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 .
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 1-20 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.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-20 recites at least one step or instruction for calculating respiratory severity values, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 1 recites receiving data, identifying and calculating particular portions of that data to determine a respiratory severity index. (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
Further, dependent Claims 2-19 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims1 (and their respective dependent Claims 2-19) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, there are no additional elements recited.
Accordingly, independent Claims 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1 include additional elements therefore, there is no analysis to be preformed at Step 2B.
For at least the above reasons, the methods of Claims 1-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Objections
The claims are objected to between the claims switch between the term “respiration” vs. “respiratory” severity metric and in many instances only “respiration/respiratory” event is recited. One term should be chosen for consistency.
Claim 6 is objected to because “provide wake up signal” should read “provide a wake up signal”.
Claim 12 is objected to because “off” should read “of”.
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.
Claims 2, 3, 17 and 20 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.
The term “highest” in claim 2 is a relative term which renders the claim indefinite. The term “highest” 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.
Regarding Claim 3, the limitation “as a first the at least” is grammatically broken and renders the claim indefinite.
The term “clinical definition” in claim 10 is a relative term which renders the claim indefinite. The term “clinical definition” 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.
The term “personal characteristics” in claim 17 is a relative term which renders the claim indefinite. The term “personal characteristics” 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.
The term “disfavored position” in claim 20 is a relative term which renders the claim indefinite. The term “disfavored position” 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.
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.
Claim(s) 1-6 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100063366 A1 to Ochs et al. (hereinafter, Ochs).
Regarding Claim 1, Ochs discloses a method for determining at least one respiratory severity metric for an individual's sleep session, the method comprising inter alia:
receiving a data signal indicative of respiration of the individual as a function of time ([0012] “The PSG signals may be limited to four signals, including data from an airflow channel, a blood oxygen saturation (SpO.sub.2) channel, a chest movement channel, and an abdomen movement channel.” e.g., Ochs takes in the same breathing signals over the sleep session);
identifying a plurality of respiratory severity events from the data signal ([0034] “an RAF event may be described as an interval where the amplitude envelope of a signal on the airflow channel from the PSG system 12 is reduced at least 40% relative to the baseline for at least 10 seconds consecutively” e.g., Ochs flags each qualifying drop in breathing as a discrete “reduction-in-airflow (RAF) event”, which is a respiratory severity event);
calculating respiratory severity values for each of the plurality of identified respiratory severity events ([0039] “the depth of the airflow reduction may be used to quantify a severity of the ventilatory instability” e.g., Ochs scores how sever each event is from how far airflow falls below a baseline);
grouping the plurality of respiratory severity events into a plurality of clusters ([0039] “numerous clusters of RAF events or data segments including RAF events may be considered in determining a severity level” e.g., Ochs expressly groups events into “clusters” / sub-segments); and
calculating, for each cluster, an accumulated respiratory severity value as a clustering index ([0039] “Each sub-segment may be analyzed separately based on certain criteria, such as a number of RAF events per time period, an amount of reduced airflow, or other characteristics, and the values associated with the sub-segments may be combined to provide an overall ventilatory instability level for the large segment of data.” e.g., Ochs combines each cluster’s events into a single severity values).
Regarding Claim 2, Ochs discloses designating the highest calculated clustering index as a first of the at least one respiration severity metric ([0038] “the epoch score may include a value of 1 for an indication that sleep apnea has been detected”)
Regarding Claim 3, Ochs discloses the method of claim 1, further comprising at least one of: calculating a global measure of accumulated flow reduction during the plurality of identified respiratory events as a first of the at least one respiration severity metric; and calculating a global measure of all accumulated flow reduction within identified clusters as a first the at least one respiration severity metric ([0039] “Each sub-segment may be analyzed separately based on certain criteria, such as a number of RAF events per time period, an amount of reduced airflow, or other characteristics, and the values associated with the sub-segments may be combined to provide an overall ventilatory instability level for the large segment of data.”).
