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 .
Drawings
The drawings are objected to because Fig. 2 includes
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The use of the term Wi-Fi, Bluetooth, Bluetooth Low Energy, Zigbee, LoRaWAN, ThingsBoard, Apache Spark, Apache Cassandra, Apache kafka, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 6, 8, 13, 15, 17, and 20 objected to because of the following informalities:
Claim 6 “the extracted features” should be “the at least one extracted feature”.
Claim 8, line 2 “SPO2” should be “SpO2”.
Claim 13 “the extracted features” should be “the at least one extracted feature”.
Claim 15, line 3 “SPO2” should be “SpO2”.
Claim 17, line 3 “SPO2” should be “SpO2”.
Claim 20 “the extracted features” should be “the at least one extracted feature”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: apnea monitoring service in claim 1, 4, 6, 7 and user service in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
As a result, “apnea monitoring service” is interpreted as the analysis service of the instant disclosure, which may extract features and be executed by a computing device, server, or system architecture (see paragraphs 0077, 0095-0098, 0187, 0190-0191, 0196).
User service is interpreted as a user interface or monitoring dashboard as shown in Fig. 7 and executed by a computing device (see paragraphs 0168-0184, 0191).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5, 8-12, and 15-19 are rejected under 35 U.S.C. 101.
Claim 1 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) "an apnea monitoring service to determine an apnea measure for the patient based on the formatted SpO2 data". 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 1 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 1, the limitations "an apnea monitoring service to determine an apnea measure for the patient based on the formatted SpO2 data" are abstract ideas as they are directed to a mental process or mathematical concept, as determining an apnea measure may be performed in the human mind such as by observing received data for levels below a particular threshold as indications that an apnea event has occurred, or counting a number of such incidents as a measure of frequency or severity. 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 device to collect SpO2 signals from a patient undergoing treatment over a plurality of sleep sessions; a gateway to connect to the device via a local connection to receive the SpO2 signals, process the SpO2 signals to generate formatted SpO2 data, and to transmit the formatted SpO2 data” and “a user service to provide a longitudinal progression of the apnea measure over the plurality of sleep sessions”. 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. The steps of gathering and SpO2 signals and data leads to the final limitation of “determin[ing]” and providing a longitudinal progression of the determination such that the end result of use of the system may be any generic output. 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 “an apnea monitoring service”, 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 gateway, apnea monitoring service, and user service 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 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 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “a device to collect SpO2 signals from a patient undergoing treatment over a plurality of sleep sessions; a gateway to connect to the device via a local connection to receive the SpO2 signals, process the SpO2 signals to generate formatted SpO2 data, and to transmit the formatted SpO2 data” and “a user service to provide a longitudinal progression of the apnea measure over the plurality of sleep sessions” 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 SpO2 sensor, a generic gateway device, a generic computing device, and a display, which Tran (“A wearable device for at-home obstructive sleep apnea assessment
…”) describes as well-understood, routine, or conventional in its description of the state of the art in sleep apnea assessment including sensors, processing and transmitting electronics, a gateway, and a display having an interface (Table 1—commercial devices for home sleep testing; Figs. 2-3; Page 4—Data acquisition and processing). 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 1 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 8 and 15 are rejected under 35 U.S.C. 101 for similar reasons.
Claims 2-5 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 1, which was rejected under 35 U.S.C. 101 in paragraph 12 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1, claim 2 recites further limitations of 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, where Tran as cited above similarly discloses that an SpO2 sensor, microcontroller, and wireless communication protocol are additionally well-understood, routine, or conventional in the state of the art; claim 3 recites further details of 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 4-5 recite further limitations of the abstract idea which are themselves abstract, as the broadest reasonable interpretation of feature extraction includes mental processes of determining features of the data.
The claim element of claim 1 of a system is recited with a high level of generality (as written, the actions of the apnea monitoring service 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.
Claims 9-12 and 16-19 are similarly rejected under 35 U.S.C. 101.
Claims 6-7, 13-14, and 20 are not rejected under 35 U.S.C. 101 as a mixed-linear model cannot be applied to the extracted features of formatted SpO2 data mentally or by hand.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-12, and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Waner (US 20180015282 A1).
