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 .
Status of Claims
Claims 1-6 and 8-19 were previously pending and subject to a non-final Office Action having a notification date of October 20, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on January 15, 2026 (the “Amendment”), amending claims 1 and 16.
The present Final Office Action addresses pending claims 1-6 and 8-19 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
Applicant’s arguments are moot in view of the new grounds of rejection as necessitated by the Amendment.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-14 of U.S. Patent No. 11,923,088 ("the '088 Patent") in view of U.S. Patent App. No. 2019/0189242 to Angiuoli et al. ("Angiuoli") and U.S. Patent App. Pub. No. 2019/0156205 to Gebre et al. ("Gebre"). Although the claims are not identical, they are not patentably distinct from each other.
Claims 1 and 5-14 of the '088 Patent disclose all the limitations of claims 1-6 and 13-19 of the present application except for transmitting the updated plurality of parameters of the first machine learning model associated with the one or more processors to the robotic system, and updating, by the robotic system, based on the updated plurality of parameters of the first machine learning model associated with the one or more processors, a plurality of parameters of the second ML model associated with the robotic system to change the first digital therapeutic environment. For reference, a comparison between claim 1 of the present application and claim 1 of the '088 Patent is presented below. The below underlined limitations in claim 1 of the '088 Patent correspond to limitations recited in claim 1 of the present application:
Claim 1 of Present Application
Claim 1 of the '088 Patent
1. (Currently Amended) A personalized health maintenance system, comprising:
1. A personalized health maintenance system, comprising:
a user activities database system configured to store one or more daily activities of a plurality of users;
one or more processors configured to:
read an input-output data pair of each medical diagnosis test of a plurality of different medical diagnosis tests conducted for a first user;
acquire genomic information of the first user:
determine a presence of mutations in the genomic information based on alignment of the genomic information with a reference genome, wherein the mutations comprise at least one of copy number variants (CNVs), indels, or single nucleotide variants (SNVs);
determine a coherent health state of the first user based on a correlation of a plurality of results of the plurality of different medical diagnosis tests associated with the presence of the mutations in the genomic information;
extract a plurality of datasets related to the first user from a user activities database system,
wherein the plurality of datasets comprises tracked daily activities for a plurality of specific timelines that precedes a date and a timepoint on which each medical diagnosis test of the plurality of different medical diagnosis tests is conducted; and
predict, using a first machine learning model associated with the one or more processors, a plurality of digital therapeutic environments based on
the coherent health state, and
an association of a set of user activities in the plurality of datasets with the correlation of the plurality of results of the plurality of different medical diagnosis tests;
a first artificial intelligence (AI)-based system that comprises one or more processors,
wherein the first AI-based system is trained based on learning information,
wherein the learning information is obtained based on at least a response to one or more specific stimulus provided to a digital therapeutic environment by each selected user of a first set of users, and
wherein the one or more processors are configured to:
read an input-output data pair of each medical diagnosis test of a plurality of different medical diagnosis tests conducted for a first user;
convert a format of the input-output data pair of the plurality of different medical diagnosis tests into a format which is readable by the one or more processors;
determine a coherent health state of the first user based on a correlation of the plurality of different medical diagnosis tests associated with the first user;
extract a plurality of datasets related to the first user from the user activities database system,
wherein the plurality of datasets comprises tracked daily activities for a plurality of specific timelines that precedes a date and a timepoint on which each medical diagnosis test of the plurality of different medical diagnosis tests is conducted;
predict, using a learning technique, a plurality of digital therapeutic environments based on the coherent health data and an association of a set of user activities in the plurality of datasets with a correlation of a plurality of results of the plurality of different medical diagnosis tests; and
a robotic system that includes at least one movable arm, wherein
the at least one movable arm is equipped with a human senses stimulator device, and
the robotic system is configured to:
output, using the human senses stimulator device of the at least one movable arm and a second machine learning model associated with the robotic system, a first digital therapeutic environment around the first user from among the plurality of digital therapeutic environments; and
communicate one of a first type of control signal or a second type of control signal to the human senses stimulator device of the at least one movable arm during the output of the first digital therapeutic environment; and
a robotic system that comprises:
a plurality of movable arms,
wherein a first movable arm is equipped with a device to generate a magnetic field at varying frequencies, and
wherein a second movable arm is equipped with a human senses stimulator device;
a plurality of sensors attachable to a body of the first user, wherein
the plurality of sensors is configured to measure a response to a specific stimulus provided by the output of the first digital therapeutic environment around the first user,
the one or more processors are further configured to:
update a plurality of parameters of the first machine learning model associated with the one or more processors based on the measured response to the specific stimulus; and
transmit the updated plurality of parameters of the first machine learning model associated with the one or more processors to the robotic system, and
the robotic system is further configured to update, based on the updated plurality of parameters of the first machine learning model associated with the one or more processors, a plurality of parameters of the second machine learning model associated with the robotic system to change the first digital therapeutic environment.
