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 .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final Office Action having a notification date of May 4, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on July 23, 2026 (the “Amendment”), amending claims 1, 6, 13, and 16-20 and canceling claim 15.
The present Final Office Action addresses pending claims 1-14 and 16-20 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Interpretation Under 35 USC §112(f)
These interpretations are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112(a) and (b)
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
Starting on page 8 of the Amendment, Applicant takes the position that "The claimed system for potassium measurement comprising a chemical sensor and a cardiac sensor is clearly a physical system that uses physical sensor devices to output electrical signals that are processed by the controller to generate the output of the controller, which is also (implicitly) an electrical signal. Processing of electrical signals is not an activity that could practically be performed in the human mind." While the Examiner agrees that use of sensors to generate (electrical) signals and a controller coupled to the sensors to process the signals are not mentally-performable activities, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the at least one abstract idea (i.e., mentally analyzing data output from one sensor to compensate for measurement error in data output from another sensor) (see MPEP § 2106.05(f)). Furthermore, using sensors to output signals indicative of potassium level estimates for use in generating an output merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (i.e., because all uses of the recited judicial exception (i.e., mentally analyzing data output from one sensor to compensate for measurement error in data output from another sensor) require such data gathering - see MPEP § 2106.05(g)).
Furthermore, the Examiner directs Applicant's attention to at least [0036]-[0037] and [0053]-[0061] of the present specification which discusses how the present application is directed to a system/method for "measuring potassium levels through the fusion of data from a chemical sensor and a cardiac sensor" ([0037]) to "[provide] a comprehensive, cohesive and more confident representation of the monitored system or environment" ([0053]) and "result in a more accurate and robust system" ([0059]). In other words, the focus of the application is on the fusing of data from multiple sources (mental-process abstract idea) while the physical sensors, electrical signals, and controller are just using a computer or other machinery as tools performing their typical functionality in conjunction with performing the mental-process abstract idea (see MPEP § 2106.05(f)) and/or merely add insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (i.e., because all uses of the recited judicial exception require such data gathering - see MPEP § 2106.05(g)).
Applicant then asserts how the claimed system addresses the technical problems associated with pseudohyperkalemia by fusing chemical sensor measurement signals with cardiac sensor measurement signals to achieve a technical improvement in the accuracy of potassium level measurements. However, fusing chemical and cardiac sensor output/data/information to improve the accuracy of potassium level measurements literally defines the mental-process abstract idea as repeatedly disclosed herein which cannot provide a "technical" improvement/practical application of itself (MPEP §2106.05(a)(II)). Furthermore, analyzing/fusing actual electrical signals (rather than the underlying data therein) just amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the mental-process abstract idea (see MPEP § 2106.05(f)).
Near the bottom of page 8 of the Amendment, Applicant then takes the position that the newly added limitations allegedly provide "significantly more" than the abstract idea because they clarify that the controller performs a sensor fusion operation on the (electrical) signals output by the chemical sensor and the cardiac sensor which is not performable in the human mind and that the sensor fusion operation is used to compensate for measurement error of the chemical sensor which introduces a clear additional technical benefit.
Again, while the Examiner agrees that the human mind cannot literally receive/process electrical signals, the human mind can literally use cardiac sensor output/data/information (which is necessarily included in the electrical signal from the cardiac sensor) to compensate for measurement error in chemical sensor output/data/information (which is necessarily included in the electrical signal from the chemical sensor). Furthermore, using the mentally-performable fusion operation (the abstract idea) to compensate for measurement error of the chemical sensor cannot provide a "technical benefit" of or "significantly more" than itself as noted above.
The 35 USC 101 rejection is maintained.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §102/103
At page 11 of the Amendment, Applicant takes the position that assessing the physiological significance of hyperkalemia using a combination of ECG data and CPM measurements per [0225] of Johnson does not provide an indication of potassium and that hyperkalemia "is [not] an indication of the potassium level of a user." However, [0002] of Applicant's specification discloses how hyperkalemia is "an elevated potassium level" which directly contradicts Applicant's current assertion that hyperkalemia is not an indication of a potassium level of a user.
