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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 13-18 in the reply filed on 14 August 2026 is acknowledged. The examiner notes that the previous Office Action described Group II as comprising claims 13-16 in error and agrees with applicant that claims 13-18 are encompassed by the elected group.
Response to Amendment
The amendment filed 14 August 2026 has been entered. Claim(s) 13-18 remain pending in the application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 13-18 are rejected under 35 U.S.C. 101.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "wherein said platform is configured to (i) enable a health care provider to create a treatment algorithm that processes at least a subset of said data from said plurality of sensors to generate a treatment recommendation" and “said platform is further configured to provide a comparison of said data and said additional set of data of said subject”. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 13 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 13, the limitations "wherein said platform is configured to (i) enable a health care provider to create a treatment algorithm that processes at least a subset of said data from said plurality of sensors to generate a treatment recommendation" and “said platform is further configured to provide a comparison of said data and said additional set of data of said subject” are abstract ideas as they are directed to methods of organizing human activity and a mental process, as “enabl[ing] a health care provider to create a treatment algorithm” may be seen as managing personal behaviors of a health care provider as it appears similar to the example of a certain activity between a person and a computer of MPEP 2106.04(a)(2)(II) and both limitations may additionally be seen as mental processes as a person creating a treatment algorithm may do so mentally by making decisions such as the particular rules and transformations by which the data will be processed and comparing data may similarly be performed in the human mind by observing two data sets for similarities and differences. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a plurality of sensors configured to collect data of said subject; a platform configured to receive and process said data” and “(ii) transmit said treatment recommendation to an electronic device of said subject or another subject; and wherein said plurality of sensors is configured to collect an additional set of data of said subject after said subject undertakes said treatment recommendation”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. It is noted that the limitation of “said platform is configured to (i) enable a health care provider to create a treatment algorithm that processes at least a subset of said data from said plurality of sensors to generate a treatment recommendation” may additionally be seen as extra-solution activity as merely enabling the creation of a treatment algorithm by a health care provider does not require that the treatment algorithm is created and thus may simply be an additional feature of the platform which is generally used to produce processed data for analysis under the later mental process step of comparison. The data collection leads to the limitation of “provid[ing] a comparison” such that the end result of use of the system is only the generic determined comparison which may be any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to first and second physiological information, such that the claim does not integrate the judicial exception into any practical application. Regarding “a platform”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the platform are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, the steps performed by the platform may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 13 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “a plurality of sensors configured to collect data of said subject; a platform configured to receive and process said data” and “(ii) transmit said treatment recommendation to an electronic device of said subject or another subject; and wherein said plurality of sensors is configured to collect an additional set of data of said subject after said subject undertakes said treatment recommendation” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic sensor and computer device, which Wellman (US 20230087299 A1) describes as well-understood, routine, or conventional in its description of sensors and computing devices which are known in the art of sleep monitoring (Paragraph 0023, 0026-0028). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 13 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 13, which was rejected under 35 U.S.C. 101 in paragraph 7 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 13, or comprise significantly more than the limitations of claim 13.
Besides the abstract idea of claim 13, claims 14 and 18 recite the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application; claims 15-17 recite additional limitations of the abstract ideas which are themselves abstract, as they refer to details of the algorithm and its outcomes which may be decided by the health care provider.
The claim element of claim 13 of a system for monitoring sleep is recited with a high level of generality (as written, the actions of the platform may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
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.
Claim(s) 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wellman (US 20230087299 A1) in view of Heldman (US 11367519 B1).
Regarding claim 13, Wellman teaches a system for monitoring sleep for a subject, the system comprising:
a plurality of sensors configured to collect data of said subject (Paragraph 0026-0028, 0033-- SpO.sub.2 sensor 102, an acoustic sensor 104… various elements of system 100 may be implemented in a wearable device such as a watch, a patch, a vest, etc.…; SpO.sub.2 sensor 102, acoustic sensor 104);
a platform configured to receive and process said data, wherein said platform is configured to (i) enable a health care provider to create a treatment algorithm that processes at least a subset of said data from said plurality of sensors to generate a treatment recommendation (Paragraph 0023, 0025, 0045-0047— a machine learning model may be configured to predict a site of an airway collapse based on snoring features identified from the snoring signals. In some embodiments, the identified site(s) of collapse may be used to determine a treatment for the OSA of the subject (e.g., mandibular advancement devices (MAD), hypoglossal nerve stimulation (HGNS), pharyngeal surgery, and positional therapy)… the machine learning model is configured to identify or determine a plurality of sites of collapse based on the input snoring features… the identified site or sites of collapse may be used to improve selection of treatment for a subject…), and (ii) transmit said treatment recommendation to an electronic device of said subject or another subject (display 112/1118; paragraph 0028, 0049-- display images and other information, such as, SpO.sub.2 signals, snoring signals, predictions of a site of airway collapse, endo-phenotypes of OSA, risk stratification of OSA patient health data, and so on).
