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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/16/2024 and 06/10/2025 were considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
Paragraphs [0072]-[0073] recite a comparative average value calculation unit 136. However, Fig. 4 depicts a comparative average value calculation unit 139. The Examiner suggests amending Fig. 4 such that the reference number 136 is associated with the comparative average value calculation unit.
Paragraph [0074] recites an offset calculation unit 139. However, Fig. 4 depicts an offset calculation unit 136. The Examiner suggests amending Fig. 4 such that the reference number 139 is associated with the offset calculation unit.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-14 is objected to because of the following informalities:
Claim 1, line 2: “body that measures” should be replaced with –body, wherein the sensor measures–;
Claims 2-14: in the preambles, “a calibration” should be replaced with –the calibration–;
Claims 9 and 12: “wherein, whether the sensor is stabilized is determined based” should be replaced with –wherein determining whether the sensor is stabilized is further based”.
Appropriate correction is required.
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.
No limitations were interpreted under 35 U.S.C. §112(f).
Claim Rejections - 35 USC § 112
Claims 1-14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As indicated in MPEP 2161.01, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the algorithm, steps, or procedure for performing the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. In other words, the algorithm, steps, or procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Claim 1 recites “generating a calibrated biometric value by applying the biosignal to the calibration factor” in lines 8-9. However, the specification is completely silent on how the biosignal is applied to the calibration factor to generate a calibrated biometric value. Specifically, there is no recitation of any algorithms, steps, or procedure for performing the above functional language. At most, the specification repeats the functional language without describing how to arrive at the calibrated biometric value. Therefore, the algorithm, steps, or procedure taken to perform the function is not described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.
Claims 2-14 are rejected by virtue of their dependence from claim 1.
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 1-14 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 recites “compensating a calibration factor” in line 1. The plain and ordinary meaning of the recitation is counterbalancing or counteracting a calibration factor. However, the claim does not include any steps for compensating, counterbalancing, or counteracting the calibration factor, which makes it unclear how the compensation is performed. The claim includes “determining the calibration factor using the offset” in line 8, but the determination does not amount to compensating the calibration factor.
Claim 1 recites “obtaining an offset from a difference between a comparison average value up to a point in time at which a reference biometric value is input and the reference average value” in lines 5-6. It is unclear how the offset is obtained from a difference. The recitation indicates that additional manipulation of the difference is required to obtain the offset. However, the specification indicates that the offset is the difference in at least Fig. 7 and ¶ [0089] of the applicant’s specification. The specification is completely silent regarding any additional manipulation for obtaining the offset. Therefore, it is unclear whether the offset is the difference or obtained from the difference. For the purposes of examination, the recitation will be interpreted to be “obtaining an offset, wherein the offset is
Claim 1 recites “a comparison average value up to a point in time at which a reference biometric value is input” in lines 5-6, which is indefinite. Does the recitation mean that (A) the comparison average value is at the point in time or (B) there are a plurality of comparison average values determined continuously up to the point in time? If the latter interpretation (B) is intended, it is unclear which of the plurality of comparison average values is used for calculating the difference. The specification does not provide clarification. For the purposes of examination, the comparison average value will be interpreted to be at a point in time at which the reference biometric value is input.
Claim 1 recites “generating a calibrated biometric value by applying the biosignal to the calibration factor” in lines 8-9. It is unclear how the calibrated biometric value is generated by applying the biosignal to the calibration factor. The specification does not clarification because it does not recite any algorithms or formulas for performing the above function. Additionally, there is no evidence that one of ordinary skill in the art would understand how the application and generation would occur using the calibration factor.
Claims 2-14 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “obtaining the reference average value from the first point in time to the second point in time based on the extracted biosignals” in lines 5-6, which is indefinite. Does the recitation mean that (A) the reference average value is based on the first point in time and the second point in time or (B) there are a plurality of reference average values determined from the first point in time to the second point in time? If the latter interpretation (B) is intended, then it is unclear which of the plurality of reference average values corresponds to the obtained single value. The specification does not clarification.
