CTNF 18/372,279 CTNF 101568 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-30-03-h AIA Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: Claim 12: “ an input apparatus structured to provide input signals to the processor apparatus” Claim 12: “ an output apparatus structured to receive output signals from the processor apparatus” Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification shows that the following appears to be the corresponding structure: Claim 12: “ an input apparatus structured to provide input signals to the processor apparatus” As identified by the specification (page 5, line 26), “Continuing to refer to FIG. 1, system 4 includes an input apparatus 8, an output apparatus 12, and a processor apparatus 16. Input apparatus 8 is in communication with processor apparatus 16 and can be any of a wide variety of input devices that might include, for example and without limitation, keyboards (physical and/or touchscreen), CD ROM readers, electronic data interfaces that follow any of a 30 variety of wired or wireless protocols (e.g., without limitation, Small Computer Systems Interface (SCSI), IEEE 802.11, Ethernet, or any other suitable arrangement), as well as any other suitable input device(s), all of which are configured to provide input signals to processor apparatus 16. As shown in the example embodiment shown in FIG. 1, system 4 may include a number of sensors 18 in wired or wireless communication with processor apparatus 16 (either directly or via input apparatus 8) for actively or 35 passively monitoring characteristics, activity, or any other suitable data of a patient. Some examples of such sensors 18 are discussed below.” Claim 12: “ an output apparatus structured to receive output signals from the processor apparatus” As identified by the specification (page 6, line 1), “Output apparatus 12 is in communication with processor apparatus 16 and can be any of a wide variety of devices and may include, for example, video displays, printers, data interfaces such as those set forth in the preceding sentence, and other output devices that all receive output signals from processor apparatus 16. Output apparatus 12 and input apparatus 8 may be provided as a single arrangement/unit that functions as both an input apparatus 8 and an apparatus 12. For example, without limitation, a smartwatch may be used to receive input from a patient, monitor various metrics of a patient, and provide output to a patient.” If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-01 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. Claims 1-17 are rejected under 35 U.S.C. 112(a), first paragraph, because the specification, while being enabling for “determining, at least in-part from the monitoring … a recommended bedtime for the patient” wherein the monitoring includes characteristics and/or activities of occurrence and timing of a user’s daily living activities such as exercise, caffeine intake, alcohol intake, light exposure, and timing of meals (pg. 7 lines 9-12 of applicant’s specification as filed), does not reasonably provide enablement for the broadness of the limitation “a number of characteristics and/or activities of the patient” . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The breadth of the claims are extremely broad such that any characteristic (ex: hair color) or activity (ex: singing) that are not relevant to sleep or sleep disorders could fall under the scope of the claims. The current nature of the invention and the state of the prior art is such that it is not known how to determine a recommended bedtime based on characteristics such as hair color or activities such as singing. The inventor has given minimal direction and working examples on what activities and characteristics can be used and how to determine a recommended bedtime based on those characteristics and/or activities. See pages 7-9 of applicant’s specification as filed. The amount of experimentation needed to make or use the invention based on the content of the disclosed specification would be excessive. Please see MPEP 2164.01 (a), and In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Claims 1-17 are also 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. Although the specification provides an example of how to determine the Target Bedtime of Wake Time - Time in Bed Algorithm, the specification does not provide enough written description on how the Time In Bed Algorithm is calculated. The specification mentions broadly “use data from the sleep debt algorithm and sleep quality prediction algorithm” where the sleep debt algorithm is just “based on homeostatic sleep drive, circadian regulation, previous week’s sleep history, and daily activities” and the sleep quality prediction algorithm is “based on the previous week’s sleep architecture and the current day’s activities” (see pages 7-9 of applicant’s specification as filed). Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. Generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. See MPEP 2106.01 and 2163. 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. Claims 1, 12, 16 and all claim dependent thereon are rejected under 35 U.S.C. 112(b) 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. Claims 1, 12 and 16 recites the limitation "determining, at least in-part from the monitoring of the number of wake periods, a recommended bedtime for the patient for starting a particular sleep period" in line 5. There is insufficient antecedent basis for this limitation in the claim. The claim describes monitoring the characteristics and/or activities during a number of wake periods but does not initially describe monitoring the number of wake periods. For examination purposes, this limitation will be interpreted as “determining, at least in-part from the monitoring during the number of wake periods”. