Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Sep 17, 2012

11296432 (P.T.A.B. Sep. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID M. GOLDENBERG and HANS J. HANSEN
____________

Appeal 2011-009765
Application 11/296,432
Technology Center 1600
____________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 3, 18, 29, 30,
39, 41, 54, 58, 61-70, 72, 74, and 84-87 (App. Br. 2).
1
We have jurisdiction
under 35 U.S.C. § 6(b).

1
Pending claims 2, 4, 71, and 76-83 stand withdrawn from consideration
(App. Br. 2; see also Advisory Action, mailed September 28, 2010).
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2
STATEMENT OF THE CASE
2

The claims are directed to a multispecific antibody or a combination
of separate antibodies that react(s) with at least two different targets. Due to
a restriction requirement and species election we limit the scope of our
review to Appellants‟ elected invention and species, which are directed to a
multispecific antibody that comprises a therapeutic agent and reacts with at
least two different targets that are (A) a proinflammatory effector of the
innate immune system and (B) a target specifically associated with an
inflammatory or immune-dysregulatory disorder, wherein the disorder is a
neuropathy. Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Claim
1 is representative and is reproduced in the Claims Appendix of Appellants‟
Brief.
Claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 stand
rejected under the written description provision of 35 U.S.C. § 112, first
paragraph.
Claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74
stand rejected under 35 U.S.C. § 102(a) and (e) as being anticipated by
Schuurman
3
as evidenced by Svejgaard.
4

Claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74

2
Examiner did not include the obviousness-type double patenting rejection
over claims 11-13 of U.S. Patent No. 7,435,803 or the provisional
obviousness-type double patenting rejection over claims 1-25 of copending
Application No. 11/929,279 in the Answer (Cf. App. Br. 5-6). Accordingly,
we consider these rejections withdrawn by Examiner. Paperless
Accounting, Inc. v. Bay Area Rapid Transit Sys., 804 F.2d 659, 663 (Fed.
Cir. 1986), cert. denied, 480 U.S. 933 (1987).
3
Schuurman et al., US 2004/0170626 A1, issued Sept. 2, 2004.
4
Arne Svejgaard, The immunogenetics of multiple sclerosis, 60
IMMUNOGENETICS 275-286 (2008).
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stand rejected under 35 U.S.C. § 102(a) and (e) as being anticipated by
Teeling.
5

Claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 8[4]
6
-87
stand provisionally rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-25 of
copending Application No. 11/929,221.
We affirm the rejection under 35 U.S.C. § 102(a) and (e) as being
anticipated by Schuurman as evidenced by Svejgaard. We reverse all other
grounds of rejection.

Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner‟s conclusion that Appellants‟ Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that while Appellants‟ Specification “discloses
examples of certain species within the recited genera of „targets,‟ „effectors,‟
[„]antigens‟ or „receptors[]‟ . . . the genera comprise[s] numerous additional
species which are not structurally related to those disclosed, and therefore
the examples are deemed not to be representative of the recited genera”

