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 Amendments
Claims 1-9, 16-19, and 21-27 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 05/02/2025.
Claims 1 and 3 are amended claims.
Claims 2, 4-7, and 16-19 are original claims.
Claims 8-9 and 21-26 are previously presented.
Claim 27 is a new claim
Claims 10-15 and 20 have been cancelled and will not be considered at this time.
Specification
The amendment filed 08/25/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
[000.5] Obesity is a disease. Provided herein are exemplary systems, methods, and compositions of matter for treating obesity.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 1 and 27 objected to because of the following informalities:
In Claim 1, Line 41 recites “causing taking of Metformin”. The line should recite “causing the taking of Metformin”
In Claim 27, Line 35 recites “causing taking of Metformin”. The line should recite “causing the taking of Metformin”
Appropriate correction is required.
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 1-9, 16-19, and 21-27 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-9, 16-19, and 21-27 are drawn to a process, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a system for automatically determine a query for a first plurality of digital data elements, the queried digital data elements including a patient’s age, gender, demographics, weight history, lifestyle factors, current eating patterns and preferences, food cravings, appetite, physical activity, medical history, and sleep; receive data in a form of answers corresponding to the queried digital data elements; receive from the data processor the data in the form of the answers corresponding to the queried digital data elements and configured to transform the data in a form of answers corresponding to the queried digital data elements to a reduced size version; cross-reference a public facing data set based on the received data in the form of the answers corresponding to the queried digital data elements; reference an electronic health record corresponding to the patient’s medical history; to receive the reduced size version and cause a first action; apply an algorithm to determine an obesity medication for the patient to take as the first action; correlating the patient’s age, gender, weight loss, a total time spent by the patient in a patient obesity application, an act by the patient in the patient obesity application, a total time spent in the patient obesity application measured by tracking a day of use, hours, and minutes by the patient in the patient obesity application, a time of day of logon, logging events by the patient with respect to food and exercise, a number of email notifications received by the patient, number of SMS notifications and a number of telehealth events; identifying that a patient has a body mass index (BMI) greater than or equal to 27, is biologically female, and does not exhibit specific health conditions including constipation, diarrhea, kidney disease, liver disease, vitamin B12 deficiency, and is not pregnant or nursing; and confirming that none of the patient's medications include Metformin or its branded equivalents (such as Fortamet, Glucophage, Riomet, Glumetza, Metaglip, ACTOplus Met, Glucovance, Avandamet, Jentadueto, Janumet, Kombiglyze, Kazano, or PrandiMet), generating a recommendation for Metformin for the patient; and causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity as evidenced by information received.
Independent claim 27 recites a method for automatically determining a query for a first plurality of digital data elements, the queried digital data elements including a patient’s age, gender, demographics, weight history, lifestyle factors, current eating patterns, food preferences, food cravings, appetite, physical activity, medical history, and sleep; receiving data in a form of answers corresponding to the queried digital data elements; receiving the data in the form of the answers corresponding to the queried digital data elements and transforming the data in the form of answers corresponding to the queried digital data elements to a reduced size version; cross-referencing a public-facing data set based on the received data in the form of the answers corresponding to the queried digital data elements in the reduced size version; referencing an electronic health record corresponding to the patient’s medical history; receiving the reduced size version and causing a first action; applying an algorithm to determine an obesity medication for the patient to take as the first action; correlating the patient’s age, gender, weight loss, a total time spent by the patient in a patient obesity application, an act by the patient in the patient obesity application, a total time spent in the patient obesity application measured by tracking a day of use, hours, and minutes by the patient in the patient obesity application, a time of day of logon, logging events by the patient with respect to food and exercise, a number of email notifications received by the patient, number of SMS notifications and a number of telehealth events; identifying that a patient has a body mass index (BMI) greater than or equal to 27, is biologically female, and does not exhibit specific health conditions including constipation, diarrhea, kidney disease, liver disease, vitamin B12 deficiency, and is not pregnant or nursing; confirming that none of the patient's medications include Metformin or its branded equivalents (such as Fortamet, Glucophage, Riomet, Glumetza, Metaglip, ACTOplus Met, Glucovance, Avandamet, Jentadueto, Janumet, Kombiglyze, Kazano, or PrandiMet), generating a recommendation for Metformin for the patient; causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity; and receiving information evidencing the weight loss.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
The claims recite the additional elements of a variable processor and memory, a data processor, insight processor and memory, an action processor and memory, and a rules engine.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
As discussed above with respect to integration of the abstract idea into a
practical application, the claims recite the additional elements of a variable processor and memory, a data processor, insight processor and memory, an action processor and memory, and a rules engine.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
For the reasons stated, these claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claim 2 recites the first action causing a first change in a first performance metric.
Dependent claim 3 recites the first performance metric being securely transmitted by the networked device to the secure intelligent networked architecture.
Dependent claim 4 recites automatically adjusting the first action automatically resulting in a second action based on the transmitted first performance metric received by the secure intelligent networked architecture.
Dependent claim 5 recites the second action causing a second change in the first performance metric, automatically resulting in a second performance metric.
Dependent claim 6 recites the second performance metric being securely transmitted by the networked device to the secure intelligent networked architecture.
Dependent claim 7 recites automatically adjusting the second action automatically resulting in a third action based on the transmitted second performance metric received by the secure intelligent networked architecture.
Dependent claim 8 correlating each of the queried digital data elements to each of the performance metrics.
Dependent claim 9 recites correlating the data in a form of answers corresponding to the queried digital data elements to each of the performance metrics.
Dependent claim 16 recites predicting a human phenotype based on some or all of data in the intelligent networked architecture.
