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 .
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
This is a response to Applicant’s amendment filed on 22 October 2025, wherein:
Claims 1-3 are canceled.
Claims 4-14 are new.
Claims 4-14 are pending.
Specification
The abstract of the disclosure is objected to because it is numbered. Numbering the paragraphs of the specification does not include the claims or the abstract. See 37 CFR. 1.52. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 4-14 are objected to because of the following informalities:
Claims 4, 13, and 14 each recite the term “baseline” as one word and as two words. Uniformity is recommended.
Dependent claims 5-12 inherit the deficiencies of their respective parent claims, and are thus objected to under the same rationale.
Appropriate correction is required.
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.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, it is unclear what constitutes a “type” that the user is classified as “at least one type selected from: stress-response type, representing characteristic biometric and event-log patterns in response to people, places, activities, or events; and relaxation-response type, representing characteristic effectiveness patterns for relaxation activities, based on prior user ratings and cohort-comparative outcomes” and how a user could classified in one or both. In particular, it is unclear what constitutes a “stress-response type” and a “relaxation-response type”. Is this a stressed state and a relaxed state or something else? What each is claimed to be representing does not aid understanding as they do not define what each type is. The disclosure also does not aid understanding as it is silent regarding such language. Thus, one of ordinary skill in the art would not be apprised of the metes and bounds of the patent protection sought.
The text of those sections of Title 35, U.S. Code 112(a) not included in this action can be found in a prior Office action.
Claims 4-14 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.
Regarding claims 4-6, 13, and 14, the originally filed disclosure is silent regarding the new limitation “establishing a cohort base line based on the selected cohort data; computing, in real time, for each deviation of the acquired biometric data relative to the selected cohort data, a speed, wherein the speed is a rate of change of the deviation of the biometric data; a magnitude, wherein the magnitude is a degree of deviation from the cohort baseline; and a persistence, wherein persistence is a duration of the deviation above the cohort baseline; classifying the deviation as a high-, medium-, or low-urgency event based on at least one of the computed speed, magnitude, and persistence exceeding a defined threshold value” in claims 4, 13, and 14, “wherein classifying the deviation as a high-, medium-, or low-urgency event is based on at least two of the computed speed, magnitude, and persistence exceeding their defined threshold value” in claim 5, and “wherein classifying the deviation as a high-, medium-, or low-urgency event comprises computing a weighted combination of the computed speed, magnitude, and persistence” in claim 6. There are two statutory provisions that prohibit the introduction of new matter. The first provision is 35 USC 132, which provides that no amendment shall introduce new matter into the disclosure of the invention. If new matter is added to the claims, the examiner should reject the claims under 35 USC 112(a) – written description requirement. See MPEP 2163.06. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). However, the disclosure is silent regarding a cohort baseline, let alone any steps for establishing a cohort baseline or comparing biometric data against one. Similarly, the originally filed disclosure is silent regarding speed being “a rate of change of the deviation of the biometric data”, magnitude being “a degree of deviation from the cohort baseline”, and a persistence. With particular respect to “a persistence”, this is also a new matter term. While the specification does discuss a duration of the deviation of a change to the stress response level, this is not a “duration of the deviation above the cohort baseline”. Thus, these limitations are new matter. Dependent claims 5-12 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Regarding claims 4, 9, 13, and 14, the originally filed disclosure is silent regarding the new limitation “computing a cumulative stress burden index over a defined period of time, wherein the cumulative stress burden index is based on the magnitude and persistence of the deviation normalized to the selected cohort data” in claims 4, 13, and 14 and “further comprising generating a report including: plots of longitudinal variation in cumulative stress burden index; comparative plots of the user against selected cohorts; and analysis of relative effectiveness of relaxation activities” in claim 9. There are two statutory provisions that prohibit the introduction of new matter. The first provision is 35 USC 132, which provides that no amendment shall introduce new matter into the disclosure of the invention. If new matter is added to the claims, the examiner should reject the claims under 35 USC 112(a) – written description requirement. See MPEP 2163.06. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). However, the disclosure is silent regarding a stress burden index, let alone a cumulative stress burden index based on the magnitude and persistence of the deviation normalized to the selected cohort data, comparative plots of the user against selected cohorts, and analysis of relative effectiveness of relaxation activities. Thus, these are all new matter. Dependent claims 5-12 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Further regarding claims 4, 13, and 14, the disclosure further fails to provide sufficient written description for “selecting, from a recommendation database, a relaxation activity and/or course of action for each deviation, wherein the relaxation activity and/or course of action is associated with prior measured effectiveness for a comparable deviation event” to show one of ordinary skill in the art that Applicant had possession of the claimed invention. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). The specification merely recites similar language as the claim without providing sufficient description of the steps, calculations, or formulas necessary to perform the claimed functionality. See, for example, Fig. 7 and at least para. 54-62 of the specification which merely recite that the function is performed in results-based language without any meaningful description. For instance, para. 61 recites that the data in the recommendation database may be adjusted by a machine learning algorithm, but neither the algorithm itself nor its parameters are disclosed. Dependent claims 5-12 inherit the deficiencies of their respective parent claims, and are thus rejected under the same rationale.
