Ex parte Fong et al.

Board of Patent Appeals and Interferences

Feb 11, 2000

08090369 (B.P.A.I. Feb. 11, 2000)

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publication in a law journal and (2) is not binding precedent of the Board.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. 34
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte TUNG M. FONG, RUEY-RUEY C. HUANG,
and CATHERINE D. STRADER

____________
Appeal No. 1996-1204
Application No. 08/090,369
____________
HEARD: January 13, 2000
____________
Before WINTERS, GRON, and ROBINSON, Administrative Patent Judges.
ROBINSON, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner's final
rejection of claims 25-30, which are all of the claims pending in the case.
Claims 25, 26, and 27 are representative of the claims on appeal, a copy of which
are attached as an appendix to this decision.
Appeal No. 1996-1204
Application No. 08/090,369
2
The references relied upon by the examiner are:
Shigemoto et al. (Shigemoto), “Cloning and Expression of a Rat Neuromedin K Receptor
cDNA,” Journal of Biological Chemistry, Vol. 265(2), pp. 623-628 (1990).
Hopkins et al. (Hopkins), “Isolation and Characterization of the Human Lung NK-1
Receptor cDNA,” Biochemical and Biophysical Research Communications, Vol. 180(2),
pp. 1110-1117 (1991).
Gerard et al. (Gerard), “The Human Neurokinin A (Substance K) Receptor,” Journal of
Biological Chemistry, Vol. 265(33), pp. 20455-20462 (1990).
Fraser et al. (Fraser), “Cloning, Sequence Analysis, and Permanent Expression of a
Human " -Adrenergic Receptor in Chinese Hamster Ovary Cells,” Journal of Biological2
Chemistry, vol. 264(20), pp. 11754-11761 (1989).
A reference relied upon by appellants:
Dietl et al. (Dietl), “Phylogeny of Tachykinin Receptor Localization in the Vertebrate Central
Nervous System: Apparent Absence of Neurokinin-2 and Neurokinin-3 Binding Sites in the
Human Brain,” Brain Research, Vol. 539, pp. 211-222 (1991).
Grounds of Rejection
Claims 25-28 and 30 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies upon Shigemoto, Hopkins, and Gerard.
Claim 29 stands rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies upon Shigemoto, Hopkins, Gerard, and Fraser.
We reverse.
Appeal No. 1996-1204
Application No. 08/090,369
3
BACKGROUND
The applicants’ invention, as described at pages 1-4 of the specification, is
directed to a cloned human neurokinin-3 receptor (NK-3) peptide and a recombinant DNA
molecule which encodes the receptor. The human NK-3 is described as useful in an assay
for the presence of neurokinin B, which binds preferentially to NK-3, as well as in
conjunction with diagnosis to determine the body fluid concentration of neurokinin-B
related substances in patients. Neurokinin B is a naturally occurring peptide belonging to
the neurokinin family of peptides, is known in the art, and has been implicated in the
pathophysiology of numerous diseases.
DISCUSSION
The rejections under 35 U.S.C. § 103
Obviousness is a legal conclusion based on the underlying facts. Graham v. John
Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966); Continental Can Co. USA, Inc.
v. Monsanto Co., 948 F.2d 1264, 1270, 20 USPQ2d 1746, 1750 (Fed. Cir. 1991); Panduit
Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566-68, 1 USPQ2d 1593, 1595-97 (Fed.
Cir. 1987). Here, the examiner has cited Shigemoto as describing (Answer, page 4-5):
an isolated cDNA encoding the rat homologue of the encoded human NK-3
(neuromedin K) receptor (Figure 1, page 625) of the instant invention.
Further disclosed by this reference was a plasmid containing that DNA and
a COS cell transformed with that plasmid (first full paragraph in the left
column on page 624). Figure 2 of this reference disclosed that the rat NK-3
(neuromedin K), NK-2 (substance K) and NK-1 (substance P) receptors, all
of which are G protein-coupled receptors for tachykinins, have substantial
sequence similarity which is greatest in the transmembrane domains.
The examiner acknowledges that (Answer, page 5):
Appeal No. 1996-1204
Application No. 08/090,369
4
[t]his reference did not describe an isolated DNA encoding a human NK-3
receptor or the protein encoded thereby.
Hopkins is cited (Answer, page 5) as describing “the isolation of a DNA encoding a
human NK-1 receptor by screening a human DNA library with a DNA encoding a rat NK-1
receptor” and disclosing that “the open reading frame from this human cDNA shared 89%
sequence homology with a cDNA encoding a rat NK-1 receptor with the two sequences
being most divergent at the two ends.” Similarly, Gerard is cited (Answer, page 6) as
describing "the isolation of a DNA encoding a human NK-2 (substance K) receptor based
upon its anticipated sequence similarity to a DNA encoding a bovine NK-2 receptor” and
