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 .
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 7 – 11 of U.S. Patent No. 10,974,053 and 1 – 20 of U.S. Patent No. 12,042,660. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the ‘053 patent claim a method, comprising: receiving a request to modify application; transmitting the request to the administrative device; receiving a response provided by the administrator; and modifying the application in response to receiving the response. The ‘053 patent and the ‘660 patent are more specific by specifying that the request to modify the application comprise a request to modify the program schedule. Therefore, the claims of the ‘053 patent anticipate the claims of the present application.
Claim Rejections - 35 USC § 102
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(s) 1, 2, 4 – 7, 9 – 12, 14 – 16, and 18 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerber et al. (US PGPUB 2006/0190051 – in IDS).
Regarding claims 1, 2, 11, 12, and 19, Gerber discloses a system and method implemented using a system having an implantable medical device (e.g. 12) including an implantable pulse generator configured for implantation in a patient (e.g. ¶ 5 and Fig. 1); an administrative device (e.g. 26, 28) configured for use by an administrator, wherein the administrator includes a physician, a clinician, a specialist, a sales representative, an insurance representative, or a customer support representative (e.g. ¶ 26); and a user device (e.g. 22) configured for use by the patient to communicate with the administrative device and the implantable medical device (e.g. Fig. 1), the method comprising: receiving at an application executing on the user device, a request to modify the application, wherein the request to change a version of the application on the user device (e.g. ¶ 34 – 38); transmitting the request to the administrative device for approval (e.g. ¶ 26); receiving a response to the request from the administrative device (e.g. ¶ 26), wherein the response is provided by the administrator using the administrative device (e.g. ¶ 26); and changing the version of the application, in response to receiving the response (e.g. ¶ 26 – 29).
Regarding claims 4, 5, 14, 15 and 20, Gerber discloses providing additional features for managing a patient condition, and rotating through programs implemented by the IMD (e.g. ¶ 26 – 29; by dynamically adjusting the stimulation parameters; Gerber teaches changing/cycling through different programs).
Regarding claim 6, Gerber discloses the response provided by the administrator using the administration device is based on a physical condition of the patient (e.g. ¶ 26).
Regarding claims 7, 9, 16, and 18, Gerber discloses a user interface configured to set test periods and provide user reports (e.g. ¶ 26 – 29)
Regarding claim 10, Gerber teaches dynamically adjusting the parameters based on evaluations (e.g. ¶ 26). This would necessarily read on choosing the best program schedule.
Claim Rejections - 35 USC § 103
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.
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 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al.
Regarding claims 8 and 17, Gerber discloses the claimed invention except for specifically reciting changing the wash-in and/or wash-out times. However, Gerber teaches using pain metrics and adjusting stimulation parameters to determine an optimal stimulation program. Was-in and wash-out times are well known parameters related treating pain. Therefore, it would have been obvious to one having ordinary skill in the art to modify the method as taught by Gerber with modifying the wash-in and wash-out times, since finding the optimal workable conditions requires only routine skill in the art.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. in view of Parker (USPN 2015/039047).
Regarding claims 3 and 13, Gerber discloses updating the program, as previously discussed, but fails to explicitly recite changing to a new release of the application.
Parker teaches it is known to periodically check for updates and change to a new release of an application when available (e.g. ¶ 33). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Gerber with the application updates as taught by Parker, since such a modification would provide the predictable results of providing the invention with software and hardware updates that will fix any known bugs and update security.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (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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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3792