DETAILED ACTION
Examiner’s Note: Applicants have not properly identified Claim 31 of the claim set filed 09/26/2025 as being amended to be depending from Claim 29. For the purposes of examination, Claim 31 is being treated as being depending from Claim 29. Compliance with proper status identifiers going forward is required to avoid a notice of non-compliance being mailed.
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 .
Status of Claims
Applicant's arguments, filed 09/26/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/26/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 22, 31, 33, and 41.
Applicants have left claims 24-30, 32, 34-40, and 42 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 1-21 and 23
Claims 22 and 24-42 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112 - Maintained and Newly Applied Necessitated by Applicant’s Amendments
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 31 and 39 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.
Regarding claim 31, the claim recites “the threshold corresponds to 4 hours of time”. However, claim 22 recites “acquiring a signal representative of respiration during a threshold period of time” and “one or more blocks identified as qualifying blocks being less than a threshold …”, and claim 29 recites “a threshold number of consecutive blocks …”. In light of the specification, it is currently unclear if “the threshold” recited in claim 31 is referring to “a threshold period of time”, “a threshold” relating to qualifying blocks, or “a threshold” relating to a number of consecutive blocks. For the purposes of examination, “the threshold corresponds to 4 hours of time” is being interpreted as being related to either “a threshold period of time”, “a threshold” relating to qualifying blocks, or “a threshold” relating to a number of consecutive blocks. It is recommended to the Applicant to amend claim 31 to clearly recite what “the threshold” is relating to.
Regarding claim 39, the claim recites “the threshold corresponds to 4 hours of time”. However, claim 33 recites “acquiring a signal representative of respiration during a threshold period of time” and “one or more blocks identified as qualifying blocks being less than a threshold …”. In light of the specification, it is currently unclear if “the threshold” recited in claim 39 is referring to “a threshold period of time” or “a threshold” relating to qualifying blocks. For the purposes of examination, “the threshold corresponds to 4 hours of time” is being interpreted as being related to either “a threshold period of time” or “a threshold” relating to qualifying blocks. It is recommended to the Applicant to amend claim 39 to clearly recite what “the threshold” is relating to.
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
Applicants have argued on page 7 of Remarks, filed 09/26/2025, that Claims 31 and 39 further limits the “number of blocks identified as qualifying blocks”, and the 112(d) rejection should be withdrawn.
The Examiner respectfully disagrees. As reiterated above, Claims 31 and 39 are rejected under 35 USC 112(b) 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, not 35 USC 112(d). Specifically, it is unclear what if “the threshold” recited in claim 39 is referring to “a threshold period of time” or “a threshold” relating to qualifying blocks. The Examiner cannot find a reason to withdraw the rejection in view of Applicants arguments.
Claim Rejections - 35 USC § 101 - Maintained and Newly Applied Necessitated by Applicant’s Amendments
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 22 and 24-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 22, 33, and 41:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 22 is directed to a device, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 33 is directed to method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 41 is directed to a non-transitory computer readable storage medium, which describes one of the four statutory categories of patentable subject matter, i.e., a product/machine. Therefore, further consideration is necessary
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 22, 33, and 41 recite an abstract idea. In particular, the claims recite the following:
Dividing the signal representative of respiration into blocks;
Identifying one or more blocks as qualifying based on one or more criteria;
In accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time;
In accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold, maintaining data corresponding to the threshold period of time; and
Identifying one or more apnea/hypopnea events.
These elements recited in claims 22, 33, and 41 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Dividing a signal representative of respiration into blocks involves a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably view a signal representative of respiration on a piece of paper and divide the signal into blocks, for example blocks of time segments. There is nothing to suggest an undue level of complexity in the claimed step.
Identifying one or more blocks as qualifying based on one or more criteria involves a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably view the one or more blocks on a piece of paper and evaluate if the blocks qualify based on one or more criteria. The claims do not limit what the criteria is. There is nothing to suggest and undue level of complexity in the claimed step. Alternatively and/or additionally, identifying one or more blocks as qualifying based on one or more criteria involves mathematical concepts and/or calculations. For example, one or more criteria can involve mathematical concepts and/or calculations such as being above or below thresholds, or simple ratios.
In accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold or greater than a threshold, discarding data or maintaining data corresponding to the threshold period of time involves a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably make a determination and evaluate if a number of the one or more blocks identified as qualifying blocks is above or below a threshold, and discard or maintain the data for further analysis. There is nothing to suggest an undue level of complexity in the claimed step.
Identifying one or more apnea/hypopnea events involves a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably view data on a piece of paper, such as a signal representative of respiration, and identify one or more apnea/hypopnea events from the signal. There is nothing to suggest an undue level of complexity in the identifying step.
Prong Two: Claims 22, 33, and 41 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “one or more processing circuits”, “memory”, “one or more programs”, “non-transitory computer readable storage medium storing instructions”); and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “acquiring a signal representative of respiration during a threshold period of time”, with no structure recited); using generic data-outputting components (e.g., “outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk”, with no structure recited)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment and the result remains within a “black box”. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
“One or more processing circuits”, “memory”, “one or more programs”, “a non-transitory computer readably storage medium storing instructions” does not qualify as significantly more because this limitation is 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)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 22, 33, and 41 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre- or post-solution activities, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). 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.
Analysis of the dependent claims:
Claims 24-32, 34-40, and 42 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold” (claim 24), “the first frequency range corresponds to a respiratory band” (claim 25), “the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold” (claim 27), “the second frequency range excludes a respiratory band and includes frequencies greater than 10Hz” (claim 28), “the one or more criteria include a third criterion that is met when a threshold number of consecutive blocks meet the first criterion and the second criterion” (claim 29), “the threshold number of consecutive blocks corresponds to 30 minutes of time” (claim 30), “the threshold corresponds to 4 hours of time” (claim 31), “the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold” (claim 32), “the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold” (claim 34), “the first frequency range corresponds to a respiratory band” (claim 35), “the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold” (claim 36), “the one or more criteria include a third criterion that is met when a threshold number of consecutive blocks meet the first criterion and the second criterion” (claim 37), “the threshold number of consecutive blocks corresponds to 30 minutes of time” (claim 38), “the threshold corresponds to 4 hours of time” (claim 39), “the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold” (claim 40), “the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold” (claim 42)), and
Further describe the pre-solution activity (or the structure used for such activity) (“calculating the amplitude of the signal representative of respiration using one or more low-pass filters” (claim 26)),
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. 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 improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment and the result remains within a “black box”. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 22 and 24-42 are rejected.
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 8-9 of Remarks, filed 09/26/2025, that “when viewed as a whole, the claim addresses a specific technological problem in improving performance in identifying apnea/hypopnea events and assessing sleep apnea risk by quality checking sensor data … a human may theoretically perform some mathematical operations in the abstract, but in practice, humans cannot feasibly analyze the volume, precision, or complexity of raw sensor data as claimed”, and “in Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), claims directed to processing sensor signals to improve accuracy were held patent-eligible because they applied mathematical concepts in a specific technological context to achieve a technological improvement. The present claims are analogous: they apply processing operations to sensor data in order to enhance the quality and usability of the resulting measurements”.
The Examiner respectfully disagrees. Applicants arguments regarding a human not feasibly being able to analyze raw sensor data as claimed is not commensurate in scope with the claims. The claims do not limit 1) what the “signal representative of respiration” is, 2) what the “threshold period of time” is, 3) what a “qualifying block” is, 4) what “one or more apnea/hypopnea events” are, and/or 5) what “sleep apnea risk” is.
Further, having the claims focus on determining the health state of the human body 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.1 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)).
Further, unlike Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), the instant claims do not recite the structure for obtaining “a signal representative of respiration”, let alone using a signal obtained from the structure in a non-conventional manner to reduce errors.
Applicants have further argued on page 10 of Remarks, filed 09/26/2025, that “amended claim 22 also includes additional operations such as further processing the data to identify one or more apnea/hypopnea events and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep risk … the judicial exception is used in a meaningful way … ”.
The Examiner respectfully disagrees. As recited above in the rejection, “identify one or more apnea/hypopnea events” is a mental process, and “outputting an indication …” is directed towards post-solution activities as the results remain within a “black box”. Further, see MPEP 2106.05(g).
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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 22, 24-26, 33-35, 39, 41, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Pinhas et al. (US 20070118054 A1) (previously cited), hereinafter referred to as Pinhas, in view of Saeed Babaeizadeh (US 20220000435 A1) (previously cited), hereinafter referred to as Babaeizadeh.
