Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Responsive to 5/27/2022 claim-set and 1/4/4026 election
Claims pending 1-20
Claims withdrawn 18-20
Claims currently under consideration 1-17
Priority
The present application has a filing date of 03/23/2022 and has
PRO 63/165,651 filed 03/24/2021.
Election/Restrictions
Applicant’s election without traverse of invention group I and SEQ ID 35 species in the reply filed on 1/4/4025 is acknowledged.
Claims 18-20 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/4/2025
The requirement is still deemed proper and is therefore made FINAL.
Applicant's elected species was not found in the prior art, so the search was expanded to the extent set forth below.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-2,4-8 are rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Sheng et al (US AppPub 20180185482).
As in claims 1,2,4,5,6,7 and 8, Sheng et al teach throughout the document and especially SEQ ID 45 therein (RASQSIRRYLN), figures 3A,4C and example 4 table 3, a antibody fragment or monoclonal antibody (T-10 = VH SEQ ID 125 + VL SEQ ID 126) comprising an amino acid sequence 100 % identical to that set forth in present SEQ ID 998 and has a TIGIT dissociation constant of less than 10 nanomolar.
Claims 9,10,12,13 are rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Tabibiazar et al (WO 2020/0176678).
As in the first embodiment of claim 9 and claims 10,12 and 13, Tabibiazar et al teach throughout the document and especially document claim 35, SEQ ID 2538 therein from table 27 that is an antibody comprising an immunoglobulin heavy chain comprising an amino acid sequence 88% (interpreted as at least about 95%) identical to present SEQ ID 35 that may be optionally a chimera.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2,4-8 & 9,10,12,13 and 11,14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tabibiazar et al (WO 2020/0176678 in view of Sheng et al (US AppPub 20180185482).
Like claims 9,10,12 and 13, Tabibiazar et al teach throughout the document and especially document claim 35, SEQ ID 2538 therein from table 27 that is a GLP1R antibody comprising an immunoglobulin heavy chain comprising an amino acid sequence 88% (interpreted as at least about 95%) identical to present SEQ ID 35 that may be optionally be a chimera or be part of a bi-specific antibody.
Tabibiazar et al do not teach: an antibody fragment that binds TIGIT with a KD of less than 10 nanomolar such as recited as the second embodiment of claim 9 and claims 14-17; nor a sequence set forth in present SEQ IDs 62-1864 of claim 11.
Sheng et al is relied upon as above regarding claims 1-2,4-8 as well as suggesting an antibody heavy chain including RASQSIRRYLN (present SEQ ID 998) that binds TIGIT with a KD of less than 10 nanomolar per claims 9,14,15,16,17 and 11, since akin to Tabibiazar et al, Sheng et al teach the disclosed antibodies may be likewise humanized from a llama (which inherently have only a heavy chain) or otherwise constitute a light chain-heavy chain fusion (cf paragraphs 0060-0061) and/or are preferably bi-specific.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared a bi-specific antibody including both a TIGIT Fv from Sheng et al and a GLP1R Fv from Tabibiazar et al.
One of ordinary skill in the art would have prepared a bi-specific antibody including both a TIGIT Fv from Sheng et al and a GLP1R Fv from Tabibiazar et al in an effort to treat cancer, which the goal of each reference (see Tabibiazar paragraph 0141 and Sheng paragraphs 0002-0006). Indeed, as interpreted in MPEP 2144.06 the courts have held "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
One of ordinary skill in the art would have had a reasonable expectation of success in making a bispecific antibody bearing a TIGIT Fv from Sheng et al and a GLP1R Fv from Tabibiazar et al since each reference expressly envision such an embodiment in the aforementioned passages.
Claim Objections
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684