Applicant's remaining arguments are moot in view of the new grounds of rejection as necessitated by the Amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-14, 16, and 17 are directed to a system (i.e., a machine), claim 18 is directed to an integrated circuit (i.e., a machine), claim 19 is directed to a method (i.e., a process), and claim 20 is directed to a system (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A system for potassium measurement comprising:
a chemical sensor configured to output a chemical sensor output signal indicative of a first estimate of a potassium level of a user of the system;
a cardiac sensor configured to output a cardiac sensor output signal indicative of a second estimate of the potassium level of the user; and
a controller coupled to the chemical sensor and the cardiac sensor, wherein the controller is configured to generate an output indicative of the potassium level of the user based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor.
The Examiner submits that the foregoing underlined limitations recite “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance, a medical professional could readily use a cardiac sensor output to compensate for measurement error of the chemical sensor (e.g., relying more on the cardiac sensor output than the chemical sensor output during times of rapid change, etc.). These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 13-14 and 16-17 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) because they call for generating an estimate of a current/future potassium level of the user based on the cardiac and/or chemical sensor output signals which is practically performable in the human mind with pen and paper.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system for potassium measurement comprising:
a chemical sensor configured to output a chemical sensor output signal indicative of a first estimate of a potassium level of a user of the system;
a cardiac sensor configured to output a cardiac sensor output signal indicative of a second estimate of the potassium level of the user; and
a controller coupled to the chemical sensor and the cardiac sensor, wherein the controller is configured to generate an output indicative of the potassium level of the user based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the system including the sensors generating signals and controller (including the "integrated circuit" of claim 18), the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). Furthermore, using sensors to output signals indicative of potassium level estimates for use in generating an output merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (i.e., because all uses of the recited judicial exception require such data gathering - see MPEP § 2106.05(g)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claims 18-20 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 1 and analogous independent claims 18-20 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claims 2-8 recite various alternative details of the chemical sensor (e.g., includes an ISE sensor, potentiometric sensor, wearable sensor, sampling venous blood/fingerprick, aptamer-based sensor) or the cardiac sensor (e.g., ECG, PPG sensor) and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
-Claim 9 recites how the system includes an "output transducer subsystem" which could be a display, etc. and thus amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 10 recites how the output transducer subsystem comprises one or more of: an audio output transducer; a haptic output transducer; and a visual indicator and thus does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
-Claim 11 further calls for a communications subsystem configured to communicate data and/or alerts from the system to an external device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 12 calls for an output transducer subsystem and a communications subsystem, wherein the controller is configured to generate an output signal for one or more of output transducer subsystem and the communications subsystem based on the output indicative of the potassium level, all of which just amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claims 13-14 call for a "predictor" including a NN/AI/ML processor to perform the (mentally-performable) generation of the estimate of the current and/or future potassium level of the user based on the cardiac and/or chemical sensor output signal (where the NN/AI/ML processor is generically trained on a relationship between potassium levels and cardiac data per claims 16-17) which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), p. 12. “[T]he way machine learning works is the inputs are defined, the model is trained, and then the algorithm is actually updated and improved over time based on the input.” Id.
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the system including the sensors generating signals and controller (including the "integrated circuit" of claim 18), the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)). Furthermore, using sensors to output signals indicative of potassium level estimates for use in generating an output merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (i.e., because all uses of the recited judicial exception require such data gathering - see MPEP § 2106.05(g)). Moreover, the Examiner has reevaluated the output of the first and second potassium estimations from the sensors and determined such limitations to not be unconventional as they merely consist of generically determining the level of a biomarker in blood (Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 79, 101 (2012)) and receiving/transmitting data over a network (See Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1321, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); See MPEP 2106.05(d)(II)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claims 2-8 recite various alternative details of the chemical sensor (e.g., includes an ISE sensor, potentiometric sensor, wearable sensor, sampling venous blood/fingerprick, aptamer-based sensor) or the cardiac sensor (e.g., ECG, PPG sensor) and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
-Claim 9 recites how the system includes an "output transducer subsystem" which could be a display, etc. and thus amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 10 recites how the output transducer subsystem comprises one or more of: an audio output transducer; a haptic output transducer; and a visual indicator and thus does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
-Claim 11 further calls for a communications subsystem configured to communicate data and/or alerts from the system to an external device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 12 calls for an output transducer subsystem and a communications subsystem, wherein the controller is configured to generate an output signal for one or more of output transducer subsystem and the communications subsystem based on the output indicative of the potassium level, all of which just amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claims 13-14 call for a "predictor" including a NN/AI/ML processor to perform the (mentally-performable) generation of the estimate of the current and/or future potassium level of the user based on the cardiac and/or chemical sensor output signal (where the NN/AI/ML processor is generically trained on a relationship between potassium levels and cardiac data per claims 16-17) which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), p. 12. “[T]he way machine learning works is the inputs are defined, the model is trained, and then the algorithm is actually updated and improved over time based on the input.” Id.
