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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 10, 2026 has been entered. Claims 1-17 are pending in the application, with claim 10-17 being withdrawn.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “ensemble averaging the SpO2 signals to remove noise by identifying a terminal time point in each of a plurality of respiratory events, splicing out the signal for each respiratory event, stacking the signals by aligning them at their terminal time points, and ensemble averaging the stacked signals to produce an average respiratory event” (see specification ¶[0033]) is being interpreted as mathematical calculations/evaluations. The recitation “determining at least one endo-phenotype for OSA based on the ensemble averaged SpO2 signals” (see specification ¶[0034]-[0036]) is being interpreted as mathematical calculations/evaluations (the different calculations for the pharyngeal collapsibility, arousal threshold, and ventilatory instability). The recitation “selecting, based on the at least one endo-phenotype for OSA, a treatment comprising at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy” (see specification ¶[0030]-[0031]) is being interpreted as judgements/observations. The recitations are computer-implemented, as indicated in the claim lines 8 and 9, and in the specification (see specification ¶[0026]-[0027]).
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 1 is directed towards a method for endo-phenotyping obstructive sleep apnea (OSA), which is directed towards a process (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(I). The courts consider mathematical calculations, when the claim is given its BRI in light of the specification, as falling within the “mathematical concept” grouping of abstract ideas. A claim does not have to recite “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using a mathematical method, or “performing” a mathematical operation, may also be considered a mathematical calculation when the BRI of the claim in light of the specification encompasses a mathematical calculation. As discussed in the claim interpretation section, the limitations include, under the BRI, various mathematical calculations/evaluations (i.e., ensemble averaging and the calculations for the pharyngeal collapsibility, arousal threshold, and ventilatory instability). Accordingly, the limitations as seen in claim 1 recite judicial exceptions (abstract ideas that fall within the mathematical calculations grouping of mathematical concepts).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formulas (i.e., calculations to ensemble average and determine the pharyngeal collapsibility, arousal threshold, and ventilatory instability) to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts (Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Furthermore, as explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, judgements/observations (i.e., the treatment determination) and mathematical calculations/evaluations (i.e., calculations to ensemble average and determine the pharyngeal collapsibility, arousal threshold, and ventilatory instability). Accordingly, the limitations as seen in claim 1 recite judicial exceptions (abstract ideas that fall within the mental process grouping). No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
In particular, claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method for endo-phenotyping obstructive sleep apnea (OSA) for a subject, the method comprising:
ensemble averaging the SpO2 signals to remove noise by identifying a terminal time point in each of a plurality of respiratory events, splicing out the signal for each respiratory event, stacking the signals by aligning them at their terminal time points, and ensemble averaging the stacked signals to produce an average respiratory event;
determining at least one endo-phenotype for OSA based on the ensemble averaged SpO2 signals, wherein the at least one endo-phenotype of OSA is one or more of pharyngeal collapsibility, arousal threshold, and ventilatory instability; and
selecting, based on the at least one endo-phenotype for OSA, a treatment comprising at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claim 1 recites the additional element of a processor (see specification ¶[0026]-[0027]) which is a generic computer. The method is merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Claim 1 further recites an additional element of a SpO2 sensor. The SpO2 sensor does not qualify as integration into a practical application because this limitation is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g) using generic components (i.e., the sensor is generic).
Alternatively and/or additionally, SpO2 sensors are known in the art to acquire oxygen saturation signals. For example, Helfenbein et al. (US Patent Application Publication 2016/0296155 – cited in prior action) teaches a patient monitoring system (see abstract) including the usage of a known SpO2 (blood oxygen) sensors to sense blood oxygen (SpO2) (see ¶[0012] and ¶[0035]). Therefore, the SpO2 sensor cannot be seen as integration into a practical application.
Furthermore, claim 1 recites the additional element “selecting, based on the at least one endo-phenotype for OSA, a treatment comprising at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy”. A claim that recites a particular treatment or prophylaxis “meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. See MPEP § 2106.04(d)(2). In order to qualify as a “treatment” or “prophylaxis", the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used. In this case, there is no step to provide the selected treatment to the subject. Merely “selecting” a treatment is not effecting a treatment. Therefore, this claimed element cannot be seen as integration into a practical application.
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, the claim recites additional elements which is directed towards the usage of a generic computer, and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. These elements/steps can be seen as well-understood, routine, and conventional individually and in combination. Claim 1 recites the additional element of a processor, (see specification ¶[0026]-[0027]) which is a generic computer. Thus, the method does not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The claims further recite an additional element of a SpO2 sensor. The SpO2 sensor does not qualify as significantly more because this is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry. For example, Helfenbein et al. (US Patent Application 2016/0296155) teaches a patient monitoring system (see abstract) including the usage of a known SpO2 (blood oxygen) sensors to sense blood oxygen (SpO2) (see ¶[0012] and ¶[0035]). Therefore, the SpO2 sensor cannot be seen as significantly more.
