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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe on 04/20/2023. It is noted, however, that applicant has not filed a certified copy of the EP23168915.9 application as required by 37 CFR 1.55.
Claim Objections
Claim 5 is objected to because of the following informalities: the claim ends with the number “306” in parentheses. No other reference numbers appear in the claims, and thus this appears to be in error. Appropriate correction is required.
Claims 2 and 10 objected to because of the following informalities: the acronyms “OSA” and “COMISA” should be introduced by their full names in these claims (similar to what is seen in claim 9) since it is the first time they appear in each claim’s respective chain of dependency. Appropriate correction is required.
Claims 8 and 10 objected to because of the following informalities: these claims each recite “the recovery response signal” (once in claim 8 and twice in claim 10) which should be amended to “the recovery response phase signal” to be in proper antecedent form. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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.
The term “likely” in claim 2 (“likely has one of OSA and COMISA …”) is a relative term which renders the claim indefinite. The term “likely” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is required in the context of this claim for a subject to “likely have” one of those two conditions, compared to not being likely to have one of those conditions.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and/or a natural phenomenon without significantly more.
Step 1: All of claims 1-14 and 16 are directed either to a method/process or to a system/machine. NOTE: Claim 15 is separately rejected below as being software per se and thus wouldn’t ordinarily proceed in this analysis; however, it is being included in this analysis since it is likely that Applicant will amend the claim to be in a proper tangible system form.
Step 2A, Prong One: The claims recite a mental process including steps such as both “determining …” steps in claim 1 (also see e.g. “determining …” in claim 2) which could be performed by the human mind and/or by a human with a physical aid such as pen and paper. A person is capable of mentally analyzing a heartrate signal to determine a recovery response phase signal, and also mentally analyzing that signal to determine a deviation from a reference signal. Additionally/alternatively, the claims are also directed to the natural phenomenon of a human having natural variations in how their heart rate responds to arousals based on whether or not they have a certain condition such as obstructive sleep apnea (OSA) or Comorbid Insomnia and Sleep Apnea (COMISA); the claims here merely observe and identify when this natural phenomenon occurs, using generic technology (described more below).
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process and/or natural phenomenon using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “receiving …” the data from the arousal and/or cardiac sensor(s) is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process. Furthermore, merely carrying out mental steps using generic computing technology such as “a processing unit” or a “computer” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components (“a processing unit” and/or “computer”) and generic data collection components (“arousal sensor” and “cardiac sensor”). The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Claim 15 is additionally/separately rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 15 is directed to a computer program/software per se. See MPEP § 2106.03(I): “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as “data per se”) or a computer program per se (often referred to as “software per se”) when claimed as a product without any structural recitations ….”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Bigalke et al. (NPL cited by Applicant: see NPL #9 on the IDS filed 04/19/2024) (hereinafter “Bigalke”).
Regarding Claim 1, Bigalke teaches a computer-implemented method (see “All data were analyzed using commercially available statis-tical software (SPSS 26.0; SPSS, Chicago, IL)” in the first paragraph under “Statistical Methods” on page H561 and “exported to analysis software for assessment (LabChart, ADInstruments, Sydney, Australia)” under the heading “Nocturnal electrocardiography” on page H560; the inclusion of this software in the overall method qualifies as “computer-implemented”) comprising:
receiving an arousal signal representative of an occurrence an arousal of a subject (see e.g. “Spontaneous arousals were scored based on AASM guide-lines, including a board-certified sleep physician (C.A.S.).Briefly, the arousals were marked by an abrupt increase inEEG frequency” under “Data Analysis” on page H560);
receiving a heartrate signal representative of a heartrate of the subject (see e.g. “The cardiac response to arousal was assessed by monitor-ing each participant’s heart rate for 30 cardiac cycles follow-ing the onset of the EEG arousal” under “Data Analysis” on page H560);
determining a recovery response phase signal in the heartrate signal (see e.g. “The cardiac response to arousal was assessed by monitor-ing each participant’s heart rate for 30 cardiac cycles follow-ing the onset of the EEG arousal” under “Data Analysis” on page H560), wherein the recovery response phase signal is representative of a recovery response phase in which the heartrate decreases after the arousal (see e.g. “HR responsiveness to nocturnal cortical arousal is marked by a transient increase, which subsequently returns to baseline within ~10 s following the arousal” under “Introduction” on page H559; the return to baseline is a decrease);
determining a deviation of the recovery response phase signal relative to a reference signal (see e.g. “a delayed HR return to baseline compared with normal sleepers” under “Discussion” on page H563; also see the title, as this is the main focus of the paper).
Regarding Claims 3, Bigalke further teaches receiving the arousal signal from an arousal sensor; receiving the heartrate signal from a cardiac sensor; wherein the arousal sensor is configured to provide the arousal signal representative of the occurrence of the arousal, wherein the cardiac sensor is configured to provide the heartrate signal representative of the heart rate (see “Measurements” section starting on page H559).
Regarding Claim 11, Bigalke further teaches wherein the reference signal represents a value of the heartrate prior to the arousal (see “The cardiac response to arousal was assessed by monitor-ing each participant’s heart rate for 30 cardiac cycles follow-ing the onset of the EEG arousal. Each postarousal cardiac cycle was then compared with a baseline taken from the average heart rate of 2–12 cardiac cycles before the arousal” under “Data Analysis”).