Regarding claims 8, 10, and 11, the disclosure further fails to provide sufficient written description for “predicting future stress events using stored historic biometric patterns and optionally scheduled calendar events of the user” in claim 8, “generating proactive notifications in advance of a predicted future stress event, and recommending one or more relaxation activities validated by prior measured user responses” in claim 10, and “identifying, for each predicted future stress event, at least one relaxation activity associated with a highest prior effectiveness rating, the rating being derived from: a user's stored historic stress events and biometric responses; prior user-entered ratings of relaxation activity effectiveness; and cohort-comparative effectiveness data from users exposed to similar events” in claim 11 to show one of ordinary skill in the art that Applicant had possession of the claimed invention. There are two statutory provisions that prohibit the introduction of new matter. The first provision is 35 USC 132, which provides that no amendment shall introduce new matter into the disclosure of the invention. If new matter is added to the claims, the examiner should reject the claims under 35 USC 112(a) – written description requirement. See MPEP 2163.06. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). The specification, at best, merely recites similar language as the claim without providing sufficient description of the steps, calculations, or formulas necessary to perform the claimed functionality. See, for example Fig. 5 and at least para. 24, 28, 34, 48-50, 59, and 67 of the specification. For instance, Fig. 5 is recited in para. 12 of the specification to be an example of a prediction module. However, “predict upcoming events” is a single, non-descript black box, not a series of steps. Furthermore, the originally filed disclosure is silent regarding “proactive notifications” and any “relaxation activity associated with a highest prior effectiveness rating”. Thus, these are new matter. Thus, the disclosure does not provide any meaningful description of the steps, calculations, or formulas necessary to perform the claimed functionality.
Regarding claim 12, the originally filed disclosure is silent regarding “classifying the user into at least one type selected from: stress-response type, representing characteristic biometric and event-log patterns in response to people, places, activities, or events; and relaxation-response type, representing characteristic effectiveness patterns for relaxation activities, based on prior user ratings and cohort-comparative outcomes” to show one of ordinary skill in the art that Applicant had possession of the claimed invention. There are two statutory provisions that prohibit the introduction of new matter. The first provision is 35 USC 132, which provides that no amendment shall introduce new matter into the disclosure of the invention. If new matter is added to the claims, the examiner should reject the claims under 35 USC 112(a) – written description requirement. See MPEP 2163.06. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP 2161.01(I). While para. 19 of the specification recites “classify individuals into different TYPES or cohorts based on these factors”, it is silent regarding “classifying the user into at least one type selected from: stress-response type, representing characteristic biometric and event-log patterns in response to people, places, activities, or events; and relaxation-response type, representing characteristic effectiveness patterns for relaxation activities, based on prior user ratings and cohort-comparative outcomes.” Thus, this claim is new matter.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code 101 not included in this action can be found in a prior Office action.
Claims 4-14 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 including additional elements that are sufficient to amount to significantly more than the judicial exception itself.
Step 1
The instant claims are directed to a method and a product which fall under at least one of the four statutory categories (STEP 1: YES).