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Step 2B: NO.
Claim 1 is not eligible.
Claims 2-9 depend from claim 1, and merely further define the abstract ideas of claims 1 with no further element that integrates the abstract ideas into a practical application or that qualifies as being significantly more. Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claim 9 recites the additional element of a display, which is merely a component of a generic computer. Therefore, the method is merely instructions to implement an abstract idea on a generic computer (i.e., the generic display of a generic computer) or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Further that, the claim recites an additional element which is directed towards the usage of a generic computer (i.e., the generic display), and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. This element/step can be seen as well-understood, routine, and conventional individually and in combination. Thus, the method does not qualify as significantly more because this limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US Patent Application Publication 2013/0338459 – cited in prior action), hereinafter Lynn, and in view of Avidor et al. (US Patent Application Publication 2011/0178418 – cited in prior action), hereinafter Avidor, and in view of Hoegh et al. (US Patent Application Publication 2015/0094962), hereinafter Hoegh.
Regarding Claim 1, Lynn teaches a pulse oximeter device to detect and calculate a SpO2 signal for a user, and analyze patterns so as to output patho-physiologic events indicated by the patterns in the SpO2 data (see abstract and Figs. 1b-2a). Lynn teaches a method for endo-phenotyping obstructive sleep apnea (OSA) for a subject (see abstract, the output patho-physiologic events indicated by the patterns in the SpO2 data, ¶[0070] and ¶[0086], and ¶[0097] the invention/method look at analyzing/characterizing obstructive sleep apnea, ¶[0250] evidence of the phenotype of the user’s breathing is determined; Figs. 1b-2a), the method comprising:
acquiring oxygen saturation (SpO2) signals over a period of time from the subject with a SpO2 sensor (abstract and ¶[0080]-[0082] various parameters are monitored for the user, including oxygen saturation; Figs. 1b-2a);
a processor (¶[0060], ¶[0070], and ¶[0074]-[0075] the different processors that may be utilized);
determining, using the processor, at least one endo-phenotype for OSA based on the SpO2 signals, wherein the at least one endo-phenotype of OSA is one or more of pharyngeal collapsibility, arousal threshold, and ventilatory instability (¶[0059]-[0063] and ¶[0082] airway instability, which results in airway collapse during respiration problems, may be determined utilizing the index magnitude of airflow and of the oxygen saturation, and the slope of the index may be correlated with airway instability, Fig. 2b; ¶[0346]-[0354] arousal response failure may be determined and analyzed, such as via values of arousal response compared to one another, in which the arousal response value is the threshold, or from the slope of consecutive nadirs, Fig. 19; ¶[0244]-[0247] and ¶[0297]-[0305] the ventilation instability calculated from the rise and fall times of the SpO2 signal, see specifically ¶[0301], it is referred to as the “fall to rise” slope ratio, the rise would be the oxygen recovery, such identified portions are considered to describe respiratory events); and
selecting, based on the at least one endo-phenotype for OSA, a treatment comprising at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy (¶[0086] the therapeutic activities that are taken in response to data, ¶[0198]-[0201] the values from the parameters, including from the SpO2, may be utilized to adjust a treatment, such as a CPAP system; Fig. 16).
Lynn does not specifically teach that the SpO2 signals are ensemble averaged to remove noise, the ensemble averaging including identifying a terminal time point in each of a plurality of respiratory events, splicing out the signal for each respiratory event, stacking the signals by aligning them at their terminal time points, and ensemble averaging the stacked signals to produce an average respiratory event.
Avidor teaches a method of diagnosis involving analyzing an absolute component and a phase component of an input signal indicative of an impedance of an organ of a subject so as to determine baseline and changes in blood flow from the components (see abstract and Figs. 1-2), in which different metrics may be calculated, such as heart contractility (HC) and ventricular ejection time (VET) (see ¶[0072]-[0074]), in which the metric may be averaged over two or more beats to avoid attenuation of random disturbances (see ¶[0122]), in which the signal may be averaged over an ensemble of beats by ensemble averaging segments of beats via two anchor points about a beat and then the averaged segments stitched together (see ¶[0132]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the ensemble averaging about beat modality of Avidor to for the oxygen saturation (SpO2) about respiratory events (i.e., the above identified portions) as determined in Lynn because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the ensemble averaging would help to avoid attenuation of random disturbances (i.e., noise) (see Avidor ¶[0122]).
