DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Pgs. 18-21, filed 5/12/26, with respect to the prior art rejections have been fully considered and are persuasive. The prior art rejections of Claims 22, 25-27, 29-32, 34-36, 40-44 have been withdrawn.
Applicant's arguments filed 5/12/26 have been fully considered but they are not persuasive.
With regards to the 101 arguments introduction, Applicants briefly make some arguments which are enumerated on later in the sections I-IV the response to these arguments are discussed below in the responses to I-IV.
In response to Applicant's argument it is noted that the features upon which applicant relies (i.e., “real time”, “continuous” etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner also notes that Applicants arguments are not facts on the record, for example discussion of advantages such as “wireless communication” maintaining computational efficiency; “power consumption limitations” (The originally filed specification does not mention power or batteries seemingly at all) etc. are not facts on the record.
With regards to the arguments of Applicants I, Examiner notes Step 1 of Alice is if the claim is directed to one of the four categories, and in the present case as stated in the rejection and discussed previously it is directed to one of the four categories. Examiner believes Applicants are arguing under Step 2A Prong 1, as Applicants are arguing that the claims when viewed as a whole it are not directed to an abstract idea. Examiner disagrees because the claim recites an abstract idea. The claim(s) (referencing claim 22 for discussion purposes), when viewed as a whole, are directed to the judicial exception/abstract idea(s) of calculating heart rate variability (HRV), calculating temperature variability (TV), comparing values for these two derived parameters to thresholds to make a determination and determining a quality of sleep parameter which are mental processes and/or mathematical concepts. There are additional elements, such as a wearable with sensors gathering data and sending said data to a process for analysis. Applicants argue that the sensing cannot be done in the head and as claimed requires a wearable with the temperature and HR sensor. This is seemingly an argument that the claims cannot practically be performed in the mind, Examiner finds the claim when viewed as a whole to be analogous to the discussion in MPEP 2106.04(a)(2)(III)(B)-(C). The recitation of sensors gathering data over time does not mean that the claim is not directed to a judicial exception. Examiner notes that while Applicants state “it requires sophisticated sensor technology” they don’t argue a wearable with skin temperature and HR sensing is the technological improvement, Applicants instead argue the improvement is with the “sleep monitoring” and as laid out in their later discussion under II more specifically the improvement is in the determination and/or distinguishing steps. With regards to the discussion of mathematical relationships determining variability of data is a mathematical process and comparisons are Boolean algebra. For the above reasons Applicants arguments are not persuasive.
With regards to Step 2A Prong Two, Applicants II, Applicants argue even if the claims contained abstract ideas then the abstract ideas are integrated into a practical application. As laid out in the 101 rejection the claim recites (referencing claim 22 for discussion purposes) judicial exception/abstract idea of determining heart rate variability (HRV), temperature variability (TV) and comparing values for these two derived parameters to thresholds to make a determination. These calculations can be performed in the mind, for example for TV and HRV by using the equations provided for variance and standard deviation (in the previous rejection). The additional elements are the wearable with the sensors sensing data, receiving the data at a processing system and processing – which are insignificant extra solution activity. Applicants argue that system address challenges in technology, arguing that its use of the HRV and TV to determine Deep Sleep and REM which improve the technology. However, these elements are part of the judicial exception/abstract idea. The analysis is to determine whether the additional elements integrate the judicial exception into a practical application. MPEP 2106.05(a): "However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology." Applicants next argue that the additional element of wireless communication, “provides a specific architecture”, Examiner notes MPEP 2106.05(g). The use of wireless communication to transmit data for processing and is part of the data gathering steps and is not a significant limitation that imposes a meaningful limitation on the claim. Examiner notes the discussion above of elements which are not claimed. Applicants also mention the use of an additional abstract idea/judicial exception step of determining an optimal instant based on sleep stages which have occurred; and an additional element of outputting the alarm. The additional elements recited do not impose meaningful limitations on the claim as laid out in the rejection below.
