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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-16, drawn to a device capable of detecting and measuring select substances in human tissue.
Group II, claim 49-52, drawn to a non-invasive blood glucose measuring device and a method for non-invasive measuring of blood glucose concentration levels.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature.
During a telephone conversation with Mr. Daniel W. Sullivan on 17 November 2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 49-52. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 49-52 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. Regarding claim 49, the phrase “the baseline glucose concentration” lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “a baseline glucose concentration”. The phrase “a microcontroller” in line 5 of claim 49 renders the claim indefinite in that it is unclear if the “a microcontroller” of line 5 is the same as or different than the “a microcontroller” recited in line 3. Clarification is requested. The phrase “the concentration of the blood glucose” in line 5 lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “a concentration of blood glucose”. The phrase “the difference between the baseline and final blood glucose concentration levels” renders the claim indefinite for the following reasons: 1) the phrase “the baseline” lacks proper antecedent basis – the phrase is being interpreted as “the baseline glucose concentration”; 2) “final blood glucose concentration levels” lacks proper antecedent basis – from where are the final blood glucose concentration levels obtained?; and 3) it is unclear how a (final) concentration of blood glucose would be measured by determining a difference between a baseline value and itself (the final blood glucose concentration levels). How would a yet to be determined value (a final blood glucose concentration level) be used to determine itself? A reading of the specification has failed to provide clarity with regard to how a concentration of the blood glucose would be measured using at least one algorithm that determines the difference between the baseline and final blood glucose concentration levels. Furthermore, a difference is a value determined between two numbers. As currently written, the claim calls for determining a single difference between more than two values (between a baseline value and final blood glucose concentration levels (plural)). The indefiniteness issues within claim 49 have rendered a proper prior art search of the claim unable to be performed. Regarding claim 50, the phrases “the ultrasonic waves of the ultrasonic transducer” and “the continuously changing intensity of the light” lack proper antecedent basis. Furthermore, it is unclear what is meant by “the ultrasonic waves of the ultrasonic transducer”. Is the phrase referring to ultrasonic waves induced by the transducer, or is it referring to ultrasonic waves sensed by the transducer? Clarification is requested. Further regarding the claim, it is unclear what further limitation the claim provides as it merely recites an inherent property of ultrasonic waves induced by light applied to body tissue. An intensity of ultrasonic waves sensed by an ultrasonic transducer will inherently be related to the intensity of a continuously changing intensity of light used to create the ultrasonic waves. The claim fails to recite any structural or functional limitation to the claimed device. Regarding claim 51, the phrases “the baseline” and “the resting tissue” in line 3 lack proper antecedent basis. For the purpose of examination, the phrases are being interpreted as “a baseline” and “resting tissue”, respectively. The phrase “the vibrations” (plural) in line 6 lacks proper antecedent basis as line 5 recites the phrase “the vibration” (singular). For the purpose of examination, the phrase “detecting the vibration” in line 5 is being interpreted as “detecting vibrations”. The phrase “the difference between the baseline and final level of vibration” renders the claim indefinite in that it is unclear what is meant by “the final level of vibration”. Clarification is requested. For the purpose of examination, the phrase is being interpreted as “the difference between the baseline and a level of vibration”. The phrase “the algorithm” in line 8 lacks proper antecedent basis as line 7 recites “at least one algorithm”. When more than one algorithm is used, to which of the plurality of algorithms is the phrase “the algorithm” referring? For examination purposes, the phrase in line 8 is being interpreted as “the at least one algorithm”. The same indefiniteness issue and interpretation also apply to claim 52. The phrase “the level of vibrations” in lines 8-9 lacks proper antecedent basis as line 5 recites “the vibration” (singular). As noted above, for the purpose of examination, “the vibration” in line 5 is being interpreted as “vibrations”. The phrase “the amount of blood glucose” in line 9 lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “an amount of blood glucose”. Regarding claim 52, the phrase “the baseline tissue values” lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “baseline tissue values”. The phrase “the baseline values” in line 3 lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “baseline values”. The phrase “this range” lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “the predetermined range”.
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 49-52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 51 follows.