a plurality of sensors,
wherein at least a group of sensors from the plurality of sensors are attached to a body of the first user; and
a second AI-based system that is communicatively coupled to the first AI-based system,
wherein the robotic system is configured to:
output using the human senses stimulator device of the second movable arm, under control of the second AI-based system and the first AI-based system, a first digital therapeutic environment around the first user based on the plurality of digital therapeutic environments that is associated with a highest impact score,
wherein the first digital therapeutic environment is a human-sense stimulating mixed reality environment that induces a specific stimulus to the first user for remediation of at least one condition of the determined coherent health state of the first user,
wherein the human-sense stimulating mixed reality environment is a combination of a virtual reality environment and tangible elements that provide a stimulus to a human body or a portion of the human body, and
wherein the second AI-based system and the first AI-based system are updated based on at least an output provided by one or more of the plurality of sensors to the first digital therapeutic environment output by the human senses stimulator device.
In relation to how the robotic system is configured to "communicate one of a first type of control signal or a second type of control signal to the human senses stimulator device of the at least one movable arm during the output of the first digital therapeutic environment" as called for in claim 1 of the present application, claim 1 of the '088 Patent recites how the robotic system is configured to "output using the human senses stimulator device of the second movable arm, under control of the second AI-based system and the first AI-based system, a first digital therapeutic environment around the first user based on the plurality of digital therapeutic environments." In this regard, the Examiner asserts how using the human senses stimulator device of the second movable arm to output a first digital therapeutic environment around the user as recited in claim 1 of the '088 Patent would necessarily require the robotic system to communicate some type of "control signal" to the human senses stimulator device of the second movable arm in order to trigger the output.
Furthermore, as claim 1 of the '088 Patent recites reading an input-output pair of each of a plurality of different medical diagnosis tests for the user and as claim 2 of the '088 Patent recites how the different medical diagnosis tests include a genetic test, then the claims of the '088 necessarily include "acquiring genomic information of the first user" as now recited in claim 1 of the present application.
However, the claims of the '088 Patent might be silent regarding determine a presence of mutations in the genomic information based on alignment of the genomic information with a reference genome, wherein the mutations comprise at least one of copy number variants (CNVs), indels, or single nucleotide variants (SNVs), where the determined coherent health state is based on a correlation of the medical diagnosis test results with the presence of mutations in the genomic information.
