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
2. Applicant’s election without traverse of Group III and Species B (i.e. claims 20, 25-28, and 31-32) in the reply filed on 6/18/2026 is acknowledged. Thus, claims 21-24 and 29-30 are withdrawn from consideration.
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.
4. Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. (12,194,290). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the instant application is anticipated by the claim of U.S. Patent No. (12,194,290) as shown below.
INSTANT APPLICATION (18/981465)
U.S. Patent No. (12,194,290)
20. A method, comprising:
placing a nerve cuff of an electrode lead on the hypoglossal nerve (HGN) that is configured for placement on either one of the HGN trunk and the branch of the HGN that is responsible for protruding the tongue (HGN GM branch);
applying stimulation energy to the HGN trunk with the nerve cuff in instances where the nerve cuff is on the HGN trunk; and applying stimulation energy to the HGN GM branch with the nerve cuff in instances where the nerve cuff is on the HGN GM branch.
10. A method, comprising:
placing the cuff body of the electrode lead claimed in claim 1 on either one of the hypoglossal nerve (HGN) trunk and the branch of the HGN that is responsible for protruding the tongue (HGN GM branch);
applying stimulation energy to the HGN trunk with at least some of the electrically conductive contacts in instances where the cuff body is on the HGN trunk; and applying stimulation energy to the HGN GM branch with at least some of the electrically conductive contacts in instances where the cuff body is on the HGN GM branch.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 25-28, and 31-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation “the hypoglossal nerve” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation will be interpreted as “a hypoglossal nerve”.
Claim 20 recites the limitation “the HGN trunk” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation will be interpreted as “an HGN trunk”.
Claim 20 recites the limitation “the branch of the HGN that is responsible for protruding the tongue (HGN GM branch)” in lines 3-4. For the purposes of examination, this limitation will be interpreted as “a branch of the HGN that is responsible for protruding a tongue (an HGN GM branch)”.
10. Claims 25-28, and 31-32 are rejected at least because they depend from a claim which is indefinite.
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.
(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 20, 25-28, and 31-32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rondoni et al. (US Pub.: 2020/0230412 A1).
Regarding claim 20, Rondoni discloses a method, comprising:
placing a nerve cuff of an electrode lead on the hypoglossal nerve (HGN) (e.g. Fig. 1 – cuff electrode 100, lead body 82; paragraph 0079 – cuff electrode is placed on a hypoglossal nerve)
that is configured for placement on either one of the HGN trunk and the branch of the HGN that is responsible for protruding the tongue (HGN GM branch) (e.g. e.g. paragraphs 0079, 0083 – along the length of the hypoglossal nerve; paragraphs 0098 – stimulation causing protrusion of the tongue. Examiner notes that the claim uses the alternative language “either one” and therefore only requires that the nerve cuff be placed on one of these stimulation sites);
applying stimulation energy to the HGN trunk with the nerve cuff in instances where the nerve cuff is on the HGN trunk (e.g. paragraphs 0079; 0083);
and applying stimulation energy to the HGN GM branch with the nerve cuff in instances where the nerve cuff is on the HGN GM branch (e.g. paragraphs 0098, 0109; This limitation is in the alternate. See Examiner note above.).
Regarding claim 25, Rondoni discloses a method as claimed in claim 20 as discussed above, and Rondoni further teaches wherein the electrode lead (82) includes an elongate lead body having a proximal end and a distal end (e.g. paragraphs 0055, 0065);
and the nerve cuff (100) comprises a biologically compatible, elastic, electrically insulative cuff body (e.g. Figs. 1, 2 – cuff body 101) affixed to the distal end of the lead body (e.g. Fig. 3; paragraphs 0048, 0080, 0132),
the cuff body being configured to be circumferentially disposed around a nerve (e.g. paragraph 0053),
having a pre-set furled state that defines an inner lumen, and being movable to an unfurled state (e.g. paragraphs 0051, 0066), and defining a length and a width in the unfurled state that is greater than the length (e.g. paragraphs 0066, 0118),
a first row of electrically conductive contacts (e.g. Fig. 8B – electrodes 323A-323C; paragraph 0126) carried by the cuff body (101) that are spaced from one another in the width direction (e.g. paragraph 0118),
a second row of electrically conductive contacts (e.g. Fig. 8B – electrodes 333A-333C; paragraph 0126) carried by the cuff body (101) that are spaced from one another in the width direction, the second row being spaced from the first row in the length direction (e.g. paragraph 0118),
a third row of electrically conductive contacts (e.g. Fig. 8B – electrodes 313A-313C; paragraph 0126) carried by the cuff body (101) that are spaced from one another in the width direction (e.g. paragraph 0118), the third row being located between the first and second rows (e.g. Fig. 8B; paragraph 0118), and a plurality of electrical conductors extending through the lead body from at least some of the electrically conductive contacts to the proximal end of the lead body (e.g. paragraphs 0070-0071, 0126).
Regarding claim 26, Rondoni discloses a method as claimed in claim 25 as discussed above, and Rondoni further teaches wherein applying stimulation energy to the HGN with the nerve cuff comprises applying stimulation energy to the HGN (e.g. paragraphs 0079; 0083) with one of the electrically conductive contacts in one of the rows and returning the stimulation energy with one of the electrically conductive contacts in another row (e.g. paragraphs 0107, 0121).
Regarding claim 27, Rondoni discloses a method as claimed in claim 26 as discussed above, and Rondoni further teaches wherein the contact this applying the stimulation energy is aligned in the width direction with the contact that is returning the stimulation energy (e.g. paragraphs 0108, 0121).
Regarding claim 28, Rondoni discloses a method as claimed in claim 26 as discussed above, and Rondoni further teaches wherein the contact this applying the stimulation energy is offset in the width direction with the contact that is returning the stimulation energy (e.g. paragraphs 0110, 0121).
Regarding claim 31, Rondoni discloses a method as claimed in claim 25 as discussed above, and Rondoni further teaches wherein the electrically conductive contacts in the first row (323A-323C) are connected to one another in series (e.g. paragraphs 0072, 0121); the electrically conductive contacts in the second row (333A-333C) are connected to one another in series (e.g. paragraphs 0072, 0121); and the electrically conductive contacts in the third row (313A-313C) are each connected to a respective one of the electrical conductors (e.g. paragraphs 0072, 0121).
Regarding claim 32, Rondoni discloses a method as claimed in claim 31 as discussed above, and Rondoni further teaches wherein applying stimulation energy comprises applying stimulation energy to one or more of the electrically conductive contacts in the third row and forming a return path with one or more of the electrically conductive contacts in the first row and/or second row (e.g. paragraphs 0102, 0121).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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