Ex Parte Roberts et al

Board of Patent Appeals and Interferences

Nov 8, 2007

10655547 (B.P.A.I. Nov. 8, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT MICHAEL ROBERTS, JONATHAN ANDREW
GREEN, and SANCAI XIE
__________

Appeal 2007-4137
Application 10/655,547
Technology Center 1600
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Decided: November 8, 2007
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and
ERIC B. GRIMES, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written description. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

Appeal 2007-4137
Application 10/655,547

Claim 182 is representative.
182. A method for detecting pregnancy in a bovine animal
comprising:
(a) obtaining a sample from said animal; and
(b) detecting at least one pregnancy associated antigen (PAG) in the
sample that is present early in pregnancy and is undetectable at about two
months post-partum; whereby detection of the PAG indicates that the animal
is pregnant.

Grounds of Rejection
Claims 182-196 stand rejected under 35 U.S.C. § 112, first paragraph
for lack of written description.

DISCUSSION
Background
Pregnancy diagnosis is an important component in sound
reproductive management, particularly in the dairy industry … where
a high proportion of artificial inseminations fail .… A reliable yet
simple pregnancy test for cattle has long been sought. Several
procedures are available, including a milk progesterone assay …
estrone sulfate analysis …, rectal palpation …, ultrasound …, and
blood tests for pregnancy-specific antigens. Of these, the
progesterone milk assay is the most cost effective for the producer.…
The presence of estrone sulfate in urine or serum provides another test
but is only useful after day 100 as concentrations rise ….

(Specification 2-3.)

The discovery of pregnancy-specific protein B (PSP-B) …
provided a new approach to pregnancy diagnosis since it could be
detected in the blood of pregnant cows by the fourth week of
pregnancy …. Two other groups have developed immunoassays that
may be based on an identical or immunologically similar antigen ….
In one case, the antigen (Mr-67 kDa) was called bovine pregnancy-
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associated glycoprotein (boPAG; now boPAG-1) …; in the second, it
was designated as pregnancy serum protein 60 (PSP60) …. The
immunoassay for PSP-B/boPAGl/PSP60 has two advantages.
First, it can detect pregnancy relatively early. Second, interpretation
of the assays does not require knowledge of the exact date of service,
since boPAG-1 immunoreactive molecules are always present in the
maternal serum of pregnant cows by day 28, and concentrations
increase as pregnancy advances.

(Specification 3.)

There remain, however, two major disadvantages to this
procedure. First, positive diagnosis in the fourth week of pregnancy
remains somewhat uncertain because antigen concentrations in blood
are low and somewhat variable. Second, boPAGl concentrations rise
markedly at term … and, due to the long circulating half-life of the
molecule …, the antigen can still be detected 80-100 day postpartum
…, compromising pregnancy diagnosis in cows bred within the early
postpartum period. Thus, the test can be carried out in dairy cows at
day 30 only if artificial insemination ("AI") is performed at or after 70
day post-partum.

(Specification 3-4.)

It is estimated that there are at least 100 PAG-related genes in cattle.
(Specification 23.)

Written Description
Claims 182-196 stand rejected under 35 U.S.C. § 112, first paragraph
for lack of written description.
The Examiner contends that
the specification does not describe all the PAGs required to
practice the method of claim 182 in a manner that satisfies
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either the Lilly[1] or Enzo[2] standards. The specification does
not provide the complete structure of any PAG, nor does the
specification provide any physical or chemical characteristics of
the other PAGs nor any functional characteristics coupled with
a known or disclosed correlation between structure and
function . . .

(Answer 5.)

The Examiner further argues that

[t]he specification describes only a few PAGs where structural
diversities exist among the different PAGs, ranging from 50%
to 90% homology (See Figure 4 in both protein and nucleic acid
identity comparison). With such diversity in terms of both
amino acid and nucleic compositions among the few
representatives (boPAG 1 to boPAG 12), one [of] ordinary skill
in the art would not conclude that applicant sufficiently
describe[s] a "representative number" of such species …. In
addition, the specification also does not describe "structural
features common to the members of the genus, which features
constitute a substantial portion of the genus." …. It is noted
that applicant describes some sequence identity around the
catalytic aspartic acid residues (Asp 32 and Asp 215) among
some BoPAGs, including boPAG 1-12 (See Figure 1).
However, there is no further study correlating this region to the
asserted function, i.e. present early in pregnancy and
undetectable at about two months post-partum, using site-
directed mutagenesis to ascertain the structural contribution to
this functionality. Thus the specification does not provide an
adequate written [description] by merely reciting the function

1 University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d
1398 (Fed. Cir. 1997).
2 Enzo Biochem v. Gen-Probe Inc., 323 F.3d 956, 63 USPQ2d 1609 (Fed.
Cir. 2002).

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limitations of the PAGs, such as detectable in early pregnancy
and undetectable at 2-month post-partum.

(Answer 5-6.)

