DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/1/2025 has been entered.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the amendment dated 8/1/2025, the following has occurred: Claims 1 – 18 have been canceled; Claims 19 – 22 have been added.
Claims 19 – 22 are pending.
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 19 – 22 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.
The claims, understood as a whole, recites subject matter within a statutory category as a process (claims 19 – 22) which recites the abstract idea steps of
(A) receiving first patient information related to the patient wherein the first patient information includes historical medical records of the patient and/or historical police records of the patient;
(B) receiving first incident information regarding a first incident involving the patient, wherein the first incident information includes a location of the first incident and one or more circumstances of the first incident;
(C) creating mathematical relationships using the first patient information and the first incident information to create a first algorithm and using the first algorithm to formulate first response information pertaining to the incident, the first response information including at least a series of questions to ask the patient;
(D) providing the first patient information, the first incident information and the first response information to a first user and deploying the first user to the location of the first incident:
(E) instructing the first user to implement the first response information to the patient at the location of the first incident:
(F) receiving first result information from the first user regarding an outcome of the implementation of the first response information;
(G) creating mathematical relationships using the first patient information, the first incident information, the first response information and the first result information to create a second algorithm, and using the second algorithm and the response formulation module to formulate second response information pertaining to the incident;
(H) creating mathematical relationships using the first patient information, the first incident information, the first response information, the first result information and the second response information to create a third algorithm, and using the third algorithm and a treatment table to determine a mental health disorder of the patient;
(I) determining, using the treatment table and the third algorithm and the determined mental health disorder, a medical treatment to treat the mental health disorder of the patient; and
(J) administering the medical treatment to the patient to treat the mental health disorder;
wherein the mental health disorder includes depression and suicidal thoughts, and the medical treatment includes the administration of a selective serotonin reuptake inhibitor
These steps of claims 19 – 22, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner understands the claimed invention in light of the Specification. As noted in paragraph 2,
FIELD OF THE INVENTION
[0002] This invention relates to systems and methods for providing health care, including a system that provides mental health care response guidance and treatments.
The invention as claimed and disclosed is not directed toward a technological improvement or an improvement in a technological field. The result of the invention is medical information that has a potential usage.
The invention is not toward a particular “treatment” for a particular disease. There is no claimed or disclosed relationship between the received “information” and the treatment provided. For example the only location for determining a disorder is found in paragraph 57
[0057] In some embodiments, the treatment module 508 processes information received by the data acquisition module 502, by the response formulation module 504, and/or by the communications module 506 ( e.g., via an external entity 400) and determines one or more mental health disorders that the patient P may be suffering from. Next, the treatment module 508 uses the aforementioned information to determine one or more treatment plans to administer to the patient P. Subsequently, the system 10 administers the treatment plan to the patient P as described herein.
Regarding the last two limitations, please See MPEP 2106.04(d)(2) Particular Treatment and Prophylaxis in Step 2A Prong Two. As stated within the cited MPEP section
a. The Particularity Or Generality Of The Treatment Or Prophylaxis
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). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.
The limitations are towards a generic treatment, “the medical treatment includes the administration of a selective serotonin reuptake inhibitor.” Please see below regarding the “treatment module” discussion.
The “machine learning” is part of the abstract idea.
[0016] In some embodiments, as shown in FIG. 3, the response formulation module 504 employs artificial intelligence (Al) using current and historical incident data and current and historical patient information to predict possible incident outcomes and to formulate a recommended incident response. For example, in some embodiments, the response formulation module 504 employs the machine learning module 512 which includes neural networks, deep learning, logic tree decisions, fuzzy logic, smart agent profiling, and case reasoning to predict possible incident outcomes and to formulate a recommended incident response.
[0039] In some embodiments, as shown in FIG. 3, the treatment module 508 employs artificial intelligence (Al) using current and historical incident data, current and historical patient information, and current and historical incident response information to formulate a recommended treatment. For example, in some embodiments, the treatment module 504 employs the machine learning module 512 which includes neural networks, deep learning, logic tree decisions, fuzzy logic, smart agent profiling, and case reasoning to predict possible incident outcomes and to formulate a recommended treatment.
Per the latest guidance, the Applicant’s list of generic processes is understood to be the step of creating mathematical relationships.
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of by one or more computers amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving first information amounts to mere data gathering, recitation of administering amounts to insignificant application, see MPEP 2106.05(g))
It should be understood that the claimed invention is similar to Mayo, MPEP 2106.04(d)2 . In particular, the court explained that Mayo’s step of administering a drug to a patient was performed in order to gather data about the recited laws of nature, and this step was thus ancillary to the overall diagnostic focus of the claims.
Please see the discussion above regarding Vanda.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 20 – 22, additional limitations which amount to invoking computers as a tool to perform the abstract idea,). 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 improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 19 – 22; by one or more computer systems, receiving, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); determining mental health disorder, determining treatment, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)
Additional Elements:
one or more computer systems- paragraphs 19, 20, 131, Figure 1, system 10
mobile phone – paragraph 20
machine learning – paragraphs 48 – 50
treatment module – please see below and paragraphs 34,
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 20 – 22, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, determining a mental health disorder, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). 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 improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: treatment module in claim 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 19 – 22 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. This is a written description rejection.
Claim limitation “treatment module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
(i) the disclosure is devoid of any structure that performs the function in the claim,
(ii) the structure described in the specification does not perform the entire function in the claim, or
(iii) no association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The Specification does not disclose the algorithm within the treatment module for determining a medical treatment to treat the mental health disorder. Further, the Specification does not disclose how the claims module or modules “includes the administration of a selective serotonin reuptake inhibitor.”
Response to Arguments
Applicant’s arguments, see Objections and Rejections, filed 8/1/2025, with respect to canceled claims 1 – 18 have been fully considered and are persuasive. The objections and rejections of canceled claims 1 – 18 has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kalia et al Pub. No.: US 2021/0082554 Techniques are described for providing live first aid response guidance using a machine learning based cognitive aid planner.
Scanlin Pub. No.: US 2021/0267515 A method for determining a state of mind of a user may include receiving one or more strings of characters composed by the user, and determining, by a processing device, the state of mind of the user by processing the one or more strings of characters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626