Ex Parte Mosser et al

Patent Trial and Appeal Board

Feb 14, 2017

12629136 (P.T.A.B. Feb. 14, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/629,136 12/02/2009 David M. Mosser 080619 7260
26285 7590 02/16/2017
KfrT flATRS T T P-Pimhnrah
EXAMINER
210 SIXTH AVENUE
PITTSBURGH, PA 15222-2613
DAHLE, CHUN WU
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
02/16/2017 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
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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. MOSSER and SHANIN CAO1
Appeal 2016-003408
Application 12/629,136
Technology Center 1600
Before DEMETRA J. MILLS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
polypeptide which have been rejected as anticipated. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The present invention is directed to “polypeptides comprising Fc
fragments of immunoglobulin G (IgG) and methods of using the same, for
1 Appellants identify the Real Parties in Interest as LeukoSight, Inc. and the
University of Maryland, College Park. Appeal Br. 1.
Appeal 2016-003408
Application 12/629,136
example, as an anti-inflammatory agent for treating inflammatory conditions
or as a laboratory reagent.” Spec. ^ 3.
Claims 89-92 are on appeal. Claim 89 is the sole independent, and
representative claim and reads as follows:
89. A polypeptide comprising:
a first Fc fragment of IgG and a second Fc fragment of
IgG, the first and the second Fc fragments of IgG being
attached in a series;
the first Fc fragment of IgG consisting of a full-length
hinge region, a full-length CH3 domain, and a full-length CH2
domain positioned intermediate to the hinge region and CH3
domain;
the second Fc fragment of IgG consisting of a full-length
hinge region, a full-length CH3 domain, and a full-length CH2
domain positioned intermediate to the hinge region and CH3
domain;
wherein the hinge region of the first Fc fragment of IgG
is the N-terminus of the first Fc fragment of IgG and wherein
the N-terminus of the first Fc fragment of IgG is the N-terminus
of the polypeptide;
wherein the CH3 domain of the second Fc fragment of
IgG is the C-terminus of the second Fc fragment of IgG and
wherein the C-terminus of the second Fc fragment of IgG is the
C-terminus of the polypeptide;
wherein the first Fc fragment of IgG and the second Fc
fragment of IgG are bound through one hinge region, the one
hinge region being the hinge region of the second Fc fragment
of IgG;
wherein the first Fc fragment of IgG and the second Fc
fragment of IgG form a chain and said polypeptide comprises
two said chains in dimeric form configured to bind and
crosslink at least two Fc-gamma receptors on a stimulated cell.
2
Appeal 2016-003408
Application 12/629,136
Claims 89-92 stand rejected under 35 U.S.C. § 102(e) as anticipated
by Strome.2
The issue with respect to the rejection is whether the Examiner has
established by a preponderance of the evidence that claim 89 is anticipated
by Strome under 35 U.S.C. § 102(e).
The Examiner finds that Strome teaches a stradomer from IgCl Fc
region with the structure of hinge-CH2-CH3-Hinge-CH2-CH3 which can be
linked into a serial stradomer. Final Act. 7. The Examiner finds that the
stradomer of Strome has the same structure as the peptide recited in claim
89. The Examiner finds that the claimed peptide structure is recited in
Figure l3 of the 1st Provisional. Final Act. 10. The Examiner also finds that
Appellants’ 131 Affidavit only shows conception before December 19, 2007
but not before June 1, 2007, the filing date of the 1st provisional. Final Act.
8.4
Appellants contend that the 1st Provisional only discloses peptides
having the following structures:
2 Strome et al., US 8,680,237 B2, issued Mar. 25, 2014 (‘Strome”). Strome
claims priority to three provisional applications, No. 60/941,644 filed June
1, 2007 (“1st Provisional”), No. 61/015,127, filed Dec. 1, 2007 (“2nd
Provisional”); and No. 61/015,547, filed Dec. 20, 2007 (“3rd Provisional.”).
3 The parties have referred to Figures 1A and IB of the 1st Provisional as
Figure 1. We shall refer to both Figures in the same way.
4 Appellants concede that their Declaration of Prior Invention under 37
C.F.R. § 1.131, filed June 18, 2014, does not show conception prior to June
1, 2007. See Appeal Br. 8-9 (“Only the Strome first provisional application
qualifies as prior art.”). Therefore we need not address the sufficiency of the
Declaration.