Nevertheless, Angiuoli teaches ([0006], [0053]) that it was known in the healthcare informatics art to compare (align) a sequencing read (genomic information) of a user to a reference (e.g., a normal sequencing read/genomic information per [0020]) to detect at least one mutation/alteration (e.g., single nucleotide variants/indels per [0019] and copy number variations per [0082]) to advantageously determine the presence/spread/progression of various types of diseases/conditions to facilitate determination of treatment approaches and the like ([0123]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the claims of the '088 Patent to have determined a presence of mutations in the genomic information of Jain based on alignment of the genomic information with a reference genome, wherein the mutations comprise at least one of copy number variants (CNVs), indels, or single nucleotide variants (SNVs) such that the determined health state is associated with the presence of mutations in the genomic information similar to as taught by Angiuoli to advantageously determine the presence/spread/progression of various types of diseases/conditions to facilitate determination of treatment approaches and the like. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Still further, while claim 1 of the '088 Patent recites "wherein the second AI-based system and the first AI-based system are updated based on at least an output provided by one or more of the plurality of sensors to the first digital therapeutic environment output by the human senses stimulator device," claim 6 recites "wherein the one or more processors are further configured to update the first AI-based system and the plurality of digital therapeutic environments based on the determined response to the specific stimulus provided by the output of the first digital therapeutic environment around the first user," and claim 8 recites "wherein the one or more processors are further configured to calibrate a plurality of parameters in a neural network schema of the first AI-based system that is associated with the learning information, based on at least the determined response to the specific stimulus provided by the output of the first digital therapeutic environment around the first user," these claims of the '088 Patent appear to be silent regarding transmitting the updated plurality of parameters of the first machine learning model associated with the one or more processors to the robotic system, and updating, by the robotic system, based on the updated plurality of parameters of the first machine learning model associated with the one or more processors, a plurality of parameters of the second ML model associated with the robotic system to change the first digital therapeutic environment as called for in claim 1 of the present application.
Nevertheless, Gebre teaches ([0041]-[0042]) that it was known in the machine learning art to update the weights (parameters) of one NN/ML model and use the updated weights to improve/update the weights of another NN/ML model (which would thus change predictions generated by the other NN/ML model) to advantageously reduce duplication of training of similar models and limit the quantity of training data needed for each model thus making the training process more efficient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have transmitted the updated plurality of parameters of the first machine learning model associated with the one or more processors to the robotic system (which includes the second AI/ML system), and updated, by the robotic system, based on the updated plurality of parameters of the first machine learning model associated with the one or more processors, a plurality of parameters of the second ML model associated with the robotic system (which would thus change the first digital therapeutic environment) in the claims of the '088 Patent similar to as taught by Gebre to advantageously reduce duplication of training of similar models and limit the quantity of training data needed for each model thus making the training process more efficient. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 11 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-14 of U.S. Patent No. 11,923,088 ("the '088 Patent") in view of U.S. Patent App. No. 2019/0189242 to Angiuoli et al. ("Angiuoli") and U.S. Patent App. Pub. No. 2019/0156205 to Gebre et al. ("Gebre"), and further in view of U.S. Patent App. Pub. No. 2021/0204867 to Toth et al. ("Toth"). Although the claims are not identical, they are not patentably distinct from each other.
While claim 1 of the '088 Patent recites how the robotic system is equipped with a device to generate a magnetic field at varying frequences and claim 5 of the '088 Patent recites how the robotic system is configured to determine a response to the specific stimulus provided by the output of the first digital therapeutic environment around the first user using the sensors, these claims are silent regarding the robotic system being configured to monitor reflexes of the first user and determining the response to the stimulus based on the monitored reflexes of the first user as called for in claims 11 and 12.
Nevertheless, Toth teaches ([0007] and [0020]-[0022]) that it was known in the healthcare informatics art to monitor reflexes of a subject based on a stimulus provided to the subject and adjust an intensity of feedback signals/stimuli provided to the subject to advantageously achieve a desired cardio-pulmonary performance enhancement level.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the robotic system of the combination of the claims of the '088, Angiuoli, and Gebre to be configured to monitor reflexes of the first user and determine the response to the stimulus based on the monitored reflexes of the first user as doing so provides an effective manner of determining how to adjust the stimulus provided to the user to achieve a desired health state. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim Rejections - 35 USC § 103
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.
