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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11, 17-19, and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Lee(US 20050061315 A1).
Regarding claim 1, Lee discloses a method comprising: receiving, via a processing resource;- stimulation therapy activity information associated with stimulation therapy applied to a patient by an implantable medical device for treating obstructive sleep apnea, patient management information associated with clinician management of patient usage of the implantable medical device by the patient; and external patient monitoring information comprising physiologic information sensed from the patient by a third party device; and integrating, via the processing resource, the stimulation therapy activity information, the patient management information, and the external patient monitoring information; receiving respiratory information as sensed from the patient by an implantable sensing component; and based on the integrated information, performing patient care by determining a stimulation therapy to be delivered by the implantable medical device to upper airway patency-related tissue of the patient and as timed with the respiratory information sensed via the implantable sensing component to treat obstructing sleep apnea(The medical system includes a monitoring unit having components disposed within an implantable housing. The monitoring unit is configured to monitor one or more patient conditions. A processor is coupled to the monitoring unit. The processor is configured to provide feedback information related to sleep disordered breathing therapy delivered to a patient based on the one or more monitored conditions. Components of a therapy device delivering the disordered breathing therapy are disposed within a therapy device housing. The therapy device housing is separate from the implantable housing of the monitoring device[0010]. Detecting the onset, termination, duration, stages, and quality of sleep experienced by a patient may be employed in connection with monitoring patient conditions and providing feedback for sleep disordered breathing therapy. Patients suffering from sleep apnea, or other types of sleep disordered breathing, may be treated with for sleep disordered breathing only during periods of sleep. Monitoring patient conditions and/or development of feedback information may involve determining if the patient is asleep and/or detecting various sleep-related processes, such as arousals from sleep and/or REM or non-REM sleep stages[0120]).
Regarding claim 2, Lee discloses The method of claim 1, wherein+ , performing the patient care is via: the processing resource determining the stimulation therapy to be delivered to upper airway patency-related tissue of the patient; and the implantable medical device delivering the stimulation therapy to the upper airway patency-related tissue as determined by the processing resource and as timed with the respiratory information, the respiratory information being received by the implantable medical device from the implantable sensing component(For example, a treatment for obstructive sleep apnea involves compensating for the decreased muscle activity by electrical activation of the tongue muscles. The hypoglossal (HG) nerve innervates the protrusor and retractor tongue muscles. In one approach, an appropriately applied electrical stimulation to the hypoglossal nerve, for example, may prevent backward movement of the tongue, thus preventing the tongue from obstructing the airway[0039].FIG. 1E is a flowchart illustrating a method for providing sleep disordered breathing therapy feedback information based on an effectiveness of the sleep disordered breathing therapy. The patient's respiration is sensed 160 and a respiration waveform is generated 162. The sensed respiration waveform is used to detect 164 disordered breathing events. An apnea/hypopnea index (AHI) is calculated 166 based on the detected disordered breathing events. The AHI is used to assess the effectiveness 168 of the sleep disordered breathing therapy. A lower AHI indicates more effective breathing treatment than a relatively higher AHI, for example. Feedback information is developed 168 based on the disordered breathing index. The feedback information is transmitted 170 to the therapy device. The therapy device uses the feedback information to adjust 172 the sleep disordered breathing therapy[0054][Fig. 1E]).
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Regarding claim 3, Lee discloses the method of claim 2, comprising: delivering, via a stimulation element of the implantable medical device, the determined stimulation therapy to the upper airway patency-related tissue, wherein the implantable medical device includes stimulation signal generating circuitry(In accordance with another embodiment of the invention, a method of adjusting sleep disordered breathing therapy includes monitoring one or more patient conditions using a monitoring device having circuitry disposed within an implantable housing. Feedback information for controlling sleep disordered breathing therapy is developed based on the one or more monitored conditions[0009]).
Regarding claim 4, Lee discloses the method of claim 2, comprising, via the processing resource: receiving the respiratory information as sensed by the implantable sensing component; integrating the respiratory information with the stimulation therapy activity information, the patient management information, and the external patient monitoring information; based on the integrated information, performing patient care by determining the stimulation therapy to be delivered by the implantable medical device to the upper airway patency-related tissue of the patient and as timed with the respiratory information to treat obstructing sleep apnea, wherein the stimulation therapy includes a stimulation therapy signal that is adjusted based on the external patient monitoring information and timed based on the respiratory information; and communicating the determined stimulation therapy to the implantable medical device(The method of claim 31, wherein: providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a respiratory therapy device delivering a patient-external respiration therapy to treat the sleep disordered breathing; and adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the patient-external respiration therapy[claim 35]. The methods illustrated in the flowcharts of FIGS. 23 and 24 contemplate real-time monitoring of patient conditions allowing the therapy system to dynamically adjust the therapy regimen to accommodate the changing needs of the patient. In one configuration, the therapy may be adjusted during the period that therapy is delivered to the patient[0214]. In one approach, the implantable device may transmit information about the sensed patient conditions to the separate medical device. The separate medical device may develop the feedback information. The feedback information and/or information related to the monitored conditions may be printed, displayed and/or stored. The feedback information may be used to manually or automatically adjust the sleep disordered breathing therapy. For example, the separate medical device may transmit the feedback information to the therapy device. The feedback information may be used by the therapy device to automatically adjust the sleep disordered breathing therapy[0048]).
