Ex Parte Briskin

Board of Patent Appeals and Interferences

Apr 24, 2008

08523004 (B.P.A.I. Apr. 24, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MICHAEL J. BRISKIN
____________

Appeal 2007-3891
Application 08/523,004
Technology Center 1600
____________

Decided: April 24, 2008
____________

Before DONALD E. ADAMS, ERIC GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 103-105, 109-112,
115, 116, 118-120, 123, 125-127, 130, 131, 133, and 134. The Examiner
indicated that claims 106, 107, 117, and 124, the only remaining pending
claims, are allowable (May 3, 2005 Office Action 8: ¶ 6). We have
jurisdiction under 35 U.S.C. § 6(b).

Appeal 2007-3891
Application 08/523,004

INTRODUCTION
The claims are directed to an isolated nucleic acid which encodes a
naturally occurring primate MAdCAM, a recombinant nucleic acid construct
comprising this nucleic acid, and a host cell comprising this nucleic acid
(claims 103-105, 115, 116, and 123); an isolated nucleic acid encoding a
naturally occurring primate MAdCAM or variant thereof which binds an
α4β7 integrin, a recombinant nucleic acid construct comprising this nucleic
acid, and a host cell comprising this nucleic acid (claims 109, 110, 118-120,
and 125); an isolated nucleic acid encoding a naturally occurring primate
MAdCAM-1 or variant thereof, a recombinant nucleic acid construct
comprising this nucleic acid, and a host cell comprising this nucleic acid
(claims 111, 112, 119, 126, and 127); and an isolated nucleic acid encoding
a fusion protein comprising a naturally occurring primate MAdCAM or
variant thereof and a host cell comprising this nucleic acid (claims 130, 131,
133, and 134). Claims 103, 109, 111, and 112 are illustrative:
103. An isolated nucleic acid which encodes a naturally occurring
primate MAdCAM, wherein said nucleic acid encodes the polypeptide
shown in Figure 1 (SEQ ID NO: 2), the polypeptide shown in Figure 2 (SEQ
ID NO: 4), or the polypeptide shown in Figure 3 (SEQ ID NO:6).
109. An isolated nucleic acid encoding a naturally occurring primate
MAdCAM or variant thereof which binds an α4β7 integrin, wherein said
nucleic acid hybridizes under wash conditions of 0.1X SSC, 0.1% SDS at
65°C with a second nucleic acid selected from the group consisting of:
a) the nucleic acid of Figure 1 (SEQ ID NO: 1);
b) the nucleic acid of Figure 2 (SEQ ID NO: 3);
c) the nucleic acid of Figure 3 (SEQ ID NO:5); and
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d) a nucleic acid having a sequence complementary to the strand
shown in Figure 1 (SEQ ID NO: 1), Figure 2 (SEQ ID NO: 3), or Figure 3
(SEQ ID NO: 5).
119. A recombinant nucleic acid construct comprising a nucleic acid
encoding a naturally occurring primate MAdCAM or variant thereof,
wherein said variant has at least about 75% amino acid sequence similarity
to the sequence of a protein shown in Figure 1 (SEQ ID NO: 2), Figure 2
(SEQ ID NO: 4) or Figure 3 (SEQ ID NO: 6), and said variant mediates
α4β7-dependent adhesion.
120. The recombinant nucleic acid construct of Claim 119, wherein
said variant has at least about 90% amino acid sequence similarity to the
sequence of a protein shown in Figure 1 (SEQ ID NO: 2), Figure 2 (SEQ ID
NO: 4), or Figure 3 (SEQ ID NO:6)

The Examiner relies on the following prior art references to show
unpatentability:
Vonderheide US 5,599,676 Feb. 4, 1997
Butcher WO 94/13312 Jun. 23, 1994
David J. Erle et al., “Expression and Function of the MAdCAM-1 Receptor,
Integrin α4β7, on Human Leukocytes,” 153 J. Immunology 517-528 (1994).

