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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed 05/11/2026 have been entered. Claims 1-2, 5-11, & 13-22 remain pending. Claims 1, 15, & 17 have been amended. Claims 3-4, &12 have been cancelled. Claims 21, & 22 are new.
Response to Arguments
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 7 lines 6 - 24, filed 05/11/2026, with respect to 35 U.S.C. § 101 rejections of claims 1-2, 5-11, and 13-20 have been fully considered but they are not persuasive.
Applicant argues that (page 7 lines 10-14):
“claims have been amended to clarify that the claimed Kalman filtering, artifact detection, and artifact-responsive updating ae not recited as disembodied mathematical operations. Rather, the independent claims now expressly require performance by sensor electronics connected with an analyte sensor while the filtered sensor signal is used to present analyte-concentration information regarding the host.”
Examiner respectfully responds:
Rule:
See MPEP 2106.05(f): “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer…. (warning against a § 101 analysis that turns on "the draftsman’s art")”
See MPEP 2106.05(I): “An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."
Analysis:
The claimed subject matter must include limitations which are not directed towards a judicial exception or which are not significantly more than ‘apply it’ with regard to the judicial exception(s). Recitation of elements which at least under the broadest reasonable interpretation are not significantly more than generic computing elements or conventional elements previously known in the art are not sufficient to incorporate a judicial exception into a patentable application. Elements such as “sensor electronics module”, “monitoring system”, “analyte sensor”, at least under the broadest reasonable interpretation are not significantly more than generic computer or generic computing elements or conventional subject matter. If recitation of generic or conventional subject matter could incorporate a judicial exception into a patentable application, then all judicial exceptions could be claimed simply by adding ‘and generic computing or conventional elements to perform the judicial exception’. A 101 analysis would then turn on the draftsman’s art. The inventive concept is entirely within the judicial exception(s).
Conclusion:
The amendments do not pass both step 2A prong two and step 2B of the 35 USC 101 analysis.
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 7 line 25 to page 8 line 22, filed 05/11/2026, with respect to 35 U.S.C. § 101 rejections of claims 1-2, 5-11, and 13-20 have been fully considered but they are not persuasive.
Applicant argues that (page 7 lines 25-26):
“The specification confirms that the amended claims are directed to a concrete technical application in continuous analyte monitoring.”
& (page 8 lines 20-22):
“Thus, the alleged mathematical operations are not claimed for their own sake. They are used as a part of a specific signal-processing scheme in a monitoring system to improve operation of the system during artifact/noise periods.”
Examiner respectfully responds:
Rule:
See MPEP 2173: “35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph requires that a patent application 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.”
Analysis:
There may be sufficient patentable subject matter within the specification for a claim(s) to overcome 35 USC 101, but that patentable subject matter must be within the claim(s) to adequately define the scope of the claim(s). The initially filed specifications can be used as a source for material to amend the claims so as to overcome rejections. One cannot claim a judicial exception(s) by having patentable subject matter in their specifications but not within the claims.
Additionally, “specific signal-processing scheme” without significantly more amounts to instructions to apply a judicial exception(s) to data.
Conclusion:
The scope of the claims is not significantly more than judicial exception(s) with either generic or conventional subject matter which would not be significantly more than stating ‘apply it’ with regard to the judicial exception(s).
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 8 line 20-30, filed 05/11/2026, with respect to 35 U.S.C. § 101 rejections of claims 1-2, 5-11, and 13-20 have been fully considered but they are not persuasive.
Applicant argues that (page 8 lines 22-24):
“This is precisely the type of claim integration recognized by MPEP 2106.04(d) and MPEP 2106.05(a), where a claim applies an alleged judicial exception in a manner that improves the functioning of a computer or technology or technical field.”
Examiner respectfully responds:
Rule:
See MPEP 2106.05(f): “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’".”
&
“(2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.”