Dependent claim 17 recites a plurality of actions causing changes in a plurality of performance metrics, the plurality of performance metrics statistically associated with an improvement in a primary chronic condition.
Dependent claim 18 recites the plurality of performance metrics statistically associated with an improvement in a secondary chronic condition.
Dependent claim 19 recites the plurality of performance metrics statistically associated with an improvement in a tertiary chronic condition.
Dependent claim 21 recites wherein the medication is liraglutide.
Dependent claim 22 recites wherein the medication is phentermine.
Dependent claim 23 recites wherein the medication is naltrexone.
Dependent claim 24 recites wherein the medication is bupropion.
Dependent claim 25 recites wherein the medication is topiramate.
Dependent claim 26 recites wherein the medication is a SGLT2 inhibitor.
Each of these steps of the preceding dependent claims 2-9, 16-19, and 21-26 only serve to further limit or specify the features of independent claim 1 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 27 recite “causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity”. The Specification recites “the secure intelligent networked architecture… cause a first action (for, example, the taking of medication) [Specification Para. 0001]”. A first action is caused by the secure intelligent action agent 150. Such actions may include the taking of a medication, adopting a particular nutritional regimen, performing an exercise, etc. For example, Appendix B shows an exemplary medication decision support recommendation algorithm that may be used for recommending an action with respect to the taking of a medication, which includes the recommendation for Metformin [Specification Para. 0049]. In addition, patient responses (e.g. changes in the various variables) may be received by the rules engine and based on such feedback, future medication recommendations may be automatically adjusted for a patient and/or a group of patients (Specification Para. 0050). Appendix C shows exemplary provider and patient health information cards. The provider health information card shows clinical recommendations. The patient health information card includes recommendations on such issues as weight, nutrition, sleep, lifestyle, medical conditions, exercise and eating [Specification Para. 0052]. Appendix D shows the system is continuously automatically evaluating such factors as the relationship between age, gender, time a patient spends interacting with the system, medication and weight loss [Specification Para. 0063]. The specification only has support for recommending Metformin and receiving feedback information from the patient which can include weight loss or weight gain via Appendix D and the specification.
Regarding Claim 1, the specification fails to disclose how the system actually performs the steps of “causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity”. Regarding Claim 27, the specification fails to explicitly disclose what functional steps are performed that causes the taking of Metformin and causing a weight loss by the patient. The specification and the associated appendices only have support for recommending Metformin and receiving feedback information from the patient which can include weight loss or weight gain (Appendix D).
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 and 27 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 and 27 recite “causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity”. The phrase is indefinite because the Specification and the associated appendices are unclear what functional steps are being claimed that would result in causing taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity.
Response to Arguments
Applicant’s arguments, see pg. 9 "Specification"', filed 05/02/2025, with respect to Appendix C have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant's arguments, see pgs. 9-27 “Claim Rejections – 35 USC 101”filed 05/02/2025 have been fully considered but they are not persuasive. Applicant argues that the claim specifies taking of Metformin by the patient. This direct causation of the patient taking the mediation is a concrete step that goes beyond a mere recommendation. This language satisfies the requirement for a particular treatment as it involves an affirmative action leading to the administration of medication. The Applicant's claim 1 explicitly recites "taking of Metformin by the patient and causing a weight loss by the patient to treat the obesity as evidenced by information received from a networked device by the secure intelligent networked architecture." This satisfies the requirement for a particular treatment or prophylaxis as per MPEP 2106.04(d)(2). Examiner respectfully disagrees. In MPEP 2106.04(d)(2) describes that the treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. The claim must positively recite and require that the treatment be administered to the patient, therefore Applicant must demonstrate support that the secure intelligent networked architecture actually administering the metformin. Merely prescribing or providing a medication to a patient is not sufficient to demonstrating a specific treatment or prophylaxis. The present claims do not provide a particular technical solution to a technical problem of the prior art that has been described in the specification and therefore, do not integrate the abstract idea into a practical application. The improvement of secure intelligent networked architecture is an improvement to the abstract idea itself. No matter how much of an advance in the field the claims recite, the advance lies entirely in the realm of abstract ideas, with no plausibly alleged innovation in the non-abstract application realm. An advance of that nature is ineligible for patenting.
Applicant argues that Subject Matter Eligibility Example 49 fully supports the eligibility of Applicant’s claims. Examiner respectfully disagrees. Claim 2 of Example 49 was deemed eligible because the abstract idea is used to identify the patient as belonging to a specific patient population, and the patient is administered a specific treatment, rather than any common anti-fibrotic treatment, that is particular to the patient. In the case of the claimed invention, the current claim language merely provides a recommendation of Metformin for the patient to take, rather than positively reciting the administration of Metformin.
Applicant's arguments, see pgs. 28-37 “Claim Rejections – 35 USC 101” filed 05/02/2025 have been fully considered but they are not persuasive.
Applicant argues that Appendixes A, B, and C provide support that overcome the 112a and 112b rejections. Examiner respectfully disagrees. The specification and the appendices merely provide support for recommending Metformin and receiving feedback information from the patient which can include weight loss or weight gain. However, the specification and the appendices fail to provide support for how the system of Claim 1 performs the steps of causing the taking of Metformin and causing a weight loss of a patient and what functional steps are performed by the method of Claim 27 that causes the taking of Metformin and causing a weight loss of a patient.
Conclusion
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 Patricia K Edouard whose telephone number is (571)272-6084. The examiner can normally be reached Monday - Friday 7:30 AM - 5:00 PM.
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/P.K.E./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682