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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 February 2026 has been entered. Claim 1 is currently amended. Claims 14-17 were previously withdrawn, and claims 47-55 are new. Claims 1, 6, 9, 11-12, 14-17, and 46-55 are pending in the application.
Claim Objections
Claims 48 and 51 are objected to because of the following informalities: in each claim, “indentations positions of which” should read --indentations, positions of which--. Appropriate correction is required.
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, 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 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.
Claims 1, 6, 9, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Scorsone et al. (US PGPub No. 2021/0177333), hereinafter Scorsone, in view of Vetter et al. (US PGPub No. 2008/0208283), hereinafter Vetter, and further in view of Keyes et al. (US PGPub No. 2020/0001042), hereinafter Keyes.
Regarding claim 1, Scorsone teaches a thin-film neural interface (par. 0024: “an implant to be implanted in the body of a patient, typically directly on the patient's cortex;” par. 0038: “the total thickness of the implant being less than 20 μm; advantageously it can be less than 10 μm;” examiner interprets a cortical implant of the disclosed thickness to be a thin-film neural interface) comprising:
a supporting structure comprising one or more layers of dielectric material (Fig. 5: electrically insulating diamond layers 5 and 6), wherein the supporting structure comprises a front side, a back side, and opposing edges between the front side and the back side (Fig. 5: front side 11, back side 12; see also annotated Fig. 5);
one or more conductive traces formed on the one or more layers of dielectric material (Fig. 5: electrically conductive layer 2);
one or more electrodes formed on the front side of the supporting structure in electrical connection with the one or more conductive traces (Fig. 5: electrode 3; par. 0109: “the implant 1 preferably comprises a plurality of electrodes 3 in contact with the electrically conductive layer 2, said electrically conductive layer 2 forming an electrical track for each electrode 3 of the implant”);
and a backing formed on the back side of the supporting structure, wherein the backing comprises a medical grade polymer material (Fig. 5: polymer layer 71 on back side 12; par. 0125: “the implant 1 according to the second embodiment may also include a layer of polymer, preferably biocompatible polymer, which is located on the back side 12 of the flexible soft implant 1”) and wraps around the opposing edges of the supporting structure from the back side of the supporting structure (annotated Fig. 5).
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Annotated Figure 5
Scorsone does not teach wherein the supporting structure includes one or more through holes, and the medical grade polymer material fills at least a portion of each of the one or more through holes. However, in related neural interface art, Vetter teaches perforations in a supporting substrate that are filled with a backing material as a means of facilitating adhesion between the two layers (Fig. 1: silicone carrier 16, thin-film polymer substrate 12; par. 0038: “To facilitate adhesion between the silicone and polymer, small non-homogeneous perforations are preferably micromachined in the polymer substrate to allow for liquid silicone to flow into and form a robust anchor after being cured”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the neural interface of Scorsone by providing the supporting structure with perforations and filling the perforations with the backing material, as taught by Vetter, in order to facilitate adhesion between the layers, as taught by Vetter.
Scorsone further teaches wherein the supporting structure adheres to the backing along at least two of the opposing edges (Fig. 5: polymer backing layer 71 deposited along back side and around edges of diamond backing layers 5 and 6) but does not explicitly teach wherein the supporting structure and backing comprise first and second respective patterns extending along the adhering edges that mechanically interlock to provide adhesion, and wherein at least one from among the first pattern and the second pattern is formed by lithography, etching, or laser machining. However, in an analogous art, Keyes teaches providing mechanically interlocking patterns at the joints between bonded parts in a medical device in order to increase bond strength and prevent delamination (Figs. 2A-2B: mechanically interlocking features 51a-52c; par. 0040: “In order to mitigate the risk of delamination of the epoxy layer, parts 51 and 52 are both patterned with T-shape undercut structures 51a and 52a (having overhangs 51b and 52b, respectively), done, for example, during the machining of parts 51 and 52. As seen, this creates recess volumes 50a for the epoxy 50 to fill, so that epoxy 50 may provide enhanced tensile strength at the bonded interfaces. Furthermore, epoxy 50 creates interlocking features at the butt joints of parts 51 and 52, preventing bond delamination by offering compressive reinforcement, in addition to the increased tensile strength at the bonded interfaces 51c and 52c”). Keyes further teaches wherein at least one from among the first pattern and the second pattern is formed by lithography, etching, or laser machining (par. 0034: “bond-strength enhancing structures, such as T-shape and/or L-shape undercuts, can be laser cut, drilled, or etched, among other manufacturing methods”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide mechanically interlocking patterns at the joints between the bonded parts of Scorsone’s medical device (i.e., the edges between the backing and the supporting structure), as taught by Keyes, in order to increase bond strength and prevent delamination, as taught by Keyes.
