DETAILED ACTION
The Examiner acknowledges the amendments received 30 January 2026. Claims 1-16 and 21-31 are cancelled; new claims 32-43 are entered; claims 17-30 and 32-43 are pending.
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 arguments, see “Remarks”, filed 30 January 2026, with respect to the rejection(s) of claim(s) 17-20 under Mercanzini have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of John.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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.
Claims 17, 20 and 32-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by John et al (U.S. 2019/0038438). John discloses (Figures 39A-40B) providing an apparatus (101) in a first, folded configuration (par. 0233, “compress” the stent), the apparatus including a flexible substrate (par. 0230; 58) having an electrically conductive layer disposed between a flexible first electrically insulating layer and a flexible second electrically insulating layer (“Electrical insulation of electrodes is achieved by RF sputtering and deposition of a non-conductive layer (52) (e.g., SiO) onto the thin-film structure (54). Electrodes and electrode tracks (50) are sputter deposited onto the non-conductive layer (using conductive and biomedically acceptable materials including gold, Pt, Ti, NiTi, PtIr), with an additional non-conductive layer deposited over the conductive track for further electrical isolation and insulation.”), at least one of the first electrically insulating layer, the electrically conducting layer, or the second electrically insulating layer including a plurality of recesses defined therein, the plurality of recesses having a predefined pattern (“conducting path 50 is left exposed to form the electrode 138 (similarly, a contact pad area can remain exposed).”); and introducing the apparatus into a biological environment of a patient, thereby causing the apparatus to transition to a second, unfolded configuration, such that the apparatus substantially conforms to a non-planar surface within the biological environment of the patient (par. 0233, stent expands).
Regarding claim 20, John discloses (par. 0224) the non-planar surface is a surface of the brain of the patient.
Regarding claim 32, John discloses (par. 0230) the electrically conductive layer includes a plurality of electrodes configured to contact the non-planar surface.
Regarding claim 33, John discloses (par. 0117) the electrically conductive layer includes a plurality of electrodes, at least one electrode from the plurality of electrodes positioned at a node from a plurality of nodes, each node from the plurality of nodes being adjacent to at least one recess from the plurality of recesses.
Regarding claim 34, John discloses (par. 0302) microelectronics one of in or on the flexible substrate.
Regarding claim 35, John discloses (par. 0155-0162) an application specific integrated circuit (ASIC) positioned at a node from a plurality of nodes of the apparatus.
Regarding claim 36, John discloses (par. 0116) a plurality of electrodes, the non-planar surface is a surface of a brain of the patient, and the plurality of electrodes includes surface electrodes configured to record signals derived from neural activity of the brain of the patient.
Regarding claim 37, John discloses (par. 0116 and 0224) a plurality of electrodes, the non-planar surface is a surface of a brain of the patient, and the plurality of electrodes includes implantable microelectrodes configured to enter neural tissue when the apparatus conforms to the surface of the brain of the patient.
Regarding claim 38, John discloses (par. 0117) the electrically conductive layer includes a plurality of electrodes configured to contact the non-planar surface, and a plurality of conductive traces configured to couple two or more components within the apparatus.
Regarding claim 39, John discloses (Figures 39A-40B) the predefined pattern has one of a mesh geometry or a lace geometry.
Regarding claim 40, John discloses (Figures 39A-40B) the predefined pattern has a honeycomb.
Regarding claim 41, John discloses (Figures 39A-40B) the plurality of recesses extends through each of the first electrically insulating layer, the electrically conductive layer, and the second electrically insulating layer.
Regarding claim 42, John discloses (Figures 39A-40B) a subset of recesses from the plurality of recesses extends through each of the first electrically insulating layer, the electrically conductive layer, and the second electrically insulating layer.
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.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over John et al (U.S. 2019/0038438) in view of Mercanzini (U.S. 2016/0059016). John discloses the claimed invention except for introducing the apparatus into the biological environment of the patient is via a craniotomy. Mercanzini, however, discloses (Figures 15-16; par. 0046 and 0067) a layered neurostimulator for introduction into a patient’s brain via craniotomy. Mercanzini and John both disclose methods of placing a layered stimulator in a brain. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify John’s stent with exposed electrodes with Mercanzini in order to be provide a minimally invasive deployment of the system for in situ stimulation.
Regarding claim 19, Mercanzini discloses (par. 0046) introducing the apparatus into the biological environment of the patient includes passing the apparatus through a burr hole.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over John et al (U.S. 2019/0038438). John discloses the claimed invention except for at least one of the first electrically insulating layer or the second electrically insulating layer includes at least one of a liquid crystal polymer (LCP), Parylene-C, a ceramic, or a silicon dioxide. It would have been obvious to one of ordinary skill in the art at the time of the invention to use these materials, 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792