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 Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/28/2025, with respect to rejections of claims 16-35 under 35 USC 101 have been fully considered but they are not persuasive.
Beginning on page 6, the applicant argues that certain features were not considered because they were not explicitly stated in the claim and therefore, the claim was not considered as a whole. This argument is fully considered but is not persuasive. The features/limitations of the claim were considered both individually and as a whole in determining and performing the 101 analysis. The limitation “:receiving, by a processing circuitry, periodic respiratory parameter information in response to detection of an event, where the respiratory parameter information includes a respiratory effort value of a patient” is merely a step for the processing circuitry to receive data which is considered to be a mere extra solution activity (i.e., pre-solution activity regarding collecting data).
On page 7, the applicant argues, with respect to Step 2A Prong two, that the additional elements integrate the judicial exception into a practical application. This argument is fully considered but is not persuasive. The additional limitations of “processing circuitry”, “memory”, etc. are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. For example, the claim recites “receiving, by a processing circuitry, periodic respiratory parameter information in response to detection of an event, where the respiratory parameter information includes a respiratory effort value of a patient”. As stated, and when read under its broadest reasonable interpretation, the claim merely requires the processing circuitry to receive data/parameters related to respiratory information. Although the claim states a respiratory effort value being part of the received parameters, it does not limit other parameters to be present. furthermore, the claim does not provide any details regarding the event, the detection of the event and nor does it require the processing circuitry to perform detection of an event. Lastly, the claim does not provide any limitations on “periodically”. Therefore, it could receive data once a day, once a month, etc. The claim as recited merely requires collecting and processing data by a processing circuitry which is considered to be mere extra-solution activity.
The applicant argues that the claim provides an improvement and technical solution. This argument is fully considered but is not persuasive. In order to have a technological improvement, the additional elements, either solely or in combination, need to reflect an improvement. Here, the improvement is provided in the abstract idea. The claim does not provide any details regarding what/if anything it intends to do with the determined sudden cardiac arrest. For example, the detected sudden cardiac arrest is not being used to provide treatment, solution, therapy, etc. The claim further does not provide any details that would provide an improvement in sensitivity and specificity for detecting SCA. It merely requires detecting SCA from cardiac parameter which includes a respiratory effort value of a patient. This is nothing more than observing, evaluating and judging (i.e., concepts performed in the human mind). Therefore, any improvement asserted is in the abstract idea.
As written, the claim(s) do not recite any additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
For at least the reasons recited above, the applicant’s arguments are not persuasive and the 101 rejection is maintained.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/28/2025, with respect to rejections of claims 16-35 under 35 USC 112 have been fully considered and are persuasive. The 112(b) rejections of claims 16-35 have been withdrawn.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/28/2025, with respect to rejections of claims 16-35 under 35 USC 103 have been fully considered and are persuasive – in part. The applicant argues that the prima facie case of obviousness was not established. This argument is fully considered but is not persuasive. The claims as written do not provide any details regarding how frequently (i.e., “periodic”) data are collected, what the “event” is, any limitations on receiving periodic respiratory parameter being only based on a response to detection of an event, how “a sudden cardiac arrest of the patient is detected using the respiratory parameter information”, etc. The claim also does not recite any specific limitations regarding the information that would be provided with the respiratory parameter information. In fact, even though the claim recites “the respiratory parameter information includes a respiratory effort value of a patient”, the claim only requires “detecting, [] based on the respiratory parameter information, whether a sudden cardiac arrest of the patient”. As written, under its broadest reasonable interpretation, the claim merely requires detecting SCA from respiratory information of a user (Disclosed by Rowlandson), which at least would include a respiratory effort value. Since the latter part as amended (i.e., respiratory effort value) is not explicitly disclosed by Rowlandson, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following:
Claim(s) 16-22, 27-32, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20050234313 to Rowlandson et al. (hereinafter “Rowlandson”) in view of US 20170202463 to Muhlseff et al. (hereinafter “Muhlseff”).
Claim(s) 23, 25, 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20170360361 to Xi et al. (hereinafter “Xi”).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20160354011 to Stahl.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20150164375 to Schindhelm et al. (hereinafter “Schindhelm”).
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 16-35 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 16-27 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03. Claims 28-35 recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03.
2A – Prong 1: The independent claims 16, 28 and 35 recite a judicial exception by reciting the limitations of “detecting, [], based on the respiratory parameter information, whether a sudden cardiac arrest of the patient is detected”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 16, 28 and 35 recite the additional limitations of “processing circuitry”, “memory”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception 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’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually 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 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. 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. 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, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 17-27, 29-34 depend on claims 16, 28 and 35. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “sensor”, etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually 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 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. 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.
