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 .
Response to Amendment
The following Office action in response to communications received August 27, 2025. Claims 19-20 have been amended. Therefore, claims 1-20 are pending and addressed below.
Applicant’s amendments to the claims are not sufficient to overcome the rejections set forth in the previous office action dated February 27, 2025.
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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1 and 19-20 are directed to a directed to reducing acute incident risks for dementia patients are provided, including methods for reducing healthcare costs, improving patient and caregiver outcomes and reducing caregiver burden.
The claim(s) recite(s) “receiving patient information for a patient, determining one or more patient risk factors based on the patient information, receiving caregiver information for at least one caregiver of the patient, determining a belief state of the at least one caregiver based on the caregiver information, determining a willingness of the at least one caregiver to change the belief state based on the caregiver information, determining one or more competencies of the at least one caregiver based on the caregiver information, determining one or more caregiver risk factors based on the belief state, the willingness of the at least one caregiver to change the belief state, and the one or more competencies of the at least one caregiver, calculating an acute incident risk, which quantifies a risk that the patient will experience an acute health incident, based on the one or more patient risk factors and the one or more caregiver risk factors, determining an engagement plan for the at least one caregiver to reduce the acute incident risk by changing the belief state of the at least one caregiver, wherein the engagement plan comprises one or more caregiver activities that require engagement with the at least one caregiver, and transmitting the caregiver engagement plan to a caregiver over a network.”
The limitations of “receiving patient information for a patient, determining one or more patient risk factors based on the patient information, receiving caregiver information for at least one caregiver of the patient, determining a belief state of the at least one caregiver based on the caregiver information, determining a willingness of the at least one caregiver to change the belief state based on the caregiver information, determining one or more competencies of the at least one caregiver based on the caregiver information, determining one or more caregiver risk factors based on the belief state, the willingness of the at least one caregiver to change the belief state, and the one or more competencies of the at least one caregiver, calculating an acute incident risk, which quantifies a risk that the patient will experience an acute health incident, based on the one or more patient risk factors and the one or more caregiver risk factors, determining an engagement plan for the at least one caregiver to reduce the acute incident risk by changing the belief state of the at least one caregiver, wherein the engagement plan comprises one or more caregiver activities that require engagement with the at least one caregiver, and transmitting the caregiver engagement plan to a caregiver over a network,” as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process concepts performed in the human mind (including an observation, evaluation, judgment, opinion), but for the recitation of generic computer components. That is, other than reciting “network, server system, first/second hardware processor, and first/second software, caregiver system,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “hardware processor” language, “receiving” in the context of this claim encompasses the user manually retrieving patient information. Similarly, the determining one or more patient risk factors based on the patient information, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “network, server system, first/second hardware processor, and first/second software, caregiver system” to perform all of the receiving, determining, calculating, transmitting, receiving and engaging steps. The “network, server system, first/second hardware processor, and first/second software, caregiver system” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has no additional elements beside the generic mentioning of a system in preamble. Claim 19 has the following additional elements (i.e., network, server system, first/second hardware processor, and first/second software, caregiver system). Claim 20 has the following additional elements (i.e., network, first/second hardware processor, server system, caregiver system). Looking to the specification, these components are described at a high level of generality (¶ 38; Specification discloses that the current invention embodiments may include patient device 20, caregiver device 30 and server 50 can be implemented on a processor enabled device with respect to FIG. 9. For example, the patient device 20 and caregiver device 30 can be a desktop computer, a laptop computer, a tablet device, a personal communication device (e.g., a smartphone) or the like.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-18 include all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein. Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-20 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Objections
Claim 20 is objected to because of the following informalities: Merely claiming a “method comprising: by at least one hardware processor of a server system,” is not clear nor does it properly claim or lay out how the amended “receiving patient information for a patient, including real-time video data of the patient during digital therapy sessions, and determining one or more patient risk factors based on automated analysis of facial expressions and body language in the real-time video data,” is carried out without structural components. Appropriate clarification and corrections are required. Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim limitation “means for (receiving, determining, calculating, delivering)” in claims 1-18 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. The disclosure is devoid of any structure that performs the function in the claim. 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 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.
Claim 19 is 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, there is no teaching in the specification of “a patient system comprising at least one third hardware processor, and third software that is configured to, when executed by the at least one third hardware processor, receiving the patient therapy from the server system over the at least one network, and deliver the patient therapy via one or both of at least one input or at least one output of the caregiver system.” Appropriate clarification and corrections are required.