With regards to Applicants III, under Step 2B, Applicants argue the additional element amount to significantly more than the judicial exception. The additional elements are the wearable with the sensors sensing data, receiving the data at a processing system and processing – which are insignificant extra solution activity. In addition to the discussion of the additional elements under II above, the additional elements when discussed under Step 2B are shown to be WRC in view of the art provided. The prior art shows it was known to have a wearable at a distal part of the body measuring temperature and heart rate continuously and transmitting that information to separate processing system typically a smartphone and/or a server. Further, reviewing Applicants specification of “detection unit” it is recited as being an apparatus and per [0036] (using PG Pub for paragraph numbers; Examiner notes that references to Applicants specification will use the PG Pub for paragraph numbers) “The apparatus may comprise control unit comprising a computing device (such as a processor, an FPGA, or an ASIC) and a memory”, which is reciting the device as generic computing device. As such the additional elements are not significantly more than the judicial exception. Examiner notes the earlier discussion about elements which are not currently claimed but are being argued as if they are; and about Applicants arguments not being facts on the record.
With regards to the IV, Applicants next argue there are “factual errors”, Examiner disagrees. Applicants argument about “in the mind” or “using pen and paper”, Examiner notes that the arguments are based on reading in limitations and do not reflect the claims. Next mentioned is the pre-solution “data gathering”, the claims recite data gathering before the analysis/abstract idea and these elements are “additional elements” which are extra solution activity in the form of presolution activity. Furthermore Applicants argument appears to be that it’s the the particular data of temperature and HR which is key but this is not persuasive see MPEP 2106.05(g). Next, Applicants again argue that the processor is specialized which is contradicted by their own specification. Applicants Pg Pub [0036] reciting “a computing device (such as a processor, an FPGA, or an ASIC) and a memory which may act as the means for implementing the method” and [0039] including “The separate detection unit may be a generic computing device or system, for example.” Next, Applicants appear to be arguing against the 101 Berkheimer discussion like it is a prior art rejection. However, the elements in the Berkheimer discussion were provided in that section for use with regards to the enumerated additional elements in the analysis under step 2b, see MPEP 2106.05(d). For the above reasons Applicants arguments are not persuasive.
With regards to the Conclusion portion, it appears to rely on the arguments discussed previously and are not persuasive for the same reasons.
Claim Objections
Claim 22 and 26 are objected to because of the following informalities:
Claim 22 recites “a wearable device . . . the wearable device being separate from the detection unit and transmitting data wirelessly to the detection unit, the wearable device being a measurement unit;” and “receive first measurement data and second measurement data wirelessly through a wireless communication unit” and claim 26 recites “comprises a wireless communication unit for relaying the first and second measurement data to the detection unit.” Both claims recite “a wireless communication unit”, however, they appear to be two separate ones one for the transmitting (claim 26) and one for the receiving (in claim 22). Support can be found in Applicants [0039]. Examiner would suggest Applicant amend to recite something such as “first wireless communication unit” and “second wireless communication unit” respectively.
Appropriate correction is required.
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 22, 25-27, 29-32, 34-36, 40-44 are rejected under 101 see the analysis below.
Step 1
The claimed invention in claims 22, 25-27, 29-32, 34-36, 40-44 are directed to the statutory category of a process (method) or machine (system). The claims recite the abstract idea of a mental process and/or mathematical concept.
