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 .
Introductory Remarks
In response to communications filed on 26 March 2026, claims 1, 3, 5-10, and 20-26 are amended per Applicant's request. Claims 2, 4, and 11-19 are cancelled. No claims were withdrawn. Claims 27-31 are new. Therefore, claims 1, 3, 5-10, and 20-31 are presently pending in the application, of which claims 1, 20, and 24 are presented in independent form.
The previously raised objection of the claims regarding the improper numbering, is withdrawn in view of the amendments to the claims.
The previously raised objection of claims 2-10, 21-23, and 25-26 is withdrawn in view of the amendments to the claims.
The previously raised 101 rejection of the pending claims is maintained.
The previously raised prior art rejections of the pending claims is withdrawn in view of the amendments to the claims. A new ground(s) of rejection has been issued.
Response to Arguments
Applicant’s arguments filed 26 March 2026 with respect to the objections of the claims (see Remarks, p. 9) have been fully considered and are persuasive. The amendments address the previously raised objections, and the objections have accordingly been withdrawn.
Applicant’s arguments filed 26 March 2026 with respect to the rejection of the claims under 35 U.S.C. 101 (see Remarks, p. 9-11) have been fully considered but are not persuasive.
Applicant’s arguments rely on the time-series measurements with respect to overcoming the 101 rejection (see, e.g., Remarks, p. 9-10). However, this is unpersuasive, as citing the source of the data collection does not amount to significantly more. These still amount to insignificant data-gathering steps (insignificant extra-solution activities); attempting to limit them to data collected from wearable devices is an insignificant field-of-use limitation, describing the context rather than a particular manner of achieving the results.
See, e.g., CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1370 (Fed. Cir. 2011) at p. 9 (finding that claim 3 which attempted to limit the data gathering step to the Internet as being the source of the data, did not amount to significantly more).
Applicant’s arguments that the claims recite specific factors involved in the determination of suitability parameters and total recommendation factors, and thus the claims amount to significantly more (see Remarks, p. 10-11), is unpersuasive. Claims merely reciting the generic factors involved, without a particular manner by which the claimed computer specifically carries out such steps, is an abstract idea (i.e., of performing such mental calculations/steps/processes).
See, e.g., CyberSource at p. 20, footnote 4 (“The Supreme Court…characterized Flook as a case involving the use of a mathematical formula in the abstract, regardless of whether the patent ‘is intended to cover all uses of the formula or only limited uses.’ 450 U.S. 175, 192 n.14 (181). Significantly, the…Court noted that, in Flook, “the patent application did not purport to explain how the variables used in the formula were to be selected, nor did the application contain any disclosure relating to chemical processes at work or the means of setting off an alarm or adjusting the alarm unit.” Id. The analogy with the claims in this case is a close one: here, the claims contain no hint as to how the information regarding the Internet transactions will be sorted, weighed, and ultimately converted into a useable conclusion that a particular transaction is fraudulent. The claims in this case are therefore even more abstract than the claims in Flook”).
In a similar vein, the present claims fail to describe how the various information is sorted, weighed, and ultimately converted into the claimed total recommendation factor / monitoring assessment factor. Therefore, even with the inclusion of the steps simply stating that type of factors involved, do nothing more than attempt to limit the abstract idea to particular types of information, thus representing an insignificant field-of-use limitation, describing the context rather than a particular manner of achieving the stated result.
For at least the aforementioned reasons and those set forth in the 101 rejection below, the 101 rejection has been maintained.
Applicant’s arguments filed 26 March 2026 with respect to the rejection of the claims under 35 U.S.C. 102/103 (see Remarks, p. 11-114) have been fully considered but are moot and/or not persuasive.
Applicant’s arguments with respect to the 102 rejection of claims 1-4, 7, and 10 (see Remarks, p. 11-12) are moot, as Applicant’s arguments do not apply to the new reference (and new combination of references) being used in the current rejection.
Applicant’s arguments with respect to the 103 rejection of claims 5-6, 8-9, and 20-26 (see Remarks, p. 12-14) are moot, as Applicant’s arguments do not apply to the new reference (and new combination of references) being used in the current rejection, and/or solely argue that the prior art does not disclose the claimed features (which the Examiner disagrees with, and the 103 rejection(s) have been updated below to conform to the modified claim language).
Claim Objections
Claim 29 is objected to because of the following informalities: the claim recites “The system as claimed in 1”. This should be “in claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent Claims 20 and 24 recite “determining…one or more suitability parameters indicative of adequacy of monitoring of the patient”. The Specification only provides support for “suitability”; however, “suitability” and “adequacy” are not synonyms or equivalents. “Suitable” means whether the treatment is “appropriate”, e.g., a good match or fit for the patient. However, “adequate” measures some quantitative value. These are two distinctly different concepts, and “suitability parameters” being indicative of “adequacy of monitoring of the patient” is not supported.
Furthermore, independent Claims 20 and 24 recite that the suitability parameters are combined “to generate a monitoring assessment factor”. The most the Specification supports is a total recommendation factor. There is no support for the suitability parameters being combined for monitoring an assessment factor, as claimed.
The rest of the dependent claims are rejected for at least by virtue of their dependency on their respective independent claims, and for failing to cure the deficiencies of their respective independent claims.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites “the [derived] temporal metrics including at least one of…a rate of change, or a variability measure”. There is no support for such a limitation in the Specification. Specification, [0242], states that the remote processing device 110 generates and stores monitor activity data representative of the HCP having viewed screen 1010, and the actions that the HCP performed as a result of those parameters, e.g., incremental changes to the intensity and repetitions on screen 1011. However, recording changes is not the same as calculating a rate of change, as claimed. Thus, no support for such a limitation exists.