Regarding claim 6, the combination teaches the device of claim 1 as described previously. Scorsone further teaches wherein the backing is coplanar with a front surface of the supporting structure, the front surface being at the front side of the supporting structure (Fig. 5: polymer layer 71 coplanar with front side 11 of insulating layer 5).
Regarding claim 9, the combination teaches the device of claim 1 as described previously. Scorsone further teaches in another embodiment wherein the backing is overmolded over the opposing edges, and the medical grade polymer material forms a backing layer on a portion of the front side of the supporting structure that is adjacent to the opposing edges (Fig. 3b: polymer layer 71 overmolded over opposing edges and on a portion of the front side), as a variant wherein the implant is completely encapsulated by polymer except for the measuring part of the electrode and the electrical contact area (par. 0119). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that applying the known technique taught by Scorsone in the embodiment of Fig. 3b (namely, the technique of overmolding the backing over the opposing edges of the supporting structure) to the device of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system that is easier to handle on both the front and back side of the implant (see par. 0116: “This polymer layer makes the flexible soft implant 1 easier to handle”).
Regarding claim 46, the combination teaches the device of claim 1 as described previously. Scorsone further teaches that it is known in the art to surround the supporting structure of a flexible soft implant with a polymer backing (par. 0018: “Today's flexible soft implants are composed of two layers of polymer that surround and thus isolate the metal tracks from the aqueous medium. The polymer layers have the advantage of forming a protective layer that is flexible enough to allow the implant to conform to the shape of the organ on which it is implanted” and par. 0022: “the metal track 3′ is surrounded by barrier layers 5′, said barrier layers 5′ themselves being surrounded by polymer layers 6′”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to surround the supporting structure of Scorsone with the polymer backing along all four sides of the supporting structure, including two pairs of the opposing edges, and further to provide the interlocking features taught by Keyes along each of the edges, for the same reason set forth in the rejection of claim 1 (i.e., for increased bond strength and prevention of delamination).
Regarding claim 48, the combination teaches the device of claim 1 as described previously. Keyes further teaches wherein one of the first pattern and the second pattern comprises protrusions (Fig. 2B: part 53 and epoxy 50 forming a pattern comprising protrusions) and another one of the first pattern and the second pattern comprises indentations, positions of which mirror positions of the protrusions (Fig. 2B: undercut structures 51a), and the protrusions are fittingly disposed in the indentations to create mechanical bonding therebetween (par. 0040: “epoxy 50 creates interlocking features at the butt joints of parts 51 and 52, preventing bond delamination by offering compressive reinforcement”).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Scorsone in view of Vetter and Keyes and further in view of Garell et al. (US PGPub No. 2006/0224060), hereinafter Garell.
Scorsone in view of Vetter and Keyes teaches the device of claim 9 as described previously. The combination is silent with respect to the distance between the backing layer and the one or more electrodes and does not explicitly teach wherein the opposing edges are configured to maintain a predetermined distance between the backing layer and the one or more electrodes, or wherein the predetermined distance is from 0.25 mm to 25 mm. However, in related neural interface art, Garell teaches a neural probe with electrodes that are separated from adjacent electrodes by a minimum distance of 0.30 mm (par. 0016: “The plurality of contacts of the neural probe array may be arranged in rows and columns along the outer surface of the first layer. Each of the plurality of contacts has a diameter in a range of 200 microns to 2 millimeters and is spaced from an adjacent contact by a minimum distance of 300 microns”).
It would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a predetermined distance of at least 0.30 mm between adjacent electrodes, as taught by Garell, and further to use the same predetermined distance between electrodes and the backing layer, since applicant has not disclosed that the predetermined distance solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any distance between the backing layer and the electrodes.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Scorsone in view of Vetter and Keyes and further in view of Chen (US PGPub No. 2013/0281793).
Scorsone in view of Vetter and Keyes teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the first pattern and the second pattern mechanically interlock with each other without intervening material disposed therein. However, in an analogous art, Chen teaches providing interlocking patterns between layers of material in a medical device in order to increase mechanical stability and prevent delamination, wherein the first pattern and the second pattern mechanically interlock with each other without intervening material disposed therein (Fig. 7B: interlocking structures of materials 764 and 766; par. 0063: “The alternating peaks and valleys of the two materials dovetail to provide mechanical stability to prevent delamination and/or hinder shearing forces at the interface”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known element (directly interlocking materials as shown in Chen) for another (interlocking epoxy-filled undercuts as shown in Keyes), since the substitution of the directly interlocking materials shown in Chen would have yielded predictable results, namely, an interlocking structure that requires only two materials for mechanical bonding.
