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 .
Information Disclosure Statement
The Information Disclosure Statements filed on June 2, 2026 and July 23, 2026 have been considered. Initialed copies of the Form 1449 are enclosed herewith.
Status of Claims
This office action is in response to arguments and amendments entered on July 9, 2026 for the patent application 17/521,784 filed on November 8, 2021. Claims 1-20 are amended. Claims 1-20 are pending. The first office action of May 7, 2025; the second office action of August 18, 2025; and the third office action of January 2, 2026 are fully incorporated by reference into this Final Office Action.
Claim Objections
Claims 1-20 are objected to because of the following informalities: Use of multiple conjunctions “and/or.”
Claims 1, 10 and 16 are objected to because the use of multiple conjunctions “and/or,” which makes it unclear whether both terms are to be considered or if only one of them is to be considered. For the purpose of examination, the Examiner will reasonably interpret the terms in the alternative only. Appropriate correction is required. Claims 2-9, 11-15 and 17-20 are also objected to based on their respective dependencies to claims 1, 10 or 16.
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.
Step 1 – “Statutory Category Identification”
Claims 1, 10 and 16 are directed to “a method” (i.e. “a process”), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
Step 2A, Prong 1 “Abstract Idea Identification”
However, the claims are drawn to the abstract idea of “administering treatment,” either in the form of “certain methods of organizing human activity,” in terms of managing personal behavior or relationships or interactions between people (including social activities, teaching and following rules or instructions), or reasonably in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion). Regardless, the claims are reasonably understood as either “certain methods of organizing human activity” or “mental processes,” which require the following limitations:
Per claim 1:
“administering, to a patient, an acute physical suicide treatment for suicidal ideation and/or attempted suicide of the patient;
obtaining within 48 hours of administering the acute physical suicide treatment, patient data related to the patient, wherein the patient data indicates timing information related to the administered acute physical suicide treatment of the patient;
adapting, within 48 hours of administering the acute physical suicide treatment, based on the patient data, a behavioral suicide treatment of the patient, including adapting a rate or order of the behavioral suicide treatment; and
administering, within 48 hours of administering the acute physical suicide treatment, to the patient, the behavioral suicide treatment to enhance effectiveness of the acute physical suicide treatment.”
Per claim 10:
“administering, to a patient, an acute physical suicide treatment for suicidal ideation and/or attempted suicide of the patient;
adapting, within 48 hours of administering the acute physical suicide treatment, for suicidal ideation and/or attempted suicide of the patient, a list of behavioral suicide treatment activities to be administered to the patient;
sending to a patient within 48 hours of administering the acute physical suicide treatment, behavioral suicide treatment activity data indicating the list of behavioral suicide treatment activities; and
administering, within 48 hours of administering the acute physical suicide treatment, the list of behavioral suicide treatment activities to the patient.”
Per claim 16:
“administering, to a patient, an acute physical suicide treatment for suicidal ideation and/or attempted suicide of the patient;
based on previous progression of the patient through the previous acute suicide treatment, selecting at least one behavioral suicide treatment activity from a list, the list including:
an interactive experience tracking module configured to track at least one metric related to behavior of the patient;
instructions on modifying behavior of the patient;
information regarding stimulus control;
relaxation training;
interactive multimedia content for paced breathing, progressive muscle relaxation, imagery-induced relaxation, and/or self-hypnosis;
instructions on use of medication; and
instructions on user monitoring of and adjustment of thoughts of the patient; and
treating the patient by administering, to the patient, the at least one behavioral suicide treatment activity within 48 hours of administering the acute physical suicide treatment.”