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-17 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. Claims 1-17 do not include additional elements that integrate the exception into a practical application of the exception or sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024). Analysis for claims 1, 12, and 16 for subject matter eligibility is as follows: Step 1: Claims 1, 12, and 16 are drawn to a system, which is a statutory category. Step 2A – Prong 1: Claim 1, 12, and 16 are drawn to an abstract idea in the form of a process that under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. In particular, claims 1, 12, and 16 recite the following limitations: [ A1]: “monitoring, a number of characteristics and/or activities of the patient during a number of wake periods of the patient” [B1]: “determining, at least in-part from the monitoring of the number of wake periods, a recommended bedtime for the patient for starting a particular sleep period” [ C1]: “providing the recommended bedtime for starting the particular sleep period to the patient.” These elements [A1] – [C1] of claims 1, 12, and 16 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, can be done mentally by a human mind or a human using a pen and paper. A skilled artisan, such as a medical doctor or sleep specialist, can readily monitor characteristics and/or activities of a patient during their wake period taking mental note or recording the activities on pen and paper, determine a recommended bedtime, and share the bedtime with the patient. Step 2A – Prong Two: Claims 1, 12, and 16 do not recite additional elements that integrate the judicial exception into a practical application. In particular, claim 1 recites the following limitations: [A2]: “monitoring, via first number of sensors” In particular, claim 12 recites the following limitations: [B2]: “ a processor apparatus comprising a processor and a memory” [C2]: “an input apparatus structured to provide input signals to the processor apparatus” [D2]: “an output apparatus structured to receive output signals from the processor apparatus” [E2]: “the memory has stored therein instructions which, when executed on the processor, cause the machine to perform operations” In particular, claim 16 recites the following limitations: [F2]: “A non-transitory machine-readable storage medium having stored thereon instructions” [A2]: “monitoring, via first number of sensors” Elements [A2], [C2], and [D2] do not integrate the judicial exception in to a practical application. These elements do not integrate the exception into a practical application of the exception because these elements are merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering and outputting (see MPEP 2106.05(g)). Elements [B2], [E2], and [F2] do not integrate the judicial exception in to a practical application. These elements do not integrate the exception into a practical application of the exception because these elements amount to merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). . Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Step 2B: Claims 1, 12, and 16 does not recite additional elements that amount to significantly more than the judicial exception itself. Claims 1, 12, and 16 recite the following additional elements: In particular, claim 1 recites the following limitations: [A2]: “monitoring, via first number of sensors” In particular, claim 12 recites the following limitations: [B2]: “ a processor apparatus comprising a processor and a memory” [C2]: “an input apparatus structured to provide input signals to the processor apparatus” [D2]: “an output apparatus structured to receive output signals from the processor apparatus” [E2]: “the memory has stored therein instructions which, when executed on the processor, cause the machine to perform operations” In particular, claim 16 recites the following limitation: [F2]: “A non-transitory machine-readable storage medium having stored thereon instructions” [A2]: “monitoring, via first number of sensors” The elements [A2]-[F2] do not amount to significantly more than the judicial exception itself. Simply reciting the elements [A2]-[F2] do not qualify as significantly more because these elements are adding insignificant extra-solution activity, e.g. mere data gathering and outputting, and are well-understood, routine, and conventional activities previously known in the industry, recited at a high level of generality, to the judicial exception, e.g., generic “sensors” and “output”; a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium both of which are well-understood, routine and conventional activity previously known in the industry. (See MPEP 2106.05(d)(II)). In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Although the claims recite in the preamble “administering sleep consolidation therapy” the claim limitations itself are directed to monitoring/collecting data, performing an abstract idea, and then outputting data. The claims seem to lack a positive recitation of therapy actually being performed/the patient receiving therapy. In order to qualify as “treatment” or "prophylaxis" the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. See MPEP 2106.04(d)(2). Claims 2-11 depend from claim 1, and they recite the same abstract idea as claim 1. Claims 13 -15 depend from claim 12, and they recite the same abstract idea as claim 12. Claim 17 depends from claim 16, and they recite the same abstract idea as claim 16. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) and/or further define the insignificant extra-solution activity and well-understood, routine, and conventional activity. In view of the above, the additional elements individually or in combination do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-8 and 12-17 are rejected under 35 U.S.C. 102 ( a)(1 ) as being anticipated by Weysen (EP 3932296) Regarding claim 1, Weysen discloses a method of administering sleep consolidation therapy (paragraph [0010] “a system for sleep restriction therapy”) to a patient to treat a sleep disorder of the patient (paragraph [0004] “Sleep restriction therapy is a very effective behavioral treatment for insomnia”. The examiner is interpreting insomnia as a sleep disorder.), the method comprising: monitoring, via a first number of sensors (paragraph [0033] “The invention also provides a system for sleep restriction therapy, comprising: a sensor arrangement for collecting sensor data;” The examiner is interpreting that the sensor arrangement is made up of a first number of sensors.) a number of characteristics and/or activities (paragraph [0080] “The sensor arrangement may instead of additionally comprise at least one monitoring sensor which is contact-less. This may for example monitor movements, but also provide additional environmental information of interest.” The examiner is interpreting movements as activities.) of the patient during a number of wake periods of the patient (paragraph [0056] “The sleep data input may for example be based on a digital sleep/wake diary maintained by the subject for self-reporting of their sleep/awake timings.” paragraph [0057] “Using the digital sleep diary, and optionally also a sensor arrangement for sleep tracking, insights into the sleep characteristics prior to the therapy are provided to the processor.” And paragraph [0062] “Thus, periods when the subject is in bed, out of bed, awake and asleep are indicated.” The examiner is interpreting that the sensor arrangement is used to track characteristics and/or activities during both wake and sleep periods.); determining, at least in-part from the monitoring during the number of wake periods , a recommended bedtime for the patient for starting a particular sleep period (paragraph [0074] “Figure 7 shows an example of a sleep restriction recommendation provided to the subject with a finer 10 minute resolution, based on the data of Figure 3.” Paragraph [0059] “Figure 3 shows the dashboard of a subject sleep report logging system, by which subjective data is collected from a subject during a period of 14 days (the left y-axis shows dates from 8 December to 21 December). Such a logging system may then be adapted to provide the sleep restriction recommendation in accordance with the invention.”) and providing the recommended bedtime for starting the particular sleep period to the patient (paragraph [0082] “The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject.”). Regarding claim 2, Weysen discloses the method of claim 1, further comprising monitoring, via a second number of sensors (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units” The examiner is interpreting that there is a system of sensor units consisting of a first number of sensors and a second number of sensors.), a number of characteristics and/or activities of the patient during a number of sleep periods (figure 5 shows averages of characteristics/ activities of a sleep session. The examiner is noting that since the averages are displayed that these characteristics and/or activities were collected during a number of sleep periods.), each sleep period occurring immediately following a corresponding prior wake period of the number of wake periods (Figure 5 displays average sleep onset latency. Paragraph [0030] “Thus, the progression over time of a sleep restriction therapy may also be handled by the system based on the continuously collected sleep data.” The examiner notes the definition of sleep onset latency is the total time it takes to transition from full wakefulness to sleep, therefore the sleep period followed a corresponding prior wake period. Further, since this is the average this was collected over a number of wake periods. Additionally, this system would continuously collect data so therefore it would be able to capture data of a sleep period occurring immediately following a corresponding prior wake period of a number of wake periods.), wherein the recommended bedtime for the patient for starting the particular sleep period is determined from the monitoring of at least a wake period of the number of wake periods and a sleep period of the number of sleep periods (paragraph [0081] “The processing of the data may be handled in various ways, either locally to the subject, or remotely. For example, data may be stored in a remote database.” and paragraph [0082] “The system may for example automatically generate summarizing reports to give the specialist a quick overview of the data. The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject. This may enable easy adaption of treatment to maximize individual adherence.” The examiner notes that the data in figure 5 (average sleep onset latency, average number of awakenings, and average wake after sleep onset) was determined from monitoring a wake period of the number of wake periods and a sleep period of the number of sleep periods.) Regarding claim 3, Weysen discloses the method of claim 2, wherein: the