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 Arguments
Applicant's arguments filed 3/4/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11 that the prior art does not teach the following 4 underlined claimed limitations “establishing a target therapy signature; providing an implantable neuromodulation device in an anterior cervical region of a patient, the device including a first electrode lead, coupled to signal generator circuitry in the device, the first electrode lead disposed at or near a first cranial nerve target in the patient; applying a first neuromodulation therapy to the first cranial nerve target using first electrical signals from the signal generator circuitry and using electrodes of the first electrode lead and, in response, detecting a first therapy signature; determining a difference between the first therapy signature and the target therapy signature; and applying a second neuromodulation therapy to the first cranial nerve target using second electrical signals from the signal generator circuitry and using the electrodes of the first electrode lead, wherein a characteristic of the second electrical signals is selected based on the determined difference between the first therapy signature and the target therapy signature”.
Regarding the limitation “establishing a target therapy signature”, [0102] of the applicant’s printed publication states “The target therapy signature can be based on sensor information, such as from one or more of the sensor(s) 606 or a different implanted or external sensor, about a physiologic status or response of a patient. In an example, establishing the target therapy signature can include providing a test neuromodulation therapy to a first nerve target and monitoring, in response to the test neuromodulation therapy, an evoked compound action potential (ECAP) magnitude at or near the first nerve target, an acoustic profile indicating an openness of an airway of the patient, and/or a tongue movement of the patient”. [0058] of Papay states “the system 50 also includes one or more sensing components 52 configured to detect at least one physiological parameter or a related symptom of OSA. The presence of the sensing component 52 enables closed-loop operation of the system 50 to treat OSA, meaning that treatment parameters (e.g., therapy signals) may be automatically adjusted in response to the sensed or detected physiological parameter or a related symptom of OSA”. Thus, the “target therapy signature” is the first iteration of the closed loop in figure 11 as it is sensed data responsive to stimulation used to work towards some optimal patient state.
Regarding the limitation “detecting a first therapy signature”. [0104] of the applicant’s printed publication states “In an example, block 1006 can include, in response to the first neuromodulation therapy, receiving or detecting a therapy response or a first therapy signature. The therapy response or signature information can be received using any one or more of the sensor(s) 606, or using a sensor external to the implantable system 602”. Thus, step 76 in figure 11 during the second iteration of the closed loop will read on “detecting a first therapy signature” as step 76 of Papay is generating sensed data in response to the previous iteration of stimulation.
Regarding the limitation “determining a difference between the first therapy signature and the target therapy signature”, [0105] of the applicant’s printed publication discloses this step. The examiner believes the cited sections (e.g. see figure 11, step 80 [0058]-[0059]) of the rejection under Papay teach this limitation. In particular, the examiner believes the closed loop stimulation will necessarily determine a difference between the current patient state and the optimal patient state. This is fundamental to the closed loop system of Papay. The examiner believes one of ordinary skill in the art would arrive at the same conclusion as the closed loop keeps iterating to arrive at an optimal patient state as sensed by the sensor signal in step 76 of figure 11 of Papay. The examiner would be more sympathetic to this argument if the applicant’s specification brought more criticality to the limitation “determining a difference between the first therapy signature and the target therapy signature”. However, [0105] simply states that a difference is determined, which the examiner believes is taught by Papay.
Regarding the limitation “wherein a characteristic of the second electrical signals is selected based on the determined difference between the first therapy signature and the target therapy signature”, [0106] of the applicant’s printed publication discloses this step. [0058] of Papay discloses “The presence of the sensing component 52 enables closed-loop operation of the system 50 to treat OSA, meaning that treatment parameters (e.g., therapy signals) may be automatically adjusted in response to the sensed or detected physiological parameter or a related symptom of OSA”. This seems to be exactly what the applicant is claiming. Similar to the previous paragraph, the examiner believes as the closed loop keeps iterating to arrive at an optimal patient state as sensed by the sensor (adjusting the stimulation signal in response to the sensed parameters), that is necessarily adjusting a characteristic of the stimulation signal based on the difference between the current state of the patient and the optimal desired patient state. The examiner believes one of ordinary skill in the art would arrive at the same conclusion.
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.
