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 .
Response to Amendment
The amendment filed on March 23, 2026 was considered by the examiner. Claims 1-17 are pending in the application, with claims 10-17 being withdrawn.
Claim 5 is objected to because of the following informalities:
in claim 5, line 2: “the” should be inserted before “heart”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “determining a risk stratification of OSA based on at least one of the hypoxic burden and the heart rate burden (ΔHR)” in lines 1-2. This is clearly a computer-implemented recitation (see specification ¶[0025]-[0027], the risk stratification module 108). Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 3, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the determination of the risk stratification. The disclosure provides no algorithm, flow chart, or other detailed description of the treatment determination, but only states that the risk stratification may be determined (see ¶[0028]-[0029] and ¶[0039]-[0041]), such that one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed (i.e., determining the risk stratification, see specification ¶[0028]-[0029] such as “the severity of the OSA and predict the risk of certain health outcomes for the subject such as, for example, cardiovascular disease and heart failure”).
Claim 4 recites “determining a risk associated with heart failure based on the heart rate burden (ΔHR)” in lines 1-2. This is clearly a computer-implemented recitation (see specification ¶[0025]-[0027], the risk stratification module 108). Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 4, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the determination of the risk associated with heart failure. The disclosure provides no algorithm, flow chart, or other detailed description of the treatment determination, but only states that the risk stratification may be determined (see ¶[0028]-[0029] and ¶[0041]), such that one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed (i.e., determining the risk stratification, see specification ¶[0028]-[0029] such as “the severity of the OSA and predict the risk of certain health outcomes for the subject such as, for example, cardiovascular disease and heart failure”).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “the heart rate burden (ΔHR)” in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending this recitation to “a heart rate burden (ΔHR)” and adding “the” in line 3; or deleting “for determining the heart rate burden (ΔHR)” in line 2, would both overcome the present rejection. The claim is being read as such for the purposes of examination.
Claims 3-6 are rejected by virtue of their dependence from claim 2.
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 “informing on a treatment for the subject including at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy based on the at least one endo-phenotype for OSA” (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
informing on a treatment for the subject including at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy based on the at least one endo-phenotype for OSA.
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 “informing on a treatment for the subject including at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy based on the at least one endo-phenotype for OSA”. 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 informed treatment to the subject. Merely “informing” on (or determining, not recited in the claim as amended) 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), hereinafter Avidor.
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
informing on a treatment for the subject including at least one of continuous positive airway pressure (CPAP), oral appliance therapy, upper airway surgery, positional therapy, or pharmacotherapy based on the at least one endo-phenotype for OSA (¶[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, which also adjusted to fit all of the beats in the ensemble to a single time scale (see ¶[0132]-[0133]).
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]); and/or (3) the ensemble may be adjusted to fit all of the respiratory events to a single time scale (see Avidor ¶[0133]).
Regarding Claim 7, Lynn in view of Avidor 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 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 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 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 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 and Zwillich teaches the method of claim 2 as stated above. The modified Lynn further teaches the endo-phenotype is 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 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 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 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).
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]).
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 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).
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]).
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, claim objections
Applicant’s arguments, see pg. 6, filed March 23, 2026, with respect to the objection of claim 4 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. 6-8, filed March 23, 2026, with respect to the rejections of claims 1-2 and 5-9 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(a)
Applicant’s arguments, see pg. 6-8, filed March 23, 2026, with respect to the rejections of claims 3-4 under 35 U.S.C. § 112(a) have been fully considered and are NOT persuasive. Applicant argues that claims 3-4 are supported by the specification, particularly ¶[0028]. The examiner respectfully disagrees. As explained above, for there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 3, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the determination of the risk stratification. The disclosure provides no algorithm, flow chart, or other detailed description of the treatment determination, but only states that the risk stratification may be determined (see ¶[0028]-[0029] and ¶[0039]-[0041]), such that one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed (i.e., determining the risk stratification, see specification ¶[0028]-[0029] such as “the severity of the OSA and predict the risk of certain health outcomes for the subject such as, for example, cardiovascular disease and heart failure”).
Similarly, with respect to claim 4, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the determination of the risk associated with heart failure. The disclosure provides no algorithm, flow chart, or other detailed description of the treatment determination, but only states that the risk stratification may be determined (see ¶[0028]-[0029] and ¶[0041]), such that one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed (i.e., determining the risk stratification, see specification ¶[0028]-[0029] such as “the severity of the OSA and predict the risk of certain health outcomes for the subject such as, for example, cardiovascular disease and heart failure”). Therefore, Applicant’s arguments are not persuasive.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 9-10, filed March 23, 2026, with respect to the rejections of claims 1-9 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Applicant’s amendment filed on March 23, 2026.