number of wake periods comprises a plurality of wake periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); the number of sleep periods comprises a plurality of sleep periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); and the recommended bedtime for the patient for starting the particular sleep period (paragraph [0014] “The sleep restriction recommendation comprises a go to bed time and a get up time.”) is determined from the monitoring of more than one wake period of the plurality of wake periods and more than one sleep period of the number of sleep periods (The examiner notes that since the system monitors a plurality of sleep sessions that it will monitor more than one wake period of the plurality of wake periods and more than one sleep period of the number of sleep periods.) Regarding claim 4, Weysen discloses the method of claim 2, wherein: the number of wake periods comprises a plurality of wake periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); the number of sleep periods comprises a plurality of sleep periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); and the recommended bedtime for the patient for starting the particular sleep period is determined from the monitoring of at least one wake period of the plurality of wake periods and at least one sleep period of the number of sleep periods (The examiner notes that since the system monitors a plurality of sleep sessions that it will monitor at least one wake period of the plurality of wake periods and at least one sleep period of the number of sleep periods.) Regarding claim 5, Weysen discloses the method of claim 1, wherein monitoring the number of characteristics and/or activities of the patient during the number of wake periods comprises monitoring the number of characteristics of the user (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units. The sensor arrangement may comprise at least one body-worn sleep sensor. This may be a head band or a wrist band. A head band for example enables EEG monitoring” EEG monitoring is a characteristic of the user) Regarding claim 6, Weysen discloses the method of claim 1, wherein monitoring the number of characteristics and/or activities of the patient during the number of wake periods comprises monitoring the number of activities of the user. (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units. The sensor arrangement may comprise at least one body-worn sleep sensor…. motion monitoring using a wrist watch type device is also well known for providing sleep data.” motion/movement is an activity of the user) Regarding claim 7, Weysen discloses the method of claim 1, wherein the first number of sensors are positioned in a wearable device positioned on the patient (paragraph [0048] “The sensor arrangement 14 may comprise at least one body-worn sleep sensor.”) Regarding claim 8, Weysen discloses the method of claim 2, wherein the first number of sensors and a second number of sensors are positioned in a wearable device on the patient. (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units. The sensor arrangement may comprise at least one body-worn sleep sensor. This may be a head band or a wrist band. A head band for example enables EEG monitoring, and such sleep tracking headband devices are well known. PPG and motion monitoring using a wrist watch type device is also well known for providing sleep data.” The examiner is interpreting that this is a system of sensor units – so the first number of sensors could be a headband device with EEG monitoring and the second number of sensors can be a wrist watch type device with PPG and motion monitoring.) Regarding claim 12, Weysen discloses a system structured to administer a sleep consolidation therapy to a patient to treat a sleep disorder of the patient (paragraph [0001] “This invention relates to sleep restriction therapy, and in particular a system for automating the decision making in sleep restriction therapy.” And paragraph [0004] “Sleep restriction therapy is a very effective behavioral treatment for insomnia” The examiner notes insomnia is a sleep disorder.), the system comprising: a processor apparatus comprising a processor and a memory (paragraph [0047] “The processor includes a memory (database) for storing the data for subsequent analysis.”; an input apparatus structured to provide input signals to the processor apparatus (paragraph [0047 “The processor has an input 12 for receiving sleep data DATA.sub.sleep for a subject for a plurality of nightly sleep sessions, which indicates at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake.” And paragraph [0048] “a sensor arrangement 14 is provided for collecting sensor data DATA.sub.sensor. The processor additionally processes the sensor data.”); and an output apparatus structured to receive output signals from the processor apparatus (paragraph [0018] “The processor may for example be part of a mobile phone or tablet on which a suitable app has been loaded. The processor may be part of an output device by which the sleep restriction recommendation is provided to the subject or clinician, or it may be a different device.”), wherein the memory has stored therein instructions which, when executed on the processor, cause the machine to perform operations comprising (paragraph [0085] “In various implementations, the processor may be associated with one or more storage media such as volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM. The storage media may be encoded with one or more programs that, when executed on one or more processors and/or controllers, perform the