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 1-6, 8-10, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2019/0207814 to Jain et al. (“Jain”) in view of U.S. Patent App. No. 2019/0189242 to Angiuoli et al. ("Angiuoli"), U.S. Patent App. Pub. No. 2019/0189259 to Clark (“Clark”), and U.S. Patent App. Pub. No. 2019/0156205 to Gebre et al. ("Gebre"):
Regarding claim 1, Jain discloses a personalized health maintenance system (Figures 3A and 4-7), comprising:
one or more processors configured to ([0197] discloses processor(s)):
read an input-output data pair of each medical diagnosis test of a plurality of different medical diagnosis tests conducted for a first user ([0135], [0151], and [0181] discuss how assessment data/survey responses/test results/etc. such as blood tests and the like can be analyzed; each test result would include at least one “input-output data pair” where the input includes for instance a parameter (e.g., blood reading, etc.) and the output includes some determination (e.g., within range, above threshold, medical condition determination, etc.));
acquire genomic information for the first user ([0170], [0181] discloses obtaining genomic/genetic information of the user);
…
determine a coherent health state of the first user based on a correlation of a plurality of results of the plurality of different medical diagnosis tests associated with the presence of … the genomic information ([0151] and [0181] discusses using the input data (the above input-output data pairs of medical diagnostic tests along with the genetic profile) to determine the current status (coherent health state) of the user);
extract a plurality of datasets related to the first user from a user activities database system ([0181]-[0182] discuss analyzing a user’s activity data and activity profile while [0160]-[0162] discloses how the activities are stored in a database; furthermore, [0094] and [0194] discusses receiving behavior detected and behavioral trends of a user (extract datasets related to user from activities database)),
wherein the plurality of datasets comprises tracked daily activities for a plurality of specific timelines that precedes a date and a timepoint on which each medical diagnosis test of the plurality of different medical diagnosis tests is conducted (as [0160]-[0162] notes how user activity data is tracked over time while [0167] notes how user data streams are frequently/continually assessed, then there are tracked daily activity datasets of the user for specific timelines that precede a date/timepoint on which the medical diagnostic tests of [0135], [0151], and [0181] were conducted); and
predict, using a first machine learning model associated with the one or more processors, a plurality of digital therapeutic environments based on
the coherent health state, and
an association of a set of user activities in the plurality of datasets with the correlation of the plurality of results of the plurality of different medical diagnosis tests ([0167]-[0169] and [0179]-[0184] discusses using ML ("first machine learning model" associated with processors per [0197]-[0200]) to identify various digital therapeutic programs/environments based on the user’s status (coherent health state) along with combinations/associations/correlations of behavior/lifestyle/activity information (user activity datasets) and testing result data (results of different medical diagnosis tests)),
a … system (the combination of server system 310 and devices/interfaces 320/420-428/530/830 in Figures 3A and 4-7) …, wherein
…equipped with a … device (devices/interfaces 320/420-428/530/830), and
the … system is configured to:
output, using … a second machine learning model associated with the …system, a first digital therapeutic environment around the first user from among the plurality of digital therapeutic environments ([0168]-[0181] discuss presenting one or more digital therapeutic programs to a user; furthermore, application 421 of user/medical devices in [0120] (along with their processors) is a “second AI-based system” that helps carry out the interactions and interventions of the management plan which is based on machine learning techniques per [0102], [0133]-[0134], [0172], and [0179]; additionally or alternatively, Figure 2 illustrates a global operating plan machine learning model 210 which is a “first AI-based system” while each of the operating plans 220a/220b/220c for the various devices is a “second AI-based system” that is coupled to the first AI-based system); and
communicate one of a first type of control signal or a second type of control signal … during the output of the first digital therapeutic environment ([0165]-[0168] and [0178] discuss how the server sends instructions (control signals) to a user device to implement the digital therapeutic programs; for instance, there would be a first type of control signal for a first of the digital therapeutic programs and a second type of control signal for a second of the digital therapeutic programs); and
a plurality of sensors attachable to a body of the first user, wherein
the plurality of sensors is configured to measure a response to a specific stimulus provided by the output of the first digital therapeutic environment around the first user ([0071]-[0077], [0106], [0120], [0151], and [0167] of Jain discuss how sensors collect data/feedback from users regarding the digital therapeutic environment for use by the server system in managing program states and providing targeted personalization over time; furthermore, the sensors can be attachable to a body of the first user (e.g., [0120] discloses pulse oximetry which would be attachable to a user's body; furthermore, [0151] discloses wearables);
the one or more processors are further configured to:
update a plurality of parameters of the first machine learning model associated with the one or more processors based on the measured response to the specific stimulus ([0071]-[0075] and [0081]-[0087] discuss training/updating parameters of the ML model based on the sensed/feedback data (the measured response to the specific stimulus)); and
…; and
the … system being further configured to update, … , a plurality of parameters of the second machine learning model associated with the … system to change the first digital therapeutic environment ([0071] discloses updating the ML models of the system (which would include the "first" and "second" ML models) based on the feedback/responses sensed by the sensors (which would necessarily include updating parameters of the first and second ML models) which would thus change the first digital therapeutic environment output using the second ML model).