Claim 20 is 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, there is no teaching in the specification of “determining one or more patient risk factors based on automated analysis of facial expressions and body language in the real-time video data.” Specification teaches in paragraphs 54-55; [54] Acute incident risk is a value that is determined by the risk module 130 and comprises and incorporates risk elements for both the dementia patient and the caregiver. Risk factors for the patient include health, behaviors, physical environment and social environment, while risk factors for the caregiver include the caregiver's decision-making ability, which incorporates the caregiver's willingness to change her belief state. [55] In one embodiment, risk module 130 is also configured to combine the patient and caregiver risk factors into a single value that represents the acute incident risk for the patient and more specifically, for the specific combination of patient and caregiver at a given moment. There are many other risk factors recognized by the inventors that can also be included in the determination of acute incident risk, including for example the activation level of the physician because more activated physicians have patients that are more compliant with treatment protocols. Accordingly, in one embodiment, the risk module 130 is configured to determine the patient's acute incident risk by assessing the patient and a plurality of caregivers (e.g., a primary caregiver and a physician; a primary caregiver and a family member; a primary caregiver and a physician and a family member; or a physician and a family member). In addition, paragraph [61] teaches: In one embodiment, measurement module 160 is configured to coordinate with therapy module 22 on patient device 20 to continuously assess the effectiveness of digital therapies administered to the dementia patient during a digital therapy session. In this case, therapy module 22 is configured to record video imagery of the dementia patient engaging in a digital therapy session and to coordinate with activity module 220 to automatically analyze the facial features and body language of the patient in order to assess the patient's engagement in the digital therapy, as well as the overall effectiveness of the digital therapy. Nowhere in specification does it explicitly teach risk factors are based on automated analysis of facial expressions and body language in the real-time video data. Appropriate clarification and corrections are required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130059283 A1 to NAGAOKA et al. in view of Patent No.: US 9875450 B1 to Hendrick, III et al US 20110131120 A1 to Sciuk.
As per Claim 1, NAGAOKA et al. teaches a system (see NAGAOKA et al. paragraph 190) comprising:
-- means for receiving patient information for a patient (see NAGAOKA et al. paragraphs 7-16; A first technical means of the present invention is a dementia care support system for outputting countermeasure information to dementia, comprising: a storage portion for storing information of questions given to a patient of the dementia or a caregiver of the patient and the countermeasure information to the dementia; a countermeasure information selection portion for selecting any of the countermeasure information stored in the storage portion based on information of an answer of the patient or the caregiver to the question; and a countermeasure information output portion for outputting the countermeasure information selected by the countermeasure information selection portion.);
-- means for determining one or more patient risk factors based on the patient information (see NAGAOKA et al. paragraphs 7-16);
-- means for receiving caregiver information for at least one caregiver of the patient (see NAGAOKA et al. paragraphs 7-16);
-- means for determining a belief state of the at least one caregiver based on the caregiver information (see NAGAOKA et al. paragraphs 7-16);
-- means for determining a willingness of the at least one caregiver to change the belief state based on the caregiver information (see NAGAOKA et al. paragraphs 7-16; A third technical means of the present invention is the dementia care support system as defined in the second technical means, further comprising: a behavior/affect information alternative setting portion for setting, information of behavior or affect to be included in the alternatives based on a frequency of the information of behavior or affect that is received by the text input when the information of behavior or affect (e.g. willingness) of the patient or the caregiver is received by selection from among alternatives or text input.);
-- means for determining one or more competencies of the at least one caregiver based on the caregiver information (see NAGAOKA et al. paragraphs 7-16);
-- means for determining an engagement plan for the at least one caregiver to reduce the acute incident risk by changing the belief state of the at least one caregiver, wherein the engagement plan comprises one or more caregiver activities that require engagement with the at least one caregiver (see NAGAOKA et al. paragraphs 7-16); and
-- means for delivering the engagement plan to the at least one caregiver (see NAGAOKA et al. paragraphs 7-16).
NAGAOKA et al. fails to explicitly teach:
-- means for calculating an acute incident risk, which quantifies a risk that the patient will experience an acute health incident, based on the one or more patient risk factors and the one or more caregiver risk factors; and
-- means for determining one or more caregiver risk factors based on the belief state, the willingness of the at least one caregiver to change the belief state, and the one or more competencies of the at least one caregiver.
