Ex parte Boime

Board of Patent Appeals and Interferences

May 27, 1999

07771262 (B.P.A.I. May. 27, 1999)

Application for patent filed October 4, 1991.1
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(2) is not binding precedent of the Board.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. 33
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte IRVING BOIME
__________
Appeal No. 95-26621
Application 07/771,262
__________
HEARD: MAY 6, 1999
__________
Before WILLIAM F. SMITH, ELLIS, and ROBINSON, Administrative Patent Judges.
ELLIS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 USC § 134 from the final rejection of claims 1 and 12
through 15, all the claims pending in the application.
Claims 1 and 15 are illustrative of the subject matter on appeal and read as follows:
Appeal No. 95-2662
Application 07/771,262
The examiner’s Answer indicates that he additionally relies on Boime (Boime II),2
U.S. Patent 5,177,193 (‘193), issued January 5, 1993 (filed June 1, 1990) and Shadle,
U.S. Patent 4,847,325 (‘325), issued July 11, 1989. However, the examiner has withdrawn
the double patenting rejection of claim 1 over the ‘193 patent, see footnote 3, infra, and
the claims which were rejected over the ‘325 patent; i.e, claims 9 and 10, have been
canceled. Accordingly, we have considered the listing of these references to be an
oversight on the part of the examiner.
The examiner has withdrawn the rejection of claim 1 under the judicially-created3
doctrine of obviousness-type double patenting over U.S. 5,177,193 which was present in
the final office action (Paper No. 9). Answer, p. 2.
2
1. A modified peptide or protein wherein said peptide or protein has biological
activity, wherein said modification comprises an extension at the C- terminus consisting
essentially of two or more tandem units wherein each unit independently consists of amino
acid sequences found natively at positions 112-118 to position 145 of the beta subunit of
human chorionic gonadotropin
15. The modified peptide or protein of claim 12 wherein said peptide or protein
is luteinizing hormone (LH) or a follicle stimulating hormone (FSH).
The reference relied on by the examiner is:2
Boime et al. (Boime) WO 90/09800 (PCT) Feb. 21, 1989
The claims stand rejected as follows:3
I. Claims 1 and 12 through 14 stand rejected under 35 USC § 112, first paragraph, as
being non-enabled.
II. Claims 1 and 12-15 stand rejected under 35 USC § 103 as being unpatentable
over Boime.
We reverse both rejections.
Appeal No. 95-2662
Application 07/771,262
3
As set forth in the claims above, the present invention is directed to modified
peptides or proteins which comprise a C-terminal extension of two or more tandem units of
a carboxyl terminal peptide (CTP) derived from human chorionic gonadotropin (amino acid
residues at positions 112-118 through 145 of the native beta subunit). In particular, the
invention concerns the modification of pharmaceutical peptides. Specification, p. 1, para.
1. According to the specification, the addition of the CTP extension to a peptide results in
an increase in its in vivo stability. Specification, p. 1, para. 1; p. 2, lines 11-29.
Enablement
The examiner argues that:
Enablement of the current specification as filed is not commensurate in scope with
claims to modification of any peptide or protein other than FSH or LH. Applicants
have demonstrated the attachment of the tandem CTP extension only to a single
protein, FSH. ... there is no basis for the assumption that said extension would
confer similar properties to other hormones, growth factors, cytokines, or other
unrelated proteins. In the absence of any alternative embodiments, there is no
basis to conclude that the innumerable claimed embodiments of the invention would
function in an analogous manner to the single exemplified species [Answer, p. 5].
It is well established that the examiner may reject the claims as being based on a
non-enabling disclosure when s/he has reason to conclude that one skilled in the art would
be unable to carry out the claimed invention without undue experimentation.
In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991);
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
Appeal No. 95-2662
Application 07/771,262
4
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 a reason to doubt the objective
truth of the statements contained therein which must be relied on for enabling support”).
