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 with traverse of Species A in the reply filed on 12/10/2025 is acknowledged. The traversal is on the ground(s) that the claims are generic and not limtted to any specific species. This is irrelevant as MPEP 809.02(a) and Form Paragraph 8.02 state that a Species restriction can be made when no Species claims are present by pointing to disclosed embodiments in the figures and/or specification. The applicant further argues that there is no search burden on the Examiner. However, the Examiner stated that the Species would require a different field of search as defined by MPEP 808.02(c). MPEP 808.02(c) states that the use of different search queries for different embodiments constitutes a search burden. The distinct and mutually exclusive structural limitations in each Species would necessarily require different search queries to fully search and examine the entire scope of the generic claims.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/12/13, 5/31/24, 7/17/24, 8/2/24, 3/3/24 and 5/23/25 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 9 is 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 9 recites the limitation "the plurality of passive electrical components" in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recited “a plurality of electrical components” and so for examination purposes, this is believed to refer back to the electrical components recited in claim 1.
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 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-24 of copending Application No. 18/245,445 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 5, 8-11, 17, 18 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheiner (US 2017/0087360).
Regarding claims 1, 2, 5, 9, 17, 18 and 24, 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 (“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, par. 0064). The units are configured for bilateral stimulation (par. 0063).
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 23, once can draw a circle (i.e., “inner circular area”) around the enclosure and conductor of the main body of the stimulation unit.
Regarding claims 10, 11 and 22, figure 31 shows the antenna having a coiled shape confined to an annular area of a “main body” of the stimulation unit.
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.
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 3, 4, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiner in view of Masiach et al. (US 2018/0280694, hereinafter Masiach).
Regarding claims 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.
Allowable Subject Matter
Claims 12-16 and 19-21 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.
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