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 .
Response to Arguments
The claim objection for claim 10 has been withdrawn as the applicant has replaced the claim language “computer program product” with “non-transitory computer readable medium”.
The 35 U.S.C. 112(b) for claims 4, 7, 9 and 12-14 have been withdrawn as the applicant has removed the claim language “preferably”, "for example", and "in particular".
The 112(f) claim interpretation notice has been withdrawn as the applicant has replaced “detection means” with “wearable device” in the claims.
The double patenting rejection will be held in abeyance until allowable subject matter is indicated.
Regarding the prior art rejection, applicant’s arguments are moot in view of the new rejection (necessitated by the claim amendments) under Arcot-Krishnamurthy (Pub. No.: US 2014/0257426 A1); hereinafter referred to as “Arcot”. The newly added rejection under Arcot is as follows:
“Badran discloses the invention but is silent as to the stimulation pulses are adjusted or set depending on one or more parameter values, and wherein these parameters include at least one parameter that is not patient-related. Arcot teaches it is known to use such a modification as set forth in figure 11 steps 1102, 1103, [0080]- [0082] to provide a patient status, 1102, (which drives target stimulation levels in step 1103) that can include physiologic status or non-physiologic status (e.g. [0080]) in a vagus nerve stimulation device (e.g. see [0027], [0063]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use environmental conditions as an input for feedback-based stimulation as taught by Arcot in the system/method of Badran, since said modification would provide the predictable results of a patient status that can include physiologic status or non-physiologic status in a vagus nerve stimulation device”.
Claim Objections
Claim 1 objected to because of the following informalities: “the control unit” should be corrected to --open-loop or closed-loop control unit--. Appropriate correction is required.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,023,494. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose detecting movement to trigger stimulation of the vagus nerve. Therefore, the claims of the patent anticipate the claims of the current application.
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) 1-8 and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badran et al. (PG Pub. 2022/0296889); hereinafter referred to as “Badran”, in view of Arcot-Krishnamurthy (Pub. No.: US 2014/0257426 A1); hereinafter referred to as “Arcot”.
Regarding claims 1 and 10, Badran discloses a device for carrying out a tVNS treatment (see par. 13), comprising at least one electrode for generating a stimulation pulse (see surface electrode, par. 30), wherein the device comprises at least one wearable device which are is configured to detect the patient movement (see par. 13), and the device comprises an open-loop or closed-loop control unit (see controller 140 and par. 28 and 47), configured to initiate the output of stimulation pulses by the electrode if a patient movement detected by the wearable device reaches or exceeds a predetermined threshold value (see par. 14). Badran discloses the use of a computer for carrying out these steps (see par. 28).
Badran discloses the invention but is silent as to the stimulation pulses are adjusted or set depending on one or more parameter values, and wherein these parameters include at least one parameter that is not patient-related. Arcot teaches it is known to use such a modification as set forth in figure 11 steps 1102, 1103, [0080]- [0082] to provide a patient status, 1102, (which drives target stimulation levels in step 1103) that can include physiologic status or non-physiologic status (e.g. [0080]) in a vagus nerve stimulation device (e.g. see [0027], [0063]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use environmental conditions as an input for feedback-based stimulation as taught by Arcot in the system/method of Badran, since said modification would provide the predictable results of a patient status that can include physiologic status or non-physiologic status in a vagus nerve stimulation device.
Regarding claim 2, Badran discloses wherein the wearable device are is configured to measure the patient movement in real time (see par. 29), and in that the open-loop or closed-loop control unit is configured to control the output of stimulation pulses by the electrode in such a way to take place simultaneously with the detected patient movement (see par. 29).
Regarding claims 3 and 11, Badran discloses wherein the open-loop or closed-loop control unit is configured to control the output of stimulation pulses by the electrode in such a way to take place continuously or intermittently during a portion of the duration or the entire duration of the detected patient movement (see par. 59).
Regarding claims 4 and 12-14, Badran discloses wherein the open-loop or closed-loop control unit is configured to cause the output of stimulation pulses by the electrode having a pulse width of approx. 0.1 milliseconds, a frequency of 25 Hz, and an intensity of between 1 and 3.2 mA (see Claim 5).
Regarding claims 5 and 15-20, Badran discloses wherein in that the open-loop or closed-loop control unit is configured to adjust or set the output of stimulation pulses by the electrode during a portion of the duration or the entire duration of the detected patient movement, on the basis of further physiological parameters of the patient (see par. 47).
Regarding Claim 6, Badran discloses wherein the open-loop or closed-loop control unit is configured to end the output of stimulation pulses by the electrode when the patient movement detected by the wearable device exceeds the predetermined threshold value and/or a predetermined time period has elapsed (see par. 14).
Regarding Claim 7, Badran discloses wherein the wearable device is configured to be worn by the patient as a wristband, and to transmit measurement data directly to a stimulation unit of the device that comprises the electrode, or an interposed processing unit, and wherein the interposed processing unit is a mobile terminal (see par. 29, 35).
Regarding Claim 8, Badran discloses using the device in the rehabilitation of people with reduced mobility (see par. 18).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badran and Arcot as applied to claims 1 and 8 above, and further in view of Stubbeman (PG Pub. 2016/0008620).
Regarding Claim 9, Badran and Arcot do not give specifics about the time period the device is used. Stubbeman discloses a similar TVNS device (see par. 93 and 226) that relies on EMG (see par. 109) wherein the device is used over several weeks, several times per week (see par. 149). It would have been obvious to one of ordinary skill in the art at the time of the invention to determine the length of treatment based on the general efficacy as taught by Stubbeman (see par. 149).
Conclusion
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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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