The claims are generally directed towards an electronic device comprising: one or more processing circuits; memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processing circuits, the one or more programs including instructions for: acquiring a signal representative of respiration during a threshold period of time; dividing the signal representative of respiration into blocks; identifying one or more of the blocks as qualifying based on one or more criteria; in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time; further processing the data to identify one or more apnea/hypopnea events; and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk.
Regarding claim 22, Pinhas discloses an electronic device (Abstract, “system for monitoring vital signs …”, Fig. 2, para. [0068]) comprising:
one or more processing circuits (Fig. 1, element 14, para. [0068], para. [0173], “system … control unit”, para. [0175], para. [0177], “breathing pattern analysis module typically comprises a digital signal processor …”);
memory (para. [0068], para. [0186], “memory”); and
one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processing circuits (para. [0068], “control unit … adapted to carry out one or more steps of the method …”, para. [0175-0176]), the one or more programs including instructions for:
acquiring a signal representative of respiration during a threshold period of time (Fig. 2, element 30, para. [0173-0174], Fig. 3, para. [0178], “motion of subject sensed by sensor 30, for example, during sleep, may include regular breathing movement …”, Fig. 5, para. [0207], “respiration rate … during the hours of 11:00 pm to 6:00 am …”);
dividing the signal representative of respiration into blocks (para. [0199], criterion is implemented for determining whether a specific measurement (e.g., during one minute) is of high quality …”, para. [0301], “divides monitored period into time epochs of a duration … typically between 30 and 300 seconds …”);
identifying one or more of the blocks as qualifying based on one or more criteria (para. [0301], “each epoch is identified as ‘quiet’ or ‘noisy’ … identified as quiet if its power spectrum has a peak in the range expected for respiration …”).
However, Pinhas does not explicitly disclose in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time; further processing data to identify one or more apnea/hypopnea events; and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk.
Babaeizadeh teaches of an analogous method and apparatus for determining respiratory information for a subject (Abstract, Fig. 2, para. [0011]). Babaeizadeh teaches acquiring a signal of respiration during a threshold period of time (Fig. 2, para. [0040], para. [0052]). Babaeizadeh teaches dividing the signal representative of respiration into blocks and identifying one or more of the blocks as qualifying based on one or more criteria (para. [0069]). Babaeizadeh further teaches in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time (para. [0065], “acquired physiological signal may be discarded or excluded from subsequent processing if the contextual information includes an indication that the quality of the signal is below a predefined threshold value …”, para. [0069], “if there are less than a threshold value of interference-free (or artefact-free) heart beats detected in the segment or if there are more than a threshold value of heart beats that are abnormal … the segment may be discarded”, para. [0071]); further processing data to identify one or more apnea/hypopnea events (para. [0068], “respiratory condition (or a breathing disorder) for the subject may be determined based on the determined respiratory information for the subject … sleep apnea”); and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk (para. [0068], “determine respiratory condition for the subject is output …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more programs disclosed by Pinhas to additionally identifying a number of one or more blocks identified as qualifying and discard or maintain data if the number is less than or greater than a threshold; maintaining data corresponding to the threshold period of time; further process data to identify one or more apnea/hypopnea events; and output an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk, as taught by Babaeizadeh. This is because Babaeizadeh teaches by discarding data if a qualifying number of segments is below a threshold, optimal physiological signals can be used for subsequent processing, such as determining sleep apnea and outputting results (para. [0065], para. [0068]). One of ordinary skill would recognize that a physiological signal with too few qualifying blocks would produce not optimal respiratory information, for example, by introducing too many artefacts or not having enough data to obtain accurate information (para. [0069]).
Regarding claim 24, modified Pinhas discloses the electronic device of claim 22, wherein the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold (para. [0301], “epoch is identified as quiet if its power spectrum has a peak in the range expected for respiration for that subject (e.g., 0.2-0.5 Hz) … threshold level for each time epoch”).
Regarding claim 25, modified Pinhas discloses the electronic device of claim 24, wherein the first frequency range corresponds to a respiratory band (para. [0301], “epoch is identified as quiet if its power spectrum has a peak in the range expected for respiration for that subject (e.g., 0.2-0.5 Hz)” - para. [0069] of the instant specification recites the frequency range corresponding to the respiratory band is less than 1 Hz).