The rejections as presented by the Examiner are as follows:
1. Claims 111, 112, 119, 120, 126, 127, 130, 131, 133, and 134 stand
rejected under the written description provision of 35 U.S.C. § 112, first
paragraph.
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2. Claims 103-105, 109-112, 115, 116, 118-120, 123, 125-127, 130, 131,
133, and 134 stand rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Butcher, Vonderheide, and Erle.
We affirm the rejection of claim 119 under the written description
provision of 35 U.S.C. § 112, first paragraph. Claims 111, 126, 130, and 133
fall together with claim 119.
We affirm the rejection of claim 120 under the written description
provision of 35 U.S.C. § 112, first paragraph. Claims 112, 127, 131, and
134 fall together with claim 120.
We affirm the rejection of claim 119 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Butcher, Vonderheide, and Erle.
Claims 111, 126, 130, and 133 fall together with claim 119.
We affirm the rejection of claim 120 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Butcher, Vonderheide, and Erle.
Claims 112, 127, 131, and 134 fall together with claim 120.
We affirm the rejection of claim 109 as unpatentable over the
combination of Butcher, Vonderheide, and Erle. Claims 110, 118, and 125
fall together with claim 109.
We reverse the rejection of claims 103-105, 115, 116, and 123 under
35 U.S.C. § 103(a) as unpatentable over the combination of Butcher,
Vonderheide, and Erle.

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DISCUSSION
Written Description:
Claims 111, 112, 119, 120, 126, 127, 130, 131, 133, and 134 stand
rejected under the written description provision of 35 U.S.C. § 112, first
paragraph.
The Examiner finds that the claims encompass nucleic acids that
encode primate MAdCAM “from any primate or alleles of said molecules
wherein the nucleic acids encode proteins that have a particular degree of
amino acid sequence similarity recited in the claims” (Ans. 4). The
Examiner finds that Appellant’s “specification discloses one nucleic acid
sequence encoding macaque MAdCAM [(SEQ ID NO: 5)] and two different
nucleic acid sequences encoding human MAdCAM [(SEQ ID NOS: 1 and
3)] as well as amino acid sequences for said molecules” (id.). From this the
Examiner concludes that “[w]ith the exception of the aforementioned nucleic
acid sequences, the skilled artisan cannot envision the detailed structure of
the encompassed nucleic acids” (id.).
In addition, the Examiner finds that “there are 11 families, 52 genera
and 181 species encompassed by the term primate. Thus, [A]ppellant has
not provided a description of the vast majority . . . of the amino acid
sequences (or nucleic acids encoding said molecules) of primate MAdCAM”
(Ans. 10). Further, the Examiner asserts that “[i]f each species had multiple
alleles or polymorphic variants than [sic] the potential number of MAdCAM
sequences would vastly increase from the 181 sequences number” (Ans. 10-
11).
Regarding the percent similarity limitations in the claims, the
Examiner finds that the “claims do not specify what particular regions of the
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sequence are similar and do not specify the identity of the nonsimilar
portion, it is unclear as to how this provides a further description of the
sequence encoding other primate variants” (Ans. 11). In addition, the
Examiner finds that
there is no disclosure in the specification as to what particular
amino acids can or cannot be substituted wherein the fusion
protein would maintain all of the required functions of
MAdCAM and there is no disclosure as to what particular
amino acids [sic] substitutions could be tolerated in any
particular section of the sequence with the retention of
MAdCAM function.

(Ans. 13.)
Appellant provides separate arguments for the following groups of
claims: I. claims 111, 119, 126, 130, and 133; and II. claims 112, 120, 127,
131, and 134. Accordingly, we limit our discussion to representative claims
119 and 120. 37 C.F.R. § 41.37(c)(1)(vii).

Claim 119:
Claim 119 is drawn to an isolated nucleic acid encoding a naturally
occurring primate Mucosal Addressin Cell Adhesion Molecule1
(MAdCAM) or variant thereof. In addition, claim 119 requires that the
variant:
a. has at least about 75% amino acid sequence similarity to the
sequence of a protein shown in Figure 1 (SEQ ID NO: 2), Figure 2 (SEQ ID
NO: 4) or Figure 3 (SEQ ID NO: 6); and
b. mediates α4β7-dependent adhesion.