Therefore, claims 1-14 and 16-20 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7, 9-12, and 18-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2019/0046032 to Stahmann et al. ("Stahmann"):
Regarding claim 1, Stahmann discloses a system for potassium measurement comprising (medical system in [0040], [0071], [0072] which is for diagnosis/monitoring of patients per [0003]):
a chemical sensor configured to output a chemical sensor output signal indicative of a first estimate of a potassium level of a user of the system (second, high-accuracy chemical sensor that generates data indicative of a level/value of an electrolyte including potassium of a patient per [0040], [0070], [0073]) ("chemical sensor output signal indicative of a first estimate of a potassium level"));
a cardiac sensor configured to output a cardiac sensor output signal indicative of a second estimate of the potassium level of the user (first, fast-response ECG sensor (cardiac sensor) that generates data indicative of a level/value of an electrolyte including potassium of a patient per [0040], [0043], [0070], [0073]) ("cardiac sensor output signal indicative of a second estimate of the potassium level")); and
a controller coupled to the chemical sensor and the cardiac sensor (e.g., see Figure 5), wherein the controller is configured to generate an output indicative of the potassium level of the user based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor ([0040], [0070]-[0072] disclose how controller creates a blended analyte value (sensor fusion output of the potassium level) via using the first value (the "cardiac sensor output signal") to normalize the second value (the "chemical sensor output signal ") so as to reduce/compensate for offset/sensor gain/measurement errors in the chemical sensor (e.g., during times of rapid changes per [0070]).
Regarding claim 2, Stahmann discloses the system of claim 1, further including wherein the chemical sensor comprises an ion-selective electrode (ISE) sensor ([0057] discloses an ISE sensor).
Regarding claim 3, Stahmann discloses the system of claim 1, further including wherein the chemical sensor comprises a potentiometric sensor ([0057] discloses a potentiometric sensor).
Regarding claim 4, Stahmann discloses the system of claim 1, further including wherein the chemical sensor comprises a wearable sensor ([0075] discloses how the sensors herein (which thus includes the chemical sensor per [0070]-[0072]) can be wearable).
Regarding claim 5, Stahmann discloses the system of claim 1, further including wherein the chemical sensor is configured to analyse a sample of venous blood or to analyse a sample of blood obtained from a fingerprick ([0081] discloses how the chemical sensor can measure blood components).
Regarding claim 7, Stahmann discloses the system of claim 1, further including wherein the cardiac sensor comprises an electrocardiogram (ECG) sensor ([0070]-[0073] discloses an ECG sensor).
Regarding claim 9, Stahmann discloses the system of claim 1, further including an output transducer subsystem ([0078] discloses display circuitry and [0089] discloses a telemetry interface for communicating with external devices such as cell phones/laptops).
Regarding claim 10, Stahmann discloses the system of claim 9, further including wherein the output transducer subsystem comprises one or more of: an audio output transducer; a haptic output transducer; and a visual indicator ([0078] discloses display circuitry and [0089] discloses a telemetry interface for communicating with external devices such as cell phones/laptops which provide audio/visual data).
