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 .
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.
DETAILED ACTION
Claims 276-278 and 284-297 are pending in the instant application. Note, newly added claims 288-289 are erroneously presented as “previously presented,” in actuality, claims 284-297 are newly added.
Priority
This application is a 371 of PCT/US2022/026708, filed on filed on 4/28/2022 which claims priority to the provisional applications 63318960 filed on 3/11/2022; 63301940 filed on 1/21/2022; 63289573 filed on 12/14/2021; 63238360 filed on 8/30/2021; and 63180827 filed on 4/28/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/180827, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
2021-0830
Compounds other than FSY appear for the first time in the provisional application 63/238360, thus claims 276-278 and 284-295 have a priority date of 8/30/2021, except when FSY is the compound.
Election/Restriction
Applicant’s election without traverse of Group IV (claims 276-278, drawn to a protein comprising the structure of Formula (X) in the reply filed on 5/13/2026 is acknowledged.
After further consideration, there is no longer a search burden for the species of compounds described in claim 273, thus these species will be examined.
Applicant canceled all claims related to the other groups. Newly added claims 284-297 read on the claimed invention, thus are examined herein.
Claims 276-278 and 284-297 are examined herein.
Information Disclosure Statement
The information disclosure statements (IDS) dated 5/17/2024, 8/7/2025, 8/26/2025, 10/15/2025, and 1/29/2026 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Objections to the Specification/Drawings
Hyperlinks
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg 7, para 0019; and pg 357, para 1713. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Missing SEQ ID NOs
The specification and figures are objected to because the amino acid sequences listed
in the “Brief Description of the Figures” section and their corresponding Drawings lack SEQ ID
numbers for the following figures:
1G, 2F, 5D, 5E, 6, 7D, 11F, 11G, and 11H
Colors referred to in black and white figures
The brief description of the figures refers to Fig 1B, 1E, 1F, 2A, 2E, 2F, 5B, 5D-5E, 6, 7D, 11F-11H, 14A, 16A, 22B, 31B, 60C-60E having blue, red, yellow, magenta colors, where no color drawings were submitted.
Correction is required. See MPEP § 608.01.
Claim Interpretation
Claims 288-289 depend on canceled claim 1, for the purposes of applying art, these claims were interpreted instead as depending on base claim 276.
Objections to the Claims
Claims 277 and 287 lack a period at the end.
Claims 288-289 depend on canceled claim 1.
Correction is required. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 112(a)
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.
Claim 297 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 297
Claim 297 parts c, e, and i-o are drawn to mixed and matched combinations of CDRs. The art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. The art also recognizes that single domain antibodies are defined by only three CDRs (Muyldermans 2001), thus underlining the importance of maintaining integrity of this binding region. Due to this unpredictability, applicant cannot meet the written description requirement via providing a representative number of species. Instead applicant must provide the core structure necessary to preserve the binding properties of the ISVD’s claimed. Because applicant has not provided that for claim 297, parts c, e, and i-o, Applicant has failed to meet the written description of these variable sequences.
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.
Claims 276-277 and 285-287 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (doi: 10.1016/j.cell.2020.05.028).
Claim 276-277
Regarding claims 276-277, Li teaches incorporating the unnatural amino acid, FSY (fluorosulfate-L-tyrosine) for the purpose of generating proximity-enabled reactivity under physiological conditions (abstract; Fig 1, reproduced in part below).
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The structure of FSY satisfies the limitations of Formula (X), wherein X and Y are peptidyl moieties; L1 is CH2; and R1 is H (Fig 1), shown above. Li teaches incorporating FSY into PD-1, generating PD-1(FSY) which was able to covalent crosslinking with its ligand, PD-L1, with high specificity (pg 88, col 1, para 2; pg 89, col 1 para 2). Because PD-1 is the receptor for PD-L1, this satisfies the limitation of being a receptor protein recited in claim 277. Li teaches the PD-1(FSY) exhibits enhanced T cell activation, yielding more potent antitumor effects (abstract).
Claim 285-287
Regarding claim 285-287, Li’s structure of FSY satisfies the limitation as R1 which is hydrogen is ortho to the -O-S(O)2F group, and the -O-S(O)2F group occupies the position para to L1. Because Li teaches incorporating FSY into the middle of the protein at position 129 of PD-1, both linkages X and Y are peptidyl, satisfying claim 286. Li’s structure of FSY satisfies the limitation of L1 being an unsubstituted C1 alkylene.
Claims 276 and 278 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (doi: 10.1021/jacs.8b01087).
Claim 276, 278
Regarding claims 276 and 278, Wang teaches incorporating the unnatural amino acid, FSY (fluorosulfate-L-tyrosine) for the purpose of generating proximity-enabled reactivity under physiological conditions (abstract; Fig 1, reproduced in part below).
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The structure of FSY satisfies the limitations of Formula (X), wherein X and Y are peptidyl moieties; L1 is CH2; and R1 is H. Wang teaches generating a mutant tRNA to genetically encode the FSY into a protein (pg 4996, col 1 para 1-2). Because tRNA is a type of RNA chaperone, this satisfies the limitation of incorporating the UAA (Unnatural Amino Acid) of claim 276 into an RNA chaperone. Wang teaches this method successfully incorporated the FSY into PCNA (proliferating cell nuclear antigen) (pg 4997, col 1, para 1); 76TAG (pg 4997, col 2, para 1); and PAPS reductase (pg 4998, col 1, para 1). Wang teaches incorporation of FSY into PAPS reductase resulted in covalent linkage with its target, Trx1, via the SuFEx reaction in vivo (Fig 5; pg 4998, col 1, para 2).
Claim 285-287
Regarding claim 285-287, Wang’s structure of FSY satisfies the limitation as R1 which is hydrogen is ortho to the -O-S(O)2F group, and the -O-S(O)2F group occupies the position para to L1. Because Wang teaches incorporating FSY into the middle of the protein at position, both linkages X and Y are peptidyl, satisfying claim 286. Wang’s structure of FSY satisfies the limitation of L1 being an unsubstituted C1 alkylene.
Relevant Prior Art
Wang (US20210002325) also teaches incorporation of FSY into proteins, as discussed in the corresponding scientific publication (doi: 10.1021/jacs.8b01087) above. Notably, Wang teaches many modifications but doesn’t replace any of the four hydrogens on the tyrosine phenyl ring.
Park (doi: 10.1021/acs.bioconjchem.9b00340) teaches using FSY as a means of conjugating payloads to antibodies, however the structures lack the -O-S(O)2-F functional group as instantly claimed.
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Allowable Subject Matter
Claim 284
Claim 284 drawn to the compound shown below was found allowable over the prior art.
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Notably, compounds FSK, SFY, and FFY were published in 7/2/2021, 2023, and 2022, respectively (See DeFaveri doi: 10.1021/acs.chemrev.4c00181).
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Claims 288-289, drawn to L1 being a heteroalkylene or amide or carbamate, would be allowable over the prior art if dependent on claim 276.
Claim 290-293
Claims 290-293, drawn to compounds comprising R1 being a substituent other than hydrogen were also not found in the prior art.
Claim 294-296
Claims 294-296, drawn to incorporating a compound of Formula (X) into the CDR regions of an antibody were also not found in the prior art.
Absent a teaching or suggestion for generating the specifically modified tyrosine residues of Formula (X) and incorporating them into a protein, one of skill in the art would not have found it obvious to generate these compounds, excluding FSY, at the priority date.
In sum, claims 284, 288-289, 290-296 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