Regarding claim 5, Lee discloses the method of claim 2, wherein determining the stimulation therapy comprising: adjusting an intensity of a stimulation therapy signal via at least one of an amplitude, a pulse width, and a duty cycle and causing application of the stimulation therapy signal with the adjusted intensity as delivered by the implantable medical device(If the therapy effectiveness is acceptable 2350, e.g., terminates or reduces the patient's disordered breathing or meets some other desired goal, then the therapy may be adapted 2360 to provide a less aggressive therapy, e.g., air delivered at a decreased pressure, cardiac pacing delivered at a higher rate, nerve stimulation delivered at a lower amplitude. If the therapy is not effective 2350, then the therapy may be adapted 2370 to enhance therapy efficacy by providing a more aggressive therapy, e.g., delivering air at an increased pressure, cardiac pacing delivered at a lower rate, nerve stimulation delivered at a lower amplitude[0209]).
Regarding claim 6, Lee discloses the method of claim 5, comprising automatically implementing the adjusting of the intensity of the stimulation therapy signal based on at least one of the externally patient monitoring information and the patient management information(As illustrated in the flowchart of FIGS. 1A and 1B, embodiments of the invention are directed to monitoring 110 one or more patient conditions using an implantable monitoring device. Feedback information is developed 112 based on the monitored conditions. The feedback information is provided 114 to a device delivering therapy to treat sleep disordered breathing. The monitoring device and the therapy device have separate housings. Components of the monitoring device are disposed within an implantable housing. The therapy device may comprise a housing that is implantable or patient-external. The feedback information may be used to adjust 120 (FIG. 1B) the sleep disordered breathing therapy[0043]).
Regarding claim 7, Lee discloses the method of claim 1, wherein receiving the externally patient monitoring information comprises receiving the physiologic information including at least one of: cardiac information; respiratory information; chest motion; oxygen desaturation information; peripheral arterial information; blood pressure; body position; and acoustic information including snoring(Patient conditions monitored by the implantable device may include both physiological and non-physiological contextual conditions affecting the patient. Physiological conditions may include a broad category of conditions associated with the internal functioning of the patient's physiological systems, including the cardiovascular, respiratory, nervous, muscle and other systems. Examples of physiological conditions include blood chemistry, patient posture, patient activity, respiration quality, sleep quality, among others[0111]).
Regarding claim 8, Lee discloses the method of claim 1, wherein receiving the externally patient monitoring information comprises receiving determined information including at least two of: sleep disorder breathing (SDB)-related index information; sleep information; and cardiac information(The monitoring device senses 134 one or more conditions associated with disordered breathing during sleep. One or more disordered breathing events occurring during sleep are detected 136. Characteristics of the sleep disordered breathing events, such as, severity, frequency, and/or duration, may be determined 138. Determination of the one or more characteristics of the sleep disordered breathing events may involve calculation of one or more indices characterizing the disordered breathing events. The indices may include, for example, an apnea/hypopnea index (AHI) and/or a percent time in periodic breathing (% PB), among other indices. Feedback information is provided 140 to a device delivering therapy for sleep disordered breathing based on the one or more characteristics of the sleep disordered breathing events[0050]).
Regarding claim 9, Lee discloses the method of claim 1, wherein performing the patient care further includes via determining patient management actions and communicating the determined patient management actions(In another embodiment of the invention, the monitoring and therapy devices 210, 220 may be used within the structure of an advanced patient management (APM) system. As previously discussed, advanced patient management systems involve a system of medical devices that are accessible through various communications technologies. For example, patient data may be downloaded from one or more of the medical devices periodically or on command, and stored at a patient information server. The physician and/or the patient may communicate with the medical devices and the patient information server, for example, to acquire patient data or to initiate, terminate or modify therapy[0070]).