Step 2A, Prong 1
Regarding Claim 22/29/32, recite the limitations of “determining” parameters based on skin temperature and HR data such as temperature variability (TV) and HR variability (HRV) such as by using equations like Mean
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; “detecting” with substeps “firstly distinguishing” and “secondly distinguishing” to determine sleep stages/cycles based on comparing the determined TV and HRV to predetermined thresholds; “providing”/determining quality of sleep information based on the sleep stages/cycles such as by determining ratios of durations (i.e. sleep quality information)/counts of sleep cycles/stages, durations and/or counts of sleep cycles/stages, reference points; and, determining an optimal wake up time based on the determined sleep stages (from claim 29), is/are a processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. That is nothing in the claim element precludes the step from practically being performed in the mind. For example, “determining” TV includes determining that the readings for temperature are changing between readings (other versions include applying known mathematical statistical concepts such as mean, variance, standard deviation equations), “determining” HRV values (time changes in intervals between R peaks, can also be done using the aforementioned known mathematical statistical concepts), comparing the TV and HRV to thresholds to determine sleep stages (mathematical Boolean comparisons), tracking parameters (such as the counts and durations) of the stages during the course of an evening and calculating optimal wake up/bed times based on multiplication and addition (number of cycles times period of cycle plus the reference point as the starting time) the data in the context of the claims encompasses the user manually using pen a paper to perform such calculations/determinations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas; if it covers mathematical relationship (for example, correspondence between data), Mathematical formulas or equations, and/or Mathematical calculations it falls under the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A, Prong 2
Regarding Claim 22/29/32, the judicial exception is not integrated into a practical application. The claim includes the additional elements a wearable device with sensors gathering data and “transmitting” the data to the detection unit”/computer system “receiving”; and, outputting an alarm (claim 29). The steps of a wearable device with sensors gathering data and “transmitting” the data to the “detection unit”/computer system which is “receiving” the data amounts to insignificant, extra- solution activity in that it is data gathering. While the step of outputting an alarm based on a determination amounts to insignificant, extra- solution activity in that it is outputting the result of the abstract idea. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “processing system”, “detection unit” etc.) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of making analyzing the data to make determinations) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding Claim 22/29/32, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above, the claim includes the additional elements a wearable device with sensors gathering data and “transmitting” the data to the detection unit”/computer system “receiving”; and, outputting an alarm (claim 29). The steps of a wearable device with sensors gathering data and “transmitting” the data to the “detection unit”/computer system which is “receiving” the data amounts to insignificant, extra- solution activity in that it is data gathering. While the step of outputting an alarm based on a determination amounts to insignificant, extra- solution activity in that it is outputting the result of the abstract idea. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “processing system”, “detection unit” etc.) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of making analyzing the data to make determinations) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Additionally, per the Berkheimer requirement, the wrist wearable with temperature/HR sensing, wireless data transmission and processor/memory at secondary element: (1) US 20160374569 to Breslow see recitations below including [0041], [0043], [0045], [0067], [0075]; (2) US 20180042540 see [0072]-[0073], [0082]-[0084], [0099]-[0100], [0175], Figs. 1-4; (3) US 20130332286 see [0014]-[0016], [0018], [0038], [0042], [0045], [0059], [0069], [0088], [0099], Figs. 1-2, 7; (4) US 20140276119 see [0122]-[0123], [0200]-[0205], Figs. 1-2. As such the elements are shown to be WURC. The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 25-27, 30-31, 34-36, 40-44 only further define the data gathering and/or outputting a result (insignificant, extra-solution activity) or further define the abstract idea (i.e., only further define the mental process/mathematical concept). Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims are ineligible.
Allowable Subject Matter
Claims 22, 25-27, 29-32, 34-36, 40-44 are allowable over the prior art, but stand rejected under 101.
The independent claims are allowable over the art based on a combination of elements together, namely the use of “temperature variability” and newly amended steps particularly breaking the stages into two groups (REM/Deep vs. Light) based on TV and then breaking Deep/REM group using HRV. The Chen reference the only one which discusses TV directly discuses using TV generally for determining sleep staging and provides disclosure for determining REM but not the specificity of the claimed breakdown.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20170238868 – to Kenyon et al. see [0063].
PT 104115 – see second or third paragraph under background section - “Classically, measurements of body temperature and melatonin secretion are used to determine the mammalian circadian cycle. The measurement of melatonin is difficult to implement since it is necessary to be performed in a laboratory or clinical setting. The most widely used method of indirect measurement for estimating the melatonin production cycle, and in turn the sleep cycle, is the measurement of body temperature, which is much easier to measure compared to the evasive method referred to above.”
Burgess (Helen Burgess et al., “The Relationship Between Slow-wave Activity, Body Temperature, and Cardiac Activity During Nighttime Sleep”, SLEEP, Vol. 24, No. 3, 2001, https://academic.oup.com/sleep/article/24/3/343/2750031?login=true, viewed on 3/14/23) – discloses distal temperature and HR changes throughout the night including during REM.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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/James Moss/Examiner, Art Unit 3792
