DETAILED CORRESPONDENCE
Application Status
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 101-120 are pending.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 101-114 in the reply filed on 05/13/2026 is acknowledged.
4. Claims 115-120 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2026.
Claims 101-114 are pending and examined on the merits.
Priority
5. Acknowledgement is made of applicants’ claimed domestic priority to U.S. Provisional Application Nos. 63/214432 and 63/155222, filed on 06/24/2021 and 03/01/2021, respectively.
Information Disclosure Statement
6. The IDSs filed on 05/22/2025, 08/08/2025, 08/26/2025, 10/15/2025, and 01/29/2026 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Drawings
7. The Drawings filed on 08/30/2023 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 103
8. 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.
9. Claim(s) 101-109 and 111-114 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2019/173760 A1; cited on IDS filed on 08/08/2025) in view of Luo et al. (Tetrahedron, published 01/09/2020; examiner cited).
10. With respect to claim 101-102, Wang et al. teach a biomolecule comprising a fluorosulfoxybenzoyl-L-lysine [see Abstract; paragraphs 0005-0015].
With respect to claims 103-104, Wang et al. teach the biomolecule comprises a protein [see Abstract; paragraphs 0005-0015].
With respect to claim 105, Wang et al. teach wherein the protein is antibody or an antigen binding fragment (any protein can be interpreted as an antigen) [see Abstract; paragraphs 0005-0015; 0083].
With respect to claim 106, Wang et al. teach the biomolecule wherein the protein is capable of binding to a target [see Abstract; paragraphs 0005-0015, 0083, 0135].
With respect to claim 107, Wang et al. teach the biomolecule wherein the protein is capable of binding to a target on a surface of a cell [see paragraphs 0005-0015].
With respect to claims 108-109, Wang et al. teach wherein the target is a hormone receptor [see paragraph 0137].
With respect to claim 111, Wang et al. teach the biomolecule wherein the protein forms a covalent bond with the target when the target is bound [see paragraphs 0005-0015; 0187].
With respect to claims 112-113, Wang et al. teach a bacterial or animal cell comprising the biomolecule [see paragraph 0014].
With respect to claim 114, Wang et al. teach a pharmaceutical composition comprising the biomolecule [see paragraphs 0003 and 0031].
However, Wang et al. does not teach the biomolecule is a fluorosulfonylbenzoyl.
Luo et al. teach a that sulfur fluoride exchange chemistry is a new generation of click chemistry with potential in drug discovery and biological study [see Abstract]. Luo et al. further teach the synthesis of amino acid derivatives functionalized with fluorosulfonyloxy benzoic acid that are capable of forming amino acid derivatives with primary, secondary and aliphatic amines of amino acids that have potential for the development of prodrugs [see p. 2-3].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Wang et al. and Luo et al. to substitute the fluorosulfoxybenzoyl of Wang et al. with the fluorosulfonyloxy benzoic acid of Luo et al. because Wang et al. teach a biomolecule comprising a fluorosulfoxybenzoyl-L-lysine for covalent crosslinking with a target for therapeutic purposes. Luo et al. teach the synthesis of amino acid derivatives functionalized with fluorosulfonyloxy benzoic acid that are capable of forming amino acid derivatives with primary, secondary and aliphatic amines of amino acids that have potential for the development of prodrugs. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Wang et al. and Luo et al. because Luo et al. acknowledges amino acid derivatives functionalized with fluorosulfonyloxy benzoic acid are capable of forming amino acid derivatives with primary, secondary and aliphatic amines of amino acids that have potential for the development of prodrugs and would require simple substitution of one functionalized group for the other. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
11. Claim 110 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2019/173760 A1; cited on IDS filed on 08/08/2025) in view of Luo et al. (Tetrahedron, published 01/09/2020; examiner cited) as applied to claims 101-109 and 111-114 above, and further in view of Li et al. (Cancer Immunology Research, 2018; examiner cited).
12. The relevant teachings of Wang et al. and Luo et al. as applied to claims 101-109 and 111-114 are set forth above.
Regarding claim 110, Wang et al. teach the biomolecule wherein the protein is capable of binding to a target on a surface of a cell [see paragraphs 0005-0015].
However, the combination of Wang et al. and Luo et al. does not teach the biomolecule of claim 110 wherein the target is PD-1 or PD-L1.
Li et al. teach peptides are emerging as an attractive area of therapeutic agents because as potential drugs, they have many advantages [see p. 186, column 2]. Luo et al. further teach that targeting PD-1/PD-L1 interaction using PD-L1 targeting peptides have yielded impressive progress in the immunotherapy of cancers [see p. 186, column 1].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Wang et al., Luo et al. and Li et al. according to the teachings of Li et al. to target PD-1/PD-L1 because Wang et al. and Luo et al. teach fluorosulfonyloxybenzoyl biomolecules comprising peptides for therapeutic drug targets. Luo et al. teach that PD-L1 targeting peptides have yielded impressive progress in the immunotherapy of cancers. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Wang et al., Luo et al. and Li et al. because Li et al. acknowledges that PD-L1 targeting peptides have yielded impressive progress in the immunotherapy of cancers. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
13. Status of the claims:
Claims 101-120 are pending.
Claims 115-120 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 101-114 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656