DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed on January 8, 2026, with respect to the rejection(s) of claim(s) 1-2, 10-11, 13-14, 18, and 22 under 35 U.S.C. 102(a)(1) and claims 3-8, 12, 15-17, and 20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection has been made in view of Applicant’s amendments as can be further seen below.
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) 1-3, 6, 10-16, 18, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0228867 A1 to Scheiner et al. (hereinafter “Scheiner”), and further in view of US 2021/0106824 A1 to Caparso et al. (hereinafter “Caparso”).
Regarding Claim 1, Scheiner teaches:
an implantable neuromodulation lead (see para [0026]) comprising:
an extension portion (see header portion of ID 30; Modified Fig. 1 below) having a proximal end portion configured to be coupled to an electronics component (see ID 30; para [0027]-[0028]) and a distal end portion (see end at connection point 36); and
a lead body (see lead assembly 34) extending distally from the distal end portion of the extension portion (See fig. 1),
wherein the lead body branches into a first arm and a second arm (see lead ends 40 and 44) and includes a first electrode (see electrodes 190) disposed on the first arm (lead 40) and a second electrode (see electrodes 194) disposed on the second arm (lead 44; Fig. 3),
wherein the lead body is configured to be implanted in a patient’s body proximate a
hypoglossal nerve and deliver an electrical signal to the hypoglossal nerve via the first and second electrodes (see para [0044]),
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but does not disclose wherein
an extension portion extending along a longitudinal axis, the extension portion configured to be coupled to an electronics component and a distal portion,
the first arm and the second arm each has a preset shape comprising;
a proximal portion extending laterally away from the distal end portion of the extension portion
and
a distal portion extending distally away from the proximal portion in a longitudinal dimension,
wherein the proximal portion is angled away from the distal end portion of the extension portion such that the longitudinal dimension of the distal portion is parallel to and spaced apart from the longitudinal axis.
However, Caparso teaches a neuromodulation lead for treating sleep apnea (See abstract and para [0005]). The system (fig. 5) teaches,
an extension portion extending along a longitudinal axis, the extension portion configured to be coupled to an electronics component and a distal portion (see annotated figs. 4-5 below),
the first arm and the second arm each has a preset shape (see fig. 5 and para [0015])
comprising;
a proximal portion extending laterally away from the distal end portion of the extension portion (see annotated figs. 4-5 below);
and
a distal portion extending distally away from the proximal portion in a longitudinal dimension (see annotated figs. 4-5 below),
wherein the proximal portion is angled away from the distal end portion of the extension portion such that the longitudinal dimension of the distal portion is parallel to and spaced apart from the longitudinal axis (see annotated fig. 13 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Scheiner with the preset shape and device configuration of Caparso to arrive at the claimed invention. Such modification would improve the system by allowing the first arm and second arm to make very precise contact to the hypoglossal nerve through the use of a compact device configuration, ultimately improving treatment efficiency when treating a suffering from sleep disorder breathing.
Regarding Claims 2, 14, and 22, Scheiner as modified teaches:
wherein the lead body is configured to be implanted such that the first and second arms are aligned with and extend along a left hypoglossal nerve and a right hypoglossal nerve, respectively (See figs. 2-3).
Regarding Claim 3, Scheiner as modified teaches:
The neuromodulation lead of claim 1, wherein the first electrode is carried by the distal portion of the first arm (See Scheiner - annotated fig. 3 below).
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Regarding claim 6, Scheiner as modified teaches:
The neuromodulation lead of claim 1, wherein the second electrode is carried by the distal portion of the second arm (See fig. 3 - electrodes 194 and lead 44).
Regarding Claim 10, Scheiner as modified teaches:
a connector between the extension portion and the first and second arms, wherein the connector is coupled to the distal end portion of the extension portion, the proximal portion of the first arm, and the proximal portion of the second arm (See modified Fig. 1 below).
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Regarding Claim 11, Scheiner discloses wherein the electrical signal is configured to treat sleep apnea (See para. [0007]).
Regarding Claim 12, Scheiner teaches:
An implantable neuromodulation lead (see para [0026]) comprising:
an extension portion (see header portion of ID 30; Modified Fig. 1 below) having a proximal end portion configured to be coupled to an electronics component (see ID 30; para [0027]-[0028]) and a distal end portion (see end at connection point 36); and
a lead body (see lead assembly 34) extending distally from the distal end portion of the extension portion (See fig. 1),
wherein the lead body branches into a first arm and a second arm (see lead ends 40 and 44) and includes a first electrode (see electrodes 190) disposed on the first arm (lead 40) and a second electrode (see electrodes 194) disposed on the second arm (lead 44; Fig. 3),
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but does not disclose wherein
an extension portion extending along a longitudinal axis, the extension portion configured to be coupled to an electronics component and a distal portion,
the first arm and the second arm each has a preset shape comprising;
a proximal portion extending laterally away from the distal end portion of the extension portion
and
a distal portion extending distally away from the proximal portion in a longitudinal dimension,
wherein the proximal portion is angled away from the distal end portion of the extension portion such that the longitudinal dimension of the distal portion is parallel to and spaced apart from the longitudinal axis, and wherein at least one of the left arm or the right arm is bent relative to the extension portion such that at least one left or right arm is positioned at a different elevation than the extension portion.
