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 .
Response to Amendment
The amendment to the claims filed 11 May 2026 has been entered. 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.
Rejections Withdrawn
Rejections of claim(s) under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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.
Claim(s) 1, 4-6, 10-15, 21, 24-25 and 28 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The pending claims recite the steps of extracting at least one respiratory parameter from data generated by at least one sensor during one or more monitoring sessions in which PAP therapy is provided to a patient; analyzing the at least one respiratory parameter to provide a prediction of ADHF or an exacerbation of COPD; and generating a probability of a future relapse, i.e., post-discharge ADHF event requiring readmission of the patient.
These limitations, as drafted, are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting the steps are performed by a controller nothing in the claim elements preclude the step from practically being performed in the mind. For example, but for the "controller" language, the step of extracting at least one respiratory parameter encompasses a user manually and/or mentally calculating a parameter, e.g., breathing rate, counting apneas, etc., from data generated by a sensor during a PAP session (e.g., overnight). The steps of analyzing the respiratory parameter(s) and generating a probability of a future relapse similarly encompasses the user manually/mentally considering the extracted parameter(s), e.g., by comparing parameters to respective thresholds; identifying changes in said parameters over a session or between sessions, etc. to judge/estimate the likelihood of another ADHF event requiring hospitalization. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, claims 1, 4-6, 10-15, 21, 24-25 and 28 recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of a controller for performing the steps of the abstract idea, a flow generator providing PAP therapy to the patient, a highly-generic sensor(s) for generating/gathering the data necessary for performing the abstract idea, and highly-generic outputting steps for presenting the results of performing the abstract idea to a clinician. With respect to the controller, said computer component is recited at a high-level of generality (e.g., as a generic processor performing generic computer functions of analyzing sensor data), such that it amounts no more than mere instructions to apply the exception using a generic computer component. With respect to the claimed sensor and flow generator limitations, the flow generator is only recited as providing PAP therapy during which the data for extracting respiratory parameters is generated. As such, said limitations amount to necessary data gathering comparable to limitations that have been identified by the courts as directed to insignificant extrasolution activity, such as performing clinical tests on individuals to obtain input for an equation. See MPEP 2106.05(g). Alternatively/Additionally, the flow generator limitation and/or the sensor data being generated during one or more PAP sessions could also or rather be considered as generally linking the use of a judicial exception to a particular technological environment or field of use, comparable to the claims at issue in Electric Power Group. See MPEP 2106.05(h). Lastly, with respect to the generating output comprising a clinical alert by displaying said alert on a display, or sending said alert to a user device, said limitation amounts to necessary outputting comparable to limitations that have been identified by the courts as directed to insignificant extrasolution activity, such as printing or downloading generated menus. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore, claims 1, 4-6, 10-15, 21, 24-25 and 28 are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the steps of the abstract idea amounts to no more than mere instructions to apply the judicial exception using a generic computer component. Furthermore, with respect to the claimed sensors, Applicant acknowledges contact sensor modalities such as masks or oronasal cannula with capability for monitoring and analyzing respiratory parameters during sleep to determine the severity of sleep disordered breathing are known (¶ [0019]). Additionally, US 2008/0119747 A1 (Mietus) discloses conventional diagnostic systems, such as polysomnography, include at least one sensor generating data comprising movement signals representing the movement of the patient, and provide data from which a sleep disordered breathing parameter(s) can be extracted (e.g., ¶ [0007]), such that there is sufficient evidence of record indicating the claimed sensors comprise and/or encompasses sensors well-understood, routine and/or conventional in the field. As discussed above, the flow generator limitation and/or the sensor data being generated during one or more PAP sessions generally link the use of a judicial exception to a particular technological environment or field of use, comparable to the claims at issue in Electric Power Group. See MPEP 2106.05(h). Lastly, as discussed above, generically providing, e.g., displaying, the result of performing the abstract idea to a user has been identified by the courts as an insignificant extrasolution activity. Additionally, presenting (e.g., displaying) data to a user and sending an alert to a user are comparable to steps identified by the courts as well-understood, routine and/or conventional computer functions and/or activities when they are claimed in a generic manner, such as presenting offers and receiving or transmitting data over a network. See MPEP 2106.05(d). Mere instructions to apply a judicial exception using a generic computer component, adding insignificant extra-solution activity to the judicial exception, generally linking the use of a judicial exception to a particular technological environment or field of use, and/or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception cannot provide an inventive concept. See MPEP 2106.05. Even when considered in combination, the additional elements of the rejected claims do no more than automate the recited mental processes, using generic computer components as a tool and well-understood, routine and/or conventional sensors and output steps to gather the data necessary to perform the abstract idea, and generically output the result of performing the abstract idea to a user, respectively. Accordingly, claims 1, 4-6, 10-15, 21, 24-25 and 28 are not patent eligible.