required functions.”): monitoring, via a first number of sensors (paragraph [0033] “The invention also provides a system for sleep restriction therapy, comprising: a sensor arrangement for collecting sensor data;” The examiner is interpreting the sensor arrangement to have a first number of sensors.) a number of characteristics and/or activities (paragraph [0080] “This may for example monitor movements, but also provide additional environmental information of interest.” The examiner is interpreting movements as activities.) of the patient during a number of wake periods of the patient (paragraph [0056] “The sleep data input may for example be based on a digital sleep/wake diary maintained by the subject for self-reporting of their sleep/awake timings.” paragraph [0057] “Using the digital sleep diary, and optionally also a sensor arrangement for sleep tracking, insights into the sleep characteristics prior to the therapy are provided to the processor.” And paragraph [0062] “Thus, periods when the subject is in bed, out of bed, awake and asleep are indicated.” The examiner is interpreting that the sensor arrangement is used to track characteristics and/or activities during both wake and sleep periods.); determining, at least in-part from the monitoring during the number of wake periods , a recommended bedtime for the patient for starting a particular sleep period (paragraph [0074] “Figure 7 shows an example of a sleep restriction recommendation provided to the subject with a finer 10 minute resolution, based on the data of Figure 3.” Paragraph [0059] “Figure 3 shows the dashboard of a subject sleep report logging system, by which subjective data is collected from a subject during a period of 14 days (the left y-axis shows dates from 8 December to 21 December). Such a logging system may then be adapted to provide the sleep restriction recommendation in accordance with the invention.”) and providing the recommended bedtime for starting the particular sleep period to the patient (paragraph [0082] “The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject.”). Regarding claim 13, Weysen discloses the system of claim 12, wherein the instructions, when executed on the processor, cause the machine to perform further operations (paragraph [0085] “In various implementations, the processor may be associated with one or more storage media such as volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM. The storage media may be encoded with one or more programs that, when executed on one or more processors and/or controllers, perform the required functions.”) comprising monitoring, from signals received via the input apparatus from a second number of sensors, (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units” The examiner is interpreting that there is a system of sensor units consisting of a first number of sensors and a second number of sensors.), a number of characteristics and/or activities of the patient during a number of sleep periods (figure 5 shows averages of characteristics/ activities of a sleep session. The examiner is noting that since the averages are displayed that these characteristics and/or activities were collected during a number of sleep periods.), each sleep period occurring immediately following a corresponding prior wake period of the number of wake periods (Figure 5 displays average sleep onset latency. Paragraph [0030] “Thus, the progression over time of a sleep restriction therapy may also be handled by the system based on the continuously collected sleep data.” The examiner notes the definition of sleep onset latency is the total time it takes to transition from full wakefulness to sleep, therefore the sleep period followed a corresponding prior wake period. Further, since this is the average this was collected over a number of wake periods. Additionally, this system would continuously collect data so therefore it would be able to capture data of a sleep period occurring immediately following a corresponding prior wake period of a number of wake periods.), wherein the recommended bedtime for the patient for starting the particular sleep period is determined from the monitoring of at least a wake period of the number of wake periods and a sleep period of the number of sleep periods (paragraph [0081] “The processing of the data may be handled in various ways, either locally to the subject, or remotely. For example, data may be stored in a remote database.” and paragraph [0082] “The system may for example automatically generate summarizing reports to give the specialist a quick overview of the data. The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject. This may enable easy adaption of treatment to maximize individual adherence.” The examiner notes that the data in figure 5 (average sleep onset latency, average number of awakenings, and average wake after sleep onset) was determined from monitoring a wake period of the number of wake periods and a sleep period of the number of sleep periods.) Regarding claim 14, Weysen discloses the system of claim 13 wherein: the number of wake periods comprises a plurality of wake periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); the number of sleep periods comprises a plurality of sleep periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); and the recommended bedtime for the patient for starting the particular sleep period (paragraph [0014] “The sleep restriction recommendation comprises a go to bed time and a get up time.”) is determined from the monitoring of more than one wake period of the plurality of wake periods and more than one