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 .
Subject Matter Free of Prior Art
Claim(s) 1-19 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “an artificial intelligence (Al) model (121), trained by a training data set comprising relationships between a time to FMP and ratios between follicle-stimulating hormone (FSH) levels and estradiol levels, configured to accept FSH data and estradiol levels from a user as input and generate a prediction of a time to FMP as output,” “B) inputting the FSH level measurement and the estradiol measurement into the Al model (121); and C) receiving the prediction of the time to FMP for the patient from the Al model (121).” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in claims 1, 7, 13, claims 1, 7, 13 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 2-6, 8-12, 14-19 incorporate the allowable features of originally numbered independent claims 1, 7, 13 through dependency, respectively.
However, the claims are still rejected under 101.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a computer system which is within the four statutory categories (i.e., machine). Claim 7 is drawn to a computer system which is within the four statutory categories (i.e., machine). Claim 13 is drawn to a computer-implemented method which is within the four statutory categories (i.e., method).
Independent claim 7 (which is representative of independent claims 1, 13) recites… an…model (121), [formed] by a training data set comprising relationships between a time to FMP and ratios between follicle-stimulating hormone (FSH) levels and estradiol levels, configured to accept FSH data and estradiol levels from a user as input and generate a prediction of a time to FMP as output; and…A) receiving a FSH level measurement and an estradiol measurement from the patient (200); B) receiving menstrual cycle data from the patient (200); C) adjusting the FSH level measurement, the estradiol measurement, or a combination thereof based on the menstrual cycle data; D) inputting the adjusted FSH level measurement and the estradiol measurement into the…model (121); and E) receiving the prediction of the time to FMP for the patient (200) from the…model (121).
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyzed the collected data, and provide an output (i.e., healthcare prediction for a patient) accordingly in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., A computer system (100) comprising: a) a processor (110) configured to execute computer-readable instructions; and b) a memory component (120) operatively coupled to the processor (110), comprising: i) an artificial intelligence (Al) model (121), trained; computer-readable instructions). Claim 7 recites additional elements (i.e., A computer system (100) comprising: a) a processor (110) configured to execute computer-readable instructions; and b) a memory component (120) operatively coupled to the processor (110), comprising: i) an artificial intelligence (Al) model (121), trained; computer-readable instructions). Claim 13 recites additional elements (i.e., a computer to implement the method; an artificial intelligence (AI) model, trained). Looking to the specifications, a computer system having a processor, memory with computer-readable instructions is described at a high level of generality (¶ 0057-0061; ¶ 0066), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “an artificial intelligence (Al) model…trained” is only used to generally apply the abstract idea without placing any limits on how the trained machine learning model functions and only recite the outcome of the abstract idea and does not include details about how “the prediction of the time to FMP” is accomplished, and thus, provide nothing more than mere instructions to implement an abstract idea on a generic computer, and merely indicates a field of use or technological environment (i.e., artificial intelligence) in which the judicial exception is performed. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computer system having a processor, memory with computer-readable instructions) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “an artificial intelligence (Al) model…trained” is only used to generally apply the abstract idea without placing any limits on how the trained machine learning model functions and only recite the outcome of the abstract idea and does not include details about how “the prediction of the time to FMP” is accomplished, and thus, provide nothing more than mere instructions to implement an abstract idea on a generic computer, and merely indicates a field of use or technological environment (i.e., artificial intelligence) in which the judicial exception is performed. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-6, 8-12, 14-19 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-3, 5-6, 8-9, 11-12, 14-16, 18-19 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claims 4, 10, 17 further recites the additional elements of “wherein the system (100) is implemented on a local computer, a cloud computing system, or a combination thereof,” which is described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components. See: MPEP § 2106.05(d)(II). Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2024/0242837 A1 teaches using a machine learning model trained on historical datasets to predict a menopause outcome trajectory.
WO 2022/098737 A1 teaches using a machine learning model trained on a longitudinal dataset to predict a state of pre-menopause.
“Predicting the Timeline to the Final Menstrual Period: The Study of Women’s Health Across the Nation” teaches using estradiol and FSH to estimate the time to final menstrual period.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY HUYNH/Primary Examiner, Art Unit 3683
Prosecution Insights