DETAILED ACTION
This action is in response to the Response to Election/Restriction filed 11/11/2025. Currently, claims 86-105 are pending in the application. Claims 1-85 are cancelled by Applicant. New claims 86-105 are added by Applicant.
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 .
Election/Restrictions
Applicant's election with traverse of Invention I, claims 86-99 in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that the search burden requirement has not been met as required to maintain a restriction. This is not found persuasive because there would be a serious search and/or examination burden if restriction were not required because the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 100-105 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/11/2025.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract includes legal phraseology, which is not permitted. The term “comprising” should be removed from the abstract to avoid this error. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 87-89, 91 and 93 are objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “wherein mechanically maneuvering” should be amended to recite ---wherein the mechanically maneuvering---. Appropriate correction is required.
Claim 89 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the at least one of the thyroid cartilage and the hyoid bone” in lines 1-2 of the claim should be amended to recite ---the at least one of the thyroid cartilage inferiorly and the hyoid bone anteriorly---. Appropriate correction is required.
Claim 92 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the maneuvering” in lines 1-2 of the claim should be amended to recite ---the mechanically maneuvering---. Appropriate correction is required.
Claim 93 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the thyroid cartilage” in lines 1-2 of the claim should be amended to recite --- the thyroid cartilage inferiorly---. Appropriate correction is required.
Claims 96 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the adjustment to the effective length” in line 1 of the claim should be amended to recite ---the adjusting the effective length---. Appropriate correction is required.
Claims 97 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “and adjusting the effective length based on the therapy outcome” in lines 2-3 of the claim should be amended to recite --- and the adjusting the effective length is based on the therapy outcome---. Appropriate correction is required.
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.
Claim(s) 86-88, 91-93, 96 and 97 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KENT (US 2023/0165704 A1).
Regarding claim 86, KENT teaches in Figure 1 and [0012-0013] promoting patency of an upper airway of a patient ([0012] teaches “systems and devices for providing inferior traction to maintain vertical tension in the airway to resist airway collapse are provided”) via mechanically maneuvering at least one of: thyroid cartilage inferiorly ([0013] teaches “any of the embodiments can include a second separate elastic member attached to the respective bones to avoid twisting about a single axis” and “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly”); and hyoid bone anteriorly.
Regarding claim 87, KENT teaches the method of claim 86. KENT teaches in [0012-0013] that mechanically maneuvering the at least one of the thyroid cartilage inferiorly ([0013] teaches “any of the embodiments can include a second separate elastic member attached to the respective bones to avoid twisting about a single axis” and “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly”) and the hyoid bone anteriorly causes at least one of an increase of and maintaining of patency of the upper airway ([0012] teaches “systems and devices for providing inferior traction to maintain vertical tension in the airway to resist airway collapse are provided”).
Regarding claim 88, KENT teaches the method of claim 86. KENT teaches in [0012-0013] that mechanically maneuvering the at least one of the thyroid cartilage inferiorly ([0013] teaches “any of the embodiments can include a second separate elastic member attached to the respective bones to avoid twisting about a single axis” and “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly”) and the hyoid bone anteriorly causes the upper airway to stretch inferiorly to stiffen and reduce collapsibility ([0012] teaches “systems and devices for providing inferior traction to maintain vertical tension in the airway to resist airway collapse are provided;” [0013] teaches “by tethering the hyoid bone and/or thyroid cartilage inferiorly, the device can maintain or improve vertical tension in the airway”).
Regarding claim 91, KENT teaches the method of claim 86. KENT teaches in [0005] that mechanically maneuvering the at least one of the thyroid cartilage inferiorly and the hyoid bone anteriorly causes tissue at least partially defining the upper airway to compress thereby causing an increase in a cross-sectional area of the upper airway ([0005] teaches “systems dilate the airway by placing anterior traction on the hyoid bone, reducing collapse of the base of the tongue and providing a localized stiffening effect on the pharyngeal soft tissues at the level of the tongue base to additionally reduce collapse”).
Regarding claim 92, KENT teaches the method of claim 86. KENT teaches in [0013] adjusting an amount of the maneuvering over time for the patient ([0013] teaches “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly” and “the elastic member can maintain a moderate degree of tension at night, that could be titratable at the time of implant or afterwards”).
