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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/27/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 5, 7, and 11-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 1, the claim limitation “estimation times” renders the claim indefinite because the limitation is unclear. It is unclear how the estimation times are correlated to the antioxidant concentrations. For purposes of examination, the claim limitation is interpreted as synchronizing the time with the corresponding antioxidant concentration. Due to the rejection of the independent claim, the dependent claims are also rejected because they are failing to cure the deficiencies as stated in the independent claim.
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, 4, 5, 7, 11, 12, and 13 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. Each of Claims 1, 4, 5, 7, 11, 12, and 13 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1, 4, 5, 7, 11, 12, and 13 recites at least one step or instruction for estimating an antioxidant concentration from the user, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claim 1, 4, 5, 7, 11, 12, and 13 recites an abstract idea.
Specifically, Claim 1 recite:
Claim 1 | “An apparatus configured to estimate an antioxidant component (Judgement), the apparatus being implemented as a wearable device, comprising:
a main body to be worn on a wrist of a user;
a wrist strap connected to the main body and to be worn around the wrist of the user;
one or more sensors provided on a rear surface of the main body and configured to measure optical signals from body parts of the user (Observation);
a storage configured to store first antioxidant concentrations estimated at a finger and second antioxidant concentrations estimated at a wrist (Observation);
a processor configured to:
estimate the first antioxidant concentrations at the finger, extract, as training data, data pairs of the first antioxidant concentrations and the second antioxidant concentrations from the storage (Evaluation/Opinion),
generate a transformation model configured to transfer the second antioxidant concentrations into a reference index based on the training data (Evaluation/Opinion);
perform update by transforming the second antioxidant concentrations, stored in the storage, into the reference index based on the generated transformation model (Evaluation/Opinion); and
a display provided on a front surface of the main body and configured to display the first antioxidant concentrations, the second antioxidant concentrations, and the reference index in a graph (Evaluation/Opinion),
wherein the transformation model is defined as a linear function, a non-linear function or a neural network-based model (Mathematical),
wherein the processor is further configured to extract one or more data pairs of the first antioxidant concentrations and the second antioxidant concentrations, corresponding to estimation times of the respective first antioxidant concentrations, as the training data from the storage (Evaluation/Opinion), and
wherein based on a time point at which a change in absorbance of an optical signal measured at the wrist is greater than or equal to a threshold value (Mathematical), the processor is further configured to extract the data pairs of the first antioxidant concentrations and the second antioxidant concentrations from the storage at a time interval after the time point (Observation),
wherein the processor is further configured to transform the second antioxidant concentrations, included in first data pair to last data pair of the training data of the generated transformation model, into the reference index (Evaluation/Opinion), and
wherein based on a missing interval existing between the first data pair of the training data of the generated transformation model and the last data pair of the training data of a transformation model generated at a previous time, the processor is configured to obtain, as the reference index, an arithmetic mean or a weighted average of values obtained by transforming the second antioxidant concentrations in the missing interval based on each of the two transformation models (Evaluation/Opinion).”
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract or organizing human activity:
These are a few examples, all applications will contain different bullets
Claims 4, and 5 include steps on extracting antioxidant concentrations.
Claims 7, 11, 12, and 13 include steps that are a mathematical process.
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrowing idea is still an abstract idea and an abstract idea with additional well-known equipment/functions are not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
Regarding Claims 1, 4, 5, 7, 11, 12, and 13 (and their respective dependent claims) meets Step 2A, Prong 2 because the above-identified abstract idea in each of independent claims are not integrated into a practical application. The above-identified abstract ideas do not improve the following: function of a particular machine, manufacture or other technology; treatment or prophylaxis for a disease or medical condition; or transforming or reducing of a particular article to a different state or thing (MPEP 2106.04(d)).
Step 2B
Lastly, the claims as a whole are analyzed to determine whether any elements, or in combination, to ensure that they amount to significantly more than the judicial exception itself. However, these claims do not appear to recite additional elements that amount to significantly more than the judicial exception.
The recited additional elements, more specifically wearable device and sensors, are not significantly more because US Reference 20190216340 A1 provides evidence within Paragraph 0002 that they are well-known, routine, and conventional.
