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 .
Drawings
Figure 4 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Per Applicants Fig. 4 and Specification [0039] (or Pg Pub [0040]) “In FIG. 4, the content therein is reproduced based on the document of "Kraus WE, Powell KE, Haskell WL, et al. Physical Activity, All- Cause and Cardiovascular Mortality, and Cardiovascular Disease" (per Applicants IDS dated 9/30/22 the full citation is William E. Kraus et al., "Physical Activity, All-Cause and Cardiovascular Mortality, and Cardiovascular Disease", Med Sci Sports Exerc., Vol. 51, No. 6, June 2019, pp. 1-23.) which published in June 2019 and is prior art. Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
Claims 12, 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per MPEP 2161.01 "It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)" and "Similarly, 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. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. ".
Claims 12 and 19 recite “a circadian status of the subject”. The specification recites in [0072] (using PG Pub) “determine a regular circadian” and “For example, if the current circadian indicates that the subject does not have regular sleep time, the processor 104 may determine the circadian status to be a lower value. On the other hand, if the current circadian indicates that the subject has regular sleep time, the processor 104 may determine the circadian status to be a higher value.”. While the second part seems to be an explanation it’s unclear how this is actually done, first is the bed time a part of the circadian? Second, how does one determine what value is used simply based on a regular or irregular sleep time? The specification recites a functional intent, to determine a circadian status, without sufficiently disclosing how the intent is achieved.
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, 3, 5-7 are rejected under 101 see the analysis below.
Step 1
The claimed invention in claim 1-20 are directed to a process or apparatus and these claims recite a mental process and/or mathematical concept. The claims recite gathering data and determining indicators using the gathered data.
Step 2A, Prong 1
Regarding Claims 1/13/20, using claim 1 as representative, claim 1 recites “determining a fitness indicator of the subject based on physiological information of the subject; determining an age indicator of the subject based on an age of the subject; and determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator.” is directed to the application of mental concepts and/or mathematical relationships. 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; while the use of mathematical relationships, mathematical formulas or equations, mathematical calculations are Mathematical concepts. Accordingly, the claim recites an abstract idea.
Step 2A, Prong 2
Regarding Claims 1/13/20, the judicial exception is not integrated into a practical application. The claim includes the additional elements of gathering data , using claim 1 as representative, claim 1 recites “obtaining a reference heart rate of the subject and determining a heart rate indicator of the subject according to the reference heart rate”. The steps of “obtaining” amounts to insignificant, extra-solution activity in that the it is data gathering. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, etc.) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of estimating using a model) 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 Claims 1/13/20, 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 of gathering data , using claim 1 as representative, claim 1 recites “obtaining a reference heart rate of the subject and determining a heart rate indicator of the subject according to the reference heart rate”. The steps of “obtaining” amounts to insignificant, extra-solution activity in that the it is data gathering. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, etc.) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of estimating using a model) 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, obtaining physiological data and processor/memory: (1) Rotham see citations below; (2) US 20150332012 to Edelson et al. abstract, [0004], [0023], [0062], [0065]; (3) US 20130211858 to Ohnemus et al. see abstract, [0007]-[0010], [0031], [0043]-[0044]. Additionally, claims 11 and 19 recite a wearable sensing HRV (1) Rotham see citations below; (2) US 20150351690 to Toth et al. see [0062], [0136], [0158], Figs. 1A, 2a, 6; (3) US 20140276119 to Venkatraman et al. See [0122], [0200], Figs. 1-2.
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 2-12 and 14-19 only further define the data gathering (insignificant, extra-solution activity) or further define elements of the model (i.e., only further define the 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claim(s) 1-2, 8-10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by US 20180247713 to Rotham.