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Appeal 2016-003408
Application 12/629,136
First Fc domain Linking domain Second Ft domain
{hinge-CM2-CH3} {hinge} {hinge-CH2-Cn3}
First Fc domain Linking domain Second Fc domain
{hinge-CH2} {hinge} {hinge*CH2}
First Fc domain Linking domain Second Fc domain
{hinge-C^-CnS} ■{hinge} {hinge-Cj+a}
First Fc domain Linking domain Second Fc domain
{hinge-CnS} {hinge} {hinge^M2-C*s3}
Appeal Br. 20. Appellants argue that none of these structures match the
structure required by the present claims in which the first Fc domain is
linked directly to the second Fc domain using the hinge present in the second
FC domain. Appeal Br. 20-22. Appellants also argue that Figure 1 of the
1st Provisional is an obvious error in that it is inconsistent with the
description in the Specification and that one skilled in the art would
recognize the error and disregard the teachings of Figure 1. Appeal Br. 22-
26.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF1. Strome claims priority to U.S. Provisional Appl. No.
61/015,547, filed Dec. 20, 2007, U.S. Provisional Appl. No. 61/015,127,
filed Dec. 19, 2007 and U.S. Provisional Appl. No. 60/941,644, filed Jun. 1,
2007.
4
Appeal 2016-003408
Application 12/629,136
FF2. The Examiner finds that Figure 1 of the 1st Provisional discloses
a peptide having the structure hinge-CH2-CH3-hinge-CH2-CH3. Final Act.
10, 1st Provisional Fig. 1(A+B).
FF3. Figure 16 of Strome is the same as Figure 1 in the 1st
Provisional. Strome, Fig. 16.
FF4. Claim 89 recites a peptide having the structure hinge-CH2-Ch3-
hinge-Ch2-Ch3. Appeal Br. 6.
FF5. The Examiner finds that the peptides disclosed in Strome would
“inherently form dimer upon expression and purification.” Ans. 8.
FF6. The 1st Provisional teaches that “we have designed a dimeric Fc
construct consisting of an Fc domain and hinge region from human IgGi
attached in series to a second IgGi domain (Figurel).” 1st Provisional 8,11.
5-6.
FF7. The 1st provisional describes Figure 1 as “a representative
sequence for an immunologically active biomolecule. Specifically it is an
IgG 1 Fc domain construct without epitope tags. This construct will express
a secretory signal peptide followed by the first Fc region and then the second
Fc.” 1st Provisional 2.
FF8. The 1st Provisional teaches that the “Fc domains may be
directly crosslinked to each other.” 1st Provisional 6,11. 20-21.
FF9. The 1st Provisional teaches that “[i]n a preferred embodiment,
the linking domain may be an intervening peptide sequence in a continuous
{Fc domain 1} {linking domain} {Fc domain 2} polypeptide sequence.” 1st
Provisional 7,11. 21-22.
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Appeal 2016-003408
Application 12/629,136
FF10. The 1st Provisional teaches that the linking domain may
comprise an immunoglobulin hinge region including those native from
hlgGi 4. 1st Provisional 7,11. 25-27.
FF11. The Specification teaches that the claimed peptide segments
“spontaneously dimerize to form dimers.” Spec. ^ 234.
Principles of Law
A person shall be entitled to a patent unless -
(e) the invention was described in (1) an application for
patent, published under section 122(b ), by another filed in the
United States before the invention by the applicant for patent or
(2) a patent granted on an application for patent by another filed
in the United States before the invention by the applicant for
patent, except that an international application filed under the
treaty defined in section 351(a) shall have the effects for
purposes of this subsection of an application filed in the United
States only if the international application designated the
United States and was published under Article 21 (2) of such
treaty in the English language.
35U.S.C. § 102(e).
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
Analysis
A preponderance of the evidence supports the Examiner’s conclusion
that claim 895 is anticipated by Strome. Strome discloses a peptide having
5 Claims 90-92 have not been argued separately and therefore fall with
claim 89. 37 C.F.R. § 41.37(c)(l)(iv).