Regarding claim 93, KENT teaches the method of claim 86. KENT teaches in [0013-0014] that mechanically maneuvering the thyroid cartilage ([0013] teaches “any of the embodiments can include a second separate elastic member attached to the respective bones to avoid twisting about a single axis” and “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly”) comprises adjusting an effective length of ([0013] teaches “the elastic member can have sufficient elasticity” and functioning “dynamically,” which is understood to correspond to elastic lengthening and shortening of the elastic member; [0014] teaches “a static member attached between the fasteners can restrict hyoid bone and/or thyroid cartilage movement above a certain length away from an inferior fastener,” which indicates that the length of the tether is capable of being adjusted within a certain threshold) at least one tether of an implantable traction apparatus (“elastic member,” taught in [0013]; [0013] teaches the elastic member being tethered to the thyroid cartilage) to perform at least one of: pulling the thyroid cartilage inferiorly cartilage ([0013] teaches “any of the embodiments can include a second separate elastic member attached to the respective bones to avoid twisting about a single axis” and “when attached to the hyoid bone or the thyroid cartilage, the elastic member can have sufficient elasticity to allow the hyoid bone or thyroid cartilage, respectively, to move inferiorly”); and pulling the hyoid bone anteriorly.
Regarding claim 96, KENT teaches the method of claim 86 and 93. KENT teaches in [0013] that the adjustment to the effective length is revised over time ([0013] teaches “the elastic member can maintain a moderate degree of tension [corresponding to a particular lengthening of the elastic member] at night, that could be titratable [or, changed] at the time of implant or afterwards”).
Regarding claim 97, KENT teaches the method of claim 86 and 93. KENT teaches in [0013] monitoring a therapy outcome during a treatment period; and adjusting the effective length based on the therapy outcome ([0013] teaches “the elastic member can maintain a moderate degree of tension [corresponding to a particular lengthening of the elastic member] at night, that could be titratable at the time of implant or afterwards, to keep the pharynx from becoming too compliant at night”).
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(s) 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over KENT (US 2023/0165704 A1) in view of GHUGE (US 2023/0000664 A1).
Regarding claim 89, KENT teaches the method of claim 86. KENT does not teach that mechanically maneuvering the at least one of the thyroid cartilage and the hyoid bone comprises at least one of electromechanically maneuvering the thyroid cartilage inferiorly and electromechanically maneuvering the hyoid bone anteriorly.
However, GHUGE teaches in [0084] an analogous method wherein mechanically maneuvering the at least one of the thyroid cartilage and the hyoid bone comprises at least one of electromechanically maneuvering the thyroid cartilage inferiorly and electromechanically maneuvering the hyoid bone anteriorly ([0086] teaches the stimulator 116 being a mechanical device that provides electrical stimulation; [0084] teaches “electrical stimulation of the entire floor of the oral cavity through the stimulator will create contraction of these muscles thus facilitating the entire bulk of the posterior aspect of the tongue to be pulled anteriorly, the floor of the mouth pulled cranially, the hyoid bone pulled anteriorly”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of KENT to include that mechanically maneuvering the at least one of the thyroid cartilage and the hyoid bone comprises at least one of electromechanically maneuvering the thyroid cartilage inferiorly and electromechanically maneuvering the hyoid bone anteriorly as taught by GHUGE because this element “widens the antero-posterior and lateral diameters of SMCA,” which is known to provide “improvement in breathing efficiency” as GHUGE teaches in [0084] and [0212].
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over KENT (US 2023/0165704 A1) in view of Conrad et al. (US 2005/0092334 A1).
Regarding claim 90, KENT teaches the method of claim 86. KENT does not teach that promoting patency of the upper airway comprises pulling the hyoid bone via the mechanically maneuvering of the hyoid bone anteriorly.
However, Conrad et al. teaches in Figure 18, [0003] and [0060] an analogous method wherein promoting patency of the upper airway ([0003] teaches “this invention pertains to a method and apparatus for treating a condition of an upper airway of a patient” and “this invention is directed to such a method and apparatus including an implant to improve patency of the airway;” [0060] teaches “the lever 160 urges the hyoid bone forward (i.e., toward the jaw bone JB) with the advantages of the mandibular advancement or mandibular osteotomy procedures”) comprises pulling the hyoid bone (hyoid bone HB) via the mechanically maneuvering of the hyoid bone anteriorly ([0060] teaches “A second end 168 of the lever 160 extends above the hyoid bone HB and projects into the interior of the tongue T. The second end 168 is secured to an anchor bolt 170 in the jawbone JB by a suture or cable 172 which is placed under tension by a surgeon. The lever 160 urges the hyoid bone forward (i.e., toward the jaw bone JB) with the advantages of the mandibular advancement or mandibular osteotomy procedures.”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of KENT to include that promoting patency of the upper airway comprises pulling the hyoid bone via the mechanically maneuvering of the hyoid bone anteriorly as taught by Conrad et al. because this element is known to “improve patency of the airway” and provide “the advantages of the mandibular advancement or mandibular osteotomy procedures,” as Conrad et al. teaches in [0003] and [0060].