Regarding claims 1, 8, and 15, Waner teaches a system (Paragraph 0034-0038—systems for treating sleep apnea) comprising:
a device to collect SpO2 signals from a patient undergoing treatment over a plurality of sleep sessions (Paragraph 0013, 0039-0040, 0045-0046-- Any suitable number and combination of wireless sensor types may be used… blood oxygen sensors (e.g., pulse oximeters)… Wireless sensors can be deployed on a patient for monitoring sleep apnea, including one or more of an accelerometer to detect movement of the chest, an ECG sensor or sensors to obtain information about the patient's heart rhythm, and an oxygen saturation sensor worn, for example, on a patient's finger; sensing component 50);
a gateway to connect to the device via a local connection to receive the SpO2 signals, process the SpO2 signals to generate formatted SpO2 data, and to transmit the formatted SpO2 data (Paragraphs 0048-0049-- The control or master node can further include a monitoring unit coupled with the communication component… one of the wireless sensors can include hardware and software configured to serve as a master node or gateway that receives detected physiological data from other wireless sensors, and forward such signals via a radio (e.g., WiFi) link to the control system 120 at an appropriate rate (e.g., to save battery power of the sensors)…);
an apnea monitoring service to determine an apnea measure for the patient based on the formatted SpO2 data (Paragraph 0011, 0046, 0072-0074, 0076-0078, 0083-- (b) running a sleep apnea detection module 630 to process the acquired physiological data and determine whether a sleep apnea event has occurred or likely will occur… processor 604 can execute instructions to identify physiological discrepancies such as a discrepancy between a measured sleep apnea index and a previously determined sleep apnea index… processor 604 can execute instructions to detect, predict or assess a pre-apnea or apnea event based on or in response to received physiological data from wireless sensors); and
a user service to provide a longitudinal progression of the apnea measure over the plurality of sleep sessions (Paragraph 0082-- The collected data may also be stored in memory 601 or wirelessly communicated to a clinician. For example, the collected data may be used to identify irregularities in the sleep patterns and if appropriate take action, e.g., send an alert for help. The data collected over time can be useful to identify problems early on, e.g., worsening breathing patterns, worsening sleeping problems, etc. The data can then be considered by the treating healthcare professional and/or automatically assessed by the processor. Likewise, by collecting data from an individual patient over time, the system can “learn” patient specific patterns of sleep and patient specific patterns of apnea, e.g., via machine learning algorithms, which can enable the system to predict when an event is likely to occur and enable the system to calibrate and select to what level to activate the device; paragraph 0103-0104-- The computing system can include any number of clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some embodiments, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device)).
Regarding claims 2, 9, and 16, Waner teaches the system of claim 1. Waner additionally teaches wherein the device comprises a SpO2 sensor and a microcontroller to process raw SpO2 signals from the SpO2 sensor and transmit the processed SpO2 signals to the gateway via a wireless communication protocol (Paragraph 0013, 0039-0040, 0045-0050-- Any suitable number and combination of wireless sensor types may be used… blood oxygen sensors (e.g., pulse oximeters)…an oxygen saturation sensor worn, for example, on a patient's finger; sensing component 50…Each of the sensors can include a sensing component configured to detect a signal corresponding to at least one physiological condition or vital sign of the patient, and a communication component configured to wirelessly transmit the detected signal to either another wireless sensor or to the control system 200…Each of the wireless sensors can be programmed such that signals detected by the sensor falling into a predetermined (e.g., an acceptable or normal) range are not transmitted, or transmitted at a lower frequency…).
Regarding claims 3, 10, and 17, Waner teaches the system of claim 2. Waner additionally teaches wherein the gateway is to control the device to enter a batch mode or a stream mode, wherein in the batch mode the device accumulates SpO2 signals over a predetermined time period before transmitting to the gateway, and in the stream mode the device transmits SpO2 signals to the gateway in real-time as they are collected (Paragraph 0049-- one of the wireless sensors can include hardware and software configured to serve as a master node or gateway that receives detected physiological data from other wireless sensors, and forward such signals via a radio (e.g., WiFi) link to the control system 120 at an appropriate rate (e.g., to save battery power of the sensors); paragraph 0087-0089-- Each sensor can provide respective sensor data (e.g., to the controlling processor) throughout the monitoring period at predetermined time intervals, or continuously… the sensing component 50 may continuously provide physiological data to the control system).
Regarding claims 4, 11, and 18, Waner teaches the system of claim 1. Waner additionally teaches wherein the apnea monitoring service performs feature extraction on the formatted SpO2 data to determine the apnea measure (Paragraph 0081-0082-- the processor is configured to implement a machine learning algorithm that identifies patient-specific correlations between physiological parameters and/or symptoms and sleep apnea events, and uses these patient-specific correlations to predict the onset of a sleep apnea event; paragraph 0088-- A machine learning algorithm can be used, for example, to determine the physiological parameters and/or symptoms represented by the set of sensor data, and/or whether those parameters and/or symptoms are indicative of the onset of a sleep apnea event; paragraph 0105-0121 describe various machine learning algorithms which may be utilized which extract features from the data).
