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
This office action is responsive to the amendment filed on August 27, 2025. As directed by the amendment: claims 1, 2, 5, 20, 22, 29, and 41 have been amended and claim 40 has been cancelled. Thus, claims 1, 2, 4, 5, 9, 20, 22, 24, 26, 27, 29, 31, 32, 36, and 41 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed May 28, 2025.
Response to Arguments
Applicant's arguments filed August 27, 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the Remarks that “A model trained to provide a response action based on a urine measurement is simply not substitutable with a model trained on glucose measurements. The data and its physical context is entirely different for both applications. Even if one were to assume that the urine based model is substitutable with a glucose based model, such a model would be deprived of any physical context or consideration”. The examiner respectfully disagrees and asserts that Verbitskiy was solely relied upon for the broader teaching of applying machine learning techniques to the trained model and not specifically applying a glucose model to the model of Wariar. PHOSITA is not an automation which merely incorporates the applied prior art and is, instead, a person of ordinary creativity. Thus, it is the examiner’s opinion that PHOSITA would be motivated to modify Wariar with the teachings of Verbitskiy with a reasonable expectation of success. Specifically, Wariar discloses a trained model (boundary generation module 214) which generates threshold data for each parameter (paragraph 46) and Verbitskiy teaches that it is advantageous to apply machine learning techniques to a trained model in order to adapt threshold data to account for variability between individuals (paragraph 38).
Applicant argues on pg. 9 of the Remarks that “While the medication could arguably be in fluid form, Charlton also discloses throughout the application that the therapy is designed to prevent excessive fluid buildup in the heart. (See, e.g., Charlton, paragraph [0075]). As such, it is unreasonable to conclude that Charlton discloses delivery of a fluid bolus as asserted by the Office.”. The examiner respectfully disagrees and maintains that in the context of a “drug pump”, PHOSITA would understand that the medication delivered would at least be partially fluidic (i.e. either partially a liquid or a gas) and would not be wholly solid. The examiner further notes that fluid buildup in the thoracic cavity increases the risk that a patient will experience a heart failure decompensation event (paragraph 50) and that one method of reducing the risk of such event is to administer the dose of medication (paragraph 93). This delivery of medication in fluid form does not involve delivery of fluid into the thoracic cavity.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 22, the claim fails to further limit claim 1 as claim 1 recites all of the claimed limitations set forth in claim 22. Lines 9-13 of claim 1 recites “wherein the healthcare monitoring system is configured to infer a change in the patient's condition … the healthcare monitoring system is further configured to determine the trained model from an application of machine learning techniques to historical data…”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 2, 4, 5, 9, 20, 22, 24, 27, 29, 31, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wariar (US 20070179389) in view of Verbitskiy (US 20090312621) and in view of Charlton (US 20130197381).
Regarding claim 1, Wariar discloses a healthcare monitoring system, the healthcare monitoring system arranged to receive a flow of biofluid from a biofluid source in or on the patient (paragraph 25 discloses the system receives urine), the healthcare monitoring system comprising:
a biofluid reservoir configured to couple to the biofluid source for receiving the flow of biofluid from the patient (collection volume 100 in fig. 1 receives a urine sample so that the volume 100 is configured to be coupled to the biofluid source); and
at least one biofluid sensing arrangement (strips 102, pads 104, detector 110, emitter 108, scale 120, remote computer 122 in fig. 1, and clearance data calculation module 206 form the “biofluid sensing arrangement”, see [0041]-[0044]) configured to determine a volume of the biofluid in the biofluid reservoir produced over a period of time (paragraph 44 discloses determining volume of the urine in the container by determining the weight, this volume would be produced over a period of time since the patient last urinated) to provide at least one output biofluid measurement value indicative of the volume of the biofluid in the biofluid reservoir (paragraphs 44 and 45 discloses using the volume to provide a clearance rate);
wherein the healthcare monitoring system is configured to infer a change in the patient's condition based, at least in part, on a trained model applied to the at least one output biofluid measurement value (paragraphs 46 and 50 discloses using a boundary generation module 214 and CHF decompensation detection module 214 to analyze, in part, the clearance rate to detect decompensation of the heart), wherein the healthcare monitoring system is further configured to determine the trained model from historical data to associate a rule with a biofluid output (paragraph 46 discloses using historical data to develop boundaries for a normal range for the patient parameters, including clearance rate), wherein, responsive to the healthcare monitoring system inferring a change in the patient's condition, by comparison of the at least one output biofluid measurement value with the associated rule, the healthcare monitoring system is configured to initiate a response action designated by the rule (paragraph 54 discloses issuing an alert).
However, Wariar fails to disclose the system is configured to determine the trained model from an application of machine learning techniques and the response action is a request to a fluid bolus mechanism to increase or decrease the amount of fluid delivered to the patient.
Verbitskiy teaches a system which is configured to apply machine learning techniques in order to set and adapt threshold values for a physiological parameter (paragraph 38). Since Wariar already disclose the use of a machine learning module (learning module 900 in fig. 7), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of Wariar so that the trained module (i.e. boundary generation module 214) is determined from the application of machine learning techniques, as taught by Verbitskiy. This modification would enable the trained module to adapt the boundary data of the patient as the patient parameters change (paragraph 38).
Charlton teaches a system in when the risk of a heart failure decompensation event is sufficiently high, the system is configured to initiate a response action which is a request to a fluid bolus mechanism to increase an amount of fluid delivered to the patient (paragraph 93). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system so that the response action is also a request to a fluid bolus mechanism to increase an amount of fluid delivered to the patient, as taught by Charlton, as Charlton teaches this action reduces the risk of the heart failure decompensation event (paragraph 93).
