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 .
Priority
This action is a continuation of US Application no. 18/742,859, now US Patent no. 12,194,300, filed 13 June 2024, which claims the benefit of domestic priority from US Provisional Application no. 63/519,463, filed 14 August 2023.
Claim Rejections - 35 USC § 102
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 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)(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) 1-8, 11-20, 22, 23, and 25 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Verzal et al. (US Publication no. 2024/0252824). In regard to claim 1, Verzal et al. disclose a system for managing obstructive sleep apnea for a person (para 59), the system comprising (see figures 4 and 5a):
a first implantable electrode 716 configured to deliver a first stimulation signal proximate to a first nerve 505R or 505L (hypoglossal nerve) of the person to stimulate the first nerve and activate at least one first muscle for an upper airway dilation of the person (para 133; hypoglossal nerve stimulation reduces collapsibility of upper airway, para 130);
a second implantable electrode 713 configured to deliver a second stimulation signal proximate to a second nerve (ansa-cervicalis related nerve) to stimulate the second nerve and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person (para 136; stimulation of muscles innervated by ansa-cervicalis cause the larynx to be pulled inferiorly which is considered the same physioloigical effect for the pulling force on the airway of caudal tracheal traction, para 74, 496, and 696 the sternothyroid muscles and/or sternohyoid muscles pull down on the thyroid/larynx) and
a stimulation signal generator (para 94, implantable pulse generator 533 as shown in at least figures 3A-5B), configured to deliver the first stimulation signal 5031 (figure 33a) to the first implantable electrode 716, and deliver the second stimulation signal 5041 (figure 33a) to the second implantable electrode 713 (para 475, protocol 5031 is applied to the hypoglossal nerve, protocol 5041 is applied to the ansa-cervicalis), the first stimulation signal 5031 having a series of first stimulation cycles 5035 each including a first stimulation period 5032 and a first non-stimulation period 5034, the second stimulation 5041 signal having a series of second stimulation cycles 5046 each including a second stimulation period 5043 and a second non-stimulation period 5045, the delivery of the first stimulation signal being coordinated with the delivery of the second stimulation signal (para 476-479, cycles are explicitly taught and demonstrated in at least figure 33a, stimulation protocol 5030 explicitly shows delivery cycle 5031 coordinated to cycle 5043 (para 74 explicitly teaches this as well); Verzal et al. apply a variety of different stimulation protocols or modes as depicts in various figures 33A-37G, wherein the protocol of figure 35 also depicts a coordinated delivery of the first stimulation signal with the second delivery signal),
wherein the second stimulation signal is configured to activate sternothyroid and sternohyoid simultaneously (para 443, upper airway patency is maintained by contraction of the sternothyroid and/or sternohyoid, the coordinating conjunction AND is considered both muscles are caused to be contracted together in simultaneous fashion).
In regard to claim 2, In Verzal et al., the second implantable electrode 713 is positioned at or proximate to a nerve segment connecting to a first branch and a second branch of an ansa cervicalis nerve to activate the sternothyroid and the sternohyoid simultaneously (para 136; stimulation of muscles innervated by ansa-cervicalis cause the larynx to be pulled inferiorly which is considered the same physioloigical effect for the pulling force on the airway of caudal tracheal traction, para 74, 496, and 696 the sternothyroid muscles and/or sternohyoid muscles pull down on the thyroid/larynx.
In regard to claim 3, In Verzal et al., a controller 10502 is functionally connected to the stimulation signal generator 533 to control one or more stimulation parameters for the stimulation signal generator (para 907, controller 10502 is electrically couplable to, and in communication with, memory 10510 to generate control signals to direct operation of at least some of the example arrangements, stimulation elements, sensing elements, microstimulators, pulse generators, control portion, instructions, engines, functions, parameters, and/or methods; para 316, parameters includes amplitude, pulse width, current, etc).
In regard to claim 4, In Verzal et al., the one or more stimulation parameters include one or more of an amplitude, a frequency, a pulse width, a rate of amplitude change, and a duty cycle (para 316, parameters includes amplitude, pulse width, current, frequency, and duty cycle).
In regard to claim 5, In Verzal et al., the controller is configured to control the operation of the stimulation signal generator in a first mode 5030 (figure 33A), wherein the stimulation signal generator is configured to synchronize the first stimulation periods 5032 and the first non-stimulation periods 5034 of the first stimulation signal 5031 with the second stimulation periods 5043 and the second non-stimulation periods 5045 of the second stimulation signal 5041, respectively (para 476-479, cycles are explicitly taught and demonstrated in at least figure 33a, stimulation protocol 5030 explicitly shows delivery cycle 5031 coordinated to cycle 5043 (para 74 explicitly teaches this as well); Verzal et al. apply a variety of different stimulation protocols or modes as depicts in various figures 33A-37G, wherein the protocol of figure 35 also depicts a coordinated delivery of the first stimulation signal with the second delivery signal).
In regard to claim 6, In Verzal et al., the controller is configured to control the operation of the stimulation signal generator in a second mode 6020 (figure 37A), wherein a first duration of the first stimulation period 6032 is greater than a second duration of the second stimulation period 6043 (para 523, the duration of the 6032 is longer than the duration of 6043).