Applicant’s arguments, 35 U.S.C. § 101
Applicant’s arguments, see pg. 10-13, filed March 23, 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 the claims recite an improvement over conventional systems, and thus is significantly more than any asserted judicial exception. Applicant first argues that the ensemble averaging as claimed provides an improvement for smoothing SpO2 signals without using filters and does not obscure nadir oxygen saturation transients. The examiner respectfully disagrees. Such an improvement is not directed towards SpO-2 monitoring technology; rather, the ensemble averaging itself, which is directed towards abstract ideas (see above claim 1 interpretation). An improved mental process is still a mental process even if such a mental process results in more accurate results.1,2 Also, having the claims focus on determining the ensemble averaging is not itself limiting the claims to improving the technology because cases that involve practical, technological improvements extend beyond simply improving the accuracy of a prediction.3 See, e.g., McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) (“The claimed process uses a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of synchronized, animated characters.”); Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1304 (Fed. Cir. 2018) (finding patent eligible a claim drawn to a behavior-based virus scan that protects against viruses that have been “cosmetically modified to avoid detection by code-matching virus scans”); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1333 (Fed. Cir. 2016) (discussing patent eligible claims directed to “an innovative logical model for a computer database” that included a self-referential table allowing for greater flexibility in configuring databases, faster searching, and more effective storage); CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368 (Fed. Cir. 2020) (explaining that the claims at issue focus on a specific means for improving cardiac monitoring technology; they are not “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery” (quoting McRO, 837 F.3d at 1314)). Therefore, the improvement cannot integrate the abstract ideas into a practical application because the improvement is directed towards the abstract ideas. As such, Applicant’s arguments are not persuasive.
Next, Applicant argues that “informing on a treatment…” provides specific, concrete treatment determinations that constitute meaning application in the medical field. The examiner respectfully disagrees. It is noted that the claim as amended recites “informing on a treatment”, not any treatment determination. Furthermore, 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 informed treatment to the subject. Merely “informing” on (or determining, not recited in the claim as amended) a treatment is not effecting a treatment. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that “[a]mended claim 1 calls for a specific technical solution that improves upon conventional SpO2 signal processing methods” which “provides a technical improvement over conventional filtering approaches that would obscure the very transient changes needed for accurate endo-phenotyping. The combination of this improved signal processing with the determination of specific treatment options provides a complete technical solution for sleep apnea diagnosis and treatment planning that goes well beyond abstract data manipulation”. The examiner respectfully disagrees. It is noted that the claim as amended recites “informing on a treatment”, not any treatment determination. Furthermore, as explained above, the improvement cannot integrate any of the abstract ideas into a practical application because the improvement is directed towards abstract ideas itself. In addition, there is no step to provide the informed treatment to the subject. Merely “informing” on (or determining, not recited in the claim as amended) a treatment is not effecting a treatment. It is not clear what additional elements, or how those elements, amount to significantly more than the recited judicial exceptions.
As explained above, 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.
Next, Applicant argues that claims 2-9 add additional specific technical features that further demonstrate the practical application of the claimed methods in medical diagnosis and treatment. The examiner respectfully disagrees. As explained above, 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. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that claim 9 is allowable for comprising a display that displays the at least one endo-phenotype for OSA. The examiner respectfully disagrees. Contrary to the cited Federal Circuit cases, the display in the present application is a generic computer display that is no different than any other prior art display at the time the present application was effectively filed. For example, the claim and the specification do not provide any details on the type of display, merely that such a display is capable to “display images and other information” (see specification ¶[0050]), including the “at least one endo-phenotype for OSA”. As explained above, as the component is merely a component of a generic computer, 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)). Therefore, Applicant’s arguments are not persuasive.
Therefore, Applicant’s arguments are not persuasive, and the rejections to the claims 1-9 under 35 U.S.C. § 101 are maintained.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 14-16, filed March 23, 2026, with respect to the rejections of claims 1-9 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Avidor et al. (US Patent Application Publication 2011/0178418).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
1 “[T]he improvement in computational accuracy alleged here does not qualify as an improvement to a technological
process; rather, it is merely an enhancement to the abstract mathematical calculation of haplotype phase itself...The
different use of a mathematical calculation, even one that yields different or better results, does not render patent
eligible subject matter.” In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir.
2021).
2 “[A] claim for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor Graphics Corp, 839 F.3d 1138
(Fec. Cir. 2016).
3 See In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir. 2021).
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