1 Spec. 9: 16-17 (“MAdCAMs (Mucosal Addressin Cell Adhesion
Molecules”)).
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We note that while claim 119 requires the MAdCAM variant to
mediate α4β7-dependent adhesion, claim 119 does not require the
MAdCAM, encoded by the claimed recombinant nucleic acid, to mediate
α4β7-dependent adhesion.
According to Appellant’s Specification:
1. “[S]ome proteins of the present invention can selectively bind to an
α4β7 integrin and thereby mediate α4β7-dependent cellular adhesion to cells
bearing the α4β7 integrin, such as leukocytes” (Spec. 9: 26-29).
2. “In another embodiment, proteins of the present invention can bind
a primate α4β7 integrin from the same or a different primate species, and/or
have cellular adhesion molecule function (e.g., the ability to mediate cellular
adhesion such as α4β7-dependent adhesion in vitro and/or in vivo)” (Spec.
10: 1-6 (emphasis added)). Appellant identifies human and macaque
MAdCAM-1 proteins as an example of MAdCAM proteins that “can
selectively bind to α4β7 integrin present on human lymphocytes, and can
function as cellular adhesion molecules capable of mediating selective
adhesion to cells bearing the α4β7 integrin” (Spec. 10: 8-11 (emphasis
added)).
Appellant’s Specification discloses the nucleotide and amino acid
sequence of two human (Spec. 6: 29 - 7: 9) and one macaque MAdCAM-1
(Spec. 7: 15-19). Appellant’s Specification also provides some structural
characterization of the human and macaque MAdCAM-1 protein in relation
to murine MAdCAM-1 (Spec. 7: 14-19).
Appellant asserts that the Specification “contains a detailed
description of the structure of naturally occurring primate MAdCAM and
variants thereof and the relationship between structure and α4β7-dependent
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adhesion function, that is sufficient to demonstrate that Appellant was in
possession of the claimed subject matter at the time the application was
filed” (App. Br. 10-11). We disagree. Appellant has provided a disclosure
of MAdCAM-1 but not the broader genus encompassed by MAdCAM,
which according to Appellant’s Specification can, inter alia, bind a primate
α4β7 integrin from the same species, a different primate species, or have
cellular adhesion molecule function (see Spec. 10: 1-6). Appellant’s
arguments focus on a species of MAdCAM protein – the MAdCAM-1
protein, particularly those MAdCAM-1 proteins from human and macaque
that have SEQ ID NOs: 2, 4, and 6 (see App. Br. 7-20).
Appellant does not identify and we find no disclosure of a nucleotide
or amino acid sequence of a non-MAdCAM-1 nucleic acid or protein that
falls within the genus of MAdCAM, or a disclosure of a correlation between
the structure and function of a non-MAdCAM-1 protein that falls within the
MAdCAM genus. Further, while Appellant discloses that “as shown herein,
human and macaque MAdCAM-1 proteins . . . can selectively bind to α4β7
integrin present on human lymphocytes, and can function as cellular
adhesion molecules capable of mediating selective adhesion to cells bearing
the α4β7 integrin”2, Appellant does not identify and we find no disclosure
that all MAdCAM proteins within the claimed genus exhibit a similar
function and selective binding ability.
Accordingly, we disagree with Appellant’s argument that his
disclosure “of three species of nucleic acids which encode naturally
occurring primate MAdCAM[-1]” and “a correlation between [MAdCAM-1]
structure and α4β7-dependent adhesion function, are adequate to convey to

2 Spec. 10: 8-11 (emphasis added).
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the person of skill in the art that Appellant was in possession of the claimed
invention at the time the application was filed” (App. Br. 12).
On facts similar to those here, the U.S. Court of Appeals for the
Federal Circuit has held claims to lack adequate description. In University
of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997), the court
held that claims generically reciting cDNA encoding vertebrate or
mammalian insulin were not adequately described by the disclosure of
cDNA encoding rat insulin. Id. at 1568. 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 held that 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. at 1569.)
We are not persuaded by Appellant’s assertion that the disclosure of
nucleotide and amino acid sequences for three MAdCAM-1 proteins, or that
the alleged structure and functional relationship of MAdCAM-1 protein
disclosed in Appellant’s Specification is sufficient to provide an adequate
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written description of the genus of MAdCAM recombinant nucleic acid
constructs encompassed by Appellant’s claim 119.
We are also not persuaded by Appellant’s assertion that the
“specification contains extensive disclosure and exemplification of the
claimed subject matter” (App. Br. 15). Assuming, arguendo, that
Appellant’s disclosure of the nucleotide and amino acid sequences of three
MAdCAM-1 proteins and a structure-function relationship for MAdCAM-1
proteins provides adequate written description of a recombinant nucleic acid
construct comprising a nucleic acid encoding a naturally occurring primate
MAdCAM-1; we find that such a disclosure fails to provide adequate written
descriptive support for the entire genus encompassed by claim 119.
As discussed above, Appellant’s Specification contemplates
MAdCAM proteins to be associated with a variety of functions.
Accordingly, we are not persuaded by Appellant’s reliance on Example 14
of the Written Description Guidelines, which discusses a single protein
whose function is to “catalyze the reaction A→B” (App. Br. 15).
For the foregoing reasons, we affirm the rejection of claim 119 under
the written description provision of 35 U.S.C. § 112, first paragraph. Claims
111, 126, 130, and 133 fall together with claim 119.

