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 6/26/26 have been fully considered but they are not persuasive. Regarding the 101 rejection the Applicant argues that the claims are not directed toward mathematical concepts, certain methods of organizing human activity or mental processes. The Applicant further argues that it is highly impractical for a human being to perform the transmitting of radar signals and for these reasons the subject matter is not an abstract idea. As previously noted, the transmitting a radar signal toward a subject and receiving the radar signal reflected from the subject is insignificant extra-solution activity of data gathering. With the gathered data, the user is then capable of performing the recited tasks with or without pen and paper. Here the applicant is relying upon the abstract idea itself (i.e., the mentally performable actions which include identifying areas of consistent complexity) for the improvement. The inventive concept cannot be furnished by the abstract idea itself, but must be furnished by the additional elements outside of the abstract idea (MPEP 2106.05, I). The use of a generic arrangement including a radar sensor, and a processing unit, all functioning in their usual capacity, is insufficient to show an improvement to the technology. It is further noted that the Applicant’s own specification states that the sleep score can be performed through a manual operation by an expert (e.g. Paragraph 7).
The broadest reasonable interpretation of the claims does not limit the assessment of complexity to any particular manner that would preclude a clinician from reviewing the data and mentally assessing a deviation from the expected or normal behavior, and identifying areas where the deviations or abnormalities were consistently appearing. Such an assessment involves the mental processes of comparison, analysis and judgement. Surely a sleep clinician is capable of recognizing deviations from the expected or normal sleep behavior and the stability/consistency of any recognized abnormal behavior when reviewing presented sleep data.
As stated in MPEP 2106.04(a)(2), Ill, B: The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another.
Further, the Applicant argues that the features of the claim, are not well-understood, routine or conventional and therefore amount to significantly more than an abstract idea. The Examiner respectfully disagrees. The additional elements of the radar sensor and processing unit fail to integrate the abstract idea into a practical application. Said elements are conventional, arranged in a conventional system, and operate in their usual capacity unaffected by the performance of the abstract idea. The prior art of record clearly shows that the features of the claim are well-understood, routine and conventional. Further, 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.
The Applicant further argues that radar devices are not known and understood and therefore are not routine and conventional. The Examiner respectfully disagrees. Utilizing radar to sense physiological parameters is so well-known that there are CPC categories that are explicitly directed toward it, including A61B 5/05; A61B5/507.
It is noted that the specification fails to elaborate and provide any structure as to the design of the radar device being unique or non-conventional. MPEP 2164 states that the disclosure must be sufficient to allow a skilled practitioner to understand and replicate the invention but need not elaborate on standard or publicly known elements. Since the specification does not elaborate on the devices (other than the radar device is a transceiver which is a known design element), it is clearly shown that the Applicant at the time of filing believed that the elements are publicly known elements that are routine and conventional, and did not need any further description or elaboration. The Applicant Therefore, the claims are directed toward an abstract idea and the rejection stands.
Applicant’s arguments, see Remarks, filed 8/13/26, with respect to the 103 rejections have been fully considered and are persuasive. The 103 rejections have been withdrawn.
Claims 1-3, 5-10, 12-18 are rejected under 35 USC 101 only.
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) 1-3, 5-10, 12-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 8
Claim 8 and dependent claims 9-10, 12-14 and 17 are drawn to a method and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 8
Claims 8 recites the step of “calculating a sleep quality score of the subject based on the calculated score” 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 method is “computer-implemented” in the preamble, nothing in the claim precludes the step from practically being performed in the mind. Further the specification states that the entire system can be done manually by an expert in paragraph 7.
Accordingly, claim 8 recites an abstract idea.
Step 2a (prong 2) – Claim 8
The judicial exception is not integrated into a practical application. Claim 8 recites the additional elements of:
Generating histograms 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),
Generating for each polysmnography component, a distribution model for at least one of component of polysomnography 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),
transmitting a radar signal toward a subject and receiving the radar signal reflected from the subject is insignificant extra-solution activity (i.e., data gathering),
deriving sleep time information is insignificant extra-solution activity (i.e., data gathering), and
calculating score for the at least one of components 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), and
calculating a sleep quality score 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),
deriving an average breathing signal is insignificant extra-solution activity (i.e., data output),
generate sleep breathing state is insignificant extra-solution activity (i.e., data output),
detect sleep breathing events is insignificant extra-solution activity (i.e., data output),
derive the event occurrence from the breathing events 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 8
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 (calculating a sleep quality score) 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, transmitting a radar signal toward a subject and receiving the radar signal reflected from the subject is considered data gathering. The radar device is generically cited and the specification provides no structure other than the radar device is a generic transceiver.
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:
a polysomnography is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
a radar device is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
deriving sleep time information is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
calculating a sleep quality score is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Claim 8 is thus consider to be directed to an abstract idea without significantly more.
Claims 9-10, 12-14 and 17 depend from claim 8. The type of data analyzed as stated in claims 9-10, 12-14 and 17 are considered extra solution activity. Thus, the dependent claims do not change the overall analysis that claims 9-10, 12-14 and 17 are also directed to an abstract idea.
Claims 1-3, 5-7 and 16
Independent claim 1 is directed to a system containing limitations similar to that for claim 8. Analyzing the system of claim 1 under step 2a, prong 1, the system is recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the system performs generic computer functions like processing data. Further, when the analysis is extended to step 2b, the system is considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 1 is also considered to be patent ineligible subject matter. Dependent claims 2-3, 5-7 and 16 are similar to dependent claims 9-10, 12-14 and 17 and are rejected on similar grounds.
Claim 15 and 18
Independent claim 15 is directed to a computer readable medium containing limitations similar to that for claim 1 and is similarly rejected as patent ineligible subject matter. Dependent claim 18 is similar to dependent claims 17 and is rejected on similar grounds.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chen et al. (U.S. Pub. 2022/0313156) – discloses using polysomnography and data processing to determine a sleep apnea score.
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 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
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