5
Teeling et al., US 2004/0208873 A1, issued Oct. 21, 2004.
6
Examiner included claim 83 in this rejection. Since claim 83 was
withdrawn from consideration we have not included this claim in our
deliberations (see App. Br. 2; see also Advisory Action, mailed September
28, 2010).
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(Ans. 4; see also id. at 9 (“there are no „common attributes or features‟ to the
generically recited molecules”)).
FF 2. Examiner finds “that not all „immune-dysregulatory disorders‟ are
presently known or understood, and neither are all the possible molecules
„associated‟ with such disorders. Therefore, theose [sic] members of the
recited groups that may be envisioned by the skilled artisan do not place
applicant in possession of the entire groups” (id. at 8).
ANALYSIS
Examiner finds that Appellants are “not in possession of the claimed
multispecific antibody” because the genus of targets to which the claimed
multispecific antibody can react is broadly defined and encompasses
structurally unrelated species, all of which are not disclosed in Appellants‟
Specification (Ans. 3-4; FF 1-2). We are not persuaded.
Appellants‟ claimed multispecific antibody recognizes two specific
target sets (see e.g., Claim 1). Examiner recognizes that Appellants‟
Specification discloses representative examples within each of these defined
target sets (FF 1). Examiner failed to establish an evidentiary basis on this
record to support a conclusion that a person of ordinary skill in this art
would not have known or recognized the targets that fall within the scope of
Appellants‟ claimed invention. As Appellants explain, on this record, “[t]he
fact that the common attribute or feature is a functional one should not
negative appellant‟s ability to properly protect the full scope of his
contribution to the art” (Reply Br. 2; Cf. FF 3). We agree.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner‟s conclusion that Appellants‟ Specification fails to provide written
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descriptive support for the claimed invention. The rejection of claims 1, 3,
18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 under the written
description provision of 35 U.S.C. § 112, first paragraph is reversed.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner‟s finding that Schuurman and/or Teeling teach Appellants‟
claimed invention?
FACTUAL FINDINGS (FF)
FF 3. “Sc[huurman] teaches bispecific antibodies that bind to CD25 and
IL-15” (Ans. 5; Schuurman 46: col. 2, ll. 20-22 and 44: col. 1, ll. 2-3).
FF 4. IL-15 is a proinflammatory effector cytokine within the scope of
Appellants‟ claimed invention (see Spec. 13: ¶ [0033]).
FF 5. Schuurman teaches a method of treating or preventing a disorder
involving cells expressing CD25, wherein the disorder is, inter alia, an
immune, autoimmune or inflammatory disease, such as multiple sclerosis
and inflammatory bowel disease the comprises administering an antibody
that binds to human CD25 (Ans. 6; Schuurman: 46: col. 2, ll. 30-37 and 44:
col. 1, ll. 2-3).
FF 6. Examiner relies on Svejgaard, a post-filing date reference, to suggest
that “CD25 is specifically associated with multiple sclerosis . . . an immune-
dysregulatory disorder” (Ans. 5; Svejgaard 281: col. 2, ll. 37-39 (“the IL2-
receptor (CD25) pathway seems to play a role in several autoimmune
diseases, which may reflect the importance of regulatory T-cells”)).
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FF 7. Examiner finds that Schuurman teaches bispecific antibodies within
the scope of Appellants‟ claimed invention that comprise a therapeutic agent
(Ans. 6).
FF 8. Examiner finds that the generic term “neuropathy” refers to a
“pathology of neurons or of the nervous system, [that is] not necessarily
limited to [the] peripheral nervous system. As such, multiple sclerosis, as a
pathology of neurons and of the nervous system, is within the scope [of] the
[generic term] . . . „neuropathy‟” (Ans. 10).
FF 9. T[eeling] teaches bispecific antibodies that bind to IL-8 and CD64”
(id. at 6).
FF 10. IL-8 is a proinflammatory effector cytokine within the scope of
Appellants‟ claimed invention (see Spec. 13: ¶ [0033]).
FF 11. Examiner finds that “CD64 expression is associated with
inflammation e.g. in Behcet‟s disease, and as such is inherently associated
with immune-dysregulatory disorders” (Ans. 6).
FF 12. Teeling teaches a method of inhibiting IL-8 induced
proinflammatory effects, wherein the disorder is Behcet‟s disease, in a
subject comprising administering an antibody that binds to human IL-8
(Teeling 40: col. 2, 4-43 and 37: claims 1 and 2).
ANALYSIS
The rejection over Schuurman as evidenced by Svejgaard:
The claims were not separately argued and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative.
Schuurman teaches an antibody within the scope of Appellants‟ claim
1 (FF 3-5 and 7). Appellants contend that Schuurman fails to teach a target
“specifically associated with an inflammatory or immune-dysregulatory
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disorder” (App. Br. 10). We are not persuaded (FF 5). Appellants contend
that Svejgaard fails to teach that CD25 is associated with multiple sclerosis
(App. Br. 10). We are not persuaded. Svejgaard teaches that “the IL2-
receptor (CD25) pathway seems to play a role in several autoimmune
diseases, which may reflect the importance of regulatory T-cells,” which is
cumulative to the teaching of Schuurman (FF 5-6).
We recognize Appellants‟ contention that “[p]eripheral neuropathy is
not a feature of MS” (App. Br. 11). Nevertheless, the elected species at
issue is a generic “neuropathy,” not “peripheral neuropathy,” as asserted by
Appellants. Therefore, we are not persuaded by Appellants‟ contention for
the reasons set forth by Examiner (Ans. 10; see also FF 8).