Claims 49-53 are rejected under 35 U.S.C. 103 as being unpatentable over Scorsone in view of Vetter and further in view of Chen.
Regarding claim 49, as laid out previously in the rejection of claim 1, Scorsone in view of Vetter teaches a thin-film neural interface comprising: a supporting structure comprising one or more layers of dielectric material, wherein the supporting structure comprises a front side, a back side, opposing edges between the front side and the back side, and one or more through holes; one or more conductive traces formed on the one or more layers of dielectric material; one or more electrodes formed on the front side of the supporting structure in electrical connection with the one or more conductive traces; and a backing formed on the back side of the supporting structure, wherein: the backing comprises a medical grade polymer material that fills at least a portion of each of the one or more through holes of the supporting structure and wraps around the opposing edges of the supporting structure from the back side of the supporting structure.
Scorsone further teaches wherein the supporting structure adheres to the backing along at least two of the opposing edges (Fig. 5: polymer backing layer 71 deposited along back side and around edges of diamond backing layers 5 and 6) but does not explicitly teach wherein the supporting structure and backing comprise first and second respective patterns extending along the adhering edges that interlock to provide adhesion, and wherein structures of the first pattern and structures of the second pattern themselves mechanically interlock with each other. However, in an analogous art, Chen teaches providing interlocking patterns between layers of material in a medical device in order to increase mechanical stability and prevent delamination, wherein structures of the first pattern and structures of the second pattern themselves mechanically interlock with each other (Fig. 7B: interlocking structures of materials 764 and 766; par. 0063: “The alternating peaks and valleys of the two materials dovetail to provide mechanical stability to prevent delamination and/or hinder shearing forces at the interface”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide mechanically interlocking patterns between the material layers of Scorsone’s medical device (i.e., the edges between the backing and the supporting structure), as taught by Chen, in order to increase mechanical stability and prevent delamination, as taught by Chen.
Regarding claims 50-51, the combination teaches the interface of claim 49 as described previously. Chen further teaches wherein the first pattern and the second pattern mechanically interlock with each other without intervening material disposed therein, and wherein one of the first pattern and the second pattern comprises protrusions and another one of the first pattern and the second pattern comprises indentations positions of which mirror positions of the protrusions, and the protrusions are fittingly disposed in the indentations to create mechanical bonding therebetween (Fig. 7B: protrusions in material 766 fittingly disposed in indentations in material 764 without intervening material disposed thereon; par. 0063: “The alternating peaks and valleys of the two materials dovetail”).
Regarding claim 52, the combination teaches the device of claim 49 as described previously. Scorsone teaches the limitations of this claim for the same reasons set forth previously in the rejection of claim 6.
Regarding claim 53, the combination teaches the device of claim 49 as described previously. Scorsone teaches the limitations of this claim for the same reasons set forth previously in the rejection of claim 9.
Claims 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Scorsone in view of Vetter and Chen and further in view of Garell.
Scorsone in view of Vetter and Chen teaches the device of claim 53 as described previously. The combination in view of Garell teaches the limitations of claims 54-55 for the same reasons set forth previously in the rejection of claims 11-12.
Response to Arguments
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant’s argument that the cited references do not teach forming the first or second pattern by lithography, etching, or laser machining is not persuasive because Keyes does teach laser machining and etching as appropriate manufacturing methods for forming bond-strength enhancing T-shaped or L-shaped cutouts (see par. 0034 as cited in the rejection of claim 1), that is, a first or second pattern for mechanically interlocking structures, as recited in the claim. Additionally, the recitation of “at least one from among the first pattern and the second pattern is formed by lithography, etching, or laser machining” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this instance, since Keyes teaches both etching and laser machining to form one or more patterns for mechanical interlocking, and the processes of lithography, etching, or laser machining do not appear to impart any structural differences in the final product, the prior art is still considered to read on this limitation.
Applicant’s arguments with respect to the limitations of claim 49 with regard to the Keyes reference have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant’s argument that there is no teaching, suggestion, or motivation in Scorsone to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, although Scorsone does explicitly not articulate a need for improved adhesion, one of ordinary skill in the art would have been motivated by the teachings in Chen to modify Scorsone’s device, since Chen teaches the benefits of interlocking patterns between two materials in that such a configuration enhances mechanical stability, prevents delamination, and hinders shearing forces at the interface between the materials.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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