DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 9/1/26 have been fully considered but they are not persuasive. The Applicant argues that Sarlija fails to provide determining a feature based on at least one hypodensity feature over a plurality of epochs. The Examiner respectfully disagrees. Sarlija clearly discloses using hypodensity epochs for its analysis in paragraph 108 to determine a feature. It is noted that the claims are vague and fail to provide the exact feature, the exact profile and the exact indicator. Therefore, as discussed in detail in the prior action and again below, Sarlija clearly reads on the claimed invention.
The Applicant further argues that Sarlija is directed toward determining a subject’s chronological age and not sleep apnea and therefore does not classify and determine the presence of sleep apnea. It is noted that the claim is written in an open ended comprising fashion and does not preclude the system from determining more than one thing, as long as the system determines apnea. It is noted that the Sarlija disclose determining chronological age, but as disclosed multiple times throughout the Sarlija reference, the same methods are used to determine sleep apnea via classification and determination (e.g. see Paragraphs 11, 111, etc…). Further the claims do not require sleep apnea classification. The claims only require the comparing of a feature to an indicator of apnea. It is noted that the indicator is not claimed, therefore the indicator that is determined by Sarlija reads on the claims. Further the claims only require the presence or severity of apnea and do not require a specific output, Sarlija clearly discloses this in Paragraphs 11 and 111. For this reason Sarlija anticipates the claims based on the prior rejection and the arguments above.
Since Sarlija clearly discloses the claimed invention, the rejections stand.
Regarding the 103 rejections, the Applicant argues that since claim 1 is not anticipated by Sarlija, claim 8 cannot be taught by Sarlija in view of De Groot. The Examiner respectfully disagrees as claim is clearly anticipated by Sarlija as disclosed in the prior action, the rejection below and in the arguments above. Therefore, the 103 rejections stand.
It is noted that upon further review and in light of the Applicant’s arguments, a 101 rejection has been added to the current action. Since this is a new rejection, the following action is non-final.
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.
Claim(s) 1-8 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 1
Claim 1 and dependent claims 2-8 are drawn to a system and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 1
Claims 1 recites the step of “determine a presence and/or severity of apnea based on the comparison” Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas. Other than reciting the system utilizes a “controller”, nothing in the claim precludes the step from practically being performed in the mind.
Accordingly, claim 1 recites an abstract idea.
Step 2a (prong 2) – Claim 1
The judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of:
receive the sensor information for the plurality of the epochs during the test period is insignificant extra-solution activity (i.e., data gathering),
derive a hypnodensity profile for each epoch is insignificant extra-solution activity (i.e., data gathering/statistics),
calculate a hypnodensity feature is insignificant extra-solution activity (i.e., data gathering/statistics),
determine a composite feature is insignificant extra-solution activity (i.e., data gathering/statistics),
compare the composite feature to at least one predetermined indicator is insignificant extra-solution activity (i.e., data gathering/statistics), and
determine a presence and/or severity is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 1
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, providing a presence or severity of apnea is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data). Further, receiving the sensor information for a plurality of epochs is considered data gathering. It is noted that the sensor is recited at a high level of generality.
The additional elements that were considered insignificant extra solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine and conventional when considered individually and in combination with evidence provided. Specifically:
at least one sensor is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
receiving a the sensor information is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
EXAMPLE *** providing a heart health indicator is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Claim 1 is thus considered to be directed to an abstract idea without significantly more.
Claims 2-8 depend from claim 1. The type of data analyzed as stated in claims 2-3 and 5-6 are considered extra solution activity. The devices utilized to collect the data as stated in claim 4 is stated at a high level of generality in applicant’s specification (“a smart watch; a touchpad device; a steering wheel; a smart handheld device; a waveform analysis kiosk; and a connected device”) and are merely used as a tool to carry out the data gathering. Claims 7-8 are directed toward a model trained using known mathematical techniques. When given their broadest reasonable interpretation in light of the background, the algorithm and training are mathematical calculations. The plain meaning of these terms are optimization algorithms, which compute neural network parameters using a series of mathematical calculations. All of the steps are recited as being performed by a computer. The recited computer is recited at a high level of generality, i.e., as a generic computer performing generic computer functions. Thus, the dependent claim do not change the overall analysis that claims 2-8 are also directed to an abstract idea.
Claims 18-20
Independent claim 18 contains limitations similar to claim 1 without any structure and are similarly rejected as patent ineligible subject matter. Dependent claims 19-20 are similar to dependent claims 5 and 7 and are rejected based on the same reasoning as above.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sarlija et al. (U.S. Pub. 2023/0337961 hereinafter “Sarlija” priority 4/22/22 and 8/31/22).
Regarding claims 1 and 18, Sarlija discloses a sleep monitoring system and method (e.g. Fig. 3), comprising: at least one sensor (e.g. 101) configured to sense physiological changes of a subject during a test period, the test period having a plurality of epochs (e.g. ¶11), and being configured to form corresponding sensor information for the plurality of the epochs (e.g. ¶11); at least one controller (e.g. 310) configured to: receive the sensor (e.g. 402) information for the plurality of the epochs during the test period from each of the at least one sensor (e.g. ¶11); derive a hypnodensity profile (e.g. 406) for each epoch of the plurality of epochs based upon the received sensor information for the plurality of the epochs (e.g. ¶108); calculate at least one hypnodensity feature based upon the hypnodensity profile for each epoch of the plurality of epochs (e.g. ¶108); determine a composite feature based on the at least one hypnodensity feature over the plurality of epochs (e.g. 410); compare the composite feature to a at least one predetermined indicator related to sleep apnea (e.g. 510); and determine a presence and/or severity of apnea based upon the comparison (e.g. 414, 540).
Regarding claim 2, Sarlija further discloses wherein at least one of the at least one sensor is configured to measure sleep (e.g. ¶¶41-42).
Regarding claim 3, Sarlija further discloses wherein the at least one controller (e.g. 110) is further configured to monitor the at least one sensor in accordance with a test type (e.g. ¶¶44, 53).
Regarding claim 4, Sarlija further discloses a mobile station (MS) (e.g. 106) having a display, wherein the at least one controller is further configured to transmit the determined presence and/or severity of apnea to the MS and to render the determined presence and/or severity of apnea on the display (e.g. ¶¶11, 94, 111, 135).
Regarding claims 5 and 19, Sarlija further discloses wherein the at least one controller is configured to calculate the at least one hypnodensity feature as information entropy, and is configured to determine an average of the information entropy (DA) over the plurality of epochs as the composite feature (e.g. ¶108).
Regarding claims 6 and 20, Sarlija further discloses wherein the at least one predetermined indicator is at least one predetermined threshold for the presence and/or the severity of apnea (e.g. ¶135).
Regarding claim 7, Sarlija further discloses wherein the hypnodensity profile is derived using a model of sleep classes, wherein the model is determined from training data from a population in which at least some of the population are determined to exhibit at least some degree of sleep apnea, and wherein the at least one predetermined threshold is determined from the training data (e.g. ¶¶11, 81 and 133).
Claim Rejections - 35 USC § 103
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarlija as applied to claims 1-7 and 18-20 above, and further in view of De Groot et al. (U.S. Pub. 2020/0405222 hereinafter “DeGroot”).
Regarding claim 8, Sarlija discloses the claimed invention except for the system using multiple thresholds to analyze the AHI data. However, DeGroot teaches that it is known to use four separate thresholds as set forth in Paragraph 7 to provide known analysis to determine apnea severity. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sarlija, with four thresholds as taught by DeGroot, since such a modification would provide the predictable results of using well-known thresholds to determine normal, mild, moderate and severe apnea.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
