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 .
Response to Amendment
The amendments filed 12/23/2025 have been entered. Claims 1-2, 5-11, & 13-20 remain pending. Claims 1-2, 5-11, & 13-20 have been amended. Claims 3-4, & 12 have been cancelled.
Applicant’s amendments & arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 7 lines 16-23, & page 8 line 5 to page 9, filed 12/23/2025, with respect to 35 USC. 112(a), 35 USC 112(b), and prior art (35 USC 102/103) have been fully considered and are persuasive. The objections and rejections due to 35 USC 112(a), 112(b), & prior art(35 USC 102/103) of claims 1-20 have been withdrawn.
Response to Arguments
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 7 lines 5-15, filed 12/23/2025, with respect to rejections of claims 1-20 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The Applicant argues that:
“Applicant thanks Examiner for the indication of allowability of pending claims 4-8, 12, 14, and 17-20, stating that such claims would be allowable if rewritten in independent form including all limitations of the base claim and any intervening claims, and/or if further amended to overcome the pending 35 USC 101 and 35 USC 112 rejections.”
The Examiner respectfully responds:
Issue:
The Non-final office action filed 09/24/2025 in the “Allowable Subject Matter” section states:
“Claims 4-8, 12, 14, & 17-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and further amended to overcome the 35 U.S.C. § 101 and 35 U.S.C. § 112(a) & 35 U.S.C. §112(b) rejections.”
It is not the case that the office action filed 9/24/2025 said that the subject matter would be patentable if “and/or if further amended to overcome the pending 35 U.S.C. §101 and 35 U.S.C. §112 rejections”.
Rule:
See MPEP 2107(I): “The Guidelines do not alter the substantive requirements of 35 U.S.C. 101 and 35 U.S.C. 112, nor are they designed to obviate the examiner’s review of applications for compliance with all other statutory requirements for patentability.”
Analysis:
The MPEP indicates (the Non-final office action filed 9/24/2025 is in agreement with the MPEP) that the statutes of 35 U.S.C. §101, 35 U.S.C. §112, & prior art (35 U.S.C. §102 or 35 U.S.C. §103) must each individually be satisfied.
Conclusion:
The claims 4-8, 12, 14, & 17-20 could be rewritten in an allowable form to overcome prior art, but would need to be amended to take into consideration 35 U.S.C. §101, 35 U.S.C. §112(a), 35 U.S.C. §112(b) as well.
Note:
35 U.S.C. §101 issues remain, as shown below in the updated 35 U.S.C. §101 section.
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 7 line 24 to page 8 line 4, filed 12/23/2025, with respect to rejections of claims 1-20 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The Applicant argues that:
“claims 1,15, and 17 have been amended to include features not capable of being performed mentally and/or with pen and paper or in the human mind.”
The Examiner respectfully responds:
Rule:
See MPEP 2106.04(a)(2)(III)(C): “examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.”
See MPEP 2106.05(h): “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.”
See MPEP 2106.04(d)(I): “The Court found this failure to explain any specifics of how to use the claimed formula informative when deciding that the additional elements in the claim were insignificant post-solution activity and thus not meaningful enough to render the claim eligible.”
See MPEP 2106.04(a)(2)(III)(A): “In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include: a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,”
Analysis:
At least under the broadest reasonable interpretation
the limitations of:
“predefined artifacts are detected in the sensor signal; detecting the one or more predefined artifacts by examining a residual signal, the residual signal being a difference between the sensor signal received from the analyte sensor and the sensor signal after filtering the sensor signal using the Kalman filter”
Can be done in the human mind or are computations done in the technological environment of computers.
The limitations of:
“and displaying, on a display, a value corresponding to the analyte concentration in the host.”
Are not significantly more than extra solution activity (post-solution) and are directed towards conventional well known activity of displaying results of the judicial exception(s).
Conclusion:
The amendments to the claims are not sufficient to overcome the 35 U.S.C. §101 rejection(s). The Examiner recommends finding (from the initially filed specifications) a physical element or interaction with the physical environment which is not extra solution activity, nor a field of art limitation, nor generic conventional activity. Based on Fig. 1 and para 0052, Examiner suggest that subject matter relating to sensor system 8 with sensor electronics 12 and continuous analyte sensor 10 might have the potential to overcome 35 U.S.C. §101 if incorporated into the base claims (any such amendments would require further search and consideration depending on the form and content of the amendment(s))
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.
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Flow diagrams from MPEP 2106(III) & MPEP 2106.04(II)(A), respectively.