Regarding Claim 1, an interpretation of Rotham discloses a method for evaluating a health condition indicator of a subject, adapted to a host ([0043], Figs. 1-3), comprising:
obtaining a reference heart rate of the subject ([0030], [0072]-[0073], [0093] including “when sensing heart rate, it may be determined if it is a resting heart rate or not”, [0176] see also [0131], [0204]) and determining a heart rate indicator of the subject according to the reference heart rate ([0072]-[0073] including “if the patient's resting heart rate has historically been”, [0093], [0176] see also [0030], [0131], [0204]);
determining a fitness indicator ([0045] including “activity levels”, [0052] including “physical activity levels”, [0072], [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208” see also [0035], [0078], [0131], [0136]-[0137], [0204]) of the subject based on physiological information of the subject ([0045], [0052], [0072], [0086] including “may comprise a gyroscope and/or accelerometer for motion sensing”, [0093] including “movement sensors such as 3-axis accelerometer, gyroscope, altimeter, 6-axis sensor, and so forth” see also [0035], [0131], [0204]);
determining an age indicator of the subject based on an age of the subject ([0138], [0171] including ”. . . other patient data may be obtained from electronic medical records or caregiver reports.” [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208”, claim 6 including ”establishing contextual information associated with the patient comprises establishing one of an age,” see also [0078], [0131], [0204]; Age is recognized as a relevant piece of patient data for determinations and is a piece of demographic information found in medical records which is disclosed as being “transformed” into a value); and
determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]).
Regarding Claim 2, an interpretation of Rotham further discloses wherein the reference heart rate is a resting heart rate of the subject ([0072]-[0073] including “if the patient's resting heart rate has historically been” see also [0131], [0204]).
Regarding Claims 8 and 17, an interpretation of Rotham further discloses wherein the step of determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator comprises: combining the heart rate indicator, the fitness indicator, and the age indicator into the health condition indicator of the subject ([0074], [0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]).
Regarding Claim 9, an interpretation of Rotham further discloses linearly combining the heart rate indicator, the fitness indicator, and the age indicator into the health condition indicator of the subject ([0074] including “combination module 250 may take the sum of each of the single-variable risks”, [0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]; The reference discloses weighting and combining/summing the values to make a determination of the a health score).
Regarding Claims 10 and 18, an interpretation of Rotham further discloses determining a heart rate variation indicator of the subject ([0030], [0070], [0087], [0092] see also [0073]-[0074], [0078], [0131], [0204]; these disclose determining the heart rate variability (HRV));
determining a sleep condition indicator of the subject ([0034] including “sleep levels, and sleep duration”, [0045], [0070], [0072], [0094] see also [0131], [0204]; these disclose determining the heart rate variability (HRV)), and
the step of determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator comprises: determining the health condition indicator of the subject based on the heart rate indicator, the fitness indicator, the age indicator, and at least one of the heart rate variation indicator and the sleep condition indicator ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]; Discloses gathering various types of patient data (including those recited) applying functions to transform them into and then combine the transformed values).
Regarding Claim 13, an interpretation of Rotham discloses a host, comprising:
a non-transitory storage circuit, storing a program code ([0194]-[0195], [0201]-[0202], fig. 13); and a
processor, coupled to the non-transitory storage circuit and accessing the program code ([0193], [0201]-[0202] including “a computer program that embodies the functions described and illustrated herein, wherein the computer program is implemented in a computer system that comprises instructions stored in a machine-readable medium and a processor that executes the instructions.”, Fig. 13) to perform:
obtaining a reference heart rate of the subject ([0030], [0072]-[0073], [0093] including “when sensing heart rate, it may be determined if it is a resting heart rate or not”, [0176] see also [0131], [0204]) and determining a heart rate indicator of the subject according to the reference heart rate ([0072]-[0073] including “if the patient's resting heart rate has historically been”, [0093], [0176] see also [0030], [0131], [0204]);
determining a fitness indicator ([0045] including “activity levels”, [0052] including “physical activity levels”, [0072], [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208” see also [0035], [0078], [0131], [0136]-[0137], [0204]) of the subject based on physiological information of the subject ([0045], [0052], [0072], [0086] including “may comprise a gyroscope and/or accelerometer for motion sensing”, [0093] including “movement sensors such as 3-axis accelerometer, gyroscope, altimeter, 6-axis sensor, and so forth” see also [0035], [0131], [0204]);
determining an age indicator of the subject based on an age of the subject ([0138], [0171] including ”. . . other patient data may be obtained from electronic medical records or caregiver reports.” [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208”, claim 6 including ”establishing contextual information associated with the patient comprises establishing one of an age,” see also [0078], [0131], [0204]; Age is recognized as a relevant piece of patient data for determinations and is a piece of demographic information found in medical records which is disclosed as being “transformed” into a value); and
determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]).