While Jain discloses ([0151], [0170], and [0181]) obtaining genomic/genetic information of the user and determining the coherent health state based on a correlation of the medical diagnosis test results with the genomic information, Jain might be silent specifically regarding determining a presence of mutations in the genomic information based on alignment of the genomic information with a reference genome, wherein the mutations comprise at least one of copy number variants (CNVs), indels, or single nucleotide variants (SNVs), where the determined coherent health state is based on a correlation of the medical diagnosis test results with the presence of mutations in the genomic information.
Nevertheless, Angiuoli teaches ([0006], [0053]) that it was known in the healthcare informatics art to compare (align) a sequencing read (genomic information) of a user to a reference (e.g., a normal sequencing read/genomic information per [0020]) to detect at least one mutation/alteration (e.g., single nucleotide variants/indels per [0019] and copy number variations per [0082]) to advantageously determine the presence/spread/progression of various types of diseases/conditions to facilitate determination of treatment approaches and the like ([0123]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a presence of mutations in the genomic information of Jain based on alignment of the genomic information with a reference genome, wherein the mutations comprise at least one of copy number variants (CNVs), indels, or single nucleotide variants (SNVs) such that the determined health state is associated with the presence of mutations in the genomic information similar to as taught by Angiuoli to advantageously determine the presence/spread/progression of various types of diseases/conditions to facilitate determination of treatment approaches and the like. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Furthermore, while Jain discusses how the disclosed management plans can be applied to manage the operation of various devices ([0168]), how the management plans can be applicable in the context of managing robots ([0013]), and how various audible, visual, and haptic information can be presented to users ([0101] and [0145]) Jain appears to be silent regarding the system specifically including a robotic system that includes at least one movable arm equipped with a human senses stimulator device that outputs the first digital therapeutic environment around the first user.
Nevertheless, Clark teaches ([0025], [0026], [0039], [0040]) that it was known in the healthcare informatics art to utilize animatronic life-like robots such as “Carebots” and robotic humans (which would thus include one or more movable arms/appendages/etc.) to implement customized therapies including sight/smell/touch/etc. therapies, where a movable arm would include a "human-sense stimulator device" such as a hand/finger/etc. to implement touch therapy, etc. (also note how [0063] and [0067] disclose mixed reality interfaces). This arrangement advantageously provides non-drug alternative therapies for managing various patient conditions such as pain, stress, anxiety, sleep, and the like ([0025]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system such that the device includes at least one movable arm equipped with a human senses stimulator device that outputs the therapeutic environment around the first user similar to as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id. As combined, first or second type of control signal of Jain would be communicated to the human senses stimulator device of the movable arm as taught by Clark during the output of the first digital therapeutic environment disclosed by Jain.
Finally, while the Jain/Angiuoli/Clark combination discloses ([0071] of Jain) updating the ML models of the system (which would include the "first" and "second" ML models) based on the feedback/responses sensed by the sensors (which would necessarily include updating parameters of the first and second ML models) as noted above, the Jain/Clark combination appears to be silent regarding
the processor(s) being further configured to transmit the updated plurality of parameters of the first machine learning model associated with the one or more processors to the robotic system,
where the updating of the parameters of the second ML model is based on the updated plurality of parameters of the first machine learning model associated with the one or more processors.