sleep period of the number of sleep periods (The examiner notes that since the system monitors a plurality of sleep sessions that it will monitor more than one wake period of the plurality of wake periods and more than one sleep period of the number of sleep periods.) Regarding claim 15, Weysen discloses the system of claim 13, wherein: the number of wake periods comprises a plurality of wake periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); the number of sleep periods comprises a plurality of sleep periods (paragraph [0010] “receiving sleep data for a subject for a plurality of nightly sleep sessions, at least time epochs during a sleep session that the subject is asleep and time epochs during the sleep session that the subject is awake”); and the recommended bedtime for the patient for starting the particular sleep period is determined from the monitoring of at least one wake period of the plurality of wake periods and at least one sleep period of the number of sleep periods (The examiner notes that since the system monitors a plurality of sleep sessions that it will monitor at least one wake period of the plurality of wake periods and at least one sleep period of the number of sleep periods.) Regarding claim 16, Weysen discloses a non-transitory machine-readable storage medium having stored thereon instructions which (paragraph [0088] “A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware”), when executed on a processor apparatus of a machine (paragraph [0083] “The processor can be implemented in numerous ways, with software and/or hardware, to perform the various functions required.”) that is structured to administer a sleep consolidation therapy to a patient (paragraph [0010] “there is provided a processor for a system for sleep restriction therapy”) to treat a sleep disorder of the patient (paragraph [0004] “Sleep restriction therapy is a very effective behavioral treatment for insomnia“ The examiner notes insomnia is a sleep disorder.), cause the machine to perform operations comprising: monitoring, via a first number of sensors (paragraph [0033] “The invention also provides a system for sleep restriction therapy, comprising: a sensor arrangement for collecting sensor data;” The examiner is interpreting that the sensor arrangement is made up of a first number of sensors.) a number of characteristics and/or activities (paragraph [0080] “This may for example monitor movements, but also provide additional environmental information of interest.” The examiner is interpreting movements as activities.) of the patient during a number of wake periods of the patient (paragraph [0056] “The sleep data input may for example be based on a digital sleep/wake diary maintained by the subject for self-reporting of their sleep/awake timings.” paragraph [0057] “Using the digital sleep diary, and optionally also a sensor arrangement for sleep tracking, insights into the sleep characteristics prior to the therapy are provided to the processor.” And paragraph [0062] “Thus, periods when the subject is in bed, out of bed, awake and asleep are indicated.” The examiner is interpreting that the sensor arrangement is used to track characteristics and/or activities during both wake and sleep periods.); determining, at least in-part from the monitoring during the number of wake periods , a recommended bedtime for the patient for starting a particular sleep period paragraph [0074] “Figure 7 shows an example of a sleep restriction recommendation provided to the subject with a finer 10 minute resolution, based on the data of Figure 3.” Paragraph [0059] “Figure 3 shows the dashboard of a subject sleep report logging system, by which subjective data is collected from a subject during a period of 14 days (the left y-axis shows dates from 8 December to 21 December). Such a logging system may then be adapted to provide the sleep restriction recommendation in accordance with the invention.) and providing the recommended bedtime for starting the particular sleep period to the patient (paragraph [0082] “The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject.”). Regarding claim 17, Weysen teaches the nontransitory machine readable storage medium of claim 16, wherein the instructions, when executed on the processor, cause the machine to perform further operations comprising monitoring, from signals received via the input apparatus from a second number of sensors, (paragraph [0035] “The sensor arrangement may comprise a single sensor unit or a system of sensor units” The examiner is interpreting that there is a system of sensor units consisting of a first number of sensors and a second number of sensors.), a number of characteristics and/or activities of the patient during a number of sleep periods (figure 5 shows averages of characteristics/ activities of a sleep session. The examiner is noting that since the averages are displayed that these characteristics and/or activities were collected during a number of sleep periods.), each sleep period occurring immediately following a corresponding prior wake period of the number of wake periods (Figure 5 displays average sleep onset latency. Paragraph [0030] “Thus, the progression over time of a sleep restriction therapy may also be handled by the system based on the continuously collected sleep data.” The examiner notes the definition of sleep onset latency is the total time it takes to transition from full wakefulness to sleep, therefore the sleep period followed a corresponding prior wake period. Further, since this is the average this was collected over a number of wake