Prosecution Insights
Last updated: April 19, 2026
Application No. 17/969,021

METHOD AND SYSTEM FOR STRUCTURE-BASED DRUG DESIGN USING A MULTI-MODAL DEEP LEARNING MODEL

Non-Final OA §102§112§DP
Filed
Oct 19, 2022
Examiner
WOITACH, JOSEPH T
Art Unit
1687
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Tata Consultancy Services Limited
OA Round
1 (Non-Final)
49%
Grant Probability
Moderate
1-2
OA Rounds
4y 8m
To Grant
78%
With Interview

Examiner Intelligence

Grants 49% of resolved cases
49%
Career Allow Rate
187 granted / 381 resolved
-10.9% vs TC avg
Strong +28% interview lift
Without
With
+28.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 8m
Avg Prosecution
71 currently pending
Career history
452
Total Applications
across all art units

Statute-Specific Performance

§101
35.0%
-5.0% vs TC avg
§103
18.7%
-21.3% vs TC avg
§102
4.2%
-35.8% vs TC avg
§112
25.4%
-14.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 381 resolved cases

Office Action

§102 §112 §DP
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. Claim Status Claims 1-15 filed 10/19/2022 are pending and currently under examination Priority This application filed 10/19/2022 claims benefit to foreign applications IN202121052045 filed 11/12/2021 in India. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See electronically retrieved copy entered 12/28/2022. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/19/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claims 1-15 are objected to because of the following informalities: in revie, there appears to be nine typographical errors in the claims of ‘ atleast ’ which should be corrected to two separate words ‘at least’. Appropriate correction is required. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/385604 (not docketed). Although the claims at issue are not identical, they are not patentably distinct from each other because each are directed to a method and products that provide the same steps of using SMILES s-VAE to design small molecules. Claim 1 of ‘604 is provided for comparison to the pending claims: A processor-implemented method comprising: receiving, via an input/output interface, a gene expression profile in a cell-specific manner as an input and a dataset of molecules from a predefined drug-like small molecule database; pre-processing, via the one or more hardware processors, the received dataset of molecules to obtain a training dataset of molecules; jointly training, via the one or more hardware processors, a simplified molecular input line entry system (SMILES) variational autoencoder (s-VAE) and a profile variational autoencoder (p- VAE) with the obtained training dataset of molecules; and generating, via the one or more hardware processors, one or more conditional novel small molecules in SMILES format from the received gene expression profile using trained s-VAE and p- VAE. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. In an inventor search several applications and patent s were identified that were generally directed to predicting protein structure, see for example 16/631333, 17/137001, 18/752455 and 18/429185, however the specific steps of the analysis required different input data and analysis steps do not appear obvious over the present claims. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are ‘hardware processors’ required of all the claims. More specifically, the method claims set forth that they are configured or are capable of performing each and any of the steps of analysis of the method, and the system claims and memory consistently provide a connection between the hardware processor and the analysis steps. In review of the specification, the literal support is acknowledged, and it appears that no unique type of processor is required for any of the steps and can be interpreted to be a general purpose computer. Additionally, the claims recite and encompass the use of a ‘conditional module generator’ ( see claim 1 final step used for designing ) and a ‘drug-target affinity predictor module’ (see claim 1 step using it to concatenating vectors of an active site) . Review of the specification does not provide any specific structure function for any specific type of physical ‘module’ and it appears that the module is directed to the instructions or coding necessary for the computer to perform the task. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claims 1-15 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. Specifically, claims 2 , 7 and 12 provide for parenthetical ( zg ), (zs) and (z) , and it is unclear if these are meant as descriptors of the terms that precede them or possible examples meant to limit the graph, string or vector is some formative way. In review of the specification, these are not specifically defined in a limiting way, and review of the art of record does not suggest these are understood terms of art. Additionally, the claims recite and encompass the use of a ‘conditional module generator’ and a ‘drug-target affinity predictor module’ , and in the review of the specification these do appear to be defined, nor does the art of record each that these are limitations known in the art. The metes and bounds of the claims are unclear and undefined as the claims rely on modules which do not physically exist, and to the extent they are simply instructions, they do not provide adequate guidance or outcomes for what is to be performed in each of the corresponding steps using the modules to establish a metes and bounds to what these limitations comprise. More clearly providing the basis of these terms or deleting them would address the basis of the rejection. Dependent claims rely on the interpretation of these terms and fail to clarify the issue and included in the basis of the rejection. Claim Rejections - 35 USC § 102 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 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. Claim s 1-15 are rejected under 35 U.S.C. 102 a as being anticipated by Krishnan et al. ( November 2021 ). Krishnan et al. provide the basis of d e n ovo s tructure- b ased d rug d esign using deep learning. More specifically, Krishnan et al. provide for a semi - supervised multimodal deep learning model utilizing a graph representation of the protein binding sites and SMILES representation of the ligand to structure. The graph and SMILES models are combined to form a target-specific molecule generator, which is subject to a short retraining phase prior to further optimization. Next, a multimodal drug-target affinity (DTA) prediction model is used to formulate a reward function for target-specific bioactivity maximization, which is utilized as the objective to optimize the molecule generation process in a reinforcement learning framework. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Joseph T Woitach whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0739 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri; 8:00-4:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Karlheinz R Skowronek can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571 272-9047 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Joseph Woitach/ Primary Examiner, Art Unit 1687
Read full office action

Prosecution Timeline

Oct 19, 2022
Application Filed
Mar 05, 2026
Non-Final Rejection — §102, §112, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
49%
Grant Probability
78%
With Interview (+28.5%)
4y 8m
Median Time to Grant
Low
PTA Risk
Based on 381 resolved cases by this examiner. Grant probability derived from career allow rate.

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