Claims 1-20 are rejected under 35 U.S.C. 101 because:
Claim 1:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
“filtering the sensor signal using a Kalman filter having process noise with a process covariance and measurement noise with a measurement covariance, wherein the filtering includes updating a value of at least one of the process covariance or the measurement covariance using a value of one or more parameters employed in a model of the Kalman filter, wherein the updating is performed when one or more predefined artifacts are detected in the sensor signal;”
“detecting the one or more predefined artifacts by examining a residual signal, the residual signal being a difference between the sensor signal received from the analyte sensor and the sensor signal after filtering the sensor signal using the Kalman filter”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
Analysis
Filtering (including Kalman filtering) consists of applying mathematical equations or algorithms to data such as values or parameters or signals.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The additional element(s)/limitation(s) of:
“receiving, from an analyte sensor, a sensor signal indicative of an analyte concentration in a host;”
“and outputting, from the Kalman filter, a filtered sensor signal representative of the analyte concentration in the host.”
“and displaying, on a display, a value corresponding to the analyte concentration of the host.”
Are extra solution activity.
Explanation:
Issue
The additional element(s)/limitation(s) are not sufficient to integrate the judicial exceptions into a practical application.
Rule
See MPEP 2106.05(g) “(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).”
and
see MPEP 2106.05(h) “As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use."
Analysis
“receiving” and “outputting” are necessarily implied by the judicial exception. If the system did not do both (pre-solution and post-solution activity, respectively) then there would not be a functional invention. Equivalently, an algorithm that acts on data requires data collection and without data output there is no purpose to the invention.
And
Recitation of “from an analyte sensor” does no more than link the invention to a field of use corresponding to at least the CPC symbol of A61B 5/14532. .{for measuring glucose, e.g. by tissue impedance measurement}.
Conclusion
Therefore, “receiving …” and “outputting …” are not significantly more than the judicial exception.
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The additional element(s)/limitation(s) as listed in Revised Step 2A Prong Two are well known conventional subject matter to one of ordinary skill in the art.
See MPEP 2106.07(a)(III) “A citation to a publication that demonstrates the well understood, routine, conventional nature of the additional element(s)”:
US 20200383643 A1 “Sensor Signal Processing with Kalman-based Calibration” (Singh) see Fig. 2 – 210 “Retrieve current from analyte sensor” & Fig. 1-110: “touch-screen display”
US 10765373 B2 “Real-time Denoising And Prediction For A Continuous Glucose Monitoring System” (Faccioli) see Abstract “The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element.” & Fig. 3-105: “mobile medical app” (is on a display)
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 2:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 2 additionally recites:
“wherein the one or more parameters used to update at least one of the process covariance and the measurement covariance includes values of at least two terms employed in the Kalman filter model.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
Analysis
“Parameters”, “covariance”, “term and a residual term” “Kalman filter model” are mathematical concepts.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 5:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 5 additionally recites:
“wherein the residual signal is a temporary residual signal that is a difference between the sensor signal received from the analyte sensor and the sensor signal after filtering the sensor signal using the filter before the at least one of the process covariance and the measurement covariance is updated.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 6:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 6 additionally recites:
“wherein the residual signal is a final residual signal that is a difference between the sensor signal received from the analyte sensor and the sensor signal after filtering the sensor signal using the filter after the at least one of the process covariance and the measurement covariance is updated.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 7:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 7 additionally recites:
“wherein one of the predefined artifacts is a residual bias reflecting that the residual signal has a consistently positive or negative value over one or more selected windows of time.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 8:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 7 and thereby from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 7 and thereby from claim 1.
Claim 8 additionally recites:
“wherein one of the predefined artifacts is a zero crossing of a final residual signal, the zero crossing of the final residual signal reflecting a number of times a value of the final residual signal undergoes a change in sign from positive to negative or negative to positive over one or more selected windows of time.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 9:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 9 additionally recites:
“further comprising undoing a previous update to the values of at least one of the process covariance and the measurement covariance upon detecting one or more specified artifacts in the sensor signal.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
This limitation(s) amounts to applying the judicial exception(s) to previously collected data (which was not significantly more than necessary data gathering).
The “detecting” “specified artifacts in the sensor signal” (of previously collected data) is not significantly more than further material directed towards the judicial exception abstract idea grouping of mathematical concepts. This would involve applying algorithms/calculations to data.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 10:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 10 additionally recites:
“wherein the one or more parameters used to update at least one of the process covariance and the measurement covariance includes a fault metric that is based on values of at least two terms employed in the Kalman filter.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
A “metric” “based on a value” “employed in the Kalman filter” is either a numerical value or an algorithm for comparing values. As such, these additional limitations are further directed towards the judicial exception abstract idea grouping of mathematical concepts
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 11:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 10 and thereby from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 10 and thereby from claim 1.