In one embodiment, the Auto-Assessment Ranking (AAR) gives a relative ranking to each resident in a facility based on a series of measures captured by the system. Residents are “ranked” on a scale that indicates the relative level of assistance the resident requires. The relative ranking is used for a number of reasons. First, it allows the facility to identify the residents with more acute needs. Second, it allows the health of each individual resident to have their health evaluated in a “crowd-sourced” method. The best ranking attainable may be a score of 1, wherein the worst possible score can be adjusted according to the facility (see Hendrick, III et al. Col 20 || 19-29)
Note that some instances are preceded by other point-generating events which compound the scoring to reflect the severity of the event. i.e. Out of bed during sleeping hours is +10 points, and Fall Detection by Logic (FDL) is +10 points. Both points would be accrued in an FDL event resulting in a total of +20 points. One of skill in the art may appreciate that these factors capture a relatively comprehensive and quantifiable perspective of each resident, wherein the risk that any one factor taken alone may potentially skew the scoring is mitigated by the breadth of the factors taken into account. However, such an array of factors is not intended as limiting on the scope of a system and method as disclosed herein, and any number of equivalent algorithms, combinations or the like may be implemented, either in a rules-based architecture or as part of a machine learning engine, for the implementation of the method described herein (see Hendrick, III et al. Col 21 || 29-45).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Hendrick, III et al. within the systems/methods as taught by reference NAGAOKA et al. with the motivation of providing reporting devices and accompanying sensors in various embodiments joined to utilize a single network over which a plurality of data can be sent, thereby establishing a more comprehensive smart remote monitoring system (see Col 7 || 57-61 Hendrick, III et al.).
NAGAOKA et al. and Hendrick, III et al. fail to explicitly teach:
-- means for determining one or more caregiver risk factors based on the belief state, the willingness of the at least one caregiver to change the belief state, and the one or more competencies of the at least one caregiver.
Sciuk teaches modules implemented in software for execution by various types of processors. The various system components and/or modules discussed herein may include one or more of the following: a host server or other computing systems including a processor for processing digital data; a memory coupled to said processor for storing digital data; an input digitizer coupled to the processor for inputting digital data; an application program stored in said memory and accessible by said processor for directing processing of digital data by said processor; a display device coupled to the processor and memory for displaying information derived from digital data processed by said processor; and a plurality of databases. Further discloses a free-text description of a provider that may include 1) the type of position(s) desired and 2) a description of some of the provider's characteristics. In the employment context, a resume may include a description of a candidate's experience, education and skills For each provider, the body of information comprising a resume may be stored (such as a record in a database) without reference to a particular order (see Sciuk paragraphs 128, 137-138, 140 and 161).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include systems/methods as taught by reference Sciuk with the system/method as taught by reference NAGAOKA et al. and Hendrick, III et al. with the motivation of providing a system and method whereby humans or human organizations may be sought out, matched up and/or selected through a series of steps that are managed automatically with little or no human intervention (Sciuk. paragraph 5).
As per Claim 2, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 1, further comprising:
-- a server system configured to identify one or more personalized digital therapies for the patient based on the patient information (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise plan as needed and modify the dosage of medicine as appropriate. A modified exercise/therapy plan and new dosage plan is then pushed to the patient and the cycle repeats as needed); and
-- a patient system configured to receive the one or more personalized digital therapies from the server system over at least one network, and provide each of the one or more personalized digital therapies to the patient via one or both of at least one input or at least one output of the patient system (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 3, NAGAOKA et al., Hendrick, III et al. and Sciuk teach system of Claim 2, wherein the one or more personalized digital therapies comprise a psychosocial therapy (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 4, NAGAOKA et al., Hendrick, III et al. and Sciuk teach system of Claim 2, wherein the one or more personalized digital therapies comprise a cognitive enrichment therapy (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 5, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the one or more personalized digital therapies comprises both a psychosocial therapy and a cognitive enrichment therapy, and wherein the server system is further configured to identify the one or more personalized digital therapies by determining a proportion of psychosocial therapy relative to cognitive enrichment therapy based on the patient information (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 6, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 5, wherein the cognitive enrichment therapy requires more interaction by the patient than the psychosocial therapy (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 7, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 5, wherein the server system is further configured to determine the proportion of psychosocial therapy relative to cognitive enrichment therapy based on the patient information by:
