DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 October 2025 has been entered.
Status of Claims
Claim(s) 1, 21 and 25 is/are currently amended. Claim(s) 2-3, 7-9, 16-20, 22-23 and 26-27 has/have been canceled. Claim(s) 1, 4-6, 10-15, 21, 24-25 and 28 is/are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 4-6, 10-15, 21, 24-25 and 28 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 23, claim 25 and claims dependent thereon, the limitation "generate an indicator based on the analysis of the at least one respiratory parameter, wherein the indicator represents a probability value of future relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input, and wherein the future relapse comprises acute decompensated heart failure (ADHF)" of claim 1 and the comparable limitations of claims 23 and 25 are indefinite, particularly in view of Applicant's remarks (e.g., pgs. 7-8). Applicant notes the term "relapse" was not identified in the previously-cited Schindhelm '921 reference. All references to "relapse" monitoring in the application as filed appear to refer to monitoring a patient who is currently hospitalized, and assessing his/her relapse probability in order to determine if he/she is ready to be released (e.g., ¶ [0101]). However, there is no explicit limit on the type of patient using the system, employing the method, etc., and/or any explicit limit as to the environment (e.g., within a hospital) in which the system, method, etc. is being utilized. Accordingly, it is unclear if a "probability value of a future relapse" is intended to limit the scope of the system, method, etc. to use with a patient who is currently hospitalized, or if the scope of a "probability value of a future relapse" is intended to encompass the probability of any future acute HF decompensation event for a HF patient, regardless of his/her current state.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 4-6, 10-15, 21, 24-25 and 28 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 23, claim 25 and claims dependent thereon, as discussed above with respect to rejections under 35 U.S.C. 112(b), the scope of a "future relapse" is not readily apparent. For example, it is not clear if a future relapse encompasses a plurality of event types (e.g., any acute decompensation, any exacerbation) or is intended to be limited to a particular type of event (i.e., a decompensation/exacerbation shortly after a hospitalization). Assuming, arguendo, that the limitation is limited to the disclosed relapse monitoring (i.e., performed in hospital to manage discharge decisions), the limitations "generate an indicator based on the analysis of the at least one respiratory parameter, wherein the indicator represents a probability value of future relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input, and wherein the future relapse comprises acute decompensated heart failure (ADHF); and modify a pressure control parameter of the flow generator based on the indicator" of claim 1 and the comparable limitations of claims 23 and 25 lack sufficient support in the application as filed. Specifically, Applicant discloses analysis of sensor data, such as an imminent decompensation or exacerbation event (e.g., ¶¶ [0091]-[0100]). Applicant further discloses a probability of relapse for a hospitalized patient may be provided (e.g., displayed) to a user (e.g., clinician), used in discharge decision making, etc. (e.g., ¶¶ [0101]-[0105]), but does not appear to disclose modifying a pressure control parameter of the flow generator based on said probability.
Claim Rejections - 35 USC § 103
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 4-6, 10-15, 21, 24-25 and 28 is/are rejected under 35 U.S.C. 103 as obvious over US 2010/0018530 A1 (previously cited, "Schindhelm '530") in view of US 2008/0228090 A1 ("Wariar").
Regarding claims 1, 21 and 25, Schindhelm '530 discloses/suggests a cardio-pulmonary health monitoring system (e.g., Fig. 3) comprising:
at least one sensor adapted to generate data related to the cardio-pulmonary health of a patient (flow and/or pressure sensor 406/426; diagnostic sensor(s) 412; etc.);
a flow generator configured to provide a Positive Airway Pressure (PAP) therapy to the patient (flow generator, such as a servo-controlled blower 424, e.g., ¶ [0080]);
a controller, or one or more processors thereof, communicatively coupled to the at least one sensor (controller 404, or processor 414 thereof), and a computer-readable medium storing program instructions configured to cause the controller/processor to carry out a method of monitoring cardio-pulmonary health of a patient (e.g., ¶ [0106]), the method comprising:
extracting at least one respiratory parameter from the data generated by the at least one sensor during one or more monitored PAP therapy sessions (Fig. 5, step 602; etc., determining respiratory-based parameters (e.g., ¶ [0063]) and/or treatment pressure (e.g., ¶ [0082]));
analyzing the at least one respiratory parameter extracted during the one or more monitored PAP therapy sessions (Fig. 5, step 604; ¶ [0082]; etc., comparing extracted parameters to established threshold(s));
generating an indicator based on the analysis of the at least one respiratory parameter (Fig. 5, step 606; ¶ [0082]; etc., providing a heart failure condition indication based on the analysis); and
modifying a pressure control parameter of the flow generator based on the indicator (Fig. 5, step 608; ¶ [0084]; ¶ [0087]; etc., automatically changing a treatment therapy provided by a respiratory treatment apparatus based on the indicator).
