DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-29, 35, 40 and 82 are pending.
3. Applicant's election with traverse of the invention of Group I, and election without traverse of the species of anti-4-1BB antibody comprising CDRs of SEQ ID NOS: 153-158, in the reply filed on 02/19/2026 is acknowledged.
Applicant’s grounds for traversal are as follows:
“Traversal of the requirement is based on the inconsistency between the present requirement and that advanced in the parent application. Specifically, applicant submits the requirement should be applied to different categories of claims, i.e., methods versus compositions of matter, as in the parent application, while the various antibodies/antibody combinations are more appropriately advanced as species elections, again as in the parent application.”
Upon reconsideration, the restriction requirement and species election requirement are modified as suggested by applicant:
Restriction Requirement
Group I. Claims 1-29 and 40, drawn to a method of treating cancer comprising administering a Treg depleting antibody and an immunostimulatory antibody, classified in A61K39/395, for example.
Group II. Claims 35 and 82, drawn to an anti-OX40 antibody and nucleic acid encoding the antibody, classified in C07K16/28, for example.
Species Election Requirement
4-1BB and 4-1BB,
4-1BB and OX40,
4-1BB and ICOS,
4-1BB and GITR,
4-1BB and CD25,
4-1BB and PD-1, PDL1 or CTLA4,
OX40 and 4-1BB,
OX40 and OX40,
OX40 and ICOS,
OX40 and GITR,
OX40 and CD25,
OX40 and PD-1, PDL1 or CTLA4,
TNFR2 and 4-1BB,
TNFR2 and OX40,
TNFR2 and ICOS,
TNFR2 and GITR,
TNFR2 and CD25,
TNFR2 and PD-1, PDL1 or CTLA4,
GITR and 4-1BB,
GITR and OX40,
GITR and ICOS,
GITR and GITR,
GITR and CD25,
GITR and PD-1, PDL1 or CTLA4,
ICOS and 4-1BB,
ICOS and OX40,
ICOS and ICOS,
ICOS and GITR,
ICOS and CD25,
ICOS and PD-1, PDL1 or CTLA4,
CTLA-4 and 4-1BB,
CTLA-4 and OX40,
CTLA-4 and ICOS,
CTLA-4 and GITR,
CTLA-4 and CD25,
CTLA-4 and PD-1, PDL1 or CTLA4,
CD25 and 4-1BB,
CD25 and OX40,
CD25 and ICOS,
CD25 and GITR,
CD25 and CD25,
CD25 and PD-1, PDL1 or CTLA4,
neuropilin-1 and 4-1BB,
neuropilin-1 and OX40,
neuropilin-1 and ICOS,
neuropilin-1 and GITR,
neuropilin-1 and CD25,
neuropilin-1 and PD-1, PDL1 or CTLA4,
Applicant’s election, as applied to the modified restriction requirement, reads on election of Group I and Species (i). In the interest of compact prosecution, the embodiment of Species (xxx) has been fully examined for patentability under 37 CFR 1.104.
Applicant did not traverse the restriction between the inventions of Groups I and II, as identified herein above, which is therefore made FINAL.
4. Claims 2, 13-15, 23-26, 35 and 82 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions and Species.
Claims 1, 3-12, 16-22, 27-29 and 40 are presently under consideration, to the extent that they read on the elected Species.
5. Claims 28 is objected to because of a typographical error in the word “tremilimumab.”
6. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
7. Claims 10, 20 and 29 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for an anti-4-1BB antibody comprising the six CDRs identified by the recited amino acid sequences, does not reasonably provide enablement for an anti-4-1BB antibody comprising fewer than six of the CDRs. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without undue experimentation.
Claim interpretation: the recitation “1-6 of the CDRs selected from SEQ. ID. NOs: 1-6” is interpreted as “from one to six CDRs selected from SEQ ID NOS: 1-6.” Accordingly, the claims read on antibodies comprising a single CDR region.
The state of the art recognizes that in most cases, the CDR3 region of the heavy chain is the primary determinant of antibody specificity, it is generally insufficient for binding to the cognate epitope with reasonable affinity (e.g. Xu et al., Immunity (2000), 13: 37-45). There do not appear to be examples of specific antibody binding mediated by single CDRs other than HCDR3, and the instant specification does not appear to provide guidance, direction, or working examples of such antibodies.