Nevertheless, Gebre teaches ([0041]-[0042]) that it was known in the machine learning art to update the weights (parameters) of one NN/ML model and use the updated weights to improve/update the weights of another NN/ML model (which would thus change predictions generated by the other NN/ML model) to advantageously reduce duplication of training of similar models and limit the quantity of training data needed for each model thus making the training process more efficient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the processor of the Jain/Angiuoli/Clark combination to be configured to transmit the updated plurality of parameters of the first ML model associated to the second ML model (which is part of the robotic system per the combination with Clark) such that the updating of the parameters of the second ML model is based on the updated plurality of parameters of the first machine learning model associated with the one or more processors similar to as taught by Gebre to advantageously reduce duplication of training of similar models and limit the quantity of training data needed for each model thus making the training process more efficient. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the human senses stimulator device is configured to generate a single sense stimulating output to stimulate a specific sense of a plurality of human senses when the first type of control signal is received from the robotic system ([0025]-[0026], and [0039] of Clark discuss various therapies including sight/smell/touch/taste/thought therapies (single stimulating output to stimulate a specific sense of a plurality of human senses) which would be based on a type of control signal from the robotic system (e.g., [0067] of Clark discloses how controllers 210 manage the therapeutic output while [0040] discloses robotic devices as noted earlier, such controllers would therefore generate a control signal (first control signal) corresponding to the single sense stimulating output); similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that generates a single sense stimulating output based on a first control signal received from the robotic system as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 3, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the human senses stimulator device is configured to generate a multi-sense stimulating output to concurrently stimulate at least two senses of a plurality of human senses when the second type of control signal is received from the robotic system ([0025]-[0026], and [0039] of Clark discuss various therapies including sight/smell/touch/taste/thought therapies as well as (per [0040]) aggregations of such therapies (multi-sense stimulating output to concurrently stimulate at least two senses of the plurality of human senses) which would be based on a type of control signal from the robotic system (e.g., [0067] of Clark discloses how controllers 210 manage the therapeutic output while [0040] discloses robotic devices as noted earlier, such controllers would therefore generate a control signal (second control signal) corresponding to the multi-sense stimulating output); similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that generates a multi-sense stimulating output based on a second control signal received from the robotic system as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 4, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the robotic system is further configured to communicate a stimulation request pack to the human senses stimulator device to control the human senses stimulator device at the output of the first digital therapeutic environment (as noted above, [0067] of Clark discloses how controllers 210 manage the therapeutic output while [0040] discloses robotic devices as noted earlier; such controllers would therefore generate a control signal to the human senses stimulator device that controls the stimulator device at the output of the first digital therapeutic environment; in the case where the control signal dictates a multi-sense output (e.g., aggregation of therapies per [0040] of Clark), then the control signal amounts to a “stimulation request pack” because it would include a plurality of different sub-signals for each of the respective sensory outputs; similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that is controlled by a “stimulation request pack” from the robotic system at the output of the digital therapeutic environment as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 5, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 4, further including wherein the stimulation request pack comprises at least one of: a time schedule that defines a specific activation time and a specific duration to generate one of a single sense stimulating output or a multi-sense stimulating output ([0069], [0087], [0089], and [0108] of Clark discuss how the sensory outputs can be delivered for a particular time, duration, frequency, etc. based on respective metadata; accordingly, the metadata