-- when the patient is in an earlier stage of a disease, selecting a higher proportion of the cognitive enrichment therapy and a lower proportion of the psychosocial therapy; and when the patient is in a later stage of the disease, selecting a higher proportion of the psychosocial therapy and a lower proportion of the cognitive enrichment therapy (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 8, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein at least one of the one or more personalized digital therapies is configured to activate neural activity in a brain region that is targeted by a pharmaceutical compound with which the patient is being treated (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 9, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the server system is further configured to identify the one or more personalized digital therapies by:
-- determining a brain region of the patient to be targeted based on the patient information; and selecting at least one personalized digital therapy that targets the determined brain region (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 11, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the server system is further configured to identify the one or more personalized digital therapies by:
-- determining whether or not personal media for the patient are available in the patient information; when determining that personal media for the patient are available in the patient information, providing at least one personalized digital therapy that comprises the personal media; and when determining that personal media for the patient are not available in the patient information, providing at least one personalized digital therapy that comprises media from a content library (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 12, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the server system is further configured to identify the one or more personalized digital therapies by selecting at least one personalized digital therapy based on an ability of the patient to interact with the at least one input or the at least one output of the patient system (see Hendrick, III et al. Col 7 || 25-35; The “user interface” as used herein may unless otherwise stated include any input-output module with respect to the hosted server including but not limited to web portals, such as individual web pages or those collectively defining a hosted website, mobile desktop applications, telephony interfaces such as interactive voice response (IVR), and the like. Such interfaces may in a broader sense include pop-ups or links to third party websites for the purpose of further accessing and/or integrating associated materials, data or program functions via the hosted system and in accordance with methods of the present disclosure. ).
As per Claim 13, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the server system is further configured to adjust the one or more personalized digital therapies for the patient over time, based on a progression of a disease of the patient (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 14, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 2, wherein the server system is further configured to relay one or more messages between a caregiver system of the caregiver and the patient system (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 15, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 14, wherein the server system is further configured to filter at least one message from the caregiver system to the patient system based on current information associated with the patient (see Sciuk paragraphs 128, 137-138, 140 and 161; After completion of an exercise session, post exercise tests 115 are performed by the patient to ascertain post exercise health and to provide input for consideration in analyzing the effectiveness of the exercise session. Data from all of the application systems 100 is transmitted to a receiving server system 300 wherein data is stored, scored and analyzed before an updated plan is sent to the plan server 400. When a new plan is received, a health care provider may review the plan and modify the exercise/therapy plan as needed and modify the dosage of medicine as appropriate. A modified exercise plan and new dosage plan is then pushed to the patient and the cycle repeats as needed).
As per Claim 16, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 15, wherein the patient is a dementia patient, and wherein the current information comprises a current state of the dementia patient (see NAGAOKA et al. paragraph 192; As described above, according to the present invention, it is possible to support a doctor so that the doctor is able to grasp a symptom and the like of a patient by asking questions the patient and a caregiver to present appropriate countermeasures corresponding to the symptom of the patient to the patient and the caregiver. Thereby, a caregiver understands and implements an appropriate countermeasure suitable for a patient so that it is possible to expect that a peripheral symptom of the patient is relieved. Further, it is possible to expect that burdens on a dementia patient and a caregiver are relieved.).
As per Claim 17, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 14, wherein the server system is further configured to ensure that the one or more messages consist only of emoticons (see Hendrick, III et al. Col 4 || 50-59; In various embodiments, a host system in accordance with the present disclosure may generally be able to make information available about a subject and distribute that information via internet, phone, text, tweet, smart watch (i.e. Pebble), etc. The system may issue alerts that prompt for intervention via, e-mail, text, tweet, phone call, smart watch (i.e. Pebble) or other communication means. The system may generate a newsletter of aggregate and/or select information from the data set(s), automate social network postings, and serve as an addendum to care record and/or EHRs (Electronic Health Records).).
As per Claim 18, NAGAOKA et al., Hendrick, III et al. and Sciuk teach the system of Claim 1, wherein the patient is a dementia patient (see NAGAOKA et al. paragraph 192; As described above, according to the present invention, it is possible to support a doctor so that the doctor is able to grasp a symptom and the like of a patient by asking questions the patient and a caregiver to present appropriate countermeasures corresponding to the symptom of the patient to the patient and the caregiver. Thereby, a caregiver understands and implements an appropriate countermeasure suitable for a patient so that it is possible to expect that a peripheral symptom of the patient is relieved. Further, it is possible to expect that burdens on a dementia patient and a caregiver are relieved.).
