Ex parte BECK et al.

Board of Patent Appeals and Interferences

May 31, 2000

07970227 (B.P.A.I. May. 31, 2000)

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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(2) is not binding precedent of the Board.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. 53
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte ANTON BECK, EDWARD BERNSTINE,
NANCY HSIUNG and VERMUNI B. REDDY
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Appeal No. 1996-3580
Application 07/970,227
__________
HEARD: May 16, 2000
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Before WILLIAM F. SMITH, SPIEGEL and SCHEINER, Administrative
Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final
rejection of claims 7, 13, 15 through 22, 24, 28, 36, 81, 82,
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89, 90, 92 and 93, all the claims remaining in the
application. Claims 7 and 81 are representative:
7. A mammalian cell consisting essentially of a cell
transfected by a first expression vector, said transfected
cell being capable of producing a biologically active
heterodimeric protein having first and second subunits, said
selected protein being selected from the group consisting of
luteinizing hormone (LH), follicle stimulating hormone (FSH),
chorionic gonadotropin (CG) and thyroid stimulating hormone
(TSH), each of said subunits of said protein being encoded by
said first expression vector under the control of a separate
promoter, or progeny of said transfected cell containing the
promoters and DNA sequences for said subunits imparted by said
vector.
81. A mammalian cell consisting essentially of a cell
transfected by a first expression vector and a distinct second
expression vector, said transfected cell being capable of
producing a biologically active heterodimeric protein having
first and second subunits, said protein being selected from
the group consisting of luteinizing hormone (LH), follicle
stimulating hormone (FSH), chorionic gonadotropin (CG) and
thyroid stimulating hormone (TSH), the first subunit of said
protein being encoded by said first expression vector and the
second subunit of said protein being encoded by said second
expression vector, or progeny of said transfected cell
containing the promoters and DNA sequences for said subunits
imparted by said vectors.
The prior art discussed by appellants includes:
Shome et al. (Shome), “The Primary Structure of Bovine
Thyrotropin,” 246 The Journal of Biological Chemistry, No. 4,
pp. 833-849 (1971).
Maghuin-Rogister et al. (Maghuin-Rogister), “Porcine
Thyrotropin. The Amino-Acid Sequence of the " and $ Subunits,”
61 Eur. J. Biochem., pp. 157-163 (1976).
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Sairam et al. (Sairam), “Human Pituitary Thyrotropin. The
Primary Structure of the " and $ Subunits,” 55 Can. J.
Biochem., pp. 755-760 (1977).
Gurr et al. (Gurr), “Cloning of cDNA Encoding the pre-$
Subunit of Mouse Thyrotropin,” 80 Proc. Natl. Acad. Sci. USA,
pp. 2122-2126 (April, 1983).
Vamvakopoulos et al. (Vamvakopoulos), “Synthesis, Cloning, and
Identification of DNA Sequences Complementary to mRNAs for "
and $ Subunits of Thyrotropin,” 77 Proc. Natl. Acad. Sci. USA,
No. 6, pp. 3149-3153 (1980).
Pierce et al. (Pierce), “Glycoprotein Hormones: Structure and
Function,”
50 Ann. Rev. Biochem., pp. 465-495 (1981).
The examiner has not relied on prior art in rejecting the
claims on appeal. Rather, the claims stand rejected under 35
U.S.C. § 112, first paragraph, as based on a non-enabling
disclosure. We reverse. In addition, we raise an issue for
the examiner and appellants to consider upon return of the
application.
DISCUSSION
Background
Luteinizing hormone (LH), follicle stimulating hormone
(FSH), chorionic gonadotropin (CG), and thyroid stimulating
hormone (TSH) are heterodimeric proteins with identical alpha
subunits and similar, but distinct, beta subunits. Claims 7,
13, 15 through 19, 28, 36, 81, 82 and 93 are drawn to
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mammalian cells transformed by one or two expression vectors
encoding both subunits, and capable of producing biologically
active heterodimeric LH, FSH, CG or TSH; claims 20 through 22
and 89 are drawn to expression vectors; and claims 24, 90 and
92 are drawn to methods of producing heterodimeric proteins.