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Appeal 2016-003408
Application 12/629,136
the same structure as recited in claim 1 with the exception of being
dimerized. FF2—4. The peptide of Strome would inherently form dimers
like those recited in claim 89. FF5 and 11. The claimed peptide structure is
disclosed in the 1st provisional which predates Appellants’ application. FF1-
5. Thus the 1st Provisional of Strome anticipates claim 89.
Appellants argue that Strome only teaches linear peptides and does
not teach the dimer structure recited in the claims. Appeal Br. 13. We are
unpersuaded. As discussed above, the peptides disclosed in Strome, in
particular the peptide in Figure 1 of the 1st Provisional, are structurally
similar to those recited in the claims. As taught by the present Specification,
those peptides spontaneously dimerize to form the claimed dimers. FF11.
Therefore one would expect the peptides in Strome to dimerize absent
evidence to the contrary. “Where ... the claimed and prior art products are
identical or substantially identical. . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. . . . [The] fairness [of the burden-
shifting] is evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255
(CCPA 1977). Appellants have offered no credible rebuttal evidence that
the peptides of Strome do not dimerize to form the polypeptide structure of
claim 89.
Appellants contend that the teachings of the 1st provisional application
are limited to peptide structures where a linker is inserted between the first
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Application 12/629,136
FC segment and the hinge of the second Fc segment. Appeal Br. 20. We are
unpersuaded. The Examiner has found that Figure 1 of the 1st Provisional
discloses a peptide where the first Fc fragment is linked to a second Fc
fragment via the hinge in the second Fc fragment. FF2. As discussed
below, this is consistent with the teachings of the 1st provisional that the Fc
fragments can be directly crosslinked and that a hinge from the same
subclass as the Fc fragment can be the linking domain. FF6 and FF8-10.
Appellants do not contest that Figure 1 of the 1st provisional
application discloses the recited peptide, but argue that it should be
disregarded as an obvious typographical error or misprint. Appeal Br. 22-
26. We do not agree that there was “an obvious typographical error or
misprint.” Rather, we agree with the Examiner that
[gjiven that provisional 1 recites an immunologically active
biomolecule in Figure 1 (e.g. see claim 14), that the Fc domains
can be linked to each other directly, and that the hinge is the
preferred linking domain, Figure 1 in provisional 1 is not an
typographic error in missing an additional hinge between the
first Fc domain and the second Fe domain. This is because the
two Fc domains can be linked directly and that the second Fc
domain already has a hinge region which is the preferred
linking domain as disclosed by provisional 1; the hinge-CH2-
CH3-hinge-CH2- CH3 has complete Fc region capable of
binding FcyRs. In addition, Figure 1 of provisional 1 is an
exemplified embodiment of the prior art because this Figure is
conserved in provisional 2 and in Strome et al. (US Patent
8,680,237).
Ans. 8.
Appellants argue that 1st Provisional Application Figure 1 must be in
error in that the teachings of the 1st Provisional call for the first Fc fragment
to be bound to the second fragment through two hinges. Appeal Br. 22. In
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Appeal 2016-003408
Application 12/629,136
support of this argument, Appellants offer the Declaration of Dr. Mosser6,
one of the inventors. Id. We find this argument unpersuasive as Dr. Mosser
does not consider the specific teaching in the 1st Provisional that the two Fc
regions can be directly crosslinked and the implication of that teaching in
conjunction with the 1st Provisional’s additional teaching that the linker can
be the hinge region from the native hlgGi. FF9 and 10. The structure is
consistent with the description of Figure 1 found in the 1st Provisional. FF6
and 7.
Appellants cite to In re Yale, 434 F2d 666 (CCPA 1970) to support
the proposition that Figure 1 is in error and should be disregarded. Appeal
Br. 25. We are not persuaded. We have considered the alleged
inconsistencies recited by Appellants and agree with the Examiner that they
do not clearly indicate the Figure 1 is an error. As discussed above and as
noted by the Examiner, the disclosure of the 1st Provisional supports the
conclusion that Figure 1 describes a peptide having the structure hinge-CH2-
CH3 -hinge-CH2 -CH3.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiners conclusion the claim 89 is anticipated by Strome under 35 U.S.C.
§ 102(e).
6 Declaration under 37 C.F.R. §1.132, filed June 2, 2014.
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Appeal 2016-003408
Application 12/629,136
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
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