With respect to the “variability measure”, the Specification appears to be entirely silent with respect to this regard.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 28 recites “weighting at least one suitability parameter based on a clinical relevance or a reliability of the corresponding patient state data”. However, the closest support appears to be found in Specification, [0183], where the suitability parameter is indicative of a degree of suitability. However, this is referring to the suitability parameter itself being a degree of suitability (i.e., the variable itself), not that the suitability parameter is weighted (i.e., the coefficient). Thus, there is a complete lack of support for any sort of weighting or coefficient of the suitability parameter itself, much less that it is based on a clinical relevance or a reliability of the corresponding patient state data.
Claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites “normalizing the suitability parameters to a common scale” and comparing “the normalized suitability parameter” to a predefined threshold. There is a complete lack of support for any transformation being applied to the suitability parameters, e.g., “normalizing” it. Note that a binary suitability parameter is not a normalization, as (1) it is the result of determining the suitability parameter, not from performing a transformation from an initial determined suitability parameter; and (2) it cannot be compared to a threshold (Specification, [0183-0184], where binary is simply indicated as being “yes” or “no”, not a threshold, e.g., degree). Thus, there is no support for such a limitation.
Claim 31 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites “wherein the time-series measurements are indicative of progression of the physiological or biomechanical parameter over time”. The closest paragraph appears to be Specification, [0206], which states that patient data may be representative of physical activity performed by the patient, e.g., activity/exercise (time and quality of). However, this is simply indicative of physiological or biomechanical parameters over time, not “a progression of”, e.g., from one stage to a next, with a logically connected sequence of events, actions, etc.
The claim further recites “wherein determining the suitability parameter comprises evaluating the extent to which the physiotherapeutic intervention is capable of reducing a gap between the patient data and the patient need data”. There is no such support for evaluating the intervention’s capabilities of reducing the gap. Rather, it simply analyzes/determines the gap (see, e.g., Specification, [0190-0194]). Determining a gap, e.g., by comparing the intervention capacity data for each intervention to determine an intervention capacity recommendation, is not the same as determining a “capability of” reducing the gap.
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 20-26 are 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.
Independent Claims 20 and 24 recite “determining…one or more suitability parameters indicative of adequacy of monitoring of the patient”. The Specification only provides support for “suitability”; however, “suitability” and “adequacy” are not synonyms or equivalents. “Suitable” means whether the treatment is “appropriate”, e.g., a good match or fit for the patient. However, “adequate” measures some quantitative value. These are two distinctly different concepts. Thus, the meaning of “adequacy of monitoring of the patient” also cannot be ascertained within the context of “suitability parameters”.
Furthermore, the meaning of “adequacy of monitoring of the patient” is unclear as a whole. This seems to indicate that the system is evaluating how well, i.e., how adequately, a patient is being monitored. However, this is completely unsupported by the Specification. Thus, it cannot be ascertained what is meant by “adequacy of monitoring of the patient” within the context of the claimed invention.
For purposes of examination, the interpretation that the suitability parameters indicate a suitability of the intervention for meeting a patient’s needs (see, e.g., Specification, [0164]) has been taken.
Furthermore, independent Claims 20 and 24 recite that the suitability parameters are combined “to generate a monitoring assessment factor”. The most the Specification supports is a total recommendation factor. There is no support for the suitability parameters being combined for monitoring an assessment factor, as claimed. Therefore, it is unclear what is meant by a “monitoring assessment factor” within the context of the claimed invention, and how this is the same or possibly different with respect to the “total recommendation factor” that is described in the Specification.
Additionally, even if they were considered to be different factors, the “suitability parameter” is derived by comparing two types of data: the intervention data elements, and the user data elements. However, as there is a lack of intervention data with respect to these claims (i.e., pertaining to monitoring), thus it is unclear what the suitability parameter is supposed to be, e.g., what is the monitored user data compared to in order to determine some sort of suitability?
For purposes of examination, the interpretation that the “monitoring assessment factor” is some sort of total recommendation factor (i.e., intervention) has been taken.
The rest of the dependent claims are rejected for at least by virtue of their dependency on their respective independent claims, and for failing to cure the deficiencies of their respective independent claims.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim recites “wherein the time-series measurements are indicative of progression of the physiological or biomechanical parameter over time”. The closest paragraph appears to be Specification, [0206], which states that patient data may be representative of physical activity performed by the patient, e.g., activity/exercise (time and quality of). However, this is simply indicative of physiological or biomechanical parameters over time, not “a progression of”, e.g., from one stage to a next, with a logically connected sequence of events, actions, etc. Thus, it is unclear what is meant by “progression of” within the context of the claimed invention.
For purposes of examination, the interpretation that the time-series measurements are indicative of the physiological or biomechanical parameter over time, has been taken.
The claim further recites “wherein determining the suitability parameter comprises evaluating the extent to which the physiotherapeutic intervention is capable of reducing a gap between the patient data and the patient need data”. There is no such support for evaluating any extent of the intervention’s capabilities of reducing the gap. Rather, it simply analyzes/determines the gap (see, e.g., Specification, [0190-0194]). Determining a gap, e.g., by comparing the intervention capacity data for each intervention to determine an intervention capacity recommendation, is not the same as determining a “capability of” reducing the gap. Therefore, it is unclear what is meant by such a limitation.
For purposes of examination, the interpretation that the gap is determined has been taken.
