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 .
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 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.
Response to Amendment
Applicant’s Response filed September 9, 2025 has been entered. Claims 1-3 and 5-28 are pending in the application.
Election/Restriction
Applicant’s election without traverse of Invention II (claims 14-28) in the reply filed on September 9, 2025 is acknowledged.
Claims 1-3 and 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 21, 2023; April 24, 2023; September 20, 2023; November 2, 2023; March 28, 2024; June 5, 2024; March 3, 2025; and September 9, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al. (U.S. Patent Application Publication No. 20030078643; hereinafter “Schulman”) in view of Rondoni et al. (U.S. Patent No. 9888864; hereinafter “Rondoni”), Bolea et al. (U.S. Patent Application Publication No. 20080103545; hereinafter “Bolea”), and Mische et al. (U.S. Patent Application Publication No. 20070112343; hereinafter “Mische”).
Regarding claim 14, Schulman discloses a method of addressing a patient's sleep apnea by positioning an implantable device at least proximate to a target location (paras. [0086]-[0100]; see also Figs. 16-18; paras. [0064]-[0074]), the method comprising:
inserting a navigation assembly (including probe (202); Fig. 16) into a delivery system (including outer sheath (216)) with an adjustable sheath (216) of the delivery system in a first configuration such that a stimulating tip of the navigation assembly extends beyond the adjustable sheath (paras. [0064]-[0065]);
moving the stimulating tip toward a first position within the patient (para. [0094]; see also Fig. 16; para [0065]),
using stimulation-based navigation to move the stimulating tip toward a second position at least proximate to the target location (para. [0094]; see also para. [0064]), wherein using the stimulation-based navigation includes
delivering one or more electrical navigation signals to the patient via the stimulating tip (para. [0094]),
observing a response of the patient to individual ones of the one or more electrical navigation signals (para. [0094]), and
based on the response, repositioning the stimulating tip and/or adjusting an amplitude of individual ones of the electrical navigation signals (para. [0006]; see also paras. [0094]-[0099]);
extending the adjustable sheath (216) of the delivery system from the first configuration to a second configuration in which the stimulating tip is positioned within the adjustable sheath (Fig. 16; para. [0065]);
with the adjustable sheath in the second configuration
removing the navigation assembly from the delivery system (para. [0066]), and
inserting an implantable device delivery assembly into the delivery system, the implantable device delivery assembly including the implantable device (222), the implantable device positioned within the adjustable sheath (Fig. 17; paras. [0069]-[0070]);
retracting the adjustable sheath from the second configuration to a third configuration in which the implantable device extends beyond the adjustable sheath (Fig. 18; paras. [0070]-[0074]);
delivering an electrical signal to the patient via the implantable device to determine whether the implantable device is positioned at least proximate to the target location (par. [0072]); and
when the implantable device is determined to be positioned proximate the target location, actuating a release mechanism (including aperture (230) of sheath (216); Figs. 17-18) of the implantable device delivery assembly to release the implantable device from the delivery system (para. [0073]).
The method of Schulman discloses the invention substantially as claimed, except for using dual-mode navigation including using image-based navigation.
Rondoni, a reference in the neurostimulator delivery field of endeavor, teaches using a dual-mode navigation including using image-based navigation to move a stimulating tip of a delivery system to ward a first position within a patient (col. 6, ll. 48-67) to facilitate maneuvering the stimulating tip to a target site during a procedure (col. 6, ll. 34-37) and reduce invasiveness of the procedure (col. 3, ll. 10-15).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Schulman to include using dual-mode navigation including using image-based navigation to move the stimulating tip toward the first position, in view of Rondoni, in order to facilitate accurate placement and mitigate complications of a more-invasive procedure.
The modified method discloses the invention substantially as claimed, except for moving the stimulating tip toward the first position including penetrating the patient’s mylohoid muscle.
Bolea, a reference in the neurostimulator delivery field of endeavor, teaches accessing target locations by penetrating a patient’s mylohoid muscle (para. [0120]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method such that moving the stimulating tip toward the first position includes penetrating the patient's mylohyoid muscle, in view of Bolea, in order facilitate accessing the target location within the patient to treat sleep apnea.
The modified method discloses the invention substantially as claimed, except for rotating an actuator of the delivery system to extend or retract the adjustable sheath.