Step 2A, Prong 2
Independent claim 4 recites:
A computer-implemented method for stress monitoring and mitigation, the method comprising:
continuously monitoring and acquiring biometric data of a user from at least one user wearable sensor;
selecting, from a cohort database, cohort data of a cohort of persons having one or more of a similar age, occupation, gender, symptom, and condition as the user;
establishing a cohort base line based on the selected cohort data;
computing, in real time, for each deviation of the acquired biometric data relative to the selected cohort data, a speed, wherein the speed is a rate of change of the deviation of the biometric data; a magnitude, wherein the magnitude is a degree of deviation from the cohort baseline; and a persistence, wherein persistence is a duration of the deviation above the cohort baseline;
classifying the deviation as a high-, medium-, or low-urgency event based on at least one of the computed speed, magnitude, and persistence exceeding a defined threshold value;
computing a cumulative stress burden index over a defined period of time, wherein the cumulative stress burden index is based on the magnitude and persistence of the deviation normalized to the selected cohort data;
selecting, from a recommendation database, a relaxation activity and/or course of action for each deviation, wherein the relaxation activity and/or course of action is associated with prior measured effectiveness for a comparable deviation event; and
transmitting a notification to the user including the classification of the deviation, the cumulative stress burden index, and the selected relaxation activity and/or course of action.
Independent claim 13 recites:
A system for biometric data-based activity recommendation for stress mitigation, comprising:
a processor;
a memory storing instructions;
at least one user wearable biometric sensor; and
wherein the processor being configured to execute the steps of:
continuously monitoring and acquiring biometric data of a user from at least one user wearable sensor;
selecting, from a cohort database, cohort data of a cohort of persons having one or more of a similar age, occupation, gender, symptom, and condition as the user;
establishing a cohort base line based on the selected cohort data;
computing, in real time, for each deviation of the acquired biometric data relative to the selected cohort data, a speed, wherein the speed is a rate of change of the deviation of the biometric data; a magnitude, wherein the magnitude is a degree of deviation from the cohort baseline; and a persistence, wherein persistence is a duration of the deviation above the cohort baseline;
classifying the deviation as a high-, medium-, or low-urgency event based on at least one of the computed speed, magnitude, and persistence exceeding a defined threshold value;
computing a cumulative stress burden index over a defined period of time, wherein the cumulative stress burden index is based on the magnitude and persistence of the deviation normalized to the selected cohort data;
selecting, from a recommendation database, a relaxation activity and/or course of action for each deviation, wherein the relaxation activity and/or course of action is associated with prior measured effectiveness for a comparable deviation event; and
transmitting a notification to the user including the classification of the deviation, the cumulative stress burden index, and the selected relaxation activity and/or course of action.
Independent claim 14 recites:
A non-transitory computer-readable medium, comprising instructions that when executed execute the steps of:
continuously monitoring and acquiring biometric data of a user from at least one user wearable sensor;
selecting, from a cohort database, cohort data of a cohort of persons having one or more of a similar age, occupation, gender, symptom, and condition as the user;
establishing a cohort base line based on the selected cohort data;
computing, in real time, for each deviation of the acquired biometric data relative to the selected cohort data, a speed, wherein the speed is a rate of change of the deviation of the biometric data; a magnitude, wherein the magnitude is a degree of deviation from the cohort baseline; and a persistence, wherein persistence is a duration of the deviation above the cohort baseline;
classifying the deviation as a high-, medium-, or low-urgency event based on at least one of the computed speed, magnitude, and persistence exceeding a defined threshold value;
computing a cumulative stress burden index over a defined period of time, wherein the cumulative stress burden index is based on the magnitude and persistence of the deviation normalized to the selected cohort data;
selecting, from a recommendation database, a relaxation activity and/or course of action for each deviation, wherein the relaxation activity and/or course of action is associated with prior measured effectiveness for a comparable deviation event; and
transmitting a notification to the user including the classification of the deviation, the cumulative stress burden index, and the selected relaxation activity and/or course of action.
All of the foregoing underlined elements amount to the abstract idea grouping of a certain method of organizing human activity because it is managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) by merely collecting information, analyzing the information, and outputting the results of the collection and analysis. This also evidences that these elements also amount to the abstract idea grouping of mental processes because the claims, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observations, evaluations, judgments, and opinions) but for the recitation of generic computer components. See MPEP 2106.04(a)(2)(III)(C) - A Claim That Requires a Computer May Still Recite a Mental Process. It is noted that “transmitting” is considered here as part of the judicial exception as it is merely providing output directly to the user and not the normal context of transmitting data from one device to another.
The dependent claims amount to merely further defining the judicial exception.