additionally disclosing “the substantial sequence similarity between the human, bovine and
rat NK-2 receptors with the three sequences being most divergent at the two ends.”
The examiner concludes (Answer, page 5):
An artisan of ordinary skill, . . . would have found the isolation of a DNA
encoding the human homologue of the rat NK-3 receptor described in the
Shigemoto et. al. reference by screening a human DNA library with a DNA
encoding that rat receptor in a manner directly analogous to the one
described for the isolation of the DNA encoding the human NK-1 receptor in
the Hopkins et. al. reference, to have been prima facie obvious at the time of
the instant invention.
The initial burden of presenting a prima facie case of obviousness rests on the
examiner. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992).
On this record, the examiner has pointed to no evidence or facts which would reasonably
establish that the presently claimed human NK-3, or the DNA which encodes it, were
Appeal No. 1996-1204
Application No. 08/090,369
5
known at the time of the invention. We find no mention in Shigemoto of the human
counterpart to the rat NK-3. Hopkins, at page 1111, makes a general reference to NK-1,
NK-2, and NK-3, but does not state the source of the listed receptors. Similarly, Gerard
only mentions NK3 at page 20455, column 2, second paragraph, and does not specify the
source of the NK-3 receptor described.
In rebuttal to the examiner's position, appellants cite Dietl (Principal Brief, page 15)
as providing information regarding the level of knowledge in the art regarding human NK-3
receptors. In describing Dietl, appellants urge that (Principal Brief, page 16):
because Dietl et al. suggest that the NK-3 receptor is not present in human
brain tissue, there would not have been a reasonable likelihood of success
that one of ordinary skill in the art would have been able to isolate the gene
encoding the human NK-3 receptor, even if they employed the cDNA
encoding the rat NK-3 receptor. Moreover, Dietl et al. actually teach away
from the successful isolation of the human NK-3 receptor by suggesting that
such an attempt would have been futile.
The examiner criticizes the Dietl disclosure (Answer, pages 13-14) urging that in
assaying for “eledoisin”, a mollusk neuropeptide, it was unlikely that a mammalian NK
receptor would have been expected to bind and “an artisan would have had no
expectations regarding the ability of the human homologue of the NK-3 receptor of
Shigemoto et al. to bind any non-native ligand." Yet, this is the only evidence, before us,
which speaks to the question of whether the human NK-3 receptor or the DNA which
encodes it, was known at the time of the invention. We do not agree that it would have
Appeal No. 1996-1204
Application No. 08/090,369
6
been obvious to use the methodology of Hopkins and Gerard to isolate, identify and
characterize a protein not demonstrated to be known at the time of the invention. The
examiner's reliance (Answer, page 14) on the concluding statements of both Hopkins and
Gerard concerning further studies relating to the neurokinin receptor genes is too general
in nature reasonably to point those of ordinary skill in this art toward the isolation and
characterization of the claimed human NK-3 receptor and DNA encoding the receptor,
when read in context of the teaching of the articles as a whole. On these facts, the
examiner has failed to establish a prima facie case of unpatentability as to the claimed
subject matter.
Where the examiner fails to establish a prima facie case, the rejection is improper
and will be overturned. In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed.
Cir.1988). Therefore the rejection of claim 25-28 and 30 under 35 U.S.C. § 103 is
reversed.
In separately rejecting claim 29 under 35 U.S.C. § 103 the examiner has relied on
Fraser in addition to Shigemoto, Hopkins and Gerard. However, Fraser does not provide
that which we have determined to be missing in the previously discussed rejection.
Therefore, this rejection is also reversed.
Appeal No. 1996-1204
Application No. 08/090,369
7
SUMMARY
To summarize, the decision of the examiner to reject claims 25-30 under 35 U.S.C.
§ 103 is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
TEDDY S. GRON ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
Appeal No. 1996-1204
Application No. 08/090,369
8
J. Eric Thies
Merck & Company, Inc.
Patent Department
P. O. Box 2000-RY60-30
Rahway, NJ 07065-0907
dwr/ki
Appeal No. 1996-1204
Application No. 08/090,369
1
APPENDIX
Appeal No. 1996-1204
Application No. 08/090,369
2
Appeal No. 1996-1204
Application No. 08/090,369
3
Appeal No. 1996-1204
Application No. 08/090,369
4