DETAILED ACTION
Response to Arguments
Applicant's arguments filed 3/5/26 have been fully considered but they are not fully persuasive.
Regarding Hahn, Applicant asserts Hahn does not disclose a modification procedure in Paragraph 46 alone. However, the rejection is based on Hahn as a whole, not just Paragraph 46. The details of the modification procedure (i.e. titration) are shown throughout Hahn (e.g. Paragraphs 24, 26, 28, 36-39, 49, 51-53, 62). In Paragraph 46, when Hahn refers to therapy/stimulation, Hahn is referring to the aforementioned titration. For instance, to better explain, a preceding Paragraph 44 (first sentence) says that the therapy titration may be controlled according to a stimulation schedule, and then the later Paragraph 46 further describes some of those stimulation schedules (for the titration), including a stimulation schedule where the therapy (i.e. the aforementioned titration) may be applied contingent on enabling conditions such as patient rest or sleep.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-2, 5-8, 12 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Hahn (US 2012/0143286).
Regarding claims 1-2, 6-8, Hahn discloses 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 first therapy with a first treatment period based on an input obtained from the patient, the first therapy including an electrical stimulation with one or more parameters (Paragraphs 24, 26, 36-39), receiving data relating to a patient’s level of consciousness (Paragraph 46: level of consciousness broadly includes sleep versus awake state), initiating a modification procedure of one or more values associated with the one or more parameters during the titration period based on the received data relating to a patient’s level of consciousness (Paragraph 46), and continuing the first therapy for the first treatment period while one or more parameters are being tolerated by the patient (Paragraphs 28, 49, 51-53, 62).
Regarding claim 5, Hahn discloses modifying titration based on adverse effects (Figure 9; Paragraphs 24, 28, 49).
Regarding claim 12, Hahn discloses timing the titration increase of a parameter to occur during a sleep state of the patient (Paragraph 46) where any given sleep state can be inherently characterized as one of the recited sleep states.
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 3, 9-11 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 3, 9-11, Hahn does not disclose initiating a third therapy based on an acute event detection as recited. However, Archer teaches interrupting a first therapy to deliver a different therapy (Figure 4; Paragraphs 15-16), 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 a third therapy based on an acute event detection as recited, in order to treat an acute epileptic event.
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 1-3, 5-12 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).
THIS ACTION IS MADE FINAL. 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, Carl Layno can be reached on 571-272-4949. 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
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