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 .
The current application has the effective filing date of 05/20/2021 according to the priority chain on the record.
Claim Status
As per applicant’s response received on 10/09/2025, claims 1-41 have been cancelled, claims 42-61 are pending, and claims 43, 58 and 59 have been amended.
Response to Amendment
The claim objection to claim 43 is withdrawn in view of claim amendment.
As for the 35 USC 112(b) rejection, these are also withdrawn in view of current claim amendment.
As for the 35 USC 102 rejection based on reference Christopherson et al. (US 2017/0151432 A1), the Applicant’s Affidavit filed under 37 CFR 1.132 submitted by the applicant dated 10/09/2025 has been fully considered. Said affidavit constitutes an expert’s opinion without specific facts and/or legal conclusion, and thus weight is not given. See MPEP 716.01(c).
In the Applicant’s Remarks, the Applicant argues that the claim term “motor end plate” is not “literally present” in Christopherson, and Christopherson’s “optimal/target site” is merely a site locator that allows practitioners to test locations along a patient’s hypoglossal nerve to identify which location or site is ‘optimal’, and thus fails to teach “motor end plate” in the claim.
The Examiner respectfully disagrees. The argued claim 42 positively recites “percutaneously inserting a needle into the patient along a trajectory toward a motor end plate…while delivering the one or more first modulation signals, observing a motor response of the genioglossus muscle to the one or more first modulation signals to determine whether the needle is positioned at least proximate to the motor end plate”
As noted above, the Applicant’s own claim does not provide a means for positively identifying a motor end plate prior to inserting a needle. In fact, the Applicant’s own claimed invention (at least claim 42) operates similarly to the alleged site location described in Christopherson. Specifically, the needle is inserted “toward” the general direction of a motor end plate, and the site is confirmed (i.e. “proximate to the motor end plate”) based on an observed motor response after emitting a ‘first modulation signal.’ These claimed steps are not functionally different than the steps for locating an “optimal/target site” in the applied reference.
The Applicant’s claim does not recite a particular motor response, the Specification also does not describe a particular advantage to stimulating the motor end plate. In fact, it would appear that the recited “motor end plate” location is one of a plurality of possible treatment sites within the genioglossus muscles (see Specification [0045, 0057] and Fig. 4D). As such, it is the Examiner’s interpretation that Christopherson’s optical/target site is sufficient to teach the argued limitations. The 35 USC 102 rejections are maintained.
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.
Claims 42-48, 50-51, 54-59 and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christopherson et al. US 2017/0151432 A1 (hereinafter “Christopherson”, cited in Applicant’s IDS 10/27/2022).
Regarding claim 42, Christopherson discloses a method for addressing sleep apnea in a patient (Abstract: system and method for treating sleep related disordered breathing), the method comprising:
percutaneously inserting a needle (needle 210) into the patient along a trajectory (percutaneous access pathway) toward a motor end plate at which one or more branches of a hypoglossal nerve of the patient innervate a genioglossus muscle of the patient (Fig. 5: 302, needle is percutaneously inserted to test sites at/near target nerve and deliver a pre-determine profile of electrical stimuli, the target nerve include hypoglossal nerve and genioglossus muscle; also see [0004, 0074, 0077-0078] percutaneous delivery system 201, shown in Fig.4, comprises needle 210 has stimulation electrode portion 65. Note: ‘optimal/target stimulation site’ discussed in Christopherson is interpreted to encompass “motor end plate” in the claim. This is because motor end plate, also known as neuromuscular junction is an anatomical structure that causes muscle contraction when stimulated; Christopherson [0172: last sentence] explicitly teaches identifying optimal/target stimulation site that causes contraction of one or more specific muscle);
delivering, via the needle (210), one or more first modulation signals to the patient (Fig. 5: 302, needle is inserted to a plurality of test sites at/near target nerve and deliver a pre-determined profile of electrical stimuli to elicit a response; see [0082-0083]);
while delivering the one or more first modulation signals, observing a motor response of the genioglossus muscle to the one or more first modulation signals to determine whether the needle is positioned at least proximate to the motor end plate (Fig.5: 304 and 306, determine the optimal stimulation site(s) from among the test sites by observing the neuromuscular response; see [0077, 0082-0083]); and
after determining that the needle (210) is positioned at least proximate to the motor end plate (optimal stimulation site), percutaneously injecting a signal delivery device (stimulation lead 430) into the patient to a location at least proximate to the motor end plate (i.e. optimal stimulation site) via the trajectory (percutaneous access pathway) defined by the needle (210, see [0083] “…After identifying a target site…identifying a percutaneous access pathway to the target site…”), wherein the signal delivery device (430) includes an electrode array (electrode portion 440; see Figs. 8A-8B), and wherein the electrode array (electrode portion 440 comprising first array 442; see [0107]) is positioned to deliver one or more second modulation signals to the motor end plate and/or the one or more branches to address the patient's sleep apnea ([0099] “…a stimulation lead is releasably coupled to the guide wire and advanced, via the guide wire, through the established percutaneous access pathway until an electrode portion of the stimulation lead is adjacent the target stimulation site…”; also see [0099-0100]).