Regarding claim 26, modified Pinhas discloses the electronic device of claim 24, further comprising calculating the amplitude of the signal representative of respiration using one or more low-pass filters (Fig. 2, element 34, para. [0186], “filter 34 typically comprises a band-pass filter or a low-pass filter …”).
Regarding claim 33, Pinas discloses a method (Abstract, “methods and systems for monitoring vital signs …”, Fig. 2, para. [0068]) comprising:
acquiring a signal representative of respiration during a threshold period of time (Fig. 2, element 30, para. [0173-0174], Fig. 3, para. [0178], “motion of subject sensed by sensor 30, for example, during sleep, may include regular breathing movement …”, Fig. 5, para. [0207], “respiration rate … during the hours of 11:00 pm to 6:00 am …”);
dividing the signal representative of respiration into blocks (para. [0199], criterion is implemented for determining whether a specific measurement (e.g., during one minute) is of high quality …”, para. [0301], “divides monitored period into time epochs of a duration … typically between 30 and 300 seconds …”);
identifying one or more of the blocks as qualifying based on one or more criteria (para. [0301], “each epoch is identified as ‘quiet’ or ‘noisy’ … identified as quiet if its power spectrum has a peak in the range expected for respiration …”).
However, Pinhas does not explicitly disclose in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time; further processing the data to identify one or more apnea/hypopnea events; and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk.
Babaeizadeh teaches of an analogous method and apparatus for determining respiratory information for a subject (Abstract, Fig. 2, para. [0011]). Babaeizadeh teaches acquiring a signal of respiration during a threshold period of time (Fig. 2, para. [0040], para. [0052]). Babaeizadeh teaches dividing the signal representative of respiration into blocks and identifying one or more of the blocks as qualifying based on one or more criteria (para. [0069]). Babaeizadeh further teaches in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time (para. [0065], “acquired physiological signal may be discarded or excluded from subsequent processing if the contextual information includes an indication that the quality of the signal is below a predefined threshold value …”, para. [0069], “if there are less than a threshold value of interference-free (or artefact-free) heart beats detected in the segment or if there are more than a threshold value of heart beats that are abnormal … the segment may be discarded”, para. [0071]); further processing data to identify one or more apnea/hypopnea events (para. [0068], “respiratory condition (or a breathing disorder) for the subject may be determined based on the determined respiratory information for the subject … sleep apnea”); and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk (para. [0068], “determine respiratory condition for the subject is output …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more programs disclosed by Pinhas to additionally identifying a number of one or more blocks identified as qualifying and discard or maintain data if the number is less than or greater than a threshold; further process data to identify one or more apnea/hypopnea events; and output an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk, as taught by Babaeizadeh. This is because Babaeizadeh teaches by discarding data if a qualifying number of segments is below a threshold, optimal physiological signals can be used for subsequent processing, such as determining sleep apnea and outputting results (para. [0065], para. [0068]). One of ordinary skill would recognize that a physiological signal with too few qualifying blocks would produce not optimal respiratory information, for example, by introducing too many artefacts or not having enough data to obtain accurate information (para. [0069]).
Regarding claim 34, modified Pinhas discloses the method of claim 33, wherein the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold (para. [0301], “epoch is identified as quiet if its power spectrum has a peak in the range expected for respiration for that subject (e.g., 0.2-0.5 Hz) … threshold level for each time epoch”).
Regarding claim 35, modified Pinhas discloses the method of claim 34, wherein the first frequency range corresponds to a respiratory band (para. [0301], “epoch is identified as quiet if its power spectrum has a peak in the range expected for respiration for that subject (e.g., 0.2-0.5 Hz)” - para. [0069] of the instant specification recites the frequency range corresponding to the respiratory band is less than 1 Hz).
Regarding claim 39, modified Pinhas discloses the method of claim 33, wherein the threshold corresponds to 4 hours of time (Fig. 5, para. [0207], “respiration rate … during the hours of 11:00 pm to 6:00 am …”).