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 2012/0253207 A1 (previously cited, "Schindhelm '530") in view of US 2012/0253207 A1 ("Sarkar").
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)); and
generating an indicator based on the analysis of the at least one respiratory parameter and generating output comprising a clinical alert for a clinician based on the indicator (Fig. 5, step 606; ¶ [0082]; etc., generating warning or message indicative of heart failure condition based on the comparison).
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 probability value of future relapse comprises a clinical prediction of a post-discharge event requiring readmission of the patient, and 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]).
Sarkar discloses/suggests a system configured to extract at least one respiratory parameter from data generated by at least one sensor (¶ [0039] respiration metrics), including at least one respiratory parameter extracted from data generated during one or more monitored sleep sessions (e.g., ¶ [0030], ¶ [0039], ¶ [0161] sleep apnea burden); analyze the respiratory parameter(s) to generate an indicator representing a probability value of future relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input (e.g., Fig. 11, generating heart failure risk levels for the patient; ¶ [0062] heart failure risk level may be determined with probability models that determine the probability of hospitalization based on the values of all patient metrics; etc.), wherein the probability value of future relapse comprises a clinical prediction of a post-discharge event requiring readmission of the patient, and wherein the post-discharge event comprises acute decompensated heart failure (ADHF) (e.g., ¶ [0102] risk level is indicative of the likelihood that the patient will be re-admitted to the hospital within a post-hospitalization period; ¶ [0028]); and generating output comprising a clinical alert for a clinician based on the indicator (¶ [0184] once the risk level is generated, processor 80 generates an alert of the risk level).
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 relapse of the patient generated by a trained classifier that utilizes the at least one respiratory parameter as input, wherein the probability value of future relapse comprises a clinical prediction of a post-discharge event requiring readmission of the patient, and wherein the future relapse post-discharge event comprises ADHF, as taught/suggested by Sarkar in order to enable a clinician to make treatment modifications or other changes to the lifestyle of the patient in order to attempt to prevent said patient from being re-hospitalized due to heart failure (Sarkar, ¶ [0174]).
Regarding claim 4, Schindhelm '530 as modified discloses and/or suggests the at least one respiratory parameter comprises a breathing rate (Schindhelm '530, ¶ [0063]).
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/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 (¶¶ [0063]-[0070], ¶ [0082]; etc.).
Regarding claim 10, Schindhelm '530 as modified discloses/suggests the assessment comprises a comparison of changes in the at least one respiratory parameter with at least one respective threshold (¶¶ [0063]-[0070], ¶ [0082], 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; Sarkar, ¶ [0122]; 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; Sarkar, ¶ [0029], ¶ [0120], etc.).
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 (Schindhelm '530, ¶ [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 (Schindhelm '530, ¶¶ [0063]-[0064] respiratory parameter(s) may include number of apneas, a number of hypopneas, an Apnea-Hypopnea Index, Cheyne-Stokes breathing, etc.; Sarkar, ¶ [0030] sleep apnea burden).
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 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 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 date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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