DETAILED ACTION
Applicant’s response filed 05/18/2026 has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied.
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 .
Status of the Claims
Claims 1-17 and 19 are pending and under consideration in this action. Claim 18 was canceled in the amendment filed 05/18/2026.
Priority
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, lnc.(38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)).
The disclosure of the prior-filed application, Application No. 63/040,379, 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. The provisional application (63/040,579) lacks support for claims 15-16 in the specification. There is not support for the therapeutic agent being a cancer drug or cytotoxic drug, or for the target protein being a tumor antigen. Accordingly, claims 15-16 are not entitled to the benefit of the prior application. The effective priority date of claims 1-14, 17, and 19 is 06/17/2020 and the effective priority date of claims 15-16 is 06/16/2021.
Response to Arguments of Priority
1. Applicant argues that all of the pending claims receive the benefit of benefit of Provisional Application Ser. No. 63/040,379, filed June 17, 2020.
It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
Applicant did not provide any support showing pending claims 15 and 16 have support in the provisional application. The provisional specification and/or drawings do not provide support for the terms "cancer'', "cytotoxic", "tumor", or "tumor antigen", as these terms are either not present or only present in the list of provisional references. Therefore, the effective priority date of claims 1-14, 17, and 19 is 06/17/2020 and the effective priority date of claims 15-16 is 06/16/2021.
Claim Rejections - 35 USC § 112(a)
The rejection of claims 1-19 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in view of Applicant’s amendments to the claims filed 05/18/2026 and Applicant’s remarks were found persuasive (Applicant’s Remarks, Pg. 5-12). Specifically, as amended, claim 1 recites the use of existing small molecule-target protein crystal structures and docking steps which are fully enabled by the Specification (see at least Para. [0037], [0048], and [0052]-[0053]).
The rejection of claims 1-19 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendments to the claims filed 05/18/2026 and Applicant’s remarks were found persuasive (Applicant’s Remarks, Pg. 12-18). Specifically, as amended, claim 1 recites the use of an existing small-molecule-target protein crystal structure, and accordingly Applicant had possession of the methods to produce the designed antibody-small molecule conjugate.
The rejection of claim 18 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of Applicant’s cancelation of claim 18 in the amendment filed 05/18/2026 (Applicant’s Remarks, Pg. 18).
Claim Rejections - 35 USC § 112(b)
Newly Recited Rejections
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly recited and necessitated by claim amendment.
Claim 1 recites the limitation “wherein the docking comprises one or more of: i) obtaining interface statistics of known antibody-target protein complexes; and ii) computationally filtering the docked structures with the interface statistics of the known antibody-target protein complexes” in step (b) of the claim. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. As currently recited, the docking may comprise (i) or (ii) or (i)+(ii). However, step (ii) requires the completion of step (i), because it uses the interface statistics of the known antibody-target protein complexes obtained in step (i). Said differently, if step (i) was not completed, the interface statistics of the known antibody-target protein complexes would lack antecedent basis. Therefore, it appears that the docking requires both steps (i) and (ii), and not one or more of the steps, as currently recited. Examiner suggests amendment of claim 1 to recite: “wherein the docking comprises” in step (b) of the claim. Claims 2-17 and 19 are also rejected due to their dependency on claim 1.
Claim 1 also recites the limitation “computationally screening against each residue of the complementarity-determining (CDR) loops of the modeled antibody to locate: i) conjugation sites with optimal bond-forming favorability with the low energy conformer of the small molecule-linker arm” in step (d) of the claim. The term “optimal bond-forming favorability” is a relative term which renders claim 1 indefinite. The term “optimal bond-forming favorability” is not defined by the claim, the Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Specification (see at least Para. [0039]) discloses that based on the finalized antibody binding conformation, the small molecule with the selected linker arm can be diversified to create a range of possible conformations. Para. [0039] further reiterates the claim language by disclosing that each generated conformer can be computationally screened against each residue of the complementarity determining region (CDR) loops of the modeled antibody to identify (1) conjugation sites with optimal bond-forming favorability with the low-energy conformer of the small molecule-linker arm and (2) conjugation sites with minimal clash with the small-molecule linker arm. However, it is unclear what parameters are required to determine the optimal bond-forming favorability, such as, for example, a specific atom type, binding distance, angle, or dihedral associated with the bond. Additionally, the “low-energy conformer” and “small molecule-linker arm” lack antecedent basis, since there is no prior mention of the low-energy conformer or the linker arm earlier in the claim. Examiner suggests amendment of claim 1 to clarify the definition of “optimal bond-forming favorability” (e.g., by including a specific atom type, binding distance, angle, or dihedral, etc.) and amendment of claim 1 to recite “… with a low energy conformer of a small molecule-linker arm” or similar to overcome the lack of antecedent basis. Claims 2-17 and 19 are also rejected due to their dependency on claim 1.
Claim Rejections - 35 USC § 101
The rejection of claims 1-19 under 35 U.S.C. 101 as being directed to an abstract idea without significantly more is withdrawn in view of Applicant’s amendments to the claims filed 05/18/2026 and Applicant’s Remarks were found persuasive (Applicant’s Remarks, Pg. 19-22). Claims 1-17 and 19 were examined under 35 U.S.C. 101 and it was found that the additional elements recited in steps (a)-(d) and (f) of independent claim 1, when viewed in combination under Step 2B amount to significantly more than the judicial exception. When considered as an ordered combination, steps (a)-(d) and (f) transform the claimed judicial exception into a patent eligible application. Thus, the claims amount to significantly more than the recited judicial exception.
Conclusion
No claims allowed.
Claims 1-17 and 19 appear to be free of the prior art because the prior art does not fairly suggest or teach the docking of antibody structures with different CDR conformations onto a crystal structure of a small molecule protein complex, as disclosed in the Conclusion section of the Office action mailed 10/23/2025.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687
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