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, 3, 5-10 and 20-31 are rejected under 35 U.S.C. 101 because the claims are directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claim 1 recites comparing one or more data elements of patient state data and/or patient need data with one or more data elements of the intervention data; determining, for each comparison, a suitably parameter indicative of suitability of the respective physiotherapeutic intervention for the patient; comparing total recommendation factors of the one or more physiotherapeutic interventions; and determining the physiotherapeutic intervention recommendation based on the comparison. Claims 5 and 6 recite determining the total recommendation factor to be zero when certain conditions are met. Claim 7 recites determining an intervention dose quantity for addressing each of the at least one need of the patient for each of the one or more interventions. Claim 8 recites comparing the patient need data with the patient state data to determine gap data representative of one or more gaps between the at least one need of the patient and the state of the patient, and analyzing the gap data to determine the intervention recommendation. Claim 9 recites comparing the gap data to the intervention capacity data to determine an intervention capacity recommendation. Claim 31 recites wherein determining the suitability parameter comprises evaluating the extent to which the physiotherapeutic intervention is capable of reducing a gap between the patient state data and the patient need data. These encompass an evaluation, observation, and/or judgment, which falls under the “Mental Processes” grouping of abstract ideas.
Claim 1 further recites generating a total recommendation factor for each physiotherapeutic intervention by combining the determined suitability parameters. Claim 28 recites wherein combining the suitability parameters comprises weighting at least one suitability parameter based on a clinical relevance or a reliability of the corresponding patient state data. Claim 29 recites wherein determining the suitability parameter for each comparison comprises calculating a numerical score, and wherein combining the suitability parameters comprises aggregating the numerical scores. Claim 30 recites wherein combining the determined suitability parameters further comprises normalizing the suitability parameters to a common scale and excluding at least one physiotherapeutic intervention from the comparison when the normalized suitability parameter fails to satisfy a predetermined threshold. These encompass both an evaluation, observation, and/or judgment, which falls under the “Mental Processes” grouping of abstract ideas, as well as mathematical calculations (i.e., “combining the determined suitability parameters”), which falls under the “Mathematical Concepts” grouping of abstract ideas.
Claims 20 and 24 recite various abstract steps. These include receiving and processing patient data to determine one or more monitoring parameters representative of a state of the patient, providing the patient data and/or information representative of the patient data, monitoring activity and/or one or more actions of the monitor to generate monitoring data representative of monitoring activity and/or action(s) of the monitor (all of these aforementioned steps pertaining to managing personal behavior or relationships or interactions between people, which falls under the “Certain methods of organizing human activity” grouping of abstract ideas); determining, based on the monitoring data, one or more suitability parameters indicative of adequacy of monitoring of the patient, combining the suitability parameters to generate a monitoring assessment factor (all of these aforementioned steps pertaining to an evaluation, observation, and/or judgment, which falls under the “Mental Processes” grouping of abstract ideas; and mathematical calculations (i.e., “combining the determined suitability parameters”), which falls under the “Mathematical Concepts” grouping of abstract ideas); and effecting an action and/or generating a notification suggesting an action and sending the notification to the monitor based on the analysis of the monitoring data (encompassing managing personal behavior or relationships or interactions between people, which falls under the “Certain methods of organizing human activity” grouping of abstract ideas; and an evaluation, observation, and/or judgment, which falls under the “Mental Processes” grouping of abstract ideas).
Because the claims cover performance of the limitation in the mind but for the recitation of generic computer components, the claims fall within the “Mental Processes” grouping of abstract ideas. Similarly, because the claims cover managing personal behavior or relationships / interactions between people but for the recitation of generic computer components, the claims fall within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application of the idea. Claims 1, 10, 20, 22-24 and 26 recite various computing hardware components (processor, wearable devices, and monitor), which are recited at a high level of generality and recited so generically that they represent no more than mere instructions to apply the judicial exception on a computer (see MPEP 2106.05(f)). These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(h)).
The claims various recite insignificant extra-solution activities of receiving, generating, storing, aggregating, combining, and transmitting/sending data (Claims 1, 10, and 20-26).1 The types of data received, generated, stored, aggregated, combined, transmitted, etc., are insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result. That the information is received from, e.g., one or more wearable devices (see, e.g., claims 1, 10, and 23), or an input from a monitor to effect an action (see, e.g., claims 22 and 26), are insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result. The types of processing data (e.g., storing, categorizing, aggregating, analyzing, combining, etc.) are also insignificant field-of-use limitations (Claims 21 and 25). Similarly, the types of data being analyzed, compared against, or used as a criteria for making some determination (see, e.g., Claims 1, 3, 5-9, 20-21, and 24-25) also amount to nothing more than insignificant field-of-use limitations, as such limitations do not describe how—by what particular process or structure—the claimed determination/analysis steps are carried out.
Additionally, that one or more temporal metrics are derived from the time-series measurements, the temporal metrics including at least one of a trend, a rate of change, or a variability measure (claim 27); that the weighting is based on a clinical relevance or a reliability of the corresponding patient state data (claim 28); that the numerical score is calculated based on at least one temporal characteristic of the time-series measurements, and aggregation of the numerical scores are according to a predefined aggregation function (claim 29); and that the patient need data is representative of at least one unmet functional or physiological capability of the patient, and wherein the time-series measurements are indicative of progression of the physiological or biomechanical parameter over time (claim 31), are also insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result Lastly, the use of a user interface is also nothing more than an attempt to limit the claims to a particular technological field—namely, implementation via computers.
As such, the additional elements do not integrate the abstract idea into a practical application of that idea.
With respect to the well-understood, routine, and conventional elements, as stated previously above, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements reciting the use of various computing hardware components amount to no more than mere instructions to apply the judicial exception using generic components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept.
Additionally, with regards to the claims’ recitation of receiving and transmitting/sending data, as well as storing data, are well-understood, routine, and conventional activities within the computing realm. See MPEP 2106.05(d)(II) (“Receiving or transmitting data over a network, e.g., using the Internet to gather data”; “Storing and retrieving data in memory” with respect to the “storing” data step; “Electronic recordkeeping” with respect to the “generating” and “storing” data steps).
Even as an ordered combination, the claims as a whole do not contain any additional elements that amount to significantly more. The focus of the claims is on collecting and analyzing (i.e., making comparisons, determinations, evaluations, and/or calculations) with respect to the received information (Claims 1, 5-9, 20, 24, and 28-31), as well as displaying the results of the collection and analysis (Claims 20 and 24). Such limitations have previously found to be directed to ineligible subject matter by the courts. See, e.g., Electric Power Group (finding the claims to be directed to the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis).