The rejection over Teeling:
Teeling teaches a bispecific antibody that binds IL-8 and CD64 (FF
9). Examiner failed to identify an evidentiary basis on this record to support
a finding that “CD64 expression is associated with inflammation e.g. in
Behcet‟s disease, and as such is inherently associated with immune-
dysregulatory disorders” (FF 11). To the contrary, Teeling teaches that a
method of inhibiting IL-8 induced proinflammatory effects, wherein the
disorder is Behcet‟s disease, in a subject comprising administering an
antibody that binds to human IL-8 (FF 12). IL-8 is a proinflammatory
effector cytokine within the scope of Appellants‟ claimed invention (FF 10).
Therefore, while Teeling‟s antibody may be bispecific and bind to both IL-8
and CD64, Examiner failed to establish that CD64 is a target specifically
associated with an inflammatory or immune-dysregulatory disorder as
required by Appellants‟ claimed invention (see generally App. Br. 14-15).
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CONCLUSION OF LAW
The preponderance of evidence on this record support Examiner‟s
finding that Schuurman teaches Appellants‟ claimed invention. The
rejection of claim 1 under 35 U.S.C. § 102(a) and (e) as being anticipated by
Schuurman as evidenced by Svejaard is affirmed. Claims 3, 18, 29, 30, 39,
41, 54, 61, 62, 64, 66, 69, 70, 72, and 74 are not separately argued and fall
together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
The preponderance of evidence on this record fails to support
Examiner‟s finding that Teeling teaches Appellants‟ claimed invention. The
rejection of claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and
74 under 35 U.S.C. § 102(a) and (e) as being anticipated by Teeling is
reversed.

Provisional Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence on this record support
Examiner‟s provisional rejection under the judicially created doctrine of
obviousness-type double patenting?
FACTUAL FINDINGS (FF)
FF 13. Examiner finds that Appellants‟ “claim 1 is directed to essentially
the same subject matter as currently pending claims 1 and 25 of USSN
11/929,221, the only difference being that . . . the claims of USSN
11/929,221 contain a recitation of target (A) which is “a proinflammatory
effector of the innate immune system” (Ans. 7 and 11-12).

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ANALYSIS
Examiner concludes that the scope of Appellants‟ claims overlaps the
subject matter of claims 1-25 of copending Application No. 11/929,221
(„221). We are not persuaded. As Appellants explain, due to restriction
requirements in this application and the „221 application the subject matter
of the two applications is distinct (Reply Br. 3
7
). This is consistent with
Examiner‟s finding in the „221 application (See Application No. 11/929,
221, paper mailed March 29, 2012, page 3 (“Application 11/296,432 is the
immediate parent of the instant application [(„221)]. . . . However, due to
restriction requirements, the invention appealed in the „432 application and
the instant application are different inventions”)).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner‟s provisional rejection under the judicially created doctrine of
obviousness-type double patenting. The provisional rejection of claims 1, 3,
18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1-25 of copending Application No. 11/929,221 is reversed.

TIME PERIOD FOR RESPONSE
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

7
The reply Brief is not paginated. Accordingly, we refer to page numbers as
if the Reply Brief was numbered consecutively beginning with the first page.
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