of each respective sensory output control signal would include stipulate a specific activation time and duration to generate the respective sensory output), or an output intensity associated with the output of the first digital therapeutic environment ([0108] of Jain discloses adjusting the intensity of interaction to improve the user's physical activity which is associated with an output of first digital therapeutic environment per [0168]; similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that is controlled by a “stimulation request pack” from the robotic system at the output of the digital therapeutic environment and that includes a time schedule including activation time and duration as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 6, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 5, further including wherein the stimulation request pack further comprises a set of sense identifiers ([0108] of Clark discloses sense type (sense identifier)), and wherein each sense identifier of the set of sense identifiers indicates a unique specific sense stimulating item to be selected for output based on the time schedule ([0108] of Clark discloses how each sense type/identifier indicates a specific sensor stimulating item (e.g., defined by genre, playlist, color, intensity, duration, etc.); similar to as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that is controlled by a “stimulation request pack” from the robotic system at the output of the digital therapeutic environment and that includes sense identifiers that each indicate a unique specific sense stimulating item to be selected for output corresponding to the time schedule as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 8, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the plurality of sensors comprises:
a set of external response sensors configured to sense and measure a level of an external response discernible from an external surface of the body of the first user when the specific stimulus is applied by the robotic system on the first user ([0077] and [0104] of Jain discloses motion and optical sensors (external response sensors) to track the user (measure level of external response) in the digital therapeutic environment when a stimulus is applied by the robotic system on the user per the combination with Clark as discussed in relation to claim 1); and
a set of internal response sensors configured to sense and measure a level of an internal response generated in the body of the first user due to the application of the specific stimulus by the robotic system ([0106]-[0107] of Jain discusses using an EKG sensor and pulse oximeter (internal response sensors) to track the user (measure level of internal response) to determine when to transition to another program state when a stimulus is applied by the robotic system on the user per the combination with Clark as discussed in relation to claim 1).
Regarding claim 9, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 8, further including wherein the set of external response sensors comprise at least one of:
an imaging device configured to detect a change in facial expressions and gestures of the first user,
an audio sensor configured to sense one or more sounds made by the first user when the specific stimulus is provided to the first user,
a light detection and ranging (LiDAR) sensor, or
a radio detection and ranging (RADAR) sensor ([0077] and [0104] of Jain discloses external response sensors to track the user (measure level of external response) in the digital therapeutic environment when a stimulus is applied by the robotic system on the user per the combination with Clark as discussed in relation to claim 1; furthermore, Clark discloses ([0031], [0033], [0075], [0077]) that it was known in the healthcare informatics art to utilize facial recognition software enabled by camera-reading of facial expressions and gestures of a patient to detect a current patient state for use in generating non-drug customized therapies for the patient; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the external sensors of the Jain/Clark combination to include an imaging device to detect a change in facial expressions and gestures of the first user as taught by Clark to advantageously provide a known device capable of detecting a current state of a user to facilitate generation of therapies to treat medical conditions of the user. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 10, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 8, further including wherein the set of internal response sensors comprise one or more of:
an electromyograph configured to measure an activity in muscles and nerves of the first user,
a blood pressure monitor,
a heart rate monitor,
a pulse rate monitor,
a temperature sensor, or
an implantable chip to monitor internal organs ([0106] of Jain discloses a pulse oximeter which measures pulse rate while [0194] discusses the tracking of a user’s blood pressure which would involve a blood pressure monitor).