The claimed determinations/evaluations, comparisons, and calculations are recited at a high level of generality, and not a particular technical manner by which such determinations/analyses are carried out by a computer. The most detail is with respect to the type of information being considered. However, similar to the claims found to be ineligible in CyberSource, the claims contain no hint as to how the information regarding the received information will be sorted, weighed, and ultimately converted into a useable conclusion what kind of intervention is needed.2 Rather, the claims are directed to the resulting goal or effect, e.g., that somehow those determinations/analyses are effected, rather than a concrete embodiment of that idea. Thus, such limitations amount to nothing more than insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result.
The actual computing steps largely rest on basic computing activities of receiving/transmitting data. The rest primarily attempt to narrow the claims to certain types of information (i.e., the field-of-use limitations), as well as certain sources of data (e.g., with the information having been received from “wearable devices” with respect to claims 1, 10, and 23; or from an input received via a monitor, with respect to claims 22 and 26). However, as a matter of law, narrowing or reformulating an abstract idea does not add significantly more to it, i.e., by reciting the generic use a system with a processor, as well as a wearable device, monitor, user interface, etc., do nothing more than attempt to move the claims to a particular technological environment (i.e., implementation via computers), which does not amount to significantly more.
In sum, the claims are not limited to any particular manner by which the determination and identification steps are performed. Instead, the claims recite the steps at such a high level of generality, and not a specific means for performing the stated functions. Instead, the claimed steps are directed to the resulting goal or effect, rather than a particular manner by which a computer would implement those steps.
In other words, at that level of generality, the claims do no more than describe a desired function or outcome, without providing any limiting detail that confines the claims to a particular solution to an identified problem. The purely functional nature of the claim confirms that it is directed to an abstract idea, not to a concrete embodiment of that idea (see Affinity Labs of Texas LLC v. Amazon.com Inc., 838 F.3d 1253 (Fed. Cir. 2016) at p. 7-8, citing Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016), slip op. 12 (“[T]he essentially result-focused, functional character of claim language has been a frequent feature of claims held ineligible under § 101”)). As a whole, the claims do not go beyond stating the relevant functions in general terms, without limiting them to a technical means for performing the functions that are arguably an advance over conventional computing technologies.
Therefore, for at least the aforementioned reasons, the claims are rejected under 35 U.S.C. 101 for being directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5-7, 10, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (“Neumann”) (US 2021/0065907 A1, incorporating by reference Neumann (“IBR-Neumann”) (US 10,553,319 B1) at [0080]), in view of Ingram et al. (“Ingram”) (US 2018/0239874 A1).
Regarding claim 1: Neumann teaches A system for determining a physiotherapeutic recommendation for a patient, the system comprising a processor configured to perform a method comprising:
receiving patient state data … the patient state data received from one or more wearable devices (IBR-Neumann, [26:22-67]-[27:1-4], where diagnostic engine 108 records at least a biological extraction that includes, e.g., a signal from at least a sensor configured to detect physiological data of a user and recording the at least a biological extraction as a function of the signal, where the sensor includes a wearable device);
receiving patient need data representative of at least one need of the patient; receiving intervention data representative of one or more characteristics of one or more physiotherapeutic interventions (Neumann, [0071-0072], where a user quality health vector may be received from user input where a user sets relative importance for each user health quality priority. See Neumann, [0082], where the system selects an intervention by generating a loss function of the plurality of interventions and the user health quality vector 156 (i.e., “analysing the patient need data and the intervention data”), minimizing the loss function, and selecting an intervention from the plurality of interventions (i.e., “determine the intervention recommendation”) as a function of minimizing the loss function (implying that both “patient need data” and “intervention data” are received for this calculation to occur));
comparing one or more data elements of the patient state data and/or the patient need data with one or more data elements of the intervention data; determining, for each comparison, a suitability parameter indicative of suitability of the respective physiotherapeutic intervention for the patient; combining the determined suitability parameters to generate a total recommendation factor for each physiotherapeutic intervention (Neumann, [0079], where each intervention is generated by combining intervention elements, which are selected according to intervention elements likely to improve a particular user’s state of health (i.e., “determining a suitability parameter for each of the compared elements”), where elements may be identified based on, e.g., links to particular endocrinal levels, change in endocrinal levels to particular nutritional goals, exercise goals, sleep goals, or cessation of bad habits (i.e., “comparing one or more data elements of the patient state data with one or more corresponding data elements of the intervention data for the respective intervention”), which in turn are used to retrieve particular intervention elements from intervention element database. See Neumann, [0081], where each intervention element may have an associated vector chosen as a subset of attributes of intervention element listed in a database, where each attribute has an attribute in user health quality vector 156 (implying “comparing one or more data elements of the patient need data…with one or more corresponding elements of the intervention data for the respective intervention and determining a suitability parameter for each of the compared data elements”));
comparing the total recommendation factors of the one or more physiotherapeutic interventions; and determining the physiotherapeutic intervention recommendation based on the comparison (Neumann, [0082], where each user health quality vector 156 and each intervention vector may be compared using an error function representing average difference between the two mathematical expressions. An intervention having a mathematical expression minimizing the error function may be selected, as representing an optimal expression of relative importance of variables to a system or user, e.g., using aggregate expression of error function and loss function calculations are combined, etc.).
Neumann does not appear to explicitly teach [the patient state data] comprising time-series measurements collected over a monitoring interval of at least one physiological or biomechanical parameter of the patient.
