success (Ans., pp. 8-9, bridging
para.). We agree.
However, in our view, (1) the evidence cited in this case
would no more than have invited persons having ordinary skill
in the art to experiment with little or no guidance or
direction, and (2) the claimed “essentially purified and
isolated DNA sequence encoding a polypeptide consisting
essentially of the amino acid sequence of a non-human
mammalian interferon” (Claim 12) in essence stands finally
rejected in view of “a general method of isolating cDNA or DNA
molecules” which is essentially “irrelevant to the question
whether the specific molecules themselves would have been
obvious, in the absence of other prior art that suggests the
claimed DNAs.” In re Deuel, 51 F.3d at 1559,
Appeal No. 94-3676
Application 07/949,327
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34 USPQ2d at 1215. Accordingly, we must reverse the
examiner’s decision to reject the patentability of the claimed
subject matter under 35 U.S.C. § 103 in view of the combined
prior art teachings.
3. Other Issues
At Oral Hearing on April 9, 1997, this panel asked
appellants’ counsel, Mr. R. Love, (1) what information had
been added to Applications 07/104,461, filed October 2, 1987,
and 06/438,128, filed November 1, 1982, which was not
explicitly described in their respective parent applications;
(2) whether appellants were aware of any intervening art which
could be material to the patentability of the subject matter
claimed; and (3) whether the examiner had determined the
effective filing date for the full scope of the subject matter
of the appealed claims. Counsel understandably was not
prepared to answer the questions presented at Oral Hearing, so
the Board entered an Order dated
April 9, 1997, requesting the information. Counsel timely
responded with papers filed on April 11, 1997.
We note from the papers filed on April 11, 1997, that
(1) Capon, “Two Distinct Families of Human and Bovine
Interferon-α Genes Are Coordinately Expressed and Encode
Appeal No. 94-3676
Application 07/949,327
We have not actually retrieved the Higashi article. 5
However, we are so excited by its title that we recommend that
the examiner retrieve the article and consider the patentability
of the subject matter claimed in this case over its teaching.
- 15 -
Functional Polypeptides,” Molecular and Cellular Biology, Vol.
5, No. 4, pp. 768-779 (Apr. 1985), which was published in
1985, (2) Leung, “The Structure and Bacterial Expression of
Three Distinct Bovine Interferon-β Genes,” Bio/Technology,
Vol. 2, pp. 458-464 (1984), which was published in 1984, and
(3) Higashi, “Structure and Expression of a Cloned cDNA for
Mouse Interferon-β,” J. Biol. Chem., Vol. 258, pp. 9522-9529
(1983), cited in Leung, which was published in 1983, are5
intervening publications. To perfect their claim for priority
under 35 U.S.C. § 120 and antedate the teachings of the
aforementioned intervening publications, the specification of
Application 06/438,128, filed November 1, 1982, must describe
and enable one skilled in the art to make and use the full
scope of the subject matter presently claimed. See
In re Scheiber, 587 F.2d 59, 62, 199 USPQ 782, 784 (CCPA
1978):
Section 120 . . . concerns only an applicant’s effective
filing date . . . and it expressly requires an earlier
application to disclose the claimed subject matter in
compliance with 35 U.S.C. § 112, first paragraph.
Appeal No. 94-3676
Application 07/949,327
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For further explanation, see In re Gosteli, 872 F.2d 1008,
1012,
10 USPQ2d 1614, 1618 (Fed. Cir. 1989)(The Board found that
Gosteli’s priority papers “did not provide a sufficient
written description of the entire subject matter of [the]
claims . . . as required by the first paragraph of section
112.")
The importance of Scheiber and Gosteli to this case is
highlighted because we find that Application 06/438,128, filed
November 1, 1982, does not describe the full scope of the DNA
claimed in this application. Note, for example, that Claim 27
is explicitly directed to and appealed Claim 12 encompasses
“[a]n essentially purified and isolated DNA sequence encoding
a non-human mammalian interferon having the amino acid
sequence essentially as set forth in Figures . . . 14a-e and
15 hereof.” The “amino acid sequence” and corresponding DNA
structure described in Figures 14a-e and 15 of this
application do not appear in Application 06/438,128, filed
November 1, 1982, i.e., Figures 14a-e and 15 appear for the
first time in Application 07/104,461, filed October 2, 1987.