Regarding Claim 20, an interpretation of Rotham discloses non-transitory computer readable storage medium ([0194]-[0195], [0201]-[0202], fig. 13), the computer readable storage medium recording an executable computer program, the executable computer program being loaded by a host to perform ([0193], [0201]-[0202] including “a computer program that embodies the functions described and illustrated herein, wherein the computer program is implemented in a computer system that comprises instructions stored in a machine-readable medium and a processor that executes the instructions.”, Fig. 13) steps of:
obtaining a reference heart rate of the subject ([0030], [0072]-[0073], [0093] including “when sensing heart rate, it may be determined if it is a resting heart rate or not”, [0176] see also [0131], [0204]) and determining a heart rate indicator of the subject according to the reference heart rate ([0072]-[0073] including “if the patient's resting heart rate has historically been”, [0093], [0176] see also [0030], [0131], [0204]);
determining a fitness indicator ([0045] including “activity levels”, [0052] including “physical activity levels”, [0072], [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208” see also [0035], [0078], [0131], [0136]-[0137], [0204]) of the subject based on physiological information of the subject ([0045], [0052], [0072], [0086] including “may comprise a gyroscope and/or accelerometer for motion sensing”, [0093] including “movement sensors such as 3-axis accelerometer, gyroscope, altimeter, 6-axis sensor, and so forth” see also [0035], [0131], [0204]);
determining an age indicator of the subject based on an age of the subject ([0138], [0171] including ”. . . other patient data may be obtained from electronic medical records or caregiver reports.” [0176] including “The transformation module 240 may be configured to transform each of the pieces of patient data obtained from collection module 220 into a numerical quantity . . . The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208”, claim 6 including ”establishing contextual information associated with the patient comprises establishing one of an age,” see also [0078], [0131], [0204]; Age is recognized as a relevant piece of patient data for determinations and is a piece of demographic information found in medical records which is disclosed as being “transformed” into a value); and
determining the health condition indicator of the subject at least based on the heart rate indicator, the fitness indicator, and the age indicator ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4, 7, 11, 14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotham in view of Eric W. Weisstein, "Relative Deviation." From MathWorld--A Wolfram Web Resource. https://web.archive.org/web/20120312083025/https://mathworld.wolfram.com/RelativeDeviation.html. 3/12/12. Viewed on 9/4/25 (hereinafter Eric).
Regarding Claim 3, an interpretation of Rotham further discloses wherein the step of determining the heart rate indicator of the subject according to the reference heart rate comprises:
converting the reference heart rate into a heart rate factor, wherein the heart rate factor is in a range ([0070] including “convert raw patient data into scaled numbers based on various derived transformation functions as presented herein . . . may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]; Rotham discloses determining values/metrics from the raw data which are then used in functions the results of the functions for each type of data are then combined into a “health condition indicator”),
inputting the heart rate factor into a heart rate indicator model ([0070] including “In one or more embodiments, the transformation module 240 may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]),
wherein the heart rate indicator model outputs the heart rate indicator in response to the heart rate factor ([0070], [0107]-[0108], [0176] see also [0131], [0204]).
While Rotham discloses the raw data being used to derive values/metrics which are scaled numbers based on various transformation functions an interpretation of Rotham may not explicitly disclose the wherein the range is between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches wherein the range is between 0 and 1 (Relative deviation equation provided; Relative deviation is a statistical calculation to determine a percent deviation from the expected value/average).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
Regarding Claim 4, an interpretation of Rotham further discloses obtaining a mortality and a reference resting heart rate of each of a plurality of reference subjects and accordingly deriving the heart rate indicator model ([0099]-[0100], [0161] including “patient data may be collected from a plurality of patients 202 at a first point in time. The collected patient data may be the same type of medical data for each of the plurality of patients 202.” See also [0108], [0131], [0204]; discloses using the same type of data from a plurality of patients and deriving a function based on the population data. As discussed in the previous claim the reference discloses gathering various types of relevant data including resting HR).
Regarding Claims 7 and 16, while Rotham discloses deriving values using functions from patient data including age for use in determining a health score ([0138], [0171], claim 6 see also [0131], [0204]; see the rejection of claim 1).