See MPEP 2106.04(d)(1): “A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment,”
Analysis:
At least under the broadest reasonable interpretation, the amended limitations of “performed by a sensor electronics module of a continuous analyte monitoring system including a analyte sensor” are not significantly more than generic computing elements or a technological environment for applying the judicial exception(s). The newly added elements do not amount to more than generally linking the judicial exception(s) to the technological environment of generic computing elements or the environment of analyte sensors (at least CPC symbol A61B 5/14532 . . {for measuring glucose, e.g. by tissue impedance measurement}).
Conclusion:
At least under the broadest reasonable interpretation, the claim is a judicial exception with either generic or conventional elements which don’t amount to significantly more than ‘apply it’ with regard to the judicial exception.
Applicant’s arguments, see "Applicant Arguments/Remarks Made in an Amendment" page 9 line 1 to page 10 line 5, filed 05/11/2026, with respect to 35 U.S.C. § 101 rejections of claims 1-2, 5-11, and 13-20 have been fully considered but they are not persuasive.
Applicant argues that (page 9 lines 3-5):
“Even assuming, without conceding, that individual sensor retrieval and display components were known, that does not establish that the claimed ordered combination is well understood, routine, and conventional.”
& (page 9 lines 12-15):
“The claimed sensor electronics module receives an ongoing sensor-signed data stream from an analyte sensor, uses residual behavior to identify artifacts in that stream, changes Kalman-filter operation responsive to those artifacts, and outputs a filtered signal that allows presentation of analyte-concentration values on a display.”
Examiner respectfully responds:
Rule:
See MPEP 2106.04(d)(III): “The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application. Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.”
See MPEP 2106.05(h): “Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use.”
Analysis:
At least under the broadest reasonable interpretation, the amended limitations do not amount to significantly more than judicial exceptions with field of art limitations corresponding to generic computing elements or analyte sensors. Without significantly more, the combination does not suffice to incorporate the judicial exception(s) into a practical application. A combination of judicial exceptions (i.e. “recite another judicial exception”) is a judicial exception and field of art limitations are not sufficient to integrate a judicial exception into a practical application. Whether a judicial exceptions is well known or not does not affect whether that judicial exception is a judicial exception.
Conclusion:
The amended claim(s) is not significantly more than judicial exception(s) and field of art limitations, and so is not sufficient to incorporate the judicial exception(s) into a practical application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 1, 15, & 17.
Claim 17 refers to "disposed within" & "body of the host" for which there is no basis within the originally filed claims, specifications, or drawings..
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding “Description requirement and new matter situations”:
Claims 1-2, 5-11, & 13-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 lines 1-2, has been amended to read:
“performed by a sensor electronics module of a continuous analyte monitoring system including a analyte sensor”
Independent claim 15 lines 1-2, has been amended to read:
“method, performed by sensor electronics of an analyte monitoring system including an analyte sensor”
Independent claim 17 lines 1-2, has been amended to read:
“method, performed by sensor electronics of a continuous analyte monitoring system including an analyte sensor”
The Examiner was unable to find sufficient support for these amendments within the originally filed Specifications, Drawings, or Claims. In particular, no previous mention of a “system” was mentioned. It is unclear what the full scope of “a continuous analyte monitoring system” is; “system” could potentially include elements which were not previously disclosed besides the “analyte sensor”.
Additionally, Independent claim 17 lines 5-6, has been amended to read:
“host, wherein the analyte sensor is a transcutaneous sensor configured to be at least partially disposed within a body of the host”
The Examiner was unable to find sufficient support for these amendments within the originally filed Specifications, Drawings, or Claims. It is unclear what the full scope of “disposed within a body of the host” is; this could mean that the sensor includes a needle drawing blood from the patient, or that there is device surgically implanted, or that the device is swallowed, or etc.
Regarding ‘rejected for inheriting the rejected limitation(s) of a parent claim without rectifying the issue(s) for which the parent claim(s) was rejected’:
Claims 2, 5-11, 13-14, & 21-22 and 16 and 18-20 are rejected for their dependence on a rejected base claim without rectifying the issue(s) for which the base claim(s) was rejected.
