DETAILED ACTION
Claims 1-10 are currently pending and have been examined.
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 1-10 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-10 are directed to a method (i.e., a process). Accordingly, claims 1-10 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A method for screening potential therapeutic substances, comprising:
(a) one or more animal subjects or human participants;
(b) sleep measurements of the entities described in (a) during a baseline period;
(c) administration of the prospective substance(s) during a testing period;
(d) sleep measurements of the entities described in (a) during the testing period;
(d) discontinuation of the prospective substance(s);
(e) sleep measurements of the entities described in (a) during the recovery period; and
(f) evaluation of changes and trends between and within the sleep measurements during baseline, treatment, and recovery periods.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because identifying evaluation of changes between and within sleep measurements during various periods are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind.
Accordingly, independent claim 1 recite at least one abstract idea.
Furthermore, dependent claims 2-10 further narrow the abstract idea described in the independent claims. Claims 6-8 recites the different types of measurement time periods, Claims 9-10 recite criteria for evaluation of changes. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. A method for screening potential therapeutic substances, comprising:
(a) one or more animal subjects or human participants;
(b) sleep measurements of the entities described in (a) during a baseline period;
(c) administration of the prospective substance(s) during a testing period;
(d) sleep measurements of the entities described in (a) during the testing period;
(d) discontinuation of the prospective substance(s);
(e) sleep measurements of the entities described in (a) during the recovery period; and
(f) evaluation of changes and trends between and within the sleep measurements during baseline, treatment, and recovery periods.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of administration of a prospective substance, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional. This administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 does not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 2: These claims recite using different methods for measuring sleep and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(h)).
Claims 3-5: Regarding the additional limitation of administration of a prospective substance, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional. This administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitation of administration of a prospective substance, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional. This administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c). The Examiner has reevaluated such limitation and determined it to not be unconventional as it merely data gathering. See MPEP 2106.05(d)(II).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Regarding the additional limitations of administration of a prospective substance which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea, the Examiner has reevaluated such limitation and determined it to not be unconventional as it merely data gathering. See MPEP 2106.05(d)(II).
Therefore, claims 1-10 are ineligible under 35 USC §101.
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 2-5, & 10 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. Regarding claims 2-5, & 10, the phrase “may”, "may include", or “such as but not limited to” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation (a) the REM density level, the frequency of eye movements during REM sleep, observed at baseline increases during the treatment period; (b) the Delta ratio, the ratio of slow wave activity between the first and second NREM cycles, increases during the treatment period as compared to baseline; (c) REM latency, the time for onset for the first REM cycle after falling asleep, as measured during baseline, increases during treatment, meaning it takes longer to enter REM sleep, and (d) changes to the ultradian rhythm or sleep cycle length. There is insufficient antecedent basis for these limitations in the claim.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westerink (US20220110582).
As per claim 1, Westerink discloses a method for screening potential therapeutic substances, comprising:
(a) one or more animal subjects or human participants (para. 80: patient);
(b) sleep measurements of the entities described in (a) during a baseline period (para. 82-32: sleep measurements prior to intervention);
(c) administration of the prospective substance(s) during a testing period (para. 89-91: sleep measurements obtained with medication information);
(d) sleep measurements of the entities described in (a) during the testing period (para. 89-91: sleep measurements obtained with medication information);
(d) discontinuation of the prospective substance(s) (para. 102, 108: system weans subject off medication in a gradual manner and reduces sleep medication over time);
(e) sleep measurements of the entities described in (a) during the recovery period (para. 48: new sleep data and medication data received); and
(f) evaluation of changes and trends between and within the sleep measurements during baseline, treatment, and recovery periods (para. 103: system incorporates medication dosage levels into the sleep recommendations provided to the subject, with the aim of gradually decreasing the sleep medication while at the same time increasing the sleep window to a desired steady state level.).
As per claim 2, Westerink discloses the method of claim 1 wherein sleep measurement methods, either direct or correlative, may include but are not limited to one or a combination of: Electroencephalography (EEG), Near-Infrared Spectroscopy (NIRS), Electrooculography (EOG), Electromyography (EMG), Heart Rate (HR), Respiration Rate, Actigraphy from any part of the body, In-Vivo Electrophysio-logical recordings such as Single- and Multiple-Unit Recording, Optogenetics, and non-contact measurement methods such as video and radar (para. 84: EEG monitoring).
As per claim 3, Westerink discloses the method of claim 1 wherein the prospective substance may be a single compound or a mixture of compounds (para. 85-87 medication dispenser).
