DETAILED ACTION
The Examiner acknowledges the amendments received 13 July 2026. Claims 1-16 and 21-31 are cancelled; new claim 44 is entered; claims 17-30 and 32-44 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 filed 13 July 2026 have been fully considered but they are not persuasive. The Applicant argues (page 6, “Remarks”) “John describes struts 108 as moveable between a reduced profile and an expanded profile in which a diameter of the frame structure increases to apply a radial force to the vessel wall (John para. [0015]). A compressed stent that radially expands within a vessel is not the same as the claimed apparatus of independent claim 17 being provided in a folded state and unfolding to conform to a non-planar tissue surface (for example as shown in Fig. 2 of Applicant's as-filed application).”
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant further argues “The element alleged to be equivalent to the recited flexible layer in the Office Action, i.e., element 58, is identified in John as a sacrificial layer 58 (which is also identified as sacrificial layer 56) which along with a substrate (with no identified element number) is indicated in John to be completely removed, leaving only the stent structure 101. See, e.g., John at para [0230] and Fig. 39c. Thus, it is John's specific disclosure that it has no flexible substrate.”
The Examiner respectfully disagrees with this assessment of John. The claim doesn’t explicitly require that the flexible substrate is permanently integrated in the system. Moreover, John’s 58 is flexible, and is structurally arranged as in the claim, and therefore anticipates the invention as claimed.
Applicant argues “The Examiner-cited exposed conductive regions or exposed portions of conductive tracks in John's stent struts are not equivalent to the recesses in the multilayer flexible substrate explicitly recited in independent claim 17. Rather, John's Figures 39A-40B and related description concern a stent lattice with integrated conductive paths and exposed electrode regions in a vessel-deployed structure, not a recess-defined architecture in the recited multilayer flexible substrate of independent claim 17.”
The Examiner respectfully disagrees with this assessment of John, and points to the explicit citations of John previously mentioned and below: “conducting path 50 is left exposed to form the electrode 138 (similarly, a contact pad area can remain exposed).”
Applicant further argues (page 7, “Remarks”) “Although the Office Action relies upon paragraph [0224] of John to reject claim 20, that reliance is in error because that cited paragraph makes no mention whatsoever of a surface of a brain or placement of its device 100 there. To the contrary, John's disclosure is explicit that its device is implanted in a blood vessel and operates from that intravascular position.”
The Examiner respectfully disagrees, and points to the previous citation and below, par. 0224: “in some variations, the length of such stent structures can include lengths up to and greater than 20 mm to accommodate desired placement along the human motor cortex. For example, variations of the device require a stent structure that is sufficiently long enough to cover the motor cortex and peripheral cortical areas.” (emphasis added)
Applicant argues (pages 8-11) various dependent claims in view of the prior art. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant further argues (pages 11-13, “Remarks”) the rejection under 35 USC 103. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 and 44 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.
Regarding claim 44, Mercanzini discloses (par. 0046) the introducing the apparatus into the biological environment of the patient is performed via a craniotomy and includes passing the apparatus through a burr hole, wherein the non-planar surface is a surface of a brain of the patient, wherein the electrically conductive layer includes a plurality of electrodes configured to contact the surface of the brain, and wherein the plurality of electrodes includes one or more implantable microelectrodes configured to enter a neural tissue when the apparatus conforms to the surface of the brain of the patient.
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
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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