The modified Avidor teaches the identification of points about a beat, but not specifically about a respiratory event from oxygen saturation data.
Hoegh teaches a screening method for evaluating patient suitability for an implanted hypogloassal nerve stimulation (HGNS) device via blood oxygen data (see abstract and Fig. 1), such that a log of respiratory events providing the timing, severity, sleep status or state, and other characteristics associated with each respiratory event or with the entire sleep period may be generated based on measured reductions in blood oxygen levels or blood oxygen saturation levels (see ¶[0159]-[0164]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the respiratory event detection (i.e., log) of Hoegh with the oxygen saturation (SpO2) data in the modified Lynn because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the modified Lynn requires identifying respiration events in oxygen saturation data and Hoegh teaches one such modality of identifying respiration events; and/or (3) the respiratory events as identified may help to develop other metrics for assessing the health of the patient for a medical professional, such as an apnea-hypopnea index (AHI) (see Hoegh ¶[0159]-[0160]).
Regarding Claim 7, Lynn in view of Avidor and Hoegh teaches the method of claim 1 as stated above. Lynn further teaches the pharyngeal collapsibility is determined using a slope of desaturation of the SpO2 signals (¶[0059]-[0063] and ¶[0082] airway instability, which results in airway collapse during respiration problems, may be determined utilizing the index magnitude of airflow and of the oxygen saturation, and the slope of the index may be correlated with airway instability, as determined during collapse, it would be desaturation as the value is decreasing; Fig. 2b).
Regarding Claim 8, Lynn in view of Avidor and Hoegh teaches the method of claim 1 as stated above. Lynn further teaches the ventilatory instability is determined based on a slope of an oxygen recovery of the SpO2 signals (¶[0244]-[0247] and ¶[0297]-[0305] the ventilation instability calculated from the rise and fall times of the SpO2 signal, referred to as the ‘fall to rise” slope ratio, the rise would be the oxygen recovery).
Regarding Claim 9, Lynn in view of Avidor and Hoegh teaches the method of claim 1 as stated above. Lynn further teaches displaying, using a display, the at least one endo-phenotype for OSA (¶[0086], ¶[0252], and ¶[0335] the processed signals may be displayed).
Claims 2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn in view of Avidor and Hoegh as applied to claim 1 above, and in view of Zwillich et al. (“Bradycardia during Sleep Apnea Characteristics and Mechanism”, J. Clin. Invest., The American Society for Clinical Investigation, Inc., Volume 69, 1286-1292, June 1982 – cited in prior action), hereinafter Zwillich, and as evidenced by “Diagnosing Bradycardia”, NYC Langone Health, accessed on September 16, 2025, accessed at https://nyulangone.org/conditions/bradycardia/diagnosis - cited in prior action), hereinafter NYC Langone Health.
Regarding Claim 2, Lynn in view of Avidor and Hoegh teaches the method of claim 1 as stated above. Lynn further teaches the SpO2 sensor additionally acquires a pulse rate signal (¶[0080]-[0082] various parameters are monitored for the user, including a pulse signal; Figs. 1b-2a).
The modified Lynn is silent regarding “the at least one endo-phenotype further comprises one or more of hypoxic burden and heart rate burden (ΔHR)”.
Zwillich teaches about studying patients with sleep apnea and without sleep apnea for evaluating bradycardia during sleep apnea (see abstract and Introduction), and evaluating their heart rate during sleep (see abstract), in which the heart rate was evaluated at an interval of 10 seconds preceding an apnea event, the last 10 seconds during the apnea event, and 10 second following the termination of the apnea event (see pg. 1287 ¶1-2). Here, the intervals would necessarily include a minimum and maximum that are being compared.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bradycardia heart rate risk assessment of Zwillich with the heart rate of the modified method of Lynn because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) bradycardia may lead to heart failure if left unmanaged, so including this heart rate risk assessment would benefit the subject in receiving appropriate and timely medical care (see NYC Langone Health pg. 1-2).
Regarding Claim 5, Lynn in view of Avidor, Hoegh, and Zwillich teaches the method of claim 2 as stated above. The modified Lynn further teaches the endo-phenotype is the heart rate burden (AHR) and wherein the heat rate burden for a respiratory event is determined as a difference between a maximum pulse rate after an airway opening and a minimum pulse rate during the respiratory event (see Zwillich pg. 1287 ¶1-2, the heart rate was evaluated at an interval of 10 seconds preceding an apnea event, the last 10 seconds during the apnea event, and 10 second following the termination of the apnea event). Here, the intervals would necessarily include a minimum and maximum that are being compared.