periods. Additionally, this system would continuously collect data so therefore it would be able to capture data of a sleep period occurring immediately following a corresponding prior wake period of a number of wake periods.), wherein the recommended bedtime for the patient for starting the particular sleep period is determined from the monitoring of at least a wake period of the number of wake periods and a sleep period of the number of sleep periods (paragraph [0081] “The processing of the data may be handled in various ways, either locally to the subject, or remotely. For example, data may be stored in a remote database.” and paragraph [0082] “The system may for example automatically generate summarizing reports to give the specialist a quick overview of the data. The clinician/doctor can review the data in a graphical interface and use this to discuss the new bedtime schedule with the subject. This may enable easy adaption of treatment to maximize individual adherence.” The examiner notes that the data in figure 5 (average sleep onset latency, average number of awakenings, and average wake after sleep onset) was determined from monitoring a wake period of the number of wake periods and a sleep period of the number of sleep periods.) Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Weysen in view of Myllymäki (US 2020/0215299) (as cited in the applicant’s IDS) . Regarding claim 9, Weysen teaches the method of claim 7 but fails to teach wherein the wearable device comprises a smartwatch. However, Myllymäki teaches a sleep monitoring system wherein the wearable device comprises a smart watch (paragraph [0097] “Movement data may be obtained using a smartwatch or smartphone's accelerometer and/or gyroscope sensors.” The examiner is modifying the wrist watch type device taught in Weysen to be modified to a smartwatch.) It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the wrist watch taught in Weysen to be a smartwatch as taught in Myllymaki. One of ordinary skill in the art would have been able to recognize that this would be simple substitution to yield the predictable results of having a wearable device to gather sleep data . 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Weysen in view of Garcia Molina (US 2021/0287776) . Regarding claim 10, Weysen discloses the method of claim 1, but fails to teach comprising providing behavioral change recommendations that, when performed, shift the recommended bedtime, monitoring, via the first number of sensors, behavioral change relating to the behavioral change recommendations, providing the recommended bedtime based on the monitored behavioral change. However, Garcia Molina teaches a system for improving sleep comprising: providing behavioral change recommendations that, when performed, shift the recommended bedtime (paragraph [0118] – [0119] “By way of illustration, if the user is experiencing difficulty falling asleep, some example behavior recommendations which may be generated are as follows: Going to bed and waking up at the same time every day. This helps to shift the circadian rhythm to be in synchrony with the user's bedtime.” The examiner notes that having a consistent bedtime that is the same every day could be different than the user’s usual bed time.) monitoring, via the first number of sensors (paragraph [0079] “In order to facilitate the determining of the actual (empirical) circadian cycle, sensor data 42 may be acquired relating to activity and/or sleep of the user. The user may carry one or more sensors on their body as they go about their daily life, and the sensors collect data as a function of time over multiple days.”), behavioral change relating to the behavioral change recommendations (paragraphs [0081]-[0083] “The sleep data can be derived from the sensor data acquired during the night time (or otherwise during sleep periods of the user) and the activity data derived from the sensor data acquired during the day time (or otherwise during the awake periods of the user). The historical activity and/or sleep data 46 may be used in some embodiments to derive the expected circadian pattern 50 for the user. This will be described in greater detail to follow. Based on comparing the expected and actual circadian patterns, a circadian inconsistency 52 can be determined. This can then be fed to a behavior recommendation module 54 which comprises one or more algorithms configured to generate a recommended behavior change 56 for the user based on the circadian inconsistency and optionally further based on one or more additional inputs such as properties of the actual circadian cycle itself or the sensor data for the user for the day d. ” ), providing the recommended bedtime based on the monitored behavioral change ([0182] “if it is detected that a user has not followed the behavior recommendation (e.g. go to bed at a defined time, such as 10 pm) and the circadian inconsistency is low at the time of the failure, the recommended bedtime and/or wake time may be altered (e.g. bedtime two hours later and/or wake time two hours later” paragraph [0125] “An optimal time for performing a recommended action varies depending upon the recommendation.” The examiner notes that the optimal time may be a different time than the usual bed time of the user meaning that the bedtime can be shifted based on the sleep data of the user.) It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the sleep system taught in Weysen to provide behavioral change recommendations as taught in Garcia Molina. One of ordinary skill in the art would have been able to recognize there is an association between level of adherence to healthy sleep behaviors and sleep improvements. There is evidence that that even modest improvements in adherence could result in improved outcomes. See paragraph [0004] of Garcia Molina . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Weysen in view of Dothie (US 2011/0015495) . Regarding claim 11, Weysen teaches the method of claim 1, comprising providing the recommended bedtime based on user feedback on bed and wake time (paragraph [0023] – [0024] “The input may be further for receiving sleep preferences of the subject, wherein the processor is adapted to derive the target timing taking into account the sleep preferences. The sleep preferences for example may relate to latest times the subject can stay in bed (e.g. because of work commitments), so that the wake up time has a latest possible time point.” And paragraph [0082] The historical activity and/or sleep data 46 may be used in some embodiments to derive the expected circadian pattern 50 for the user.” ) HoHowever, Weysen fails to teach the recommended bedtime based on subjective feelings of sleep quality. Dothie teaches a system for managing a user’s sleep that collects user subjective feelings of sleep quality. (paragraph [0147] “The general cycle of the system is to use the sensor unit to record objective data at least whilst the user is asleep or is trying to go to sleep, and to record objective and subjective data using the portable unit whilst the user is awake. The processing means (16), indicated above as preferably a software service provided via the Internet, processes all the information from the sensor unit and portable unit and establishes correlations between the data. The results, including at least the sleep metric(s) and/or sleep quality metric(s), cognitive and/or psychomotor performance metric(s) or the combined sleep indicator metric(s), are presented back to the user, along with behavioural recommendations” paragraph [0066] “iii) a portable user interaction device, e.g. a mobile phone, which can collect objective test data, e.g. periodically or sporadically, from the user when awake indicative of cognitive and/or psychomotor performance, optionally together with other data relevant to assessing sleep quality, which may include, e.g. periodically or sporadically, subjective feedback from the user on sleep-related parameters,”. Figure 8 displays an interface for users to provide feedback on how well they slept and how refreshed they feel. Paragraph [0163] “further information presented to the user may include customized times for going to bed and waking up, particularly if an irregular sleep schedule has been identified.” The examiner notes in figure 16, that the bedtime recommendations are based on sensor date in step S1410.) It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the sleep system taught in Weysen to recommend a bedtime based on the subjective feelings of the user on sleep quality. One of ordinary skill in the art would be able to recognize a personalized system to help each user achieve quality sleep can only be achieved by considering both objective data collected by sensors and subjective data inputted by the users to customize sleep recommendations . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lim (US 2016/0367184) teaches a sleep restriction therapy system for sleep disorder diagnosis and treatment with wearable devices. Westerink (US 2022/0110582) teaches a personalized sleep restriction therapy system. Naujokat (US 2011/0034811) teaches a sleep restriction therapy system for insomnia. Kaplan (US 2004/0225179) teaches an automated insomnia treatment system. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /A.L.D./Examiner, Art Unit 3791 /JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 18/372,279 Page 2 Art Unit: 3791 Application/Control Number: 18/372,279 Page 3 Art Unit: 3791 Application/Control Number: 18/372,279 Page 4 Art Unit: 3791 Application/Control Number: 18/372,279 Page 5 Art Unit: 3791 Application/Control Number: 18/372,279 Page 6 Art Unit: 3791 Application/Control Number: 18/372,279 Page 7 Art Unit: 3791 Application/Control Number: 18/372,279 Page 8 Art Unit: 3791 Application/Control Number: 18/372,279 Page 9 Art Unit: 3791 Application/Control Number: 18/372,279 Page 10 Art Unit: 3791 Application/Control Number: 18/372,279 Page 11 Art Unit: 3791 Application/Control Number: 18/372,279 Page 12 Art Unit: 3791 Application/Control Number: 18/372,279 Page 13 Art Unit: 3791 Application/Control Number: 18/372,279 Page 14 Art Unit: 3791 Application/Control Number: 18/372,279 Page 15 Art Unit: 3791 Application/Control Number: 18/372,279 Page 16 Art Unit: 3791 Application/Control Number: 18/372,279 Page 17 Art Unit: 3791 Application/Control Number: 18/372,279 Page 18 Art Unit: 3791 Application/Control Number: 18/372,279 Page 19 Art Unit: 3791 Application/Control Number: 18/372,279 Page 20 Art Unit: 3791 Application/Control Number: 18/372,279 Page 21 Art Unit: 3791 Application/Control Number: 18/372,279 Page 22 Art Unit: 3791 Application/Control Number: 18/372,279 Page 23 Art Unit: 3791 Application/Control Number: 18/372,279 Page 24 Art Unit: 3791 Application/Control Number: 18/372,279 Page 25 Art Unit: 3791 Application/Control Number: 18/372,279 Page 26 Art Unit: 3791 Application/Control Number: 18/372,279 Page 27 Art Unit: 3791 Application/Control Number: 18/372,279 Page 28 Art Unit: 3791 Application/Control Number: 18/372,279 Page 29 Art Unit: 3791 Application/Control Number: 18/372,279 Page 30 Art Unit: 3791
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