Ingram teaches [the patient state data] comprising time-series measurements collected over a monitoring interval of at least one physiological or biomechanical parameter of the patient (Ingram, [0025], where data about an individual may be gathered using sensors connected to or adjacent to the individual, where by monitoring sensor data associated with the individual, the system obtains information about the current physical condition of the individual, e.g., heart rate of an individual, or number of steps that were taken, during a particular period (i.e., “time-series measurements”). See Ingram, [0035], where the system receives information from sensor 310 associated with the individual on a periodic basis (i.e., “time-series measurements”), e.g., monitored and captured by the system over time (Ingram, [0014])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Neumann and Ingram (hereinafter “Neumann as modified”) with the motivation of enabling users to track their wellness changes over time (see, e.g., Ingram, [0044]), which allows users to more closely monitor their health.
Regarding claim 3: Neumann as modified teaches The system as claimed in claim 1, wherein the intervention data comprises intervention capability data and/or intervention capacity data (IBR-Neumann, [16:12-42], where ameliorative processes include exercise programs including amount, intensity, and/or types of exercise recommended, as well as nutritional recommendations such as nutritional content, digestibility, or the like).
Regarding claim 5: Neumann as modified teaches The system as claimed in claim 1 wherein the method further comprises determining the total recommendation factor to be zero for an intervention of the one or more interventions if the intervention is categorised in a group that does not correspond to an intervention group determined as being suitable for addressing the need of the patient (Neumann, [0080], where a machine learning process may identify persons having the greatest similarity to a user, where similarity is matched according to endocrinal levels, telomere lengths, and/or negative habits, combined with a life-expectancy improvement goal from user health quality vector 156 (i.e., “need of the patient”). A list of interventions may be selected using one of various machine learning algorithms. See also Neumann, [0082], where the system may select an intervention having an associated vector that minimizes a measure of difference from user health quality vector 156).
Although Neumann does not appear to explicitly state that the total recommendation factor is set to “0” for the one or more interventions, as claimed, one of ordinary skill in the art would have found it obvious to have modified Neumann to equivalently ignore interventions that are the least desirable with the motivation of ignoring irrelevant interventions, thereby minimizing one or more possible negative impacts upon the health state of the user.
Regarding claim 6: Neumann as modified teaches The system as claimed in claim 1 wherein the method further comprises determining the total recommendation factor to be zero for an intervention of the one or more interventions if the intervention data for the intervention comprises a contra-indication that corresponds to one of the data elements of the patient state data (IBR-Neumann, [42:27-47], where a plan generation module receives at least an element of user data and filters diagnostic output using the at least an element of user data, which may include a constitutional restriction that includes any health-based reason that a user may be unable to engage in a given ameliorative process; at least a constitutional restriction may include any counter-indication, a medication that is counter-indicated, an injury, diagnosis of something preventing use of the one or more ameliorative processes, allergy or food-sensitivity, etc.).
Regarding claim 7: Neumann as modified teaches The system as claimed in claim 1, wherein the method further comprises, for each of the one or more interventions, determining an intervention dose quantity for addressing each of the at least one need of the patient (Neumann, [0078], where intervention elements correspond to dietary changes such as an increase/reduction in the daily consumption of a particular nutrient, nutritional goals such as meal plans, measurable exercise goals such as some target number of steps per day, etc., a goal to engage in a certain amount of resistance training at a given intensity level, amount of sleep, etc. See Neumann, [0081], where each intervention element may have an associated vector chosen as a subset of attributes of intervention element listed in a database, where each attribute has an attribute in user health quality vector 156 (i.e., “addressing each of the at least one need of the patient”), e.g., large impact on life expectancy, represented by a large number in an attribute field associated with change to life expectancy, low cost, large weekly time commitment, etc.).
Regarding claim 10: Neumann as modified teaches The system as claimed in claim 1, wherein the system further comprises one or more wearable devices configured to generate patient state data and send the patient state data to the processor (IBR-Neumann, [26:22-67]-[27:1-4], where biological extraction that generates biological extraction data includes at least a sensor including a wearable device, where the sensor may be in communication with diagnostic engine 108. Recall from IBR-Neumann, [46:8-51] in claim 2 above that a diagnostic engine 108 receives the biological extraction (i.e., “patient state data”) from a user, thus implying that the “patient state data” was sent to the “processor” (i.e., the diagnostic engine) as claimed).
Regarding claim 27: Neumann as modified teaches The system as claimed in claim 1, deriving one or more temporal metrics from the time-series measurements, the temporal metrics including at least one of a trend, a rate of change, or a variability measure (Ingram, [0026], where the system calculates wellness scores based on evaluating the individual’s monitored direct factors, where the wellness scores are calculated for an individual based on the direct factors monitored at that time, where the wellness scores are then maintained in a time series for the individual, thereby capturing the changes in the individual’s wellness over time).
Although Neumann as modified does not appear to explicitly state “the temporal metrics including at least one of a trend, a rate of change, or a variability measure”, the claimed invention does not distinguish over the prior art because the differences in the claim limitations and the prior art’s disclosure are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The steps of claim 1 would have been performed the same regardless of what type of information the patient need data represented (i.e., the temporal metrics including at least one of a trend, a rate of change, or a variability measure as claimed, or some other data). Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability. See In re Gulack, 703 F.2d 1381, 1385, 217 USPQ2d 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art to have referred to Neumann as modified’s teachings in making the claimed invention, because such data does not functionally relate to the steps in the method claimed and because the subjective interpretation of the data does not patentably distinguish the claimed invention over the prior art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Neumann and Ingram with the motivation of facilitating individualized wellness monitoring and intervention based on dynamic contextual factors (Ingram, [0002]).
Regarding claim 28: Neumann as modified teaches The system as claimed in claim 1, wherein combining the suitability parameters comprises weighting at least one suitability parameter based on a clinical relevance or a reliability of the corresponding patient state data (Neumann, [0082], where each user health quality vector 156 and each intervention vector may be compared using an error function representing average difference between the two mathematical expressions. An intervention having a mathematical expression minimizing the error function may be selected, as representing an optimal expression of relative importance of variables (i.e., implying a “weighting”) to a system or user (i.e., “based on a clinical relevance or a reliability of the corresponding patient state data”)).