Thus, claims 16-35 are directed to an abstract idea and are therefore rejected.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 16-22, 27-32, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20050234313 to Rowlandson et al. (hereinafter “Rowlandson”) in view of US 20170202463 to Muhlseff et al. (hereinafter “Muhlseff”).
Regarding Claim 16. (New) Rowlandson discloses a method comprising: receiving, by a processing circuitry, periodic respiratory parameter information in response to detection of an event, where the respiratory parameter information includes respiratory effort of a patient; and determining, by the processing circuitry and based on the respiratory parameter information, whether a sudden cardiac arrest of the patient is detected (abstract, para 0009, 0029, 0031, etc., claim 1, “predicting sudden cardiac death in a patient being monitored for sleep apnea, the method comprising: acquiring respiration data” and event is considered to be “apnea”) but fails to disclose the respiratory parameter to include a respiratory effort value.
Muhlseff, from a similar field of endeavor teaches a similar monitoring system/method to obtain vital parameters of a user to extract respiration rate from the respiration signal (para 0029, 0046, 0056) which include respiration effort (para 0030), wherein the analysis of the correlation of respiration effort and PAT measures allows determining, apnea (para 0030), normal and abnormal respiration movements (para 0061). 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 disclosure of Rowlandson with the teachings Muhlseff, because doing so would allow for monitoring the respiration effort and its impact on PAT measures to allow the predictable result of detecting obstructive events.
Regarding Claim 17. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 16, wherein the respiratory parameter information includes respiratory rate of the patient (Muhlseff, para 0029, 0046, 0056).
Regarding Claim 18. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 16, wherein receiving respiratory parameter information comprises continuously receiving respiratory parameter information (para 0024, continuous operation of the system/method).
Regarding Claim 19. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 16, wherein the event comprises one or more of sudden cardiac arrest, stroke, myocardial infarction, or patient falls based on another physiological parameter (see rejection of claim 1, para 0017).
Regarding Claim 20. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 16, wherein receiving respiratory parameter information comprises: receiving a signal from a sensor; and determining the respiratory parameter information from the signal (para 0018).
Regarding Claim 21. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 20, wherein receiving the signal comprises receiving one or more of an impedance signal, an accelerometer signal, an electromyogram signal, an electrocardiogram signal, an optical signal, or a soundwave signal (para 0018 “impedance measurements”, 0023 ECG).
Regarding Claim 22. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 20, wherein determining the respiratory parameter information comprises estimating, with the processing circuitry, the respiratory effort value of the patient (Muhlseff, para 0029, 0046, 0056).
Regarding Claim 27. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 16, further comprising comparing a current respiratory parameter information to a control respiratory parameter information, wherein determining whether sudden cardiac arrest is detected comprises determining whether sudden cardiac arrest is detected based on the comparison (para 0053).
Regarding Claims 28 and 35. (New) Rowlandson discloses a device and non-transitory computer-readable medium storing instructions for causing processing circuitry to perform a method comprising: processing circuitry; and memory comprising program instructions that, when executed by the processing circuity, cause the processing circuitry to: receive periodic respiratory parameter information in response to detection of an event; and determine, based on the respiratory parameter information, whether a sudden cardiac arrest of the patient is detected (abstract, para 0009, 0029, 0031, etc., claim 1, “predicting sudden cardiac death in a patient being monitored for sleep apnea, the method comprising: acquiring respiration data” and event is considered to be “apnea”) but fails to disclose where the respiratory parameter information includes respiratory effort of a patient.
Muhlseff, from a similar field of endeavor teaches a similar monitoring system/method to obtain vital parameters of a user to extract respiration rate from the respiration signal (para 0029, 0046, 0056) which include respiration effort (para 0030), wherein the analysis of the correlation of respiration effort and PAT measures allows determining, apnea (para 0030), normal and abnormal respiration movements (para 0061). 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 disclosure of Rowlandson with the teachings Muhlseff, because doing so would allow for monitoring the respiration effort and its impact on PAT measures to allow the predictable result of detecting obstructive events.
Regarding Claim 29. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 28 wherein the instructions cause the processing circuity to receive respiratory parameter information in response to detection of one or more of sudden cardiac arrest, stroke, myocardial infarction, or patient falls based on another physiological parameter (see rejection of claim 28, para 0017).