The above-identified additional elements, more specifically the storage, processor, and display, are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Therefore, none of the Claims 1, 4, 5, 7, 11, 12, and 13 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 4, 5, 7, 11, 12, and 13 are not patent eligible and rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claim 1 and its dependent claims would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 1 and its dependent claims, the closet prior art of record is: Diab et al. (US 20210113121 A1), Nielsen et al. (US 20110316704 A1), Khorram et al. (Trainable Time Warping: Aligning Time-series in the Continuous-time Domain, 2019, reference U on PTO-892), Callahan et al. (US 20130332173 A1), Morelli et al. (Analysis of the Impact of Interpolation Methods of Missing RR-Intervals Caused by Motion Artifacts on HRV Features Estimations, 2019, reference V on PTO-892), Lee et al. (US 20210282676 A1) and Jang et al (US 20210113087 A1).
Regarding Claim 1 Diab discloses an apparatus (patient monitor – elements 102 and 202) configured to estimate an analyte component (Paragraph 0097, The patient monitor 102 can, for example, determine physiological parameters corresponding to the patient, such as an amount of light absorbed, transmitted through, or reflected at a tissue site, path length (for example, distance that light travels through the material), concentration of an analyte; [Examiner’s note, both patient monitors preform the same function.]), the apparatus comprising:
one or more sensors configured to measure optical signals from body parts of the user (Diab | Paragraphs 0100, 0105);
a storage (memory device – element 228; Paragraph 0124) configured to store first analyte concentrations estimated at a finger (tissue site – element 206A; Figure 2; Paragraphs 0091, 0120) and second analyte concentrations estimated at a wrist (tissue site – element 206B; Figure 2; Paragraphs 0091, 0120; [Examiner’s note, the two or more sensors can be configured to measure analyte signals at different tissue sites, where one tissue site is the finger while the other is the wrist.]);
a processor (DSP – elements 212A-C; Figure 2; Paragraphs 0107, 0110, and 0118) configured to:
estimate the first analyte concentrations at the finger (1308 of Figure 12A; Paragraph 0175; [Examiner’s note, the learning condition is the skin geometry information.]),
extract, as training data (Paragraph 0171; [Examiner’s note, wherein the sensors can include an OCT sensor. As a result, the two sensors being used to measure the two analyte concentrations can be measured by a OCT sensor.]; Paragraphs 0301-0305, [Examiner’s note, the data from the OCT sensors is used as the training data, which goes through the trained CNN.]), data pairs of the first analyte concentrations and the second analyte concentrations (Figure 2 and Element 1308 of Figure 12A; Paragraphs 0119-0120, 0175; [Examiner’s note, the data pairs are the data collected by the DSP 212A, DSP 212B, and DSP 212C from corresponding tissue sites 206A, 206B, and 206C, which is then sent to the instrument manager (210).]) from the storage (Paragraph 0124),
generate a transformation model (training CNN – element 2804; [Examiner’s note, the applicant states within the specification the transformation model may be defined as a linear or non-linear function or a neural network-based model. The CNN is a neural network-based model.]) configured to transfer the second analyte concentrations into a storage (Paragraph 0124) based on the training data (Paragraph 0171; [Examiner’s note, wherein the sensors can include an OCT sensor. As a result, the two sensors being used to measure the two analyte concentrations can be measured by an OCT sensor.]; Paragraphs 0301-0305, [Examiner’s note, the data from the OCT sensors is used as the training data, which goes through the trained CNN.]);
perform update by transforming the second analyte concentrations (Paragraph 0104), stored in the storage, into the storage (Paragraph 0124) based on the generated transformation model (training CNN – element 2804); and
a display (user interface – element 222) configured to display the first analyte concentrations, the second analyte concentrations, and the data from storage (Paragraph 0101, 0121, 0181),
wherein the transformation model is defined as a linear function, a non-linear function or a neural network-based model (training CNN – element 2804),
wherein the processor is further configured to extract one or more data pairs of the first analyte concentrations and the second analyte concentrations, corresponding to time transformation of the respective first analyte concentrations (timing processor system – element 1800; Paragraphs 0245, 0247), as training data (Paragraph 0171; [Examiner’s note, wherein the sensors can include an OCT sensor. As a result, the two sensors being used to measure the two analyte concentrations can be measured by an OCT sensor.]; Paragraphs 0301-0305, [Examiner’s note, the data from the OCT sensors is used as the training data, which goes through the trained CNN.]) from storage (Paragraph 0124), and