Therefore, the claims recite a judicial exception. (STEP 2A, PRONG 1: YES).
Step 2A, Prong 2
The judicial exception is not integrated into a practical application because the independent and dependent claims do not include additional elements that are sufficient to integrate the exception into a practical application under the considerations set forth in MPEP 2106.04(d). The elements of the claims above that are not underlined constitute additional elements.
The following additional elements, both individually and as a whole, merely generally link the judicial exception to a particular technological environment or field of use: reciting the method as “computer-implemented” (claim 4), at least one user wearable sensor (claims 4 and 14), a mobile application (claim 7), a system comprising a processor, a memory, and at least one user wearable biometric sensor (claim 13), and a non-transitory computer-readable medium (claim 14). Although some of the claims recite computer components for performing at least some of the recited functions, these elements are recited at a high level of generality for performing their basic computer functions (i.e., collecting, processing, outputting data). This is evidenced by the lack of significant structure in the figures (i.e., Fig. 1 merely illustrates the elements as non-descript black boxes and while Fig. 2-10 illustrate the claimed invention as purely software) and the generic nature in which any structural items are described in the specification. See, for example, at least para. 20-33 of the specification which merely provide stock descriptions of generic computer hardware and software components in any generic arrangement and illustrate that the claimed invention is merely using a software application to cause a computer to implement the judicial exception. Thus, the components are merely an attempt to link the abstract idea to a particular technological environment, but do not result in an improvement to the technology or computer functions employed. The claims do not recite any specific rules with specific characteristics that improve the functionality of the computer system. The disclosed mere use of non-descript machine learning does not improve computer functionality as it merely invokes the use of a computer or other machinery in its ordinary capacity to process information. The at least one user wearable sensor (claim 13: at least one user wearable biometric sensor), as claimed and disclosed, merely adds insignificant extra-solution activity to the judicial exception as it mere passively recites a source of data external to the claimed invention. None of the hardware offer a meaningful limitation beyond generally linking the performance of the steps to a particular technological environment, that is, implementation via computers. Again, this is evidenced by the manner in which these elements are disclosed in the drawings and specification as identified above. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of the additional elements does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014). Additionally, the claims do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition nor do they apply or use a judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. For instance, the independent claims recite that the claimed invention is for stress mitigation. However, the claims and disclosure are silent regarding any treatment, let alone any actual treatment for any disease or medical condition. Accordingly, based on all of the considered factors, these additional elements do not integrate the abstract idea into a practical application. Therefore, the claims are directed to the judicial exception. (STEP 2A, PRONG 2: NO).
Step 2B
The independent and dependent claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception under the considerations set forth in MPEP 2106.05. As identified in Step 2A, Prong 2, above, the claimed product and the process it performs do not require the use of a particular machine, nor do they result in the transformation of an article. Although the claims recite components (identified in Step 2A, Prong 2) for performing at least some of the recited functions, these elements are recited at a high level of generality in a conventional arrangement for performing their basic computer functions (i.e., collecting, processing, outputting data). BASCOM Global Internet Servs. v. AT&T Mobility LLC (827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243-44 (2016)), Electric Power Group, LLC v. Alstom S.A. (830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). This is at least evidenced by the manner in which this is disclosed that indicates that Applicant believes the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 USC 112(a) as identified in Step 2A, Prong 2, above. Thus, the computer components are merely an attempt to link the abstract idea to a particular technological environment, but do not result in an improvement to the technology or computer functions employed. This is evidenced by at least Fig. 1 which merely illustrates elements as non-descript black boxes and the generic nature in which any structural items are described in the specification. See, for example, at least para. 20-33 of the published specification. Furthermore, the components are merely an attempt to link the abstract idea to a particular technological environment, but do not result in an improvement to the technology or computer functions employed. Again, this is evidenced by the lack of significant structure in the figures and the generic nature in which any structural items are described in the specification as identified above. The claims do not recite any specific rules with specific characteristics that improve the functionality of the computer system. Thus, the focus of the claimed invention is on the analysis of the collected data, which is itself at best merely an improvement within the abstract idea. See pg. 2-3 in SAP America Inc. v. lnvestpic, LLC (890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018) which proffered “[w]e may assume that the techniques claimed are groundbreaking, innovative, or even brilliant, but that is not enough for eligibility. Nor is it enough for subject-matter eligibility that claimed techniques be novel and nonobvious in light of prior art, passing muster under 35 U.S.C. §§ 102 and 103. The claims here are ineligible because their innovation is an innovation in ineligible subject matter. Their subject is nothing but a series of mathematical calculations based on selected information and the presentation of the results of those calculations. Furthermore, the steps are merely recited to be performed by, or using, the elements while the specification makes clear that the computerized system itself is ancillary to the claimed invention as identified above. This further identifies that none of the hardware offer a meaningful limitation beyond, at best, generally linking the performance of the steps to a particular technological environment, that is, implementation via computers. Viewed as a whole, these additional claim elements do not provide meaningful limitation to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea of itself (STEP 2B: NO).