As per Claim 19, Claim 19 is directed to a system. Claim 19 recites the same or substantially similar limitations as those addressed above for Claim 1 as taught by NAGAOKA et al., Hendrick, III et al. and Sciuk. Claim 19 is therefore rejected for the same reasons as set forth above for Claim 1 respectively.
As per Claim 20, Claim 20 is directed to a method. Claim 20 recites the same or substantially similar limitations as those addressed above for Claim 1 as taught by NAGAOKA et al., Hendrick, III et al. and Sciuk. Claim 20 is therefore rejected for the same reasons as set forth above for Claim 1 respectively.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over NAGAOKA et al., Hendrick, III et al. and Sciuk as applied to claims 1-9 and 11-20 above, and further in view of Pub. No.: US 20140052475 A1 to Madan et al.
As per Claim 10, NAGAOKA et al., Hendrick, III et al. and Sciuk fail to teach the system of Claim 2, wherein the one or more personalized digital therapies comprise displaying personal imagery of the patient.
Madan et al. teaches alternatively at Block S150, prompting the care provider to enter a custom textual and/or image-based (e.g., infographic) notification for the patient and then pass the notification back to the patient (see paragraph 128 Pub. No.: US 20140052475 A1 to Madan et al.).
Therefore it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Madan et al. with the systems/methods as taught by reference NAGAOKA et al., Hendrick, III et al. and Sciuk with the motivation of providing health-related data that can be implemented within a patient's mobile computing device to privately guide a patient through a treatment program by a care provider, thereby anticipating the risk of increasing medical symptoms or risk of a change in health status of the patient, by a doctor to monitor a patient's progress or to modify a prescription, by a nurse to identify a need to provide manual support to the patient, and/or by a pharmacologist to research drug therapies and drug responses within a population, etc. (see Madan et al. paragraph 33 ).
Response to Arguments
Applicant’s arguments filed August 27, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
Claim Interpretation, Claim Rejections Under 35 U.S.C. 112 & Claim Rejections Under 35 U.S.C. §101.
Claim Rejections Under 35 U.S.C. §103
In response to argument (1), the Examiner has considered Applicant's arguments regarding the definiteness of claims 1-18. The arguments are not persuasive, and the rejection under 35 U.S.C. 112(b) is maintained. Furthermore, for the avoidance of doubt and as required by examination procedure, the rejection of claim 1 under 35 U.S.C. 101 is also maintained for the reasons stated below.
Regarding 35 U.S.C. 112(b) Indefiniteness:
Applicant correctly notes that for a computer-implemented means-plus-function claim, the specification must disclose an algorithm that defines the structure of the special-purpose computer. However, the arguments fail to identify a specific, concrete algorithm for performing the claimed functions. While Figures 4 and 5 and paragraphs [96] and [99] describe a high-level process flow, they do not provide the requisite algorithmic detail for the specific functions recited. For example, the claim requires "means for determining a belief state of the at least one caregiver" and "means for determining a willingness... to change the belief state." The cited figures and paragraphs describe only the inputs and outputs of such determinations (e.g., receiving caregiver information, outputting an engagement plan) without disclosing the mathematical, logical, or decision-making steps the processor must execute to transform the input data into these specific, abstract psychological constructs. Merely pointing to a generic processor in Figure 9 and stating it is "programmed" to carry out the flowcharts is insufficient. The specification must disclose the how—the algorithm itself—not just the result. As such, one of ordinary skill in the art would not be apprised of the specific structure corresponding to the claimed means, rendering the claims indefinite.
Regarding 35 U.S.C. 101 Patent Eligibility:
Even assuming, arguendo, that the claims were definite, claim 1 is directed to patent-ineligible subject matter. Under Step 2A Prong One, the claim is directed to the abstract idea of "gathering and analyzing information about a patient and a caregiver to assess risk and formulate a plan." This is a mental process that mirrors the cognitive steps a healthcare coordinator would perform: evaluating patient risk factors, assessing a caregiver's mindset and competency, calculating a combined risk, and devising an engagement strategy. The claim's use of generic "means for" language to recite data reception, determination, calculation, and delivery merely automates this abstract, human-centric process of evaluation and planning.
Proceeding to Step 2A Prong Two, the claim elements, individually and in combination, do not integrate this abstract idea into a practical application. The recited means are implemented on generic computing components (as implied by Figure 9) performing generic computer functions (receiving, processing, outputting data). No specific, non-conventional technological improvement to computer functionality or any other technology is claimed. The alleged innovation lies in the abstract concept of modeling caregiver belief states and willingness to change—a psychological and managerial method—not in a novel technological implementation. The claim's tie to the field of healthcare is merely a field-of-use limitation, which is insufficient to transform the judicial exception into a patent-eligible application. Therefore, claim 1 fails both prongs of the Alice test.