Claim 5 recites “wherein the obtaining the reference average value calculates the reference average value from the first point in time to the second point in time” in line 5. The recitation is so grammatically awkward that the meaning is unclear. How are “the obtaining and “calculates” are related to each other? What is calculating the reference average value? Are there a plurality of reference average values calculated with the different time points beginning at the first point in time until the second point in time? Clarification is required. Claim 6 recites a similar recitation in lines 5-6, so it is rejected on similar grounds.
Claim 6 recites “the second point in time at which the sensor is determined to not be stabilized” in line 4. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a second point in time at which the sensor is determined to not be stabilized.
Claim 6 recites “a point in time at which the sensor is stabilized, when the sensor is determined to be stabilized? In lines 6-7, which is indefinite. The grammatical structure makes it unclear how is the recitation of “when the sensor is determined to be stabilized” related to the previously recited limitations? Additionally, the recitation of “when the sensor is determined to be stabilized” appears to be redundant. The Examiner suggests deleting the recitation of “when the sensor is determined to be stabilized”.
Claim 6 recites “calculates the reference average value based on the biometric information from the first point in time to a point in time at which the sensor is stabilized” in lines 5-7. Claim 5 recites “calculates the reference average value from the first point in time to the second point in time” in lines 5-6. Claim 5 indicates that there is one calculation of the reference average value based on first parameters, and claim 6 indicates that there is another calculation of the reference average value based on second parameters. It is unclear whether (A) the reference average value is based on both calculations or (B) the reference average value is based on only one of the two calculations. Clarification is required.
Claim 8 recites “the comparative average value” in line 2. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a comparative average value. For the purposes of examination, the recitation will be “the comparison average value”.
Claim 8 recites “a comparative average value” in line 5. Claim 1 recites “a comparison average value” in line 5. It is unclear if these values are the same as, related to, or different from each other. The specification appears to use the terms interchangeably, which suggests that they values are the same. However, the different terminology suggests that they are different. For the purposes of examination, the recitation in claim 8 will be interpreted to be “the comparison average value”.
Claims 13 and 14 recite “whether the sensor is stabilized is determined” in line 2, which appears to refer the previous determination of stabilization. However, there is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a determination of stabilization. The Examiner suggests replacing “wherein, whether the sensor is stabilized is determined” with –further comprising determining whether the sensor is stabilized–.
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 1-14 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. Claims 1-14 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a process, which is a statutory category.
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. Additionally or alternatively, claim 1 is directed to an abstract idea in the form of mathematical algorithms and/or formulas.
In particular, claim 1 recites the following limitations:
[A1]: obtaining a reference average value from the biosignal;
[B1]: obtaining an offset from a difference between a comparison average value up to a point in time at which a reference biometric value is input and the reference average value based on that the reference biometric value for calibrating the biosignal is input;
[C1]: and determining the calibration factor using the offset, and generating a calibrated biometric value by applying the biosignal to the calibration factor.
These elements [A1]-[C1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of reading a printout of blood glucose signals, determining a first average value of the blood glucose between a time of insertion and a time of stabilization, determining a second average value between the time of insertion and a time of calibration, determining an offset between the first average value and the second average value based on an input of a reference blood glucose value, calculating a calibration factor, and calculating a calibrated blood glucose value by applying the blood glucose signals to the calibration factor. Additionally or alternatively, the elements [A1]-[C1] are directed to an abstract idea because they are mathematical algorithms and/or formulas. See at least ¶ [0075]-[0078] with regards to the mathematical nature of [A1]-[C1].
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional element:
[A2]: receiving a biosignal from a sensor inserted into a body that measures biometric information of a user.
The element [A2] does not integrate the exception into a practical application of the exception.
The element [A2] does not integrate the exception into a practical application of the exception because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional element:
[A2]: receiving a biosignal from a sensor inserted into a body that measures biometric information of a user.
The element [A2] does not amount to significantly more than the judicial exception itself.