Here, we do not find that the examiner has applied the appropriate legal standard
for determining whether a specification provides an enabling disclosure. We caution the
examiner that the initial burden lies with her to provide reasons, preferably supported with
factual evidence, as to why it would require undue experimentation for one skilled in the art
to make and use the invention as claimed. The factors to be considered in determining
whether a disclosure would require undue experimentation have been set forth by the court
in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The
examiner has not provided any reasons as to why one skilled in the art would (i) have “no
basis to conclude” that the addition of the claimed C-terminal extension would confer
similar properties to other unrelated proteins, and (ii) not have been able to make and use
the claimed invention throughout its scope, absent undue experimentation. Accordingly,
we must reverse this rejection.
Obviousness
The examiner has predicated her conclusion of obviousness on the teachings of
Appeal No. 95-2662
Application 07/771,262
5
Boime, a reference which discloses, inter alia, the addition of a C-terminal extension
comprising from about amino acid residues 112-118 through 145 of human chorionic
gonadotropin to follicle-stimulating hormone (FSH) and to luteinizing hormone (LH).
The examiner acknowledges that the Boime reference differs from the claimed
invention in that only a single CTP extension is used rather than two or more tandem CTP
extensions. Answer, p. 4, first complete para. The examiner argues, however, that :
The ‘800 [Boime] publication discloses the extensive O-linked glycosylation
as being responsible for the increased half-life of the protein. Given this, it would
have been obvious to one of ordinary skill in the art that further increasing the level
of glycosylation would be reasonably expected to further decrease plasma
clearance, and that a reasonable way to achieve this would [be] by reiteration of the
CTP peptide bearing glycosylation sites. [Answer, p. 4, para. 2].
We find the examiner’s position untenable.
It cannot be gainsaid that the examiner has the initial burden under 35 USC § 103
of presenting a prima facie case of obviousness. In re Piasecki, 745 F.2d 1468, 1471-
72, 223 USPQ 785, 787-88 (Fed. Cir. 1984). Before a conclusion of obviousness can be
made based on a single reference, or a combination of references, there must have been
a reason, motivation or suggestion in said reference(s) to make the claimed invention.
Pro-Mold & Tool Co. V. Great Lakes Plastics, inc., 75 F3.d 1568, 1573, 37 USPQ2d
1626, 1629 (Fed. Cir. 1996); In re Ochiai, 71 F3.d 1565, 1570,
37 USPQ2d 1127, 1131 (Fed. Cir. 1995)(“The mere chemical possibility that one of those
prior art acids could be modified such that its use would lead to the particular cephem
recited in claim 6 does not make the process recited in claim 6 obvious ‘unless the prior
Appeal No. 95-2662
Application 07/771,262
Answer, p. 7. 4
6
art suggested the desirability of [such a] modification’”). Here, the examiner has not
provided any factual evidence, or sound scientific reasoning, as to why “the ordinary
artisan would have recognized that ‘if some is good, more is better.”’ Answer, p. 6. As
pointed out by the appellant, this is not a generically true proposition. Reply Brief, p. 2.
For example, in the medical arts, “more” may be lethal; e.g., “more” of a drug can result in
an overdose. Id. As to the examiner’s statement that he “feels that the invention [sic,
would have been] immediately obvious to the ordinary artisan upon reading the ‘800
[Boime] disclosure, and asserts that the ordinary artisan would immediately envision how
to carryout such a modification,” we remind him that a conclusion of obviousness must be4
based on fact, not unsupported assertions and generalities. In re Freed, 425 F.2d 785,
787, 165 USPQ 570, 571 (CCPA 1970);
In re Warner 379 F.2d 1011, 1017, 154 USPQ 173, 178 (CCPA 1967), cert. denied,
389 U.S. 1057 (1968). Accordingly, we reverse the rejection.
The decision of the examiner is reversed.
Appeal No. 95-2662
Application 07/771,262
7
REVERSED
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Joan Ellis )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Douglas W. Robinson )
Administrative Patent Judge )
dm
Morrison & Foerster
2000 Pennsylvania Avenue, N.W.
Suite 5500
Washington, D.C. 20006-1812
Appeal No. 95-2662
Application 07/771,262
8