Regarding Claim 6, Lynn in view of Avidor, Hoegh, and Zwillich teaches the method of claim 5 as stated above. Lynn further teaches the respiratory event is one of an apnea or a hypopnea (see abstract, the output patho-physiologic events indicated by the patterns in the SpO2 data, ¶[0070] and ¶[0086], and ¶[0097] the invention/method look at analyzing/characterizing obstructive sleep apnea, ¶[0250] evidence of the phenotype of the user’s breathing is determined; Figs. 1b-2a).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn in view of Avidor, Hoegh, and Zwillich as applied to claim 2 above, and in view of Haddad et al. (US Patent Application Publication 2020/0353250 – cited in prior action), hereinafter Haddad.
Regarding Claim 3, Lynn in view of Avidor, Hoegh, and Zwillich teaches the method of claim 2 as stated above. The modified Lynn is silent regarding determining a risk stratification of OSA based on at least one of the hypoxic burden and the heart rate burden (ΔHR), wherein the risk stratification comprises categorizing at least one of the hypoxic burden and the heart rate burden into a plurality of risk categories, each risk category being associated with a level of risk of a health outcome for the subject.
Haddad teaches an adaptive treatment management system including sensor, treatment optimization, and treatment delivery subsystems (see abstract), in which the treatment optimization includes generating risk scores for the patient (see ¶[0008]-[0010]), in which the risk score may be generated based off of patient metrics for heart failure risk (see ¶[0074]-[0075]) or sleep apnea risk (see ¶[0109]), and the patient metrics may include heart rate (see ¶[0055] and ¶[0109]-[0110]), wherein the risk stratification comprises categorizing at least one of the hypoxic burden and the heart rate burden into a plurality of risk categories, each risk category being associated with a level of risk of a health outcome for the subject (¶[0075] and ¶[0109], the incorporated reference US Patent Application Publication 2019/0069851 ¶[0042], ¶[0127], and ¶[0154] the categories of risk; Fig. 9).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sleep apnea risk score of Haddad with the sleep apnea metrics, including heart rate, of the modified Lynn because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) bradycardia may lead to heart failure if left unmanaged (see NYC Langone Health pg. 1-2), so providing a risk assessment to that metric would help the user understand their own health risks with sleep apnea and the heart.
Regarding Claim 4, Lynn in view of Avidor, Hoegh, and Zwillich teaches the method of claim 2 as stated above. The modified Lynn is silent regarding determining a risk associated with heart failure based on the heart rate burden (ΔHR), wherein the risk associated with heart failure is determined by categorizing the heart rate burden into a plurality of risk levels, each risk level being associated with a likelihood of heart failure for the subject.
Haddad teaches an adaptive treatment management system including sensor, treatment optimization, and treatment delivery subsystems (see abstract), in which the treatment optimization includes generating risk scores for the patient (see ¶[0008]-[0010]), in which the risk score may be generated based off of patient metrics for heart failure risk (see ¶[0074]-[0075]), and the patient metrics may include heart rate (see ¶[0055] and ¶[0109]-[0110]), wherein the risk associated with heart failure is determined by categorizing the heart rate burden into a plurality of risk levels, each risk level being associated with a likelihood of heart failure for the subject (¶[0075] and ¶[0109], the incorporated reference US Patent Application Publication 2019/0069851 ¶[0042], ¶[0127], and ¶[0154] the categories of risk; Fig. 9).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the heart failure risk score of Haddad with the heart rate metric of the modified Lynn because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) bradycardia may lead to heart failure if left unmanaged (see NYC Langone Health pg. 1-2), so providing a risk assessment to that metric would help the user understand their own health risks with sleep apnea and the heart.
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 5, filed August 10, 2026, with respect to the objection of claim 5 have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(a)
Applicant’s arguments, see pg. 5-6, filed August 10, 2026, with respect to the rejections of claims 3-4 under 35 U.S.C. § 112(a) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 5, filed August 10, 2026, with respect to the rejections of claims 2-6 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 101
Applicant’s arguments, see pg. 6-9, filed August 10, 2026, with respect to the rejections of claims 1-9 under 35 U.S.C. § 101 have been fully considered and are NOT persuasive. Applicant argues that as the claim selects a particular treatment based on the at least one endo-phenotype for OSA. The examiner respectfully disagrees. As explained above, a claim that recites a particular treatment or prophylaxis “meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. See MPEP § 2106.04(d)(2). In order to qualify as a “treatment” or “prophylaxis", the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used. In this case, there is no step to provide the selected treatment to the subject. Merely “selecting” a treatment is not effecting a treatment. Therefore, this claimed element cannot be seen as integration into a practical application. As such, Applicant’s arguments are not persuasive.
