DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/22/26 has been entered.
Response to Arguments
Applicant's arguments filed 2/22/26 have been fully considered but they are not fully persuasive.
Referring to the Series 1 in the previous response to arguments (see below), Applicant asserts that Series 1 is linear, and refers to an Oxford definition. Examiner is unable to verify this particular definition, since no citation or copy is provided. Nevertheless, Examiner disagrees that one of ordinary skill in the art would consider Series 1 to be a linear function. Examiner additionally notes that using a particular definition of linear out of context would be inappropriate. One of ordinary skill in the art would understand that Series 1 is clearly a non-linear function.
The previous response to arguments are reproduced below for clarity:
Applicant asserts Hahn does not show a titration step magnitude that is non-linear as recited, and asserts that the moving from 0.3 mA to 0.2 mA to 0.1 mA in Hahn is linear. Examiner agrees that going from 0.3 to 0.2 to 0.1 is linear. However, this progression from 0.3 to 0.2 to 0.1 is the change in titration step magnitude, not the titration step magnitude itself. Below is a graph using the numbers disclosed in the Paragraph 30 example of Hahn (solid line) versus a linear titration step magnitude (dotted line):
[Chart]
As can be seen above, the titration step magnitude progresses non-linearly across the ranges disclosed in the example of Hahn (slope of 0.3 mA between 0-1.5 mA, then slope of 0.2 mA between 1.5-2.5 mA, and slope of 0.1 mA for 2.5 mA and above).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 6-10, 12-14, 17-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hahn (US 2012/0143286) in view of Archer (US 2002/0077670).
Regarding claims 1-2, 6-8, 12-14, 19, Hahn discloses substantially the same invention as claimed, including a treating a medical condition of a patient via an implantable medical device comprising initiating via one or more processors of the implantable medical device a titration period for a non-event-specific therapy with a first treatment period based on an input obtained from the patient, the non-event specific therapy including an electrical stimulation with one or more parameters (Paragraphs 24, 26, 36-39), initiating a modification procedure of one or more values associated with the one or more parameters during the titration period, and continuing the non-event-specific therapy for the first treatment period while one or more parameters are being tolerated by the patient (Paragraphs 28, 49, 51-53, 62).
Further regarding claims 1 and 12, and claims 9-10, 17-18, Hahn does not disclose initiating a third therapy based on an acute event detection as recited. However, Archer teaches interrupting a non-event-specific therapy to deliver an event-specific therapy (Figure 4; Paragraphs 15-16), where the event-specific therapy is based on a seizure determination (Paragraphs 3, 52, 79: e.g. first and second event-specific therapies for first and second seizure types) in order to treat an acute epileptic event. 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 Hahn as taught by Archer to include initiating an event-specific therapy based on a seizure event detection as recited, in order to treat an acute epileptic event.
Further regarding claims 1 and 12, Hahn discloses a titration step magnitude may be non-linear (Paragraph 30: e.g. step magnitude changes linearly with steps of 0.3 mA when current level is less than 1.5 mA, and then makes an immediate non-linear change to a different step magnitude of 0.2 mA when current level crosses a threshold to between 1.5-2.5 mA, etc).
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 1-2, 6-10, 12-14, 17-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,305,121. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the instant application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Osorio (US 2012/0330369) shows interrupting a therapy to treat an acute event (Paragraph 8; Figure 4).
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.
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/Eugene T Wu/Primary Examiner, Art Unit 3792
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