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 .
Status of the Claims
The office action is in response to the claims filed on October 7, 2024 for the application filed October 7, 2024 which is a continuation of application no. 17/221,384 filed April 2, 2024. Claims 1-20 are currently pending and have been examined.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,112,244.
Although the claims at issue are not identical, they are not patentably distinct from each other because anticipated by claims 1-20 of U.S. Patent No. 12,112,244.
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 2 and 12 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 2 and 12 recite the limitation "wherein producing a procreant enumeration further comprises". There is insufficient antecedent basis for this limitation in the claim as claims 1 and 11 do not recite producing a procreant enumeration.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-10 are directed towards a system for generating a functional program (i.e. a machine), which is a statutory category. Claims 11-20 are directed towards a method for generating a functional program (i.e. a process), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1 and 11 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 1 is identified as:
a computing device, the computing device configured to:
obtain a procreant marker as a function of a procreant system;
determine a procreant appraisal as a function of the procreant marker,
receive a conduct indicator;
identify a functional signature as a function of the conduct indicator; and
generate a functional program as a function of the functional signature and procreant appraisal using a program machine-learning model.
The identified limitations of the abstract idea of claims 1 and 11 fall within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior (including social activities, teaching, and following rules or instructions). The claims recite a series of steps/instructions to follow to generate a functional program, which is an activity performed regularly by healthcare professionals when treating patient procreant system issues.
The identified limitations of the abstract idea of claims 1 and 11 also fall within the subject matter grouping of mental processes. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. The limitations of obtaining, determining, receiving, identifying and generating are steps of a method which can be performed mentally, or which are the equivalent of human mental work as these steps are observations, evaluations, judgments, and opinions. Other than reciting “the computing device configured to”, “by the computing device” and “using a … machine-learning model”, nothing in the claim element precludes the identified steps from practically being performed in the mind.
Accordingly, claims 1 and 11 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that 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. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 1 are identified in italics as:
a computing device, the computing device configured to:
obtain a procreant marker as a function of a procreant system;
determine a procreant appraisal as a function of the procreant marker,
receive a conduct indicator;
identify a functional signature as a function of the conduct indicator; and
generate a functional program as a function of the functional signature and procreant appraisal using a program machine-learning model.
The additional limitations of “a computing device, the computing device configured to”, “using a program machine-learning model” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The computing device is recited at a high level of generality and used for its ordinary capacity to obtain, determine, identify and generate data. The program machine-learning model is used to generally apply the abstract idea without placing any limits on how the program machine-learning model functions. Rather, this limitation only recite the outcome of “generat[ing] a functional program as a function of the functional signature and procreant appraisal” and does not include any details about how the “generating” is accomplished. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
Accordingly, claims 1 and 11 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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 limitations of “a computing device, the computing device configured to” and “using a program machine-learning model” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). which is does not amount to significantly more than the abstract idea.
Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above.
Claims 2-10 and 12-20 recite additional steps/instructions and details thereof to follow to generate a functional program, which is an activity performed regularly by healthcare professionals when treating patient procreant system issues and which can be performed in the human mind using observations, evaluations judgments and opinions. Therefore, claims 2-10 and 12-20 are also directed to can abstract idea falling under grouping of certain methods of organizing human activity and mental processes.
Regarding claims 10 and 20, the additional limitation of “using a goal machine-learning model” is determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f) which does not amount to significantly more for similar reasons to the additional element of “using a program machine-learning model” recited in claims 1 and 11.
Therefore, whether taken individually or as an ordered combination, 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Apte et al. (U.S. Pub. No. 2019/0078142).
Regarding claim 1, Apte discloses system for generating a procreant functional program (Abstract), the system comprising:
a computing device, the computing device configured to (Paragraph [0233]):
obtain a procreant marker as a function of a procreant system (Paragraph [0175], processing one or more biological samples from a user…. to facilitate generation of a microorganism dataset for a user, such as for use in deriving inputs for the characterization process (e.g., for generating a female reproductive system-related characterization for the user). Paragraph [0177], processing and analyzing biological samples (e.g., to generate a user microorganism dataset; etc.) from the user is preferably performed in a manner similar to that of one of the embodiments, variations, and/or examples of sample reception described in relation to Block S110 above. Paragraph [0076], Block S110 can function to process samples in order to determine compositional, functional, pharmacogenomics, and/or other suitable aspects associated with the corresponding microbiomes, such as in relation to one or more female reproductive system-related conditions. Also see paragraphs [0077]-[0078].);