Therefore, the claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code 102 not included in this action can be found in a prior Office action.
Claims 4 and 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adler et al. (US 2012/0290215, hereinafter referred to as Adler).
Regarding claims 4, 13, and 14, Adler teaches a computer-implemented method (claim 4) and a system comprising a processor (Adler, Fig. 1, Local 120, Remote 150, Local 130, Remote 140), a memory storing instructions (Adler, para. 408, “memory 1604 includes main memory for storing instructions for processor 1602 to execute”) and at least one user wearable biometric sensor (Adler, Fig. 1, sensor array 110) (claim 13) for stress monitoring and mitigation, and a non-transitory computer-readable medium, the method comprising:
continuously monitoring and acquiring biometric data of a user from at least one user wearable sensor (Adler, para. 43, one or more sensors 212 may measure a variety of things, including physiological, psychological, behavior, and environmental stimulus.” Para. 120, “One or more of the sensors may be affixed to a person's body.”);
selecting, from a cohort database, cohort data of a cohort of persons having one or more of a similar age, occupation, gender, symptom, and condition as the user (Adler, para. 210, “the stress model may be a stress model of one or more persons who are not currently the subject of sensor array 110. That is to say that analysis system 180 may currently be measuring and monitoring stress in a first person and the stress model may be based on baseline data of one or more second persons. This stress model of the one or more second persons may be based on baseline data collected from the second persons during a control period. Generating and using a stress model of one or more second persons may allow stress to be accurately measured in the first person without having to generate a personalized stress profile for the first person, which may be expensive and time-consuming. The first person and the one or more second persons may be in the same Subset of patients, patient group, or patient cohort. As an example and not by way of limitation, the first person and the second persons may be in the same age group, ethnic group, racial group, patient population, or another Suitable category of persons. As another example and not by way of limitation, the patients may be part of the same medically plausible subset of the patient population for a common disease or condition. Medically plausible Subsets generally include groups of patients with special requirements or characteristics that distinguish them from the larger disease grouping. A medically plausible subset may be a patient subpopulation that demonstrates unique pharmacological or pharmacodynamic characteristics.”);
establishing a cohort base line based on the selected cohort data (Adler, para. 210, “the stress model may be a stress model of one or more persons who are not currently the subject of sensor array 110. That is to say that analysis system 180 may currently be measuring and monitoring stress in a first person and the stress model may be based on baseline data of one or more second persons.”);
computing, in real time, for each deviation of the acquired biometric data relative to the selected cohort data, a speed, wherein the speed is a rate of change of the deviation of the biometric data (Adler, para. 158, “Based on the comparison, analysis system 180 may then determine whether the user's stress level has changed over time. Analysis system 180 may also model the stress level with respect to time and identify any trends in the stress level of the user.”); a magnitude, wherein the magnitude is a degree of deviation from the cohort baseline (Adler, para. 240, “Analysis system 180 may determine the current stress index of the person by determining the magnitude that each of the psychological, behavioral, or physiological states correlates with stress or lack of stress.”); and a persistence, wherein persistence is a duration of the deviation above the cohort baseline (Adler, para. 71, “a time or duration of the psychological or behavioral state may be inputted manually by the user.”);
classifying the deviation as a high-, medium-, or low-urgency event based on at least one of the computed speed, magnitude, and persistence exceeding a defined threshold value (Adler, para. 134, “the model may determine a subject's severity or grade of a disease state.” Para. 159-164, “analysis system 180 could grade the stress level of a person on a 0-to-4 Liker scale, where the five-level Likert item may be: 0. Very unstressed 1. Moderately unstressed 2. Neither stressed nor unstressed 3. Moderately stressed 4. Very stressed”);
computing a cumulative stress burden index over a defined period of time, wherein the cumulative stress burden index is based on the magnitude and persistence of the deviation normalized to the selected cohort data (Adler, para. 388, “a stress model of the patient that correlates a variety of physiological, psychological, behavioral, or environmental data of the patient with the stress or RI of the patient.”);
selecting, from a recommendation database, a relaxation activity and/or course of action for each deviation, wherein the relaxation activity and/or course of action is associated with prior measured effectiveness for a comparable deviation event (Adler, para. 158, “Based on the comparison, analysis system 180 may then determine whether the user's stress level has changed over time. Analysis system 180 may also model the stress level with respect to time and identify any trends in the stress level of the user. Based on these changes and trends in stress level, various alerts or warnings may be provided to the user or to a third-party (e.g., the user's physician).” Para. 402, “An alert may contain a notice, warning, or recommendation for the user or third-party.”); and
transmitting a notification to the user including the classification of the deviation, the cumulative stress burden index, and the selected relaxation activity and/or course of action (Adler, para. 402, “display system 190 may message one or more alerts to a user or third-party based on the analysis output. An alert may contain a notice, warning, or recommendation for the user or third-party.”).