Regarding claim 29: Neumann as modified teaches The system as claimed in claim 1, wherein determining the suitability parameter for each comparison comprises calculating a numerical score based on at least one temporal characteristic of the time-series measurements (Ingram, [0026], where each wellness score is associated with a timestamp or other temporal marker corresponding to the time at which the director factors (on which the wellness score is calculated) are observed, where the wellness scores for a particular aspect and associated timestamps form a time series for that aspect), and wherein combining the suitability parameters comprises aggregating the numerical scores according to a predefined aggregation function (Neumann, [0082], where each user health quality vector 156 and each intervention vector may be compared using an error function representing average difference between the two mathematical expressions. An intervention having a mathematical expression minimizing the error function may be selected, as representing an optimal expression of relative importance of variables to a system or user, e.g., using aggregate expression of error function and loss function calculations are combined, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Neumann and Ingram with the motivation of characterizing various wellness aspects of an individual (see, e.g., Ingram, [0026]), thereby providing a more holistic picture of the user’s overall health.
Regarding claim 30: Neumann as modified teaches The system as claimed in claim 1, wherein combining the determined suitability parameters further comprises normalizing the suitability parameters to a common scale and excluding at least one physiotherapeutic intervention from the comparison when the normalized suitability parameter fails to satisfy a predefined threshold (Neumann, [0081], where each intervention’s vector may be scaled and/or normalized. See also Neumann, [0069], where each vector may be “normalized” or divided by a “length” attribute (i.e., “normalizing…to a common scale”). See IBR-Neumann, [31:48-67]-[32:1-34], where categories of physiological data and/or categories of prognostic labels may be eliminated from current use if they fail a threshold comparison, which may include a comparison of a significance score (of the category of physiological data and categories of prognostic labels) to a threshold number).
Claims 8-9 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (“Neumann”) (US 2021/0065907 A1, incorporating by reference Neumann (“IBR-Neumann”) (US 10,553,319 B1) at [0080]), in view of Ingram et al. (“Ingram”) (US 2018/0239874 A1), in further view of McRaith et al. (“McRaith”) (US 2017/0329917 A1).
Regarding claim 8: Neumann as modified teaches The system as claimed in claim 1, but does not appear to explicitly teach wherein the method further comprises comparing the patient need data with the patient state data to determine gap data representative of one or more gaps between the at least one need of the patient and the state of the patient, and analysing the gap data to determine the intervention recommendation.
McRaith teaches wherein the method further comprises comparing the patient need data with the patient state data to determine gap data representative of one or more gaps between the at least one need of the patient and the state of the patient, and analysing the gap data to determine the intervention recommendation (McRaith, [0048-0054], where the system may determine a goal based on user’s disease state, history of user’s disease, and/or other initial user data received, and/or based on the user’s cohort to help determine the goal. The goal may include multiple parameters that should be improved over the course of the treatment window. The treatment plan may be based on a perceived best combination of mechanisms based on user preferences, empirical data, cohort user data, etc., where the treatment plan includes a schedule of activities to be performed by the user. For example, the treatment plan may include dietary guidelines such as food type guidelines, timing guidelines, etc. Additionally as an example, when the goal is related to lowering A1C and/or blood glucose levels (i.e., implying that there is a need for the user to lower A1C levels to a certain level (i.e., “at least one need of the patient”), which are too high (i.e., “the state of the patient”)), i.e., the A1C levels being too high being a form of “gap data”, in which this information may be used to generate the treatment plan that includes blood glucose testing, meal logging, exercise activity, sleep activity, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Neumann as modified and McRaith (hereinafter “Neumann as modified”) with the motivation of aiding users in following a particular treatment plan to improve health outcomes (see, e.g., McRaith, [0048]).
Regarding claim 9: Neumann as modified teaches The system as claimed in claim 8, wherein the method further comprises comparing the gap data to the intervention capacity data to determine an intervention capacity recommendation, wherein the intervention recommendation comprises the intervention capacity recommendation (McRaith, [0008] and [0069], where the system may determine compliance of the user with each prescribed activity, where the system will adjust the user’s treatment plan (i.e., “intervention recommendation”) based on compliance with each prescribed activity, or other suitable aspect, of the original goal and/or plan, e.g., compliance to the diet, medication, exercise, and sleep portions of the treatment plan. This is done by comparing received types, timing, and dosages of medication, diet, exercise, sleep, etc. to the prescribed types, timing, and dosages of medication, diet, exercise of the treatment plan (i.e., analogous to “comparing the gap data to the intervention capacity”). Revising the treatment plan includes a change in the prescribed timing, dosage of medication, prescribed blood glucose measurement pairs to be measured before/after meals, prescribed exercise, prescribed amount of carbohydrates to be consumed, etc. (i.e., “intervention capacity recommendation”)).
Although McRaith discloses the claimed steps in terms of revising a treatment plan (i.e., intervention), one of ordinary skill in the art would have found it obvious to have modified McRaith to apply this to the initial setup of the treatment plan with the motivation of customizing the treatment plan from the beginning to the user’s personalized needs and states.
Regarding claim 31: Neumann as modified teaches The system as claimed in claim 1, wherein patient need data is representative of at least one unmet functional or physiological capability of the patient (Neumann, [0071-0072], where a user quality health vector may be received from user input where a user sets relative importance for each user health quality priority), and wherein the time-series measurements are indicative of progression of the physiological or biomechanical parameter over time (Ingram, [0025], where data about an individual may be gathered using sensors connected to or adjacent to the individual, where by monitoring sensor data associated with the individual, the system obtains information about the current physical condition of the individual, e.g., heart rate of an individual, or number of steps that were taken, during a particular period. See Ingram, [0035], where the system receives information from sensor 310 associated with the individual on a periodic basis (i.e., “time-series measurements”), e.g., monitored and captured by the system over time (Ingram, [0014])) … .
