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 without traverse of Group I, draw to the system for reducing analyte sensor variability, in the reply filed on 8/12/26 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/12/26.
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).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim Rejections - 35 USC § 112(a)
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 7-10 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.
Claim 7 positively recites “… wherein the real-time data includes a portion that is based on a blood glucose value and a portion that is unrelated to the blood glucose value, and the instructions, when executed by the one or more processors, further causes performance of: determining, by the machine learning model, a portion of the real-time data that is unrelated to the blood glucose value”.
Claim 8, depending from claim 7, positively recites “…wherein the instructions, when executed by the one or more processors, further causes performance of: generating an adjusted Isig based on the determined portion of the real-time data that is unrelated to the blood glucose value”.
Claim 9 positively recites “…wherein when correcting the glucose sensitivity, the instructions, when executed by the one or more processors, further causes performance of: estimating by the machine learning model a calibration factor as a function of time based on the real-time data; and calibrating the real-time data at least in part based on the calibration factor”.
Claim 10, depending from claim 7, positively recites “…wherein the portion of the real-time data that is unrelated to the blood glucose value is based on a design configuration of the sensor”.
For claims 7, 8, and 10, the instant Specification, while reciting verbatim that the real time data may have a portion “unrelated to the blood glucose value” (see original claims and instant Specification [0014-0024, 0088]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to portions of data “unrelated to blood glucose value”. Indeed, the term is only cursorily mentioned in the original claim, the invention summary, and at one point in the detailed description. In the absence of specific corresponding description demonstrating possession of the claimed invention, claims 7, 8, and 10 lack written description.
For claim 9, similarly and to a greater extent, the instant Specification, while reciting verbatim the “calibration factor” (see original claims and instant Specification [0016, 0025]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to “design configuration”. Indeed, the term is only cursorily mentioned in the original claim and the invention summary. In the absence of specific corresponding description demonstrating possession of the claimed invention, claim 9 lacks written description.
For claim 10, similarly and to a greater extent, the instant Specification, while reciting verbatim the “design configuration” (see original claims and instant Specification [0017]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to “design configuration”. Indeed, the term is only cursorily mentioned in the original claim and the invention summary. In the absence of specific corresponding description demonstrating possession of the claimed invention, claim 10 lacks written description.
Claim Rejections - 35 USC § 112(b)
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 7-10 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 7 positively recites “… wherein the real-time data includes a portion that is based on a blood glucose value and a portion that is unrelated to the blood glucose value, and the instructions, when executed by the one or more processors, further causes performance of: determining, by the machine learning model, a portion of the real-time data that is unrelated to the blood glucose value”.
Claim 8, depending from claim 7, positively recites “…wherein the instructions, when executed by the one or more processors, further causes performance of: generating an adjusted Isig based on the determined portion of the real-time data that is unrelated to the blood glucose value”.
Claim 9 positively recites “…wherein when correcting the glucose sensitivity, the instructions, when executed by the one or more processors, further causes performance of: estimating by the machine learning model a calibration factor as a function of time based on the real-time data; and calibrating the real-time data at least in part based on the calibration factor”.
Claim 10, depending from claim 7, positively recites “…wherein the portion of the real-time data that is unrelated to the blood glucose value is based on a design configuration of the sensor”.
For claims 7, 8, and 10, the instant Specification, while reciting verbatim that the real time data may have a portion “unrelated to the blood glucose value” (see original claims and instant Specification [0014-0024, 0088]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to portions of data “unrelated to blood glucose value”. In the absence of specific corresponding description the scope of the claimed invention is indeterminate because one of ordinary skill in the light of the instant Specification would not be apprised of the metes and bounds of the claimed invention because they would be guessing as to what may and/or may not be explicitly, implicitly, inherently, and/or inferentially required and/or excluded from the scope of the claimed invention by the recitation of “unrelated to the blood glucose value”. Claims 7, 8, and 10 are indefinite given the deficient claim term support because the claim scope is indeterminate.
For claim 9, similarly and to a greater extent, the instant Specification, while reciting verbatim the “calibration factor” (see original claims and instant Specification [0016, 0025]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to “design configuration”. In the absence of specific corresponding description the scope of the claimed invention is indeterminate because one of ordinary skill in the light of the instant Specification would not be apprised of the metes and bounds of the claimed invention because they would be guessing as to what may and/or may not be explicitly, implicitly, inherently, and/or inferentially required and/or excluded from the scope of the claimed invention by the recitation of “calibration factor”. Further, one or ordinary skill would be guessing as to how machine learning model would estimate a “calibration factor” in the absence of a description thereof. Claim 9 is indefinite given the deficient claim term support because the claim scope is indeterminate.