Regarding Claim 4, Ochs discloses a method for determining at least one respiratory severity metric for an individual's sleep session, the method comprising inter alia:
receiving a data signal indicative of respiration of the individual as a function of time from a nasal pressure sensor, an air flow sensor, or a sensor affixed to the individual and configured to detect breathing related bodily movements ([0012] “The PSG signals may be limited to four signals, including data from an airflow channel, a blood oxygen saturation (SpO.sub.2) channel, a chest movement channel, and an abdomen movement channel.” e.g., Ochs takes in the same breathing signals over the sleep session)
identifying a plurality of respiratory severity events from the data signal ([0034] “an RAF event may be described as an interval where the amplitude envelope of a signal on the airflow channel from the PSG system 12 is reduced at least 40% relative to the baseline for at least 10 seconds consecutively” e.g., Ochs flags each qualifying drop in breathing as a discrete “reduction-in-airflow (RAF) event”, which is a respiratory severity event);
calculating respiratory severity values for each of the plurality of identified respiratory severity events ([0039] “the depth of the airflow reduction may be used to quantify a severity of the ventilatory instability” e.g., Ochs scores how sever each event is from how far airflow falls below a baseline).
Regarding Claim 5, Ochs discloses the method of claim 2, further comprising calculating a global measure of all accumulated flow reduction within identified clusters as a second respiration severity metric ([0039] “ For example, a large segment of data, e.g., 4 hours of data, may include various sub-segments having different levels of apnea. Each sub-segment may be analyzed separately based on certain criteria, such as a number of RAF events per time period, an amount of reduced airflow, or other characteristics, and the values associated with the sub-segments may be combined to provide an overall ventilatory instability level for the large segment of data.”).
Regarding Claim 6, Ochs discloses the method of claim 4, further comprising:
calculating global measure of accumulated flow reduction during the plurality of identified respiratory events as a second respiration severity metric ([0039] “the values associated with the sub-segments may be combined to provide an overall ventilatory instability level for the large segment of data.”); generating a command to provide wake up signal if the second respiration severity metric exceeds a threshold level ([0038] “the epoch score may include a value of 1 for an indication that sleep apnea has been detected”).
Regarding Claim 8, Ochs discloses the method of claim 1, wherein the step of receiving the data signal indicative of respiration further comprises: receiving a signal from a nasal pressure sensor or an air flow sensor ([0012] “The PSG signals may be limited to four signals, including data from an airflow channel”).
Regarding Claim 9, Ochs discloses the method of claim 1, wherein the step of receiving the data signal indicative of respiration further comprises: receiving a signal from a sensor affixed to the individual and configured to detect breathing related bodily movements as a function of time ([0012] “The PSG signals may be limited to four signals, including data from an airflow channel, a blood oxygen saturation (SpO.sub.2) channel, a chest movement channel, and an abdomen movement channel.” e.g., Ochs takes in the same breathing signals over the sleep session” e.g., Ochs’ chest and abdomen movement channels are sensors detecting breathing-related bodily movement over time).
Regarding Claim 10, Ochs discloses the method of claim 1, further comprising,
receiving a second data signal indicative of blood oxygenation as a function of time; and
wherein the step of identifying the plurality of respiratory severity events from the data signal further comprises: identifying each respiratory severity event if and only if the data signal indicates that a clinical definition of apnea or hypopnea has been met, and the second data signal indicates reduced blood oxygenation ([0012] “The PSG signals may be limited to four signals…a blood oxygen saturation channel…”) ([0035] “if the measured SpO.sub.2 value does not change at least a certain amount, e.g., 3%, during the RAF even or within a certain time, e.g., 30 seconds, after the RAF event, the RAF event may be disqualified”) ([0034] “reduced at least 40% relative to the baseline for at least 10 seconds consecutively”).
Regarding Claim 11, Ochs discloses the method of claim 1, wherein the step of identifying a plurality of respiratory severity events from the data signal further comprises: identifying each respiratory severity event if the data signal indicates there has been a predefined change in respiration for at least a set period of time ([0034] “a determination may be made as to whether a certain level of reduction (e.g., a 40% reduction) in airflow has occurred for at least a threshold amount of time (e.g., 10 seconds)”).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs in view of US 20190142625 A1 A1 to Goff et al. (hereinafter, Goff).