Claim 120:
Claim 120 depends from and further limits the variant of claim 119 to
have at least about 90% amino acid sequence similarity to the sequence of a
protein shown in Figure 1 (SEQ ID NO: 2), Figure 2 (SEQ ID NO: 4) or
Figure 3 (SEQ ID NO: 6). Appellant’s arguments with regard to claim 120
are substantially the same as those for claim 119 with the exception that
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Appellant emphasizes that claim 120 requires that the variant of claim 119
exhibit at least about 90% amino acid sequence similarity to one of the
stated sequences.
Claim 120 further limits only the variant portion of claim 119. Claim
120 does nothing to further limit the claimed recombinant nucleic acid
construct comprising a nucleic acid encoding a naturally occurring primate
MAdCAM. Accordingly, for the same reasons as set forth above with
regard to claim 119, we affirm the rejection of claim 120 under the written
description provision of 35 U.S.C. § 112, first paragraph. Claims 112, 127,
131, and 134 fall together with claim 120.

Obviousness:
Claims 103-105, 109-112, 115, 116, 118-120, 123, 125-127, 130, 131,
133, and 134 stand rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Butcher, Vonderheide, and Erle.
The Examiner makes the following findings:
1. Butcher teaches vectors and host cells containing a nucleic acid sequence
of murine MAdCAM (Ans. 7).
2. Butcher teaches complementary nucleic acids to those encoding
MAdCAM nucleic acids (id.).
3. Butcher does “not teach nucleic acids encoding primate MAdCAM” (id.).
4. Erle teaches “human MAdCAM binds to α4β7” (id.).
5. Erle teaches “that MAdCAM is found in mucosal lymphoid organ HEV
and gut lamina propria venules” (id.).
6. Erle teaches “human cell lines expressing α4β7 and MAdCAM” (id.).
7. Erle teaches “a source of human MAdCAM nucleic acids” (id.).
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8. Vonderheide teaches “methods to isolate nucleic acids encoding
molecules that bind α4β7” which require “human cell lines expressing α4β7
and human cells expressing MAdCAM” (id.).
9. Vonderheide teaches “nucleic acids encoding molecules that bind α4β7”
(id.).
10. Vonderheide “teach that molecules that bind α4β7 can be used for a
variety of art recognized purposes . . . and the art recognizes that nucleic
acids encoding said molecules . . . can be used to recombinantly produce
said molecule” (Ans. 8).
Based on these findings the Examiner concludes that
[i]t would have been prima facie obvious to one of ordinary
skill in the art at the time the invention was made to have
created the claimed invention because Butcher et al. teach
murine nucleic acids encoding MAdCAM, Erle et al. teach that
human MAdCAM binds to α4β7 and human cell lines
expressing α4β7 and MAdCAM, while Vonderheide et al. teach
methods to isolate nucleic acids encoding molecules that bind
α4β7 wherein said methods require human cell lines expressing
α4β7 and MAdCAM.

(Ans. 7-8.)
Butcher teaches “[m]ammalian purified nucleic acids and proteins
encoding mucosal addressins” (Abstract). In this regard, Butcher discloses
“the cDNA sequence of murine MAdCAM-1 . . . and the encoded amino
acid sequence” (Butcher 3: 11-12). According to Butcher
[n]ucleotide sequences are provided encoding mammalian
mucosal addressin, where the sequences can be used for
expressing the addressin or fragments thereof. The addressin or
fragments thereof may be used to produce antibodies which
may find therapeutic purposes. The addressin or fragments
thereof, by themselves or joined to other molecules, may find
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use in tagging leukocytes, inhibiting leukocyte binding to
endothelial cells, in isolating leukocytes, in transporting various
agents to leukocytes, and the like. Also as a tool for screening
to identify molecules that bind to the mucosal addressins, that
might themselves find therapeutic uses in inhibiting MAd
functions, or might be used to target other agents to MAdCAM-
1 and endothelial cells (“EC”) for therapeutic purposes.
Methods are provided for isolating or synthesizing DNA which
encodes at least a portion of the mucosal addressin, for
introducing the DNA into host cells, and for expression of the
addressin or fragments thereof. In addition, the addressin can
serve as a source of the carbohydrate side chains which serve as
binding entities to the leukocytes.

