DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 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.
Claims 15, 20, and 29 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.
Claims 15, 20, and 29 recite the limitation "himself". There is insufficient antecedent basis for this limitation in the claim.
Claim 15
Issue: Claim 15 recites “wherein said collecting data related to a determined user comprises collecting data from one or more of user himself, one or more sensors connected to said user and one or more external sources; and wherein said collecting data from the user himself…”. The claim first introduces a “determined user”, then switches to “user himself”, and then to “the user himself”, which may create an antecedent basis issue.
Suggested remedy: Amend “user himself” to “the/said user” and amend “the user himself” to “the/said user”.
Claim 20
Issue: Claim 20 recites “wherein said external sensors are one or more of ECG sensor, Blood pressure sensor, Bioimpedance sensor, Respiratory sensor, Movement sensor and Sleep sensor; and wherein said collecting data related to a determined user comprises collecting data from one or more of user himself, one or more sensors connected to said user and one or more external sources; wherein said collecting data from the user himself…”. The claim first introduces a “determined user”, then switches to “user himself”, and then to “the user himself”, which may create an antecedent basis issue.
Suggested remedy: Amend “user himself” to “the/said user” and amend “the/said user himself” to “the user”.
Claim 29
Issue: Claim 29 recites “wherein said collecting one or more status data of said user comprises collecting data from one or more of user himself, one or more sensors connected to said user, one or more external sources; and wherein said collecting data from the user himself comprises providing said user with a dedicated questioner…”. The claim first introduces a “said user”, then switches to “user himself”, and then to “the user himself”, which may create an antecedent basis issue.
Suggested remedy: Amend “user himself” to “the/said user” and amend “the user himself” to “the/said user”.
Claim Objections
Claims 15, 20, and 29 are objected to because of the following informalities: the use of a gendered pronoun, which introduces ambiguity into the scope of the patent (if patent only covers data collection from male users). Appropriate correction is required.
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, 4-8, 10-13, 15, 17-20, 24, 27-29, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
Claims 1, 4-8, 10-13, 15, 17-20, 24, 27-29, and 31 are within the four statutory categories. However, as will be shown below, claims 1, 4-8, 10-13, 15, 17-20, 24, 27-29, and 31 are nonetheless unpatentable under 35 U.S.C. 101.
Claims 1, 12, and 18 are representative of the inventive concept and recite:
Claim 1
A system for monitoring a status of a user, comprising:
a. an implantable device, configured to communicate with an external electronic device;
b. an external electronic device, comprising:
i. a generated reference database;
ii. an assessment module comprising instructions to generate a personalized prediction index;
and iii. a user database comprising user data; wherein said implantable device is an Implantable Cardioverter-Defibrillator (ICD); and wherein said ICD is configured to perform one or more of monitoring the cardiac activity, providing Cardiac resynchronization therapy (CRT) and providing Cardiac contractility modulation (CCM).
Claim 12
A method of generating a personalized prediction index, comprising:
a. collecting a plurality of data related to a plurality of different users;
b. generating a plurality of reference prediction indexes based on said collected plurality of data;
c. collecting data related to a determined user;
d. comparing said collected data related to said determined user with said reference prediction indexes;
e. generating a personalized prediction index according to said comparing.
Claim 18
A method of monitoring a status of a user, comprising:
a. generating a personalized prediction index;
b. collecting one or more status data of said user;
c. updating said personalized prediction index according to said collected status data.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the
highlighted components can practically be performed by the human mind (in this case, the process of
generating, monitoring, comparing, and updating) or using pen and paper. Other than reciting generic computer components/functions such as “system”, “device”, and “module”, nothing in the claims precludes the highlighted portions from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components/functions, then it falls within “Mental Processes” grouping of abstract ideas. Additionally, the mere nominal recitation of a generic computer does not take the claim limitation out of the mental process grouping. Thus, the claim recites a mental process. The recitation of generic computer components/functions of generating, monitoring, and collecting also covers behavioral or interactions between people (i.e. a computer), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions, hence the claim falls under “Certain Methods of Organizing Human Activity”.