determine a procreant appraisal as a function of the procreant marker (Paragraph [0178], processing of the microorganism dataset to extract user microbiome features (e.g., extract feature values; etc.) that can be used to determine the one or more female reproductive system-related characterizations; etc.) derived from the biological sample of the user. Paragraph [0152], determining feature values for a user for microbiome features determined to be associated with, such as correlated with, the one or more female reproductive system-related conditions; etc.)Paragraph [0123], generating features can include generation of features related to pathogenicity of a taxon and/or products attributed to a taxon. Also see paragraph [0052], , parameters, metrics, inputs, outputs, and/or other suitable data can be associated with value types including: scores (e.g., female reproductive system-related condition propensity scores; feature relevance scores; correlation scores, covariance scores, microbiome diversity scores, severity scores; etc.).);
receive a conduct indicator (Paragraph [0111], can additionally or alternatively include Block S120, which can include processing (e.g., receiving, collecting, transforming, determining supplementary features, ranking supplementary features, identifying correlations, etc.) supplementary data (e.g., one or more supplementary datasets, etc.) associated with (e.g., informative of; describing; indicative of; correlated with; etc.) one or more female reproductive system-related conditions, one or more users, and/or other suitable entities. Paragraph [0112], Supplementary data can include… behavior data describing behaviors; environmental factor data describing environmental factors; diet-related data such as data from food establishment check-ins, data from spectrophotometric analysis, user-inputted data, nutrition data associated with probiotic and/or prebiotic food items, types of food consumed, amount of food consumed, caloric data, diet regimen data, and/or other suitable diet-related data; etc. Also see paragraphs [0113]-[0116].);
identify a functional signature as a function of the conduct indicator (Paragraph [0111], determining a set of supplementary features based on the at least one of the survey-derived data, the user data, the site-specific data, and the device data (and/or other suitable supplementary data). Paragraph [0181], supplementary features (e.g., extracted from supplementary data collected for the user; such as survey-derived features, medical history-derived features, sensor data, etc.); and
generate a functional program as a function of the functional signature and procreant appraisal using a program machine-learning model (Paragraph [0111], generating one or more female reproductive system-related characterization models based on the supplementary features, microbiome features, and/or other suitable data. Paragraph [0172], processing a therapy model can include determining one or more therapies for a user based on one or more therapy models, user microbiome features (e.g., inputting user microbiome feature values into the one or more therapy models, etc.), supplementary data (e.g., prior knowledge associated with therapies such as in relation to microorganism-related metabolization; user medical history; user demographic data, such as describing demographic characteristics; etc.), and/or any other suitable data. Paragraph [0224], Female reproductive system-related characterization models… can employ analytical techniques including any one or more of: artificial intelligence approaches (e.g., machine learning approaches, etc.). Paragraph [0162], types of therapies can include any one or more of: probiotic therapies, bacteriophage-based therapies, small molecule-based therapies, cognitive/behavioral therapies, physical rehabilitation therapies, clinical therapies, medication-based therapies, diet-related therapies, and/or any other suitable therapy designed to operate in any other suitable manner in promoting a user's health.).
Regarding claim 2, Apte further discloses the system of claim 1, wherein producing a procreant enumeration further comprises identifying a procreant disorder and producing the procreant enumeration as a function of the procreant disorder (Fig. 6).
Regarding claim 3, Apte further discloses the system of claim 1, wherein the conduct indicator includes a dimensional element (Paragraph [0113], Behavioral data can describe behaviors including one or more: health-associated states (e.g., health and disease states), dietary habits (e.g., alcohol consumption, caffeine consumption, omnivorous, vegetarian, vegan, sugar consumption, acid consumption, consumption of wheat, egg, soy, treenut, peanut, shellfish, food preferences, allergy characteristics, consumption and/or avoidance of other food items, etc.), behavioral tendencies (e.g., levels of physical activity, drug use, alcohol use, habit development, etc.), different levels of mobility (e.g., amount of exercise such as low, moderate, and/or extreme physical exercise activity; related to distance traveled within a given time period; indicated by mobility sensors such as motion and/or location sensors; etc.), different levels of sexual activity (e.g., related to numbers of partners and sexual orientation), and any other suitable behavioral data.).
Regarding claim 4, Apte further discloses the system of claim 1, wherein receiving the conduct indicator further comprises obtaining an exposure element and receiving the conduct indicator as a function of the exposure element (Paragraph [0113], processing supplementary data can include processing survey-derived data, where the survey-derived data can provide behavioral tendencies (e.g., levels of physical activity, drug use, alcohol use, habit development, etc.).).
Regarding claim 5, Apte further discloses the system of claim 1, wherein identifying the functional signature further comprises: producing an indicator index as a function of the conduct indicator; and identifying the functional signature as a function of the indicator index (Paragraph [0113], Survey-derived data can include quantitative data, qualitative data, and/or other suitable types of survey-derived data, such as where qualitative data can be converted to quantitative data (e.g., using scales of severity, mapping of qualitative responses to quantified scores, etc.). Paragraph [0111], determining a set of supplementary features based on the at least one of the survey-derived data, the user data, the site-specific data, and the device data (and/or other suitable supplementary data). Also see paragraph [0052].).