Regarding claim 43, Christopherson teaches the method of claim 42 wherein:
the needle (210 comprising cannula 360) includes one or more electrodes of the needle (electrode portion 65 of needle 210; see [0074, 0082]) and defines a lumen (lumen 370) configured to contain the signal delivery device (stimulation lead 430),
delivering the one or more first modulation signals includes delivering the one or more first modulation signals via the one or more electrodes (Fig. 5: 302-304), and
percutaneously injecting the signal delivery device into the patient includes percutaneously injecting the signal delivery device (stimulation lead 430) into the patient through the lumen ([0089-0090] “…assuming a position suitable to direct a stimulation lead to be slidably advanced along the hypoglossal nerve to a desired stimulation site…”).
Regarding claim 44, Christopherson teaches the method of claim 42 wherein: the needle (distal tip 214 of needle 210) is positioned within a lumen (lumen 370) of an outer delivery sheath (cannula 360); the method further comprises withdrawing the needle distally from the lumen of the outer delivery sheath; and percutaneously injecting the signal delivery device into the patient includes percutaneously injecting the signal delivery device into the patient through the lumen of the outer delivery sheath (see [0116-0117]).
Regarding claim 45, Christopherson teaches the method of claim 42 wherein percutaneously inserting the needle into the patient includes percutaneously inserting the needle into the patient at an insertion point (entry point) located posteriorly of the motor end plate. (See [0080, 0091-0093] site location tool 200 is used to trace the path of the hypoglossal nerve or other suitable anatomical landmark to identify a skin entry point)
Regarding claim 46, Christopherson teaches the method of claim 42, further comprising: generating, via a pulse generator (IPG 109, [0055]) of the signal delivery device, the one or more second modulation signals ([0106]); and delivering, via the electrode array (electrode section 440 first array 442), the one or more second modulation signals to the motor end plate ([0106] “…Via control from the IPG 55, each electrode 444 of stimulation electrode portion 440 is independently programmable to apply a stimulation signal that has a selectively controllable polarity, amplitude, frequency, pulse width, and/or duration”).
Regarding claim 47, Christopherson teaches the method of claim 42, further comprising: wirelessly providing power (wireless power via the IPF) to the signal delivery device ([0060] external power source, provides power wirelessly); causing the signal delivery device to delivery the one or more second modulation signals ([0106] electrode of the stimulation electrode delivers stimulation signal); and while delivering the one or more second modulation signals, observing a response of the genioglossus muscle to the one or more second modulation signals to confirm that the electrode array (first array 442) of the signal delivery device (stimulation lead) is positioned at least proximate to the motor end plate. ([0080-0081, 0083-0085] response array 275 measuring a muscle response to the nerve stimulation to obtain real-time feedback and the determining the optimal stimulation site)
Regarding claim 48, Christopherson teaches the method of claim 42 wherein the one or more first modulation signals have one or more first frequencies in a first frequency range, wherein the one or more second modulation signals have one or more second frequencies in a second frequency range, and wherein the second frequency range is higher than the first frequency range. ([0085] “… the pre-determined electrical stimuli as a stimulation signal with differing values for each signal parameter (e.g., pulse width, electrode polarity, frequency, duration, and amplitude) to determine which combination of values yields the best impact of the stimulation signal upon the target nerve at a potential site...” [0106: last sentence]; the (neuro-)stimulation signals applied is varied in frequency, this implicitly teaches a first frequency, and second frequency that is higher than the first frequency)
Regarding claim 50, Christopherson teaches the method of claim 42 wherein the one or more first modulation signals have a first range of frequencies, wherein the one or more second modulation signals have a second range of frequencies, and wherein at least one frequency in the second range of frequencies is at least 3 times greater than one or more frequencies in the first range of frequencies. ([0085] “… the pre-determined electrical stimuli as a stimulation signal with differing values for each signal parameter (e.g., pulse width, electrode polarity, frequency, duration, and amplitude) to determine which combination of values yields the best impact of the stimulation signal upon the target nerve at a potential site...” [0106: last sentence]; the (neuro-)stimulation signals applied is varied in frequency, this implicitly teaches a first frequency, and second frequency that is at least 3 times higher than the first frequency)