Regarding Claim 30. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 28, wherein the instructions cause the processing circuitry to: receive a signal from a sensor; and determine the respiratory parameter information from the signal (para 0018, Muhlseff, para 0029, 0046, 0056).
Regarding Claim 31. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 30, wherein to receive the signal the instructions cause the processing circuitry to receive one or more of an impedance signal, an accelerometer signal, an electromyogram signal, an electrocardiogram signal, an optical signal, or a soundwave signal (para 0018 “impedance measurements”, para 0023 ECG).
Regarding Claim 32. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 31, wherein the instructions cause the processing circuitry to estimate the respiratory effort value of the patient based on the one or more of the impedance signal, the accelerometer signal, the electromyogram signal, the electrocardiogram signal, the optical signal, or the soundwave signal (para 0018 “impedance measurements”, 0023 “ECG”).
Claim(s) 23, 25, 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20170360361 to Xi et al. (hereinafter “Xi”).
Regarding Claim 23. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 22, but fails to explicitly disclose wherein estimating the respiratory effort value comprises determining a peak-to-peak amplitude of the signal for two or more respiratory cycles of the patient.
Xi, from a similar field of endeavor, teaches that it is known to determine amplitude metric peaks to determine individual frequencies of respiratory (effort) (para 0024). 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 disclosure of Rowlandson as modified by Muhlseff with the known teachings of Xi to provide the predictable result of determining respiratory (effort).
Regarding Claim 25. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 20, but fails to explicitly disclose wherein determining the respiratory parameter information from the signal comprises averaging, with the processing circuitry, the signal over a plurality of respiratory cycles.
Xi, from a similar field of endeavor, teaches that it is known to determine amplitude metric peaks to determine individual frequencies of respiratory (effort) by averaging normalized power spectral density within the individual epochs of time (para 0024). 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 disclosure of Rowlandson as modified by Muhlseff with the known teachings of Xi to provide the predictable result of determining respiratory (effort).
Regarding Claim 33. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 32, wherein, to estimate the respiratory effort value, the instructions cause the processing circuitry to determine one or more of a peak-to-peak amplitude of the signal for two or more respiratory cycles of the patient or an area under a curve of the signal for at least one respiratory cycle.
Xi, from a similar field of endeavor, teaches that it is known to determine amplitude metric peaks to determine individual frequencies of respiratory (effort) (para 0024). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Rowlandson as modified by Muhlseff with the known teachings of Xi to provide the predictable result of determining respiratory (effort).
Regarding Claim 34. (New) Rowlandson as modified by Muhlseff renders obvious the device of claim 30, wherein to determine the respiratory parameter information from the signal, the instructions cause the processing circuitry to perform one or more of: average the signal over a plurality of respiratory cycles; or determine at least one of a respiratory cycle length, inspiratory slope, or expiratory slope.
Xi, from a similar field of endeavor, teaches that it is known to determine amplitude metric peaks to determine individual frequencies of respiratory (effort) by averaging normalized power spectral density within the individual epochs of time (para 0024). 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 disclosure of Rowlandson as modified by Muhlseff with the known teachings of Xi to provide the predictable result of determining respiratory (effort).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20160354011 to Stahl.
Regarding Claim 24. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 22, but fails to explicitly disclose wherein estimating the respiratory effort value of the patient comprises determining an area under a curve of the signal for at least one respiratory cycle.
Stahl, from a similar field of endeavor teaches that area under the curve or slope of the envelope be used to determine respiratory effort (para 0057). 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 disclosure of Rowlandson as modified by Muhlseff with the teachings of Stahl to provide the predictable result of determining respiratory effort.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson as modified by Muhlseff as applied to claims above, and further in view of US Pat Pub No. 20150164375 to Schindhelm et al. (hereinafter “Schindhelm”).
Regarding Claim 26. (New) Rowlandson as modified by Muhlseff renders obvious the method of claim 20, but fails to explicitly disclose wherein determining the respiratory parameter information from the signal comprises determining at least one of a respiratory cycle length, inspiratory slope, or expiratory slope.
Schindhelm, from a similar field of endeavor, teaches the detection module uses the modulation cycle length estimated by the modulation cycle length estimation module to make a set of one or more generic SDB respiratory effort templates specific to the patient. 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 disclosure of Rowlandson as modified by Muhlseff with the teachings of Schindhelm to provide the predictable result of generating respiratory effort templates specific to the patient.
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 SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796