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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/22/2025 has been entered.
Applicants Amendment
Applicants’ amendment filed 8/22/2025 has been received and entered. Claim 1, 15, 23 and 27 have been amended.
Claims 1-30 are pending.
Election/Restrictions
Applicant’s election of species A and the method of claim 1 in the reply filed on 11/22/2021 was acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As outlined below, claims 1, 8-15, 22-27, 30 are directed to subject matter that is allowable in view of the issues raised during prosecution, except for a new issue of double patenting resulting from a newly filed application.
The restriction requirement as set forth in the Office action mailed on 11/22/2022, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, claims 2-7, 16-21, 28-29 are no longer withdrawn from consideration because the claim(s) are dependent and requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-30 are pending and currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/8/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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).
Claims 1-30 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/339520 (non-final mailed 12/6/2023) is withdrawn.
The terminal disclaimer filed 8/22/2025 has been received and APPROVED (see decision entered 9/3/2025).
Claims 1,8-15, 22-27, 30 rejected on the grounds of nonstatutory double patenting as being unpatentable over reference claims in patents 11,049,590 (application 16/870,611) and 11,462,304 (application 17/339,422) in view of Sadiq (of record) is withdrawn.
Response to Applicant’s arguments
Applicants note the requirements of the claims, and the failure of Sadiq to provide evidence that this an obvious equivalent or broader limitation in view of the teachings.
In review of the amended claims and claim limitation requirements, it is agreed that the specific limitations set forth in the claims are not obvious, nor does Sadiq provide sufficient evidence that the two claim sets are obvious over each other in light of the differences in limitations.
Accordingly, the rejection is withdrawn.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/377874 (filed 11/3/2025)
In an update inventor and applicant search, application 19/377874 was identified. Application ‘874 is a continuation of US Patent 12,462902, application 17/339520, and provides claim limitations as a continuation consistent with the parent. While there is a terminal disclaimer filed for the parent, this does not address the nonsatutory patenting issue between the instant claims and those newly presented and pending.
This is a provisional nonstatutory double patenting rejection.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 8-15, 22-27, 30 rejected under 35 USC § 101 because the claimed invention is directed to non-statutory subject matter is withdrawn.
Claim analysis
Claims 1, 15, 23 and 27 have been amended and are still generally directed to a computer implemented method of assessing candidate compounds by training AI models by using structure and physiochemical structures. The claims have been amended consistently to add the limitation that the process provides for a reduced set of candidate drug compounds through each iteration. The claims provide for complex data representing the candidate products as ‘vector representation’ and using structures to assess “using at least the effectiveness of the first candidate drug compound,” prior to the step of “training, by the one or more processing device..” and provide the same steps previously analyzed which set forth the use of AI to generate a protein sequence based on vector representation by compressing a higher order dimension level to a lower order dimensional level to reduce processing complexity. The claims encompass any protein serving as a broad non-specific drug compound without any specific indication of the purpose, property or effect of the drug seemingly for any or all conditions possibly treatable by a protein. The claim does not set forth any specific rules or guidance on how the steps are of the claim are to be practiced, the specification teaches that algorithms such as SMILES genetic algorithm, graph GAMonte-Carlo tree search and other known protein analysis algorithms can be applied (see [01024] and Figure 1G and 5C for example).
Comprised within the breadth of claims would be assessing a known protein with a known property, for example an antibody which targets an antigen and asking if a modification at the CDR would affect the binding and consequentially the potential effect of the change, or modifying the active site of an enzyme making in inactive. The specification does not have any specific examples or any specific guidance on the various elements required to practice ‘real world’ outcomes and relies completely on the literature research and screening for inputs, comparisons and possible target outcomes as evidenced by figure 1C for example.
Response to Applicants Arguments
Applicants assert the claims are rooted in computer technology and provide a practical application, more specifically that the compressing the vector representations for biological data is not a process that could be performed in one’s mind is not an abstract idea.
In response, upon review of the amended claims, Applicants comments and review of the specification, it is agreed that claims provide data and data processing which can not be performed manually and is tied to the computer technology.
Conclusion.
No claims are allowed.
The closest art of record demonstrates that computer implemented methods to analyze candidate drug compounds were known and as evidenced by Hodgkin (1994) and Peiretti et al. (2018) that the idea of using Artificial Intelligence in organic chemistry provide a review for the use of artificial intelligence in drug design. Similarly, Guney et al. teach AI-enhanced drug optimization applied to the repurposing of existing drugs in new indications, while Vamathevan et al. (2019) teach that all stages of drug discovery and development utilize artificial intelligence and machine-learning algorithms and software to identify novel targets, provide stronger evidence for target–disease associations, improve small-molecule compound design and optimization, develop new biomarkers for drug efficacy. While the art provides the general support for the use of AI in drug analysis, it fails to provide the analysis steps set forth in the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R Skowronek can be reached on 571 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joseph Woitach/ Primary Examiner, Art Unit 1687