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Step 2A, Prong 2 – “Practical Application”
Furthermore, the applicants claimed elements of “a device,” “at least one processor,” and “a communication network,” are merely claimed to generally link the use of a judicial exception (e.g., pre-solution activity of data gathering and post-solution activity of presenting data) to (1) a particular technological environment or (2) field of use, per MPEP §2106.05(h); and are applying the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, per MPEP §2106.05(f). In other words, the claimed “administering treatment,” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Step 2B – “Significantly More”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a device,” “at least one processor,” and “a communication network,” are claimed, these are generic, well-known, and conventional data gather computing elements. As evidence that these are generic, well-known, and a conventional data gathering computing elements (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known, the Applicant’s specification discloses these in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a). As such, this satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
Specifically, the Applicant’s claimed “a device,” as described in para. [0071] of the Applicant’s written description as originally filed, provides the following: “[0071] In some embodiments, devices 120 may be configured to receive a list of selected treatment activities from computer 110 for administering to the patient. As shown in FIG. 1A, each device 120 includes at least one processor 122 and a memory 124. In some embodiments, devices 120 may be patients' personal devices. For example, devices 120 may include mobile phones belonging to various patients. Alternatively or additionally, devices 120 may include multiple devices for each patient, such as a mobile phone and tablet computer, laptop computer, desktop computer, or other such devices.” As such, the Applicant’s “a device,” is reasonably interpreted as a generic, well-known, and conventional data gathering computing element commercially available today.
Likewise, the Applicant’s claimed “at least one processor,” as described in para. [0126] of the Applicant’s written description as originally filed, provides the following: “[0126] The above-described embodiments can be implemented in any of numerous ways. For example, the embodiments may be implemented using hardware, software or a combination thereof. When implemented in software, the software code can be executed on any suitable processor or collection of processors, whether provided in a single computer or distributed among multiple computers. Such processors may be implemented as integrated circuits, with one or more processors in an integrated circuit component, including commercially available integrated circuit components known in the art by names such as CPU chips, GPU chips, microprocessor, microcontroller, or co-processor. Alternatively, a processor may be implemented in custom circuitry, such as an ASIC, or semicustom circuitry resulting from configuring a programmable logic device. As yet a further alternative, a processor may be a portion of a larger circuit or semiconductor device, whether commercially available, semicustom or custom. As a specific example, some commercially available microprocessors have multiple cores such that one or a subset of those cores may constitute a processor. Though, a processor may be implemented using circuitry in any suitable format.” As such, the Applicant’s “at least one processor,” is also reasonably interpreted as a generic, well-known, and conventional data gathering computing element commercially available today.
Finally, the Applicant’s claimed “a communication network,” as described in para. [0083] of the Applicant’s written description as originally filed, provides the following: “[0083] Communication network 102 may include a wired and/or wireless network over which computer 110 and devices 120 may communicate. In some embodiments, communication network 102 may also facilitate access to a patient's electronic health records, the patient's healthcare provider, and/or contacts of the patient. In some embodiments, communication network 102 may include the Internet. In some embodiments, communication network 102 may include a local area network (LAN), a wireless local area network (WLAN) such as Wi-Fi, a Bluetooth network, or other suitable networks.” As such, the Applicant’s “a communication network,” is also reasonably interpreted as a generic, well-known, and conventional data gathering computing element commercially available today. Thus, the Applicant’s own specification discloses “a device,” “at least one processor,” and “a communication network,” as ubiquitous standard equipment within modern computing and does not provide anything significantly more. Therefore, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 2-9, 11-15 and 17-20 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-9, 11-15 and 17-20 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to claim 1, 10 or 16. Therefore, claims 1-20 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject-matter.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
Claims 1, 2, 3, 5, 10, 11 and 16-18 recite the following limitation: “an acute physical suicide treatment.” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitation is reasonably rejected under a theory of new matter. Therefore, claims 1, 2, 3, 5, 10, 11 and 16-18 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement. Claims 2-9, 11-15 and 17-20 are also rejected under 35 U.S.C. § 112(a), based on their respective dependencies to claim 1, 10 or 16.
Claims 1-4, 6-7, 10, 12-14, 16 and 18-19 recite the following limitation: “a behavioral suicide treatment.” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitation is reasonably rejected under a theory of new matter. Therefore, claims 1-4, 6-7, 10, 12-14, 16 and 18-19 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement. Claims 2-9, 11-15 and 17-20 are also rejected under 35 U.S.C. § 112(a), based on their respective dependencies to claim 1, 10 or 16.
