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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Species B in the reply filed on 5/8/2026 is acknowledged.
Applicant's election with traverse of Group 2, Species Z in the reply filed on 5/8/2026 is acknowledged. The traversal is on the ground(s) that all claims are generic and therefore the Election of Species Requirement is improper. This is not found persuasive because claims do not define species, instead, species are disclosed in the original specification. See MPEP 809.02 and FP 8.02. The applicant must elect a single species when a group of Species is disclosed in the original specification. The Species requirement can be withdrawn at allowance if only generic claims remain, but the applicant can only pursue the elected species in future amendments.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/21/23, 3/28/24, 6/6/24, 3/3/25, 11/13/25, 1/14/26 and 5/11/26 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be amended to indicate that US App. No. 18/331,109 is now US Patent No. 11,964,154.
Appropriate correction is required.
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)(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.
Claims 1, 2, 4-6, 8-11, 14-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caparso et al. (US 2021/0106824, hereinafter Caparso).
Regarding claims 1, 2, 4-6, 11, and 20, Caparso discloses a method for treating sleep apnea (par. 0005). As seen in figures 10-16, an incision 50 is made at a submandibular point below the chin 52 in order to percutaneously insert an injection needle in an anterior-to-posterior direction, a medial-to-lateral direction and then finally a lateral-to-medial direction (par. 0041-0042). A signal delivery device 24 with an array of electrodes is attached to and carried by the injection needle and is therefore inserted using the same approach to place the electrodes 34/36 transverse to the anterior branches of the hypoglossal nerve to stimulate those branches (par. 0042 and figures 6-7). Caparso discloses one or more anterior branches of a hypoglossal nerve that are distal of a medial branch of the nerve and that enter/innervate the left and right genioglossus muscles (par. 0005, 0007, 0032 and 0039, matching what is described in par. 0045 of the applicant's specification). The lead is three dimensional, such that at least a portion of the electrodes and lead have a vector component aligned with an inferior-superior axis.
Regarding claim 8, the advancing is done using ultrasound guidance (par. 0039).
Regarding claim 9, there is a single, at least generally linear path that will exist from the sub-mandibular incision toward the anterior branches before the needle and lead changes directions (par. 0041-0042).
Regarding claim 10, the lead and electrodes are shown transverse the branches of the hypoglossal nerve (figures 6 and 7).
Regarding claims 14 and 15, the lead is pushed into the genioglossus muscle (par. 0034).
Regarding claims 16-17, the lead is placed between the chin 52 and the hyoid bone and between the left and right sides of the mandible (figures 1 and 10-16).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Caparso in view of Ward et al. (US 2023/0414945, hereinafter Ward).
Regarding claim 13, Caparso discloses the applicant’s basic invention, but is silent as to applying stimulation to determine proper location of the lead and electrodes. Ward is analogous art that also discloses electrical stimulation to treat sleep apnea (see abstract). Ward discloses that test stimulations may be delivered to the nerve to determine if the location results in optimal treatment (par. 0213 and 0238). It would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Caparso to apply test stimulations to the nerve to determine if the location results in optimal treatment, as taught by Ward (par. 0213 and 0238).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Caparso.
Regarding claims 18 and 19, Caparso is silent as to exactly how the head should be positioned before lead insertion begins. However, the head would obviously need to be positioned in a manner that exposes the insertion point. Furthermore, moving the head posteriorly would more readily expose the underside of the chin then moving the head anteriorly, which would push the chin onto the chest and make the insertion point inaccessible. Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Caparso to expose the insertion point by moving the head posteriorly as the operation could not be performed without exposing the insertion point.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-6, 8-10, 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 12 of U.S. Patent No. 11,964,154 in view of Caparso. Regarding claims 1, 2, 4-6, 8-10 and 20, the patented claims disclose all limitations of the current claims with the exception of percutaneously advancing the electrodes to the hypoglossal nerve in a superior direction. Caparso also discloses a method for treating sleep apnea (par. 0005) and is thus analogous art. As seen in figures 10-16, an incision 50 is made at a submandibular point below the chin 52 in order to percutaneously insert an injection needle in an anterior-to-posterior direction, a medial-to-lateral direction and then finally a lateral-to-medial direction (par. 0041-0042). A signal delivery device 24 with an array of electrodes is attached to and carried by the injection needle and is therefore inserted using the same approach to place the electrodes 34/36 transverse to the anterior branches of the hypoglossal nerve to stimulate those branches, such that there is a single, at least generally linear path that will exist from the sub-mandibular incision toward the anterior branches before the needle and lead changes directions (par. 0041-0042). (par. 0042 and figures 6-7). Caparso discloses one or more anterior branches of a hypoglossal nerve that are distal of a medial branch of the nerve and that enter/innervate the left and right genioglossus muscles (par. 0005, 0007, 0032 and 0039, matching what is described in par. 0045 of the applicant's specification). The lead is three dimensional, such that at least a portion of the electrodes and lead have a vector component aligned with an inferior-superior axis. The advancing is done using ultrasound guidance (par. 0039). Therefore, it would have been obvious to use the insertion path of Caparso with the patented claims as Caparso teaches this path allows for individual activation of nerves for optimal desired effect (par. 0025).
Regarding claims 14 and 15, the lead is pushed into the genioglossus muscle using the insertion path described above (par. 0034).
Regarding claims 16-17, the lead is placed between the chin 52 and the hyoid bone and between the left and right sides of the mandible using the insertion path described above (figures 1 and 10-16).
Regarding claims 18 and 19, Caparso is silent as to exactly how the head should be positioned before lead insertion begins. However, the head would obviously need to be positioned in a manner that exposes the insertion point. Furthermore, moving the head posteriorly would more readily expose the underside of the chin then moving the head anteriorly, which would push the chin onto the chest and make the insertion point inaccessible. Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Caparso to expose the insertion point by moving the head posteriorly as the operation could not be performed without exposing the insertion point.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 12 of U.S. Patent No. 11,964,154 in view of Caparso in view of Ward.
Regarding claim 13, the patented claims as modified by Caparso discloses the applicant’s basic invention, but is silent as to applying stimulation to determine proper location of the lead and electrodes. Ward is analogous art that also discloses electrical stimulation to treat sleep apnea (see abstract). Ward discloses that test stimulations may be delivered to the nerve to determine if the location results in optimal treatment (par. 0213 and 0238). It would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the patented claims to apply test stimulations to the nerve to determine if the location results in optimal treatment, as taught by Ward (par. 0213 and 0238).
Allowable Subject Matter
Claims 7 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 7, par. 0041-0042 teach against deploying the lead from within the needle. Regarding claim 12, par. 0041 teaches against inserting the lead without dissecting tissue at a submental region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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