Note:
Applicant should state in their arguments where in the originally filed specifications support for the amendments can be found.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding “Failure to particularly point out & distinctly claim [indefinite]”
Claim 21 in lines 1-3 recites the limitation "the analyte sensor is configured to produce measurements substantially continuously such that the sensor signal is received at intervals of time". ‘continuously’ means not ‘received at intervals of time’; it is not clear how it can be continuous and at intervals.
Regarding “relative term-term of degree”:
The term “substantially” in claim 21 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
“continuously” is rendered indefinite because it is not clear what ‘substantially’ is intended to imply about ‘continuously’; in particular, it is seems to be a contradiction with ‘at intervals of time’.
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.”
See MPEP 2106.05(I): “An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."
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 using the filtered sensor signal.”
Are extra solution activity.
The amended limitation of:
“performed by a sensor electronics module of a continuous analyte monitoring system including a analyte sensor”
Is not significantly more than field of art limitations corresponding to a computer environment or analyte sensors (corresponding to at least CPC symbol A61B 5/14532 . . {for measuring glucose, e.g. by tissue impedance measurement})
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, by the sensor electronics, the sensor signal using a Kalman filter;”
“detecting, by the sensor electronics, 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, by the sensor electronics, 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, by the sensor electronics and from the analyte sensor, a sensor signal indicative of an analyte concentration in a host, wherein the sensor electronics are configured to receive measurements from the analyte sensor at predetermined intervals of time;”
“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 based on the filtered sensor signal.”
Are extra solution activity.
The amended limitations of:
“performed by sensor electronics of an analyte monitoring system including an analyte sensor”
Is not significantly more than field of art limitations corresponding to a computer environment or analyte sensors (corresponding to at least CPC symbol A61B 5/14532 . . {for measuring glucose, e.g. by tissue impedance measurement})
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, performed by sensor electronics of a continuous analyte monitoring system including an analyte sensor, 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, by the sensor electronics, the sensor signal using a Kalman filter;”
“during the filtering, examining, by the sensor electronics, 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, by the sensor electronics and from the analyte sensor, a sensor signal indicative of an analyte concentration in a host, wherein the analyte sensor is a transcutaneous sensor configured to be at least partially disposed within a body of the host;”
“and displaying, on a display, a value corresponding to the analyte concentration in the host, using the updated estimated filtered sensor signal, wherein the updated estimated filtered sensor signal allows data to be presented on the display during more periods than if the estimated filtered sensor signal had not been updated.”
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)
Regarding the amended limitation of:
“wherein the analyte sensor is a transcutaneous sensor configured to be at least partially disposed within a body of the host”
The reference of US 20200383643 A1(Singh) teaches this limitation in the Abstract: “from an analyte sensor placed interstitially in tissue of the subject”.
The reference of US 10765373 B2 (Faccioli) teaches this limitation in Fig. 3-100: “sensor (subcutaneous)”
Establishing that the amended limitation is conventional.
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”
Claim 21:
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.
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).
Claim 21 recites the additional limitation of:
“wherein the analyte sensor is configured to produce measurements substantially continuously such that the sensor signal is received at intervals of time.”
Explanation:
This limitation does not amount to significantly more than necessary extra solution activity in the form of data gathering. If the system didn’t collect data either continuously or at intervals of time then the judicial exception would not have data as necessary input.
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 22:
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 21 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 21 and thereby from claim 1.
Claim 22 additionally recites the limitation of:
“wherein the filtered sensor signal allows data to be continuously presented on the display”
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
“filtered sensor signal” is applying mathematical operations to transitory 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).
Note: the element of a “display” was addressed in the parent claim 1 as extra solution (post solution) activity.
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 20110160555 A1 "Universal Models For Predicting Glucose Concentration In Humans" (Reifman) is relevant to the Applicant's disclosure, see Figs. 1 & Figs. 2.
US 11087868 B2 "Methods, Devices And Systems For Analyte Monitoring Management" (Budiman) is relevant to the Applicant's disclosure, see Fig. 1 & Fig. 3.
US 10881334 B2 "Accuracy Continuous Glucose Monitoring Method, System, And Device" (Facchinetti) is relevant to the Applicant's disclosure, see Fig. 5 & Fig. 6.
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.
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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
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