DETAILED ACTION
Response to Arguments
Applicant's arguments filed 9/26/25 have been fully considered but they are not persuasive.
Regarding the claim objections, the amendment resolves the issue.
Regarding the double-patenting rejections, the terminal disclaimers are under review and the double patenting rejections are expected to be withdrawn once the terminal disclaimers are approved.
Regarding the prior art rejections, Applicant’s remarks regarding support for the amendments has been considered, but the amendments raise some 112(a) issues, as noted below. In addition, it appears to be obvious to utilize a frequency of the frequency signal equal to or smaller than a frequency of the electrical stimulation signal, as described further below in the rejection.
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 1-2, 4-6, 9-12, 15-26 and 29-37 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 23: The original specification does not clearly disclose the particular relationship requiring a frequency of the frequency signal being equal to or smaller than a frequency of the electrical stimulation signal. See MPEP 2163.05. Examiner suggests reciting the particular supported numerical ranges for each signal.
Claims 17, 30: Frequencies 1-1.2 MHz and 6-45 MHz are not supported in combination with a frequency of the frequency signal being equal to or smaller than a frequency of the electrical stimulation signal.
Claim 18: Frequency of 13.56 MHz is not supported in combination with a frequency of the frequency signal being equal to or smaller than a frequency of the electrical stimulation signal.
Claims 32, 35: Specification does not support the conditional feature of performing frequency multiplication with a timer if frequency is less than a stimulation frequency as recited.
Claim 34, 37: Specification does not support specifically a same frequency at 500 kHz for both frequencies.
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.
Claim(s) 1, 2, 4, 16, 23, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 2016/0001085) in view of Pivonka (US 2018/0028824).
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Regarding claim 1, 16, 23, 29, Pan discloses substantially the same invention as claimed (Figure 2 shown above for example), including an electrical stimulation device (Paragraph 30) comprising a signal receiving circuit configured to receive and output a frequency signal (Figure 2: e.g. receiving coil 231), a rectifying circuit configured to receive the frequency signal and rectify the frequency signal to generate a rectified signal (Figure 2: 232), and a signal processing circuit configured to receive the rectifying signal to generate an electrical stimulation signal (Figure 2: 21, 26; Paragraph 48).
Further regarding claims 1, 23, Pan does not disclose the frequency details recited. However, Pivonka teaches it is common to configure a signal processing circuit for frequency multiplication, and set a frequency of a received power signal equal to or smaller than a frequency of the stimulation signal (Paragraphs 152, 197), in order to be able to set the stimulation parameters independently of the power signal. In addition, there is no evidence of criticality or unexpected results with the particular frequency relationship recited. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan as taught by Pivonka to include the frequency details as recited, in order to be able to set the stimulation parameters independently of the power signal.
Regarding claim 2, Pan discloses an electrode as recited (Figure 2: S6; Paragraph 48).
Regarding claim 4, Pan discloses the stimulation device does not have a battery (Figure 2).
Regarding claims 32, 35, the frequency multiplication of Pivonka includes a timer (Paragraphs 197-198).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 2016/0001085) and Pivonka (US 2018/0028824) in view of Lu (US 2012/0035687).
Regarding claim 5, Pan or Pivonka not explicitly disclose a counter or PWM circuit. However, Lu teaches a PWM circuit is commonly used to generate a stimulus signal (Paragraph 61). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Lu to include a PWM as recited, to generate the stimulus signal.
Claim(s) 6, 9, 19-22, 24, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 2016/0001085) and Pivonka (US 2018/0028824) in view of Chang (US 2017/0113047).
Regarding claims 6, 9, 24, Pan or Pivonka do not disclose a sine signal. However, Chang teaches a signal converting circuit to generate a sine wave electrical stimulation signal as recited (Paragraph 58), in order to customize the stimulation signal as desired. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Chang to include a signal converting circuit as recited, in order to customize the stimulation signal as desired.
Regarding claims 19-22, 31, Pan or Pivonka do not disclose the electrical stimulation parameters as recited. However, Chang teaches it is common to select a frequency of 480-520 kHz (Paragraph 61) and voltage between -25 to 25 V (Paragraph 58) and current between 0 to 60 mA (Paragraph 64), in order to deliver an appropriate stimulus signal. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Chang to include the stimulation parameters as recited, in order to deliver an appropriate stimulus signal.
Claim(s) 11, 12, 15, 17-18, 25-26, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 2016/0001085) and Pivonka (US 2018/0028824) in view of Kisker (WO 2012/013360; cited in IDS 4/25/23).
Regarding claims 11-12, 25-26, Pan or Pivonka do not disclose a protection circuit as recited. However, Kisker teaches a protection circuit including a reed switch as recited (e.g. Figure 1: 13, 14; Page 29, line 5), in order to appropriately generate stimulus signals. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Kisker to include a protection circuit as recited, in order to appropriately generate stimulus signals.
Regarding claim 15, Pan discloses an electrode as recited (Figure 2: S6; Paragraph 48).
Regarding claims 17-18, 30, Pan or Pivonka do not disclose the frequency as recited. However, Kisker teaches it is common to select a frequency such as 13.56 MHz (Page 64, line 8), in order to couple internal and external coils. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Kisker to include a frequency as recited, in order to couple internal and external coils.
Claim(s) 33-34, 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 2016/0001085) and Pivonka (US 2018/0028824) in view of Parramon (US 2005/0131495) and Chang (US 2017/0113047).
Regarding claims 33-34, 36-37, Pan or Pivonka do not disclose the frequency details recited. However, Parramon teaches a frequency of the power signal between 9-200 kHz or 500 kHz as recited (Paragraph 45), since any frequency as best serves a particular application may be selected. Furthermore, Chang teaches it is common to select a frequency of 480-520 kHz (Paragraph 61), in order to deliver an appropriate stimulus signal. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Pan and Pivonka as taught by Parramon and Chang to include the frequency parameters as recited, since any frequency as best serves a particular application may be selected and in order to deliver an appropriate stimulus signal.
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 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 17687186 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 4-6, 9-12, 15-22, 24-26, 29-37 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 20-24 of copending Application No. 17687186 (reference application) in view of Pan (US 2016/0001085). The copending claims recite substantially the same subject matter except for the rectifying circuit. However, Pan teaches it is common to include a rectifying circuit (Figure 2: 232), in order to convert the received coil energy to stimulation energy. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the copending application as taught by Pan to include a rectifying circuit as recited, in order to convert the received coil energy to stimulation energy.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and a terminal disclaimer is filed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pan (US 2016/0096023) shows energy transmission to an implanted device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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, Niketa Patel can be reached on 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796
