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 .
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 1-6 and 13-17 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.
In particular, the following claim limitations newly added to claim 1 are not supported by the original disclosure, and constitute new matter:
using discriminant analysis to generate a discriminant vector of a subset of said physiological markers measurements that changed more than others of said physiological markers measurements for said individual, and using said discriminant vector to create a personal profile for said individual that includes a baseline set of data based on the physiological markers measurements before being given said medication and a prediction pattern based on the physiological markers measurements after being given said medication;
executing the machine learning logic to re-learn the effect of the medication for treating the anxiety or depression disorder on said physiological markers measurements and use the feedback data to iteratively optimize said discriminant vector to enhance effectiveness of future treatment changes recommended to be implemented by said individual.
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 1-6 and 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method and system for dealing with anxiety and depression. Under MPEP 2106.04(a)(2)(lIl), concepts relating to mental processes are drawn to abstract ideas. This judicial exception is not integrated into a practical application because the provision of generic computer components does not add a meaningful limitation to the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception under the factors set forth in MPEP 2106. Such factors include:
• Improvements to another technology or technical field;
• Improvements to the functioning of the computer itself;
• Applying the judicial exception with, or by use of, a particular machine;
• Transformation or reduction of a particular article to a different state of being;
• Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or
• Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Further guidance is provided by Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (U.S. 2014). Alice held that a method of mitigating settlement risk was drawn to an abstract idea. Alice further held that the performance of the method performed on a computer did not amount to “significantly more” than the abstract idea, and thus the claimed invention was drawn to a patent-ineligible abstract idea:
These cases demonstrate that the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention. Stating an abstract idea “while adding the words ‘apply it’” is not enough for patent eligibility. Mayo, supra, at_(slip op., at 3). Nor is limiting the use of an abstract idea “‘to a particular technological environment.’” Bilski, supra, at 610-611. Stating an abstract idea while adding the words “apply it with a computer” simply combines those two steps, with the same deficient result. Thus, if a patent's recitation of a computer amounts to a mere instruction to “implement]” an abstract idea “on ... a computer,” Mayo, supra, at_(slip op., at 16), that addition cannot impart patent eligibility. This conclusion accords with the preemption concern that undergirds our §101 jurisprudence. Given the ubiquity of computers, see 717 F.3d, at 1286 (Lourie, J., concurring), wholly generic computer implementation is not generally the sort of “additional feature]” that provides any “practical assurance that the process is more than a drafting effort designed to monopolize the [abstract idea] itself.” Mayo, 566 U.S., at_(slip op., at 8-9).
Id at pp 1983-1984. Alice further held that apparatus claims drawn to a computer system were subject to the same analysis as the method claims, and were also not patentable subject matter:
Petitioner's claims to a computer system and a computer-readable medium fail for substantially the same reasons. Petitioner conceded below that its media claims rise or fall with its method claims. En Banc Response Brief for Defendant-Appellant in No. 11 -1301 (CA Fed.) p. 50, n. 3. As to its system claims, petitioner emphasizes that those claims recite “specific hardware” configured to perform “specific computerized functions.” Brief for Petitioner 53. But what petitioner characterizes as specific hardware— a “data processing system” with a “communications controller” and “data storage unit,” for example, see App. 954, 958, 1257—is purely functional and generic. Nearly every computer will include a “communications controller” and “data storage unit” capable of performing the basic calculation, storage, and transmission functions required by the method bclaims. See 717 F.3d, at 1290 (Lourie, J., concurring). As a result, none of the hardware recited by the system claims “offers a meaningful limitation beyond generally linking ‘the use of the [method] to a particular technological environment,’ that is, implementation via computers.” Id., at 1291 (quoting Bilski, 561 U.S., at 610-611).
Id. at pp 1984-1985. Turning to the claimed invention, a method and system for receiving and analyzing information, and displaying the results of the analysis, is directed to an abstract idea. See MPEP 2106.04(a)(2)(ll)(D) and Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351 -52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016). Each of the recited steps – taking measurements, creating a cluster, generating differences to create a unique personal data set, diagnosing and monitoring a problem, and predicting treatment efficacy – is a mental process pertaining to receiving and analyzing information. The method is performed by a generic computing device which under Alice is not sufficient to impart patentability to the system or method.
