DETAILED ACTION
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 .
Response to Amendment
Claims 2-3, 5, 7, 9-10, and 15-16 have been cancelled. Claims 1, 4 and 6 have been amended as requested in the amendment filed on 23 July 2026. Following the amendment, claims 1, 4, 6, 8, and 11-14 are pending in the instant application.
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 4, 6, and 8 are under examination in the instant office action. Applicant has elected the species of CTLA4 and ADCC for prosecution upon the merits.
Withdrawn rejections:
As currently amended, the rejection of Claims 1, 4, 6, and 8 under 35 U.S.C. 112(a) written description requirement, is withdrawn. Applicant has presented evidence of antibodies that bind a cell surface marker of a Treg, wherein the cell surface marker of the Treg is selected from the group consisting of CCR8, CCR4, CTLA4, CD25, TIGIT, OX40, ICOS, CD38, GITR, 4-1BB, NRP1, and LAG-3. One need not describe what was known in the art
Claim Rejections - 35 USC § 112 (Maintained)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
As currently amended, Claims 1, 4, 6, and 8 stand as are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, as applied to Claims 1-9 and 16 in the previous action. Briefly, while being enabling for the Treg depleting anti-CTLA4 in combination with the LTBR agonist of VHH-16 (pg. 56, Example 7), does not reasonably provide enablement for any other combination comprising a Lymphotoxin Beta Receptor (LTBR) agonist; and a regulatory T cell (Treg) depletor antibody.
On pages 9-14, Applicant traverses this rejection on the following grounds.
Applicant argues Examples 6 and 7 provide evidence of combined LTBR agonistic antibody (VHH-16) and two Treg-depleting antibodies against two markers (CCR8 and CTLA4). Applicant asserts that the presence of only a few working examples is not a per se bar to enablement, and further asserts that the Office is too stringently applying Amgen v. Sanofi, which was directed to a composition (pg. 10). Applicant argues that Teva v. Eli Lilly (Fed Circuit 2026) enablement was reinstated for a single exemplary humanized antibody species when the claims recited a genus. Lastly, under the Wands Factors, Applicant argues that while biotechnology is generally unpredictable, generation of antibodies is entirely predictable, conventional and highly standardized (pg. 11).
While all these arguments have been reviewed in full, they are not persuasive for the following reasons. The Teva case law does not supersede the guidance provided by the Supreme Court, so until Teva has been considered by the higher court, the Office will continue to apply the Amgen v. Sanofi guidance. Therefore, Applicants arguments based on Teva are moot (pgs. 10-11). Secondly, while the claims in Amgen were directed to an antibody per se, TC1600-specific training (Examples 5-7, guidance dated 6/3/19) nevertheless requires examiners to apply this case law to method claims comprising any antibody. Regardless, the instant claims are directed to a combination or composition of matter, so Applicant’s arguments that the Amgen case law is not applicable are moot. Regarding the predictability of antibodies, the Supreme Court itself has said “An antibody’s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.’ Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12. Despite recent advances, aspects of antibody science remain unpredictable.”
The standard of an enabling disclosure is not the ability to make and test if the invention works but rather the ability to make and use with a reasonable expectation of success. While the working examples 6 and 7 provide evidence of combined LTBR agonistic antibody (VHH-16) and two Treg-depleting antibodies against two markers (CCR8 and CTLA4), the amount of further experimentation goes beyond just selecting another alternative from the closed Markush group of 12 targets (as Applicant asserts, Remarks pg. 11 at “Level of Ordinary Skill”). The Examiner agrees that selecting a target other than the exemplified CCR8 and CTLA4 is routine, but the instant specification is not enabling because one cannot follow the guidance presented and make and use the composition of matter claimed, without first making a substantial inventive contribution. Therefore, Claims 1, 4, 6, and 8 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Claim Rejections - 35 USC § 103 (Maintained)
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
As amended, Claims 1, 4, 6, and 8 stand as rejected under 35 U.S.C. 103 as being unpatentable over US PGPub 2006/0104971 A1 published 18 May 2006 (hereafter Garber et al.) in view of Selby et al. 2013, NPL citation No. 3 on the IDS filed 1 June 2023.
Applicant traverses the rejection on the grounds that Garber teaches multivalent LTBR agonist antibody constructs for use in cancer (Remarks pg. 12, last paragraph). Selby teaches antitumor anti-CTLA4 antibodies (title and abstract). Applicant asserts the combination of references does not teach or suggest combining the two elements.
This is not persuasive because In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) expressly states that it is prima facie obvious to combine two things that are useful for the same purpose, namely, two antitumor compositions, into a single composition of matter. No specific teaching or suggestion is needed for said combination because the idea of combining them flows logically from their having been individually taught in the prior art as useful for the same purpose.
Therefore, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.N.M/Examiner, Art Unit 1675
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