wherein based on a time point at which a change in absorbance of an optical signal measured (Figure 25A; Paragraph 0294; [Examiner’s note, the change in absorbance is measured by Beer’s Law Equation (equation 1), which is rewritten as
∆
A
=
ε
b
(
C
2
-
C
1
), where
C
1
and
C
2
are the first and second analyte concentrations. The bottom graph displays the change in absorbance at different wavelengths based on the baseline portion (2504), a heating portion (2506), and a cooling portion (2508) based on the radiant heating from a laser associated with the Raman sensor (refer to Paragraph 0288 for further details). The graph displays when radiant heating from the laser increases, the change in absorbance decreases.]) at the wrist (tissue – element 2410) is greater than or equal to a threshold value (temperature of a tissue site as a function of time – element 2510 on Figure 25A; Paragraphs 0285, 0291; [Examiner’s note, the increase in temperature is used to improve signal collection from the various tissue depths. The two graphs on 25A show the relationship that as radiant temperature increases, the temperature on the tissue site increases while the change in absorbance at different tissue depths decrease. Meaning, the increase in skin temperature causes vasodilation, which expands the local blood vessels and increasing blood volume near the surface. This larger blood pool delivers a stronger optical or chemical analyte signal. Vasodilation changes wavelength absorbance by increasing overall photon absorption and altering the ratio of oxygenated to deoxygenated hemoglobin. Because of this, the change in absorbance at different skin depths decreases.]), the processor is further configured to extract the data pairs of the first analyte concentrations and the second analyte concentrations from the storage at a time interval after the time point (Figure 25A; [Examiner’s note, the time between 2.5 minutes to 4 minutes display when the model output (line 2512) is greater than the threshold (line 2510).]),
wherein the processor is further configured to transform second analyte concentrations, included in first data pair to last data pair of the training data of the generated transformation model (training CNN – element 2804), into the storage (Paragraph 0124) in a graph (Figure 28; Paragraphs 0304-0305), and
wherein based on a missing interval existing between the first data pair of the training data of the generated transformation model and the last data pair of the training data of a transformation model generated at a previous time (training CNN – element 2804; [Examiner’s note, the trained CNN transformation model can determine and reconstruct missing data through spatial patterns, previous data, and correlations.]), the processor is further configured to obtain, as the storage (Paragraph 0124), an interpolation obtained by transforming second analyte concentrations in the missing interval based on at least one of the two transformation models (Interpolate – element 3346 and trained CNN – element 2804).
Diab is silent in teaching the reference index that is found within the storage. Nielsen teaches the reference index (Nielsen | indexed storage database – element 590; Abstract; Paragraphs 0013, 0044). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus of Diab to incorporate the teachings of an indexed searchable data set from Nielsen because the index within the memory provides a reliable and efficient way to access and search patient data (Nielsen | Abstract; Paragraphs 0013, 0044).
Diab in view of Nielsen is silent in teaching the transformation that utilizes estimation time as the training data. Khorram teaches estimation time as the time transformation (Khorram | Abstract; 5. Conclusion – Page 3505; [Examiner’s note, the dynamic time warping transformation is the estimation time.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus from Diab in view of Nielsen to incorporate the teachings of dynamic time warping (DTW) transformation from Khorram because dynamic time warping (DTW) transformation allows for aligning multiple time-series data. For example, Diab teaches multiple sensors are utilized to measure analyte concentrations from multiple tissue locations. With DTW, the transformation will allow to synchronize multiple analyte data with the correct time series (Khorram | 5. Conclusion – Page 3505).
Diab in view of Nielson and Khorram is silent in teaching the processor extracting data when the data is greater than or equal to the threshold. Callahan teaches the processor (Callahan | feature extraction processor – element 46) extracting data when the data is greater than or equal to the threshold (Callahan | Paragraph 0047). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus of Diab in view of Nielson and Khorram to incorporate the teachings of extracting data based on the data being greater than a threshold from Callahan because data collected above the set threshold is optimal because it resists transient noise and signal artifacts. (Callahan | Paragraph 0030).
