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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/1/24 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicants’ arguments, see Remarks, filed 7/29/26, with respect to 102 rejections have been fully considered and are persuasive. The rejections of claims 1. 3-4, 9-13 and 16 have been withdrawn.
Applicants’ arguments filed 7/29/26 regarding the double patenting rejecitons have been fully considered but they are not persuasive. The Applicant argues that the newly amended claims make the rejections moot. The Examiner respectfully disagrees as the prior art discloses adjusting an intensity by a heath care provider. Therefore, the rejections stand.
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 1-3 and 5-11 of U.S. Patent No. 12,076,566. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences are merely an obvious variation. See the remarks below regarding each claim.
Regarding claim 1 of the current claim set and claim 1 of the ‘566 patent, both disclose monitoring T-wave alternans magnitude value, transmitting them to an external device and adjusting an intensity by a heath care provider to reach a desired TWA magnitude value. It is noted that the current claim 1 is broader than claim 1 of the ‘566 patent and is therefore anticipated by the ‘566 patent.
Claim 2 of the current claim set is anticipated by claim 2 of the ‘566 patent as both are directed toward increasing the intensity of the stimulation.
Claim 3 of the current claim set is anticipated by claim 2 of the ‘566 patent as both are directed toward delivering stimulation the intensity resulting in the target TWA magnitude.
Claim 4 of the current claim set is anticipated by claim 1 of the ‘566 patent which clearly discloses activating the IMD to deliver stimulation signals to the patient.
Claim 5 of the current claim set is anticipated by claim 1 of the ‘566 patent which clearly discloses determining that the TWA magnitude is above a threshold and then increasing the intensity of the stimulation until the target is achieved.
Claim 6 of the current claim set is anticipated by claim 2 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 7 of the current claim set is anticipated by claim 3 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 8 of the current claim set is anticipated by claim 5 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 9 of the current claim set is anticipated by claim 6 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 10 of the current claim set is anticipated by claim 7 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 11 of the current claim set is anticipated by claim 8 of the ‘566 patent as the claims are merely duplicates of each other.
Claim 12 of the current claim set is anticipated by claim 9 of the ‘566 patent as the claims are merely duplicates of each other.
Regarding claim 13 of the current claim set and claim 10 of the ‘566 patent, both disclose monitoring T-wave alternans magnitude value, transmitting them to an external device and adjusting an intensity by a heath care provider to reach a desired TWA magnitude value. It is noted that the current claim 13 is broader than claim 10 of the ‘566 patent and is therefore anticipated by the ‘566 patent.
Claim 14 of the current claim set is anticipated by claim 11 of the ‘566 patent as both are directed toward increasing the intensity of the stimulation.
Claim 15 of the current claim set is anticipated by claim 11 of the ‘566 patent as both are directed toward delivering stimulation the intensity resulting in the target TWA magnitude.
Claim 16 of the current claim set is anticipated by claim 10 of the ‘566 patent which clearly discloses activating the IMD to deliver stimulation signals to the patient.
Claim 17 of the current claim set is anticipated by claim 10 of the ‘566 patent which clearly discloses determining that the TWA magnitude is above a threshold and then increasing the intensity of the stimulation until the target is achieved.
Conclusion
It is noted that claims are rejected under a double patenting rejection only.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhou et al. (U.S. Pub. 2006/0116592) – discloses a similar system but fails to teach adjusting the stimulation using stimulation parameters provided externally by a health care provider.
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 REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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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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/REX R HOLMES/
Primary Examiner, Art Unit 3796
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