(Butcher 2: 28 - 3: 8.) In addition, Butcher teaches that the addressin
peptide or protein may be fused to other proteins to provide a fusion protein.
However, as the Examiner recognizes, Butcher does “not teach nucleic acids
encoding primate MAdCAM” (Ans. 7). The Examiner relies on Erle and
Vonderheide to make up for this deficiency.
Erle teaches that MAdCAM-1 is “expressed selectively on mucosal
lymphoid organ HEV and on gut lamina propria venules” (Erle 518: col. 1,
ll. 13-16). In addition, Erle teaches that human α4β7 “mediates adhesion to
MAdCAM-1 in vitro” (Erle 518: col. 1, ll. 48-50). Vonderheide teaches “a
method for isolating a novel receptor for α4 integrins” including “[i]solated
nucleic acids encoding the receptor” (Vonderheide, Abstract). Vonderheide
defines “[t]he term ‘α4 integrins’ as . . . molecules comprising the α4
integrin subunit, including but not limited to VLA-4 (α4β1), α4β7, and the
α4 subunit itself” (Vonderheide, col. 4, ll. 27-30). Based on this evidence
the Examiner concludes that an isolated nucleic acid encoding a naturally
occurring primate MAdCAM or MAdCAM-1 and fusion protein thereof
would have been prima facie obvious to a person of ordinary skill in the art
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as Butcher teaches a murine MAdCAM nucleic acid and fusion protein, Erle
teaches the source of primate MAdCAM and Vonderheide teaches the
methodology of obtaining α4 integrin receptors, including α4β7 receptors
such as MAdCAM-1 (Ans. 7-8 and 15-18). We find no error in the
Examiner’s conclusion that claims 111, 112, 119, 126, 127, 130, 131, 133,
and 134 are prima facie obvious in view of the combination of Butcher,
Vonderheide, and Erle.
In response, Appellant asserts that Butcher “does not suggest the
claimed nucleic acids to the person of ordinary skill in the art or provide a
reasonable expectation of success, because murine MAdCAM and primate
or human MAdCAM have a very low degree of sequence similarity” (App.
Br. 22). We are not persuaded. Claims 111, 112, 119, 126, 127, 130, 131,
133, and 134 do not require any amount of sequence similarity to a
particular nucleic acid sequence. These claims only require an isolated
nucleic acid encoding a (1) naturally occurring primate MAdCAM or
MAdCAM-1; or (2) fusion protein comprising a naturally occurring primate
MAdCAM. As Vonderheide teaches a method of obtaining nucleic acids for
α4 integrin receptors that does not involve hybridization, we are not
persuaded by Appellant’s reliance on Shyjan (App. Br. 22-23).
We are also not persuaded by Appellant’s assertion that the
combination of Vonderheide and Erle fails to make up for the deficiency in
Butcher because “at best Vonderheide et al. discloses a method suitable for
isolating a cDNA that encodes an α4 integrin receptor, and Erle et al.
demonstrates that primate or human MAdCAM was not known, but believed
to exist” (App. Br. 23; see also id. at 26-30). Erle identifies the cellular
source of MAdCAM which can be used in Vonderheide’s methodology to
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obtain the primate homologue of the murine MAdCAM identified by
Butcher.
As stated in Ex parte Goldgaber, 41 USPQ2d 1172, 1176 (BPAI
1995), “[w]e find nothing intrinsically wrong, however, in the application of
methodology in rejecting product claims under 35 U.S.C. § 103, depending
on the particular facts of the case, the manner and context in which
methodology applies, and the overall logic of the rejection.” On this record,
the combination of Butcher and Erle provides a road map that would have
directed a person having ordinary skill in the art to a nucleic acid meeting
the claimed limitations. Vonderheide provides the methodology to obtain
that nucleic acid. Here, similar to the facts presented in Goldgaber, and in
contrast to the facts presented in In re Bell, 991 F.2d 781 (Fed. Cir. 1993)
and In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), “there is something in the
prior art to lead to the particular DNA and indicate that it should be
prepared.” Deuel, 51 F.3d at 1558. Stated differently, the combination of
prior art relied upon by the Examiner puts the key in the lock of the door of
success. All that remains for a person having ordinary skill is to turn the key
and, in so doing, open the lock. That, in our judgment, does not give rise to
a patentable invention. Cf. Goldgaber, 41 USPQ2d at 1175. “The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR Int’l Co.
v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007).
We are also not persuaded by Appellant’s assertion that “none of the
cited references demonstrate that primate or human MAdCAM binds α4β7
integrin, or even that primate or human MAdCAM proteins existed” (App.
Br. 24). Claims 111, 112, 119, 126, 127, 130, 131, 133, and 134 do not
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require that the primate MAdCAM bind α4β7 integrin. Further, Butcher
teaches that “[t]he results of this study support the hypothesis that α4β7
plays a crucial role in mucosal homing of human lymphocytes by mediating
adhesion to the mucosal addressin, MAdCAM-1” (Butcher 526: col. 2, ll.
41-44). Thus, contrary to Appellant’s assertion, while the MAdCAM
receptor was not isolated, the preponderance of the evidence on this record
suggests that a primate MAdCAM receptor existed, provided the cellular
source, and the methodology for the isolation of the nucleic acid for this
receptor.
In addition, we are not persuaded by Appellant’s assertion that the
Examiner’s rejection is based on hindsight reconstruction (App. Br. 31). In
this regard, we note that Appellant’s assertion in based on a rejection over a
combination of references presented in the “first Office Action on the
merits” and later withdrawn by the Examiner (see App. Br. 31-32).
Appellant provides separate arguments for the following groups of
claims: I. claims 103-105, 115, 116, and 123; II. claims 109, 110, 118, and
125; III. claims 111, 119, 126, 130, and 133; and IV. Claims 112, 120, 127,
131, and 134.