Regarding claim 10, Lee discloses the method of claim 9, wherein the patient management actions comprise at least one of: scheduling a patient office visit; implementing at least one of a communication and a command to adjust parameters of the stimulation therapy; and implementing at least one of a communication and a command to adjust parameters of the external patient monitoring(The monitoring unit uses inputs from the patient internal sensors 241, patient-external sensors 242, patient input device 243, and/or other information systems 244 to monitor one or more patient conditions. In one embodiment, a therapy feedback unit 216 having circuitry disposed within the implantable housing of the monitoring device uses the sensed conditions to develop feedback information that may be used to adjust the sleep disordered breathing therapy delivered to the patient by the therapy device 220. In another embodiment, the therapy feedback unit 216 is disposed within a separate device, such as a patient management server 230 of an APM system. In yet another embodiment, the therapy feedback unit 216 may be disposed within the therapy device 220[0061]).
Regarding claim 11, Lee discloses the method of claim 9, comprising: performing the determined patient management actions via: receiving, via a-the processing resource, patient information from a patient device; and displaying, via the processing resource, at least some of the patient information on a clinician portal, wherein the integrated information comprises the patient information(The monitoring circuitry 627 includes a memory 636 for storing information derived from signals produced by the patient-internal sensors 611, patient-external sensors 612, patient input devices 613, and/or other information systems 614. The memory 636 may also store information about detected events, e.g., sleep and disordered breathing events, and/or information related to calculated indices characterizing various events such as sleep and/or disordered breathing events. The stored data may be transferred to the feedback unit 625 and used to develop feedback information to control disordered breathing therapy. The stored data may be retrieved by another component of the medical device 601 for later use, or may be transmitted to a separate device 640 for storage, further processing, trending, analysis and/or display, for example. In one scenario, the stored data can be downloaded to a separate device periodically or on command. The stored data may be presented to the patient's health care professional on a real-time basis, or as a long-term, e.g., month long or year long, trend of daily measurements[0116]).
Regarding claim 17, Lee discloses the method of claim 1, wherein the implantable sensing component comprises an accelerometer(The sleep-related conditions may be sensed using implantable sensors and/or patient-external sensors, for example. In one embodiment, patient activity may be compared to a sleep threshold to determine when the patient is asleep. A low level of activity is indicative that the patient is sleeping. Patient activity may be sensed, for example, using an accelerometer positioned on or in the housing of an implantable cardiac device, or in another convenient location. The accelerometer signal may be correlated with activity level or workload[0128]).
Regarding claim 18, Lee discloses the method of claim 1, comprising: receiving the stimulation therapy activity information from the implantable medical device as communicated from the implantable medical device to a patient remote control device to a patient computing device to the processing resource; receiving the patient management information from a clinician computing device; and receiving the external patient monitoring information from the third party device as communicated from the third party device to the processing resource or from the third party device to the patient computing device to the processing resource(The APM patient information server 230 may be used to download and store data collected by the monitoring device 210 and/or the therapy device 220. In one implementation, the patient internal device 210 and/or the patient-external device 220 may be communicatively coupled to device programmers 260, 270. The programmer 260 may provide indirect communication between the patient internal device 210 and the patient information server 230. The programmer 270 may provide indirect communication between the patient external device 220 and the patient information server 230[0071][Fig. 2]).
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Regarding claim 19, Lee discloses the method of claim 1, comprising: receiving the stimulation therapy activity information from a plurality of implantable medical devices including the implantable medical device; receiving the patient management information from a plurality of clinician computing devices; and receiving the external patient monitoring information from a plurality of third party devices including the third party device(The APM patient information server 230 may be used to download and store data collected by the monitoring device 210 and/or the therapy device 220. In one implementation, the patient internal device 210 and/or the patient-external device 220 may be communicatively coupled to device programmers 260, 270. The programmer 260 may provide indirect communication between the patient internal device 210 and the patient information server 230. The programmer 270 may provide indirect communication between the patient external device 220 and the patient information server 230[0071]. The data stored on the APM patient information server 230 may be accessible by the patient and the patient's physician through terminals 250, e.g., remote computers located in the patient's home or the physician's office. The APM patient information server 230 may be communicate with one or more of the monitoring and therapy devices 210, 220 to effect remote control of the monitoring, diagnosis, and/or therapy functions of the medical devices 210, 220[0072]).
Regarding claim 21, Lee discloses the method of claim 1, wherein the implantable sensing component is: on-board the implantable medical device; or separate from a housing of the implantable medical device and in communication therewith(The sleep-related conditions may be sensed using implantable sensors and/or patient-external sensors, for example. In one embodiment, patient activity may be compared to a sleep threshold to determine when the patient is asleep. A low level of activity is indicative that the patient is sleeping. Patient activity may be sensed, for example, using an accelerometer positioned on or in the housing of an implantable cardiac device, or in another convenient location. The accelerometer signal may be correlated with activity level or workload[0128]).
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:
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) 13-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Hughes(US 20220323766 A1) (cited previously).