Response to Arguments
The Applicant’s arguments filed on July 9, 2026 related to claims 1-20 are fully considered, but are not persuasive.
Rejections Under 35 U.S.C. § 101
A. Step 2A Prong 2: Practical Application Through Particular Treatment Under Vanda
The Applicant respectfully argues “The amended claims recite a method of treating patients with suicidal ideation by combining an acute physical suicide treatment with a processor-adapted behavioral suicide treatment within 48 hours. For example, amended claim 1 recites "administering. an acute physical suicide treatment" "adapting a behavioral suicide treatment of the patient, including adapting a rate or order of the behavioral suicide treatment," and "administering, by the at least one processor within 48 hours of administering the acute physical suicide treatment, to the patient, the behavioral suicide treatment to enhance effectiveness of the acute physical suicide treatment." Amended claims 10 and 16 recite analogous limitations. The claims thus enhance an acute physical suicide treatment with specifically timed and adapted behavioral treatment. This combination is unconventional and provides an unexpected improvement beyond the individual components of the combination, rendering it patent-eligible.”
The Examiner respectfully disagrees. Arguments with regard to “unconventional” and “provides an unexpected improvement,” are best suited for arguing rejections under 35 U.S.C. §§ 102 and 103. The test for 35 U.S.C. § 101 subject-matter eligibility requires claims to be examined using the “two-part Mayo test” for determining subject-matter eligibility, as previously performed above. As such, the argument is not proper for facilitating a 35 U.S.C. § 101 subject-matter eligibility discussion.
The Applicant respectfully argues “Under MPEP § 2106.04(d)(2), a claim is not directed to a judicial exception if it applies or uses the alleged exception to effect a particular treatment or prophylaxis for a disease or medical condition. The amended claims do exactly this. The claims recite a specific treatment protocol in which (A) an acute physical suicide treatment is administered to a patient, and then, (B) within 48 hours, a processor obtains patient data, adapts a behavioral suicide treatment based on that data, and administers the behavioral suicide treatment to the patient to enhance effectiveness of the acute physical treatment. This is not a claim that merely recites "treatment" and then "apply it"; the claim recites a specific multi-step treatment regimen (physical and adapted behavioral treatments within a specified window) for a specific medical condition (suicidal ideation and/or attempt).”
The Examiner respectfully disagrees. First, the Applicant’s claims are not “a specific multi-step treatment regimen.” Instead, the Applicant’s claims provide broad steps of processing data pertaining to treatment. Second, the Applicant’s written description of the specification as originally filed fail to provide any support related to the limitations of “an acute physical suicide treatment” and “a behavioral suicide treatment,” warranting a lack of written description rejection under 35 U.S.C. §112(a). As such, the argument is not persuasive.
The Applicant respectfully argues “The claims satisfy the three MPEP § 2106.04(d)(2) factors:
(a) Particularity: The treatment recited in the amended claims is particular, not generic. The claims specify the type of treatment (acute physical suicide treatment followed by processor-adapted behavioral suicide treatment), the timing (within 48 hours of the acute physical treatment), and the purpose (enhancing effectiveness of the acute physical suicide treatment). Each processor step is expressly tied to the 48-hour post-treatment window, confining the claim to a specific therapeutic application rather than all possible uses of the recited concepts. This is unlike Example 43, Claim 1, which was ineligible because it covered "any possible treatment" without specifying what the treatment is or how it relates to the identified condition.
(b) More than nominal relationship: The behavioral suicide treatment has a direct and significant therapeutic relationship to the acute physical suicide treatment. As disclosed in paragraphs [0059]-[0060] of the present application, the inventor recognized that acute treatments such as electroconvulsive therapy and ketamine reduce symptoms in the short term, but paradoxically increase suicide risk in subsequent weeks and months, and that suicide risk may be reduced independently of depression symptoms by administering behavioral treatment during or shortly after the acute treatment. The 48-hour timing is not an arbitrary time period but targets the window when the combined treatments are believed to be the most effective (e.g., patients may be most vulnerable). Moreover, this timing window is when the skilled person would have observed the physical acute treatments to be working effectively and thus would have expected behavioral treatment to be less necessary. The claimed behavioral treatment within the specified window is thus meaningfully linked to the acute physical treatment because it is specifically designed to address the post-treatment vulnerability that the inventors recognized the acute treatment creates.