Mische, a reference in the electrode delivery field of endeavor, teaches configuring a delivery system (70) to include an actuator (76), rotating the actuator in a first direction to extend an adjustable sheath (74), and rotating the actuator in a second direction opposite the first direction to retract the adjustable sheath (Fig. 4; para. [0040]) to control an amount of energy delivered to a target region (para. [0040]).
Schulman teaches that the amount of energy delivered toa target region may need to be adjusted while finding an optimum delivery location (paras. [0094]-[0096]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the delivery system with an actuator and have the method include rotating the actuator of the delivery system in a first direction to extend the adjustable sheath of the delivery system from the first configuration to a second configuration in which the stimulating tip is positioned within the adjustable sheath; and rotating the actuator in a second direction opposite the first direction to retract the adjustable sheath from the second configuration to a third configuration in which the implantable device extends beyond the adjustable sheath, in view of Mische and Schulman, in order to control the amount of stimulation energy delivered to the patient’s tissue to facilitate a search for an optimum delivery location for the implantable device.
Regarding claim 15, the modified method discloses wherein one or both of using image-based navigation to move the stimulating tip and using stimulation-based navigation to move the stimulating tip (Schulman para. [0094]) includes moving the stimulating tip in an anterior-to-posterior direction (as the stimulating tip is advanced toward a nerve).
Regarding claim 16, the modified method is silent as to moving the stimulating tip in a posterior-to-anterior direction.
Schulman discloses that a stimulating tip may be advanced toward a stimulation site (para. [0006]) or retracted from a stimulation site (para. [0006]).
Rondoni teaches that observation of a sub-optimal electrode placement may trigger a physician to adjust the placement of electrode (col. 21, ll. 7-10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have one or both of using image-based navigation to move the stimulating tip and using stimulation-based navigation to move the stimulating tip includes moving the stimulating tip in a posterior-to-anterior direction (e.g., away from a stimulation site), in view of Schulman and Rondoni, in order to adjust the placement of the stimulating tip within a patient to a more optimal location.
Regarding claim 17, The modified method discloses wherein
using image-based navigation to move the stimulating tip including using image-based navigation to move the stimulating tip along a first trajectory (912; Rondoni Fig. 14) and toward the first position (Rondoni col. 21, ll. 50-61), and
using stimulation-based navigation to move the stimulating tip includes using stimulation-based navigation to move the stimulating tip along a second trajectory (914; Rondoni Fig. 14) different than the first trajectory and toward the second position (Rondoni col. 21, ll. 50-61).
Regarding claim 18, the modified method discloses the method further comprising repositioning the delivery system to reorient the stimulating tip from the first trajectory toward the second trajectory (Rondoni col. 21, ll. 7-10).
Regarding claim 19, the modified method discloses wherein the target location includes a genioglossus muscle of the patient (Schulman para. [0099]).
Regarding claim 20, the modified method discloses wherein the target location includes a hypoglossal nerve of the patient (Schulman para. [0093]).
Regarding claim 21, the modified method discloses the invention substantially as claimed, except for the target location including an ansa cervicalis nerve.
Bolea, a reference in the neurostimulator delivery field of endeavor, teaches stimulating or co-stimulating different target nerves of a patient, including the ansa cervicalis nerve, to manipulate different muscles to treat sleep apnea (paras. [0079]-[0092]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the modified method’s target location include an ansa cervicalis nerve of the patient, in view of Bolea, in order to stimulate appropriate muscles to treat sleep apnea.
Claims 22-24, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Rondoni.
Regarding claim 22, Schulman discloses a method of addressing a patient's sleep apnea (paras. [0086]-[0100]), the method comprising:
moving a stimulating tip of a delivery system toward a first position within the patient (para. [0093]; see also para. [0064]);
using stimulation-based navigation to move the stimulating tip toward a second position at least proximate a target location within the patient (para. [0094]; see also para. [0064]);
moving an adjustable sheath of the delivery system from a first configuration in which the stimulating tip extends beyond the adjustable sheath to a second configuration in which the stimulating tip is positioned within the adjustable sheath (para. [0097]; see also Fig. 16; para. [0065]);
with the adjustable sheath in the second configuration
removing the stimulating tip from the delivery system (para. [0097]; see also para. [0066]), and
inserting an implantable device into the delivery system, the implantable device positioned within the adjustable sheath (para. [0098]; see also Fig. 17; para. [0069]);
moving the adjustable sheath from the second configuration to a third configuration in which the implantable device extends beyond the adjustable sheath (para. [0099]; see also Fig. 18; para. [0072]-[0074]);
delivering an electrical signal to the patient via the implantable device to determine whether the implantable device is positioned at least proximate to the target location (para. [0099]; see also paras. [0072]-[0073]); and
when the implantable device is determined to be positioned at least proximate to the target nerve, releasing the implantable device from the delivery system (para. [0099]; see also paras. [0073]-[0074]).
