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 .
Response to Arguments
Applicant’s amendment and arguments filed 12/16/2025 have overcome the previously applied 35 USC 101 and 35 USC 112 rejections of the claims.
Applicant's arguments filed 12/16/2025 with respect to the 35 USC 102 rejections have been fully considered but they are not persuasive.
Applicant argues on p. 8 under the Remarks that Soederstroem is silent regarding “the set of criteria corresponding to the desired neuronal response comprising identifying one or more target neurons(s) for activation or conduction block”. The Examiner respectfully disagrees. Soederstroem discloses defining a target volume of activation “T” (see par. [0021]), which corresponds to Applicant’s claimed “one or more target neurons”. Soederstroem then discloses determining a correspondence of an actual volume of activation (VOA) to T, which is labeled a receiver operating characteristic (ROC), see par. [0033]. Lastly, Soederstroem discloses selecting a point on ROC curve that corresponds to the best match of the VOA to target T, which then sets the stimulation parameters to those associated with that point on the ROC curve (par. [0036]).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Soederstroem (PGPUB 2013/0104066).
Regarding Claim 20, Soederstroem discloses inputting a set of criteria corresponding to a target (T) volume of activation (VOA) of neural tissue (which encompasses one or more target neurons) into a model, such as a Jaccard index (par. [0023], eq. 1); and generate one or more stimulation criteria based on the output of the model ( a point on the receiver operating characteristic, ROC, such as the knee point, can be selected and stimulation parameters corresponding to that point can be selected, see par. [0036]). Soederstroem discloses programming an IPG with the stimulation values and delivering the stimulation (par. [0049]).
In regards to Claim 19, Soederstroem discloses setting pulse amplitudes, pulse widths, etc. (par. [0039]).
Claims 15-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by McIntyre et al. (U.S. Patent 8,538,543).
Regarding Claims 17-20, McIntyre discloses inputting a set of criteria corresponding to a desired volume of tissue activation (VTA) of neural tissue into a model and outputting stimulation criteria such as electrode size, spacing, implantation depth, stimulation parameters, etc. required to achieve the input set of criteria (Abstract; col. 12, lines 8-40). McIntyre discloses programming an implantable pulse generator to apply the stimulation parameters (col. 5, lines 50-65).
In regard to Claim 15, McIntyre discloses optimizing the output with optimization algorithms such as search algorithms (col. 12, lines 40-48).
Regarding Claim 16, McIntyre discloses selecting the stimulation criteria that provide the maximum therapeutic benefit (matches the desired VTA); and/or minimizes side effects (col. 11, lines 8-45).
Claims 14 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Moffitt et al. (U.S. Patent 9,586,053).
Regarding Claims 14 and 20, Moffitt discloses inputting a set of criteria (desired stimulation sites) into a model and outputting one or more stimulation parameters sets to achieve the input criteria, wherein the output is optimized with algorithms such as a gradient descent algorithm (col. 5, lines 15-29). Moffitt discloses communicating the settings to an implantable pulse generator to provide stimulation (Claim 1).
Conclusion
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796