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 III in the reply filed on 8/12/2026 is acknowledged.
Claims 21-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The first paragraph should list all parent applications found in the ADS filed on 8/6/2024 and all continuity data of the application, including Patent No’s of the applications, if applicable.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for applying stimulation signals to an ear/cochlea, does not reasonably provide enablement for providing stimulation signals to ANY sensory organ (e.g., eye, nose, mouth, etc.). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Claim 35 recites “electrodes configured to deliver…electrical stimulation signals to a sensory organ” in combination with the rest of the limitations of the claim. As currently worded, the scope of this recitation would cover ANY AND ALL sensory organs. The original specification provides absolutely no discussion of providing stimulation signals to any sensory organ besides the ear/cochlea. Merely applying signals to these sites in synchronization with stimulating the vagus nerve would seem to be inadequate, given the level of predictability in the art (Wands factor (E)), and the inventor has given no direction as to the specific type of stimulation to be applied or how the signals should be applied (Wands factor (F)). Therefore, the quantity of experimentation needed to make or use the invention based on the content of the disclosure would be burdensome (Wands factor (H)). Furthermore, the breadth of the claim is broad, as it goes into no specificity as to what, exactly, is being stimulated, or how (Wands factor (A)). As but examples, it could be the eye, nose or mouth, and there is no disclosure that would enable any of these. Taking all of the Wands factors into account, it does not appear that the original specification enables one of ordinary skill in the art to make or use the invention without undue experimentation.
Claims 36-46 depend from claim 35 and are rejected based on their association.
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 35-38, 41, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 14, 18, 20 and 24 of U.S. Patent No. 11,547,854. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the current claims.
Claims 35-38, 42, 44 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, 12 and 15-18 of U.S. Patent No. 12,076,563. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the current claims.
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.
Claim 35-37 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erfan (US 2005/0165460).
Regarding claims 35 and 37, Erfan discloses a medical device as seen in figures 1 and 7. The device includes a stimulator/processing unit 16 that provides/controls first electrical stimulation signals to a left arm 12 and supplemental electrical stimulation signals to a right arm 14 for all periods of time after the device is activated (par. 0040). Electrodes 56 on each arm simultaneously apply signals to a conch of an ear (i.e., sensory organ) and/or the vagus nerve (par. 0039).
Regarding claim 36, the device controls timing of the delivery of the signals. “To optimize a learning period” is an intended use of the timing. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 46, as seen in figure 7, the electrodes are implanted within the ear of the patient.
Claim 35-37 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US 2011/0230938, hereinafter Simon).
Regarding claims 35, 37 and 44, Erfan discloses a medical device as seen in figure 3. The device includes a stimulator/processing unit 310/330 that provides/controls first electrical stimulation signals to a vagus nerve via electrodes and supplemental electrical stimulation signals to a tongue (i.e., sensory organ) via electrodes for all periods of time after the device is activated in order to enhance perception of the individual input signals (par. 0103).
Regarding claim 36, the device controls timing of the delivery of the signals. “To optimize a learning period” is an intended use of the timing. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, especially US 2015/0126802, which discloses stimulating the cochlea in combination with the vagus nerve (par. 0100) and US 2019/0151646, which discloses electrodes to simultaneously stimulate the ear and the vagus nerve (see abstract).
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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