DETAILED ACTION
This action is pursuant to the claims filed on January 5, 2025. Claims 1-15 are pending. A first action on the merits of claims 1-15 is as follows.
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 . 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 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.
Claim Rejections - 35 USC § 102
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 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mercanzini et al. (hereinafter ‘Mercanzini’, U.S. PGPub. No. 2012/0277834).
In regards to independent claim 1, Mercanzini discloses a multi-electrode array device (see Fig. 1), comprising:
a substrate having a substrate body (support backing layer 120 having a rigid or semi-rigid support, [0118]), and
a multiplicity of electrodes (a microelectrode array film 110, [0115]-[0117]) formed by a multiplicity of needle elements (the microelectrode array film forms in part the cortical depth probes 130) arranged on said substrate body (the microelectrode array film 110 is disposed on the support backing layer 120) and spaced with respect to each other along a plane (the probes 130 are spaced apart from each other as shown in Fig. 1),
characterized in that said needle elements (probes 130 formed from the microelectrode array film 110) are formed from a metal layer ([0115]-[0116]: the microelectrode array comprises multiple layers including a polymeric layer and metallic layer), each needle element comprises a contact section (probe 130 of the film 110 which extends parallel to the substrate 120 proximal to the bent portion of the probe 130) and a needle section (the probe 130 that extends perpendicularly to the substrate 120) and having a tip (tip of the probe 130), wherein said needle section is bent with respect to said contact section such that the needle section with its tip protrudes from said plane (the probes 130 are bent with respect to the layer 120 in that the tip of the probe 130 protrudes from the bottom surface of the layer 120 as shown in Fig. 6A).
In regards to claim 2, Mercanzini further discloses wherein the substrate body forms a surface extending along said plane (P) (the substrate layer 120 comprises upper and lower surfaces defining a plane), the needle elements being arranged on said surface such that the contact sections are placed on the surface and the needle sections protrude from the surface ([0115]-[0116]: the electrode film 110 is disposed along the backing layer 120 and forms the probes 130 protrude from the bottom surface of the layer 120).
In regards to claim 3, Mercanzini further discloses wherein a first cover layer covering said surface of the substrate body and said contact sections on the surface ([0116]: polymeric layer disposed along the uppermost trace of the film 110 isolate the traces from each other; note that the uppermost polymeric layer is disposed on and covers the upper surface of the substrate body 120).
In regards to claim 4, Mercanzini further discloses wherein the substrate body is formed from a thermoplastic material ([0118]: the backing layer 120 is formed from a variety of materials such as polyimide, or polyetheretherketone (PEEK)).
In regards to claim 6, Mercanzini further discloses an electronic device (electrodes 140), wherein said needle elements are arranged on a first side of the substrate body (the probes 130 extends from an upper surface of the backing layer 120 and protrudes from a lower surface of the backing layer 120 in Fig. 6A) and a semiconductor device (a control module 150 as shown in implanted configuration Fig. 11 and its cable extends is arranged on the upper surface of the backing layer 120; alternatively, the control module 150 can be positioned above the backing layer 120 as shown in Fig. 12) is arranged on a second side of the substrate body opposite to the first side (Fig. 12), the electronic device being electrically connected to the contact sections of the needle elements by an arrangement of electrical vias extending through said substate body (the electrodes 140 are electrically connected to the traces along the probes 130 and respective contacts that eventually connect to the control module 150; note that the cutouts in which the probes 130 protrude from are interpreted as electrical vias that extending from the upper surface to the lower surface of the backing layer 120 because each of the probes 130 comprises a portion in which electrical traces along the portion of the probe 130 extends through the cutout).
In regards to claim 7, Mercanzini further discloses that the electronic device is encapsulated within electrically insulating material of a second cover layer on said second side of the substrate (([0116]: multilayer configuration in which metal layer and polymeric layer are stacked; note that a polymeric layer that is disposed on one of the metal layer that defines trace(s) along the film 110 reads on ‘a second cover layer’).
In regards to independent claim 8, Mercanzini discloses a method for fabricating a multi-electrode array device (see Fig. 1), comprising:
providing a substrate having a substrate body (support backing layer 120 having a rigid or semi-rigid support, [0118]), and
providing a multiplicity of electrodes (a microelectrode array film 110, [0115]-[0117]) formed by a multiplicity of needle elements (the microelectrode array film forms in part the cortical depth probes 130) arranged on said substrate body (the microelectrode array film 110 is disposed on the support backing layer 120) and spaced with respect to each other along a plane (the probes 130 are spaced apart from each other as shown in Fig. 1),
characterized in that said providing said multiplicity of electrodes formed by said multiplicity of needle elements includes:
forming the needle elements from a metal layer arranged on said substrate body (probes 130 formed from the microelectrode array film 110) are formed from a metal layer ([0115]-[0116]: the microelectrode array comprises multiple layers including a polymeric layer and metallic layer), such that each needle element comprises a contact section (probe 130 of the film 110 which extends parallel to the substrate 120 proximal to the bent portion of the probe 130) and a needle section (the probe 130 that extends perpendicularly to the substrate 120) and having a tip (tip of the probe 130), wherein said needle section is bent with respect to said contact section such that the needle section with its tip protrudes from said plane (the probes 130 are bent with respect to the layer 120 in that the tip of the probe 130 protrudes from the bottom surface of the layer 120 as shown in Fig. 6A).