An interpretation of Rotham may not explicitly disclose the function determining the age indicator of the subject based on the age of the subject comprises: determining a deviation degree of the age of the subject relative to an average age as the age indicator of the subject, wherein the deviation degree ranges between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches a particular function for determining a deviation degree of the age of the subject relative to an average age as the age indicator of the subject (Relative deviation equation provided; the known statistical function provides a deviation as a percentage of the mean),
wherein the deviation degree ranges between 0 and 1 (Relative deviation equation provided; Examiner is interpreting this in view of Applicants Pg Pub [0052]-[0054], most specifically with regards to “may be a positive value negatively related to a difference between AGE and AGE_avg if AGE is lower than AGE_avg.” because if the age is less than the average the value when applying the equation in [0054] you get a negative value. However, Applicants seem to be considering this a “positive” as if it were an absolute value.).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
Regarding Claim 11, Rotham discloses obtaining a heart rate variation detected by a wearable device worn on the subject ([0030] including “The wearable sensor device 100 can provide various physiological metrics such as . . . heart rate variability”, Fig. 3), converting the heart rate variation into the heart rate variation indicator of the subject is in a range ([0030], [0070], [0073]-[0074], [0087], [0092] see also [0078], [0131], [0204]; these disclose determining the heart rate variability (HRV)).
An interpretation of Rotham may not explicitly disclose wherein the subject range is between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches wherein the subject range is between 0 and 1 (Relative deviation equation provided; Relative deviation is a statistical calculation to determine a percent deviation from the expected value/average).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
Regarding Claim 14, an interpretation of Rotham further discloses wherein the reference heart rate is a resting heart rate of the subject ([0072]-[0073] including “if the patient's resting heart rate has historically been” see also [0131], [0204]), and the processor performs:
converting the reference heart rate into a heart rate factor, wherein the heart rate factor is in a range ([0070] including “convert raw patient data into scaled numbers based on various derived transformation functions as presented herein . . . may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]; Rotham discloses determining values/metrics from the raw data which are then used in functions the results of the functions for each type of data are then combined into a “health condition indicator”),
inputting the heart rate factor into a heart rate indicator model ([0070] including “In one or more embodiments, the transformation module 240 may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]),
wherein the heart rate indicator model outputs the heart rate indicator in response to the heart rate factor ([0070], [0107]-[0108], [0176] see also [0131], [0204]).
While Rotham discloses the raw data being used to derive values/metrics which are scaled numbers based on various transformation functions an interpretation of Rotham may not explicitly disclose the wherein the range is between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches wherein the range is between 0 and 1 (Relative deviation equation provided; Relative deviation is a statistical calculation to determine a percent deviation from the expected value/average).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
Claim Rejections - 35 USC § 103
Claim(s) 5, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotham in view of William E. Kraus et al., "Physical Activity, All-Cause and Cardiovascular Mortality, and Cardiovascular Disease", Med Sci Sports Exerc., Vol. 51, No. 6, June 2019, pp. 1-23., hereinafter Kraus (cited in IDS dated 9/30/22 and referenced in Applicants Specification Pg Pub [0040]).
Regarding Claims 5 and 15, an interpretation of Rotham may not explicitly disclose wherein the step of determining the fitness indicator of the subject based on the physiological information of the subject comprises: determining a physical activity indicator of the subject according to the physiological information of the subject; converting the physical activity indicator into a hazard ratio as the fitness indicator of the subject, wherein the hazard ratio ranges between 0 and 1.
However, in the same field of endeavor (medical diagnostic methods), Kraus teaches determining a physical activity indicator of the subject according to the physiological information of the subject (From Kraus NPL provided Pgs. 2, 6-7, 20 (pg 20 in other editions is labeled Figure 3) under Dope-Response subsection of Results Section; Kraus discloses specifically determining “moderate-to-vigorous physical activity (MVPA)” and quantifying physical activity (PA) in terms of energy expenditure (MET-hours per week, MET h/wk). The function provided by the Figure on Pg. 20 shows the relationship for conversion between MET h/wk);
converting the physical activity indicator into a hazard ratio as the fitness indicator of the subject (From Kraus NPL provided Pgs. 2, 6-7, 20 (pg 20 in other editions is labeled Figure 3) under Dope-Response subsection of Results Section; The function provided by the Figure on Pg. 20 shows the relationship for conversion between MET h/wk),
wherein the hazard ratio ranges between 0 and 1 (From Kraus NPL provided Pg. 6-7, 20 (pg 20 in other editions is labeled Figure 3) under Dope-Response subsection of Results Section; The function provided by the Figure on Pg. 20 shows the relationship for conversion between MET h/wk and the hazard ratio ranges between 0-1).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions gathering, including activity/fitness information, and analysis of user’s data as recited by Rotham to include the particular analysis of fitness as taught by Kraus because Kraus provides an analysis which associates levels fitness to health risk (Kraus NPL provided Pgs. 2, 6-7, 20). Additionally, it is Applying a known technique (elements disclosed by Kraus) to a known device (health gathering and analysis of Rotham) ready for improvement to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 12, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotham in view of Eric in further view of US 20220313098 to Steven LeBoeuf et al. (hereinafter Steven).
