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 .
Election/Restrictions
Applicant’s election without traverse of Group II claims 13-17 in the reply filed on 12/10/25 is acknowledged.
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) 13-17 and 21-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 13
Claim 13 and dependent claims 14-17 and 21-30 are drawn to a method and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 13
Claims 13 recites the step of “identifying, from the neurologic measures of the user and from the cardiac parameters of the user, a disease state for the user”, 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.
Accordingly, claim 13 recites an abstract idea.
Step 2a (prong 2) – Claim 13
The judicial exception is not integrated into a practical application. Claim 13 recites the additional elements of:
One or more processors are stated at a high level of generality in applicant’s specification and are merely used as a tool to carry out the data gathering.
Determining cardiac parameters of a user is insignificant extra-solution activity (i.e., data gathering).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 13
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, determining cardiac parameters of a user is considered data gathering. It is noted that the processors are 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:
Determining cardiac parameters of a user is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
Claim 13 is thus consider to be directed to an abstract idea without significantly more.
Claims 14-17 and 21-30 depend from claim 13. The devices utilized to collect the data as stated in claims 14-17 are stated at a high level of generality in applicant’s specification (“bed, wearable device, load-cells, etc.”) and are merely used as a tool to carry out the data gathering. The type of data analyzed as stated in claims 21-27 and 29-30 are considered extra solution activity. Claim 28 is directed to the extra solution activity of presenting the data. Thus, the dependent claims do not change the overall analysis that claims 14-17 and 21-30 are also directed to an abstract idea.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-17 and 21-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 13 states that “computer-readable instructions that, when executed by the one or more processors, cause the processors to perform operations comprising: determining cardiac parameters of a user; identifying, from the cardiac parameters of the user…”. The written description is silent as to how a processor without any inputs can determine a cardiac parameter of the user. While the written description provides support for a processor analyzing data inputs to determine cardiac parameters, the specification is silent as to how a processor alone is capable of performing this without any data.
Claims 14-17 and 21-30 are rejected for inheriting the same deficiencies as claim 13.
Claim Rejections - 35 USC § 112(b)
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 22-26 and 28 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.
Claim 22 recites the limitation "disease state" in line 2. This is vague as it is unclear if this is the same or different “a disease state” from claim 13.
Claims 23-26 and 28 are rejected for inheriting the same deficiencies as claim 22.
Claim 26 recites the limitation "a disease state" in line 2. This is vague as it is unclear if this is the same or different “a disease state” from claim 13 or the “disease state” from claim 22.
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)(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) 13-17, 21-22 and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fonseca et al. (U.S. Pub. 2017/0360363 hereinafter “Fonseca”).
Regarding claim 13, Fonseca discloses a system comprising: one or more processors (e.g. 20); and computer-readable instructions that, when executed by the one or more processors, cause the processors to perform operations comprising: determining cardiac parameters of a user (e.g. ¶¶ 27-29); identifying, from the cardiac parameters of the user, one or more neurologic measures of the user (e.g. ¶¶ 28-29); and identifying, from the neurologic measures of the user and from the cardiac parameters of the user, a disease state for the user (e.g. ¶¶ 27-29).
Regarding claim 14, Fonseca further discloses the system further comprising a bed having one or more sensors for sensing the user for the determining of the cardiac parameters of the user (e.g. ¶17; “Bed with sensors”).
Regarding claim 15, Fonseca further discloses wherein the one or more sensors include load-cells (e.g. ¶17; “load-cells”).
Regarding claim 16, Fonseca further discloses wherein the one or more sensors include pressure sensors (e.g. ¶17; “pressure sensors”).
Regarding claim 17, Fonseca further discloses a wearable device for sensing the user for the determining of the cardiac parameters of the user (e.g. ¶17; “wearable device”).
Regarding claim 21, Fonseca further discloses wherein the cardiac parameters include at least one of the group consisting of heart rate (HR), heart rate variability (HRV), standard deviation of normal to normal intervals (SDNN), a PNN50 metric, and a R-R interval metric (e.g. ¶¶27, 35).
Regarding claim 22, Fonseca further discloses wherein to identify the neurologic measures and to identify disease state, the system is configured to: provide, to a classifier, the cardiac parameters of the user (e.g. ¶42); and receive, from the classifier, a classification of the user into an insomnia-state or a non-insomnia state (e.g. ¶42; “sleep state”).
Regarding claim 27, Fonseca further discloses wherein the system is configured to determine the disease state of the user using cardiac parameters of a single sleep session while the user is asleep in the single sleep session (e.g. ¶¶3-5; “each session”).
Regarding claim 28, Fonseca further discloses wherein the system is configured to cause the identification of the disease state to be displayed to the user upon ending the single sleep session (e.g. ¶¶3-5; “output after each session”).
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) 23-26 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fonseca as applied to claims 13-17, 21-22 and 27-28 above, and further in view of Beattie et al. (U.S. Pub. 2015/0157258 hereinafter “Beattie”).
Regarding claims 23-26 and 30, Fonseca discloses the claimed invention including determining HR, SDNN in NREM (e.g. ¶233) to determine a disease state out of multiple disease states but fails to explicitly disclose the use of a linear model and the data processing utilizing normalization to select the disease state including PLM. However, Beattie teaches that it is known to use linear models and normalization as set forth in Paragraphs 31, 36, 42 and 52-53 to provide a known means for analyzing data to determine disease states including PLM. 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 Fonseca, with linear models and data processing as taught by Beattie, since such a modification would provide the predictable results of using known methods for enhancing the classification to provide accurate disease states including PLM.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fonseca as applied to claims 13-17, 21-22 and 27-28 above, and further in view of Burton (U.S. Pub. 2021/0169417).
Regarding claim 29, Fonseca discloses the claimed invention except for the system determining the disease state being REM behavior disorder. However, Burton teaches that it is known to use cardiac and neurological measures as set forth in Paragraphs 222, 320, 3036 to provide analysis using cardiac and neurological measures to determine REM behavior disorder to determine early clinical manifestation of evolving neurodegenerative disorder. 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 Fonseca, with the analysis of cardiac and neurological measures to determine REM behavior disorder as taught by Burton, since such a modification would provide the predictable results of providing analysis using cardiac and neurological measures to determine REM behavior disorder to determine early clinical manifestation of evolving neurodegenerative disorder.
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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/REX R HOLMES/Primary Examiner, Art Unit 3796