Regarding claim 41, Pinhas discloses a non-transitory computer readable storage medium storing instructions (Abstract, “system for monitoring vital signs …”, Fig. 2, para. [0068]), which when executed by one or more processing circuits, cause the one or more processing circuits to (para. [0068], “control unit … adapted to carry out one or more steps of the method …”, para. [0175-0176]):
acquire a signal representative of respiration during a threshold period of time (Fig. 2, element 30, para. [0173-0174], Fig. 3, para. [0178], “motion of subject sensed by sensor 30, for example, during sleep, may include regular breathing movement …”, Fig. 5, para. [0207], “respiration rate … during the hours of 11:00 pm to 6:00 am …”);
divide the signal representative of respiration into blocks (para. [0199], criterion is implemented for determining whether a specific measurement (e.g., during one minute) is of high quality …”, para. [0301], “divides monitored period into time epochs of a duration … typically between 30 and 300 seconds …”);
identify one or more of the blocks as qualifying based on one or more criteria (para. [0301], “each epoch is identified as ‘quiet’ or ‘noisy’ … identified as quiet if its power spectrum has a peak in the range expected for respiration …”).
However, Pinhas does not explicitly disclose in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discard data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintain data corresponding to the threshold period of time; further process the data to identify one or more apnea/hypopnea events; and output an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk.
Babaeizadeh teaches of an analogous method and apparatus for determining respiratory information for a subject (Abstract, Fig. 2, para. [0011]). Babaeizadeh teaches acquiring a signal of respiration during a threshold period of time (Fig. 2, para. [0040], para. [0052]). Babaeizadeh teaches dividing the signal representative of respiration into blocks and identifying one or more of the blocks as qualifying based on one or more criteria (para. [0069]). Babaeizadeh further teaches in accordance with a number of one or more blocks identified as qualifying blocks being less than a threshold, discarding data corresponding to the threshold period of time; and in accordance with the number of the one or more blocks identified as qualifying blocks being greater than the threshold: maintaining data corresponding to the threshold period of time (para. [0065], “acquired physiological signal may be discarded or excluded from subsequent processing if the contextual information includes an indication that the quality of the signal is below a predefined threshold value …”, para. [0069], “if there are less than a threshold value of interference-free (or artefact-free) heart beats detected in the segment or if there are more than a threshold value of heart beats that are abnormal … the segment may be discarded”, para. [0071]); further processing data to identify one or more apnea/hypopnea events (para. [0068], “respiratory condition (or a breathing disorder) for the subject may be determined based on the determined respiratory information for the subject … sleep apnea”); and outputting an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk (para. [0068], “determine respiratory condition for the subject is output …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more programs disclosed by Pinhas to additionally identifying a number of one or more blocks identified as qualifying and discard or maintain data if the number is less than or greater than a threshold; further process data to identify one or more apnea/hypopnea events; and output an indication of a number of one or more apnea/hypopnea events identified or an indication of sleep apnea risk, as taught by Babaeizadeh. This is because Babaeizadeh teaches by discarding data if a qualifying number of segments is below a threshold, optimal physiological signals can be used for subsequent processing, such as determining sleep apnea and outputting results (para. [0065], para. [0068]). One of ordinary skill would recognize that a physiological signal with too few qualifying blocks would produce not optimal respiratory information, for example, by introducing too many artefacts or not having enough data to obtain accurate information (para. [0069]).
Regarding claim 42, modified Pinhas discloses the non-transitory computer readable storage medium of claim 41, wherein the one or more criteria include a first criterion that is met when an amplitude of the signal representative of respiration within a first frequency range exceeds an amplitude threshold (para. [0301], “epoch is identified as quiet if its power spectrum has a peak in the range expected for respiration for that subject (e.g., 0.2-0.5 Hz) … threshold level for each time epoch”).
Claims 27, 28, 32, 36, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Pinhas et al. (US 20070118054 A1) (previously cited), hereinafter referred to as Pinhas, in view of Saeed Babaeizadeh (US 20220000435 A1) (previously cited), hereinafter referred to as Babaeizadeh as applied to claims 22, 24, 33, and 34 above, and further in view of Halperin et al. (US 20080275349 A1) (previously cited), hereinafter referred to as Halperin.
Regarding claim 27, modified Pinhas discloses the electronic device of claim 24.
However, modified Pinhas does not explicitly disclose wherein the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold.