Claim(s) 94 and 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over KENT (US 2023/0165704 A1) in view of Cartledge et al. (US 2007/0016287 A1).
Regarding claims 94 and 95, KENT teaches the method of claim 86 and 93. KENT does not teach that the implantable traction apparatus comprises at least one implantable winch; and wherein the at least one implantable winch operates by one of: solely mechanically; and electromechanically.
However, Cartledge et al. teaches in Figures 90 and 101-104, the abstract, [0204] and [0248] an analogous method wherein the implantable traction apparatus (the abstract teaches “an implantable device is provided for controlling shape and/or size of an anatomical structure or lumen;” this controlling of the shape and/or size of an anatomical structure or lumen requires application of force, or traction, thereto) comprises at least one implantable winch ([0204] teaches “an adjustable implant employs a winch;” Figures 90 and 101-104 teach the winch system 1900 being implanted); and wherein the at least one implantable winch ([0204] teaches “an adjustable implant employs a winch;” Figures 90 and 101-104 teach the winch system 1900 being implanted) operates by one of: solely mechanically ([0248] teaches “a winch system 1900 that serves to affect the circumference of the implant 1865 through mechanical action”); and electromechanically.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of KENT to include that the implantable traction apparatus comprises at least one implantable winch; and wherein the at least one implantable winch operates by one of: solely mechanically; and electromechanically as taught by Cartledge et al. because this element is known to “provide for adjustment [of the implant] before, during or after the anatomical structure or lumen resumes near normal to normal physiologic function” and enable the user “to take up or to let out” the implant as desired, as Cartledge et al. teaches in the abstract and [0204].
Claim(s) 98 is/are rejected under 35 U.S.C. 103 as being unpatentable over KENT (US 2023/0165704 A1) in view of Weadock et al. (US 2011/0100377 A1).
Regarding claim 98, KENT teaches the method of claim 86 and 93. KENT does not teach anchoring the at least one tether to non-nerve tissue to which upper airway-dilating muscles attach.
However, Weadock et al. teaches in Figure 7 and [0066] an analogous method that includes anchoring the at least one tether (tongue suspension element 20) to non-nerve tissue (“tissue of the tongue,” taught in [0066]) to which upper airway-dilating muscles (like the geniohyoid muscles, for instance) attach ([0066] teaches “the tongue suspension element 20 preferably includes the center section 24 implanted in the patient's tongue T and the first and second free ends 26, 28 extending through the tissue of the tongue toward the anterior end of the geniohyoid muscles”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of KENT to include anchoring the at least one tether to non-nerve tissue to which upper airway-dilating muscles attach as taught by Weadock et al. because this element is known “to shift a posterior surface of the tongue T away from an opposing pharyngeal wall,” as Weadock et al. teaches in [0066].
Claim(s) 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over KENT (US 2023/0165704 A1), in view of Weadock et al. (US 2011/0100377 A1) and further in view of BOLEA (US 2014/0228905 A1).
Regarding claim 99, KENT and Weadock et al. teach the method of claim 86, 93 and 98. KENT and Weadock et al. do not teach at least one of reducing an amount of retraction and releasing the at least one tether in response to tension on the at least one tether that is outside a threshold.
However, BOLEA teaches in Figure 22A and [0192] an analogous method that includes at least one of reducing an amount of retraction and releasing the at least one tether (neurostimulator system 10, stimulation lead body 62, nerve cuff electrode 2000, compliant sheet wrap 2002) in response to tension on the at least one tether (neurostimulator system 10, stimulation lead body 62, nerve cuff electrode 2000, compliant sheet wrap 2002) that is outside a threshold ([0192] teaches “opening 2002e may be configured to release projection 2002c when forces greater than a predetermined threshold are exerted on sheet wrap 2002”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of KENT to include at least one of reducing an amount of retraction and releasing the at least one tether in response to tension on the at least one tether that is outside a threshold as taught by BOLEA because this element is known to “prevent injury,” as BOLEA teaches in [0192].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 2/25/2026