Regarding claim 6, Apte further discloses the system of claim 1, wherein identifying the functional signature further comprises determining a root cause and identifying the functional signature as a function of the root cause (Paragraph [0113], processing supplementary data can include processing survey-derived data, where the survey-derived data can provide behavior data. Behavioral data can describe behaviors including one or more: health-associated states (e.g., health and disease states), dietary habits (e.g., alcohol consumption, caffeine consumption, omnivorous, vegetarian, vegan, sugar consumption, acid consumption, consumption of wheat, egg, soy, treenut, peanut, shellfish, food preferences, allergy characteristics, consumption and/or avoidance of other food items, etc.), behavioral tendencies (e.g., levels of physical activity, drug use, alcohol use, habit development, etc.), different levels of mobility (e.g., amount of exercise such as low, moderate, and/or extreme physical exercise activity; related to distance traveled within a given time period; indicated by mobility sensors such as motion and/or location sensors; etc.), different levels of sexual activity (e.g., related to numbers of partners and sexual orientation), and any other suitable behavioral data. Survey-derived data can include quantitative data, qualitative data, and/or other suitable types of survey-derived data, such as where qualitative data can be converted to quantitative data (e.g., using scales of severity, mapping of qualitative responses to quantified scores, etc.). Paragraph [0111], determining a set of supplementary features based on the at least one of the survey-derived data, the user data, the site-specific data, and the device data (and/or other suitable supplementary data). Determining a quantitative supplementary features (i.e. functional signature), such as a behavior tendency based on behavioral data is construed as determining a root cause (i.e. behavioral data) of the behavioral tendency.).
Regarding claim 7, Apte further discloses the system of claim 1, wherein identifying the functional signature further comprises determining a habit as a function of the conduct indicator and identifying the functional signature as a function of the habit (Paragraph [0113], processing supplementary data can include processing survey-derived data, where the survey-derived data can provide… behavior data. Behavioral data can describe behaviors including one or more: dietary habits (e.g., alcohol consumption, caffeine consumption, omnivorous, vegetarian, vegan, sugar consumption, acid consumption, consumption of wheat, egg, soy, treenut, peanut, shellfish, food preferences, allergy characteristics, consumption and/or avoidance of other food items, etc.), behavioral tendencies (e.g., levels of physical activity, drug use, alcohol use, habit development, etc.). Paragraph [0120], performing the characterization process, Block S130 can use computational methods (e.g., statistical methods, machine learning methods, artificial intelligence methods, bioinformatics methods, etc.) to characterize a subject as exhibiting features associated with one or more female reproductive system-related conditions.).
Regarding claim 8, Apte further discloses the system of claim 1, wherein generating the functional program further comprises: determining a holistic prospect and generating the functional program as a function of the holistic prospect (Paragraph [0162]).
Regarding claim 9, Apte further discloses the system of claim 1, wherein the functional program includes a nourishment program (Paragraph [0184], As such, outputs of Block S140 can be used to directly promote a customized therapy formulation and regimen (e.g., dosage, usage instructions) to the user based upon a trained therapy model. Additionally or alternatively, therapy provision can include recommendation of available therapeutic measures configured to shift microbiome composition and/or functional features toward a desired state. In variations, therapies can include any one or more of: consumables, topical therapies (e.g., lotions, ointments, antiseptics, etc.), medication (e.g., medications associated with any suitable medication type and/or dosage, etc.), bacteriophages, environmental treatments, behavioral modification (e.g., diet modification therapies, stress-reduction therapies, physical activity-related therapies, etc.), diagnostic procedures, other medical-related procedures, and/or any other suitable therapies associated with female reproductive system-related conditions. Consumables can include any one or more of: food and/or beverage items (e.g., probiotic and/or prebiotic food and/or beverage items, etc.), nutritional supplements (e.g., vitamins, minerals, fiber, fatty acids, amino acids, prebiotics, probiotics, etc.), consumable medications, and/or any other suitable therapeutic measure. In an example, providing one or more therapies and/or otherwise facilitating therapeutic intervention can include providing a recommendation for the one or more therapies to one or more users at one or more computing devices (e.g., at a user interface such as a web application, presented at the computing devices; etc.) associated with the one or more users.).
Regarding claim 10, Apte further discloses the system of claim 1, wherein generating the functional program further comprises: obtaining a procreant functional goal; and generating the functional program as a function of the functional signature and the procreant functional goal using a goal machine-learning model (Paragraph [0169], the therapy model can be derived in relation to identification of a “normal” or baseline microbiome composition and/or functional features, as assessed from subjects of a population of subjects who are identified to be in good health. Upon identification of a subset of subjects of the population of subjects who are characterized to be in good health (e.g., using features of the characterization process), therapies that modulate microbiome compositions and/or functional features toward those of subjects in good health can be generated in Block S140. Paragraph [0168], Any other suitable machine learning algorithm described above can facilitate generation of the therapy provision model.).
Regarding claims 11-20: all limitations as recited have been analyzed and rejected with respect to claims 1-10. Claims 11-20 pertain to a method, corresponding to the system of claims 1-10. Claims 11-20 do not teach or define any new limitations beyond claims 1-10; therefore claims 11-20 are rejected under the same rationale.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Peri et al. (U.S. Pub. No. 2021/0118574) discloses a system to help clinicians predict the risk of maternal mortality by detecting diseases early and identifying possible risks in mothers, fetuses and infants across pre, peri and post-natal stages of pregnancy.
Yao et al. (U.S. Pub. No. 2011/0313790) discloses a decision support system for reproductive care.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
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/DEVIN C HEIN/Examiner, Art Unit 3686