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 .
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 1-14 are rejected under 101 see the analysis below.
Step 1
The invention claimed in claims 1-14 are directed to statutory subject matter as the claims recite a method.
Step 2A, Prong 1
Regarding Claim 1, the recited steps of determining what heart rates meet the predetermined standard based on the heart rate and motion data, “acquiring . . . a reference resting heart rate calculated using . . . ” using the determined heart rates meeting the predetermined standard, calculating a “current resting heart rate”, “determining . . . a prediction result . . .” using reference RHR and current RHR are directed to a mental process of performing concepts in the human mind (including by a human using the aid of pen and paper) and/or mathematical concepts. For example, this limitation simply amounts to the mental process of a clinician reviewing data (such as heart rate, motion etc.) and performing a mental analysis (or with pen and paper) determining when the user is resting or not moving (such as by determining there are no changes in acceleration etc. in the motion data), taking the associated heart rates from the resting period (or resting heart rates (RHR)) for a first set of consecutive days and determining a reference resting heart rate (such as an average or median of the RHRs over those days. See for example applicants [0009]-[0011] using Pg Pub for paragraph numbers), taking the RHRs over a second set of days and calculate a current RHR (average, median etc.), compare the current RHR to the reference RHR and based on the comparison (such as elevated to reference) there is a prediction related to the thyroid state. 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.
Step 2A, Prong 2
Regarding Claim 1, the judicial exception is not integrated into a practical application. The claims include the additional elements of “acquiring” data over sets of tie and taking a blood test; and “inducing” (instructing etc.). The step of “acquiring . . .” the data amounts to insignificant, extra-solution activity in that the it is data gathering. The step of “inducing . . .” is extra solution as merely outputting a result to the user. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) 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 1, 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 additional elements of “acquiring” data over sets of tie and taking a blood test; and “inducing” (instructing etc.). The step of “acquiring . . .” the data amounts to insignificant, extra-solution activity in that the it is data gathering. The step of “inducing . . .” is extra solution as merely outputting a result to the user. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) 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 heart rate sensor, motion sensor and processing device: (1) US 20180035899 see [0003], [0027], [0031], [0045], [0090]-[0091], [0116]; (2) KR 20170017648 to Hong shows the heart/motion sensing see discussion of sensor unit 140; (3) US 20180256094 shows the heart/motion sensing see [0043]; (4) US 20170095159 shows the heart/motion sensing see Fig. 2; (5) Klein (Irwin Klein et al., Thyroid Disease and the Heart, Circulation. 2007;116:1725–1735, https://doi.org/10.1161/CIRCULATIONAHA.106.678326, viewed on 7/13/21) shows thyroid sensing see Effects of Thyroid Hormone on Cardiovascular Hemodynamics section and Hyperthyroidism Section; (6) Gammage (Gammage et al. Association Between Serum Free Thyroxine Concentration and Atrial Fibrillation. Arch Intern Med. 2007;167(9):928–934. doi:10.1001/archinte.167.9.928, viewed on 7/13/21) shows thyroid sensing see Abstract and Methods sections; (7) Al-Musawy et al., Pulse Rate can be taken as a marker for serum levels of T3 and T4 in thyrotoxic patients, Iraqi J. Comm. Med. January. 2007 20, https://www.iasj.net/iasj/download/5635f048ffce9fbc shows the thyroid sensing see the abstract and discussion sections. All of the above references are recited in the IDS dated 3/31/25. As such the elements are shown to be WRC.
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 2-14 only further define the data gathering (insignificant, extra-solution activity) or further define elements of the analysis (i.e., only further define the mental process; such as using the motion to define the RHR segments, or determining reference/current RHR using medians or averages). 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11571170 in view of US 20170095159 to Bonomi et al. (hereinafter Bonomi).
Regarding Claim 1 an interpretation of ’170 claims disclose a method for managing a thyroid abnormality of a person (‘170 Claim 1), the method comprising:
acquiring, by one or more processors, a plurality of heart rates during at least a first consecutive days and a second consecutive days (‘170 Claim 1),
wherein the plurality of heart rates measured by a wearable device worn by the person (‘170 Claim 1),
wherein the first consecutive days comprise a test day on which a thyroid function of the person is assessed by a thyroid hormone concentration of the blood of the test day measured by a blood test (‘170 Claim 1),
wherein the second consecutive days comprise a managing day on which a thyroid function of the person is not assessed by a blood test (‘170 Claim 1),
wherein the number of the first consecutive days and the number of the second consecutive days are greater than 1 (‘170 Claim 1), and
wherein the managing day is later than the test day (‘170 Claim 1);
acquiring, by one or more processors, a reference resting heart rate calculated using heart rates of the first consecutive days (‘170 Claim 1),
calculating, by one or more processors, a current resting heart rate using heart rates of the second consecutive days (‘170 Claim 1);
determining, by one or more processors, a prediction result related to a thyroid function state of the managing day using the current resting heart rate and the reference resting heart rate of the person (‘170 Claim 1); and
inducing to conduct an additional blood test on the person based on the prediction result (‘170 Claim 1).
While ‘170 claim 1 recites using “resting” heart rates, an interpretation of ‘170 claim 1 may not explicitly disclose that heart rates meet a predetermined standard among the heart rates, wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period, wherein the predetermined standard is determined using a sensing value of a gravity sensor, an acceleration sensor, a gyroscope, a GPS sensor, or a combination thereof.
However, in the same field of endeavor (medical devices), Bonomi teaches that heart rates meet a predetermined standard among the heart rates to be resting heart rates ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is determined using a sensing value of a an acceleration sensor ([0048] including “accelerometer sensors”, [0056] including “The motion sensor 200 can be any sensor which can be used to determine inactive periods of time.”).
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 analysis to determine resting heart rate (RHR) as recited by ‘170 to include determining there is no motion using a motion sensor as disclosed by Bonomi which is merely combining prior art elements (RHR analysis of ‘170 to include determining when heart rates are resting using sensors as recited by Bonomi) according to known methods to yield predictable results.
The claims of ‘170 render obvious (by their dependency on the rejection above) the remaining claims of the current application
Claims 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 11903743 in view of Bonomi.
Regarding Claim 1 an interpretation of ’170 claims disclose a method for managing a thyroid abnormality of a person (‘743 Claim 1), the method comprising:
acquiring, by one or more processors, a plurality of heart rates during at least a first consecutive days and a second consecutive days (‘743 Claim 1),
wherein the plurality of heart rates measured by a wearable device worn by the person (‘743 Claim 1),
wherein the first consecutive days comprise a test day on which a thyroid function of the person is assessed by a thyroid hormone concentration of the blood of the test day measured by a blood test (‘743 Claim 1),
wherein the second consecutive days comprise a managing day on which a thyroid function of the person is not assessed by a blood test (‘743 Claim 1),
wherein the number of the first consecutive days and the number of the second consecutive days are greater than 1 (‘743 Claim 1), and
wherein the managing day is later than the test day (‘743 Claim 1);
acquiring, by one or more processors, a reference resting heart rate calculated using heart rates of the first consecutive days (‘743 Claim 1),
calculating, by one or more processors, a current resting heart rate using heart rates of the second consecutive days (‘743 Claim 1);
determining, by one or more processors, a prediction result related to a thyroid function state of the managing day using the current resting heart rate and the reference resting heart rate of the person (‘743 Claim 1); and
inducing to conduct an additional blood test on the person based on the prediction result (‘743 Claim 1).
While ‘170 claim 1 recites using “resting” heart rates, an interpretation of ‘743 claim 1 may not explicitly disclose that heart rates meet a predetermined standard among the heart rates, wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period, wherein the predetermined standard is determined using a sensing value of a gravity sensor, an acceleration sensor, a gyroscope, a GPS sensor, or a combination thereof.
However, in the same field of endeavor (medical devices), Bonomi teaches that heart rates meet a predetermined standard among the heart rates to be resting heart rates ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is determined using a sensing value of a an acceleration sensor ([0048] including “accelerometer sensors”, [0056] including “The motion sensor 200 can be any sensor which can be used to determine inactive periods of time.”).
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 analysis to determine resting heart rate (RHR) as recited by ‘743 to include determining there is no motion using a motion sensor as disclosed by Bonomi which is merely combining prior art elements (RHR analysis of ‘743 to include determining when heart rates are resting using sensors as recited by Bonomi) according to known methods to yield predictable results.
The claims of ‘743 render obvious (by their dependency on the rejection above) the remaining claims of the current application.
Claims 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 12285276 in view of Bonomi.
Regarding Claim 1 an interpretation of ’170 claims disclose a method for managing a thyroid abnormality of a person (‘276 Claim 1), the method comprising:
acquiring, by one or more processors, a plurality of heart rates during at least a first consecutive days and a second consecutive days (‘276 Claim 1),
wherein the plurality of heart rates measured by a wearable device worn by the person (‘276 Claim 1),
wherein the first consecutive days comprise a test day on which a thyroid function of the person is assessed by a thyroid hormone concentration of the blood of the test day measured by a blood test (‘276 Claim 1),
wherein the second consecutive days comprise a managing day on which a thyroid function of the person is not assessed by a blood test (‘276 Claim 1),
wherein the number of the first consecutive days and the number of the second consecutive days are greater than 1 (‘276 Claim 1), and
wherein the managing day is later than the test day (‘276 Claim 1);
acquiring, by one or more processors, a reference resting heart rate calculated using heart rates of the first consecutive days (‘276 Claim 1),
calculating, by one or more processors, a current resting heart rate using heart rates of the second consecutive days (‘276 Claim 1);
determining, by one or more processors, a prediction result related to a thyroid function state of the managing day using the current resting heart rate and the reference resting heart rate of the person (‘276 Claim 1); and
inducing to conduct an additional blood test on the person based on the prediction result (‘276 Claim 1).
While ‘276 claim 1 recites using “resting” heart rates, an interpretation of ‘170 claim 1 may not explicitly disclose that heart rates meet a predetermined standard among the heart rates, wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period, wherein the predetermined standard is determined using a sensing value of a gravity sensor, an acceleration sensor, a gyroscope, a GPS sensor, or a combination thereof.
However, in the same field of endeavor (medical devices), Bonomi teaches that heart rates meet a predetermined standard among the heart rates to be resting heart rates ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is set for selecting heart rates related to a period free of motion or a sleep period ([0040]-[0041], [0048], [0056]), wherein the predetermined standard is determined using a sensing value of a an acceleration sensor ([0048] including “accelerometer sensors”, [0056] including “The motion sensor 200 can be any sensor which can be used to determine inactive periods of time.”).
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 analysis to determine resting heart rate (RHR) as recited by ‘276 to include determining there is no motion using a motion sensor as disclosed by Bonomi which is merely combining prior art elements (RHR analysis of ‘276 to include determining when heart rates are resting using sensors as recited by Bonomi) according to known methods to yield predictable results.
The claims of ‘276 render obvious (by their dependency on the rejection above) the remaining claims of the current application
Conclusion
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/James Moss/Examiner, Art Unit 3792
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