Although Neumann as modified does not appear to explicitly state that the “patient need data is representative of at least one unmet functional or physiological capability of the patient” as claimed, the claimed invention does not distinguish over the prior art because the differences in the claim limitations and the prior art’s disclosure are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The steps of claim 1 would have been performed the same regardless of what type of information the patient need data represented (i.e., unmet functional or physiological capability of the patient, as claimed, or some other data). Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability. See In re Gulack, 703 F.2d 1381, 1385, 217 USPQ2d 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art to have referred to Neumann as modified’s teachings in making the claimed invention, because such data does not functionally relate to the steps in the method claimed and because the subjective interpretation of the data does not patentably distinguish the claimed invention over the prior art.
Neumann as modified does not appear to explicitly teach wherein determining the suitability parameter comprises evaluating the extent to which the physiotherapeutic intervention is capable of reducing a gap between the patient state data and the patient need data.
McRaith teaches wherein determining the suitability parameter comprises evaluating the extent to which the physiotherapeutic intervention is capable of reducing a gap between the patient state data and the patient need data (McRaith, [0048-0054], where the system may determine a goal based on user’s disease state, history of user’s disease, and/or other initial user data received, and/or based on the user’s cohort to help determine the goal. The goal may include multiple parameters that should be improved over the course of the treatment window. The treatment plan may be based on a perceived best combination of mechanisms based on user preferences, empirical data, cohort user data, etc., where the treatment plan includes a schedule of activities to be performed by the user. For example, the treatment plan may include dietary guidelines such as food type guidelines, timing guidelines, etc. Additionally as an example, when the goal is related to lowering A1C and/or blood glucose levels (i.e., implying that there is a need for the user to lower A1C levels to a certain level (i.e., “at least one need of the patient”), which are too high (i.e., “the state of the patient”)), i.e., the A1C levels being too high being a form of “gap data”, in which this information may be used to generate the treatment plan that includes blood glucose testing, meal logging, exercise activity, sleep activity, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Neumann as modified and McRaith with the motivation of aiding users in following a particular treatment plan to improve health outcomes (see, e.g., McRaith, [0048]).
Claims 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sudharsan et al. (“Sudharsan”) (US 2015/0006192 A1), in view of Kendall et al. (“Kendall”) (US 2021/0402182 A1), in further view of Neumann (“Neumann”) (US 2021/0065907 A1, incorporating by reference Neumann (“IBR-Neumann”) (US 10,553,319 B1) at [0080]).
Regarding claim 20: Sudharsan teaches A system for monitoring, and/or facilitating monitoring of, the monitoring of a patient, the system comprising a processor configured to perform a method comprising (Sudharsan, [0059] and [0062], where each server may include a memory, processor, and/or database configured to perform the various claimed steps, including retrieving data, processing data, etc., and for generally performing the disclosed steps):
receiving patient data (Sudharsan, [0025], where patient data may be electronically received by the system, e.g., from an electronic device of the patient that measures patient health values);
processing the patient data to determine one or more monitoring parameters representative of a state of the patient (Sudharsan, [0024-0027], where patient data is received and stored by the system in a database, where the patient data measures, e.g., patient health values, such as heart rate, blood glucose, blood oxygen, blood pressure, activity, etc. (i.e., “one or more monitoring parameters representative of a state of the patient”). See Sudharsan, [0028], where the data stored in the database at step 106, e.g., received by the system through retrieval, upload, etc. (Sudharsan, [0025-0026]), may be electronically processed using various algorithms to learn from/be trained by analyzing the data. For example, machine learning algorithms and/or other higher-level algorithms may be applied to the data to extract information from the data);
monitoring activity and/or one or more actions of the monitor on the user interface to generate monitoring data representative of the monitoring activity and/or action(s) of the monitor on the user interface (Sudharsan, [0028], where the system learns provider decision-making patterns and behaviors. See Sudharsan, [0024], where the provider may interact with a computer software application 502 that has a graphical user interface (GUI) that enables the provider to view, transmit, and receive information to and from the service via the GUI. See Sudharsan, [0047], where an internal medicine physician registers with a web-based provider of clinical recommendations, where the service provider may continuously receive physician data over a period of time, thereby collecting and storing historical data on the provider’s practice, where the historical data may be continually processed using machine-learning algorithms to determine any patterns. Note that the disclosure pertains to a physician interacting with the disclosed service, which is done via the GUI disclosed in Sudharsan, [0024], thereby implying “action(s) of the monitor on the user interface”); … and
effecting an action and/or generating a notification suggesting an action based on [a monitoring assessment] (Sudharsan, [0033], where the system may apply decision models to make recommendations based on applying the machine learning data algorithms at step 108 to learn the provider’s decision-making characteristics and application of the decision model. See, e.g., Sudharsan, [0041], where the provider may interact with a computer software application 502 that has a graphical user interface (GUI) that enables the provider to view, transmit, and receive information to and from the service via the GUI (Sudharsan, [0024]), to evaluate and provide electronic feedback on a recommendation presented to the provider, where the provider may provide corrective adjustments of the recommendation and/or the rationale).
Sudharsan does not appear to explicitly teach providing the patient data and/or information representative of the patient data to a monitor via a user interface on a computing device; determining, based on the monitoring data, one or more suitability parameters indicative of adequacy of monitoring of the patient; combining the suitability parameters to generate a monitoring assessment factor; [and effecting an action and/or generating a notification suggesting an action based on] the monitoring assessment factor.