In summary, the claims are indefinite for failing to disclose corresponding algorithmic structure for the computer-implemented means-plus-function limitations, and, separately, claim 1 is directed to non-statutory subject matter. Both rejections are maintained.
In response to argument (2), the Examiner has considered Applicant's arguments and respectfully disagrees.
Applicant’s arguments have been considered but are not persuasive with respect to the rejection under 35 U.S.C. §103. Because claims 1–18 invoke 35 U.S.C. §112(f), each “means for” limitation is interpreted to cover only the function recited in the claim and the corresponding structure disclosed in the specification. As explained in the prior Office Action, the specification fails to disclose any specialized structure or algorithm that meaningfully limits the scope of the claimed “means.” As a result, and under the broadest reasonable interpretation, each “means for” limitation reads on any technique capable of performing the recited function, including manual, mental, or pen-and-paper implementations. In other words, the claim as interpreted under §112(f) encompasses non-computerized methods of receiving information, determining risk factors, evaluating caregiver attitudes or competencies, calculating risks, and generating engagement plans. Under this broad interpretation, the claimed subject matter represents a collection of well-known human processes involving clinical assessment and caregiver evaluation, which have long been performed by clinicians, social workers, case managers, and care-coordination professionals.
For example, the limitation “means for receiving patient information” broadly covers a clinician manually reviewing a paper chart, intake form, or asking the patient questions. The “means for determining one or more patient risk factors” reads on a nurse or physician mentally identifying risk factors based on patient history, such as age, comorbidities, or medication adherence. The “means for determining a belief state of the caregiver” covers a social worker interviewing a caregiver and evaluating their understanding of the patient’s condition. The “means for determining willingness of the caregiver to change the belief state” can be performed by a case manager using standardized motivational-interviewing techniques. The “means for determining caregiver competencies” is routine in the field of caregiving, where professionals routinely assess whether a caregiver can manage medication schedules or perform daily tasks. Similarly, “means for calculating an acute incident risk” can be performed mentally using known risk-scoring sheets, triage protocols, or checklists. Finally, “means for determining an engagement plan” and “means for delivering the engagement plan” include familiar actions such as a clinician writing care instructions or handing the caregiver a checklist of recommended activities.
Because the claim limitations, under the proper §112(f) interpretation, do not require any specialized computer structure or technical improvement, the prior art cited in the §103 rejection renders the claim obvious. The cited references collectively teach (or render obvious) the steps of gathering patient and caregiver information, evaluating risks, assessing caregiver readiness and competencies, calculating incident likelihood, and generating care-engagement plans—activities well established in the medical and care-coordination fields. Applicant has not identified any structural feature or non-obvious technical improvement distinguishing the claim over the prior art. Accordingly, the rejection under 35 U.S.C. §103 is maintained.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20140113263 A1: Another approach is cognitive training on computers. Among the computer methods to train decision making skills are systems based on decision trees that embody diagnostic and treatment algorithms at the case level. These include no biomechanistic processes, and the user is limited to selecting one of the pre-scripted options at fixed points in case (see, e.g., E. H. Shortliffe, "The computer and clinical decision making: Good advice is not enough," in IEEE Engineering in Medicine and Biology Magazine, v8, pp. 16-18, 1982).
US 20140172442 A1: New methods and machine implemented systems measure patient health symptoms and clinical endpoints, communicate prescribed exercise programs to patients, coach or encourage patients to exert themselves within a predetermined protocol or beyond accustomed levels (in treatment of Parkinson's disease), or below accustomed levels (in treatment of cardiac rehabilitation), track patient compliance to exercise instructions, record and commutate data for physician review and for system optimization wherein databases of exercise programs may be modified to comport with measured patient success. Measurements of patient exercises and health changes are also used to provide refined diagnosis and status of disease. Individual exercise programs may be modified in response to physician input and/or patient progress. The continues loop feedback between a patient and the system optimizes the use of exercise as a treatment for disease.
US 9560967 B2: Apparatus and systems are described that include physical media related to accepting at least one attribute associated with an individual from a licensed health care provider and/or presenting an output of an artificial sensory experience associated with a request to measure at least one effect of a bioactive agent on the attribute associated with individual.
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 EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683
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