In regard to claim 7, In Verzal et al., when in the second mode 6020, the first duration of the first stimulation period is two or more times greater than the second duration of the second stimulation period (para 523, the duration of the 6032 is longer than the duration of 6043, wherein figure 37A depicts the durations of 6021/6032 at least 2x the duration of 6041/6043).
In regard to claim 8, In Verzal et al., the first implantable electrode 716 is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle (para 133; hypoglossal nerve stimulation reduces collapsibility of upper airway, para 130; para 206 teaches that stimulation of this nerve innervates muscles of the tongue)
In regard to claim 11, In Verzal et al., the stimulation signal generator comprises an internal timer to provide timing to coordinate the series of first stimulation cycles and the series of second stimulation cycles, independent of a respiratory status of the person (para 662, “without synchronizing” may refer to performing the stimulation independently of timing of a respiratory cycle).
In regard to claim 12, In Verzal et al., one or more sensors 560 are used to detect one or more physiological parameters including an apnea-hypopnea index (AHI), a posture change, a sleep stage, and a time of day (para 98, an accelerometer may be used to sense various physiologic information such as body position, respiration, sleep; para 99, posture; para 664, sensing of events such as elevated AHI is used to adjust stimulation).
In regard to claim 13, In Verzal et al., the controller is configured to control one or more stimulation parameters of the stimulation signal generator based at least in part on the one or more physiological parameters (para 98-102, sensed respiration may be used for timing application of stimulation to treat sleep disordered breathing).
In regard to claim 14, In Verzal et al., comprises a third implantable electrode 513A configured to deliver a third stimulation signal proximate to a third nerve to stimulate the third nerve (para 76, 468).
In regard to claim 15, Verzal et al. disclose a method for managing obstructive sleep apnea for a person, the method comprising (para 59): providing a first implantable electrode 716 configured to deliver a first stimulation signal proximate to a first nerve to stimulate the first nerve 505R or 505L (hypoglossal nerve) and activate at least one first muscle for upper airway dilation (para 133; hypoglossal nerve stimulation reduces collapsibility of upper airway, para 130); providing a second implantable electrode 713 configured to deliver a second stimulation signal proximate to a second nerve to stimulate the second nerve (ansa-cervicalis related nerve) and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person (para 136; stimulation of muscles innervated by ansa-cervicalis cause the larynx to be pulled inferiorly which is considered the same physioloigical effect for the pulling force on the airway of caudal tracheal traction, para 74, 496, and 696 the sternothyroid muscles and/or sternohyoid muscles pull down on the thyroid/larynx); delivering the first stimulation signal 5031 to the first implantable electrode 716; and delivering the second stimulation signal 5041 to the second implantable electrode 716 (para 475, protocol 5031 is applied to the hypoglossal nerve, protocol 5041 is applied to the ansa-cervicalis), wherein the first stimulation signal and the second stimulation signal are coordinated (para 476-479, cycles are explicitly taught and demonstrated in at least figure 33a, stimulation protocol 5030 explicitly shows delivery cycle 5031 coordinated to cycle 5043 (para 74 explicitly teaches this as well); Verzal et al. apply a variety of different stimulation protocols or modes as depicts in various figures 33A-37G, wherein the protocol of figure 35 also depicts a coordinated delivery of the first stimulation signal with the second delivery signal), and wherein the first stimulation signal 5031 has a series of first stimulation cycles 5035 each including a first stimulation period 5032 and a first non-stimulation period 5046, the second stimulation signal 5041 has a series of second stimulation cycles 5046 each including a second stimulation period 5043 and a second non-stimulation period 5045 (para 476-479, cycles are explicitly taught and demonstrated in at least figure 33a, stimulation protocol 5030 explicitly shows delivery cycle 5031 coordinated to cycle 5043, and wherein the second stimulation signal is configured to activate sternothyroid and sternohyoid simultaneously (para 443, upper airway patency is maintained by contraction of the sternothyroid and/or sternohyoid, the coordinating conjunction AND is considered both muscles are caused to be contracted together in simultaneous fashion).
In regard to claim 16, In Verzal et al., the second implantable electrode 716 is positioned at or proximate to a nerve segment connecting to a first branch and a second branch of an ansa cervicalis nerve to activate the sternothyroid and the sternohyoid simultaneously (para 136; stimulation of muscles innervated by ansa-cervicalis cause the larynx to be pulled inferiorly which is considered the same physioloigical effect for the pulling force on the airway of caudal tracheal traction; para 66, stimulation of the ansa cervicalis may be applied to any one or the branches 331; para 74, 496, and 696 the sternothyroid muscles and/or sternohyoid muscles pull down on the thyroid/larynx..
In regard to claim 17, Verzal et al. teaches controlling one or more first stimulation parameters for the first stimulation signal; and controlling one or more second stimulation parameters for the second stimulation signal (para 907, controller 10502 is electrically couplable to, and in communication with, memory 10510 to generate control signals to direct operation of at least some of the example arrangements, stimulation elements, sensing elements, microstimulators, pulse generators, control portion, instructions, engines, functions, parameters, and/or methods; para 316, parameters includes amplitude, pulse width, current, etc).