Diab in view of Nielson, Khorram, and Callahan is silent in teaching an arithmetic mean or weight average is the interpolation method. Morelli teaches an arithmetic mean (Morelli | Equation 7; 3rd Bullet on Page 5; [Examiner’s note, a linear interpolation uses an arithmetic mean.]) or weight average [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus of Diab in view of Nielson, Khorram, and Callahan to incorporate the teachings of a linear interpolation from Morelli because linear interpolation formula predicts missing data in environments with consistent rates (Morelli | Equation 7; 3rd Bullet on Page 5).
Diab in view of Nielson, Khorram, Callahan, and Morelli is silent in teaching the apparatus being implemented as a wearable device; a main body to be worn on a wrist of a user; a wrist strap connected to the main body and to be worn around the wrist of the user; the sensor is on a rear surface of the main body; a display provided on a front surface of the main body.
Lee teaches the apparatus being implemented as a wearable device (Lee | wearable device – element 1100; Figure 11); a main body to be worn on a wrist of a user (Lee | Figure 11; Paragraphs 0130-0131); a wrist strap connected to the main body and to be worn around the wrist of the user (Lee | Figure 11; Paragraphs 0130-0131); the sensor is on a rear surface of the main body (Lee | Paragraphs 0132-0133); a display provided on a front surface of the main body (Lee | display – element 1111; Figure 11). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus from Diab in view of Nielson, Khorram, Callahan, and Morelli to incorporate the teachings of the wearable device from Lee because the wearable device serves as a non-invasive tool for continuous analyte monitoring. For example, it allows users with diabetes to track their glucose levels without the need for finger-prick tests (Lee | Paragraph 0003).
Diab in view of Nielson, Khorram, Callahan, Morelli, and Lee is silent on explicitly teaching an antioxidant component/concentration.
Jang teaches an optical sensor used to estimate an antioxidant component/concentration (Jang | Paragraphs 0007, 0055; [Examiner’s note, one skilled in the art can determine if an antioxidant value is determined from the optical sensor, then a component/concentration is determined.]). Diab in view of Khorram and Lee teaches of an analyte concentration and Jang teaches an optical sensor used to estimate an antioxidant component/concentration. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the apparatus of Diab in view of Nielson, Khorram, Callahan, Morelli, and Lee to incorporate the teachings of determining an antioxidant component/concentration from Jang because the level of antioxidant component/concentration correlates to the prevention of oxygen toxicity within the user (Jang | Paragraph 0005).
However, the prior art of record does not disclose and would not have rendered obvious the “ordered combination” of elements recited in the claims. Although the prior art can teach each individual part of the claim, a skilled artisan would not find it obvious to combine them together without hindsight reasoning.
Response to Arguments
Applicant’s arguments and amendments filed 02/27/2026 have been fully considered.
The applicant’s amendments to the claims have overcome the Claim Objections and the 35 U.S.C 112(b) Rejections.
Regarding 35 U.S.C. 101 Rejection, the amendments to the claims do not overcome the rejection because the claims meet Step 2A Prong 1, Step 2B Prong 2, and Step 2B. The amended claims meet Step 2A Prong 1 because the claims discuss instructions to estimate an antioxidant concentration of the user; the claims are read as a mental process. The amended claims meet Step 2A Prong 2 because the abstract idea in each of independent claims are not integrated into a practical application, refer to Step 2A, Prong 2 for further clarification. Lastly, the amended claims meet Step 2B because the additional elements of wearable device, and sensor are well-known, routine, and conventional as taught in US Reference 20190216340 A1; the additional elements of storage, processor, and display are generically claimed computer components.
Regarding the 35 U.S.C. 103 Rejection, the applicant’s amendments have overcome the rejection.
Claims 1 and its dependent claims are currently objected to due to the base claim's 101 rejection, but they will be allowable once that rejection is overcome. Please refer to the Allowable Subject Matter section for further clarification.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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