Applicant next argues that the claim considered as a whole, recites a specific, ordered combination of steps that amounts to significantly more than any abstract idea. The examiner respectfully disagrees. As explained above, this part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, the claim recites additional elements which is directed towards the usage of a generic computer, and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. These elements/steps can be seen as well-understood, routine, and conventional individually and in combination. Claim 1 recites the additional element of a processor, (see specification ¶[0026]-[0027]) which is a generic computer. Thus, the method does not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The claims further recite an additional element of a SpO2 sensor. The SpO2 sensor does not qualify as significantly more because this is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry. For example, Helfenbein et al. (US Patent Application 2016/0296155) teaches a patient monitoring system (see abstract) including the usage of a known SpO2 (blood oxygen) sensors to sense blood oxygen (SpO2) (see ¶[0012] and ¶[0035]). Therefore, the SpO2 sensor cannot be seen as significantly more.
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Therefore, Applicant’s arguments are not persuasive and the rejections to the claims under 35 U.S.C. § 101 are maintained.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 9-12, filed August 10, 2026, with respect to the rejections of claims 1-9 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. Applicant argues that Avidor is focused on “determining blood flow using bioimpedance/reactance signals, not pulse oximetry or SpO2 measurements…A person of ordinary skill in the art would not look to impedance cardiography (Avidor) when seeking to process oxygen saturation signals, because the signal characteristics, noise profiles, and temporal dynamics are entirely different”. The examiner respectfully disagrees. In response to Applicant's argument that Avidor is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Avidor is relevant to the problem of removing signal noise from sensor values. One of ordinary skill in the art would look to other modalities, not limiting themselves to any one signal type, in order to reduce noise. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that Avidor averages heart or cardiac information and the claimed invention averages respiratory events (apneas and hypopneas), and “Unlike heart or cardiac signals, which are comparatively consistent, the claimed signals are irregular, and aperiodic events that very substantially in duration, depth, and timing…Respiratory events, by contrast, vary dramatically in duration (a 10-second hypopnea versus a 60-second apnea), making Avidor’s approach of warping to a single time scale inappropriate”. The examiner respectfully disagrees. Avidor teaches that the time scale is adjusted “In various exemplary embodiment”. Avidor does not require the time scaling. As the rejection of the present application does not include time scaling, Applicant’s arguments are not persuasive.
Applicant argues that Avidor uses anchor points and warps beats to a uniform (single) time scale, while the claimed method utilizes a terminal time point. The examiner respectfully disagrees. As explained above, the rejection of the present application does not include time scaling. Furthermore, the portions between the anchor points may be utilized (see ¶[0132]), such that at least one of the anchor points is the terminal point of the respiratory event. There is no requirement in the claim that only a terminal point is utilized. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that Avidor “derives parameters like heart contractility, ventricular ejection time from impedance measurements…These are entirely different medical fields (cardiology versus sleep medicine), with different physiological parameters, different clinical goals, and different treatment paradigms”. The examiner respectfully disagrees. In response to Applicant's argument that Avidor is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Avidor is relevant to the problem of removing signal noise from sensor values. One of ordinary skill in the art would look to other modalities, not limiting themselves to any one signal type, in order to reduce noise. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that the combination does not provide adequate motivation to combine because “(a) Avidor’s time warping would obscure duration differences between respiratory events that are essential for determining arousal threshold; (b) Avidor does not teach or suggest any way to use its two-anchor approach with respiratory events that have a variable onset but a well-defined termination (arousal); and (c) The ‘predictable results’ rationale fails because applying Avidor’s cardiac bear alignment to respiratory events would not yield predictable results when it would destroy the very temporal feature (desaturation rate, event duration) needed for the claimed endo-phenotyping”. The examiner respectfully disagrees. As explained above, the rejection of the present application does not include time scaling, so time scaling would not alter the respiratory analysis in the combination of Lynn in view of Avidor. Avidor teaches a two-anchor approach, of which one would be the terminal point. There is presently no requirement in the claim for “respiratory events that have a variable onset but a well-defined termination”. Furthermore, the rejection as now recited includes Hoegh et al. (US Patent Application Publication 2015/0094962) for identification of respiratory events in oxygen saturation data. Therefore, Applicant’s arguments are not persuasive. Applicant’s arguments are not persuasive and the rejection to the claims under 35 U.S.C. § 103 are maintained.
Conclusion
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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