Regarding claim 11, Stahmann discloses the system of claim 1, further including a communications subsystem configured to communicate data and/or alerts from the system to an external device ([0089] discloses a telemetry interface for communicating with external devices such as cell phones/laptops which provide audio/visual data).
Regarding claim 12, Stahmann discloses the system of claim 1, further including an output transducer subsystem ([0078] discloses display circuitry) and a communications subsystem ([0089] discloses a telemetry interface for communicating with external devices such as cell phones/laptops which provide audio/visual data), wherein the controller is configured to generate an output signal for one or more of output transducer subsystem and the communications subsystem based on the output indicative of the potassium level (the controller generates a sensor fusion/blend indicative of the potassium level per [0040], [0070]-[0072] as discussed above; furthermore, as the entire purpose of the disclosure of Stahmann is to generate such electrolyte/potassium sensor fusion/blended values (see Title, Abstract, [0040], [0070], claim 1, etc.), then the controller would be "configured to" generate (i.e., capable of generating) output data signals related to such electrolyte/potassium sensor fusion/blended values for one or more of the "output transducer subsystem" or the "communications subsystem").
Regarding claim 18, Stahmann discloses an integrated circuit (circuitry of [0078]-[0079], [0098]-[0099]) comprising a controller (controller of Figure 5, [0040], [0070]-[0073], [0078]-[0079], [0098]-[0099]) configured to:
receive, from a chemical sensor, a chemical sensor output signal indicative of a first estimate of a potassium level of a user of a system incorporating the integrated circuit (second, high-accuracy chemical sensor that generates data indicative of a level/value of an electrolyte including potassium of a patient ("chemical sensor output signal indicative of a first estimate of a potassium level") which is received by controller per [0040], [0070], [0073]) of integrated circuit per [0078]-[0079], [0098]-[0099]));
receive, from a cardiac sensor, a cardiac sensor output signal indicative of a second estimate of the potassium level of the user (first, fast-response ECG sensor (cardiac sensor) that generates data indicative of a level/value of an electrolyte including potassium of a patient ("cardiac sensor output signal indicative of a second estimate of the potassium level") which is received by controller per [0040], [0043], [0070], [0073]); and
generate an output indicative of the potassium level of the user based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor ([0040], [0070]-[0072] disclose how controller creates a blended analyte value (sensor fusion output of the potassium level) via using the first value (the "cardiac sensor output signal") to normalize the second value (the "chemical sensor output signal ") so as to reduce/compensate for offset/sensor gain/measurement errors in the chemical sensor (e.g., during times of rapid changes per [0070]).
Claim 19 is rejected in view of Stahmann as discussed above in relation to claim 1.
Claim 20 is rejected in view of Stahmann as discussed above in relation to claim 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2023/0263434 to Johnson et al ("Johnson") in view of U.S. Patent App. Pub. No. 2019/0046032 to Stahmann et al. ("Stahmann"):
Regarding claim 1, Johnson discloses a system for potassium measurement comprising (system 100 in Figure 1 which measures/predicts potassium levels/imbalances per [0076]):
a chemical sensor configured to output a chemical sensor output signal indicative of a first estimate of a potassium level of a user of the system (Figure 1 and [0076] illustrate/disclose how system 100 includes a continuous analyte monitoring system 104 which includes a continuous analyte sensor 202 per [0111] and Figure 2 in the form of a chemical sensor that measures a potassium level of a user per [0112]; for instance, step 402 in Figures 4A-4B and [0187], [0212] illustrate/disclose measuring potassium levels using a continuous monitoring sensor ("chemical sensor output signal indicative of first estimate of potassium level");
a cardiac sensor configured to output a cardiac sensor output signal indicative of a second estimate of the potassium level of the user ([0121] discloses how continuous analyte monitoring system 104 can also include a non-analyte (e.g., ECG) sensor 206; for instance, [0212]-[0213], [0225] disclose using a non-analyte sensor such as an ECG sensor to generate signals indicative of potassium levels of the user ("cardiac sensor output signal indicative of a second estimate of the potassium level")); and
a controller coupled to the chemical sensor and the cardiac sensor, wherein the controller is configured to generate an output indicative of the potassium level of the user based on … the chemical sensor output signal and the cardiac sensor output signal
([0139], [0180] discloses how decision support engine 114 (controller) can use AI/ML algorithms that analyze inputs 128 (which include the continuous analyte sensor data indicative of the first potassium level estimate and the non-analyte/ECG/cardiac sensor output indicative of the second potassium level estimate per Figure 3, [0112], [0133], [0135], [0225]) for predicting a potassium imbalance of the user (output indicative of the potassium level of the user based on the first and second estimates); for instance, [0225] discloses how the ECG measurements (second estimate) combined with the CPG measurements (first estimate) can provide an indication of hyperkalemia which is an output indicative of the potassium level of the user)…
However, Johnson might be silent regarding the potassium level of the user being generated based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor.