For claim 10, similarly and to a greater extent, the instant Specification, while reciting verbatim the “design configuration” (see original claims and instant Specification [0017]), appears devoid of any reasonable corresponding description, let alone with any corresponding specificity, of what data may and/or may not correspond to “design configuration”. In the absence of specific corresponding description the scope of the claimed invention is indeterminate because one of ordinary skill in the light of the instant Specification would not be apprised of the metes and bounds of the claimed invention because they would be guessing as to what may and/or may not be explicitly, implicitly, inherently, and/or inferentially required and/or excluded from the scope of the claimed invention by the recitation of “design configuration”. Claim 10 is indefinite given the deficient claim term support because the claim scope is indeterminate.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ajemba et al. (WO 2022/165136 A1, hereinafter Ajemba).
For claim 1, Ajemba discloses a system (100) for reducing analyte sensor variability (Figs 1,2,5,7,9,10) ([0023-0078]), the system comprising inter alia:
a sensor (12) (Fig 2) ([0027]) configured to generate real-time data relating to glucose sensitivity (Figs 7,9,10) ([0048-0078]);
one or more processors (224) (Fig 2) ([0030]); and
one or more processor-readable media storing instructions (Figs 7,9,10) ([0048-0078]) which, when executed by the one or more processors, causes performance of:
accessing the real-time data from the sensor relating to glucose sensitivity (Figs 7,9,10) ([0048-0078]);
inputting the real-time data into a machine learning model (Figs 7,9,10) ([0048-0078]);
estimating by the machine learning model an expected glucose sensitivity based on the real-time data (Figs 7,9,10) ([0048-0078]); and
correcting the glucose sensitivity of the sensor based on the expected glucose sensitivity (Figs 7,9,10) ([0048-0078]).
For claim 2, Ajemba discloses the system of claim 1, wherein the real-time data includes electrical properties associated with the sensor (Figs 7,9,10) ([0048-0078]).
For claim 3, Ajemba discloses the system of claim 1, wherein the real-time data includes an Isig value (sensor current) and at least one of a Vcntr value or an EIS signature value (impedance measurement) (Figs 7,9,10) ([0048-0078]).
For claim 4, Ajemba discloses the system of claim 3, wherein estimating by the machine learning model the corrected glucose sensitivity includes estimating an Isig trend over time for the sensor (Figs 7,9,10) ([0048-0078]).
For claim 5, Ajemba discloses the system of claim 4, wherein the Isig trend over time is independent of any sensed glucose fluctuations (Figs 7,9,10) ([0048-0078]).
For claim 6, Ajemba discloses the system of claim 4, wherein a calibration ratio is a blood glucose value divided by Isig, and the instructions, when executed by the one or more processors, further causes performance of: stabilizing the calibration ratio based on correcting Isig using the estimated Isig trend over time and the EIS signature value (Figs 7,9,10) ([0048-0078]).
For claim 7, Ajemba discloses the system of claim 4, wherein the real-time data includes a portion that is based on a blood glucose value and a portion that is unrelated to the blood glucose value, and the instructions, when executed by the one or more processors, further causes performance of: determining, by the machine learning model, a portion of the real-time data that is unrelated to the blood glucose value (Figs 7,9,10) ([0048-0078]).
For claim 8, Ajemba discloses the system of claim 7, wherein the instructions, when executed by the one or more processors, further causes performance of: generating an adjusted Isig based on the determined portion of the real-time data that is unrelated to the blood glucose value (Figs 7,9,10) ([0048-0078]).
For claim 9, Ajemba discloses the system of claim 1, wherein when correcting the glucose sensitivity, the instructions, when executed by the one or more processors, further causes performance of: estimating by the machine learning model a calibration factor as a function of time based on the real-time data; and calibrating the real-time data at least in part based on the calibration factor (Figs 7,9,10) ([0048-0078]).
For claim 10, Ajemba discloses the system of claim 7, wherein the portion of the real-time data that is unrelated to the blood glucose value is based on a design configuration of the sensor (Figs 7,9,10) ([0048-0078]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for processing analyte signals to reduce sensor variability.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