Regarding claim 51, Christopherson teaches the method of claim 42 wherein delivering the one or more first modulation signals to the patient includes delivering the one or more first modulation signals at successively increasing amplitudes. ([0085] “… the pre-determined electrical stimuli as a stimulation signal with differing values for each signal parameter (e.g., pulse width, electrode polarity, frequency, duration, and amplitude) to determine which combination of values yields the best impact of the stimulation signal upon the target nerve at a potential site...” [0106: last sentence]; amplitude of the applied stimulation signal is varied, this encompasses “successively increasing amplitude” in the claim. Alternatively, [0081] “a ramping stimulation pattern”)
Regarding claim 54, Christopherson teaches the method of claim 42 wherein percutaneously inserting the needle into the patient includes percutaneously inserting the needle into the patient at submandibular insertion point. ([0074] selecting the optimal stimulation site and/or a point of penetration to perform percutaneous delivery of a stimulation lead; as shown in Fig.1, the site for stimulation electrode 65 is submandibular and Fig. 7A-7C illustrate that the entry point on skin surface is close to the stimulation implantation site)
Regarding claim 55, Christopherson teaches the method of claim 42 wherein percutaneously inserting the needle into the patient includes percutaneously inserting the needle into the patient along an underside of a jaw of the patient, and wherein the trajectory (percutaneous access pathway) is oriented at one or more angles relative to the underside of the jaw of the patient. ([0083] “…identifying a percutaneous access pathway to the target site. In one aspect, this identification includes identifying a skin entry site (such as D, E, F, or G), which may or may not be directly above the target stimulation site on the hypoglossal nerve…”; the hypoglossal nerve in on the underside of a jaw)
Regarding claim 56, Christopherson teaches the method of claim 55 wherein: during a first portion of the insertion of the needle, the trajectory is oriented at a first angle relative to the underside of the jaw, and during a second portion of the insertion of the needle, the trajectory is oriented at a second angle relative to the underside of the jaw, wherein the second angle is different than the first angle. (As shown in Figs. 7A-7V, the angle of the needle is changed, or adjusted to approach targets sites A, B, and C, the changing of angles to move various distances D1 and D2 as described in [0090] first oriented parallel to the hypoglossal nerve, and then oriented at obtuse angle; also see [0093-0094]. This is taken to encompass the “first angle” and “second angle” in the claim. Also see [0095, 0096])
Regarding claim 57, Christopherson teaches the method of claim 42 wherein percutaneously injecting the signal delivery device includes percutaneously injecting the signal delivery device through a single puncture formed through the patient's skin. ([0080] “…to identify an entry point for percutaneous delivery of the stimulation electrode portion...” the single entry point described here is interpreted as a “single puncture” in the claim. Also see [0096] operator identify a skin entry point, e.g. G in Fig. 7C)
Regarding claim 58, Christopherson teaches the method of claim 42, further comprising observing, via ultrasound, a first portion of the percutaneous insertion of the needle along the trajectory, wherein observing the motor response includes observing the motor response during a second portion of the percutaneous insertion of the needle along the trajectory. ([0074-0075] percutaneous delivery system, also see [0080] providing a predetermine stimulation signal to evoke response wherein the “…observation/measurement being performed via endoscopy, ultrasound, or other visualization techniques…”)
Regarding claim 59, Christopherson teaches the method of claim 42 wherein the signal delivery device further includes a flexible lead carrying the electrode array ([0134] “…an electrode portion 565 includes a flexible carrier 581 supporting electrodes 582 with the carrier 581 configured to flexibly conform to the arcuate shape of the cross-section of the nerve 558…”), wherein percutaneously injecting the signal delivery device includes percutaneously injecting the flexible lead ([0134] and Fig. 14B), and wherein the method further comprises:
positioning a housing including a pulse generator within the patient (IPG 55 has a housing as shown in Fig. 1); and
operably coupling the flexible lead to the pulse generator ([0055] stimulation lead 52 is electrically coupled to IPG 55).
Regarding claim 61, Christopherson teaches the method of claim 42 wherein percutaneously injecting the signal delivery device into the patient to the location includes percutaneously injecting the electrode array to a location anterior to a medial branch of the hypoglossal nerve of the patient. ([0082-0085] identifying an optimal site along a length of the hypoglossal nerve)
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.
Claims 49 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Christopherson as applied to claim 42 in view of Fayram et al. US 2018/0085593 A1 (hereinafter “Fayram”, cited in the Applicant’s IDS).