Claim 11 additionally recites:
“wherein the fault metric is a moving average of an instantaneous fault metric averaged over a specified number of measurement samples received from the analyte sensor.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
A “metric” is a numerical value based on math (averaging) applied to data (from extra solution activity). As such, these additional limitations are further directed towards the judicial exception abstract idea grouping of mathematical concepts
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 13:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 1.
Claim 13 additionally recites:
“further comprising retroactively determining from historical data at least one parameter for the Kalman filter.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
“Determining” from data a “Kalman filter” are mathematical/algorithmic concepts.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 14:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 13 and thereby from claim 1) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 13 and thereby from claim 1.
Claim 14 additionally recites:
“wherein the determining is performed using a residual bias and a zero crossing, the residual bias reflecting that a residual signal has a consistently positive or negative value over one or more selected windows of time and the zero crossing reflecting a number of times the residual signal undergoes a change in sign from positive to negative or negative to positive over one or more selected windows of time.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
The limitations regarding “bias”, “crossings”, “positive or negative value”, “number of times”, & “change in sign” are mathematical concepts applied to data.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 15:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
“filtering the sensor signal using a Kalman filter;”
“detecting one or more artifacts in the sensor signal by examining a residual signal, the residual signal being a difference between the sensor signal received from the analyte sensor and the sensor signal after filtering the sensor signal using the Kalman filter;”
“performing a corrective action upon detecting the one or more artifacts in the sensor signal, wherein the corrective action includes updating values of one or more of parameters employed in a model of the Kalman filter;”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
Analysis
“Filtering” (including Kalman filtering) consists of applying mathematical equations or algorithms to data such as values or parameters or signals.
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
The “corrective action” (based on para 0028) is “updating values” “ employed in the Kalman filter model”. Updating values and Kalman filters are math/algorithms.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The additional element(s)/limitation(s) of:
“receiving, from an analyte sensor, a sensor signal indicative of an analyte concentration in a host;”
“outputting, from the Kalman filter, a filtered sensor signal representative of the analyte concentration in the host.”
“and displaying, on a display, a value corresponding to the analyte concentration in the host.”
Are extra solution activity.
Explanation:
Issue
The additional element(s)/limitation(s) are not sufficient to integrate the judicial exceptions into a practical application.
Rule
See MPEP 2106.05(g) “(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).”
and
see MPEP 2106.05(h) “As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use."
Analysis
“receiving” and “outputting” are necessarily implied by the judicial exception. If the system did not do both (pre-solution and post-solution activity, respectively) then there would not be a functional invention. Equivalently, an algorithm that acts on data requires data collection and without data output there is no purpose to the invention.
And
Recitation of “from an analyte sensor” does no more than link the invention to a field of use corresponding to at least the CPC symbol of A61B 5/14532 .. {for measuring glucose, e.g. by tissue impedance measurement.
Conclusion
Therefore, “receiving …” and “outputting …” are not significantly more than the judicial exception.
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The additional element(s)/limitation(s) as listed in Revised Step 2A Prong Two are well known conventional subject matter to one of ordinary skill in the art.
See MPEP 2106.07(a)(III) “A citation to a publication that demonstrates the well understood, routine, conventional nature of the additional element(s)”:
US 20200383643 A1 “Sensor Signal Processing with Kalman-based Calibration” (Singh) see Fig. 2 – 210 “Retrieve current from analyte sensor” & Fig. 1-110 “touch-screen display”.
US 10765373 B2 “Real-time Denoising And Prediction For A Continuous Glucose Monitoring System” (Faccioli) see Abstract “The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element.” & Fig. 3-105 “mobile medical app” (is on a display)
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 16:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 15) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 15.
Claim 16 additionally recites:
“wherein the detecting the one or more artifacts in the sensor signal comprises examining one or more internal variables of the Kalman filter to detect the artifact, wherein the one or more internal variables include a fault metric.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
A “internal variables” which include “fault metric” is either a numerical value or an algorithm for comparing values. As such, these additional limitations are further directed towards the judicial exception abstract idea grouping of mathematical concepts
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 17:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
“filtering the sensor signal using a Kalman filter;”
“during the filtering, examining a residual signal to detect an artifact in the sensor signal, the residual signal comprising a difference between the sensor signal and an estimated filtered sensor signal generated by the Kalman filter;”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
Analysis
“Filtering” (including Kalman filtering) consists of applying mathematical equations or algorithms to data such as values or parameters or signals.