Regarding claims 5, 12, and 19, Waner teaches the system of claim 4. Waner additionally teaches wherein the feature extraction includes extracting at least one of a sleep architecture feature, a sleep arousal feature, an oxygen saturation feature, or a heart rate feature from the formatted SpO2 data (Paragraph 0081, 0088-- Symptoms that may be correlated with onset of a sleep apnea event include but are not limited to: changes in blood oxygen level, changes in heart rate, changes in breathing rate or rhythm, changes in body temperature, changes in electrical resistance (e.g., of the skin), increase in sweating, or decrease in sweating. Computer-based approaches such as machine learning algorithms can be used to determine combinations of physiological parameters and/or symptoms that are useful for detecting the onset of sleep apnea events; paragraph 0105-0120 additionally describe machine learning algorithms including the extraction of features, where extracting features from the formatted SpO2 data would necessarily include at least an oxygen saturation feature).
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) 6-7, 13-14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waner in view of Solà-Soler (“Linear Mixed Effects Modelling of Oxygen Desaturation after Sleep Apneas and Hypopneas: A Pilot Study”).
Regarding claims 6 and 13, Waner teaches the system of claim 5. However, Waner does not explicitly disclose wherein the apnea monitoring service applies a mixed-linear model to the extracted features to determine the apnea measure.
Solà-Soler, in the same field of endeavor of monitoring sleep apnea, discloses applying a mixed-linear model to extracted features to determine a sleep apnea measure (Abstract-- A mixed effects model was defined to account for the influence of event duration (AD), event type, and their interaction on SaO2 parameters…; Page 5732—Mixed effects modelling—a linear mixed effects model M…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Waner by substituting one of the various machine learning algorithms for the mixed-linear model of Solà-Soler in order to predictably improve the accuracy of the apnea service determinations by utilizing a model which can combine both continuous and categorical independent variables as well as their interactions to account for event duration, type, and repeated events (Solà-Soler, page 5731 and 5734—linear mixed-effects modelling is an alternative statistical approach that allows to overcome these limitations…).
Regarding claims 7 and 14, the combination of Waner and Solà-Soler discloses the system of claim 6. Solà-Soler additionally discloses wherein the apnea monitoring service applies a logarithmic transformation to the output of the mixed-linear model to determine the apnea measure (Page 5732-- variables AD and y were logarithmically transformed to ensure normality).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Waner to further apply a logarithmic transformation as described by Solà-Soler in order to provide a normalized apnea measure which would enable easier comparison to other apnea measures, both over time and in comparison to other patients.
Regarding claim 20, Waner teaches the non-transitory computer-readable medium of claim 19. However, Waner does not explicitly disclose applying a mixed-linear model to the extracted features to determine the apnea measure; and applying a logarithmic transformation to the output of the mixed-linear model to determine the apnea measure.
Solà-Soler, in the same field of endeavor of monitoring sleep apnea, discloses applying a mixed-linear model to extracted features to determine a sleep apnea measure (Abstract-- A mixed effects model was defined to account for the influence of event duration (AD), event type, and their interaction on SaO2 parameters…; Page 5732—Mixed effects modelling—a linear mixed effects model M…).
Solà-Soler additionally discloses wherein the apnea monitoring service applies a logarithmic transformation to the output of the mixed-linear model to determine the apnea measure (Page 5732-- variables AD and y were logarithmically transformed to ensure normality).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Waner by substituting one of the various machine learning algorithms for the mixed-linear model of Solà-Soler in order to predictably improve the accuracy of the apnea service determinations by utilizing a model which can combine both continuous and categorical independent variables as well as their interactions to account for event duration, type, and repeated events (Solà-Soler, page 5731 and 5734—linear mixed-effects modelling is an alternative statistical approach that allows to overcome these limitations…).
It would have additionally been obvious to one having ordinary skill in the art at the time of filing to modify Waner to further apply a logarithmic transformation as described by Solà-Soler in order to provide a normalized apnea measure which would enable easier comparison to other apnea measures, both over time and in comparison to other patients.
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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/ANNA ROBERTS/Examiner, Art Unit 3791
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