Appellants, on the other hand, argue that the Examiner
has

improperly blend[ed] the separate standards that permit
satisfaction of the written description requirement. The Written
Description Guidelines ("Guidelines") as recited in MPEP §
2163, which cite Lilly and Enzo in large part, state the
following:

The written description requirement for a claimed genus may be
satisfied through sufficient description of a representative
number of species by
(1) actual reduction to practice,
(2) reduction to drawings, or by
(3) disclosure of relevant, identifying characteristics, i.e.,
(a) structure or other physical and/or chemical
properties,
(b) by functional characteristics coupled with a
known or disclosed correlation between function and structure,
or
(c) by a combination of such identifying
characteristics, sufficient to show the applicant was in
possession of the claimed genus." Id. (emphases and indenting
added). …. Thus, there are at least the three separate means
identified in the Guidelines by which a disclosure may satisfy
the written description requirement regarding a claimed genus,
the third of which entails three further, separate options. That
is, if a disclosure meets either of (a), (b) or a combination
thereof according to (c) sufficient to show possession of a
claimed genus, the written description requirement has been
satisfied. More specifically concerning element (b), a showing
of correlation between structure and function is only one means
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by which an applicant may satisfy the written description
requirement.

(Reply Br. 3.)

“The ‘written description’ requirement [under 35 U.S.C. § 112, first
paragraph] implements the principle that a patent must describe the
technology that is sought to be patented; the requirement serves both to
satisfy the inventor’s obligation to disclose the technologic knowledge upon
which the patent is based, and to demonstrate that the patentee was in
possession of the invention that is claimed.” Capon v. Eshhar, 418 F.3d
1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005).
The written description must define the genus in a manner sufficient
to enable one skilled in the art to “visualize or recognize the identity of the
members of the genus,” e.g., by providing a description of “structural
features commonly possessed by members of the genus that distinguish them
from others.” University of California v. Eli Lilly & Co., 119 F.3d 1559,
1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). We agree with the
Examiner and find that the Specification does not provide an adequate
description of the claimed invention nor does it define the genus such that
one skilled in the art can “visualize or recognize the identity of the members
of the genus,” e.g., by providing a description of “structural features
commonly possessed by members of the genus that distinguish them from
others.” Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In Lilly, the court held that claims generically reciting cDNA
encoding vertebrate or mammalian insulin were not adequately described by
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the disclosure of cDNA encoding rat insulin. Id. at 1568, 43 USPQ2d at
1406. The court held that
a generic statement such as “vertebrate insulin cDNA” or
“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
possessed by members of the genus that distinguish them from
others. One skilled in the art therefore cannot, as one can do
with a fully described genus, visualize or recognize the identity
of the members of the genus.

Id. The court described two ways of properly describing a claimed genus:
A description of a genus of cDNAs may be achieved by means
of a recitation of a representative number of cDNAs, defined by
nucleotide sequence, falling within the scope of the genus or of
a recitation of structural features common to the members of the
genus, which features constitute a substantial portion of the
genus.