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
The “examining” a “signal” to detect an “artifact in the sensor signal” is to apply math/algorithms to data/signal in order to acquire data or an equation which fits the signal.
The “detecting” an “artifact” and “updating the estimated filtered senor signal” is to apply algorithms/math to data/artifact and returning data.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The additional element(s)/limitation(s) of:
“receiving, from an analyte sensor, a sensor signal indicative of an analyte concentration in a host;”
“and displaying, on a display, a value corresponding to the analyte concentration in the host.”
Are extra solution activity.
Explanation:
Issue
The additional element(s)/limitation(s) are not sufficient to integrate the judicial exceptions into a practical application.
Rule
See MPEP 2106.05(g) “(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).”
and
see MPEP 2106.05(h) “As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use."
Analysis
“receiving” and “outputting” are necessarily implied by the judicial exception. If the system did not do both (pre-solution and post-solution activity, respectively) then there would not be a functional invention. Equivalently, an algorithm that acts on data requires data collection and without data output there is no purpose to the invention.
And
Recitation of “from an analyte sensor” does no more than link the invention to a field of use.
Conclusion
Therefore, “receiving …” and “outputting …” are not significantly more than the judicial exception.
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The additional element(s)/limitation(s) as listed in Revised Step 2A Prong Two are well known conventional subject matter to one of ordinary skill in the art.
See MPEP 2106.07(a)(III) “A citation to a publication that demonstrates the well understood, routine, conventional nature of the additional element(s)”:
US 20200383643 A1 “Sensor Signal Processing with Kalman-based Calibration” (Singh) see Fig. 2 – 210 “Retrieve current from analyte sensor” & Fig. 1-110 “touch-screen display”.
US 10765373 B2 “Real-time Denoising And Prediction For A Continuous Glucose Monitoring System” (Faccioli) see Abstract “The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element.” & Fig. 3-105 “mobile medical app” (is on a display)
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 18:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 17) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 17.
Claim 18 additionally recites:
“wherein the artifact is detected based on a residual bias reflecting that the residual signal has a consistently positive or negative value over one or more time periods.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
The “consistently positive or negative value” is a statement about a mathematical relation and therefore directed towards a mathematical concept.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 19:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 17) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 17.
Claim 19 additionally recites:
“wherein the artifact is detected based on a zero crossing indicating a number of times the residual signal undergoes a change in sign over one or more time periods.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
The “zero crossing” is a statement about the mathematical values that the data is at times equal to.
The “number of times” is a mathematical value resulting from math.
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Claim 20:
Step
Analysis
Step 1:
“Is the claim to a process, machine, manufacture or composition of matter?”
Yes;
The claim is directed towards a “A method for monitoring an analyte concentration” (as inherited from claim 17) which is a process and one of the four statutory categories.
Revised Step 2A Prong One:
“Does the claim recite an abstract idea, law of nature, or natural phenomenon?”
Yes;
The claim recites:
The judicial exception(s) as inherited from claim 17.
Claim 20 additionally recites:
“wherein the artifact is detected by comparing the residual signal to a predefined threshold.”
Explanation:
Issue
The claim recites element(s)/limitation(s) which are directed towards the abstract idea grouping of “Mathematical Concepts”
Rule
See MPEP 2106.04(A)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
See MPEP 2106.03(I) : “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations”
Analysis
An ‘artifact’ in a signal or a ‘signal’ is either data (no physical or tangible form) and therefore not patentable subject matter or is a term in an equation which fits the signal and is thus a mathematical concept.
The “comparing” to a “threshold” is to determine a mathematical relationship to numerical value(s).
Conclusion:
Therefore the claim includes limitations directed towards the abstract idea grouping of ‘Mathematical Concepts’.
Revised Step 2A Prong Two:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No;
The claim does not recite additional element(s).
Step 2B:
“Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No;
The claim does not recite additional element(s).
Conclusion:
Therefore, “Claim is not eligible subject matter under 35 USC 101”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7931599 B2 "Method And Apparatus For Estimating A Physiological Parameter" (Baker) is relevant to the Applicant's disclosure, see Fig. 1 & Fig. 6.
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 MARTIN WALTER BRAUNLICH whose telephone number is (571)272-3178. The examiner can normally be reached Monday-Friday 7:30 am-5:00 pm.
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, Huy Phan can be reached at (571) 272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN WALTER BRAUNLICH/Examiner, Art Unit 2858
/HUY Q PHAN/Supervisory Patent Examiner, Art Unit 2858