(c) Not extra-solution activity: The treatment steps are the focus of the claims, not ancillary data-gathering. Unlike the claims in Mayo, where the administering step was performed in order to gather data about a natural relationship and was thus "ancillary to the overall diagnostic focus of the claims" (Vanda, 887 F.3d at 1134-35), the amended claims here are directed to treatment, not diagnosis. The obtaining and adapting steps serve the treatment objective of delivering an effective behavioral suicide treatment within the claimed post-treatment window, and the claims culminate in affirmatively administering that treatment to the patient, not merely displaying or indicating information.”
The Examiner respectfully disagrees. First, the Applicant fails to provide any “particularity” with regard to treatment by broadly collecting, analyzing and outputting data under the guise of treatment. Further, Example 43 relates to “Tracking Kidney Disease” and was identified as having a judicial exception of a “Mathematical Concept,” which was not identified in the Applicant’s case.
Second, paras. [0059]-[0060] are not commensurate with the scope of the claims. Further, the Applicant’s claims fail to articulate how “the acute physical treatment because it is specifically designed,” rendering the argument as conclusory.
Finally, the Applicant’s claims are in fact “ancillary data-gathering,” by “obtaining patient data.” The claims continue to mirror closely to “Electric Power Group” by analyzing the data via the Applicant’s step of “adapting treatment based on the patient data” and outputting a result of the analysis through “administering treatment.” As such, the argument is not persuasive.
The Applicant respectfully argues “The claims are analogous to Vanda Pharm. Inc. V. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), where the Federal Circuit held eligible claims reciting (1) a genotyping assay and (2) administering a drug at specific doses depending on the genotype. The court held that the claims were "directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome." 887 F.3d at 1136. Here, the claims recite (1) administering an acute physical suicide treatment and (2) within 48 hours, obtaining patient data, adapting a behavioral suicide treatment, and administering the behavioral suicide treatment to enhance effectiveness of the acute physical treatment. In both Vanda and the present claims, the claims prescribe a specific treatment protocol that applies patient-specific information to deliver a particular treatment, not merely an indication to adjust treatment.”
The Examiner respectfully disagrees, since a specific treatment is not claimed. Examples of “treatment” and “prophylaxis” limitations include (but are not limited to) administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. The Applicant’s (1) administering an acute physical suicide treatment and (2) within 48 hours, obtaining patient data, adapting a behavioral suicide treatment, and administering the behavioral suicide treatment to enhance effectiveness of the acute physical treatment,” merely provides the environment in which data is collected and analyzed. As such, the argument is not persuasive.
The Applicant respectfully argues “The Office Action's characterization of the claims as analogous to Electric Power Group (collecting, analyzing, displaying information) is not conceded to be appropriate, and further does not apply to the amended claims. The claims in Electric Power Group ended at information being displayed. The amended claims here go well beyond information being generated or displayed: they require affirmatively administering both an acute physical suicide treatment and a processor-adapted behavioral suicide treatment to a patient within a specific time window to achieve a specific therapeutic outcome.”
The Examiner respectfully disagrees. The “ended information” from “Electric Power Group” is an output based on the analysis. Here, the Applicant’s step of “adapting treatment based on the patient data” and outputting a result of the analysis through “administering treatment,” clearly reads on “Electric Power Group.” As such, the argument is not persuasive.
B. Step 2B: Inventive Concept in the Ordered Combination Under BASCOM
The Applicant respectfully argues “Even assuming the claims recite an abstract idea not integrated into a practical application (which is not conceded), the ordered combination of elements provides an inventive concept at Step 2B because it would not have been conventional to administer behavioral therapy within the claimed window following acute physical treatment.
