DETAILED ACTION
Status of Claims
This is the first office action on the merits in response to the application filed on 30 May 2023.
Claims 3-15 were amended in a preliminary amendment. Claims 16-20 were added in a preliminary amendment.
Claim(s) 1-20 are currently pending and have been examined.
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 .
Priority
This application is a 371 filing of PCT/US2021/053764 filed on 6 October 2021, which claims priority of EP20212280.0 filed on 7 December 2020.
Applicant’s claim for the benefit of these prior filed applications is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on 30 May 2023, 10 July 2023, 26 July 2024, and 25 August 2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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.
Claim 12 recites “detecting data leakage associated with the reasoning module.” There is no antecedent basis for the term “reasoning module” in the claim. The lack of antecedent basis makes it unclear whether the data leakage is associated with an element within the claim boundaries, which would make the scope of the claim unclear to one of ordinary skill in the art, rendering the claim indefinite.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1, which is representative of claims 14 and 15, recites: a
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of evaluating mutational data to determine a predicted treatment outcome. This concept is analogous to the examples of “evaluation” and “judgement” given in MPEP2106.04(a)(2)(III). At the level of generality presently claimed, the broadest reasonable interpretation of these limitations is practically performable in the human mind. As such, the claim concept falls within the mental processes grouping. Therefore the claims are determined to recite an abstract idea. Alternatively, like the example of “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C), the concept describes a mental process that someone should follow when predicting a treatment outcome for a patient. As such, the claim concept falls within the methods of organizing human activity grouping. Therefore the claim is determined to recites an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 1 describes the method as “computer-implemented.” Claim 14 recites the additional element of a system comprising: one or more processors; and a non-transitory computer-readable storage medium. Claim 15 recites the additional element of a non-transitory machine-readable storage medium. These additional elements are all recited at a high level of generality, and are interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application. The claims further recite the additional element of a trained model. The general recitation of a trained model amounts to instruction to apply the abstract idea with a generic computing device. As such, previously noted, such limitations do not integrate an abstract idea into a practical application. As such, this additional element does not integrate the abstract idea into a practical application. The claims further recite the additional element of retrieving data. This limitation does not impose a meaningful limit on the claim, and further amounts to necessary data gathering. As such, this additional element is considered insignificant extra-solution activity, and as such does not integrate the abstract idea into a practical application. There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea and insignificant extra-solution activity to a technological environment of a computing device. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not amount to significantly more. As previously noted, the claims recite the additional element of retrieving data. Per MPEP 2106.05(d)(II), retrieving information in memory has been recognized by the courts as a conventional computer function. The conventionality of this additional element further reinforces prior conclusion that this additional element is insignificant extra-solution activity. As such, this additional element does not amount to significantly more. There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea and insignificant extra-solution activity to a technological environment of a computing device. As such, the combination of additional elements does not amount to significantly more than the abstract idea. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the judicial exception. Thus the independent claims are not patent eligible.
Dependent claims 2-13 and 16-20 further narrow the abstract idea, but the claims continue to recite an abstract idea, albeit a narrowed one. Dependent claim 2, 3, 5, 6, 10, 13, 16, 17, 19, and 20 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for the same reasons as explained above. Therefore claims 2, 3, 5, 6, 10, 13, 16, 17, 19, and 20 are directed to an abstract idea. Additionally, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract idea for the same reasons as explained above.
Dependent claim 4 and 18 further describes the additional element of the trained model, but this additional element continues to amount to instructions to implement the abstract idea with a generic computing device. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for the same reasons as explained above. Therefore claim 4 is directed to an abstract idea. Additionally, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract idea for the same reasons as explained above.
Dependent claim 7 recites the additional element of querying a data store. This limitation does not impose a meaningful limit on the claim and further amounts to necessary data gathering. As such, this additional element is considered insignificant extra-solution activity, and as such does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device, and as such the combination does not integrate the narrowed abstract idea into a practical application. Therefore claim 7 is directed to an abstract idea. Yankowski (US 2001/0004338 A1) demonstrates (“the database is searched using conventional query methods” [0055]) that querying a data store was conventional long before the priority date of the claimed invention. The conventionality of this additional element further reinforces prior conclusion that this additional element is insignificant extra-solution activity. As such, this additional element does not amount to significantly more than the narrowed abstract idea. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device, and therefore the combination does not amount to significantly more than the narrowed abstract idea.
