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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/17/2026 has been entered.
Response to Arguments
35 USC § 112
The examiner has raised a 35 USC § 112 written description rejection for the phrase “determining the difference”.
35 USC § 103
Applicant's arguments filed 9/17/2026 have been fully considered but they are not persuasive in view of the new grounds of rejection as necessitated by the applicant’s claim amendment. The prior art is now being applied for the “determining” and “applying” as follows:
“determining a difference between the first therapy signature and the target therapy signature (e.g. see figure 11 step 80, [0078]-[0079], Note: In [0079], Papay discloses “Advantageously, the method 70 provides a minimally invasive, automatic, and aesthetically acceptable treatment modality for OSA that is continually titrated to optimize its efficacy based on continuous physiological feedback, thereby enabling a high degree of patient-specific customization”. The examiner believes this closed loop stimulation will necessarily determine a difference between the current patient state and the optimal patient state and that 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); wherein determining the difference includes measuring a difference between one or more characteristics associated with the target therapy signature and one or more corresponding characteristics associated with the first therapy signature (e.g. see [0049], [0059], [0078]-[0079]. Note: In [0078], Papay discloses “In patients with OSA, the posterior base of the tongue can fall backwards and obstruct breathing, especially when individuals lay flat on their backs. Therapy signal(s) from the neuromuscular stimulator 16 can be delivered to the first target tissue on a continuous, periodic, or an as-needed basis to displace the posterior base of the tongue in an anterior direction (and/or change the surface morphology of the posterior tongue base to allow and increase oropharyngeal airway volume) while the subject is sleeping. This prevents obstruction of the airway during sleep by ensuring that airflow through the airway of the subject is properly maintained”. Thus, the “characteristic associated with the target therapy signature” is the tongue position, as disclosed by Papay in [0049], [0059], and [0078]. The applicant discloses using the same characteristic in “Example 20” in [0143] and [0162] of the applicant’s specification. The applicant’s specification also discloses in [0105] that ECAP or acoustic measurements may be the “characteristic associated with the target therapy signature”. The prior art also contemplates these scenarios. See the rejection for claims 32 and 50 below) 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 [0078]-[0079]. 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 [0078]-[0079], [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” and [0078] discloses “The controller 26 can then control operation of the neuromuscular stimulator to adjust application of the therapy signal(s) to the first target tissue in response to the sensor signal”. 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), it 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. Stimulation timing will read on “characteristic of the stimulation signal”)”.
Note in the rejection that the “characteristic associated with the target therapy signature” is the tongue position, as disclosed by Papay in [0049], [0059], and [0078]. The applicant discloses using the same characteristic in “Example 20” in [0143] and [0162] of the applicant’s specification. The applicant’s specification also discloses in [0105] that ECAP or acoustic measurements may be the “characteristic associated with the target therapy signature”. The prior art also contemplates these scenarios. See the rejection for claims 32 and 50 below.
Claim Rejections - 35 USC § 112
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 28-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The examiner contends the phrase “determining the difference” does not meet the written description requirement. The determined difference is disclosed in the following paragraphs of the applicant’s specification:
[0105] At block 1008, the second routine 1000 can include determining a difference between the first therapy signature (e.g., received at block 1006) and the target therapy signature (e.g., established at block 1002). In an example, the difference can be determined automatically using processing circuitry in the implantable system 602, or can be determined manually or automatically outside of the implantable system 602. In an example, determining the difference between the therapy signatures includes qualifying or measuring a difference between one or more characteristics associated with the target therapy signature (e.g., an ECAP, acoustic, movement, posture, or other characteristic) and one or more corresponding characteristics associated with the first therapy signature.
[0106] At block 1010, the second routine 1000 can include 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. In an example, at least one characteristic of the second electrical signals can be selected or changed based on the determined difference between the first and target therapy signatures (e.g., from block 1008). The second routine 1000 can optionally continue with further iterations of establishing or updating a target therapy signature, providing a subsequent neuromodulation therapy, and monitoring a patient response.