Nevertheless, Stahmann teaches ([0040], [0070]-[0072]) that it was known in the healthcare informatics art for a controller of a potassium measurement system to create a blended analyte value (sensor fusion output of potassium level) via using a cardiac/ECG sensor output signal indicative of one potassium level estimate of a patient to normalize a chemical sensor output signal indicative of another potassium level estimate of the patient so as to reduce/compensate for offset/sensor gain/measurement errors in the chemical sensor (e.g., during times of rapid changes per [0070]) which thereby increases the accuracy of the determined potassium level estimate of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the potassium level of the user in Johnson to be generated based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor as taught by Stahmann to advantageously increase the accuracy of the determined potassium level estimate of the patient. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the chemical sensor comprises an ion-selective electrode (ISE) sensor ([0662]-[0664], [0667], [0669] of Johnson disclose how the continuous analyze monitoring sensor for measuring the potassium level can include ISE sensor).
Regarding claim 3, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the chemical sensor comprises a potentiometric sensor ([0662]-[0664], [0667] of Johnson disclose how the continuous analyze monitoring sensor for measuring the potassium level is based on a potential difference between first and second electrodes (potentiometric sensor); furthermore, the ISE sensor per [0669] necessarily is a potentiometric analysis technique).
Regarding claim 4, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the chemical sensor comprises a wearable sensor ([0112] of Johnson discloses how the continuous analyte sensor can be a transdermal (wearable) device while [0119] discloses an on-skin sensor).
Regarding claim 5, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the chemical sensor is configured to analyse a sample of venous blood or to analyse a sample of blood obtained from a fingerprick ([0112] of Johnson discloses how the continuous analyte sensor can be an intravascular device (configured to analyze sample of venous blood)).
Regarding claim 6, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the chemical sensor comprises an aptamer-based sensor configured to track a biomarker associated with potassium levels ([0515]-[0518], [0540], [0542] of Johnson disclose how the continuous monitoring device/analyte sensor can include a sensing portion/region having one or more aptamers with analyte binding regions configured to provide an indication of the level of the analyte/biomarker/potassium).
Regarding claim 7, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the cardiac sensor comprises an electrocardiogram (ECG) sensor ([0121] of Johnson discloses how the non-analyte sensor 206 can be an ECG monitor).
Regarding claim 8, the Johnson/Stahmann combination discloses the system of claim 1, further including wherein the cardiac sensor comprises a photoplethysmogram (PPG) sensor ([0121] of Johnson discloses how the non-analyte sensor 206 can be a pulse oximeter (PPG sensor)).
Regarding claim 9, Johnson discloses the system of claim 1, further including an output transducer subsystem (display device 107 in Figure 1 of Johnson, display devices 210-240 in Figure 2 of Johnson, haptic sensors in [0249] of Johnson).
Regarding claim 10, the Johnson/Stahmann combination discloses the system of claim 9, further including wherein the output transducer subsystem comprises one or more of: an audio output transducer; a haptic output transducer; and a visual indicator (display device 107 in Figure 1 of Johnson, display devices 210-240 in Figure 2 of Johnson, haptic sensors in [0249] of Johnson).