Regarding claim 13, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the first digital therapeutic environment is a human-sense stimulating mixed reality environment that induces the specific stimulus to the first user for remediation of at least one condition of the determined coherent health state of the first user ([0165] and [0168] of Jain discuss how the digital therapeutic environment treats/addresses the medical condition/actual effects (determined coherent health state) of the user while [0025], [0026], [0039], [0040] of Clark discloses using animatronic life-like robots such as “Carebots” and robotic humans to implement customized therapies including sight/smell/touch/etc. therapies (human-sense stimulating mixed reality environment while [0063] and [0067] of Clark disclose mixed reality interfaces); similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that generates a human-sense stimulating mixed reality environment as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 14, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 13, further including wherein the human-sense stimulating mixed reality environment is a combination of a virtual reality environment ([0063]-[0067] of Clark disclose mixed and virtual reality) and tangible elements that provide the specific stimulus to the body or a portion of the body of the first user ([0039] and [0067] of Clark disclose how the robotic system can touch the patient which thus includes a tangible element, where the MR/VR/tangible elements provide a stimulus to a human body or portion thereof of the “first user”; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of Jain to have been a robotic system and the device of Jain to have been a human senses stimulator device that generates a human-sense stimulating mixed reality environment including VR and tangible elements as taught by Clark to advantageously provide non-drug alternative therapies for managing various conditions such as pain, stress, anxiety, sleep, and the like (where Jain similarly discloses medical conditions such as anxiety ([0168]), pain ([0185]), sleep ([0166]), etc.). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 15, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, further including wherein the robotic system is further configured to output a sequence of digital therapeutic environments predicted based on a time schedule and a current health state specific to the first user, and wherein the outputted sequence of digital therapeutic environments induces a series of different stimuli specific to the first user for remediation of at least one condition of the determined coherent health state of the first user ([0149] of Jain discusses how the management program can include different segments corresponding to different sequential periods of time which are based on a current health state of a user per [0181]; furthermore, [0165] and [0168] discuss how the digital therapeutic environment activated by the server system (part of a “robotic system” per the combination with Clark as discussed in relation to claim 1) can include a combination of various programs to treat/address the medical condition/actual effects (determined coherent health state) of the user which would thus induce different stimuli specific to the user for remediation of the condition of the “determined coherent health state”; accordingly, the robotic system of the Jain/Clark combination is configured to output a sequence of digital therapeutic environments predicted in accordance to a time schedule and a current health state specific to the first user to induce a series of different stimuli specific to the first user for the remediation of at least one condition of the determined coherent health state of the first user).
Claims 16-19 are rejected in view of the Jain/Angiuoli/Clark/Gebre combination as respectively discussed above in relation to claims 1-4.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2019/0207814 to Jain et al. (“Jain”) in view of U.S. Patent App. No. 2019/0189242 to Angiuoli et al. ("Angiuoli"), U.S. Patent App. Pub. No. 2019/0189259 to Clark (“Clark”), and U.S. Patent App. Pub. No. 2019/0156205 to Gebre et al. ("Gebre"), and further in view of U.S. Patent App. Pub. No. 2019/0192874 to Shukla (“Shukla”):
Regarding claim 11, the Jain/Angiuoli/Clark/Gebre combination discloses the personalized health maintenance system according to claim 1, but appears to be silent regarding wherein the robotic system further comprises a device to generate a magnetic field at different frequences and monitor reflexes of the first user.
Nevertheless, Shukla teaches that it was known in the healthcare informatics art for a robotic arm to administer a magnetic field stimulation ([0060]-[0061]) to a body part at various frequencies ([0096]) for purposes of noninvasive pain therapy ([0015]) and to measure feedback from the body (monitor “reflexes,” where a reflex is interpreted to be a body’s response/feedback to a stimulus, which is this case is the administered magnetic field) during the therapy session) to advantageously provide noninvasive pain thereby and determine optimal administration parameters to ensure that the user is experiencing a reduction in pain.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the robotic system of the Jain/Angiuoli/Clark/Gebre combination to include a device to generate a magnetic field at different frequency and monitor reflexes of the first user as taught by Shukla to advantageously provide noninvasive pain thereby and determine optimal administration parameters to ensure that the user is experiencing a reduction in pain. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 12, the Jain/Angiuoli/Clark/Gebre/Shukla combination discloses the personalized health maintenance system according to claim 11, further including wherein the robotic system is further configured to determine the response to the specific stimulus based on the monitoring of the first user (the measurement/monitoring of the feedback/reflexes of the user’s body during the administration of the magnetic field stimulation (which is part of the “digital therapeutic environment” in the Jain/Angiuoli/Clark/Gebre/Shukla combination) provides a response to the magnetic field stimulation provided by the output of the digital therapeutic environment around the first user in the Jain/Angiuoli/Clark/Gebre/Shukla combination; again, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the robotic system of the Jain/Angiuoli/Clark/Gebre/Shukla combination to include a device to generate a magnetic field at different frequencies and monitor reflexes of the first user as taught by Shukla to advantageously provide noninvasive pain thereby and determine optimal administration parameters to ensure that the user is experiencing a reduction in pain. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
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.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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