However, Caparso teaches a neuromodulation lead for treating sleep apnea (See abstract and para [0005]). The system (fig. 5) teaches,
an extension portion extending along a longitudinal axis, the extension portion configured to be coupled to an electronics component and a distal portion (see annotated figs. 4-5 below),
the first arm and the second arm each has a preset shape (see fig. 5 and para [0015])
comprising;
a proximal portion extending laterally away from the distal end portion of the extension portion (see annotated figs. 4-5 below);
and
a distal portion extending distally away from the proximal portion in a longitudinal dimension (see annotated figs. 4-5 below),
wherein the proximal portion is angled away from the distal end portion of the extension portion such that the longitudinal dimension of the distal portion is parallel to and spaced apart from the longitudinal axis (see annotated fig. 13 below), and wherein at least one of the left arm or the right arm is bent relative to the extension portion such that at least one left or right arm is positioned at a different elevation than the extension portion (see figs. 5-7 – 24 & 38 and annotated fig. 13 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Scheiner with the preset shape and device configuration of Caparso to arrive at the claimed invention. Such modification would improve the system by allowing the first arm and second arm to make very precise contact to the hypoglossal nerve through the use of a compact device configuration, ultimately improving treatment efficiency when treating a suffering from sleep disorder breathing.
Regarding Claim 13, Scheiner as modified teaches wherein the lead body is configured to deliver electrical stimulation energy to a hypoglossal nerve of a patient to treat sleep disorder breathing (See Scheiner, para [0007] and para [0044]).
Regarding Claims 15 and 20, Scheiner as modified teaches:
The neuromodulation lead of claim 12, but does not disclose wherein:
when the lead is implanted, the at least one of the left arm or the right arm extends superiorly from the proximal end portion located at the extension portion and proximate a geniohyoid muscle of a patient to the distal end portion located proximate a genioglossus muscle of the patient.
However, Caparso teaches,
Wherein, when the lead is implanted, the at least one of the left arm or the right arm extends superiorly from the proximal end portion located at the extension portion and proximate a geniohyoid muscle of a patient to the distal end portion located proximate a genioglossus muscle of the patient (See Caparso - para [0005] and para [0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Scheiner with the teachings of Caparso to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the prior art of Caparso teaches having the arms extend superiorly from the geniohyoid muscle to the genioglossus muscle because in order to mirror the anatomy of the hypoglossal nerve (see para [0023] and para [0026]).
Regarding Claim 16, Scheiner as modified teaches:
The neurostimulation lead of claim 12, but does not explicitly disclose wherein
Caparso discloses wherein,
when the lead is implanted, the proximal end portion of the extension portion is positioned inferior of a mylohyoid muscle of a patient and the distal end portion of the extension portion is positioned superior of a geniohyoid muscle of the patient.
However, Caparso teaches wherein, when the lead is implanted, the proximal end portion of the extension portion is positioned inferior of a mylohyoid muscle of the patient and the distal end portion of the extension portion is positioned superior of a geniohyoid muscle of the patient (see Fig. 10 and 13-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Scheiner with the teachings of Caparso to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the prior art of Caparso teaches that the fat pads holding the hypoglossal nerve trunk and branches are localized (See para [0041]).
Regarding Claim 18, Scheiner as modified teaches similarly worded Claims 1 and 11 above. Scheiner further discloses sublingual placement (see Fig. 4).
Claim(s) 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner in view of Caparso, and further in view of US 2014/0358197 A1 to Masiach et al. (hereinafter “Masiach”).
Regarding Claim 9, Scheiner as modified teaches:
The neuromodulation lead of claim 1, but does not disclose wherein the first and second arms extend laterally away from the distal end portion of the extension portion in opposing directions.
However, Masiach discloses an implant for hypoglossal stimulation wherein the proximal regions of the first arm/first arm extension (see first extension 162a) and the second arm/second arm extension (see second extension 162b) extend laterally away from the distal end portion of the extension portion (see arm 162) in opposing directions (See fig. 11a and para [0102]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Scheiner with the arm configuration of Masiach to arrive at the claimed invention. Such modification would improve the system by allowing the arms to extend laterally away in order to permit bilateral hypoglossal nerve stimulation.
Regarding Claim 17, Scheiner as modified teaches:
the neuromodulation lead of claim 12, but does not disclose wherein the extension portion is between a right and left geniohyoid muscle.
However, Masiach teaches wherein the extension portion/flexible carrier is between a right and left geniohyoid muscle (see fig. 11a, fig. 20, para [0197], and para [0199]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Scheiner with the teachings of Masiach to arrive at the claimed invention. Such modification would improve the system by allowing both extension arms to wrap around the genioglossus muscle from either side for precise bilateral stimulation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Verzal et al. (US 2023/0172479 A1) discloses treating apnea with hypoglossal stimulation with an extension (1102; Fig. 7B) and two leads for right and left stimulation (see para [0065]).
Baysham (US 2014/0135868 A1) discloses bilateral stimulation of the hypoglossal nerve with an extension (clip 606) that splits off to the right and left electrodes under the tongue (see Fig. 6A).
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 KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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