However, Wellman does not explicitly disclose wherein said plurality of sensors is configured to collect an additional set of data of said subject after said subject undertakes said treatment recommendation, and said platform is further configured to provide a comparison of said data and said additional set of data of said subject.
Heldman, in the same field of endeavor of a monitoring data of a subject and providing recommended treatments based on the data, teaches wherein said plurality of sensors (Col. 5, line 23-Col. 6, line 3; Col. 11, line 12-18) is configured to collect an additional set of data of said subject after said subject undertakes said treatment recommendation, and said platform is further configured to provide a comparison of said data and said additional set of data of said subject (Col. 37, line 3-5, Col. 60, line 18-Col. 61, line 40--such artificial intelligence (AI) algorithms may compare, contrast, and/or correlate the instant subject's measured data with a plurality of data, such as in a database, comprising historical data from the instant patient… the historical data preferably includes data related to any treatments or therapies…indexes or scores representing the severity or level of the disorders and/or symptoms when on and/or off of the treatment or therapy, length of time between recurrences of disorders and/or symptoms, duration of the occurrence of disorders and/or symptoms, and the like…The result, as stated, is the calculation of a disorder and/or symptom index that is preferably a quantitative, numerical index value that provides a clear representation of the level, amount or severity of the subject's disorders and/or symptoms…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wellman, which enables a treatment recommendation, to include a comparison between data sets as described by Heldman in order to predictably improve the system by enabling a user to determine the efficacy of the treatment recommendation which may affect future treatment recommendations.
Regarding claim 14, the combination of Wellman and Heldman teaches the system of claim 13. Wellman additionally teaches further comprising a wearable device housing at least some of the plurality of sensors and configured to be one or more of worn or attached to a body of the subject during sleep of the subject (Paragraph 0026-0028, 0033-- SpO.sub.2 sensor 102, an acoustic sensor 104… various elements of system 100 may be implemented in a wearable device such as a watch, a patch, a vest, etc.).
Regarding claim 15, the combination of Wellman and Heldman teaches the system of claim 13. Wellman additionally teaches wherein the treatment algorithm comprises a machine learning algorithm (Paragraph 0023, 0025, 0045-0047— a machine learning model).
Regarding claim 16, the combination of Wellman and Heldman teaches the system of claim 13. Wellman additionally teaches wherein said machine learning algorithm uses at least a Linear Regression model, Random Forest model, or Gradient Boosting model (Paragraph 0045-0047-- In an embodiment, the machine learning model is a “random forest” machine learning model…).
Regarding claim 17, the combination of Wellman and Heldman teaches the system of claim 13. Wellman additionally teaches wherein the treatment recommendation comprises prescribing said subject with a remedial device (Paragraph 0023, 0025, 0045-0047— a machine learning model may be configured to predict a site of an airway collapse based on snoring features identified from the snoring signals. In some embodiments, the identified site(s) of collapse may be used to determine a treatment for the OSA of the subject (e.g., mandibular advancement devices (MAD), hypoglossal nerve stimulation (HGNS), pharyngeal surgery, and positional therapy)…).
Regarding claim 18, the combination of Wellman and Heldman teaches the system of claim 13. Wellman additionally teaches wherein the collected data comprises one or more members selected from the group consisting of heart rate, oxygen intake, respiratory rate, body temperature, sleep duration, sleep efficiency, and sleep stage score (Paragraph 0024-0029, 0033-0036, 0040-- SpO.sub.2 sensor 102, an acoustic sensor 104… the SpO.sub.2 sensor 102 may be part of a pulse oximetry system, the acoustic sensor 104 may be a microphone positioned near the subject… the SpO.sub.2 sensor may be implemented in a pulse oximetry device and the pulse oximetry device may also be used to acquire a pulse rate signal… the sensors or hardware used to detect SpO.sub.2 signals may designed to detect oxygen changes that occur slowly over several minutes… the terminal time point (associated with the terminal breath) in each hypopnea and apnea is identified… where it is noted that these measured data comprise heart rate, oxygen intake, and respiratory rate).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/ Examiner, Art Unit 3791