Regarding claim 7, Adler teaches the method of claim 4, wherein the wearable sensor is configured to transmit biometric data to a mobile application (Adler, para. 120, “The method begins at step 810, where a mobile computing device accesses an original data stream from each of one or more sensors. The mobile computing device may be a data aggregation system 614 or 714, a node 114, or another suitable system.” Para. 389, “The subjects conduct their daily activities normally while various sensors continuously monitor them. The patients wear a blood-pressure monitor, an actigraph, a pulse Oximeter, the iPod Touch described above, and a data aggregation system. All of these are portable devices that the subjects can carry. Also, periodically the Subject's renal blood Velocity, blood glucose level, and cortisol level is measured. The Subjects can report psychological and behavioral data using an iPod Touch application, similar to mood sensor 400. The iPod Touch also has custom software to verify the operation of the sensors and the data aggregation system.”).
Regarding claim 8, Adler teaches the method of claim 4, further comprising predicting future stress events using stored historic biometric patterns and optionally scheduled calendar events of the user (It is noted that the scheduled calendar events of the user are not required to be taught by the prior art as this limitation is explicitly identified as optional. Regardless, Adler, para. 57, “an electronic calendar functions as a user-input sensor for gathering behavioral data. A user may input the time and day for various activities, including appointments, social interactions, phone calls, meetings, work, tasks, chores, etc. Each inputted activity may be further tagged with details, labels, and categories (e.g., ‘important,’ ‘personal,’ ‘birthday’). The electronic calendar may be any Suitable personal information manager, such as Microsoft Outlook, Lotus Notes, Google Calendar, etc. The electronic calendar may then transmit the activity data as a data stream to analysis system 180, which could map the activity data over time and correlate it with data from other sensors in sensor array110. For example, analysis system 180 may map a heart-rate data stream against the activity data stream from an electronic calendar, showing that the user's heart-rate peaked during a particularly stressful activity (e.g., dinner with the in-laws).” Para. 246, “Once the predictive model is established, analysis system 180 could then be used to predict future health states, anticipated or hypothetical sensor readings, and other aspects of a Subject's physiology or psychology.”).
Regarding claim 9, Adler teaches the method of claim 4, further comprising generating a report including: plots of longitudinal variation in cumulative stress burden index; comparative plots of the user against selected cohorts; and analysis of relative effectiveness of relaxation activities (Adler, para. 110, “a data aggregation system, analysis system 180, or display system 190 may analyze or display the results of correlating the data streams by associating each data point in the results with a timestamp.”).
Regarding claim 10, Adler teaches the method of claim 7, further comprising generating proactive notifications in advance of a predicted future stress event, and recommending one or more relaxation activities validated by prior measured user responses (Adler, para. 147, “analysis system 180 may monitor disease-state progression and other health State changes over time. As an example and not by way of limitation, analysis system 180 could continuously monitor a Subject's blood pressure over time to determine whether the Subject's hypertension is improving. Such monitoring may be used to identify trends and to generate alerts or predictions regarding possible health states.” Para. 402, “display system 190 may message one or more alerts to a user or third-party based on the analysis output. An alert may contain a notice, warning, or recommendation for the user or third-party.” Para. 403, “display system 190 may display one or more therapies to a user based on analysis output from analysis system 180.”).