Schindhelm '530 does not expressly disclose the indicator represents a probability value of future relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input, wherein the future relapse comprises ADHF. However, Schindhelm '530 discloses the patient using the system, employing the method, etc., is a patient that has been diagnosed with congestive heart failure, wherein said patient is monitoring for changes in his/her condition indicative of a decompensation event (e.g., ¶ [0081]). Schindhelm '530 further discloses and/or suggests providing an indicator indicative of the potential for an acute decompensation should be beneficial (e.g., ¶ [0050]).
Wariar discloses a system comprising a controller (heart failure analyzer 360) configured to generate an indicator based on the analysis of extracted parameters, which may include at least one respiratory parameter (¶ [0028] processor 366 produces one or more parameters indicative of one or more conditions associated with heart failure using the diagnostic data received by data input 362, such as respiration rate), the indicator representing a probability value of future relapse of the patient generated by a trained classifier that utilizes the at least one extracted parameter(s) as input (e.g., ¶ [0039] risk analyzer 586 is activated during hospitalization mode and produces a risk class parameter indicative of the probability of rehospitalization within a specified period of time, wherein said probability is calculated using an empirically established mathematical formula using the one or more parameters produced by diagnostic data processor 366). Wariar further discloses one of more therapies may be adjusted based on heart failure indicator(s) (e.g., ¶ [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Schindhelm '530 with the indicator representing a probability value of future ADHF relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input as taught/suggested by Wariar in order to facilitate assessing a hospitalized patient's risk of rehospitalization for more effective discharge planning, thereby reducing rates of hospitalization (Wariar, ¶ [0019]); enable monitoring efficacy of therapy on relapse risk probabilities and/or how therapy adjustments affect the relapse probability (Wariar, ¶ [0038]), etc.
Regarding claim 4, Schindhelm '530 as modified discloses and/or suggests the at least one respiratory parameter comprises a breathing rate (Schindhelm '530, ¶ [0063]; Wariar, ¶ [0028]; etc.).
Regarding claim 5, Schindhelm '530 as modified discloses and/or suggests the at least one respiratory parameter comprises a measure of ventilation (¶ [0082] treatment pressure).
Regarding claim 6, Schindhelm '530 as modified discloses and/or suggests the analysis of the at least one respiratory parameter comprises an assessment of a change in the at least one respiratory parameter over the one or more monitored PAP therapy sessions (Schindhelm '530, ¶¶ [0063]-[0070], ¶ [0082]; Wariar, ¶ [0034]; etc.).
Regarding claim 10, Schindhelm '530 as modified discloses and/or suggests the assessment comprises a comparison of changes in the at least one respiratory parameter with at least one respective threshold (Schindhelm '530, ¶¶ [0063]-[0070], ¶ [0082]; Wariar, ¶ [0034]; etc.).
Regarding claim 11, Schindhelm '530 as modified discloses and/or suggests the controller is further configured to display the indicator on a display (Schindhelm '530, ¶ [0072] the controller, in response to an affirmative heart failure condition change indicator, may activate a status light (e.g., an LED or an icon on a display screen or LCD) of the monitoring device; Wariar, ¶ [0024]; etc.).
Regarding claim 12, Schindhelm '530 as modified discloses and/or suggests the controller is further configured to send the indicator to a user of the system (Schindhelm '530, ¶ [0072] the controller may also, or alternatively, send a message to a clinician of physician).
Regarding claims 13, 24 and 28, Schindhelm '530 as modified discloses and/or suggests the data generated by the at least one sensor comprises movement signals representing the movement of the patient (¶ [0056] movement sensor(s) that provide a measure of patient respiration and may be used as an alternative to a flow sensor or in conjunction with other flow sensors in the determination of respiratory parameters), and the at least one respiratory parameter is a sleep disordered breathing feature (¶¶ [0063]-[0064] respiratory parameter(s) may include number of apneas, a number of hypopneas, an Apnea-Hypopnea Index, Cheyne-Stokes breathing, etc.).
Regarding claim 14, Schindhelm '530 as modified discloses and/or suggests a sensor unit (e.g., monitoring and treatment device 400) comprises the at least one sensor (flow and/or pressure sensor 406/426) and the controller (e.g., controller 404 or processor 414 thereof).
Regarding claim 15, Schindhelm '530 as modified discloses and/or suggests a sensor unit comprises the at least one sensor (e.g., ¶ [0054] ECG monitor having an ECG sensor), and wherein an external computing device comprises the controller (¶ [0054] ECG data from the ECG monitor may be transmitted to the controller, e.g., 404).
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground(s) 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791