In regard to claim 18, Verzal et al. teaches that one or more first stimulation parameters and the one or more second stimulation parameters each include one or more of an amplitude, a frequency, a pulse width, a rate of amplitude change, and a duty cycle (para 316, parameters includes amplitude, pulse width, current, frequency, and duty cycle).
In regard to claim 19, Verzal et al. teaches the first implantable electrode 713 is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle (para 133; hypoglossal nerve stimulation reduces collapsibility of upper airway, para 130; para 206 teaches that stimulation of this nerve innervates muscles of the tongue).
In regard to claim 20, Verzal et al. teaches delivering the first stimulation signal further comprises delivering the first stimulation signal proximate to one or more medial branches of a hypoglossal nerve (m-XII) to stimulate the one or more medial branches and activate one or more protrusion muscles of the at least one tongue muscle including genioglossus (para 62, 64, 206 teach stimulation of the genioglossus muscles and protrusor muscles to innervate the tongue).
In regard to claim 22, Verzal et al. teaches comprising controlling operation of a stimulation signal generator in a first mode 5030 (figure 33A), wherein the stimulation signal generator is configured to synchronize the first stimulation periods 5032 and the first non-stimulation periods 5034 of the first stimulation signal 5031 with the second stimulation periods 5043 and the second non- stimulation periods 5045 of the second stimulation signal 5041, respectively (para 476-479, cycles are explicitly taught and demonstrated in at least figure 33a, stimulation protocol 5030 explicitly shows delivery cycle 5031 coordinated to cycle 5043 (para 74 explicitly teaches this as well); Verzal et al. apply a variety of different stimulation protocols or modes as depicts in various figures 33A-37G, wherein the protocol of figure 35 also depicts a coordinated delivery of the first stimulation signal with the second delivery signal).
In regard to claim 23, Verzal et al. teaches controlling operation of a stimulation signal generator in a second mode 6020 (figure 37A), wherein a first duration of the first stimulation period 6032 is two or more times greater than a second duration of the second stimulation period 6043 (para 523, the duration of the 6032 is longer than the duration of 6043).
In regard to claim 25, Verzal et al. teaches synchronizing the series of first stimulation cycles of the first stimulation signal with a current respiratory waveform of the person.
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) 9 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al. (US Publication no. 2024/0252824) in view of EP 4 241 675.
In regard to claims 9 and 21, Verzal et al. substantially discloses the invention as claimed, however does not teach that the second implantable electrode is configured to: deliver the second stimulation signal proximate to an ansa cervicalis nerve to stimulate the ansa cervicalis nerve; and activate a plurality of infrahyoid muscles within a strain range between a first strain value and a second strain value. Verzal et al. does teach stimulating the ansa cervicalis in order to activate a plurality of infrahyoid muscle (para 10-116, 569). The ‘675 reference teaches treating obstructive sleep apnea with stimulation of the hypoglossal nerve and ansa cervialis to order to innervate the genioglossus and infrahyoid muscles (para 18). The efficacy of the stimulation is monitored using various sensors including an inertial measurement unit or strain gauge in order to track the movement of one or more muscles related to the subjects tonight during stimulation (para 24). The movement is tracked in this manner to assess therapy effectiveness, especially since stimulation of the tongue muscles cause movement oft the chin. It is considered that overstimulation may cause sever chin movement, and under stimulation insufficient movement to abate the disorder breathing. The sensor of the ‘675 would provide a useful measure of strain or movement deemed acceptable and adjust stimulation accordingly. It is considered to have been obvious to one of ordinary skill in the art to modify Verzal et al. to control stimulation of tongue muscles within a range of strain values in order to achieve desired degree of muscle contraction, thereby improving therapy consistency and avoiding over- or under- stimulation.
Claim(s) 10 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al. (US Publication no. 2024/0252824) in view of Wagner et al. (US Publication no. 2020/0398051).
In regard to claims 10 and 24, Verzal et al. substantially discloses the invention as claimed, however does not teach that the stimulation signal generator is configured to coordinate the delivery of the first stimulation signal and the delivery of the second stimulation signal based at least in part on a historical respiratory waveform. Wagner et al. teach a system and method for treating disordered breathing including obstructive sleep apnea including stimulation of the hypoglossal nerve (para 2). Wagner et al. explicitly teach that a reference respiratory cycle for synching respiration therapy includes is defined by a historical patient-specific average respiratory cycle for stable respiration (para 48). In view of this, it is considered to have been obvious to one of ordinary skill in the art to modify Verzal et al. to coordinate delivery of the stimulation signals with a historical respiratory waveform since Wagner et al. explicitly teach using the historical respiratory waveform as reference to stabilize respiration in patient by accounting for variations in the respiratory cycle from breath-to-breath that may be unique to each patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kent (WO 2020/185549) is directed to a similar technique for treating obstructive sleep apnea by stimulation of the hypoglossal nerve and ansa cervicalis. The sternothyroid and sternohyoid muscles are also activated during the stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 30 July 2026
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