Id. The court has since clarified that the description of representative
species does not necessarily have to include their complete structure
(nucleotide sequence). See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d
956, 964, 63 USPQ2d 1609, 1613 (Fed. Cir. 2002).
Nevertheless, the holding of Lilly supports the Examiner’s conclusion
that the instant Specification does not adequately describe the claimed genus
of pregnancy associated antigen (PAG) that is present early in pregnancy
and is undetectable at about two months post-partum used in the claimed
method. The Specification does not describe any structural features that
distinguish “early boPAGs” from boPAGs that are expressed late in
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pregancy or throughout pregnancy. The Specification states that the “data
also show that the ‘early’ PAGs are relatively numerous and differ
considerably from each other and from boPAG1 in sequence” (Specification,
p. 61, ll. 19-21).
Thus, the Specification does not describe the boPAGs detected in the
claimed method adequately to enable one skilled in the art to “visualize or
recognize the identity of the members of the genus.” Lilly, 119 F.3d at 1568,
43 USPQ2d at 1406. Instead, the Specification informs those skilled in the
art that a group of bovine proteins are expressed during pregnancy, that
those expressed in a certain temporal manner are especially useful for
detecting pregnancy, and that several specific proteins are expressed in the
desired manner. But the claims are not limited only to those specific
boPAGs that are disclosed to be expressed in the desired manner; the claims
also encompass using any other boPAG that is found to be expressed in the
desired manner as a pregnancy marker. The Specification does not show
possession of the group of boPAGs having the desired expression pattern.
In particular, Lilly states that “[a] definition by function … does not
suffice to define the genus because it is only an indication of what the gene
does, rather than what it is…. It is only a definition of a useful result rather
than a definition of what achieves that result.” Lilly at 1568, 43 USPQ2d at
1406. Appellants have claimed a method of detecting a pregnancy
associated antigen (PAG) that has been defined by its function, i.e., that it is
present early in pregnancy and is undetectable at about two months post-
partum, contrary to Lilly.
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Appellants argue that the Specification provides the complete
structure of at least seven boPAGs within the scope of the claims and that
the described species are representative of the claimed genus (Appeal Br. 3-
5, 7-8).
We disagree. As discussed above, the evidence shows that some
boPAGs were known in the prior art, and the Specification provides the
complete structure of several boPAGs. The Specification’s disclosure,
combined with the knowledge in the art, may well constitute an adequate
description of boPAGs generically. That, however, is not the issue
presented here. The issue is whether the Specification adequately describes
the subset of boPAGs that are expressed early in pregnancy but not
detectable two months post-partum. Appellants have pointed to no structural
features shared by the disclosed “early boPAGs” that distinguish them from
boPAGs that are expressed at different times during pregnancy.
An adequate written description is one that allows those skilled in the
art to distinguish compounds within the scope of the claims from those
outside the claims. Here, that description would be one that allows a skilled
artisan to determine, based on structure, whether a new, uncharacterized
boPAG would be expressed early in pregnancy and not detectable two
months post partum. Appellants have pointed to no description that would
allow those skilled in the art to make such a determination.
Appellants argue, however, that those skilled in the art can follow the
methods taught in the Specification to identify and “isolate additional, novel
PAGs that are present early in pregnancy and are undetectable at about two
months post-partum” (Appeal. Br. 8; Reply Br. 7). But an adequate written
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description requires more than a description of methods for identifying such
compounds; it requires a description of the compounds used in the claimed
method themselves.
For example, in University of Rochester v. G.D. Searle & Co., Inc.,
358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004), the subject patent claimed
a method of selectively inhibiting the enzyme PGHS-2 (also known as COX-
2) by “administering a non-steroidal compound that selectively inhibits
activity of the PGHS-2 gene product in a human.” Id. at 918, 69 USPQ2d at
1888. The patent “described in detail how to make cells that express either
COX-1 or COX-2, but not both . . . , as well as ‘assays for screening
compounds, including peptides, polynucleotides, and small organic
molecules to identify those that inhibit the expression or activity of the
PGHS-2 gene product.[’]” Id. at 927, 69 USPQ2d at 1895.
The court held that the disclosure of screening assays and general
classes of compounds was not adequate to describe compounds having the
desired activity: without disclosure of which peptides, polynucleotides, or
small organic molecules have the desired characteristic, the claims failed to
meet the description requirement of § 112. See id. (“As pointed out by the
district court, the ‘850 patent does not disclose just ‘which “peptides,
polynucleotides, and small organic molecules” have the desired
characteristic of selectively inhibiting PGHS-2.’. . . Without such disclosure,
the claimed methods cannot be said to have been described.”).
It is true that this case differs from Rochester in that the patent in
Rochester did not disclose any compounds having the properties recited in
the claims, while the Specification here apparently describes seven “early”
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boPAGs. However, the test for adequate description still requires
description of the compounds within the genus in a manner that shows
possession of the genus to those skilled in the art.
Whether a description is adequate to show possession, and thereby
satisfy the written description requirement, depends on “a variety of factors,
such as the existing knowledge in the particular field, the extent and content
of the prior art, the maturity of the science or technology, [and] the
predictability of the aspect at issue.” Capon, 418 F.3d at 1085. The
evidence in this case shows that it is entirely unpredictable whether a given
boPAG is expressed early in pregnancy and undetectable two months post-
partum. The Specification provides no description that allows those skilled
in the art to distinguish boPAGs having those properties from others, except
by empirically testing each boPAG individually.
In short, the evidence does not show that Appellants were in actual or
constructive possession of the genus of boPAGs that are expressed early in
pregnancy but undetectable two months post-partum. Rather, it shows that
they were in possession of several boPAGs with those characteristics, and
hoped that others might also be shown to have those characteristics but
could provide no description of the hoped-for additional species that would
direct those skilled in the art to which ones they would be. The
Specification does not adequately describe the boPAGs recited in the claims,
and the assays disclosed do not make up for the deficiency of the
Specification’s description.
Appellants also argue that there is a high level of conservation among
the seven “early” PAGs that have been reduced to practice, as illustrated by
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the sequence alignments and the consensus sequences provided in Figure 1,
and in the phylogenic tree provided in Figure 5 of the Specification.
(Appeal Br. 7). In addition, Appellants argue that the claimed genus “is
limited by what PAGs are produced by a bovine animal, . . . thus dictat[ing]
a finite and limited class of PAGs” (id. at 8), which “share both structural
and functional characteristics” (id.).
However, Appellants have not explained how the level of
conservation among PAGs in general, or their shared structure and function,
would allow those skilled in the art to distinguish “early” boPAGs from
other boPAGs, except by empirically testing each boPAG individually.
In view of the above, the written description rejection is affirmed.

Other Issue for Consideration
If this application is subject to further prosecution, it is recommended
that the Examiner review the claims of U.S. Patent No. 6,869,770 directed to
a Composition and Method for Early Pregnancy Diagnosis, to determine
whether a rejection of any of the instant claims for obviousness-type double
patenting is warranted.

SUMMARY
The rejection of claims 182-196 under 35 U.S.C. § 112, first
paragraph for lack of written description is affirmed.

AFFIRMED

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