[0142] In Example 19, the subject matter of Examples 1-18 can optionally include or use the processor circuit configured to determine whether a magnitude of an ECAP signal response to the subsequent electrostimulation therapy is different than a magnitude of an ECAP signal response to the first electrostimulation therapy, and the processor circuit can be configured to use information about the difference in ECAP signal responses to select a parameter for use in a further subsequent electrostimulation therapy.
[0143] In Example 20, the subject matter of Examples 1-19 can optionally include or use the processor circuit configured to determine whether a tongue excursion or displacement response to the subsequent electrostimulation therapy is different than a tongue excursion or displacement response to the first electrostimulation therapy, and the processor circuit can be configured to use information about the difference in tongue excursion or displacement to select a parameter for use in a further subsequent electrostimulation therapy.
[0144] In Example 21, the subject matter of Examples 1-20 can optionally include or use the processor circuit configured to determine whether an acoustic response following the first electrostimulation therapy is different than an acoustic response following the subsequent electrostimulation therapy, wherein the acoustic responses indicate different levels of airway obstruction for the patient, and the processor circuit can be configured to use information about the difference in acoustic responses to select a parameter for use in a further subsequent electrostimulation therapy.
[0151] Example 28 is a method for treating a sleep disorder or a breathing disorder of a patient, the method comprising 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.
[0162] In Example 39, the subject matter of Examples 28-38 can optionally include or use determining the difference between the first therapy signature and the target therapy signature including identifying a tongue tissue position bias or direction toward a particular side of the patient.
Thus, the applicant discloses a difference is determined, but never actually discloses how the difference is determined. The examiner is not clear if determining a difference entails a subtraction step, a binary comparison, a difference based on magnitude, an algorithm determined difference, etc. No written description is provided. Further, the applicant never discloses how the determined difference is then used to select the stimulation signals. The examiner is not clear if the determined difference is scaled to select the stimulation, or the absolute magnitude is used to select the stimulation, or an algorithm-based approach, etc. No written description is provided. Without written description for these steps, the phrases may be interpreted broadly.
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, [0078]-[0079], Note: In [0079], Papay discloses “Advantageously, the method 70 provides a minimally invasive, automatic, and aesthetically acceptable treatment modality for OSA that is continually titrated to optimize its efficacy based on continuous physiological feedback, thereby enabling a high degree of patient-specific customization”. The examiner believes this closed loop stimulation will necessarily determine a difference between the current patient state and the optimal patient state and that 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); wherein determining the difference includes measuring a difference between one or more characteristics associated with the target therapy signature and one or more corresponding characteristics associated with the first therapy signature (e.g. see [0049], [0059], [0078]-[0079]. Note: In [0078], Papay discloses “In patients with OSA, the posterior base of the tongue can fall backwards and obstruct breathing, especially when individuals lay flat on their backs. Therapy signal(s) from the neuromuscular stimulator 16 can be delivered to the first target tissue on a continuous, periodic, or an as-needed basis to displace the posterior base of the tongue in an anterior direction (and/or change the surface morphology of the posterior tongue base to allow and increase oropharyngeal airway volume) while the subject is sleeping. This prevents obstruction of the airway during sleep by ensuring that airflow through the airway of the subject is properly maintained”. Thus, the “characteristic associated with the target therapy signature” is the tongue position, as disclosed by Papay in [0049], [0059], and [0078]. The applicant discloses using the same characteristic in “Example 20” in [0143] and [0162] of the applicant’s specification. The applicant’s specification also discloses in [0105] that ECAP or acoustic measurements may be the “characteristic associated with the target therapy signature”. The prior art also contemplates these scenarios. See the rejection for claims 32 and 50 below) 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 [0078]-[0079]. 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 [0078]-[0079], [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” and [0078] discloses “The controller 26 can then control operation of the neuromuscular stimulator to adjust application of the therapy signal(s) to the first target tissue in response to the sensor signal”. 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), it 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. Stimulation timing will read on “characteristic of the stimulation signal”).
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
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.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
