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 .
Applicant filed a response dated 11/21/2025 in which claims 1, 5, 7-10, 12, 14, 16, and 18 have been amended. Thus, the claims 1-20 are pending in the application.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of identifying resolution action based on a future alarm or a future failure state without significantly more.
For 101 analysis, Examiner has identified claim 1 as the claim that represents the claimed invention described in independent claims 1, 11, and 18.
Claim 1 is directed to a system, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 recites a health service provider computing system comprising one or more processing circuits including one or more processors communicably coupled to one or more memories having instructions stored thereon that, when executed by the one or more processors, cause the one or more processing circuits to: ingest information associated with an at-home dialysis device from the at-home dialysis device and at least one secondary device, the information including sensor information from a sensor of the at-home dialysis device; predict one of a future alarm or a future failure state associated with the at-home dialysis device based at least in part on the sensor information; identify at least one potential resolution action based on the one of the future alarm or the future failure state and the information ingested from the at-home dialysis device and the at least one secondary device. These limitations (with the exception of italicized limitation) describe the abstract idea of identifying resolution action based on a future alarm or a future failure state, which correspond to a Certain Methods of Organizing Human Activity. The additional elements of a processing circuits, processors, memories, dialysis device, secondary device, and a sensor do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a processing circuits, processors, memories, dialysis device, secondary device, and a sensor result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a processing circuits, processors, memories, dialysis device, secondary device, and a sensor are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a processing circuits, processors, memories, dialysis device, secondary device, and a sensor are recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these limitations provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Similar arguments can be extended to other independent claims 11 and 18 and hence the claims 11 and 18 are rejected on similar grounds as claim 1.
Dependent claims 2-10, 12-17, and 19-20 further define the abstract idea that is present in their respective independent claims 1, 11, and 18, thus correspond to a Certain Methods of Organizing Human Activity, and hence are abstract in nature for the reason presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 1-20 are not patent-eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Blasberg et al., US Patent Application No. 2021/0358608 in view of Zeflris, US Patent Application No. 2023/0091413.
Regarding claim 1, Blasberg discloses a health service provider computing system comprising one or more processing circuits including one or more processors communicably coupled to one or more memories having instructions stored thereon that, when executed by the one or more processors, cause the one or more processing circuits to:
ingest information associated with an at-home dialysis device from the at-home dialysis device and at least one secondary device, the information including sensor information from a sensor of the at-home dialysis device ([0010]-[0012], receiving values, for example, measured pressured, flow rates, conductivities, and the like implies that there are sensors associated with the home dialysis machine; this interpretation is consistent with Applicant’s disclosure in paragraph [0048] which states that the device states that are trending toward a given failure or other problem (e.g., last cycle data over time showing a measurement moving out of a normal or expected range; [0021], a transmitter, send, via the transmitter, a status signal pertaining to a status of the home dialysis machine, [0029], [0042]-[0043], a diagnostic tool that comprises an artificial intelligence (AI) system, build a database and learn how to best predict a necessary course of action in order to service a home dialysis machine diagnosed by the diagnostic tool);
predict one of a future alarm or a future failure state associated with the at-home dialysis device based at least in part on the sensor information ([0010]-[0012], causing the machine or treatment to run with sub-optimal performance (i.e., future failure state) or to not run at all; receiving values, for example, measured pressured, flow rates, conductivities, and the like; the diagnosis can comprise comparing received values to values stored in a local memory, stored in a look-up tables, obtained from a website, or the like; [0029], course-of-action);
identify at least one potential resolution action based on the one of the future alarm or the future failure state and the information ingested from the at-home dialysis device and the at least one secondary device ([0010]-[0012], [0029], [0031], [0042]-[0043]).
Blasberg does not specially disclose
one secondary device.
However, Zeflris discloses
one secondary device (claim 7, [0158], control unit).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg with the above-noted disclosure of Zeflris. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Regarding claim 2, Blasberg discloses wherein the at least one secondary device comprises one or more of a power supply device structured to supply power to the at-home dialysis device, a water treatment and supply device structured to supply treated water to the at-home dialysis device, a patient device associated with a patient, or a climate control device associated with a home of the patient ([0012], [0031]).
Regarding claim 3, Blasberg discloses wherein the at least one potential resolution action is identified using a machine learning model ([0042]-[0043], AI system serves as a machine learning model).
Regarding claim 4, Blasberg discloses wherein the machine learning model is trained using historical information associated with one or more of past alarms or past failure states associated with other at-home dialysis devices of other patients ([0010]-[0012], [0042]-[0043]).
Regarding claim 5, Blasberg discloses wherein the instructions, when executed by the one or more processors, further cause the one or more processing circuits to:
receive an indication of a resolution action resulting in resolution of the one of the future alarm or the future failure state ([0010]-[0012], [0029], [0031], [0042]-[0043]); and
store the indication of the resolution action and the information ingested from the at-home dialysis device and the at least one secondary device ([0010]-[0012], [0029], [0031], [0042]-[0043], the diagnostic tool).