Regarding Claims 12, an interpretation of Rotham discloses wherein the step of determining the sleep condition indicator of the subject comprises:
obtaining an obstructive sleep apnoea status of the subject ([0034], [0094] see also [0131], [0204]);
obtaining a sleep stage status of the subject ([0072], [0136] see also [0131], [0204]); and
determining the sleep condition indicator of the subject based on at least one of the obstructive sleep apnoea status of the subject or the sleep stage status of the subject ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]),
wherein the sleep condition indicator of the subject in a range ([0070] including “convert raw patient data into scaled numbers based on various derived transformation functions as presented herein . . . may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]; Rotham discloses determining values/metrics from the raw data which are then used in one or more functions the results of the functions for each type of data are then combined into a health score based on the combination (or phrased differently a “health condition indicator”)).
An interpretation of Rotham may not explicitly disclose wherein the range is between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches wherein the subject range is between 0 and 1 (Relative deviation equation provided; Relative deviation is a statistical calculation to determine a percent deviation from the expected value/average).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
an interpretation of Rotham may not explicitly disclose obtaining a circadian status of the subject.
However, in the same field of endeavor (medical diagnostic systems), Steven teaches obtaining a circadian status of the subject ([0125]-[0126]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathered by Rotham to further include circadian status as recited by Steven because circadian status can provide important contextual information and depending on the status may adjust how the other metrics should be processed ([0125]).
Regarding Claims 19, an interpretation of Rotham discloses wherein the step of determining the sleep condition indicator of the subject comprises:
obtaining a heart rate variation detected by a wearable device worn on the subject ([0030] including “The wearable sensor device 100 can provide various physiological metrics such as . . . heart rate variability”, Fig. 3);
converting the heart rate variation into the heart rate variation indicator of the subject which is in a range ([0030], [0070], [0073]-[0074], [0087], [0092] see also [0078], [0131], [0204]; these disclose determining the heart rate variability (HRV)).
obtaining an obstructive sleep apnoea status of the subject ([0034], [0094] see also [0131], [0204]);
obtaining a sleep stage status of the subject ([0072], [0136] see also [0131], [0204]); and
determining the sleep condition indicator of the subject based on at least one of the obstructive sleep apnoea status of the subject or the sleep stage status of the subject ([0177]-[0178] including “The combination module 250 may be configured to take the transformed quantities from transformation module 240, apply weighting modifiers, combine them, and then scale them onto a range”, see also [0131], [0171], [0176], [0204]),
wherein the sleep condition indicator of the subject in a range ([0070] including “convert raw patient data into scaled numbers based on various derived transformation functions as presented herein . . . may take a past value of one type of patient data, compare it with a current value of the same type of patient data, determine the change in the patient data value, and use the change in value as the input to an excess risk function.”, [0107]-[0108], [0176] including “The transformation module 240 may convert each piece of patient data to health score values using a set of functions stored within the health score system 208.” see also [0131], [0204]; Rotham discloses determining values/metrics from the raw data which are then used in one or more functions the results of the functions for each type of data are then combined into a health score based on the combination (or phrased differently a “health condition indicator”)).
An interpretation of Rotham may not explicitly disclose wherein the ranges are between 0 and 1.
However, in the same field of endeavor (statistical functions), Eric teaches wherein the subject range is between 0 and 1 (Relative deviation equation provided; Relative deviation is a statistical calculation to determine a percent deviation from the expected value/average).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the functions which Rotham recites include scaling/normalizing used in the transforming and/or combining steps of the analysis to include the particular scaling method recited by Eric because it is applying the known technique of this particular scaling/normalizing approach to a known device (method, or product) the analysis of these signals ready for improvement to yield predictable results of providing a scaled output which can be used in further analysis.
An interpretation of Rotham may not explicitly disclose obtaining a circadian status of the subject.
However, in the same field of endeavor (medical diagnostic systems), Steven teaches obtaining a circadian status of the subject ([0125]-[0126]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathered by Rotham to further include circadian status as recited by Steven because circadian status can provide important contextual information and depending on the status may adjust how the other metrics should be processed ([0125]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20140156308 to Ohnemus et al. see abstract, [0122], [0166]-[0167], Fig. 8
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