DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 08/17/2026 has been entered. Claims 1-19 and 21 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection of claims 1-20 previously set forth in the Non-Final Office Action mailed 05/15/2026.
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 1-6, 8, 10-16, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identifying, from the sensor data obtained over the multiple days, patterns of the sensor data consistent with hemodialysis treatments of the patient; determining a change in the patterns of the sensor data indicative of a change in the hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “obtaining, over multiple days, sensor data for a patient using one or more physiologic sensors of the ambulatory medical device;" and “producing, in response to determining the change in the patterns, an alert associated with the hemodialysis treatments,” which are the steps of data gathering and insignificant well-known, conventional post-solution activity. Summarizing, The ordered combination simply amounts to gathering data over time, analyzing the data for changes, and issuing an alert. Applying well-known computational analysis steps to collected data using generic sensors does not transform an unpatentable abstract idea into a patent-eligible invention. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 2, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identifying a change in the physiologic impedance data indicative of a change in the recurring hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “sensing physiologic impedance data using an impedance sensor of the one or more physiologic sensors of the ambulatory medical device;" and “producing the alert using the identified change in the physiologic impedance data,” which are the steps of data gathering and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 2 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identifying a change in the heart sound data indicative of a change in the recurring hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “sensing heart sound data using a heart sound sensor of the one or more physiologic sensors of the ambulatory medical device;" and “producing the alert using the identified change in the heart sound data,” which are the steps of data gathering and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of base claim which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the sensing heart sound data includes sensing one or both of S3 heart sound data and S4 heart sound data; and wherein the producing the alert includes producing the alert using an identified change in the one or both of the S3 heart sound data and the S4 heart sound data that is inconsistent with a schedule of recurring hemodialysis treatments of the patient” which are the steps of pre-solution data gathering and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 5, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identifying a change in the heart sound data indicative of a change in the hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “sensing blood pressure data of the patient; wherein the sensing heart sound data includes sensing S2 heart sound data; and wherein the producing the alert includes producing an alert regarding risk of fainting using the S2 heart sound data and the blood pressure data when the blood pressure data indicates blood pressure below a blood pressure threshold and the S2 heart sound data indicates S2 amplitude above an S2 amplitude threshold " which are the steps of pre-solution data gathering and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 5 is therefore non-statutory and not patent eligible.
Regarding claim 6, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identifying a change in the physiologic impedance data indicative of risk of intradialytic hypotension” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “sensing physiologic impedance data using an impedance sensor of the ambulatory medical device;" and “producing an alert regarding the risk of intradialytic hypotension in response to identifying the change in the physiologic impedance data,” which are the steps of data gathering and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 6 is therefore non-statutory and not patent eligible.
Regarding claim 8, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “comparing, …, the sensor data for a hemodialysis treatment to sensor data for another hemodialysis treatment” and “determining, …, a change in dialysis dosage based on the sensor data,” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “using a separate device that communicates information with the ambulatory medical device” and “determining, by the separate device,” which are insignificant post-solution activity and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 8 is therefore non-statutory and not patent eligible.
Regarding claim 10, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “determine, from the sensor data obtained over multiple days, patterns of the sensor data consistent with recurring hemodialysis treatments; identify a change in the patterns of the sensor data indicative of a change in the recurring hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “ambulatory medical device including: one or more physiologic sensors configured to output sensor data containing physiological information of a patient; and a communication circuit to transmit the sensor data to a second device; a second device including: another communication circuit configured to receive the sensor data from ambulatory medical device; and processing circuitry configured to:”, and “produce an alert associated with the hemodialysis treatments in response to determining the change in the patterns of the sensor data” which are related to pre-solution data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 10 is therefore non-statutory and not patent eligible.
Regarding claim 11, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify a change in the physiologic impedance data indicative of a change in the recurrent hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the ambulatory medical device includes an impedance sensor of the one or more physiologic sensors, configured to produce physiologic impedance data; wherein the processing circuitry of the second device is configured to:” and “produce the alert based on the identified change in the physiologic impedance data,” which are related to the steps of pre-solution data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 11 is therefore non-statutory and not patent eligible.
Regarding claim 12, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify a change in the heart sound data indicative of a change in the recurrent hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the ambulatory medical device includes a heart sound sensor of the one or more physiologic sensors, configured to produce heart sound data; wherein the processing circuitry of the second device is configured to:” and “produce the alert based on the identified change in the heart sound data,” which are related to the steps of pre-solution data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 12 is therefore non-statutory and not patent eligible.
Regarding claim 13, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify one or both of S3 heart sounds and S4 heart sounds in the heart sound data” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the processing circuitry of the second device is configured to: … produce the alert when detecting a change in the one or both of the S3 heart sound and the S4 heart sound that is inconsistent with a schedule of recurrent hemodialysis treatments" which are mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 13 is therefore non-statutory and not patent eligible.