Claim(s) 28-29, 31-41, and 48-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papay et al. (Pub. No.: US 2020/0016401 A1); hereinafter referred to as “Papay in view of Scheiner et al. (Pub. No.: US 2021/0228873 A1); hereinafter referred to as “Scheiner” and further evidenced by Rise et al. (U.S. Pat. No. 5,716,377); hereinafter referred to as “Rise”.
Regarding claim 28, Papay discloses a method for treating a sleep disorder or a breathing disorder of a patient (e.g. see abstract), the method comprising: establishing a target therapy signature (e.g. see figure 11 step 76, the “target therapy signature” is the first iteration of the closed loop in figure 11 as it is sensed data responsive to stimulation used to work towards some optimal patient state); providing an implantable neuromodulation device (e.g. see figure 3 element 50, [0051], [0053]) the device including a first electrode lead (e.g. see figures 1, 4, 5, element 22, [0056], [0060]), coupled to signal generator circuitry (e.g. see figure 3 element 14 [0052]) in the device, the first electrode lead disposed at or near a first cranial nerve target in the patient (e.g. see [0048], [0057], [0071]); applying a first neuromodulation therapy to the first cranial nerve target using first electrical signals from the signal generator circuitry and using electrodes of the first electrode lead (e.g. see figure 11, step 78) and, in response, detecting a first therapy signature (e.g. figure 11 step 76, the second iteration of the closed loop will read on “detecting a first therapy signature” as step 76 of Papay is generating sensed data in response to the previous iteration of stimulation); determining a difference between the first therapy signature and the target therapy signature (e.g. see figure 11 step 80, [0058]-[0059], Note: The examiner believes the closed loop stimulation will necessarily determine a difference between the current patient state and the optimal patient state. This is fundamental to the closed loop system of Papay. The examiner believes one of ordinary skill in the art would arrive at the same conclusion as the closed loop keeps iterating to arrive at an optimal patient state as sensed by the sensor signal in step 76 of figure 11 of Papay); and applying a second neuromodulation therapy to the first cranial nerve target using second electrical signals from the signal generator circuitry and using the electrodes of the first electrode lead (e.g. see figure 11, step 80 [0058]-[0059]. Note: The closed loop system and method of the prior art will apply “a second neuromodulation therapy”), wherein a characteristic of the second electrical signals is selected based on the determined difference between the first therapy signature and the target therapy signature (e.g. see figure 11, step 80 [0058]-[0059]. Note: [0058] of Papay discloses “The presence of the sensing component 52 enables closed-loop operation of the system 50 to treat OSA, meaning that treatment parameters (e.g., therapy signals) may be automatically adjusted in response to the sensed or detected physiological parameter or a related symptom of OSA”. This seems to be exactly what the applicant is claiming. The examiner believes as the closed loop keeps iterating to arrive at an optimal patient state as sensed by the sensor (adjusting the stimulation signal in response to the sensed parameters), that is necessarily adjusting a characteristic of the stimulation signal based on the difference between the current state of the patient and the optimal desired patient state).
Papay discloses providing an implantable neuromodulation device (e.g. see figure 3 element 50, [0051], [0053]) but is silent as to the implantable neuromodulation device being implanted in an anterior cervical region of a patient. Scheiner teaches that it is known to use such a modification as set forth in [0062], figure 1 element 16 (NOTE: The examiner is interpreting the anterior cervical region as the region in front of the spine in the neck) to provide stimulation generation circuitry spaced apart from the stimulation electrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an IMD implanted in the neck as taught by Scheiner in the system/method of Papay, since said modification would provide the predictable results of stimulation generation circuitry spaced apart from the stimulation electrodes.
Regarding claim 29, Papay discloses the target therapy signature includes information about a target position or target displacement of a tongue of the patient (e.g. see [0049], [0059], [0078]).
Regarding claim 31, Papay discloses the claimed invention but is silent as to the target therapy signature includes information about an acoustic profile indicative of an airway obstruction or airway openness for the patient. Scheiner teaches that it is known to use such a modification as set forth in [0090] to provide sensor data indicative of the onset of OSA (e.g. see [0090]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use acoustic sensing as taught by Scheiner in the system/method of Papay, since said modification would provide the predictable results of sensor data indicative of the onset of OSA.