Regarding claim 49, Christopherson teaches the method of claim 48 wherein the frequency range of the stimulation signal is adjustable based on the operator’s preferences ([0106]); but does not explicitly disclose wherein the first frequency is from about 1 Hz to about 3 Hz and wherein the second frequency range is from about 10 Hz to about 500 Hz. Fayram, another prior art reference in the analogous art of stimulation therapy devices and methods for treating sleep apnea (Abstract: [0209]) teaches a stimulation device capable for stimulating at a range from 0.1 HZ to 100000HZ ([0294: first sentence). As for providing stimulation to evoke specific therapeutic effect, Fayram discloses using a range of 10Hz to 100Hz ([0752]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Christopherson in view of Fayram so as to provide a stimulation device capable of delivering a wide range of stimulation frequencies. Since Christopherson provides support that an operator can selectively change the frequency of the stimulation signal, it would have been further obvious to a person at the time of invention to use set the first frequency range to about 1Hz to about 3 Hz, because the first frequency range is associated with a test stimulation signal to determining optimal implantation site, as such a low frequency signal would be sufficient to elicit muscle contraction without causing discomfort (Christopherson: Fig. 5 and [0082-0083]). As for the second frequency for delivering therapeutic stimulation, it would have further been obvious to a person to set it to about 10 Hz to about 500 Hz, the motivation is to achieve therapeutic effect as taught in Fayram.
Regarding claim 60, Christopherson teaches the method of claim 59, Christopherson, as illustrated in Fig. 1, teaches the inserted stimulation lead 65 coupled to the pulse generator IPG 55, the housing being implanted. Christopherson does not teach wherein positioning the housing (comprising the pulse generator) within the patient includes percutaneously injecting the housing (comprising the pulse generator) within the patient. Fayram, another prior art reference in the analogous art of stimulating therapy for addressing sleep apnea ([0209, 0576]), teaches an implantable stimulation device ([0012]) that can be inserted and comprising an antenna 108 that receives wireless power to activate electrodes to provide stimulation therapy to the implantation target site ([0225]). In Fayram, the pulse generator is not a separate device, but the pulse generator is replaced with antenna 108 to receive wireless power from an external power device 104, and carried within the same housing as electrodes E0-E3, illustrated in Fig. 1: 110. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Christopherson in view of Fayram to replace the IPG with an antenna for wireless power and data commination in view of Fayram, the motivation for doing so is to eliminate having to separately implant an IPG.
Claims 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Christopherson as applied to claim 42 above, and in view of Kent US 2020/0069947 A1.
Regarding claim 52, Christopherson teaches the method of claim 42 wherein: the signal delivery device is a first signal delivery device having a first electrode array and positioned at a first location ([0055, 0078] and as shown in Fig. 1: 65), and the method further comprises percutaneously injecting a second signal delivery device into the patient to a second location wherein the second signal delivery device includes a second electrode array, and wherein the second electrode array (see [0170] implanting a stimulation lead on a left and right side of the hypoglossal nerve, or other target nerve; this implies two different stimulation lead implants.) Christopherson does not explicitly teach wherein the second signal delivery device is located at least proximate to an ansa cervicalis nerve of the patient, and the second electrode array is positioned to deliver one or more third modulation signals to the ansa cervicalis nerve. Kent, another prior art reference in the analogous field of stimulators for treating obstructive sleep apnea (Abstract), teaches providing at least a first stimulators to stimulate the hypoglossal nerve, and a second stimulator to stimulate the ansa cervicalis ([0021, 0049]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Christopherson in view of Kent to include a second or additional stimulator for stimulating the ansa cervicalis; the motivation for doing so is because it is a target area in OSA treatment.
Regarding claim 53, Christopherson in view of Kent teaches the method of claim 52 wherein: the motor end plate is a first motor end plate, the one or more branches are one or more first branches, and percutaneously injecting the second signal delivery device into the patient to the second location includes percutaneously injecting the second signal delivery device into the patient such that the second electrode array is positioned at least proximate to a second motor end plate at which one or more second branches of the ansa cervicalis nerve innervate one or more infrahyoid strap muscles of the patient. (Christopherson teaches percutaneously inserting a first and a second stimulator into optimal target site(s) including motor end plate as taught in [0081-0099]. Also see rejection to claim 42 above. Christopherson in view of Kent would teach providing a second stimulator to stimulate ansa cervicalis nerve innervate one or more infrahyoid strap muscles, see Kent [0021] “…An example of a peripheral nerve stimulator is one that can stimulate a portion or totality of the ansa cervicalis, activating the suprahyoid and/or infrahyoid strap muscles...”)
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 SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
January 5, 2026