Group III (claims 111, 119, 126, 130, and 133):
We limit our discussion to representative claim 119. Claims 111, 126,
130, and 133 stand or fall with claim 119. 37 C.F.R. § 41.37(c)(1)(vii).
According to Appellant
[a] prima facie case has not been established against claims
111, 119, 126, 130 and 133 because the combined teachings of
the cited references fail to suggest a nucleic acid that encodes a
naturally occurring primate MAdCAM or variant thereof that
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mediates α4β7-dependent adhesion and has at least 75% amino
acid sequence similarity to the sequence of a protein[ ] shown
in Figure 1 (SEQ ID NO:2), Figure 2 (SEQ ID NO: 4) or Figure
3 (SEQ ID NO: 6), to a person of ordinary skill in the art.

(App. Br. 25-26.) We are not persuaded.
As discussed above, while Appellant focuses on alternative limitations
set forth in claim 119, we note that the scope of claim 119 includes a nucleic
acid encoding a naturally occurring primate MAdCAM. For the reasons set
forth above, we affirm the rejection of claim 119 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Butcher, Vonderheide, and Erle.
Claims 111, 126, 130, and 133 fall together with claim 119.

Group IV (claims 112, 120, 127, 131, and 134):
We limit our discussion to representative claim 120. Claims 112, 127,
131, and 134 stand or fall with claim 120. 37 C.F.R. § 41.37(c)(1)(vii).
According to Appellant “[t]hese claims are drawn to a smaller
subgenus of nucleic acids than claims that recite at least 75% amino acid
sequence similarity, and therefore a more precise motivation or suggestion
must be found in the prior art to establish a prima facie case” (App. Br. 26).
We disagree.
Claim 120 limits the variant of claim 119. However, as discussed
above, the scope of claim 119 is not limited to a variant. Accordingly, for
the reasons set forth above, we are not persuaded by Appellant’s assertion
that “there is noting in the combined teachings of the cited references that
suggests a nucleic acid[ ] that meets the limitations of the claims” (id.). For
the reasons set forth above, we affirm the rejection of claim 120 under 35
U.S.C. § 103(a) as unpatentable over the combination of Butcher,
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Vonderheide, and Erle. Claims 112, 127, 131, and 134 fall together with
claim 120.