Regarding claim 51, the claim recites a series of steps or acts, including measuring a baseline, transmitting light energy pulses to tissue, detecting vibrations of body tissue resulting from the light energy pulses being transmitted, and analyzing a resultant acoustic signal. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of analyzing an acoustic signal using at least one algorithm to determine a difference between a baseline and a final level of vibration, wherein the at least one algorithm interprets the level of vibrations into an amount of blood glucose sets forth a judicial exception. This step describes both use of a mathematical formula and a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to both a Mathematical Concept a Mental Process, which are both Abstract Ideas.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 51 fails to recite any application of the determined difference or of the blood glucose amount interpretation. The determination of the difference and interpretation of the amount of blood glucose do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined difference or the interpreted blood glucose amount, nor does the method use a particular machine to perform the Abstract Ideas.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of measuring a baseline, transmitting light energy pulses into a body tissue, and detecting the vibration of body tissue resulting from the light energy pulses being transmitted. The measuring, transmitting, and detecting steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 49, the device recited in the claim is a generic device comprising generic components configured to perform the Abstract Ideas. The recited ultrasonic transducer is a generic sensor configured to perform pre-solutional data gathering activity, the laser diode light source is a generic device configured to perform pre-solutional data gathering activity, and the microcontroller is configured to perform the Abstract Ideas. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 51 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al.’450 (US Pub No. 2020/0352450) in view of Kamath et al.’013 (US Pub No. 2010/0223013).
Regarding claim 51, Zhou et al.’450 discloses a method for non-invasive measuring of blood glucose concentration levels in a patient (see TITLE), the method comprising the steps of: transmitting light energy pulses into a body tissue of a user (section [0076]); detecting the vibration of body tissue resulting from the light energy pulses being transmitted, wherein the vibrations generate an acoustic signal (section [0078]); and analyzing the acoustic signal using at least one algorithm to interpret levels of vibration as an amount of blood glucose (sections [0081-0082]).
Zhou et al.’450 discloses all of the elements of the current invention, as discussed above, except for the method comprising the steps of measuring a baseline of resting tissue of the user, and determining a difference between the baseline and a final level of vibration. Kamath et al.’013 teaches measuring a baseline signal of resting tissue of a user, wherein the baseline signal is then subtracted from an active glucose measurement signal in order to produce a glucose-only signal that is not subject to baseline and/or interfering species on the active glucose measurement signal (section [0123]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Zhou et al.’450 to include measuring a baseline of the resting tissue of the user, and subtracting the baseline from the acoustic signal (the active glucose measurement signal), as Kamath et al.’013 teaches that this would provide a more accurate signal from which to determine a blood glucose amount.
Regarding claim 52, Zhou et al.’450 in view of Kamath et al.’013 discloses all of the elements of the current invention, as discussed above, except for the method comprising the additional step of using a microcontroller to determine if baseline tissue values are within a predetermined range, wherein the at least one algorithm proceeds if the baseline tissue values are within the predetermined range. Kamath et al.’013 teaches using a microcontroller to determine if baseline values are within a predetermined range, wherein a method proceeds if the baseline values are within the predetermined range. Kamath et al.’013 discloses that this ensures that a method will not process or display errant data (section [0282]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Zhou et al.’450 in view of Kamath et al.’013 to include using a microcontroller to determine if baseline values are within a predetermined range, wherein the at least one algorithm proceeds if the baseline values are within the predetermined range, as this would ensure that errant data is not processed or displayed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Pikov et al.’171 (US Pub No. 2016/0051171) discloses a photoacoustic based non-invasive blood glucose measuring device and method. Nagar et al.’002 (US Pub No. 2003/0167002) discloses a photoacoustic based non-invasive blood glucose measuring device and method comprising use of an ultrasonic transducer and laser diode light source. Esenaliev et al.’141 (US Pub No. 2007/0255141) discloses a photoacoustic based non-invasive blood glucose measuring device and method comprising use of an ultrasonic transducer and laser diode light source. Kim et al.’908 (US Pub No. 2018/0160908) discloses a photoacoustic based non-invasive blood glucose measuring device and method comprising use of an ultrasonic transducer and laser diode light source. MacKenzie et al. (Advances in Photoacoustic…) teaches a photoacoustic noninvasive glucose device and method.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791