Halperin teaches of an analogous apparatus and method for monitoring large body movements (Abstract, Fig. 2, para. [0011]). Halperin teaches acquiring a signal representative of respiration (Fig. 2, Fig. 3, para. [0595-0596], para. [0620]). Halperin teaches identifying one or more blocks as qualifying based on one or more criteria (para. [0829]). Halperin further teaches the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold (para. [0790-0795], “large body movements are defined as having an amplitude that is substantially greater than that of respiration-related body movement, and/or having frequency components that are higher than those of respiratory motion (e.g., frequencies greater than about 1 Hz) …”, para. [0829]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and one or more criteria disclosed by modified Pinhas to additionally include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold, as taught by Halperin. This is because Halperin teaches by identifying large body movements, interfering effects of the sensing large body movements on the analysis of a physiological parameter can be minimized by rejecting the data (para. [0128-0129]).
Regarding claim 28, modified Pinhas discloses the electronic device of claim 27.
However, modified Pinhas does not explicitly disclose wherein the second frequency range excludes a respiratory band and includes frequencies greater than 10Hz.
Halperin further teaches the second frequency range excludes a respiratory band and includes frequencies greater than 10Hz (para. [0613], “acoustic signals … 100 Hz to about 8 kHz”, para. [0790], “identify large body movement … frequency components that are higher than those of respiratory motion (e.g., frequencies greater than about 1 Hz) …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second frequency range to explicitly exclude a respiratory band and include frequencies greater than 10Hz, as taught by Halperin. This is because Halperin teaches by identifying large body movements, interfering effects of the sensing large body movements on the analysis of a physiological parameter can be minimized by rejecting the data (para. [0128-0129]).
Regarding claim 32, modified Pinhas discloses the electronic device of claim 22.
However, modified Pinhas does not explicitly disclose wherein the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold.
Halperin teaches of an analogous apparatus and method for monitoring large body movements (Abstract, Fig. 2, para. [0011]). Halperin teaches acquiring a signal representative of respiration (Fig. 2, Fig. 3, para. [0595-0596], para. [0620]). Halperin teaches identifying one or more blocks as qualifying based on one or more criteria (para. [0829]). Halperin further teaches the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold (para. [0826]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and one or more criteria disclosed by modified Pinhas to additionally include a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold, as taught by Halperin. This is because Halperin teaches a signal-to-noise ratio can be calculated and used to determine if a physiological signal accurately detects a monitoring criteria to prevent false alarms (para. [0826]).
Regarding claim 36, modified Pinhas discloses the method of claim 34.
However, modified Pinhas does not explicitly disclose wherein the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold.
Halperin teaches of an analogous apparatus and method for monitoring large body movements (Abstract, Fig. 2, para. [0011]). Halperin teaches acquiring a signal representative of respiration (Fig. 2, Fig. 3, para. [0595-0596], para. [0620]). Halperin teaches identifying one or more blocks as qualifying based on one or more criteria (para. [0829]). Halperin further teaches the one or more criteria include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold (para. [0790-0795], “large body movements are defined as having an amplitude that is substantially greater than that of respiration-related body movement, and/or having frequency components that are higher than those of respiratory motion (e.g., frequencies greater than about 1 Hz) …”, para. [0829]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and one or more criteria disclosed by modified Pinhas to additionally include a second criterion that is met when an energy of the signal representative of respiration within a second frequency range is less than an energy threshold, as taught by Halperin. This is because Halperin teaches by identifying large body movements, interfering effects of the sensing large body movements on the analysis of a physiological parameter can be minimized by rejecting the data (para. [0128-0129]).
Regarding claim 40, modified Pinhas discloses the method of claim 33.
However, modified Pinhas does not explicitly disclose wherein the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold.
Halperin teaches of an analogous apparatus and method for monitoring large body movements (Abstract, Fig. 2, para. [0011]). Halperin teaches acquiring a signal representative of respiration (Fig. 2, Fig. 3, para. [0595-0596], para. [0620]). Halperin teaches identifying one or more blocks as qualifying based on one or more criteria (para. [0829]). Halperin further teaches the one or more criteria includes a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signal-to-noise ratio threshold (para. [0826]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and one or more criteria disclosed by modified Pinhas to additionally include a criterion that is satisfied when a signal-to-noise ratio of the signal representative of respiration is greater than a signa