Group II (claims 109, 110, 118, and 125):
We limit our discussion to representative claim 109. Claims 110, 118,
and 125 stand or fall with claim 109. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 109 is drawn, inter alia, to an isolated nucleic acid encoding a
naturally occurring primate MAdCAM that hybridizes under wash
conditions of 0.1X SSC, 0.1% SDS at 65°C with a second nucleic acid
selected from the group consisting of:
a) the nucleic acid of Figure 1 (SEQ ID NO: 1);
b) the nucleic acid of Figure 2 (SEQ ID NO: 3);
c) the nucleic acid of Figure 3 (SEQ ID NO:5); and
d) a nucleic acid having a sequence complementary to the strand
shown in Figure 1 (SEQ ID NO: 1), Figure 2 (SEQ ID NO: 3), or Figure 3
(SEQ ID NO: 5).
Based on the foregoing discussion we find that the preponderance of
evidence on this record supports a conclusion that a nucleic acid encoding a
naturally occurring primate MAdCAM woud have been prima facie obvious
to a person of ordinary skill in the art at the time the invention was made.
The question then is whether this nucleic acid would have been expected to
hybridize under the claimed conditions to a nucleic acid selected from the
group consisting of:
a) the nucleic acid of Figure 1 (SEQ ID NO: 1);
b) the nucleic acid of Figure 2 (SEQ ID NO: 3);
c) the nucleic acid of Figure 3 (SEQ ID NO:5); and
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d) a nucleic acid having a sequence complementary to the strand
shown in Figure 1 (SEQ ID NO: 1), Figure 2 (SEQ ID NO: 3), or Figure 3
(SEQ ID NO: 5).
Appellant does not identify, and we do not find, any evidence on this
record to suggest that a nucleic acid taught by the combination of references
relied upon by the Examiner would not have been expected to hybridize to
any one of the sequences set forth in the claims under the claimed
conditions. Instead, Appellant asserts that “the cited references provide a
research plan that might have been used to arrive at the claimed invention”
(App. Br. 25). For the reasons set forth above, we disagree with this
assertion. Accordingly, we affirm the rejection of claim 109 as unpatentable
over the combination of Butcher, Vonderheide, and Erle. Claims 110, 118,
and 125 fall together with claim 109.

Group I (claims 103-105, 115, 116, and 123):
Claims 103-105, 115, 116, and 123 stand on a different footing.
These claims require a nucleic acid which encodes a naturally occurring
primate MAdCAM, wherein said nucleic acid encodes the polypeptide
shown in Figure 1 (SEQ ID NO: 2), the polypeptide shown in Figure 2 (SEQ
ID NO: 4), or the polypeptide shown in Figure 3 (SEQ ID NO: 6) (see
claims 103-105, 115, 116 and 123).
The Examiner has failed to establish that a person of ordinary skill in
the art would have had a reasonable expectation of successfully isolating a
nucleic acid molecule that meets the sequence requirements set forth in
claims 103-105, 115, 116, and 123. Accordingly, we reverse the rejection of
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Appeal 2007-3891
Application 08/523,004

claims 103-105, 115, 116, and 123 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Butcher, Vonderheide, and Erle.

CONCLUSION
In summary:
We affirm the rejection of claim 119 under the written description
provision of 35 U.S.C. § 112, first paragraph. Claims 111, 126, 130, and 133
fall together with claim 119
We affirm the rejection of claim 120 under the written description
provision of 35 U.S.C. § 112, first paragraph. Claims 112, 127, 131, and
134 fall together with claim 120.
We affirm the rejection of claim 119 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Butcher, Vonderheide, and Erle.
Claims 111, 126, 130, and 133 fall together with claim 119.
We affirm the rejection of claim 120 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Butcher, Vonderheide, and Erle.
Claims 112, 127, 131, and 134 fall together with claim 120.
We affirm the rejection of claim 109 as unpatentable over the
combination of Butcher, Vonderheide, and Erle. Claims 110, 118, and 125
fall together with claim 109.
We reverse the rejection of claims 103-105, 115, 116, and 123 under
35 U.S.C. § 103(a) as unpatentable over the combination of Butcher,
Vonderheide, and Erle.
20
Appeal 2007-3891
Application 08/523,004

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

Ssc:

HAMILTON, BROOK, SMITH & REYNOLDS, P.C.
530 VIRGINIA ROAD
P.O. BOX 9133
CONCORD, MA 01742-9133
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