Regarding claim 11, the Johnson/Stahmann combination discloses the system of claim 1, further including a communications subsystem configured to communicate data and/or alerts from the system to an external device ([0116]-[0119] of Johnson discloses how data/alerts can be communicated to one or more display devices 210-240 (external system(s)) which can be in wireless communication with each other per [0111], [0119] which thus requires a "communications subsystem").
Regarding claim 12, the Johnson/Stahmann combination discloses the system of claim 1, further including an output transducer subsystem (devices 210-240 in Figure 2 of Johnson) and a communications subsystem (Figures 1-2 and [0119] of Johnson disclose various wireless communication which amounts to a "communications subsystem"), wherein the controller is configured to generate an output signal for one or more of output transducer subsystem and the communications subsystem based on the output indicative of the potassium level ([0118]-[0119] and Figure 1 of Johnson disclose/illustrate how decision support engine 114 (controller) generates output indicative of the user's current health/physiological parameters (which includes potassium levels as discussed herein) for display by display devices 210-240 (output transducer subsystem) which would be via the communications subsystem).
Regarding claim 13, the Johnson/Stahmann combination discloses the system of claim 1, further including a predictor comprising a trained neural network, artificial intelligence or other machine learning processor, wherein the predictor is configured to generate an estimate of a current and/or future potassium level of the user based on the cardiac sensor output signal ([0180]-[0182] of Johnson disclose how decision support engine 114 (controller) can use AI/ML algorithms (predictor) that analyze inputs 128 (which include the non-analyte/ECG/cardiac sensor output signal/data per Figure 3, [0133], [0135]) for predicting a potassium imbalance of the user (current/future potassium level based on the cardiac sensor output signal).
Regarding claim 14, the Johnson/Stahmann combination discloses the system of claim 13, further including wherein the predictor is configured to generate the estimate of the current and/or future potassium level of the user based on the cardiac sensor output signal and the chemical sensor output signal ([0139], [0180]-[0182] of Johnson disclose how decision support engine 114 (controller) can use AI/ML algorithms (predictor) that analyze inputs 128 (which include the continuous analyte chemical sensor data and the non-analyte/ECG/cardiac sensor output signal/data per Figure 3, [0112], [0133], [0135]) for predicting a potassium imbalance of the user (current/future potassium level based on the cardiac sensor output signal and the chemical sensor output signal)).
Regarding claim 16, the Johnson/Stahmann combination discloses the system of claim 13, further including wherein the predictor has been trained on a relationship between a potassium level and cardiac data ([0125] of Johnson discusses how decision support engine 114 (predictor) processes inputs 128 (which include non-analyte/ECG/cardiac data per [0083], [0135]) to generate output metrics 130 (which include potassium levels per Figure 3) such that there would be some relationship between the input ECG/cardiac data and the output potassium level(s); [0125] also discloses how such inputs 128 and outputs 130 (which thus include the above-noted relationship) can be used by training server to train and deploy ML models for use by decision support engine 114 (predictor)) to generate, based on the cardiac sensor output signal, the estimate of the current and/or future potassium level of the user ([0180]-[0182] of Johnson disclose how decision support engine 114 (controller) can use the trained AI/ML algorithms (predictor) that analyze inputs 128 (which include the non-analyte/ECG/cardiac sensor output signal/data per Figure 3, [0133], [0135]) for predicting a potassium imbalance of the user (current/future potassium level based on the cardiac sensor output signal); also, [0084], [0092], [0125] disclose how the decision support engine 114 processes the inputs 128 (which include non-analyte/ECG/cardiac data per [0083], [0135]) to generate output metrics 130 (which include potassium levels per Figure 3)).
