DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Species C from both Species groups I and II, (claims 4, 15 and 20, and claim 8, respectively) in the reply filed on 07/22/2026 is acknowledged.
Claims 2-3, 5-7, 9-10, 13-14, 16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
Claim Status
Claims 1-20 are pending.
Claims 2-3, 5-7, 9-10, 13-14, 16, and 18-19 are withdrawn pursuant to a Election/Restriction requirement, as discussed above.
Claims 1, 4, 8, 11-12, 15, 17, and 20 are pending and under examination herein.
Claims 1, 4, 8, 11-12, 15, 17, and 20 are rejected.
Priority
The instant application is a Continuation of PCT/US2025/031891, filed 06/02/2025, which claims priority from US Provisional Application 63/655575 , filed 06/03/2024 and US Provisional Application 63/803471, filed 05/09/2025. As such, the effective filing date assigned to each of claims 1, 4, 8, 11-12, 15, 17, and 20 is 06/03/2024.
Drawings
The drawings filed 12/29/2025 and 03/06/2026 are accepted by the examiner.
Information Disclosure Statement
The Information Disclosure Statement filed 01/26/2026 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
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, 4, 8, 11-12, 15, 17, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1, 12 and 17 recite performing a data quality assurance on the received data to identify at least one anomalous data point; applying a Bayesian statistical normalization model to the data to: model a batch-specific systemic variation; account for a technical factor contributing to a batch effect; separate a signal from the technical factor; and generate normalized data.
These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, performing a data quality assurance on the received data to identify at least one anomalous data point, modeling a batch-specific systemic variation, accounting for a technical factor contributing to a batch effect, separating a signal from the technical factor, and generating normalized data can be practically performing the human mind as claimed, since the mind can read, flag, and normalize data and account for factors as claimed to separate signals, and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps of applying a Bayesian statistical normalization model to the data, modeling a batch-specific systemic variation, and generating normalized data equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations fall under the “mathematical concepts” grouping of abstract ideas. Claims 4, 8, 11, 15 and 20 further qualify the judicial exceptions. As such, claims 1, 4, 8, 11-12, 15, 17, and 20 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Rather, the instant claims recite additional elements that amount to mere data gathering and outputting and mere instructions to implement the abstract idea in a generic computing environment. Specifically, the claims recite the following additional elements:
Claims 1, 12 and 17 recite in an AI-guided analytic platform, receiving data from a plurality of sources and outputting the normalized data for use in a machine learning application.
Claim 1 further recite computer-implemented.
Claim 12 recites one or more computers; and one or more storage devices communicatively coupled to the one or more computers.
Claim 17 recites one or more non-transitory computer storage media and one or more computers.
Claims 1, 12, and 17 recite limitations of how data is obtained, which equate to mere data gathering activity to obtain the data necessary for the mental evaluations and judgements (see MPEP 2106.05(g)). Claims 1, 12, and 17 also recite limitations for outputting data that the courts consider to be an insignificant extra-solution activity (see MPEP 2106.05(d)). Claims 1, 12, and 17 merely recites using a generic computing systems and computer program products to carry out instructions to implement an abstract idea on a computer. The AI-guided platform is recited generically, and appears to be performed on a generic computer. The computer system and computer program product as claimed fails to recite details of how a solution to a problem is accomplished and only recites the idea of a solution or outcome. There are no limitations that indicate that the claimed steps require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Furthermore, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1, 4, 8, 11-12, 15, 17, and 20 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). Further analyzing the additional elements under step 2B, the additional elements as described above do not rise to the level of significantly more than the judicial exception. As set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims under the 2B analysis, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1, 4, 8, 11-12, 15, 17, and 20 are not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 11-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Malo et al. (Nature biotechnology 2006, 24(2), pp.167-175; hereafter referred to as Malo) in view of Mballo and Makarenkov (Combinatorial Chemistry & High Throughput Screening 2010, 13(5), pp.430-441; hereafter referred to as Mballo).
With respect to claims 1, 12 and 17, Malo discloses statistical aspects of data preprocessing and hit identification for primary high-throughput screening (HTS) data analysis (title; abstract).
Malo discloses HTS is a large-scale process that screens many thousands of chemical compounds in order to identify potential lead candidates rapidly and accurately, whereas the plating format and number of compounds per plate can vary, and that the automated process allows the testing of several hundred plates over a period of weeks (fig 1; p 167, col 2, para 1-p 168, col 1, para 1).