Regarding claim 13, Lee discloses the method of claim 11, but fails to disclose wherein the displaying comprises: arranging the clinician portal to be displayable on a user interface of a clinician computing device in communication with the processing resource.
However, Hughes teaches “FIG. 6 depicts a representation of an example user interface of a clinician programmer device with additional details for facilitating graphic controls with respect to an AV communication session and a remote therapy session in an integrated remote care service application for purposes of some embodiments of the present disclosure. As illustrated, GUI screen 600 is representative of a display screen that may be presented at the clinician device after establishing that remote therapy programming is to be effectuated for a selected remote patient[0082]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep disorder feedback system of Lee with the neurostimulation therapy of Hughes. Doing so would clarify a display and portal for the clinician to view patient information and decide on adjustments to the therapy.
Regarding claim 14, Lee discloses the method of claim 11, but fails to explicitly state wherein the receiving from the patient device comprises: receiving the patient information via a communication link between the patient device and the processing resource; and receiving the patient information at the patient device, via a patient app hosted on the patient device.
However, Hughes teaches “The GUI display for reporting patient outcomes may be provided as a single app or may be integrated with other digital health apps (such as a remote programming/virtual clinic app and/or the patient controller app for controlling operations of the IMD or minimally invasive device). Example GUI display screen 1100F shown in FIG. 11F is illustrative of a menu panel for use by the patient to input data related to the patient's condition related to the therapy provided by the patient's IMD or minimally invasive device[0106]. As previously noted, one or more remote data logging platforms 1216 of system 1200 (shown in FIG. 12) may be configured to obtain, receive or otherwise retrieve data from patient controller devices, clinician programmer devices and other authorized third-party devices[0109]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neuromodulation treatment of Hyde with the neurostimulation therapy of Hughes. Doing so would specify the third party device could be an app configured to both send and receive patient information.
Regarding claim 15, Lee in view of Hughes teaches he method of claim 14, but Hyde fails to disclose comprising: receiving, via the patient app, the patient information from a patient remote control, wherein the patient information comprises at least one of: information received from the implantable medical device; and information, from the patient remote control, regarding patient use of the patient remote control.
However, Hughes teaches “The GUI display for reporting patient outcomes may be provided as a single app or may be integrated with other digital health apps (such as a remote programming/virtual clinic app and/or the patient controller app for controlling operations of the IMD or minimally invasive device). Example GUI display screen 1100F shown in FIG. 11F is illustrative of a menu panel for use by the patient to input data related to the patient's condition related to the therapy provided by the patient's IMD or minimally invasive device[0106]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep disorder feedback system of Lee with the neurostimulation therapy of Hughes. Doing so would specify the third party device could be an app configured to both send and receive patient information.
Regarding claim 16, Lee in view of Hughes teaches the method of claim 14, but Hyde fails to disclose comprising: receiving, via the patient app, the patient information from a third party device, wherein the patient information comprises the physiologic information.
However, Hughes teaches “System 4000 may include one or more wearable devices 4004 (such as a smartwatch device) with, possibly, one or more patient apps. System 4000 may include patient controller device 4003 with, possibly, one or more patient apps. Patient controller device 4003 and wearable device(s) 4004 may communicate with digital health infrastructure 4005 as discussed herein[0194]. As previously noted, one or more remote data logging platforms 1216 of system 1200 (shown in FIG. 12) may be configured to obtain, receive or otherwise retrieve data from patient controller devices, clinician programmer devices and other authorized third-party devices[0109]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep disorder feedback system of Lee with the neurostimulation therapy of Hughes. Doing so would specify the third party device could be an app configured to both send and receive patient information.
Regarding claim 20, Lee discloses the method of claim 1, wherein the patient management information includes patient information, patient survey information, patient usage information indicative of the stimulation therapy, and visit information associated with patient care provided by a clinician.
However, Hughes teaches “Patient aggregate data (PAD) 1250 may include basic patient data including patient name, age, and demographic information, etc. PAD 1250 may also include information typically contained in a patient's medical file such as medical history, diagnosis, results from medical testing, medical images, etc. The data may be inputted directly into system 1200 by a clinician or medical professional. Alternatively, this data may be imported from digital health records of patients from one or more health care providers or institutions[0110]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep disorder feedback system of Lee with the neurostimulation therapy of Hughes. Doing so would specify the patient data in the system to encompass all forms of patient information to allow the system to optimize patient treatment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 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. New art Lee has been found and teaches all newly claimed material of claims 1-11 and new claims 18, 19, and 21. Lee has been combined with prior art Hughes to disclose all claimed material. Therefore, the new 102 rejections and 103 rejections for all claims stand.
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 MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796