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 .
Response to Arguments
Applicant's arguments filed 7/21/26 have been fully considered but they are not persuasive. Specifying that devices that record voice data and predict blood glucose levels use sensors and processors does not change the scope of the claims. See rejections below. All arguments have been addressed in the body of the rejections.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: receiving unit for, extraction unit for, determining unit for, output unit for in claim 1, network unit for, storage unit for in claim 2; device for, receiving unit for, extraction unit for, determining unit for, output unit for in claim 13; storage unit for in claim 14
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner Note
SPE Shmatov has taken the position that “based on” should be given patentable weight as if audio/speech data is input into a prediction module/algorithm and real blood glucose levels are output (see a determining unit for determining the blood glucose level for the subject “based on” the at least one voice biomarker feature value and a blood glucose level prediction model).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 13-23 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.
If the claims are read using that interpretation then claims read as if actual voice/speech data, voice biomarker or a voice signature is input into a undefined prediction module and somehow real world BG levels are output without using any blood samples, glucometer, blood level meters.
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Therefore, 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.
How exactly is voice data converted in BG levels when e.g., a patient is excited, scared, tired, drunk, stoned, depressed? What are the actual inputs to the prediction module? What is output, an exact BG level, a range or an indication that BG is high or low? How exactly does a person speak into a microphone and have an algorithm/model output that their blood glucose level is 187?
The NPL cited by applicant Hamdan et al. Vocal characteristics in patients with type 2 diabetes mellitus, 2012) discloses that there was no significant difference in any of the acoustic variables between patients with diabetes and the control, abstract.
Response to Amendment
Applicant's arguments filed 6/30/26 have been fully considered but they are not persuasive.
In re pgs. Applicant argues paragraphs 34 and 53 (reproduced below) from the applicant’s specification describe 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.
[34] In one aspect, there is provided a system for determining a blood glucose level for a subject. In one embodiment, the system comprises: a memory, the memory comprising: a blood glucose level prediction model; a processor in communication with the memory, the processor configured to: receive a voice sample from the subject; extract at least one voice biomarker feature value from the voice sample for at least one predetermined voice biomarker feature; determine the blood glucose level for the subject based on the at least one voice biomarker feature values and the blood glucose level prediction model; and outputting, at an output device, the blood glucose level for the subject.
[53] In one aspect, there is provided a device for determining a blood glucose level for a subject. In one embodiment, the device comprises: a receiving unit for obtaining a voice sample from the subject; an extraction unit for extracting at least one voice biomarker feature value from the voice sample for at least one predetermined voice biomarker feature; a determining unit for determining the blood glucose level for the subject based on the at least one voice biomarker feature value and a blood glucose level prediction model; and an output unit for outputting the blood glucose level for the subject.
In response, stating that blood glucose levels are determined from speech data with no further explanation is similar to saying one possesses a perpetual motion machine because the disclosure specifies a machine that spins or outputs energy for an infinite amount of time with no energy inputs. Where in the disclosure does it specifically state how one can make and use the invention of listening to a person’s voice and somehow outputting their blood glucose level?
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.
Claim(s) 1, 2, 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hadad (US 2019/0290172) in view of Tshope et al. (Estimating Blood Sugar from Voice Samples, A Preliminary Study, 2015 International Conference on Computational Science and Computational Intelligence).
Hadad discloses:
1, 13. A device for determining a blood glucose level for a subject, the device comprising a processor and a memory (inherent in devices, 112, 114, 116, 118; 0356, 0363) in communication with the processor, the device comprising:
the memory (inherent memory in devices, 112, 114, 116, 118) comprising a blood glucose level prediction model (101, Fig. 60; prediction models, “The insights and recommendation engine 230 can determine various effects of food consumption on the user's body by applying at least one predictive model to a plurality of data sets”, 0233, 0235-9; 0245-6);
one or more sensors (microphone, cell phone, mobile units) a receiving unit for obtaining a voice sample from the subject recorded “proximate” (subjective) to the device (“The devices 110 can include a wearable device 112 (e.g., a smart watch, fitness tracker, etc.), a mobile device 114 (e.g., a cell phone, a smart phone, a voice recorder, etc.), can’t be good”, 0087);
the processor in communication with the one or more sensors and the memory (devices, 112, 114, 116, 118), the processor configured to
extract at least one voice biomarker feature value from the voice sample for at least one predetermined voice biomarker feature (a voice biomarker is used to initiate communication or authenticate a private, personal health system that has data protected by HIPPA, “GUI-based software interface for voice recognition analysis”, 0028, 0228;
“voice-based food log”, 0221, 0307; voice recognition, 0352;
“user can initiate a communication with the virtual health assistant 280 by providing (e.g., via voice or text messaging) a question (e.g., regarding the user's diet, glucose or additional biomarker level, etc.) to the virtual health assistant 280”, 0348);
(in order to recognize voice and determine what client says they ate that affects their glucose their voice biomarker is recognized, “GUI-based software interface for voice recognition analysis”, 0028, 0228; “voice-based food log”, 0221, 0307; voice recognition, 0352; “user can initiate a communication with the virtual health assistant 280 by providing (e.g., via voice or text messaging) a question (e.g., regarding the user's diet, glucose or additional biomarker level, etc.) to the virtual health assistant 280”, 0348);
determine the blood glucose level (“based on changes to the user's glucose level as measured by the glucose level monitor”, abstract, 0005-6, 0039; 101, Fig. 60) for the subject based on the at least one voice biomarker feature value and a blood glucose level prediction model (based on biomarker reads on a plurality of factors or ways that the voice is used in the process of determining a BG level, does not claim using a closed ended list of factors that contribute to determining a BG level, just that one of a plurality of factors can be voice data, “At least one decision tree learning algorithm can be used to predict how foods previously consumed by a user may affect personalized biomarkers of the user (e.g. glucose level). At least one decision tree learning algorithm can also be used to predict how foods that the user has never consumed or other lifestyle events that may affect the user's biomarkers (e.g. glucose level)”, 0236; 0235-9; 0245-6 “predict a user's general biomarkers. In an example, the insights and recommendation engine 230 can predict a user's glucose metabolism”, 0245;
Hadad discloses that voice is one of many known biomarkers that can be used, “The user can initiate a communication with the virtual health assistant 280 by providing (e.g., via voice or text messaging) a question (e.g., regarding the user's diet, glucose or additional biomarker level, etc.) to the virtual health assistant 280”, 0348; voice recognition, 0028; “perform food tracking by textual and voice recognition analysis”, 0228; “sending a voice message or a text message) “How is my glucose level doing?””, 0346); and
output the blood glucose level or an output based on the blood glucose level for the subject (does not claim that a real BG meter cannot be used in the process, user initiates communication via voice and informs VA about food they ate that will affect they blood glucose/A1C, “based on changes to the user's glucose level as measured by the glucose level monitor”, abstract, 0005-6, 0039).
Examiner Note
Applicant discloses “[330] Optionally, the user device may be a smart speaker; the user input may be a voice query for the blood glucose level; the user prompt may be a voice prompt output; and the output device may be a speaker device. For example, a user may ask an Alexa device “Alexa, what is my blood glucose level””.
Hadad discloses “sending a voice message or a text message) “How is my glucose level doing?””, 0346).
Hadad only discloses a determining unit for determining the blood glucose level for the subject based on the at least one voice biomarker feature value and a blood glucose level prediction model in the sense that voice is used as a method to activate/authenticate the BG measuring system and that there is a voice biomarker and voice recognition, and that voice is used to log on, authenticate, or ask what is my BG level or indicate what a patient consumed.
In a narrow interpretation of the claims, it can be argued that Hadad fails to particularly call for a determining unit for determining the blood glucose level for the subject based on the at least one voice biomarker feature value and a blood glucose level prediction model.
Tshope teaches a determining unit for determining the blood glucose level for the subject based on the at least one voice biomarker feature value and a blood glucose level prediction model in the sense that voice is sampled and believed to comprise of features that pertain to a person’s BG level (“It is well-known that the human voice carries all kinds of information and depends on various factors. Therefore we conjectured that it may also be influenced by the blood sugar level. This paper presents a preliminary study which shows that a patient’s blood sugar condition actually seems to manifest itself in the voice.; - an extraction unit for extracting at least one voice”, abstract).
It would have been obvious to combine the references before the effective filing date because they are in the same field of endeavor and using a patient’s voice to authenticate a private/personal medical system, to indicate what factors a person has experienced that may affect their BG and to hear their general state of mind/health, in case they are very weak and can barely talk due to a low blood level.
2, 14. The device of claim 1, further comprising:
- a network unit for receiving the blood glucose level prediction model; and a storage unit for storing the blood glucose level prediction model (devices, 110, wearable device, 112, network, 120, “based on changes to the user's glucose level as measured by the glucose level monitor”, abstract, 0005-6, 0039).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hallock US 2020/0053558) teaches obtaining a plurality of voice biomarkers (signature 0074).
Only claims 1,2,13,14 were rejected under USC 102.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R VINCENT whose telephone number is (571)272-3080. The examiner can normally be reached ~Mon-Fri 12-8:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexey Shmatov can be reached at 5712703428. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R VINCENT/ Primary Examiner, Art Unit 2123
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