Ex Parte Cocks et al

Board of Patent Appeals and Interferences

Mar 31, 2004

09208206 (B.P.A.I. Mar. 31, 2004)

1 Application for patent filed December 9, 1998. According to appellants, this
application is a divisional of application serial no. 08/602,208, filed February 15, 1996,
now U.S. Patent 5,866,332.
2 Claims 11, 13, 19, 21 and 22 are also pending; claims 11, 13 and 19 have been
withdrawn from consideration, while claims 21 and 22 stand objected to.
The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte BENJAMIN GRAEME COCKS, JANICE AU-YOUNG
and JEFFREY J. SEILHAMER
___________
Appeal No. 2002-0870
Application No. 09/208,2061
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, SCHEINER and GRIMES, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the final rejection of
claims 6 and 23.2
Claim 6 is representative:
6. A purified polypeptide comprising an amino acid sequence selected from the
group consisting of
a) an amino acid sequence of SEQ ID NO:2,
b) a naturally-occurring amino acid sequence found in humans and having at
least 90% sequence identity to the sequence of SEQ ID NO:2, and,
c) an antigenically-active fragment of the amino acid sequence of SEQ ID NO:2.
DISCUSSION
Appeal No. 2002-0870
Application No. 09/208,206
Page 2
Claims 6 and 23 stand rejected under the first paragraph of 35 U.S.C. § 112,
“because the specification, while being enabling for polypeptides that contain SEQ ID
NO: 2, does not reasonably provide enablement for all naturally occurring polypeptides
found in humans that have 90% sequence identity to SEQ ID NO:2.” Answer, page 3.
According to the examiner (id.),
[t]he instant application does not provide guidance for one of skill in the art
to obtain active or otherwise useful embodiments of the claimed invention
commensurate with the scope of the claims without performing undue
experimentation. For example, the number of insertion embodiments
alone that are 90% identical to SEQ ID NO:2 is 2.95 x 1042. Additionally,
there are approximately 3.38 x 1082 nucleotide sequences that encode the
amino acid sequence that is SEQ ID NO:2; thus yielding about 10120
nucleotide sequences that would encode amino acid sequences that are
at least 90% identical to SEQ ID NO:2. With this vast number of
sequence[s], there exist sequences that would not hybridize specifically to
any probe sequence disclosed in the instant application and that will not
be amplified in a PCR run by any set of primers disclosed in that instant
application and yet would encode either SEQ ID NO:2 or a polypeptide
sequence at least 90% similar to SEQ ID NO:2.

If we understand the examiner’s principal concern, it is that the claims are
extremely broad, and it is likely that the amplification and hybridization protocol
provided in the specification will fail to identify some polypeptides with naturally-
occurring sequences that are at least 90% identical to SEQ ID NO:2.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification
of a patent enable any person skilled in the art to which it pertains to make and use the
claimed invention. Although the statute does not say so, enablement requires that the
specification teach those in the art to make and use the invention without ‘undue
experimentation.’ In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
1988). That some experimentation may be required is not fatal; the issue is whether the
amount of experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d
Appeal No. 2002-0870
Application No. 09/208,206
Page 3
3
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).
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
1438, 1444 (Fed. Cir. 1991) (emphasis in original).3 Nevertheless, “[w]hen rejecting a
claim under the enablement requirement of section 112,” it is well settled that “the PTO
bears an initial burden of setting forth a reasonable explanation as to why it believes
that the scope of protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the application; this includes,
of course, providing sufficient reasons for doubting any assertions in the specification as
to the scope of enablement.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510,
1513 (Fed. Cir. 1993).
Thus, the dispositive issue here is not whether appellants have established that
the disclosure is broadly enabling for the scope of the claims, rather, the issue is
whether the PTO has met its “initial burden of setting forth a reasonable explanation as
to why” it is not.
In the present case, the examiner barely touches on two of the factors to be
considered in establishing undue experimentation: the breadth of the claims, and the
guidance provided in the specification. While we might agree that the first of these
factors, at least, would tend to weigh against a finding of enablement, it is but one of
many relevant factors, yet the examiner has not analyzed it in conjunction with other
relevant factors.
Appeal No. 2002-0870
Application No. 09/208,206
Page 4
With respect to the guidance provided by the specification, the examiner does
not appear to question the ability of one skilled in the art to follow the protocol disclosed
in the specification. Nor, apparently, does the examiner appear to question whether
that protocol would have enabled one skilled in the art to obtain naturally occurring
polypeptides found in humans that have a 90% sequence identity to SEQ ID NO:2. We
accept, for the sake of argument, that it would be iterative and time consuming to
identify naturally occurring polypeptides found in humans that have a 90% sequence
identity to SEQ ID NO:2, but undue experimentation has little to do with the quantity of
experimentation; it is much more a function of the amount of guidance or direction
provided. As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
[T]he question of undue experimentation is a matter of degree. The fact
that some experimentation is necessary does not preclude enablement;
what is required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co. v. E.I. DuPont de Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction
in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of
the invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
Further, to the extent the examiner requires the specification to “provide
enablement for all naturally occurring polypeptides found in humans that have 90%
sequence identity to SEQ ID NO:2” (Answer, page 3, emphasis added), we note that no
authority has been cited in support of this requirement. On the contrary, “appellants are
Appeal No. 2002-0870
Application No. 09/208,206
Page 5
not required to disclose every species encompassed by their claims even in an
unpredictable art.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 218 (CCPA
1976) (emphasis in the original).
Finally, the examiner’s bare assertion that “the instant application does not
provide enough guidance for one of skill in the art to make and use antigenically active
fragments of SEQ ID NO:2” (Answer, page 3) does not provide a reasonable basis to
question the adequacy of the disclosure provided for this aspect of the claimed
invention.
Appeal No. 2002-0870
Application No. 09/208,206
Page 6
In our view, the reasons cited in support of the examiner’s rejection are
insufficient to support the examiner’s conclusion that the claims are not enabled by the
specification (Answer, page 3). Accordingly, the rejection of claims 6 and 23 under the
first paragraph of 35 U.S.C. § 112 is reversed.
REVERSED
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
)
Toni R. Scheiner ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
)
Eric Grimes )
Administrative Patent Judge )
Appeal No. 2002-0870
Application No. 09/208,206
Page 7
Richard C. Ekstrom, Esq.
Incyte Corporation
3160 Porter Drive
Palo Alto, CA 94304