As per claim 4, Westerink discloses the method of claim 1, wherein the prospective substance may also denote non-pharmacological interventions, including physical methods such as, but not limited to, stimulation with lights, electricity, and magnetic fields (para. 11: non-pharmacologic behavioral therapies including stimulus control therapy, sleep restriction therapy and relaxation training).
As per claim 5, Westerink discloses the method of claim 1 wherein administration encompasses variable dosage frequencies such as but not limited to once per hour, once per day, once per week, etc. (para. 103: system incorporates medication dosage levels into the sleep recommendations provided to the subject, with the aim of gradually decreasing the sleep medication while at the same time increasing the sleep window to a desired steady state level).
As per claim 6, Westerink discloses the method of claim 1 wherein the baseline period denotes a period during screening where animal models or human participants are monitored to establish typical, ecological measures, and there is a refrain from any external variables which could affect the measures (para. 82-32: sleep measurements obtained prior to intervention).
As per claim 7, Westerink discloses the method of claim 1 wherein treatment period denotes a period during screening where an-imal models or human participants are exposed to the experimental substance(s) in question (para. 89-91: sleep measurements obtained with medication information).
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.
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.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Westerink (US20220110582) in view of Narayanan (US20230148956).
As per claim 8, Westerink discloses the method of claim 1 but does not expressly teach wherein the recovery period, otherwise known as the post treatment period, denotes a period during screening where animal models or human participants have previously been exposed to the substance(s) in question, and that exposure has been discontinued. During the recovery period there is a refrain from any external variables that could affect the sleep measures.
Narayanan, however, teaches to monitoring a user's health and/or sleep and/or the efficacy of a treatment (e.g. a sleep treatment or other type of health treatment) where sleep scores are calculating using various parameters including REM values (para. 255). Narayanan also teaches to providing output indicating that consumption of a drug could be problematic and that the patient should attempt to avoid such consumption for a pre-selected remediation time period to try and evaluate whether that change can improve the patient's sleep quality and/or sleep duration (para. 211).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Narayanan with Westerink based on the motivation of analyze the sensor data to track a condition of the user, and generate output to help the user improve the condition or maintain the condition (Narayanan – para. 7).
As per claim 9, Westerink discloses the method of claim 1 but does not expressly teach wherein the evaluation of changes between screening periods of baseline, treatment, and recovery must meet 3 criteria, comprising: (a) an obvious decrease in REM % during treatment, as evidenced by consideration of the REM % difference between baseline and treatment %; (b) an obvious REM rebound post treatment, as evidenced by consideration of the REM % difference between baseline and recovery, such that there is an increase in the latter; and (c) should any decrease in REM % occur during treatment, an obvious resistance to habituation to this decrease exists.
Narayanan, however, teaches to monitoring a user's health and/or sleep and/or the efficacy of a treatment (e.g. a sleep treatment or other type of health treatment) where sleep scores are calculating using various parameters including REM values (para. 255). Narayanan also teaches to establishing a baseline sleep score and comparing subsequently calculated sleep scores with the baseline score and determine if there is any meaningful improvement (para. 250, 283, 286-287).
The motivations to combine the above mentioned references are discussed in the rejection of claim 8, and incorporated herein.
As per claim 10, Westerink discloses the method of claim 1 but does not expressly teach wherein the evaluation of changes between and within screening periods may include as further evidence for a successful candidate, wherein: (a) the REM density level, the frequency of eye movements during REM sleep, observed at baseline increases during the treatment period; (b) the Delta ratio, the ratio of slow wave activity between the first and second NREM cycles, increases during the treatment period as compared to baseline; (c) REM latency, the time for onset for the first REM cycle after falling asleep, as measured during baseline, increases during treatment, meaning it takes longer to enter REM sleep, and (d) changes to the ultradian rhythm or sleep cycle length.
Narayanan, however, teaches to monitoring a user's health and/or sleep and/or the efficacy of a treatment (e.g. a sleep treatment or other type of health treatment) where sleep scores are calculating using various parameters including REM values and sleep cycle length (para. 29, 255). Narayanan also teaches to establishing a baseline sleep score and comparing subsequently calculated sleep scores with the baseline score and determine if there is any meaningful improvement (para. 250, 283, 286-287).
The motivations to combine the above mentioned references are discussed in the rejection of claim 8, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kahn (US20210402133) teaches to a sleep monitoring system is described, which increases the efficacy of sleep aids by monitoring user's sleep patterns continuously, and in one embodiment adjusting the sleep aids used based on real and continuous data.
Morris (US20150199484) teaches to using sensors and demographic data of a user to personalize and automatically adjust recommended dosages of a medication in a non-clinical environment. The medication can be identified, where the recommended dosages of the medication can be desirably personalized for the user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/ Primary Examiner, Art Unit 3619