Malo discloses that once the screen has been run, data mining software packages are increasingly being used for quality control (i.e. computer-implemented) (p 174, col 2, para 3).
Malo further discloses statistical methods offer the means to characterize quality of screens and of hits within a probabilistic framework, and discloses an empirical Bayes approach can be used, including to examine the distribution of sample variances (Box 2; p 173, col 1, para 4-p 174, col 2, para 6).
Malo discloses HTS data processing requires quality control and normalization of raw data to remove systemic plate-to-plate variation, in which biases from inferential errors can be caused by ‘noise’ due to technical or procedural factors can affect all measurements equally or can depend on factors (such as well location, liquid dispensing and signal intensity), the importance of accounting for outliers, including identifying and deleting measurement outliers, as they may cause the distribution of the compound measurements to be skewed, and further discloses numerous models that can be used to model a measured compound activity as a function of the compound’s true activity and random error, and generate/output normalized data that separate a signal from the error (i.e. technical factor) for further analysis (fig 5; p 169, col 1, para 5-p 173, col 1, para 3).
However, Malo does not appear to disclose using the normalized data in a machine learning application.
However, the prior art to Mballo, in the same field of endeavor, discloses using machine learning methods to predict experimental high throughput screening data, and further discloses normalizing the data before further analysis by numerous machine learning applications (title; abstract; section 2; sections 4-5).
Mballo further discloses field of HTS is also very suitable for applying machine learning methods (section 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the steps for performing quality control and normalization of HTS data as disclosed by Malo, with use of the data in machine learning models as disclosed by Mballi, since field of HTS is also very suitable for applying machine learning methods as disclosed by Mballo and normalizing the raw data would help remove biases and inferential error as disclosed by Malo. There would be a reasonable expectation of success because using the generated normalized data would not impede the steps of Malo in generating it, and furthermore Mballo uses normalized data in the machine learning models.
With respect to claims 8 and 11, Malo discloses normalization of raw data includes models to remove systemic plate-to-plate variation (box 1; p 169, col 1, para 5-p 172, col 1, para 2).
Therefore, the invention is prima facie obvious.
Claims 4, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Malo et al. (Nature biotechnology 2006, 24(2), pp.167-175; hereafter referred to as Malo) in view of Mballo and Makarenkov (Combinatorial Chemistry & High Throughput Screening 2010, 13(5), pp.430-441; hereafter referred to as Mballo) as applied to claims 1, 12 and 17 above, and further in view of Meehan et al. (NATURE reviews microbiology 2019, 17(9), pp.533-545; hereafter referred to as Meehan).
With respect to claims 4, 15 and 20, Malo in view of Mballo discloses the steps of claims 1, 12 and 17, as applied above.
Malo further discloses using positive and negative controls in quality control (p 169, col 1, para 5-p 173, col 2, para 4). However, Malo and Mballo do not appear to disclose flagging a readout that falls outside an expected range based on historical data for a similar strain.
However, the prior art to Meehan, in the same field of endeavor, discloses expected SNP range is useful for quality control, as deviations may indicate poor quality sequencing, co/super-infections and contaminations (section 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the steps for performing quality control and normalization of HTS data as disclosed by Malo, by flagging a readout that falls outside an unexpected historical range for a strain as disclosed by Meehan, because deviations may indicate poor quality sequencing, co/super-infections and contaminations. There would be a reasonable expectation of success because flagging samples that fall outside an expected range would not impede the steps of Malo, as Malo uses controls and could use similar strains with historical data as controls.
Therefore, the invention is prima facie obvious.
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, 4, 8, 11-12, 15, 17, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19430775 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite obvious equivalent or broader limitations in comparison to the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 8, 11-12, 15, 17, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19431807 in view of Malo et al. (Nature biotechnology 2006, 24(2), pp.167-175), further in view of Mballo and Makarenkov (Combinatorial Chemistry & High Throughput Screening 2010, 13(5), pp.430-441).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI DHARITHREESAN whose telephone number is (571)272-5486. The examiner can normally be reached Monday - Friday 9:00 - 5:00.
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, Larry D Riggs II can be reached at (571) 270-3062. 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.
/N.D./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
Prosecution Insights