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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/5/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/26/2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s amendments and associated arguments filed 3/5/2026 with respect to the 102 and 103 rejections of the claims have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Albright (US 4,429,314).
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.
Claims 1, 2, 5, 8-9, 17, 18, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner (US 2017/0087360) in view of Albright (US 4,429,314).
Regarding claims 1, 2, 5, 9, 17 and 18, Scheiner discloses a device for implantation proximal a genioglossus muscle 90 near a hypoglossal nerve as see in figures 2, 22 and 31 (See abstract). A flexible body 43 has a first arm and a second arm. Each arm includes a leadless stimulator unit 48a/48b attached to the arm (see figure 2). Each stimulator unit includes a receiving antenna (i.e., wire coils and ferromagnetic core being a “main body”) and a plurality of electric components on a second surface (“electronics”) encapsulated in a hermetically sealed enclosure and conductors (“electrodes” and/or wires) in electrical connection with the electric components via an electric circuit (see figure 31). However, Scheiner is silent as to the material of the ferromagnetic core of the antenna.
Albright also discloses an antenna with a ferromagnetic core, and thus is analogous art with Scheiner. Albright discloses antennas can have ceramic ferromagnetic cores as the main body of the antenna (Col. 1, lines 50-66). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to make the ferromagnetic core of the antenna of Scheiner out of ceramic as taught by Albright since this material increases the inductance of the antenna and permits reductions in antenna size (Col. 1, lines 50-66).
Regarding claim 8, the receiving antenna is configured to receive power/stimulation signals from transmitting antenna 32 that are located outside the body (par. 0046).
Regarding claim 22, figure 31 shows the antenna having a coiled shape confined to an annular area of the ferromagnetic core (“main body”) of the stimulation unit.
Regarding claim 24, each stimulator unit is attached to (and thus comprises) a processor 66 and a battery 76 (par. 0055 and 0064).
Claims 1, 2, 5, 8-9, 11, 17, 18, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner (US 2017/0087360) in view of Gross et al. (US 2015/0018728, hereinafter Gross).
Regarding claims 1, 2, 5, 9, 11, 17 and 18, Scheiner discloses a device for implantation proximal a genioglossus muscle 90 near a hypoglossal nerve as see in figures 2, 22 and 31 (See abstract). A flexible body 43 has a first arm and a second arm. Each arm includes a leadless stimulator unit 48a/48b attached to the arm (see figure 2). Each stimulator unit includes a receiving antenna (i.e., wire coils) and a plurality of electric components on a second surface (“electronics”) encapsulated in a hermetically sealed enclosure and conductors (“electrodes” and/or wires) in electrical connection with the electric components via an electric circuit (see figure 31). However, Scheiner is silent as to the antenna being encapsulated in a ceramic main body.
Gross also discloses an implantable stimulator with an antenna 30 and thus is analogous art with Scheiner. Gross discloses the antenna can be encapsulated in a ceramic main body (par. 0260, 0273). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to encapsulate the antenna of Scheiner in a ceramic main body as taught by Gross in order to hermetically seal the antenna and protect it from the body’s environment when implanted (par. 0273).
Regarding claim 8, the receiving antenna is configured to receive power/stimulation signals from transmitting antenna 32 that are located outside the body (par. 0046).
Regarding claim 22, figure 31 shows the antenna having a coiled shape confined to an annular area of the ferromagnetic core (“main body”) of the stimulation unit.
Regarding claim 24, each stimulator unit is attached to (and thus comprises) a processor 66 and a battery 76 (par. 0055 and 0064).
Claims 3, 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner and Albright or Gross in view of Masiach et al. (US 2018/0280694, hereinafter Masiach).
Regarding claims 3, 4 and 6, Scheiner, as described above, discloses the applicant’s basic invention, including a device with two arms for implantation proximal a genioglossus muscle near a hypoglossal nerve, but is silent as to the device including silicone and arms including suture holes. Mashiach also discloses a device with two arms for implantation proximal a genioglossus muscle near a hypoglossal nerve as seen in figures 10-13, and thus is analogous art with Scheiner. The device includes a flexible body 161/1061 made of silicone (par. 0059, 0110). The flexible body contains arms 162a and 162b and each arm comprises suture holes 160 (par. 0103). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s invention to modify Scheiner so the device includes silicone and the arms include suture holes as taught by Masiach in order to maintain the device in the desired location and prevent drifting of the device, while also ensuring the device is made of a material that is biocompatible.
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, 20 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 and 19-21 of copending Application No. 18/465,225. Claims 1, 10 and 19 anticipate claims 1, 20 and 21 of the current application but does not explicitly recite a first and second arm. However, the Examiner takes the position that whatever portion of the flexible body the first stimulator unit is attached to is considered the first arm and whatever portion of the flexible body the second stimulator unit is attached to is considered the second arm.
Claims 1-6, 8, 9,11-18 and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 22-24 of copending Application No. 18/465,225 in view of Gross and/or Albright. Claim 1, 10 and 19 anticipate claim 1 of the current application but does not explicitly recite a first and second arm nor a ceramic main body. However, the Examiner takes the position that whatever portion of the flexible body the first stimulator unit is attached to is considered the first arm and whatever portion of the flexible body the second stimulator unit is attached to is considered the second arm.
Furthermore, Albright also discloses an antenna with a ferromagnetic core, and thus is analogous art with the copending claims. Albright discloses antennas can have ceramic ferromagnetic cores as the main body of the antenna (Col. 1, lines 50-66). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to make the ferromagnetic core of the antenna of the copending claims out of ceramic as taught by Albright since this material increases the inductance of the antenna and permits reductions in antenna size (Col. 1, lines 50-66).
Alternatively, Gross also discloses an implantable stimulator with an antenna 30 and thus is analogous art with the copending claims. Gross discloses the antenna can be encapsulated in a ceramic main body (par. 0260, 0273). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to encapsulate the antenna of the copending claims in a ceramic main body as taught by Gross in order to hermetically seal the antenna and protect it from the body’s environment when implanted (par. 0273).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 12-16 and 20-21 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 and if the Double Patenting rejections were overcome.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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