The method of Schulman discloses the invention substantially as claimed, except for using image-based navigation to move the stimulating tip toward the first position.
Rondoni, a reference in the neurostimulator delivery field of endeavor, teaches using image-based navigation to move a stimulating tip of a delivery system to ward a first position within a patient (col. 6, ll. 48-67) to facilitate maneuvering the stimulating tip to a target site during a procedure (col. 6, ll. 34-37) and reduce invasiveness of the procedure (col. 3, ll. 10-15).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Schulman to include using image-based navigation to move the stimulating tip toward the first position, in view of Rondoni, in order to facilitate accurate placement and mitigate complications of a more-invasive procedure.
Regarding claim 23, the modified method discloses the method further comprising, prior to using the image- based navigation to move the stimulating tip (e.g., prior to moving the tip to a subsequent potential stimulation site; Rondoni col. 6, ll. 48-64), inserting the stimulating tip through the adjustable sheath to position an electrode of the stimulating tip at a distance beyond a body of the delivery system (Schulman para. [0065]), wherein inserting the implantable device into the delivery system includes positioning a center of an electrode array (223) of the delivery system at the distance beyond the body of the delivery system (Schulman Figs. 17-18; paras. [0070]-[0074]).
Regarding claim 24, the modified method discloses wherein releasing the implantable device includes moving a handle portion (224) of an implantable device delivery assembly relative to a shaft (216) of the implantable device delivery assembly to uncouple the implantable device from the implantable device delivery assembly (Schulman Fig. 18; paras. [0073]-[0074]).
Regarding claim 26, the modified method discloses wherein the target location includes a hypoglossal nerve of the patient (Schulman para. [0093]).
Regarding claim 28, the modified method discloses wherein the target location includes a genioglossus muscle of the patient (Schulman para. [0099]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Rondoni, as applied to claim 22 above, and further in view of Oron et al. (U.S. Patent No. 10004896; hereinafter “Oron”).
Regarding claim 25, the modified method discloses wherein using stimulation-based navigation includes delivering, via the stimulating tip, one or more electrical signals to the patient's tissue (Schulman para. [0094]). The modified method is not explicitly disclosed with using image-based navigation includes using an ultrasound probe to visualize a position of the stimulating tip.
However, Rondoni discloses that image-based navigation may include a variety of imaging systems (col. 3, ll. 54-64).
Oron, a reference in the neurostimulator delivery field of endeavor, teaches using image-based navigation including using an ultrasound probe to visualize a positioning of a stimulating tip (1260; Figs. 7-9; col. 14, n. l18 – col. 15, 20 ln.20) to facilitate accurate positioning of the stimulating tip during a procedure (col. 15, ll. 21-28).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the modified method utilize ultrasound imaging such that using image-based navigation includes using an ultrasound probe to visualize a position of the stimulating tip, in view of Oron, in order to facilitate accurate placement of the stimulating tip at a target site within a patient.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Rondoni, as applied to claim 22 above, and further in view of Bolea.
Regarding claim 27, the modified method discloses the invention substantially as claimed, except for the target location including an ansa cervicalis nerve.
Bolea, a reference in the neurostimulator delivery field of endeavor, teaches stimulating or co-stimulating different target nerves of a patient, including the ansa cervicalis nerve, to manipulate different muscles to treat sleep apnea (paras. [0079]-[0092]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the modified method’s target location include an ansa cervicalis nerve of the patient, in view of Bolea, in order to stimulate appropriate muscles to treat sleep apnea.
Conclusion
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/JONATHAN A HOLLM/Examiner, Art Unit 3771