Regarding claim 11, Adler teaches the method of claim 9, further comprising identifying, for each predicted future stress event, at least one relaxation activity associated with a highest prior effectiveness rating, the rating being derived from: a user's stored historic stress events and biometric responses; prior user-entered ratings of relaxation activity effectiveness; and cohort-comparative effectiveness data from users exposed to similar events (Adler, para. 309-391 disclose this under the section – Calculating and Monitoring the Efficacy of Stress-Related Therapies).
Regarding claim 12, Adler teaches the method of claim 4, further comprising classifying the user into at least one type selected from:
stress-response type, representing characteristic biometric and event-log patterns in response to people, places, activities, or events (Adler, para. 385, “The shape of the Doppler waveform clearly changed when questions were asked, making it simple to identify and distinguish stressed and relaxed stated.”); and
relaxation-response type, representing characteristic effectiveness patterns for relaxation activities, based on prior user ratings and cohort-comparative outcomes (Adler, para. 311, “Particular therapies may be associated with particular changes in the stress index of a person (i.e., stress factors). For example, one could have a “meditation stress factor a “biofeedback stress factor” a “cognitive reframing stress factor, an “intervention stress factor” and so on. Therefore, the stress index may be calibrated with respect to specific therapies. Each person may have personalized responses and recovery patterns for each type of therapy, indicating a variety of stress factors and stress resilience coefficients. Analysis system 180 may be used to measure and monitor stress factors and stress resilience. This may allow a user to determine the types of therapies that are most effective in a given individual or population, which may be useful for helping with stress management.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Adler et al. (US 2012/0290215, hereinafter referred to as Adler) as applied to claim 4 above.
Regarding claim 5, Adler teaches the method of claim 4.
While Adler does teach the criteria being computed speed, magnitude, and persistence as identified in the rejection of claim 1 above and classifying based on the criteria exceeding their defined threshold value (Adler, para. 402, “when one or more threshold criteria are met”), Adler does not explicitly teach wherein classifying the deviation as a high-, medium-, or low-urgency event is based on at least two of the computed speed, magnitude, and persistence exceeding their defined threshold value.
However, it would have been obvious to a person having ordinary skill in the art for threshold criteria in Adler to include at least two of the computed speed, magnitude, and persistence exceeding their defined threshold value since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 6, Adler teaches the method of claim 4.
While Adler does teach the criteria being computed speed, magnitude, and persistence as identified in the rejection of claim 1 above and classifying based on the criteria exceeding their defined threshold value (Adler, para. 402, “when one or more threshold criteria are met”), Adler does not explicitly teach wherein classifying the deviation as a high-, medium-, or low-urgency event comprises computing a weighted combination of the computed speed, magnitude, and persistence.
However, it would have been obvious to a person having ordinary skill in the art for threshold criteria in Adler to include computing a weighted combination of the computed speed, magnitude, and persistence since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant’s arguments with respect to the specification objection have been fully considered. The substitute specification obviates the objection. Thus, this objection has been withdrawn. However, the substitute specification necessitates a new objection.
Applicant’s arguments with respect to the rejections of claims 1-3 under 35 USC 112(a) have been fully considered. The canceling of claims 1-3 renders the associated rejections moot. Thus, these rejections have been withdrawn. However, new claims 4-14 necessitate new rejections.
Applicant’s arguments with respect to the rejections of claims 1-3 under 35 USC 101 have been fully considered but they are not persuasive. While the canceling of claims 1-3 renders the associated rejection moot, new claims 4-14 are not directed to statutory subject matter. Applicant is directed to the updated rejection addressing the new claims above.
Applicant’s arguments with respect to the rejections of claims 1-3 under 35 USC 102 have been fully considered but they are not persuasive. While the canceling of claims 1-3 renders the associated rejections moot, Applicant’s arguments are directed to new claims 4-14. Applicant is directed to the updated rejections addressing the new claims above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LANE whose telephone number is (303)297-4311. The examiner can normally be reached Monday - Friday 8:00 - 4:30 MT.
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/DANIEL LANE/Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715