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 .
Response to Amendment
Applicant’s amendments to the claims, filed 3/3/2026, are accepted and appreciated by the examiner.
Response to Arguments
Applicant’s arguments filed 3/3/2026 have been fully considered but they are moot in view of the new grounds of rejection as necessitated by Applicant’s amendments. Examiner notes that the U.S.C.§101 rejection regarding computer-readable instructions, has been withdrawn due to Applicant’s amendments.
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 1-4,6-12,14-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. With respect to Claims 1, 9, 17 the limitation receiving an original data set associated with a plurality of patients; processing the original data set using a multivariate probabilistic distribution operation to identify patients of the plurality of patients having similar characteristics; modifying at least a portion of the original data set based on an output of the multivariate probabilistic distribution operation to generate a modified data set having modified data for at least some of the patients having similar characteristics; applying a statistical test to the original data set and the modified data set to generate a statistical test output; and in response to determining that the statistical test output indicates that the original data set and the modified data set are statistically different, outputting the modified data set as synthetic data including providing the synthetic data to a computing device for performing data analysis to generate one or more predictive outputs.
This limitation is directed to an abstract idea and would fall within the “Mathematical Concept” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application.In particular, the claim recites the additional element – A synthetic data generation system comprising: one or more processors one or more non-transitory computer-readable memories storing processor-executable instructions that, when executed by the one or more processors, cause the one or more processors to perform operations comprising: (A computer-implemented method comprising: by one or more processors) (A non-transitory computer-readable medium with computer-executable instructions stored thereon that when executed by at least one computing device cause the at least one computing device to:) These limitations are recited at a high-level of generality (i.e., as a generic processor performing a generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such Examiner does NOT view that the claims -Improve the functioning of a computer, or to any other technology or technical field
-Apply the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
-Effect a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
-Apply or use 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 - see MPEP 2106.05(e) and Vanda Memo The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements analysis amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Examiner further notes that such additional elements are viewed to be well known routine and conventional as evidenced by Wittenbach (US 2022/0067737 A1) Soni (US 2020/0342362 A1) Lesh (US 2023/0010686 A1) Considering the claim as a whole, one of ordinary skill in the art would not know the practical application of the present invention since the claims do not apply or use the judicial exception in some meaningful way. As currently claimed, Examiner views that the additional elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, because the claims fails to recite clearly how the judicial exception is applied in a manner that does not monopolize the exception. Dependent claims 2-8, 10-16, 18-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as detailed below: there is no additional element(s) in the dependent claims that adds a meaningful limitation to the abstract idea to make the claim significantly more than the judicial exception (abstract idea). Claims 2-4, 6-8, 10-12, 14-16, 18-20 further limit the abstract idea with an abstract idea and thus the claims are still directed to an abstract idea without significantly more.
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 applicant regards as his invention.
Claims 1-4,6-12,14-22 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.
Claims 1, 9, 17 recite processing the original data set using a multivariate probabilistic distribution operation to identify patients of the plurality of patients having similar characteristics; modifying at least a portion of the original data set based on an output of the multivariate probabilistic distribution operation to generate a modified data set having
modified data for at least some of the patients having similar characteristics; However it is not clear what “the patients” is referring to and is therefore indefinite. As currently claims these patients could be different than the identified patients and is not clear. Furthermore using a multivariate probabilistic distribution operation and an output of the multivariate probabilistic distribution operation, is not clear for the processing step and modifying step because it is not clear if this is the same operation or not. Examiner recommends amending the claims to clearly specify step by step how one limitation steps relates to the next limitation step so the claims are clear. Claims that depend on the above rejected claims are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Examiner recommends Applicant to schedule an interview and discuss amendments to overcome the rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Warfield (US2023/0289467 A1) teaches a method for generating high volumes of synthetic data records for testing data processing applications associated with one or more operating fields, such as healthcare without using any confidential Information. In operation, the present invention provides for retrieving a predefined dataset. Further, the present invention provides for extracting data values associated with selected relevant data fields from the retrieved predefined dataset. Furthermore, the present invention provides for defining rules for generating data values of specific data fields out of the selected relevant data fields. Yet further, the present invention provides for evaluating a number of possible data records. Yet further, the present invention provides for generating evaluated number of synthetic data records using a predefined file format based on the extracted data values and the defined rules.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YOSHIHISA ISHIZUKA whose telephone number is (571)270-7050. The examiner can normally be reached M-F 11:00-7:00.
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, Catherine Rastovski can be reached at (571) 270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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YOSHIHISA . ISHIZUKA
Examiner
Art Unit 2857
/YOSHIHISA ISHIZUKA/Primary Examiner, Art Unit 2857
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