Kendall teaches providing the patient data and/or information representative of the patient data to a monitor via a user interface on a computing device (Kendall, [0575], where a clinician can be provided with any determined indicator and/or measured response signals, allowing the clinician to identify any interventions needed. See also, e.g., Kendall, [0578], where the system may transfer data to remote systems for analysis, including allowing a clinician to access records associated with patients in real-time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Sudharsan and Kendall (hereinafter “Sudharsan as modified”) with the motivation of allowing for remote oversight (Kendall, [0578]), e.g., greater convenience for both clinicians and their patients.
Sudharsan as modified does not appear to explicitly teach determining, based on the monitoring data, one or more suitability parameters indicative of adequacy of monitoring of the patient; combining the suitability parameters to generate a monitoring assessment factor; [and effecting an action and/or generating a notification suggesting an action based on] the monitoring assessment factor.
Neumann teaches determining, based on the monitoring data, one or more suitability parameters indicative of adequacy of monitoring of the patient; combining the suitability parameters to generate a monitoring assessment factor (Neumann, [0079], where each intervention is generated by combining intervention elements, which are selected according to intervention elements likely to improve a particular user’s state of health (i.e., “determining … one or more suitability parameters indicative of adequacy of monitoring of the patient”), where elements may be identified based on, e.g., links to particular endocrinal levels, change in endocrinal levels to particular nutritional goals, exercise goals, sleep goals, or cessation of bad habits. See Sudharasan above with respect to the “monitoring data”. See Neumann, [0081], where each intervention element may have an associated vector chosen as a subset of attributes of intervention element listed in a database, where each attribute has an attribute in user health quality vector 156. See Neumann, [0082], where each user health quality vector 156 and each intervention vector may be compared using an error function representing average difference between the two mathematical expressions. An intervention having a mathematical expression minimizing the error function may be selected, as representing an optimal expression of relative importance of variables to a system or user, e.g., using aggregate expression of error function and loss function calculations are combined, etc.); [and]
[effecting an action and/or generating a notification suggesting an action based on] the monitoring assessment factor (see Sudharsan above with respect to the “effecting an action and/or generating a notification suggesting an action based on” some value; see Neumann above with respect to the “monitoring assessment factor”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Sudharsan as modified and Neumann (hereinafter “Sudharsan as modified”) with the motivation of selecting an intervention from the plurality of interventions based on a multitude of considered factors (see, e.g., Neumann, [0082]).
Regarding claim 21: Sudharsan as modified teaches The system as claimed in claim 20, wherein the step of processing the patient data comprises any one or more of: storing the patient data in a memory; categorising the patient data; aggregating the patient data; and analysing the patient data (Sudharsan, [0027-0028], where the received data may be stored in a database or any other digital memory device, and processed in any suitable manner including, e.g., applying various algorithms to learn from/be trained by analyzing the data).
Regarding claim 22: Sudharsan as modified teaches The system as claimed in claim 20, wherein the method further comprises receiving input from the monitor to effect an action (Kendall, [0455-0456], where the monitoring device could be used to trigger other actions, e.g., the output could be used to alert a caregiver that an intervention is required, e.g., transferring a notification to a client device and/or computer of the caregiver. A semi-automated system could be used, e.g., providing a clinician with a notification including an indicator, and a recommended intervention, allowing the clinician to approve the intervention, which is then performed automatically. See also, e.g., Kendall, [0578], where a clinician may be alerted or notified of a deleterious health state, allowing an intervention to be triggered, e.g., approve treatment prior to administration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Sudharsan as modified and Kendall with the motivation of enabling a clinician to respond rapidly as needed, and to provide oversight specifically where a treatment material is to be delivered (Kendall, [0578]).
Regarding claim 23: Sudharsan as modified teaches The system as claimed in claim 20, wherein the system further comprises one or more wearable devices configured to generate patient data and send the patient data to the processor (Kendall, [0452], the system including a wearable patch and a monitoring device that performs the measurements, where the monitoring device can be attached or integrally formed with the patch. See Kendall, [0457], where the monitoring device interfaces with a separate processing system, e.g., a client device and/or computer system, where the monitoring device generates subject data including the processed response signals, and transfer this to a client device and/or computer system for analysis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Sudharsan as modified and Kendall with the motivation of enabling measurements to be captured that are more accurately reflective of the health or other status of the subject, allowing variations in a subject’s condition during a course of the day to be measured and avoids measurements being made under artificial conditions, such as within a clinic, which are not typically indicative of the actual condition of the subject (Kendall, [0252]), in addition to allowing conditions to be detected as they arise as monitoring is performed substantially continuously, which can allow more rapid intervention to be sought (Kendall, [0252]). Furthermore, processing and analysis tasks can be distributed between the monitoring device and the client device and/or computer system (Kendall, [0457]), enabling greater processing efficiencies, e.g., offloading some of the more complex or heavy tasks to remote systems.
Regarding claim 24: Claim 24 recites substantially the same claim limitations as claim 20, and is rejected for the same reasons.
Regarding claim 25: Claim 25 recites substantially the same claim limitations as claim 21, and is rejected for the same reasons.
Regarding claim 26: Claim 26 recites substantially the same claim limitations as claim 22, and is rejected for the same reasons.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRENE BAKER whose telephone number is (408)918-7601. The examiner can normally be reached M-F 8-5PM PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boris Gorney can be reached at (571) 270-5626. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IRENE BAKER/Primary Examiner, Art Unit 2154
2 July 2026
1 Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016) at p. 9 (finding that the claims were directed to the abstract idea of combining data from different sources, and that there were no limitations confining the claim to a particular means of combining information from different sources).
2 CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011) at p. 20, footnote 4 (“…the claims contain no hint as to how the information regarding the Internet transactions will be sorted, weighed, and ultimately converted into a useable conclusion that a particular transaction is fraudulent. The claims in this case are therefore even more abstract than the claims in Flook”).
Prosecution Insights