Simply reciting the elements [A2] not qualify as significantly more because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. US 2022/0361778 A1 (Jepson) teaches conventional glucose sensor systems for producing glucose measurements in which a sensor is inserted into the user’s body (¶ [0023]).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-14 depend from claim 1, and they recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) except for the following limitations.
Claim 2 recites “extracting biosignals received from a first point in time to a second point in time after the sensor is inserted into the body”. However ,the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. as is evidenced by US 2022/0361778 A1 (Jepson) teaches conventional systems include a warm up time during which glucose measurements are produced between an insertion time and a stabilization time (¶ [0023]).
Claim 11 recites “the biosignal is a blood sugar signal of the user”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amounts to (A) merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g), or (B) generally linking the use of a judicial exception to a particular technological environment or field of use- see MPEP 2106.04(d); MPEP § 2106.05(h) Additionally, the element is well-understood, routine, and conventional. See ¶ [0023] of US 2022/0361778 A1 (Jepson).
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8, 10, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0071512 A1 (Garcia).
With regards to claim 1, Garcia teaches a method of compensating a calibration factor (Fig. 24 and ¶¶ [0259]-[0264] depict a method for updating a sensitivity (i.e., a calibration factor)), comprising: receiving a biosignal from a sensor inserted into a body that measures biometric information of a user (Fig. 24 and ¶ [0260] depict measuring values of an analyte concentration by a sensor; ¶ [0138] discloses that the continuous analyte sensor may be implanted as at least one of the following types of sensors: an implantable glucose sensor, a transcutaneous glucose sensor, implanted in a host vessel or extracorporeally, a subcutaneous sensor, a refillable subcutaneous sensor, an intravascular sensor); obtaining a reference average value from the biosignal (¶ [0260] discloses determining a first slow moving average over a first period of time at step 254); obtaining an offset from a difference between a comparison average value up to a point in time at which a reference biometric value is input and the reference average value (In view of the indefiniteness of “a comparison average value up to a point in time at which a reference biometric value is input”, the recitation is being interpreted to be “a comparison average value at a point in time at which a reference biometric value is input”. ¶ [0263] discloses, at step 268, determining a difference (i.e., an offset) between the first slow moving average and a second slow moving average determined over a second period of time at step 258, wherein the second period of time includes a plurality of input analyte concentration values, an average of which is used as a reference for determining sensitivity change); based on that the reference biometric value for calibrating the biosignal is input (¶ [0263] and Fig. 24 depict a second slow moving average determined over a second period of time at step 258, wherein the second period of time includes a plurality of input analyte concentration values, an average of which is used as a reference for determining sensitivity change); and determining the calibration factor using the offset (¶ [0263] discloses correcting a sensitivity based on the difference).
The above embodiment of Garcia is silent regarding generating a calibrated biometric value by applying the biosignal to the calibration factor.
In a similar embodiment, Garcia teaches generating a calibrated biometric value by applying the biosignal to the calibration factor (¶ [0250] and Fig. 23A depict updating values of an analyte concentration based on the change in sensitivity). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 24 of Garcia to incorporate generating a calibrated biometric value by applying the biosignal to the calibration factor as taught by the embodiment of Fig. 23A of Garcia. The motivation would have been to apply the adjusted sensitivity to the biosignal, thereby providing a more accurate diagnostic picture of the biosignal.
With regards to claim 2, the above combination teaches or suggests obtaining the reference average value includes: extracting biosignals received from a first point in time to a second point in time after the sensor is inserted into the body; and obtaining the reference average value from the first point in time to the second point in time based on the extracted biosignals (¶ [0260] of Garcia discloses determining a first slow moving average over a first period of time at step 254).
With regards to claim 3, the above combination teaches or suggests the second point in time is after a sensor stabilization time has elapsed based on the first point in time (¶ [0260] of Garcia discloses the slow moving average is defined by measuring the counts over a long period of time, such as over several hours, a half day, 24 hours, or 2-3 days).
With regards to claim 4, the above combination is silent with regards to whether the sensor stabilization time is preset.