Regarding Claim 12, Bigalke further teaches determining a pre-arousal phase signal in the heartrate signal; determining the reference signal based on the pre-arousal phase signal; wherein the pre-arousal phase signal is representative of the heartbeat prior to an onset of the arousal (see “The cardiac response to arousal was assessed by monitor-ing each participant’s heart rate for 30 cardiac cycles follow-ing the onset of the EEG arousal. Each postarousal cardiac cycle was then compared with a baseline taken from the average heart rate of 2–12 cardiac cycles before the arousal” under “Data Analysis”).
Regarding Claim 13, Bigalke further teaches wherein the pre-arousal phase signal is based on a number of cardiac cycles prior to the onset of the arousal, wherein the number is in the range of 2-12 (see “The cardiac response to arousal was assessed by monitor-ing each participant’s heart rate for 30 cardiac cycles follow-ing the onset of the EEG arousal. Each postarousal cardiac cycle was then compared with a baseline taken from the average heart rate of 2–12 cardiac cycles before the arousal” under “Data Analysis”).
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 2, 7-10 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bigalke.
Regarding Claim 2, Bigalke is admittedly not focused on diagnosing sleep apnea and actually omitted those patients known to suffer from it because the purpose of the study was to analyze the heart rate recovery to arousals in short sleepers. However, it is known, and Bigalke teaches, that both short sleep duration and insomnia and sleep apnea are all known to negatively impact cardiovascular outcomes (see “Discussion” on page H563). It thus logically follows that in a commercial implementation one of ordinary skill of the art would seek to also determine whether a subject has OSA and/or COMISA since both of these were known to affect cardiovascular outcomes, and thus they would affect the subsequent results of the diagnosis (e.g. treatment recommendations). As such, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Bigalke to, upon determining the deviation of the heart rate recovery from the baseline/reference, subsequent determine whether a subject likely has OSA and/or COMISA, since these were disorders known to impact the ultimate determination of a subject’s cardiovascular status.
Regarding Claims 7-10, Bigalke fails to explicitly teach using different reference signals for non-sleep disordered breathing, and sleep disordered breathing, including OSA and COMISA. However, the presence of sleep disordered breathing is known to affect the heart rate response to arousals. This is demonstrated in the fact that Bigalke excluded patients suffering from these conditions (i.e. because Bigalke was solely focused in this experimental setup on short sleep and how it impacted the HR response), and measured indicators for insomnia and apnea even in those patients selected (see e.g. Table 1 ISI, and Table 2 AHI). As such, building on the explanation given for claim 2 above, it would logically follow that in a commercial implementation of Bigalke’s setup, one would expect different heart rate responses from health individuals, those with only OSA, and those with COMISA. Given that, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to use different baselines, or “reference signals” for each of these categories (i.e. non-SDB, OSA, and COMISA) because it would predictably allow for a more accurate diagnosis of a patient’s specific condition(s).
Regarding Claims 14-16, Bigalke teaches the method of claim 1, but fails to specifically teach that a processing unit carries out all of the steps (rather, Bigalke includes some manually implemented determining steps in the process, which is not unexpected since it was an experimental setup for a research article). However, transitioning an experimental setup into an automated setup which is carried out by one or more processors is incredibly common and routine in the medical diagnostic arts, and presents well-understood benefits (e.g. convenience, accuracy, speed among others). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Bigalke’s experimental setup into a fully automated processor/computer-implemented setup in which the steps are carried out by the processor(s)/computer(s) since this is extremely well known in medical diagnostics and provides numerous well-understood benefits.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bigalke as applied to claim 1 above, and further in view of US 2016/0374569 A1 to Breslow et al. (hereinafter “Breslow”).
Regarding Claim 4, Bigalke fails to teach that the arousal signal also comes from the same cardiac sensor as the heartrate signal. However, it was known to use a cardiac sensor to detect sleep arousals, as seen in Breslow (see e.g. Paras. 4, 5). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Bigalke to use the cardiac sensor to detect the arousals because it would reduce the overall cost and complexity of the sensing apparatus, thus making it more practical for commercial implementation compared to Bigalke’s experimental setup which uses a wide variety of different sensors (which will not practically be available for certain desirable commercial implementations such as a simple at-home useable diagnostic device).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bigalke as applied to claim 2 above, and further in view of Goff et al. (NPL cited by Applicant in the 04/19/2024 IDS; see NPL #11) (hereinafter “Goff”).
Regarding Claim 5, Bigalke fails to explicitly teach determining a peak response phase signal in the heartrate signal, wherein the peak response phase signal is representative of a peak response phase in which the heartrate increases after the arousal, wherein the recovery response phase signal starts after the peak response phase signal. However, Goff teaches this limitation (see “Data Analysis” and the discussion of early and late response). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Bigalke to include determining a peak response phase signal in the heartrate signal, wherein the peak response phase signal is representative of a peak response phase in which the heartrate increases after the arousal, wherein the recovery response phase signal starts after the peak response phase signal, as taught by Goff, because this would predictably increase the accuracy of the diagnosis.
Regarding Claim 6, Bigalke further teaches wherein the peak response phase signal represents a number of cardiac cycles in the range of 2-12 after the arousal, wherein the recovery response phase signal represents a number of cardiac cycles in the range of 5-25 after an end of the peak response phase (see e.g. “Data Analysis” section).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792