Based on this, an ordinary artisan would readily recognize that antibodies comprising less than the full complement of six CDRs would almost certainly fail to bind 4-1BB with sufficient specificity and affinity, and any experimentation with such non-functional antibodies would be unnecessary, improper, and undue.
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
9. Claims 1, 3-4, 6-7, 9 and 18-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Taniguchi et al. (US 20180171017).
Claim interpretation: Claim 1 is directed to a method of treating cancer comprising administering a Treg depleting antibody followed by administering an immunostimulatory antibody. Claims 6 and 7 depend on claim 1 and specify that the Treg depleting antibody is an anti-4-1BB antibody. Claims 18 and 19 depend on claim 1 and specify that the immunostimulatory antibody is an anti-4-1BB antibody. Accordingly, a method of treating cancer comprising administering an anti-4-1BB antibody more than once is within the scope of the claims.
Taniguchi teaches repeated administration of an anti-CD137 (i.e. anti-4-1BB) antibody (e.g. [0303]), thereby anticipating the claimed invention.
10. Claims 1, 3-5, 8, 18 and 27-28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sainson et al. (US 20190330345).
Instant claims are directed to a method of treating cancer comprising administering a Treg depleting antibody followed by administering an immunostimulatory antibody (claim 1), wherein the Treg depleting antibody is an anti-ICOS antibody (claim 8), and wherein the immunostimulatory antibody is an anti-PD-L1 antibody (claim 18).
Sainson teaches and claims a method of treating cancer comprising administering a single dose of an anti-ICOS antibody followed by multiple doses of an anti-PD-L1 antibody (e.g. claims 1, 38, 40, 41, 58 and 59), wherein the anti-ICOS antibody is a human IgG1 antibody (e.g. claims 1, 18, 19 and 22), and wherein the anti-PD-L1 antibody is atezolizumab (e.g. [0267]), which is within the scope the instant claims.
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1, 3-7, 9-12, 16-22, 27-29 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11447549.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 3-7, 9-12, 16-18, 27-29 and 40 are anticipated by the claims of US ‘549, and instant claims 19-22 are anticipated by or obvious over the claims of US ‘549.
The present application was filed as a continuation of USSN 16633740 which issued as the ‘549 patent, and as such follows the same sequence numbering.
US ‘549 claims 1 and 2 are directed to a method of depleting Treg cells in a subject having cancer, wherein an anti-4-1BB Treg depleting antibody is administered prior to administration of an anti-PD1 immunostimulatory antibody, and wherein the anti-4-1BB antibody comprises the same CDRs as recited in instant claims 10 and 29. Accordingly, US ‘549 claims 1 and 2 anticipate instant claims 1, 6-7, 9-10, and 18.
The limitations of instant claims are recited in the following US ‘549 claims:
Instant claims US ‘549 claims
3 3, 11, 12
4 4
5 5
11 6
12 7
16 8
17 9
29 10
Claim 40 is included in the rejection, because teachings of a recombinantly produced antibody inherently comprise teachings of an isolated nucleic acid encoding the antibody.
Claims 19-22 read on a method comprising administering a Treg depleting anti-4-1BB antibody followed by an immunostimulatory anti-4-1BB antibody, and as such are anticipated by or obvious over the claims of US ‘549 for the following reasons:
A Treg depleting antibody, by definition, depletes immunosuppressive Treg cells, thereby reducing immune suppression and increasing immune activity. Therefore, a Treg depleting antibody, such as an anti-4-1BB antibody, has immunostimulatory effect.
As a person of skill in the art would be aware, cancer immunotherapy, to be successful, requires more than a single administration of the respective therapeutic antibody. Therefore, a person of skill in the art would at once envisage repeated administration of anti-4-1BB antibody in view of US ‘549 claims. Alternatively, in would have been obvious to a person of skill in the art to administer anti-4-1BB antibody more than once in practicing the method of US ‘549 claims.
13. Conclusion: no claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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