In a related embodiment, Garcia teaches a sensor stabilization time is preset (¶ [0232] discloses a steady state is determined according to a predetermined period of time). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor stabilization time of Garcia such that it is preset as taught by ¶ [0232] of Garcia. The motivation would have been to ensure that the slow moving average is representative of a steady-state.
With regards to claim 8, the above combination teaches or suggests the obtaining the comparative average value includes: extracting biosignals received from a first point in time after the sensor is inserted into the body to a point in time at which a reference blood glucose value is input (Fig. 24 and ¶ [0262] of Garcia discloses a second slow moving average determined over a second period of time at step 258, wherein the second period of time corresponds to a plurality of input analyte concentration values which includes a value at a first point in time after the sensor is inserted and a final reference input value); and obtaining a comparative average value from the extracted biosignals (Fig. 24 and ¶ [0262] of Garcia depict determining the second slow moving average based on the analyte values).
With regards to claim 10, the above combination teaches or suggests obtaining a sensor sensitivity from the reference biometric value and the biosignal; and applying the offset to the sensor sensitivity (¶ [0262] of Garcia discloses determining a second sensitivity based on the second slow moving average, wherein the second slow moving average includes the input reference analyte values and the biosignal, ¶ [0263] of Garcia discloses the sensitivity may be adjusted based at least in part on the difference between the two slow moving averages).
With regards to claim 11, the above combination teaches or suggests the biosignal is a blood sugar signal of the user (¶ [0260] of Garcia discloses the analyte concentration is measured by the sensor; ¶ [0138] of Garcia discloses that the continuous analyte sensor may be implanted as at least one of the following types of sensors: an implantable glucose sensor, a transcutaneous glucose sensor, implanted in a host vessel or extracorporeally, a subcutaneous sensor, a refillable subcutaneous sensor, an intravascular sensor).
With regards to claim 14, the above combination is silent regarding whether the sensor is stabilized is determined based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation.
In an embodiment for determining a stable glucose period, Garcia teaches calculating a stable or stead-state period based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation (¶ [0235] discloses determining a stable or stead-state using an absolute rate of change threshold may be set at 0.25 or 0.5 mg/dL/minute over the last 25 minutes of glucose data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the stable period of the above combination to incorporate that it is based on at least one of a rate of change of the biosignal as taught by Garcia. The motivation would have been to provide an objective method for determining stabilization, thereby improving the accuracy of the determination.
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0071512 A1 (Garcia), as applied to claim 4 above, and in view of US 2012/0123234 A1 (Atlas).
With regards to claim 5, the above combination is silent regarding whether the obtaining the reference average value further includes: determining whether the sensor is stabilized based on the biosignals at the second point in time, wherein the obtaining the reference average value calculates the reference average value from the first point in time to the second point in time based on the biosignals when the sensor is determined to be stabilized.
In a system relevant to the problem of monitoring glucose levels, Atlas teaches determining whether the sensor is stabilized based on the biosignals at the second point in time (¶ [0340] discloses a stable glucose is determined as +/-10 mg/dl for a period of at least 30 minutes), wherein the obtaining the reference average value calculates the reference average value from the first point in time to the second point in time based on the biosignals when the sensor is determined to be stabilized (¶ [0340] discloses determining the glucose level at the stable state). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the obtaining of the reference average value of the above combination to incorporate determining whether the sensor is stabilized based on the biosignals at the second point in time, wherein the obtaining the reference average value calculates the reference average value from the first point in time to the second point in time based on the biosignals when the sensor is determined to be stabilized as taught by Atlas. The motivation would have been to improve the determination of the average and sensitivity by ensuring that the glucose level is stable.
With regards to claim 9, the above combination is silent regarding whether the sensor is stabilized is determined based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation.