Dependent claims 4-8, 10-11, 13, 15, 17, 19-20, 24, 27-29, and 31 recite additional subject matter which further narrows or defines the abstract idea embodied in the claims.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the claims recite the
following additional limitations:
Claim 1 recites: “system”, “device”, and “module”
In particular, the additional elements do not integrate the abstract idea into a practical application,
other than the abstract idea per se, because the additional elements amount to no more limitations
which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations of
are recited as being performed by a “system”, “device”, and “module”. A computer is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Dependent claims 6 and 7 recite device and server
Dependent claim 13, 15, 20 and 29 recites sensor
In particular, the additional elements do not integrate the abstract idea into a practical application,
other than the abstract idea per se, because the additional elements amount to no more limitations
which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations of
are recited as being performed by a “system”, “device”, and “module”. A computer is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Dependent claims 4-5, 8, 10-11, 17, 19, 24, 27-28, and 31, do not include any additional elements beyond those already recited in independent claims 1, 12, and 18 and dependent claims 6-7, 13, 15, 20, and 29, and hence do not integrate the aforementioned abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-7, 10-13, 17-19, 24, 28, and 31 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Westphal(WO2022194817A1).
Claim 1
Westphal discloses:
A system for monitoring a status of a user, comprising: a. an implantable device, configured to communicate with an external electronic device(Para 0117, Westphal discloses an external computing device); b. an external electronic device, comprising: i. a generated reference database(Para 0136 Westphal discloses dataset from reference data);ii. an assessment module comprising instructions to generate a personalized prediction index(Figure 6B, #220, Westphal discloses an estimation model); and iii. a user database comprising user data(Para 0074, Westphal discloses patient data codified into structured datasets); wherein said implantable device is an Implantable Cardioverter-Defibrillator (ICD)(Para 0005, Westphal discloses ICD); and wherein said ICD is configured to perform one or more of monitoring the cardiac activity(Para 0005, Westphal discloses an ICD monitoring cardiac mechanical and electrical activity), providing Cardiac resynchronization therapy (CRT) and providing Cardiac contractility modulation (CCM).
Claim 5
Westphal discloses:
The system according to claim 1, wherein said personalized prediction index is generated according to a method comprising: a. collecting a plurality of data related to a plurality of different users(Para 0107 Westphal discloses training data comprising of cardiac activity data for a patient population or subgroup); b. generating a plurality of reference prediction indexes based on said collected plurality of data(Para 0136, Westphal discloses training data on reference data provided my medical devices) ; c. collecting data related to a determined user(Para 0105, Westphal discloses an estimated value collected from a patient); d. comparing said collected data related to said determined user with said reference prediction indexes(Para 0145, Westphal discloses comparing patient data to the reference data); e. generating a personalized prediction index according to said comparing(Para 0048, Westphal discloses the generation of estimation values for parameters based on another parameter).
Claim 6
Westphal discloses:
The system according to claim 1, wherein said external electronic device is a server(Para 0117, Westphal discloses an external computing device, such as a server).
Claim 7
Westphal discloses:
The system according to claim 1, wherein said external electronic device is an electronic device comprising instructions for delivering data to a server(Para 0117, Westphal discloses an external computing device, such as a server).
Claim 10
Westphal discloses:
The system according to claim 1, further comprising one or more external sources for providing data related to said user(Para 0132, Westphal discloses the use of external data sources).
Claim 11
Westphal discloses:
The system according to claim 1, wherein said personalized prediction index is used to predict an expected change in said status of said user(Para 0122, Westphal discloses a model which determines that the health status of a patient has changed).
Claim 12
Claim 12 recites similar limitations as claim 5. See claim 5 analysis.
Claim 13
Westphal discloses:
The method according to claim 12, wherein said data related to a determined user comprises one or more of user medical history, clinical parameters(Para 0009, Westphal discloses measured physiological parameters), data from an implantable device and data(Para 0026, Westphal discloses collecting data from a implanted medical device) from external sensors(Para 0047, Westphal discloses external sensors); and wherein said external sensors are one or more of ECG sensor(Para 0047, Westphal discloses ECG), Blood pressure sensor, Bioimpedance sensor, Respiratory sensor(Para 0044, Westphal discloses sensed respiration), Movement sensor(Para 0047, Westphal discloses movement) and Sleep sensor.
Claim 17
Claim 17 recites similar limitations as claim 11. See claim 11 analysis.