Regarding claim 17, the Johnson/Stahmann combination discloses the system of claim 14, further including wherein the predictor comprises a trained neural network, artificial intelligence or other machine learning processor ([0180]-[0182] of Johnson disclose how decision support engine 114 (controller) can use trained AI/ML algorithms (predictor) while [0326] discloses an NN), wherein the predictor has been trained on a relationship between a potassium level and cardiac data and for different levels of potassium ([0125] of Johnson discusses how decision support engine 114 (predictor) processes inputs 128 (which include non-analyte/ECG/cardiac data per [0083], [0135]) to generate output metrics 130 (which include potassium levels per Figure 3) such that there would be some relationship between the input ECG/cardiac data and the output potassium level(s); [0125] also discloses how such inputs 128 and outputs 130 (which thus include the above-noted relationship) can be used by training server to train and deploy ML models for use by decision support engine 114 (predictor); furthermore, [0067], [0069], [0104], [0180] disclose iteratively training the ML models based on historical/population data of patients over time which would necessarily involve relationships between cardiac/ECG data and various different levels of potassium) to generate, based on the cardiac sensor output signal and the chemical sensor output signal, the estimate of the current and/or future potassium level of the user ([0180]-[0182] of Johnson disclose how decision support engine 114 (controller) can use the trained AI/ML algorithms (predictor) that analyze inputs 128 (which include the non-analyte/ECG/cardiac sensor output signal/data per Figure 3, [0133], [0135]) for predicting a potassium imbalance of the user (current/future potassium level based on the cardiac sensor output signal); also, [0084], [0092], [0125] disclose how the decision support engine 114 processes the inputs 128 (which include non-analyte/ECG/cardiac data per [0083], [0135]) to generate output metrics 130 (which include potassium levels per Figure 3)).
Regarding claim 18, Johnson discloses an integrated circuit ([0082] discloses how decision support engine 114 of Figure 1 can be executed on one or more computing devices which would include an IC) comprising a controller (decision support engine 114) configured to:
receive, from a chemical sensor, a chemical sensor output signal indicative of a first estimate of a potassium level of a user of a system incorporating the integrated circuit ([0139], [0180]-[0182] disclose how decision support engine 114 (controller) (which is executed on one or more computing devices (system) which would include an IC per [0082]) can use AI/ML algorithms that analyze inputs 128 (which include continuous analyte chemical sensor data indicative of a first potassium level estimate per Figure 3, [0112], [0133]);
receive, from a cardiac sensor, a cardiac sensor output signal indicative of a second estimate of the potassium level of the user ([0139], [0180]-[0182] disclose how decision support engine 114 (controller) can use AI/ML algorithms that analyze inputs 128 (which include non-analyte/ECG/cardiac sensor output signal/data indicative of a second potassium level estimate per Figure 3, [0135], [0225]); and
generate an output indicative of the potassium level of the user based on … the chemical sensor output signal and the cardiac sensor output signal ([0139], [0180] discloses how decision support engine 114 (controller) can use AI/ML algorithms that analyze inputs 128 (which include the continuous analyte sensor data indicative of the first potassium level estimate and the non-analyte/ECG/cardiac sensor output indicative of the second potassium level estimate per Figure 3, [0112], [0133], [0135], [0225]) for predicting a potassium imbalance of the user (output indicative of the potassium level of the user based on the first and second estimates); for instance, [0225] discloses how the ECG measurements (second estimate) combined with the CPG measurements (first estimate) can provide an indication of hyperkalemia which is an output indicative of the potassium level of the user)…
However, Johnson might be silent regarding the potassium level of the user being generated based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor.
Nevertheless, Stahmann teaches ([0040], [0070]-[0072]) that it was known in the healthcare informatics art for a controller of a potassium measurement system to create a blended analyte value (sensor fusion output of potassium level) via using a cardiac/ECG sensor output signal indicative of one potassium level estimate of a patient to normalize a chemical sensor output signal indicative of another potassium level estimate of the patient so as to reduce/compensate for offset/sensor gain/measurement errors in the chemical sensor (e.g., during times of rapid changes per [0070]) which thereby increases the accuracy of the determined potassium level estimate of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the potassium level of the user in Johnson to be generated based on a sensor fusion of the chemical sensor output signal and the cardiac sensor output signal in which the cardiac sensor output signal is used to compensate for measurement error of the chemical sensor as taught by Stahmann to advantageously increase the accuracy of the determined potassium level estimate of the patient. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 19 is rejected in view of the Johnson/Stahmann combination as discussed above in relation to claim 1.
Claim 20 is rejected in view of the Johnson/Stahmann combination as discussed above in relation to claim 18.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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