Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Nov 2, 2017

13678832 (P.T.A.B. Nov. 2, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/678,832 11/16/2012 David M. GOLDENBERG IMMU-0016US1A 1293
37013 7590 11/06/2017
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
EXAMINER
ROONEY, NORA MAUREEN
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
11/06/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. GOLDENBERG and HANS J. HANSEN
Appeal 2016-007109
Application 13/678,8321
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellants request rehearing of the Decision entered June 21, 2017
(Decision) affirming the rejections of: (1) claims 1, 10, 37, 38, and 40 under
U.S.C. § 103(a) as unpatentable over the combination of Cohen,2 Lu,3 and
1 Appellants identify the real party in interest as “Immunomedics, Inc.”
(App. Br. 2.)
2 Jonathan Cohen, The immunopathogenesis of sepsis, 420 NATURE 885—
891 (2002).
3 Dan Lu et al., Mechanisms of Signal Transduction: Simultaneous
Blockade of Both the Epidermal Growth Factor Receptor and the Insulinlike
Growth Factor Receptor Signaling Pathways in Cancer Cells with a Fully
Human Recombinant Bispecific Antibody, 279 J. Biol. Chem. 2856—65
(2004).
Appeal 2016-007109
Application 13/678,832
Hansen4 and (2) the rejection of claim 41 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Cohen, Lu, and Middleton5 (see
Decision 13).6 Because our rationale for affirming rejection 2 differed from
Examiner’s, we designated “our affirmance [of rejection 2] a new ground of
rejection” (id.).
Upon further consideration, given the ambiguities on this record,
which were created by both Appellants and Examiner, we GRANT the
requested relief, withdraw the new ground of rejection, and reverse the
rejections of record.
ANALYSIS
The ambiguity in this record began with Appellants’ response to
Examiner’s requirement for a species election (see Decision 4—7).
Specifically, “[i]n response to Examiner’s requirement for a species election,
Appellants elected: ‘ [A] multispecific antibody, IL-6 as the single specific
target A, HMGB-1 as the single specific target B, and angiogenesis inhibitor
as [the] therapeutic agent’” (Decision 4 (emphasis added)). Appellants’
species election also expressly identified several, then pending, claims as
“readable on the elected species,” including claim 32 (id.).
4 Hansen, US 6,458,933 Bl, issued Oct. 1, 2002.
5 Kathryn Middleton et al., Interleukin-6: An angiogenic target in solid
tumours, 89 Critical Reviews in Oncology/Hematology 129-39 (2014).
6 With respect to rejection 1: “Claims 3, 5—8, 11, 17, 26, 29, 32, 38, and 39
[were] not separately argued and [fell] with claims 1,10, and 37
respectively” (Decision 13). With respect to rejection 2: “Claims 42 45
[were] not separately argued and [fell] with claim 41” (id.).
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Application 13/678,832
Appellants’ originally presented claim 32, as it was presented at the
time of the requirement for a species election, is reproduced below:
32. A multispecific antibody or combination of separate
antibodies according to claim 27, wherein target (A) is selected
from the groups consisting of TNF-a, IL-1, IL-4, IL-5, IL-6, IL-
8, IL-12, IL-15, IL-17 and IL-18, and said therapeutic agent is
activated protein C.
{id. at 5 (emphasis added).)
Thus, as a matter of basic claim construction, if Appellants elected an
angiogenesis inhibitor as the therapeutic agent and asserted that claim 32
reads on the elected species; then, as Examiner explained, “from the
Examiner’s perspective it could be extrapolated that ‘activated protein C’
was an angiogenesis inhibitor since Appellant [sic] indicated that claim 32
read on their elected species” {id. (alteration original)). See RiverwoodInt 7
Corp. v. R.A. Jones & Co., Inc., 324 F.3d 1346, 1354 (Fed. Cir. 2003)
(“Valid prior art may be created by the admissions of the parties”). As the
Decision explains, “Examiner may rely on Appellants’ express statement
and/or admissions on the record” {id. at 5).