In regards to claim 9, Mercanzini further discloses that the needle elements are formed from the metal layer by forming the contact section and the needle sections to commonly extend along said plane and to subsequently bend the needle sections with respect to the contact sections such that the needle sections protrude from said plane (Fig. 9 illustrates that the film 110, when attached to the substrate 120, extends along a common plane prior to bending the probes 130, [0139]-[0140]).
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini as applied to claim 1 above, and further in view of Henderson (U.S. PGPub. No. 2019/0184366).
In regards to claim 5, Mercanzini discloses the invention substantially as claimed in claim 1 and discussed above.
However, Mercanzini does not discloses a form element wherein said needle elements are arranged on a first side of the substrate body, and said form element is arranged on a second side of the substrate body opposite to the first side, said form element comprising a multiplicity of protrusion members abutting the needle sections of the multiplicity of needle elements.
Henderson teaches providing a form element (forming die 310 in Figs. 11A-11B) which is pressed against a photoetched microarrays in a substrate body (microarray sheet 240) to facilitate the bending of the plurality of etched projections (microtips 100A-100E along the substrate body 240 as bent into the Z-plane as the projections 250A-250E of the die 310 presses against the microtips 100A-100E, [0096]). Given that Mercanzini discloses various ways to form bend the needle sections ([0207]: “FIG. 33B is a perspective view of a portion of the stencil frame tree 740, illustrating several semi-rigid backing members 742 formed therein. The general shape semi-rigid backing members 742 can be formed by any suitable means, including pushing, molding, or stamping”), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the bent needle sections by pressing against the needle elements with a forming element as taught by Henderson, as doing so provides the same result of the multiplicity of needle elements projected in a Z-plane ([0096]).
In regards to claim 10, Mercanzini discloses the invention substantially as claimed in claim 1 and discussed above.
However, Mercanzini does not discloses a form element wherein said needle elements are arranged on a first side of the substrate body, and said form element is arranged on a second side of the substrate body opposite to the first side, said form element comprising a multiplicity of protrusion members abutting the needle sections of the multiplicity of needle elements.
Henderson teaches providing a form element (forming die 310 in Figs. 11A-11B) which is pressed against a photoetched microarrays in a substrate body (microarray sheet 240) to facilitate the bending of the plurality of etched projections (microtips 100A-100E along the substrate body 240 as bent into the Z-plane as the projections 250A-250E of the die 310 presses against the microtips 100A-100E, [0096]). Given that Mercanzini discloses various ways to form bend the needle sections ([0207]: “FIG. 33B is a perspective view of a portion of the stencil frame tree 740, illustrating several semi-rigid backing members 742 formed therein. The general shape semi-rigid backing members 742 can be formed by any suitable means, including pushing, molding, or stamping”), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the bent needle sections by pressing against the needle elements with a forming element as taught by Henderson, as doing so provides the same result of the multiplicity of needle elements projected in a Z-plane ([0096]).
In regards to claim 11, Mercanzini/Henderson combination further discloses that prior to placing the form element on the substrate body for bending the needle sections, openings (cutouts of the structure that creates the cortical depth probe backing 132 as shown in Fig. 9, [0139]) are formed on the substrate body such that each needle section projects into a space aligned with a corresponding opening and, for bending the needle sections with respect to the contact sections (the probe 130g in exemplary Fig. 8 projects into a space defined by a cutout pattern along structure 120 and film 110), the form element is placed on the substrate body such that the protrusion members are introduced into said openings in said substrate body to act onto said needle section (Henderson, microtips 100A-100E along the substrate body 240 as bent into the Z-plane as the projections 250A-250E of the die 310 presses against the microtips 100A-100E, [0096]).
In regards to claim 12, Mercanzini/Henderson combination further discloses that, prior to or after placing the form element on the substrate body for bending the needle sections, a first cover layer is formed on the substrate body to at least cover said contact sections of the needle elements ([0116]: polymeric layer is disposed along the uppermost trace of the film 110 to isolate the trances from each other; note that the uppermost polymeric layer is disposed on and covers the upper surface of the substrate body 120).
In regards to claim 13, Mercanzini/Henderson combination further discloses that bending the needle sections, the form element is placed on the substrate body along a placement direction (A) such that the substrate body is arranged on a first side of the form element (as taught by Henderson, the substrate body 240 is arranged on an upper side of the die 310 in order to push and bend the microtips in Fig. 11A-11B).
Allowable Subject Matter
Claims 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 14, Mercanzini/Henderson combination discloses the invention substantially as claimed in claim 13 and discussed above. However, Mercanzini/Henderson combination does not disclose after placing the form element on the substrate body for bending the needle sections, an electronics device is placed on a second side of the form element and is electrically connected to the contact sections of the needle elements.
Mercanzini is silent as to the use of the form element as explained above. And Henderson teaches the use of the form element to bend the needle sections as explained above. However, Mercanzini and Henderson are both explicit in that the form element which is part of the manufacturing process tool to provide bending of the needle sections is removed after and is not incorporated into the final apparatus (Mercanzini, Fig. 11B). Therefore, there is no reason to provide an electronics device on a second side of the form elements as required in claim 14. Accordingly, claim 15 is allowable as being dependent on claim 14.
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/24/2026
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