As stated in a most recent decision in Regents of the Univ. Of
Appeal No. 94-3676
Application 07/949,327
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California v. Eli Lilly & Co., 119 F.3d 1559, 1566-67, 43
USPQ2d 1398, 1404 (Fed. Cir. 1997):
An adequate written description of a DNA, such as
the
cDNA of the recombinant plasmids and microorganisms . . .
“requires a precise definition, such as by structure,
formula, chemical name, or physical properties,” not a
mere
wish or plan for obtaining the claimed chemical
invention.
Fiers v. Revel, 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606
(Fed. Cir. 1993). Accordingly, “an adequate description
of a DNA requires more than a mere statement that it is
part of the invention and reference to a potential method
for isolating it; what is required is a description of
the
DNA itself.” Id. at 1170, 25 USPQ2d at 1606.
Citing Deuel and Bell, the court added, Id. at 1567-68,
43 USPQ2d at 1405-1406:
Thus, a fortiori, a description that does not render a
claimed invention obvious does not sufficiently describe
that invention for purposes of § 112 . . . .
. . . . .
. . . [A] description of rat insulin cDNA is not
a description of the broad classes of . . . mammalian
insulin cDNA.
. . . . .
. . . In claims to genetic material . . . a generic
statement such as . . . “mammalian insulin cDNA,” without
more, is not an adequate written description of the genus
because it does not distinguish the claimed genus from
others, except by function. It does not specifically
define any of the genes that fall within its definition.
It does not define any structural features commonly
Appeal No. 94-3676
Application 07/949,327
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possessed by members of the genus that distinguish them
from others.
We suggest that the examiner carefully consider whether
the teachings of Higashi (1983), Leung (1984), and Capon
(1985) are material to the subject matter appellants now
claim. If the references are material, the examiner should
determine the effective filing date of the claimed subject
matter, i.e., the filing date of the earliest application
which would have both described and enabled the full scope of
the claimed subject matter, so to establish whether Higashi,
Leung, and Capon are prior art with respect to the subject
matter claimed. After considering the highlighted new matter
in the various specifications of appellants’ earlier
applications (the highlighted prior specifications were filed
April 11, 1997, in response to an Order entered April 9,
1997), we find that Application 07/104,461, filed October 2,
1987, is the first application to describe the amino acid
sequences of rabbit and porcine interferons and the
corresponding DNAs which encode those amino acid sequences.
Therefore, the effective filing date of all claims which are
directed to DNA which encodes rabbit and porcine interferons
is October 2, 1987. That is not to say that the full scope of
Appeal No. 94-3676
Application 07/949,327
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the subject matter claimed in this case complies with the
description and enablement requirements of
35 U.S.C. § 112, first paragraph, for all other DNA
encompassed by the claims. For the most part, we leave the
question of whether the present claims satisfy the
requirements of the first paragraph of section 112 for the
examiner to determine in the first instance. See In re Deuel,
supra, and Regents of the Univ. Of California v. Eli Lilly &
Co., supra, for instruction. Moreover, we remind the examiner
that if Higashi, Leung, and Capon are material prior art with
respect to the claimed subject matter, new grounds of
rejection under 35 U.S.C. § 102 or 103 may very well be
appropriate.
4. Conclusion
We reverse the examiner’s decision to reject Claims 12-
17, 24-28, and 32 under 35 U.S.C. § 103 as unpatentable in
view of the combined teachings of Yabrov and Goeddel.
We reverse the examiner’s decision to reject Claims 12-
22, 24-28, 32, and 35 under 35 U.S.C. § 103 as unpatentable in
view of the combined teachings of Yabrov, Goeddel, and Nagata.
We reverse the examiner’s decision to reject Claims 12-
22, 24-28, 32, and 35 under 35 U.S.C. § 103 as unpatentable in
Appeal No. 94-3676
Application 07/949,327
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view of the combined teachings of Yabrov, Goeddel, and
Ptashne.
We remand this application to the examiner for further
action consistent with the “Other Issues” raised herein.
This application, by virtue of its "special" status,
requires an immediate action. Manual of Patent Examining
Procedures § 708.01(d)(6th ed., rev. 3, July 1997). It is
important that the Board be informed promptly of any action
affecting the appeal in this case.
Reversed and Remanded
Teddy S. Gron )
Administrative Patent Judge )
)
)
)
Fred E. McKelvey, Senior ) BOARD OF
PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Elizabeth C. Weimar )
Administrative Patent Judge )
Appeal No. 94-3676
Application 07/949,327
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tdc
Appeal No. 94-3676
Application 07/949,327
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Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990