Regarding Claim 7, Ochs discloses the method of claim 1, further comprising receiving a second data signal indicative of a position of the individual as a function of time and recording the position of the individual for each cluster. However, Goff teaches a sleep apnea detection device (Abstract) that receives a second data signal indicative of a position of the individual as a function of time ([0022] “a position sensor adapted to determine patient sleeping position”) and records the position of the individual for each cluster ([0022] “determine and record in memory blood oxygen saturation values computed from the detected light signal and user position information from the position sensor”) ([0044] “ frequency and/or severity of apnea events when the patient is back sleeping to the events occurring when the patient is side sleeping”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Ochs to include the position as a function of time and recording position of the individual for each cluster of Goff, as Goff teaches at [0043] that position data can be used to help differentiate between different conditions and situations.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs in view of US 20050131283 A1 to Grant et al. (hereinafter, Grant).
Regarding Claim 12, Ochs discloses the method of claim 1 wherein the step off calculating the respiratory severity of each of the plurality of identified respiratory events further comprises, for each identified respiratory event: calculating an instantaneous flow reduction signal ([0034] “reduced at least 40% relative to the baseline for at least 10 seconds consecutively”) ([0033] “baseline may be determined as the top 10% or ninetieth percentile of the root mean square value”). Ochs does not expressly disclose summing the instantaneous flow reduction signal. However, Goff teaches a sleep apnea detection device (Abstract) where an instantaneous flow reduction signal is summed ([0005] “indices include the number of oxyhemoglobin desaturation events below a certain threshold, usually 3% or 4% decline from baseline, the cumulative time spent below an oxyhemoglobin saturation of 90% (CT 90)”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Ochs with the summing of an instantaneous flow reduction signal of Grant, as Grant teaches at [0020] that bootstrap aggregation models involving a combination of oximetry indices improved precision.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs in view of US 20060276701 A1 to Ray.
Regarding Claim 18, Ochs discloses the method of claim 1 including detection if the accumulated respiratory severity for at least one cluster exceeds a threshold level ([0039] “numerous clusters of RAF events or data segments including RAF events may be considered in determining a severity level”) except for expressly disclosing wherein the method is performed in real time during the individual's sleep session, and further comprises generating a command to provide wake up signal if the accumulated respiratory severity for at least one cluster exceeds a threshold level. However, Ray teaches a device for sensing a respiration signal (Abstract) where a method is performed in real time during the individual's sleep session (Abstract “the control unit is adapted to prompt the conditioning signal electrode(s) to transmit a warning to the wearer upon detecting a variation in respiratory cycle time”) (), and further comprises generating a command to provide wake up signal ([0032] “This shock will arouse the patient causing him to breathe, which then restarts the respiratory cycle”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Ochs with the shock of Ray, as Ray teaches at [0024] this would prevent dangerously prolonged apneic periods.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs in view of Goff and further in view of Ray
Regarding Claims 19 and 20, Ochs discloses method of claim 7, wherein the method is performed in real time during the individual's sleep session ([0013]) and calculating global measure of accumulated flow reduction during the plurality of identified respiratory events as a second respiration severity metric ([0039] “Each sub-segment may be analyzed separately based on certain criteria, such as a number of RAF events per time period, an amount of reduced airflow, or other characteristics, and the values associated with the sub-segments may be combined to provide an overall ventilatory instability level for the large segment of data.”). except for expressly disclosing generating a command to provide wake up signal if the accumulated respiratory severity for at least one cluster exceeds a threshold level and the second data signal indicates the individual is in a disfavored position.
However, Goff teaches a sleep apnea detection device (Abstract) that receives a second data signal indicative of a position of the individual as a function of time ([0022] “a position sensor adapted to determine patient sleeping position”) and records the position of the individual for each cluster ([0022] “determine and record in memory blood oxygen saturation values computed from the detected light signal and user position information from the position sensor”) ([0044] “ frequency and/or severity of apnea events when the patient is back sleeping to the events occurring when the patient is side sleeping”).
And Ray teaches a device for sensing a respiration signal (Abstract) where a method is performed in real time during the individual's sleep session (Abstract “the control unit is adapted to prompt the conditioning signal electrode(s) to transmit a warning to the wearer upon detecting a variation in respiratory cycle time”) (), and further comprises generating a command to provide wake up signal ([0032] “This shock will arouse the patient causing him to breathe, which then restarts the respiratory cycle”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Ochs to include the position as a function of time and recording position of the individual for each cluster of Goff, as Goff teaches at [0043] that position data can be used to help differentiate between different conditions and situations and one having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Ochs with the shock of Ray, as Ray teaches at [0024] this would prevent dangerously prolonged apneic periods.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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