Although Appellants concede that their “remarks to restriction did
include claim 32 in the list of claims readable on their invention,”
notwithstanding the foregoing discussion of claim construction, Appellants
contend that they “never [made] any statement during prosecution before the
Examiner that would lead the Examiner to understand that activated protein
C is an angiogenesis inhibitor” ((Req. Rh’g 2 and 5). Stated differently,
Appellants’ “remarks to restriction” were incorrect and created an ambiguity
on this record {cf. id. at 2).
Appellants further assert that “in subsequent responses they identified
claim 32 with a ‘withdrawn’ status identifier, and even particularly
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Application 13/678,832
addressed this status in their remarks” (id.; see id. at 6 (“[AJppellants have
repeatedly stated on the record that activated protein C is not an
angiogenesis inhibitor, and have always used a ‘withdrawn ’ status identifier
for claim 32 during prosecution before the Examiner for claim 32”
(emphasis added)); id. at 9).
Notwithstanding the foregoing, Appellants included claim 32, as it
was amended during prosecution, in the Claims Appendix of their Briefing
to this Board with an “Original” claim designation. For clarity, claim 32, as
it was presented to this panel in the “CLAIMS APPENDIX” of Appellants’
Brief, is reproduced below:
32. (Original) A multispecific antibody or combination
of separate antibodies according to claim 29, wherein target (A)
is IL-6, and said therapeutic agent is activated protein C.
(App. Br. 13 (emphasis added); cf. Decision 5 (reproducing Appellants’
“original” claim 32); Reg. Rh’g. 2—3 (Appellants’ reproduction of
“Withdrawn — Currently amended” claim 32 filed August 27, 2014).)
Appellants contend, however, that
[cjlaim 32 was only included in the list of claims in
[Appellants’] Appeal Brief both because (i) the Examiner
included it in the rejected claims, and (ii) later in prosecution
the Examiner had apparently decided to include a second
species of therapeutic agent in her examination (Final Rejection
— “a therapeutic agent that is an activated protein C or
angiogenesis inhibitor”).
(Req. Rh’g 2 (emphasis added).)
In sum, having an opportunity to reconsider this record, given the
ambiguities, exemplified above, which were created by both Appellants and
Examiner, we find that this record lacks a clear evidentiary basis to support a
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Application 13/678,832
conclusion that activated protein C is an angiogenesis inhibitor. Therefore,
we withdraw the new grounds of rejection presented in the Decision.
To be complete, we revisit the rejections presented by Examiner (see
Ans. 3-12).
Examiner’s articulated basis for rejection 1 does not account for a
reagent that is not activated protein C and, therefore, for the reasons
discussed above, fails to establish a sufficiently clear evidentiary basis on
this record to support a conclusion that the combination of Cohen, Lu, and
Hansen makes obvious a multispecific antibody or a combination of separate
antibodies, within the scope of Appellants’ claimed invention, and
Appellants’ elected species of therapeutic agent, i.e. an angiogenesis
inhibitor (see Ans. 3—6 and 8—10).
Examiner’s articulated basis for rejection 2 is that an anti-IL-6
antibody, as suggested by the combination of Cohen, Lu, and Middleton,
serves the purpose of both an antibody that targets IL-6, as required by
Appellants’ claimed invention, and Appellants’ elected species of
therapeutic agent, i.e. an angiogenesis inhibitor (see Ans. 6—7 and 10-12).
This, however, dismisses the separate requirement in Appellants’ claimed
invention, as limited by Appellants’ species election, for an antibody that
targets IL-6 and a separate angiogenesis inhibitor (i.e. therapeutic agent)
(see Ans. 11 (“Appellants] argue[] that the multispecific antibody is not a
therapeutic and that their therapeutic agent must be a separate agent”)).
Thus, in view of the foregoing ambiguities, the rejections set forth in
Examiner’s Answer are reversed. The claims currently stand free from
rejection. In the event of further prosecution, we encourage Appellants and
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Examiner to work cooperatively to resolve the: status of each claim and
ambiguities on this record.
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).
REHEARING GRANTED: REVERSED
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