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 .
Election/Restrictions
Applicant’s election of Species A-1, B-6, and C-1 in the reply filed on 13 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3, 5-13, 17, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 February 2026.
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, 2, 4, 14-16, 18-20, and 22 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.
Claim 1 calls for “calculating at least one peak distance between first feature peak positions for each of the plurality of ECG waveforms”; it is unclear how more than one peak distance could be calculated for each waveform when the only data points are two peak positions and the distance being found is the distance between each, an unvarying amount. It is unclear if the intent is to potentially involve some other data points in calculating additional peak distances for each waveform, or if this should refer to calculating a distance for each waveform. Clarification is required.
Claim 1 further calls for “estimating the blood glucose value of the user based on the peak distance”. It is entirely unclear if the intent is to find a blood glucose value for each waveform, where each peak distance is used to find a blood glucose value, or if some step has been omitted where the plurality of distances for the plurality of waveforms are somehow correlated or compared in order to find one single “peak distance” that is then used to estimate a single blood glucose value, and if so, how are these plurality of distances reduced to a single distance, whether by averaging or selecting one that meets some criteria or some other method. Clarification is required.
Claim 2 calls for “normalizing the peak distance” – normalizing with respect to what? It is unclear if some other previously determined distance is involved, or if this involves use of more than one of the peak distances of the plurality of waveforms as set forth in claim 1, or some other process of normalization. Clarification is required.
Claim 14 calls for “extracting at least one fourth ECG feature”; as claim 14 depends directly from claim 1 which only defines extracting first ECG features, there is no antecedent basis for extracting any “fourth ECG feature” without also calling for extracting second and third ECG features. It is unclear if performing the method of claim 14 is operable on its own without also finding second and third ECG features, or how extraction of any one feature might affect extraction of a subsequent feature. Clarification is required.
Further, claim 14 calls for extracting at least one of these features from each of the plurality of waveforms, and then calls for “calculating at least one sharpness result based on the fourth ECG feature” – does “at least one” refer to the plurality of waveforms being involved? Or does “at least one” refer to the sharpness result(s) found in each waveform? Further, as the estimating of glucose is “further based on the sharpness result”, which of the at least one sharpness results is used in this estimating, particularly if a sharpness result is found for each waveform? Clarification is required.
Claim 15 in the preamble refers to “calculating the sharpness result”; there is insufficient antecedent basis for this limitation in the claim as claim 14 defines “calculating at least one sharpness result”. Further, claim 15 continues by calling for “calculating a first sharpness” and “calculating a second sharpness” – it is unclear if either of these is considered a sharpness result or if a sharpness somehow differs from a sharpness result. Clarification is required.
Claim 16 calls for “normalizing the peak distance and the sharpness result, respectively”; as above, it is unclear how these are “normalized” when only one value of each is involved.
Claim 18 calls for “evaluating the quality of the plurality of ECG waveforms”, then refers to “a normal ECG signal” and “a noise signal”. Are “normal” and “noise” the result of evaluating the quality? Or are these signals identified as normal/noise via some other means? Clarification is required.
Further, claim 18 calls for “outputting an immediate blood glucose value of the user” or “outputting a previous blood glucose value of the user” – it is entirely unclear how these values are determined or otherwise obtained. Is the “immediate” value a most recently estimated value? Or if the value is “estimated immediately” how does the method “further comprise” evaluating quality after a value has already been estimated? Is the method of claim 1 intended to be performed multiple times with all estimates saved in order to acquire a “previous” value or is this obtained from some other source or database? Clarification is required.
Claim 19 calls for “re-receiving the plurality of ECG waveforms when the plurality of ECG waveforms of the user is less than the default value”. It is entirely unclear how or why this would take place as the plurality of ECG waveforms would still have the same number of waveforms which would inherently still be less than the default value causing the method to enter a perpetual loop of re-receiving the same data forever. Clarification is required.
Claim 20 calls for the device to store “a plurality of codes” – it appears the intent is to store a plurality of instructions unless there is some other activity involving secret meanings also included in the operations. Further, it is entirely unclear what this device might be programmed to do if it both executes these unidentified unrelated codes and then also subsequently follows the method of claim 1; the same is true of claim 22.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
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.
Claim(s) 1, 2, 4, 14-16, 18-20, and 22 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving a plurality of electrocardiogram (ECG) waveforms”, “extracting at least two first ECG features”, “determining a first feature peak position”, “calculating at least one peak distance”, and “estimating the blood glucose value". This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are that the steps of the judicial exception are “suitable for… a computing device”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one, particularly as the invention as claimed does not positively recite actually using the “computing device” at any point. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2, 4, 14-16, 18-20, and 22 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Dependent claim 2 generally calls for use of “a machine learning model” to estimate the blood glucose value; this would fall into the category of mathematical concepts, but as the claim recites only the idea of the outcome without any particularity of how the machine learning module operates and invokes a generic model only as a tool for making the recited mathematical calculation, the limitation represents no more than mere instructions to apply the judicial exception on a computer which here is no more than an attempt to generally link the use of the judicial exception to the technological environment of computers. See the Office’s 101 guidance example 48. Dependent claim 4 also falls into the category of mathematical concepts, with no specificity as to the concept involved and no recited practical application of such concept, where the general idea of calibrating data is well-understood, routine, and conventional. Claims 14, 15, 18, 19 present further aspects of the judicial exception itself. Claim 16 includes a mathematical concept as discussed with respect to claim 2 above. Claims 20 and 22 are directed to computing products recited at a high level of generality and only for providing a technological environment for execution of the abstract idea itself, such that they do not add anything significantly more. Thus, claim(s) 2, 4, 14-16, 18-20, and 22 is/are rejected under 35 U.S.C. 101.
Conclusion
No art has been applied against the claims at this time; however, as all pending claims are rejected under 112b and 101 they are not presently allowable and the question of prior art will be revisited when the scope and indefiniteness of the claims are resolved.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2022/0338743 to Seo, US 2022/0087577 to Lee, US 2015/0245780 to Nguyen, US 7103412 to Kroll, US 6572542 to Houben, and US 5741211 to Renirie, which all disclose using distances between features in an ECG waveform to estimate blood glucose level; US 2024/0307003 to Cronin, US 2022/0346676 to Pecchia teach using the slope of a feature in an ECG waveform as part of estimating a blood glucose value from features of that waveform
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791