Claim 18
Westphal discloses:
A method of monitoring a status of a user, comprising: a. generating a personalized prediction index(Para 0048, Westphal discloses the generation of estimation values for parameters based on another parameter); b. collecting one or more status data of said user c. updating said personalized prediction index according to said collected status data(Para 0053, Westphal discloses updating/refining the model, which would update the prediction index).
Claim 19
Claim 19 recites similar limitations as claim 5. See claim 5 analysis.
Claim 24
Westphal discloses:
The method according to claim 18, wherein said personalized prediction index is used to predict an expected change in said status of said user(Para 0122, Westphal discloses a model which determines that the health status of a patient has changed); and further comprising analyzing said collected data after said collecting and before said updating; wherein said analyzing comprises comparing said collected data with one or more reference data of one or more reference prediction indexes(Para 0145, Westphal discloses comparing patient data to the reference data).
Claim 28
Westphal discloses:
The method according to claim 18, further comprising sending an alert when a change in said personalized prediction index(Para 0120, Westphal discloses providing an alert based on status of a patients health condition) reaches a predetermined threshold(Para 0146, Westphal discloses the establishments for data thresholds).
Claim 31
Claim 31 recites similar limitations as claim 11. See claim 11 analysis.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Westphal(WO2022194817A1) in view of Schaeffer(US20220059240A1).
Claim 4
Westphal discloses:
The system according to claim 1, wherein said generated reference database is generated according to a method comprising: (Para 0122, Westphal discloses storage of estimates).
Westphal does not explicitly disclose:
collecting historical data from a plurality of users; said historical data comprises a chronological timeline; b. indexing said collected data; c. analyzing said indexed data; d. grouping said analyzed indexed data according to similarities at a beginning of said chronological timeline; e. analyzing each of said analyzed groups to recover similarities and differences in the outcomes of said plurality of users; f. identifying diverging points in said chronological timeline; g. providing indexing values at said diverging points of said analyzed chronological timeline.
Schaeffer discloses:
The system according to claim 1, wherein said generated reference database is generated according to a method comprising: a. collecting historical data from a plurality of users(Para 0087, Schaeffer discloses patient clinical histories); said historical data comprises a chronological timeline(Para 0010, Schaeffer discloses timeline associated with each patient); b. indexing said collected data(Para 0092, Schaeffer discloses clustering patient groups based on attributes); c. analyzing said indexed data(Para 0135, Schaeffer discloses analyzing filtered subset of patients); d. grouping said analyzed indexed data according to similarities at a beginning of said chronological timeline(Para 0245, Schaeffer discloses the determination of a similarity metric); e. analyzing each of said analyzed groups to recover similarities and differences in the outcomes of said plurality of users(Para 0401, Schaeffer discloses analyzing patients by identifying similarities); f. identifying diverging points in said chronological timeline(Para 0156, Schaeffer discloses the ability to identify divergent features); g. providing indexing values at said diverging points of said analyzed chronological timeline(Fig 26, Schaeffer discloses values of potentially divergent features on a timeline)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for indirect sensing for cardiac monitoring of Westphal to add collecting historical data from a plurality of users; said historical data comprises a chronological timeline; b. indexing said collected data; c. analyzing said indexed data; d. grouping said analyzed indexed data according to similarities at a beginning of said chronological timeline; e. analyzing each of said analyzed groups to recover similarities and differences in the outcomes of said plurality of users; f. identifying diverging points in said chronological timeline; g. providing indexing values at said diverging points of said analyzed chronological timeline, as taught by Schaeffer. One of ordinary skill would have been so motivated to organize data in a way to help improve predictions and hence patient outcomes, but in this case for mobile wearable monitoring systems (Para 0003, Schaeffer discloses: “Despite this wealth of data, there is a dearth of meaningful ways to compile and analyze the data quickly, efficiently, and comprehensively.”).
Claims 8, 15, 20, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Westphal(WO2022194817A1) in view of Burton(US20210169417A1).
Claim 8
Westphal discloses:
The system according to claim 1, wherein said external electronic device comprises a dedicated software comprising instructions to allow said user to insert user data(Para 0042, Westphal discloses user inputting data); wherein said dedicated software comprises instructions for providing said user with a
Westphal does not explicitly disclose:
dedicated questioner
Burton discloses:
dedicated questioner(Para 0452, Burton discloses a health survey)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for indirect sensing for cardiac monitoring of Westphal to add questioner, as taught by Burton. One of ordinary skill would have been so motivated to further incorporate patient inputs as data points to predict an outcome related to the patient, for improved determination accuracy, but in this case for mobile wearable monitoring systems (Abstract, Burton discloses: “These systems enable diagnostic or prognostic monitoring applicable to monitoring relevant parameters and corresponding analysis determination and characterization applicable to the onset or detection of events or health conditions of interest.”).