In an embodiment for determining a stable glucose period, Garcia teaches calculating a stable or stead-state period based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation (¶ [0235] discloses determining a stable or stead-state using an absolute rate of change threshold may be set at 0.25 or 0.5 mg/dL/minute over the last 25 minutes of glucose data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the stable period of the above combination to incorporate that it is based on at least one of a rate of change of the biosignal as taught by Garcia. Because both the parameters of Atlas and Garcia are capable of being used for determining stable periods of glucose data, It would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0071512 A1 (Garcia) in view of US 2012/0123234 A1 (Atlas), as applied to claim 5 above, and further in view of US 2013/0267809 A1 (Brister).
With regards to claim 6, the above combination teaches or suggests determining whether the sensor is stabilized based on the biosignals received from the sensor at the second point (¶ [0340] of Atlas discloses a stable glucose is determined as +/-10 mg/dl for a period of at least 30 minutes), wherein the obtaining the reference average value calculates the reference average value based on the biometric information from the first point in time to a point in time at which the sensor is stabilized (¶ [0340] of Atlas discloses determining the glucose level at the stable state).
The above combination is silent regarding determining whether the sensor is stabilized based on the biosignals received from the sensor after the second point in time at which the sensor is determined to not be stabilized.
In a system relevant to the problem of detecting stable glucose measurements, Brister teaches determining whether the sensor is stabilized based on the biosignals received from the sensor after a point in time when the sensor is determined to not be stabilized (¶ [0556] discloses that a system evaluates stability by monitoring the frequency content of the sensor data stream over a predetermined amount of time (e.g., 24 hours), and if the stability is determined to be insufficient, additional sensor data can be repeatedly taken at predetermined intervals until a sufficient degree of stability is achieved). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of stability of the above combination to incorporate determining whether the sensor is stabilized based on the biosignals received from the sensor after the second point in time at which the sensor is determined to not be stabilized, as taught by Brister. The motivation would have been to improve the accuracy of the calibration adjustment by ensuring that the reference average is taken while the glucose is stable.
With regards to claim 12, the above combination is silent regarding whether the sensor is stabilized is determined based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation.
In an embodiment for determining a stable glucose period, Garcia teaches calculating a stable or stead-state period based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation (¶ [0235] discloses determining a stable or stead-state using an absolute rate of change threshold may be set at 0.25 or 0.5 mg/dL/minute over the last 25 minutes of glucose data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the stable period of the above combination to incorporate that it is based on at least one of a rate of change of the biosignal as taught by Garcia. Because both the parameters of Atlas and Garcia are capable of being used for determining stable periods of glucose data, It would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0071512 A1 (Garcia), as applied to claim 3 above, and in view of US 2013/0267809 A1 (Brister).
With regards to claim 7, the above combination is silent regarding whether
the sensor stabilization time varies depending on whether the sensor is stabilized.
In a system relevant to the problem of detecting stable glucose measurements, Brister teaches a sensor stabilization time varies depending on whether the sensor is stabilized (¶ [0556] discloses that a system evaluates stability by monitoring the frequency content of the sensor data stream over a predetermined amount of time (e.g., 24 hours), and if the stability is determined to be insufficient, additional sensor data can be repeatedly taken at predetermined intervals until a sufficient degree of stability is achieved, which indicates that the sensor stabilization time extends based on the stability). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of stability of the above combination to incorporate that the sensor stabilization time varies depending on whether the sensor is stabilized, as taught by Brister. The motivation would have been to improve the accuracy of the calibration adjustment by ensuring that the reference average is taken while the glucose is stable.
With regards to claim 13, the above combination is silent regarding whether the sensor is stabilized is determined based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation.
In an embodiment for determining a stable glucose period, Garcia teaches calculating a stable or stead-state period based on at least one of a rate of change of the biosignal, a difference between the reference biometric value and the biosignal, a rate of change of sensor sensitivity, and a coefficient of variation (¶ [0235] discloses determining a stable or stead-state using an absolute rate of change threshold may be set at 0.25 or 0.5 mg/dL/minute over the last 25 minutes of glucose data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the stable period of the above combination to incorporate that it is based on at least one of a rate of change of the biosignal as taught by Garcia. The motivation would have been to provide an objective method for determining stabilization, thereby improving the accuracy of the determination.
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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