Regarding claim 2, in the modified system of Wariar, Wariar discloses the system is configured to generate an alert based on an inference of the change in the patient's condition (see Wariar, [0070], 709 can receive alerts regarding the patient’s health and well-being).
Regarding claim 4, in the modified system of Wariar, Wariar discloses the biofluid sensing arrangement (see Wariar, Fig. 1, strips 102, pads 104, detector 110, emitter 108, scale 120, remote computer 122, and clearance data calculation module 206, see [0041]-[0044]) is further configured to determine values indicative of at least one of composition (see Wariar, [0025], 104 changes state (color shade and/or intensity) in proportion to the concentration of a given chemical constituent in the urine, each pad may sense a different constituent), temperature or other biometric of the biofluid in the biofluid reservoir.
Regarding claim 5, in the modified system of Wariar, Wariar discloses the system is further configured to communicate the alert to a device (see Wariar, Fig. 7, peripheral devices 709) to enable a user to be notified of the inference of the change in the patient's condition (see Wariar, [0070], 709 can receive alerts regarding the patient’s health and well-being).
Regarding claim 9, in the modified system of Wariar, Wariar discloses the biofluid sensing arrangement (see Wariar, Fig. 1, strips 102, pads 104, detector 110, emitter 108, scale 120, remote computer 122, and clearance data calculation module 206, see [0041]-[0044]) is configured to determine the volume of biofluid in the biofluid reservoir by weighing the biofluid reservoir (see Wariar, the weight of the container is taken by scale 120, [0044]).
Regarding claim 20, in the modified system of Wariar, Wariar discloses the system is configured to infer the change in the patient's condition using a knowledge base (see Wariar, Fig. 7, analysis module 716, see [0095]-[0096]) and rules (see Wariar, [0099], information from patients with similar disease states) determined using the knowledge base (see Wariar, Fig. 7, analysis module 716, [0099]).
Regarding claim 22, modified Wariar teaches the system is further configured to determine the trained model (see Wariar, Fig. 7, learning module 906) from the application of machine learning techniques to historical data (see Verbitskiy, paragraph 38), wherein the trained model (see Wariar, Fig. 7, learning module 906) is used to infer a change in the patient's condition (see Wariar, [0105]-[0106]).
Regarding claim 24, in the modified system of Wariar, Wariar discloses the historical data (see Wariar, [0107]-[0108], 906 uses various algorithms and mathematical modeling) comprises a field (see Wariar, [0103], data related to a given population) pertaining to a demographic group (see Wariar, Fig. 7, population analysis module 904, [0103)).
Regarding claim 26, in the modified system of Wariar, Wariar discloses the system is configured to determine at least one rule (see Wariar, paragraph 46 discloses generating a boundary for each parameter) from the trained model (boundary generation module 214 in fig. 2).
Regarding claim 27, in the modified system of Wariar, Wariar discloses the rule defines a danger zone on at least one parameter (paragraph 46 discloses a “normal range” for each parameter with the zone outside of this range being the “danger zone”), wherein the danger zone defines a threshold on the at least one parameter to indicate when a measurement for that parameter indicates deterioration in the patient (paragraphs 46 and 50).
Regarding claim 29, in the modified system of Wariar, Wariar discloses the system is configured to infer the change in the patient's condition responsive to a determination that the at least one parameter is indicating deterioration in the condition of the patient (see Wariar, paragraph 53 discloses decompensation of CHF being detected).
Regarding claim 31, in the modified system of Wariar, Wariar discloses the response action is an instruction to a connected device (paragraph 54).
Regarding claim 36, in the modified system of Wariar, Charlton discloses the fluid bolus mechanism, responsive to receiving the request, implements the request and delivers the requested amount or rate to the patient (paragraph 93 discloses a drug pump delivering a dose of medication).
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Wariar in view of Verbitskiy and in view of Charlton, as applied to claim 1 above, and in further view of Wong (US 2010/0081951).
Regarding claim 32, modified Wariar teaches all of the claimed limitations set forth in claim 1, as discussed above. Wariar discloses the response action (see [0070], alert to the caregiver) is a message to a remote device (see [0070], remote peripheral device 709). However, modified Wariar fails to teach wherein the message comprises content relating to the frequency of monitoring of the patient.
Wong teaches a similar device in the same field of endeavor wherein the message (see Fig. 1, electronic display 7 with message, see [0073]) comprises content relating to the frequency of monitoring of the patient (see [0073], message displayed indicates that an increased frequency of monitoring is required).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the response action as taught by modified Wariar to indicate the need for an increased frequency as of monitoring as taught by Wong as this can detect and increased likelihood of discovering the issue at an earlier stage (see [0073]).
Claim(s) 41 is rejected under 35 U.S.C. 103 as being unpatentable over Wariar in view of Verbitskiy and in view of Charlton, as applied to claim 1 above, and in further view of Joshua (US 2016/0058286).
Regarding claim 41, modified Wariar teaches all of the claimed limitations set forth in claim 1, as discussed above. Wariar further discloses the response action (see Wariar, [0070], alert to the caregiver) is a message to a remote device (see Wariar, [0070], remote peripheral device 709). However, modified Wariar fail to disclose to indicate a need to decrease a currency frequency of monitoring of the patient.
Joshua teaches a similar device in the same field of endeavor to indicate a need to decrease a currency frequency of monitoring of the patient (see [0115]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the message as taught by modified Wariar to indicate the need to decrease a frequency of monitoring the patient as taught by Joshua as frequency at which data is acquired may be decreased based on the condition of the patient (see [0115]).
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783