Claim 15
Westphal discloses:
The method according to claim 12, wherein said collecting data related to a determined user comprises collecting data from one or more of user himself(Para 0107 Westphal discloses training data comprising of cardiac activity data for a patient population or subgroup), one or more sensors connected to said user(Para 0080, Westphal discloses the use of multiple sensors) and one or more external sources(Para 0132, Westphal discloses external data sources); and wherein said collecting data from the user himself comprises providing said user with a
Westphal does not explicitly disclose:
dedicated questioner
Burton discloses:
dedicated questioner(Para 0452, Burton discloses a health survey)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for indirect sensing for cardiac monitoring of Westphal to add questioner, as taught by Burton. One of ordinary skill would have been so motivated to further incorporate patient inputs as data points to predict an outcome related to the patient, for improved determination accuracy, but in this case for mobile wearable monitoring systems (Abstract, Burton discloses: “These systems enable diagnostic or prognostic monitoring applicable to monitoring relevant parameters and corresponding analysis determination and characterization applicable to the onset or detection of events or health conditions of interest.”).
Claim 20
Westphal discloses:
The method according to claim 19, wherein said data related to a determined user comprises one or more of user medical history, clinical parameters(Para 0009, Westphal discloses measured physiological parameters), data from an implantable device(Para 0026, Westphal discloses collecting data from a implanted medical device) and data from external sensors(Para 0047, Westphal discloses external sensors); wherein said external sensors are one or more of ECG sensor(Para 0047, Westphal discloses ECG), Blood pressure sensor, Bioimpedance sensor, Respiratory sensor(Para 0044, Westphal discloses sensed respiration), Movement sensor(Para 0047, Westphal discloses movement) and Sleep sensor; and wherein said collecting data related to a determined user comprises collecting data from one or more of user himself(Para 0107 Westphal discloses training data comprising of cardiac activity data for a patient population or subgroup), one or more sensors connected to said user(Para 0080, Westphal discloses the use of multiple sensors) and one or more external sources(Para 0132, Westphal discloses external data sources); wherein said collecting data from the user himself comprises providing said user with a
Westphal does not explicitly disclose:
dedicated questioner
Burton discloses:
dedicated questioner(Para 0452, Burton discloses a health survey)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for indirect sensing for cardiac monitoring of Westphal to add questioner, as taught by Burton. One of ordinary skill would have been so motivated to further incorporate patient inputs as data points to predict an outcome related to the patient, for improved determination accuracy, but in this case for mobile wearable monitoring systems (Abstract, Burton discloses: “These systems enable diagnostic or prognostic monitoring applicable to monitoring relevant parameters and corresponding analysis determination and characterization applicable to the onset or detection of events or health conditions of interest.”).
Claim 29
Claim 29 recites similar limitations as claim 15. See claim 15 analysis.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Westphal(WO2022194817A1) in view of Jain(US20200356353A1).
Claim 27
Westphal does not explicitly disclose:
The method according to claim 18, further comprising updating at least one external entities with said updated personalized prediction index.
Jain discloses:
The method according to claim 18, further comprising updating at least one external entities(Para 0100. Jain discloses updating external data in response to a prediction) with said updated personalized prediction index.
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for indirect sensing for cardiac monitoring of Westphal to the update of external entities, as taught by Jain. One of ordinary skill would have been so motivated to further update external databases in response to changes of in predictions related to patient health, but in this case for publishing customized application modules(Para 0004, Jain discloses: “Typically, it is very difficult for organizations to create and distribute mobile applications and other solutions that can meet the needs of their members. Different organizations have widely varying health policies. For example, different organizations may have different insurance options and health goals for their members. Similarly, individuals have widely varying healthcare needs.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tran(WO2014201515A1) discloses a medical data processing system for risk prediction.
Koymans(US20200234829A1) discloses a system for facilitating response prediction for a condition
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/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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