Enablement
It is well settled that the examiner bears the initial
burden of providing reasons why a supporting disclosure does
not enable a claim. As stated in In re Marzocchi,
439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971):
[A] specification disclosure which contains a
teaching of the manner and process of making and
using the invention in terms which correspond in
scope to those used in describing and defining the
subject matter sought to be patented must be taken
as in compliance with the enabling requirement of
the first paragraph of § 112 unless there is reason
to doubt the objective truth of the statements
contained therein which must be relied on for
enabling support.
Having carefully reviewed the specification, including
the working examples, in light of the examiner’s commentary on
pages 3 through 5 of the Examiner’s Answer,
and the arguments on pages 13 through 37 of appellants’ main
Brief, we hold that the examiner has not set forth a
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reasonable basis for questioning the enablement of the claims
on appeal.
The specification contains several working examples
demonstrating production of active, heterodimeric human,
bovine, porcine, and equine LH, FSH and CG, and various
methods were used to obtain cDNA encoding the required "- and
$-subunits (specification, pages 9 through 57). For example,
cDNA encoding the $-subunit of porcine FSH was identified by
screening a cDNA library with synthetic probes corresponding
to portions of the mature protein sequence (specification,
page 31). In addition, clones encoding the $-subunits of
equine LH and FSH were found by screening with bovine LH$ cDNA
and bovine FSH$ cDNA, respectively (specification, pages 34
and 38). The specification indicates that the same strategies
can be used to produce biologically active TSH (specification,
pages 2 and 59).
According to the examiner, the specification is not
enabling for production of biologically active TSH, primarily
because “[t]he specification discloses reproducible methods
for obtaining DNA sequences encoding both subunits of LH, FSH
and CG, and the "-subunit of TSH” but “does not disclose a
reproducible source for the TSH$ DNA sequences” (Examiner’s
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Answer, page 4). However, “a patent need not teach, and
preferably omits, what is well known in the art.” Hybritech,
Inc. V. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231
USPQ 81, 94 (Fed. Cir. 1986), cert. denied,
480 U.S. 947 (1987). In our view, the flaw in the examiner’s
reasoning is the failure to acknowledge the level of skill in
the art at the time of appellants’ invention.
The record establishes that “the amino acid and/or DNA
sequences of [the] TSH $-subunit were well known to those of
ordinary skill in the art” at the time of the invention (main
Brief, page 28). In particular, the sequence of cDNA encoding
the $-subunit of murine TSH was known, as were the amino acid
sequences of the $-subunits of human, bovine, porcine and
murine TSH. See Shome, Maghuin-Rogister, Gurr, Vamvakopoulos,
Pierce (1981) and Sairam. The examiner has not explained why
appellants’ disclosure, together with what was known in the
art at the time of the invention, does not satisfy the
enablement requirement.
In addition, we note the examiner’s concern that “an
undue amount of experimentation” would be required to practice
the claimed invention because ”[t]he specification has not
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taught the ratios of vectors containing DNA sequences encoding
TSH" and $ subunits which would result in the production of
biologically active TSH” (Examiner’s Answer, pages 4 and 5).
As explained in In re Wands, 858 F.2d 731, 737, 8 USPQ2d
1400, 1404 (Fed. Cir. 1988):
Factors to be considered in determining whether a disclosure would require undue
experimentation have been summarized by the board in Ex parte Forman, [230 USPQ
546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation
necessary, (2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state of the
prior art, (6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims. (footnote omitted).
Here, the fact finding needed to support the examiners
assertion of undue experimentation has not been done.
Accordingly, the rejection of claims 7, 13, 15 through
22, 24, 28, 36, 81, 82, 89, 90, 92 and 93 under 35 U.S.C. §
112, first paragraph is reversed.
OTHER ISSUES
We note the issuance of U.S. Patent 5,639,639 to
appellants. Patented claim 10 appears to be so similar to the
present claims as to raise the issue of obviousness-type
double patenting. It is suggested that the examiner and
appellants review the patent upon return of the application to
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the examining group and take whatever action may be
appropriate.
REVERSED

William F. Smith
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Carol A. Spiegel )
Administrative Patent Judge ) APPEALS
AND
)
) INTERFERENCES
)
Toni R. Scheiner )
Administrative Patent Judge )
Browdy and Neimark, P.L.L.C.
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