Regarding claim 6, Blasberg discloses wherein the instructions, when executed by the one or more processors, further cause the one or more processing circuits to: train the machine learning model using the stored indication of the resolution action and the information ingested from the at-home dialysis device and the at least one secondary device ([0012], [0029], [0031], [0042]-[0043], AI system).
Zeflris discloses
one secondary device (claim 7, [0158], control unit).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg with the above-noted disclosure of Zeflris. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Regarding claim 7, Blasberg discloses wherein the sensor information is first sensor information, the sensor is a first sensor, the information further includes second sensor information from a second sensor of the at least one secondary device, and predicting the one or the future alarm or the future failure state is performed using the machine learning model based on the first sensor information and the second sensor information ([0012], [0029], [0031], [0042]-[0043]).
Zeflris discloses
sensor information from a second sensor of the at least one secondary device (claim 7, [0158], control unit).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg with the above-noted disclosure of Zeflris. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Regarding claim 8, Blasberg discloses wherein the sensor information comprises sensor data pertaining to at least one of a temperature, a pressure, a conductivity, or a flow rate within at least one of the at-home dialysis device and the at least one secondary device ([0010]-[0012], [0029]-0032]).
Zeflris discloses
one secondary device (claim 7, [0158], control unit).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg with the above-noted disclosure of Zeflris. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Regarding claim 11, Blasberg does not specifically disclose wherein the at least one secondary device comprises a temperature sensor structured to continuously monitor ambient air temperatures proximate the at-home dialysis device, the temperature sensor being integrated with the at-home dialysis device.
However, Zeflris discloses wherein the at least one secondary device comprises a temperature sensor structured to continuously monitor ambient air temperatures proximate the at-home dialysis device, the temperature sensor being integrated with the at-home dialysis device ([00158]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg with the above-noted disclosure of Zeflris. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Claims 12-20 are substantially similar to claims 1 and 4-7 and hence rejected on similar grounds.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Blasberg et al., US Patent Application No. 2021/0358608 in view of Zeflris, US Patent Application No. 2023/0091413 in view of Long et al., US Patent Application No. 2020/0051674.
Regarding claim 9, Long discloses wherein the sensor information is real-time sensor data ([0101]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg and Zeflris with the above-noted disclosure of Long. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Regarding claim 10, Long discloses wherein the sensor information is historical sensor data ([0031], [0123]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Blasberg and Zeflris with the above-noted disclosure of Long. The motivation for combining these references would have been to perform maintenance on the dialysis device.
Response to Arguments
Applicant's arguments filed dated 11/21/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-20 under 35 U.S.C. 101, Applicant states that the alleged abstract idea of “identifying resolution action based on the alarm or failure state” does not fall within one of the three enumerated sub-groupings of “certain methods of organizing human activity”.
Examiner respectfully disagrees and notes that identifying resolution action based on a future alarm or a future failure state can be handled by an expert technician who is familiar with diagnosing the dialysis machine based on a future alarm or a future failure state. Thus, the claim limitations describe an abstract idea which can be carried out by a human. Thus, the claim recites an abstract idea.
With respect to Step 2A, Prong Two, Applicant states that the features recite in the pending claims improve the technical field of home dialysis machines.
Examiner respectfully disagrees and notes that there is no technical improvement or improvement to home dialysis machine. In this case, Applicant is making use of machine learning model to diagnose the technical problem associated with dialysis machine. The machine learning model is already trained with the data obtained from past issues and the potential diagnostic solution. The claimed invention makes use of the data stored in the database associated with the machine learning model to provide diagnostic solution. The claimed invention merely uses the stored data to predict a diagnostic solution that is no different than an expert technician coming up a diagnostic solution to a technical problem associated with the dialysis machine. There is no technical improvement or prediction that are not within the capability of an expert technician. In this way, the claim simply makes use of a technology in providing a solution. However, there is no technical improvement to the model or dialysis machine. The claimed invention may provide efficiency/accuracy in providing diagnostic solution to a technical problem. However, this improvement is to an abstract idea and not to technology.
With respect to Step 2B, Applicant states that the pending claims include various features and/or combinations of features that are not well-understood, routine, or conventional activity in the field. For example, as discussed above, the pending claims include unique combinations of claim features that allow for the proactive identification, prevention, and resolution of current and potential future issues, thereby reducing or eliminating the duration or need for machine servicing required by technicians. Applicant respectfully submits that at least these features and/or combinations of features are not well-understood, routine, or conventional activity in the field. Thus, Applicant respectfully submits that the pending claims recite significantly more than an abstract idea, and are thus further eligible under the Step 2B analysis.
Examiner respectfully disagrees and notes that the arguments do not make it clear which additional elements are not well-understood, routine, or conventional. For example, it is unclear which features of the claim allow for the proactive identification, prevention, and resolution of current and potential future issues. The additional elements that have been identified in the 35 U.S.C. 101 rejection are recited at a high level of generality in that it merely amounts to applying the abstract idea. The claim does not present an inventive concept. The improvements to reducing or eliminating the duration or need for machine servicing required by technicians is an improvement to an abstract idea which is not sufficient to add significantly more. Thus, these arguments are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684