Under MPEP § 2106.05, the inquiry at Step 2B requires evaluating additional elements both individually and "as an ordered combination" to determine whether they amount to significantly more than the judicial exception. MPEP § 2106.05 further provides that "the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art." To the extent the analysis in the Office Action identified only "a device," "at least one processor," and "a communication network" as additional elements, it does not apply to the amended claims that specify an acute physical treatment, especially when evaluating the combination of elements as a whole including the behavioral treatment.
Under BASCOM Global Internet V. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016), "an inventive concept may be found in the non-conventional and non-generic arrangement of the additional elements" even where individual elements are conventional. 827 F.3d at 1350. The amended claims present precisely such a non-conventional arrangement: administering an acute physical suicide treatment, followed by processor-adapted behavioral suicide treatment within 48 hours, to enhance effectiveness of the acute treatment.
Even if it were established that the claimed acute physical treatments and behavioral treatments were individually known, which is not the case on the current record, the specific ordered combination of these treatment modalities within a 48-hour window is not conventional, well-understood, or routine. The specification discloses that this combination addresses a problem recognized by the inventor: acute treatments paradoxically increase suicide risk in subsequent weeks and months (para. [0059]), and administering behavioral treatment within this window reduces that risk (para. [0060]).”
The Examiner respectfully disagrees. The Applicant’s claimed “a device,” “at least one processor,” and “a communication network,” are reasonably understood, and described in the written description of the specification as originally filed, as ubiquitous standard equipment within modern computing and does not provide anything significantly more. As such, the argument is not persuasive.
The Applicant respectfully argues “The art of record does not disclose or even suggest the claimed combination of treatment steps. While novelty alone does not establish eligibility, the unconventional nature of a combination of concrete steps is relevant to the Step 2B analysis per MPEP § 2106.05. In this case, the combination of particular treatments claimed are not themselves abstract and further are not disclosed in the art, which indicates a patent-eligible inventive concept.
To the extent that the § 101 rejections rely on the claims reciting allegedly generic computer components, the rejections should be withdrawn at least because the inventive concept does not rely on the recited computer components to provide an inventive step. The amended claims provide a specific treatment protocol combining acute physical and behavioral suicide treatments within a 48-hour window, which is the type of "non-conventional and non-generic arrangement" of elements that BASCOM found sufficient. 827 F.3d at 1350. Thus, the ordered combination of elements provides an inventive concept at Step 2B
For at least these reasons, independent claims 1, 10, and 16 are patent-eligible. Accordingly, withdrawal of the rejections of claims 1-20 under 35 U.S.C. § 101 is respectfully requested.”
The Examiner respectfully disagrees. As previously indicated above, arguments with regard to “the art of record “are best suited for arguing rejections under 35 U.S.C. §§ 102 and 103. The test for 35 U.S.C. § 101 subject-matter eligibility requires claims to be examined using the “two-part Mayo test” for determining subject-matter eligibility, as previously performed above.
Further, the Applicant is misconstruing the proper analysis under 35 U.S.C. § 101. The lack of prior art, clearing the claims of any 35 U.S.C. §§102 or 103 rejections, is not evidence of subject-matter eligibility under 35 U.S.C. §101. A prior art search is not necessary to resolve whether the additional element is a well-understood, routine, conventional activity because lack of novelty (i.e., not finding the element in the prior art) does not necessarily show that an element is well-understood, routine, conventional activity previously engaged in by those in the relevant field. In the present case, Applicant’s claims merely recite a generic computer performing generic computer functions at a high level of generality which do not meaningfully limit the claims to amount to anything “significantly more.”
Finally, the Applicant is not claiming a technologically new and improved “device,” “at least one processor,” and “communication network.” Instead, merely an application to be applied to an existing “device,” “at least one processor,” and “communication network,” which does not meaningfully limit the claims to amount to anything “significantly more.” As such, the argument is not persuasive. Therefore, the rejections under 35 U.S.C. §101 are not withdrawn.
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 extension fee 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 date of this final action.
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/Robert P Bullington, Esq./
Primary Examiner, Art Unit 3715
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