Dependent claim 8 recites the additional element of a outputting data using a chatbot. This additional element does not reflect any improvement to any technology or technical field. Additionally, this additional element does not implement the judicial exception with or using a particular machine. Further, this additional element does not effect a transformation or reduction of a particular article. Finally, this additional element does not apply or use the abstract idea in some other meaningful way. Instead, this addition element only generally links the abstract idea to a computing device with a chatbot. As such, this additional element does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device with a chatbot, and as such the combination does not integrate the narrowed abstract idea into a practical application. Therefore claim 8 is directed to an abstract idea. Kim (WO2006/129968 A1) demonstrates (“another example of the conventional conversational agent. The conversational agent of Fig. 3, Simsimi recommends a product” [8]) that outputting data via a chatbot was conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more than the narrowed abstract idea. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device with a chatbot, and therefore the combination does not amount to significantly more than the narrowed abstract idea.
Dependent claim 9 recites the additional element of an electronic record. This additional element does not reflect any improvement to any technology or technical field. Additionally, this additional element does not implement the judicial exception with or using a particular machine. Further, this additional element does not effect a transformation or reduction of a particular article. Finally, this additional element does not apply or use the abstract idea in some other meaningful way. Instead, this addition element only generally links the abstract idea to a computing device. As such, this additional element does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device, and as such the combination does not integrate the narrowed abstract idea into a practical application. Therefore claim 9 is directed to an abstract idea. Per MPEP 2106.05(d)(II), the courts have recognized storing information in memory as a well-understood, routine, and conventional computer function. As such, this additional element does not amount to significantly more than the narrowed abstract idea. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a computing device, and therefore the combination does not amount to significantly more than the narrowed abstract idea.
Dependent claim 11 recites the additional element of a cloud-based application. This additional element does not reflect any improvement to any technology or technical field. Additionally, this additional element does not implement the judicial exception with or using a particular machine. Further, this additional element does not effect a transformation or reduction of a particular article. Finally, this additional element does not apply or use the abstract idea in some other meaningful way. Instead, this addition element only generally links the abstract idea to a cloud based computing device. As such, this additional element does not integrate the narrowed abstract idea into a practical application. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a cloud based computing device, and as such the combination does not integrate the narrowed abstract idea into a practical application. Therefore claim 11 is directed to an abstract idea. Long et al. (US 2011/0113086 A1) demonstrates (“the term ‘cloud’ refers to the conventional term ‘cloud computing’ in which application execution is carried by a server owned and/or operated by a 3.sup.rd party provider accessible via the internet or ‘cloud.’” [0030]) that cloud executed software was conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more than the narrowed abstract idea. When considered in combination with the previously identified additional elements, the combination only generally links the narrowed abstract idea and insignificant extra-solution activity to a technological environment of a cloud based computing device, and as such the combination does not amount to significantly more than the narrowed abstract idea.
Dependent claim 12 recites the additional element of a module. This additional element amounts to instructions to implement the abstract idea with a generic computing device. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for the same reasons as explained above. Therefore claim 12 is directed to an abstract idea. Additionally, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract idea for the same reasons as explained above.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 Notice of References Cited.
Hall et al. (US 2020/0370124 A1) contains much that is analogous to the claimed invention, but does not disclose or suggest inputting, for each reference subject, the reference subject’s genetic information and the particular subject’s genetic information into a trained similarity model to generate a predicted degree to which the subjects are similar.
Casey et al (US 10902944 B1) describes determining a patient outcome based on similar patient outcomes, but does disclose or suggest inputting, for each reference subject, the reference subject’s genetic information and the particular subject’s genetic information into a trained similarity model to generate a predicted degree to which the subjects are similar.
Lum et al. (US 2013/0144916 A1) and Abraham et al. (US 2022/0093217 A1) describe determining genetically similar patients, but do not disclose or suggest inputting, for each reference subject, the reference subject’s genetic information and the particular subject’s genetic information into a trained similarity model to generate a predicted degree to which the subjects are similar.
Ubels (The Best Treatment For Every Patient) describes methods for predicting cancer treatment outcomes based on analyses of similar patients, but does not disclose or suggest inputting, for each reference subject, the reference subject’s genetic information and the particular subject’s genetic information into a trained similarity model to generate a predicted degree to which the subjects are similar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2025-09-14