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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-5 and 8-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-5 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 16/569,694 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Application ‘694 has been found to anticipate each and every element of the present invention for instance both provide an electrical stimulator including: a base wire configured with a core wire having an insulating film, and an outer winding wire wound around the core wire with the core wire serving as a winding axis; wherein an annulus is formed by winding the base wire in a loop shape (helical shape includes loops and thus is considered “a loop shape”), a first end of the core wire is electrically connected to a first end of the outer winding wire, a second end of the core wire is connected to a first terminal of an external circuit, and a second end of the outer winding wire is connected to a second terminal of the external circuit, and treating the living body by holding the living body or a part of the living body of a subject in the annulus and generating a current in the external circuit for a therapeutically effective time period to apply an electrical stimulation to the living body or the part of the living body.
As set forth above, the present invention is not viewed to be patentably distinct from the co-pending application 16/569,694. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Goodwin et al. (US 8,795,147 B1).
As to claim 1, Goodwin et al. discloses treating a disorder related to an articular cartilage of an arthritis patient using an electrical stimulator (Abstract) , the electrical stimulator including: a base wire configured with a core wire having an insulating film (Figures 3 and 6), and an outer winding wire wound around the core wire with the core wire serving as a winding axis (col. 14, lines 32-55); an annulus formed by winding the base wire one turn or a plurality of turns, a target part having the articular cartilage of the arthritis patient (col. 8, lines 15-21) being configured to be inserted in an inner space of the annulus (Figures 3 and 6); a first end of the core wire is electrically connected to a first end of the outer winding wire (col. 14, lines 32-55; Figures 3 and 6); a second end of the core wire is connected to a first terminal of an external circuit (Figure 3); and a second end of the outer winding wire is connected to a second terminal of the external circuit (Figure 3), the method comprising the steps of: holding the target part in the inner space of the annulus (Figure 6); and generating an alternating current in the external circuit for a therapeutically effective time period to apply an electrical stimulation to the target part (Figure 6).
Goodwin et al. discloses the invention substantially as claimed, but does not explicitly disclose “an intensity of an electric field in the inner space of the annulus is in a range of 0.17 to 0.27 V/m, and the therapeutically effective time period is at least 30 minutes/day for at least one week to observe a state of the arthritis patient in which an amount of proteoglycan in the articular cartilage is increased compared with a pre-treatment state of the arthritis patient”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the parameters of the stimulation therapy, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 2, Goodwin et al, and thus the modified Goodwin et al., disclose the target part is a joint of the arthritis patient (col. 8, lines 15-21).
As to claim 3, Goodwin et al, and thus the modified Goodwin et al., disclose the joint is a knee joint of the arthritis patient in need of treatment for osteoarthritis of a knee (Figure 6).
As to claim 4, Goodwin et al, and thus the modified Goodwin et al., disclose a frequency of the alternating current is in a range of 10 to 50 kHz (col. 8, lines 35-50).
As to claim 5, the modified Goodwin et al. discloses the invention substantially as claimed but does not explicitly disclose “a frequency of the alternating current is approximately 20 kHz”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the frequency of the alternating current, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 8, the modified Goodwin et al. discloses the invention substantially as claimed but does not explicitly discloses the intensity of the electric field
As to claim 9, Goodwin et al, and thus the modified Goodwin et al., disclose the annulus is formed in a concentric shape of multiple layers (Figures 3 and 6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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