DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/13/2025 has been entered.
Response to Arguments
The Examiner has withdrawn the double patenting rejections over US 9,656,075 and US 11,844,944. The double patenting rejection over US 11,000,685 is still considered proper. The applicant presented no arguments against this rejection.
Applicant's amendments and arguments filed 6/13/2025 have been fully considered but they are not persuasive. The applicant argues that the amendments overcome Llinas because Llinas does not disclose delivering currents to multiple sites at more than one pulse width. The Examiner respectfully disagrees.
As currently written, the claim does not require the pulse widths to be applied simultaneously or concurrently to multiple sites. Nor does the claim require the pulse widths to be different. Nor does the claim require multiple, different pulse widths to be delivered to each site. If a current with a pulse width is applied to a first site, and then a second current with a second pulse width is applied to a second site, then the claim is met, as that would result in the delivery of currents to multiple sites at more than one pulse width to a target tissue (i.e., the brain).
This scenario is clearly taught by Llinas. As disclosed in par. 0025-0030, Llinas discloses that wave rhythmicity of brain activity is tracked to determine sites for delivering brain stimulation. If stimulation is needed at multiple sites, then Llinas will deliver current with a pulse width to each site, such that multiple, separate currents with multiple, separate pulse widths will be delivered to multiple sites. The rejections are still considered proper.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 4-7 and 10-14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Llinas et al. (US 2002/0055675, hereinafter Llinas).
Regarding Claim 1, Llinas discloses a medical device configured to treat an
epileptic event (see par. 0062) comprising: one or more processors configured to
determine a wave rhythmicity of brain activity of a patient (see par. 0027), and a treatment unit configured to apply a therapy to a target tissue of the patient (see par. 0030), wherein the target tissue is based upon the wave rhythmicity (see par. 0025-0026). As disclosed in par. 0025-0030, Llinas discloses that wave rhythmicity of brain activity is tracked to determine sites for delivering brain stimulation. If stimulation is needed at multiple sites, then Llinas will deliver current with a pulse width to each site, such that multiple, separate currents with multiple, separate pulse widths will be delivered to multiple site.
Regarding Claim 4, Llinas discloses wherein the one or more processors are
configured to determine a second therapy based on patent specific data, where the
second therapy is tailored to the patient (see par. 62, 73, 101).
Regarding Claim 5, Llinas discloses wherein the treatment unit is further
configured to deliver the second therapy to the patient (see par. 101).
Regarding Claim 6, Llinas discloses wherein at least one of: a time of therapy
delivery; a therapy intensity; a therapy dosage; a type of therapy; a therapy delivery
location; a geometric configuration; and a number of therapy sources are part of the
tailoring procedure (see par. 73).
Regarding Claim 7, Llinas discloses wherein the one or more processors are
further configured to determine a therapy effect on a brain activity and modify the
therapy based on the determined therapy effect on the brain activity (see par. 106).
Regarding Claim 10, Llinas discloses wherein the one or more processors are
configured to generate a warning based on the wave rhythmicity (see par. 28-29).
Regarding Claim 11, Llinas discloses determining a current rhythmicity level (see
par. 26 and 96).
Regarding Claim 12, Llinas discloses comparing the current rhythmicity level to a
target rhythmicity level (see par. 65-66, 71).
Regarding Claim 13, Llinas discloses wherein the therapy is further based on the
comparison of the current rhythmicity level to the target rhythmicity level (see par. 73).
Regarding Claim 14, Llinas discloses wherein the comparison determines that
current rhythmicity level is below the target value which is associated with a high
probability of a blockage of the epileptic event (see par. 67).
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
over Llinas in view of John (US 2007/0142874).
Regarding Claims 8-9, Llinas does not elaborate on the efficacy and low
rhythmicity. John discloses a similar epilepsy system where therapy can be adjusted to
switched based on low efficacy or low rhythmicity (see par. 74, 117, and 137). It would
have been obvious to one of ordinary skill in the art before the applicant’s invention to initiate a second therapy based on a low efficacy in order to increase or maintain the efficacy of treatment (see par. 121 and 137).
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
over Llinas in view of Osorio et al. (US Patent 8024032).
Regarding Claim 15, Llinas does not elaborate on a specific autocorrelation
function value. Osorio discloses a similar method of analyzing brain activity wherein the
rhythmicity level being below the target rhythmicity level value means that a rhythmicity
level value is below an auto- correlation function which is below a specific value (see
col. 15, line 53-col. 16, line 1). It would have been obvious to one of ordinary skill in the
art before the applicant’s invention to compare the rhythmicity value to a specific value
because Osorio teaches it helps indicate an impending brain state change (see col. 15,
line 53-col. 16, line 1). Osorio does not explicitly disclose this value is 0.6. It would have
been obvious to one of ordinary skill in the art before the applicant’s invention to make the value 0.6 since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272,205 USPQ 215 (CCPA 1980)).
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 and 4-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,000,685. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the current claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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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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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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