Consideration of the factors listed above pertaining to what is significantly more than the judicial exception, as viewed in light of the holding in Alice, weighs against patentability. While the method includes the use of a computer, the method does not involve an improvement in the function of a computer or other technology. Rather, generic computer components are used in their usual and customary way to perform the method. Mere automation of mental processes to improve efficiency is not sufficient to show an improvement in computer functionality. See Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017), as cited in MPEP 2106.05(a)(I), and Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015), as cited in MPEP 2106.05(f).
Regarding the recitation of various implementations of machine learning processes, these limitations amount to no more than generally linking the use of the abstract mental process to a particular technological environment under MPEP 2106.05(e). The claimed invention does not constitute an improvement in the functioning of machine learning technology, as the claims and disclosure discuss the use of machine learning algorithms in broad and general terms. The claimed invention does not constitute an improvement in machine learning technology. As a result, these limitations do not amount to significantly more than the abstract idea of receiving and analyzing information.
The claimed method does not require the use of a particular machine, as a generic computer system is not a “particular machine” under Alice, nor does it result in the transformation of a physical article. Rather, the result of the claimed method is an assessment including a diagnosis and prediction, which itself is an abstract concept.
With respect to the recitation of “wearable devices” in claim 7, the use of such devices is insignificant extra-solution activity under MPEP 2106.05(g). Such devices are a well-known type of sensor being used in their ordinary way, for mere data gathering. See also Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017), as cited in MPEP 2106.05(a)II), which held that using well known standard laboratory techniques to detect enzyme levels in a subject’s blood was not sufficient to amount to substantially more than the abstract idea. The use of wearable devices to take a user’s physiological measurements is considered to be analogous to the use of standard equipment in Cleveland Clinic.
With respect to the recitation in claim 13 of a “wearable device” to acquire physiological measurements, the mere use of a sensor in this fashion is not sufficient to amount to substantially more than the abstract idea. Rather, the step of acquiring this information from a sensor is insignificant extra-solution activity under MPEP 2106.05(g). The claim recites a generic and well-known sensor, used in its customary way for mere data gathering, and does not involve any advancement in the technology of physiological measurements. The limitation further amounts to mere data gathering. See e.g. In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989), as cited in MPEP 2106.05(g), which held that performing clinical tests on individuals to obtain input for an equation was insignificant extra-solution activity. See also Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012), which held that a generic step of determining a level of a biomarker in blood was similarly insignificant extra-solution activity. The step of using a wearable device is analogous to the steps of performing clinical tests on individuals to obtain input for an equation and determining a level of a biomarker in blood and is also not sufficient to constitute substantially more than the abstract idea.
Dependent claims 2-6 and 13-17 also fail to recite limitations which would overcome the rejection. These claims are generally directed to the types of information being received and analyzed as part of the method as well as the use of known types of sensors, which do not amount to substantially more than the abstract idea under Cleveland Clinic Foundation. Again, generic computer components are being used in their routine and conventional way. Because the claimed invention does not involve significantly more than the abstract concept of analyzing information, the claims are rejected under 35 USC 101.
Response to Arguments
Applicant's arguments filed January 21, 2026 have been fully considered but they are not persuasive. With respect to applicant’s argument that the claimed subject matter resembles the claimed subject matter of issued U.S. patent 11,707,217, previously issued patents do not hold any precedential power or relevance in determining patent subject matter eligibility. Under MPEP 2106.07(a)(III), determination of whether a claim is eligible is a question of law. See also the first paragraph of MPEP 2106.07, which notes that “Eligibility rejections must be based on failure to comply with the substantive law under 35 USC 101 as interpreted by judicial precedent.” It remains the Examiner’s position that the present claims recite ineligible subject matter under the pertinent provisions of 35 USC 101 and corresponding judicial precedent, as set forth above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KURT FERNSTROM whose telephone number is (571)272-4422. The examiner can normally be reached M-F 10-6.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
March 6, 2026