Regarding claim 32, Papay discloses establishing the target therapy signature includes providing a test neuromodulation therapy (e.g. see figure 11, step 76 [0058]-[0059]) to the first cranial nerve target and monitoring, in response to the test neuromodulation therapy, an evoked compound action potential (ECAP) magnitude at or near the first cranial nerve target (e.g. see [0059], incorporated reference U.S. Pat. No. 5,716,377, Rise, see column 4 lines 13-18) and a tongue movement of the patient (e.g. see [0059], [0078]) but is silent as to sensing an acoustic profile indicating an openness of an airway of the patient. Scheiner teaches that it is known to use such a modification as set forth in [0090] to provide sensor data indicative of the onset of OSA (e.g. see [0090]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use acoustic sensing as taught by Scheiner in the system/method of Papay, since said modification would provide the predictable results of sensor data indicative of the onset of OSA.
Regarding claim 33, Papay discloses establishing the target therapy signature includes using information from an accelerometer implanted in or coupled to the patient (e.g. see [0059], incorporated reference U.S. Pat. No. 5,716,377 see column 3 lines 55-67).
Regarding claim 34, Papay discloses detecting the first therapy signature includes using acoustic signal or physical displacement information from an accelerometer, and wherein establishing the target therapy signature includes using information from the same accelerometer (e.g. see [0059], incorporated reference U.S. Pat. No. 5,716,377 see column 3 lines 55-67).
Regarding claim 35, Papay discloses applying the second neuromodulation therapy includes changing one or more of a pulse width, pulse amplitude, waveform shape, stimulation frequency, burst pattern, or electrode configuration relative to the first neuromodulation therapy (e.g. see [0052]).
Regarding claim 36, Papay discloses applying the first neuromodulation therapy to the first cranial nerve target includes applying the first neuromodulation therapy to a hypoglossal nerve of the patient to treat obstructive sleep apnea (e.g. see [0048], [0057], [0071]).
Regarding claim 37, Papay discloses the claimed invention but is silent as to the target therapy signature includes using information about a patient posture. Scheiner teaches that it is known to use such a modification as set forth in [0090] to provide sensor data indicative of the patient lying down (e.g. see [0090]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use posture sensing as taught by Scheiner in the system/method of Papay, since said modification would provide the predictable results of sensor data indicative of the patient lying down.
Regarding claim 38, Papay discloses applying the first neuromodulation therapy includes using a unilateral electrostimulation therapy, and wherein applying the second neuromodulation therapy includes using a bilateral electrostimulation therapy (e.g. see [0057], [0078]).
Regarding claim 39, Papay discloses determining the difference between the first therapy signature and the target therapy signature includes identifying a tongue position bias toward a particular side of the patient (e.g. see [0049], [0059]).
Regarding claim 40, Papay discloses the second electrical signals comprise a bilateral electrostimulation therapy provided across at least a portion of a midline of the patient (e.g. see [0057], [0078]).
Regarding claim 41, Papay discloses the second electrical signals comprise a pair of electrostimulation therapy signals provided to respective neural targets on opposite sides of a midline of the patient (e.g. see [0057], [0078]).
Regarding claims 48-52, see the rejection for claims 28-41 above.
Regarding claim 53, the target therapy signature corresponds to an unobstructed airway for the patient (e.g. see [0075], [0078]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Papay in view of Scheiner and further evidenced by Rise as applied to claim 28 above, and further in view of Mauger et al. (Pub. No.: US 2023/0310862 A1); hereinafter referred to as “Mauger”.
Regarding claim 30, Papay discloses sensing evoked compound action potentials (e.g. see [0059], incorporated reference U.S. Pat. No. 5,716,377 see column 4 lines 13-18) but is silent as to the target therapy signature includes information about an evoked compound action potential for a hypoglossal nerve target. Mauger teaches that it is known to use such a modification as set forth in [0025] to provide stimulation of the hypoglossal nerve that can be used to move the tongue from blocking the recipient's airway (e.g., during inhalation), with the stimulation level selected to provide the desired opening of the airway while avoiding having the recipient experience pain (e.g. see [0013]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use ECAP sensing of the hypoglossal nerve as taught by Mauger in the system/method of Papay, since said modification would provide the predictable results of stimulation of the hypoglossal nerve that can be used to move the tongue from blocking the recipient's airway (e.g., during inhalation), with the stimulation level selected to provide the desired opening of the airway while avoiding having the recipient experience pain (e.g. see [0013]).
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 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, Unsu Jung can be reached at 571-272-8506. 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.
/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights