DETAILED ACTION
This action is pursuant to the claims filed on March 9, 2026. Claims 25 and 45-57 are pending. Claims 1-24 and 26-44 is/are canceled. A final action on the merits of claims 25 and 45-57 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 25, 49 and 53 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Oxley (U.S. PGPub. No. 2014/0288667).
In regards to independent claim 25, Oxley discloses a method of transmitting neural activity of a patient outside a blood vessel (abstract, [0107]-[0108]; note that the neural signal originating from a brain tissue is external to an outer wall of a human vessel, such as a cerebral artery), the method comprising:
advancing an implantable neural interface device through a vasculature (see intravascular device 4 is advanced through a vasculature within a cerebral artery 6 in Figs. 1-3; [0011]: an intravascular device for placement with an animal vessel; [0081]: human vessel includes cerebral artery; [0110]: “retaining or depositing the intravascular device within an animal vessel proximate a deep brain region”), wherein the implantable neural interface device comprises an expandable frame advanceable through the vasculature in a delivery configuration, wherein the expandable frame comprises a plurality of struts defining a lattice ([0128], [0209]: the intravascular device 4 is disposed within a catheter 10 prior to deployment of the device 4 as shown in Fig. 6; the device 4 comprises a stent 20 formed from a plurality of struts/wires defining a lattice structure);
deploying the expandable frame to a deployed configuration (Fig. 7 illustrates the device 4 advanced through the catheter 10 in the deployed configuration);
measuring neural activity outside the blood vessel using a plurality of electrode sites distributed along the expandable frame ([0108]: “sensing or stimulating electrical activity of neural tissue from various regions in one or more animal vessels”; [0159]-[0160]: the device 4 comprises stent 20 which holds a plurality of electrodes 14 as shown in Fig. 8);
communicating electrical signals between the plurality of electrode sites and a control circuitry coupled to the expandable frame ([0188]: the signal from the electrodes 14 is passed to the channel amplifier 24 which amplifies the signal from the electrodes; [0189] the amplified signal is converted from analogue to digital by the converter 28; an external computing device 52 for processing data, [0156]) via a lead assembly (conductor wires 56 and wire bundle 58 in Fig. 8 transmit the signals from the electrodes 14 to the external computing device 52), wherein the lead assembly is coupled to the expandable frame and comprises a plurality of conductors (wires 56 and wire bundle 58 are electrically and mechanically connected to the electrodes 14 of the stent 20 in Fig. 8) and a connector region (distal tip of the wires 56 in Fig. 8) comprising a plurality of contact elements (distal tip of each of the wires 56 bonded onto the board 16 and directly connected to its respective electrodes 14) electrically coupled to each of the plurality of conductors (the distal tip of the wires 56 is electrically connected to the wire bundle 58).
In regards to claim 49, Oxley further discloses wherein the plurality of conductors comprise a plurality of wires (Fig. 8 illustrates a plurality of conductors 56).
In regards to claim 53, Oxley further discloses deploying the expandable frame comprises positioning the expandable frame at a target site ([0108]: “sensing or stimulating electrical activity of neural tissue from various regions in one or more animal vessels”), and further routing the lead assembly along a vasculature pathway from the expandable frame toward an extracranial access location when the implantable neural interface device is deployed (the conductors and wire bundles 56 and 58 respectively, are routed from the device 4 which is deployed in a neural vasculature and toward an extracranial access location or outside of the skull; note that an access point outside the skull, is the percutaneous access from a patient’s thigh as shown in Fig. 9).
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.
Claims 48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley (U.S. PGPub. No. 2014/0288667).
In regards to claim 48, Oxley discloses the method as claimed in claim 25 and discussed above. However, Oxley is silent as to the plurality of contact elements that are longitudinally separated by a plurality of insulators. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide an insulator to insulate each of the conductors of Oxley since it is notoriously well known to insulate wires or wire bundles to reduce noise during signal acquisition or to prevent injecting current in areas other than the exposed electrodes. Given that Fig. 8 already discloses that the electrodes are longitudinally separated (the electrodes 14 form a grid arrangement), the contact region between each of the electrodes and its respective distal tip of the conductor (which is interpreted as the contact element) is necessarily longitudinally separated by a corresponding insulator.
In regards to claim 50, Oxley further discloses wherein the plurality of wires form a wire bundle (see Fig. 8 in which the wires 56 form a wire bundle 58) but is silent as to wherein the wire bundle is covered by a tubular member, wherein the wire bundle couples to the plurality of contact elements at an exposed section of the wire bundle. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a tubular member for insulating the wire bundle such that only distal tip of the plurality of wires are exposed to directly connect with the electrodes since it is notoriously well known to insulate wires or wire bundles to reduce noise in the signals during signal acquisition or to prevent injecting current in areas other than the exposed electrodes.
Allowable Subject Matter
Claims 45-47, 51-52 and 54-57 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 regard to claims 45 and 46, Oxley fails to disclose that the plurality of electrode sites are defined by opening through an insulating layer on the expandable frame, wherein the openings exposed portions of a conductive layer extending along the expandable frame.
Cattaneo et al. (hereinafter ‘Cattaneo’, U.S. PGPub. No. 2013/0226272) discloses an expandable frame formed from a plurality of lattice shaped alternating layers of conductive layers (conductive layers 16 in Fig. 8) forming the conductive region (12), and insulating layer (insulator layer 15). However, Cattaneo only discloses that each of the insulating layers terminates proximally to its respective conductive layer so as to expose a distal portion of the respective conductive layer to form a conductive region (12). Therefore, Cattaneo does not disclose defining openings through an insulating layer to expose a conductive layer.
Helmus (U.S. PGPub. No. 2006/0089709) discloses an expandable frame (see Figs. 1-2) comprising a plurality of electrodes (electrodes 250) wherein the plurality of electrodes are either disposed on an insulating layer (310) of an outer surface of the frame (110 Fig. 3A) or flushed with an outer surface of the expandable frame (electrodes 350 is flushed with the frame 365 in Fig. 3B, [0073]). However, in both embodiments, the stacked arrangement is a conductive layer disposed on an insulating layer. Therefore, there is no reason to modify the two layers such that the insulating layer is disposed on the conductive layer and to expose a portion of the conductive layer. Accordingly claim 46 is allowable as being dependent on claim 45.
In regards to claim 47, Oxley fails to disclose electrically coupling the plurality of conductors to conductive paths of the expandable frame using a connection panel of the connector region, wherein the connector panel comprises a first set of pads and a second set of pads and electrically coupled to the plurality of conductors, wherein the first set of pads and the second set of pads are electrically coupled via at least one jumper.
Oxley discloses that the plurality of conductors (electrode wires 56) are directly connected to wide bundles (wire bundles 58) and does not necessarily disclose a connection panel as claimed in claim 47.
Cattaneo discloses a plurality of conductors of an expandable frame comprising a plurality of struts defining a lattice (lattice structure 10 in Fig. 2 comprising a plurality of struts/webs 11 connected to a plurality of supply lines 23 or electrical cables that are insulated and connected to the central supply line 24, [0055]). However, Cattaneo fails to disclose the connection panel as claimed in claim 47. Similarly, Muessig et al. (hereinafter ‘Muessig’, U.S. PGPub. No. 2016/0067474) discloses an expandable frame formed from a plurality of struts defining a lattice (electrode lead 1 in Fig. 1) and a plurality of conductors extending from the expandable frame (filaments 3). Similar to Oxley and Cattaneo, it fails to disclose wherein the plurality of conductors is connected to the connection panel as claimed in claim 47.
In regard to claims 51-52 and 54-57, Oxley fails to disclose wherein the plurality of conductors comprises a first helical coil defining a lumen and a second helical coil disposed radially outward of the first helical coil. Fig. 8 of Oxley only shows the plurality of conductors (56) and its wires (58) bundled as a single wire bundle.
Cattaneo discloses a plurality of conductors of an expandable frame comprising a plurality of struts defining a lattice (lattice structure 10 in Fig. 2 comprising a plurality of struts/webs 11 connected to a plurality of supply lines 23 or electrical cables that are insulated and connected to the central supply line 24, [0055]). However, Cattaneo fails to disclose wherein the plurality of conductors comprises a first helical coil defining a lumen and a second helical coil disposed radially outward of the first helical coil.
Similarly, Muessig discloses an expandable frame formed from a plurality of struts defining a lattice (electrode lead 1 in Fig. 1) and a plurality of conductors extending from the expandable frame (filaments 3). Similar to Oxley and Cattaneo, it fails to disclose wherein the plurality of conductors comprises a first helical coil defining a lumen and a second helical coil disposed radially outward of the first helical coil. There is no motivation to modify the linearly arranged plurality of conductors of Oxley, Cattaneo, and Muessig into two helical coils as required in claim 51. Accordingly, claims 52, 54-57 are allowable.
Response to Arguments
Applicant’s Remarks filed on March 9, 2026 is acknowledged.
However, Applicant has made significant amendments to independent claim 25, canceled claims 26-44 and added new dependent claims 45-57. There are no specific arguments directed to the reference Oxley (U.S. PGPub. No. 2014/0288668). The examiner notes that Oxley anticipates the newly amended independent claim 25. Specifically, the Examiner notes that the preamble recite “[a] method of transmitting neural activity of a patient outside a blood vessel” but does not require in the body of the claim to contact a specific neural tissue outside the blood vessel, therefore, Oxley discloses a method of transmitting to the device, a neural activity adjacent to or outside an outer wall the blood vessel and the rejection of independent claim 25 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Oxley is tenable.
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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 4/30/2026
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