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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 16-24 and 32 as well as Species F (the investigation, electrical stimulation and RF treatment embodiment) in the reply filed on 1/16/2026 is acknowledged. The traversal is on the ground(s) that “The Office has not provided a detailed analysis demonstrating how Mercanzini discloses or renders obvious all of the recited technical features, particularly the specific combination of a distal part, proximal part, and connecting part of non-cylindrical shape all formed from a multilayer film comprising a substrate of at least one polymer material with at least one conductive layer forming transmission tracks connecting intracerebral contacts in the distal part to connector contacts in the proximal part. This is not found persuasive because the features argued have been specifically cited with respect to the art of Mercanzini and Applicant has not provided any specific reasons why the cited structures don’t show the claimed features. The requirement is still deemed proper and is therefore made FINAL. Claims 25-31 are withdrawn.
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.
Claim16-18, 20, 22-24 and 32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mercanzini et al. (2014/0303703).
Regarding Claims 16, 18, 24 and 32, Mercanzini discloses at least one distal part (205) of cylindrical shape (Fig. 7C-7D) comprising at least one intracerebral contact (204, 207) intended to be implanted in the brain of a patient; at least one proximal part (206, Fig. 7C-D) of cylindrical shape comprising at least one connector contact (211) intended to be connected to at least one device; at least one connecting part of non-cylindrical shape (intermediate part between 205 and 206) configured to connect the distal and proximal parts; wherein one or more of the at least one distal part, proximal part and connecting part comprises a multi-layer film ("microelectrode film") comprising a substrate (claim 29: "first insulative layer"; fig. 29B-I) and at least one conductive layer ("conductive traces", "plurality of microelectrode elements") ; and wherein the substrate comprises at least one polymer material (polymer layer 654), the at least one conductive layer comprises at least one transmission track ("conductive traces"), at least one intracerebral contact in the distal part, at least one connector contact in the proximal part, wherein each of the at least one transmission track is connected to the at least one intracerebral contact in the distal part and the at least one connector contact in the proximal part (par. [0113]; Fig. 7C-D).
In regard to Claim 17, Mercanzini discloses a polymer player 672 that overlays or encapsulates conductive portions 690 (par. [0195-0196]; Fig. 29H-F).
Regarding Claims 20 and 22, Mercanzini discloses inserting an end cap 209 (that can be a polymer) in the cavity of the distal cylindrical part (par. [0156]; Fig. 7D, E). This end cap can be considered the claimed “distal stud”.
With regard to Claim 23, Mercanzini discloses a cylindrical member 213 that fits within the proximal part (7D) and effectively closes off the proximal end when finally assembled as shown in Fig. 7B (there are no open portions visible).
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 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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini et al. (2014/0303703) in view of Shah et al. (2018/0169406). Mercanzini discloses a microelectrode array having a proximal cylindrical end, a distal cylindrical end, a non-cylindrical connector part, all having a polymer substrate (see rejection of Claim 16) but ails to disclose the polymer as specifically being a liquid crystal polymer. However, Shah, in the same field of endeavor of microelectrode arrays, shows that liquid crystal polymer is an equivalent polymer structure for a substrate known in the art. Therefore, because the polymers of Mercanzini and Shah were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the liquid crystal polymer for the polymer of Mercanzini.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use liquid crystal polymer as the substarte, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini et al. (2014/0303703) in view of Mehregany et al. (2011/0264178). Mercanzini discloses all of the claimed invention except for the inclusion of a temperature sensor. However, in the same field of endeavor of neural stimulators, Mehregany discloses including a temperature sensor at the distal part for the purpose of monitoring the temperature at the implantation site to avoid inadvertent tissue heating cause by situation current (par. [0056]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Mercanzini reference to include a distal temperature sensor, as taught and suggested by Mehregany, for the purpose of monitoring the temperature at the implantation site to avoid inadvertent tissue heating cause by situation current.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796