Regarding claim 14, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify S2 heart sounds in the heart sound data” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the processing circuitry of the second device is configured to: receive blood pressure data of the patient… produce an alert regarding risk of fainting using the S2 heart sound data and the blood pressure data when the blood pressure data indicates blood pressure below a blood pressure threshold and the S2 heart sound data indicates S2 amplitude above an S2 amplitude threshold" which are mere instructions to implement the abstract idea on a computer, pre-solution data gathering, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 14 is therefore non-statutory and not patent eligible.
Regarding claim 15, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “identify a change in the physiologic impedance data indicative of risk of intradialytic hypotension;” which, under the broadest reasonable interpretation, encompasses a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the ambulatory medical device includes an impedance sensor configured to produce physiologic impedance data; wherein the processing circuitry of the second device is configured to: … produce an alert regarding the risk of intradialytic hypotension in response to identifying the change in the physiologic impedance data,” which are mere instructions to implement the abstract idea on a computer, pre-solution data gathering, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 15 is therefore non-statutory and not patent eligible.
Regarding claim 16, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “compare the sensor data sensed for a first hemodialysis treatment to sensor data sensed for another hemodialysis treatment” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “wherein the processing circuitry of the second device is configured to: … determine a change in hemodialysis dosage based on the comparing of the sensor data,” which are insignificant post-solution activity and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 16 is therefore non-statutory and not patent eligible.
Regarding claim 18, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify, from the sensed physiological signal obtained over multiple days, patterns in the physiological signal consistent with hemodialysis treatments of the patient; determine a change in the identified patterns indicative of a change in the recurring hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “at least one physiologic sensor configured to produce a sensed physiological signal representative of physiological information of a patient; and signal processing circuitry configured to: ... produce an alert associated with the recurring hemodialysis treatments in response to the determined change in the patterns of the physiological signal,” which are mere instructions to implement the abstract idea on a computer, device configuration for pre-solution data gathering, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 18 is therefore non-statutory and not patent eligible.
Regarding claim 19, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “identify a change in the sensed impedance signal indicative of a change in the hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “impedance sensor of the at least one physiologic sensor, configured to produce a sensed impedance signal representative of physiological impedance of the patient; and wherein the signal processing circuitry is configured to: … produce the alert using the identified change in the sensed impedance signal,” which are mere instructions to implement the abstract idea on a computer, device configuration for pre-solution data gathering, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 19 is therefore non-statutory and not patent eligible.
Regarding claim 21, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “identify a change in the heart sound signal indicative of a change in the hemodialysis treatments” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea. Additionally, the “averaging the sensor data for predetermined periods of time within a day into respective bins of data, wherein identifying the patterns includes identifying the patterns from the bins of data, wherein the multiple days extend over a week and the bins of data correspond to respective predetermined periods within respective days of the week.” is a math-type abstract idea combined with a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 21 is therefore non-statutory and not patent eligible.
Allowable Subject Matter
Claims 7, 9, and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 08/17/2026 have been fully considered and are persuasive. Therefore, the 102 and 103 rejections have been withdrawn.
Response to the 35 U.S.C. §101 rejection arguments on pages 8-14 of the REMARKS.
Claims 1-19 and 21
The Applicant argues that “Following the PowerBlock directive to consider claims "in their entirety," claim 1 does not merely require identifying an unspecified pattern or mentally comparing previously presented information. The claim requires operation of an ambulatory medical device to obtain physiologic measurements from a patient over multiple days and to use patterns in those longitudinal physiologic measurements to identify recurring hemodialysis treatments. The claimed method then determines from a change in those sensor-data patterns that the patient's recurring hemodialysis treatments have changed and responsively produces an alert associated with the treatment change.” (Page 14). The Examiner notes that obtaining physiologic measurements from a patient over multiple days simply amounts to a pre-solution data gathering. The ordered combination merely amounts to gathering data over time, analyzing the data for changes, and issuing an alert. Applying well-known computational analysis steps to collected data using generic sensors does not transform an unpatentable abstract idea into a patent-eligible invention. Producing an alert is a well-known, conventional post-solution activity (akin to displaying data or triggering a generic indicator). Therefore, this judicial exception is not integrated into a practical application. The Applicant argues that “Claim 7 is even more directly integrated into a practical application because it uses sensed physiologic impedance data to adjust a filtration rate of a hemodialysis treatment.” (Page 14). The Examiner notes that claims 7, 9, and 17 were not rejected under the 35 U.S.C. §101.
Response to the 35 U.S.C. §102 and §103 rejection arguments on pages 15-22 of the REMARKS.
Claims 1-19 and 21
The Applicant argues that “Banet does not disclose identifying, from sensor data obtained over multiple days” (Page 17). The Examiner agrees and therefore the rejection has been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
Prosecution Insights