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 .
Election/Restrictions
Applicant’s election without traverse of Species with the following sub-species: 1B, 2A, 3A, 4B, 5A, 6E, 7A, 8A, and 9D in the reply filed on April 09, 2026 is acknowledged. Claims 1-20 are pending under examination.
Claim Objections
Claim 12 is objected to because of the following informalities:
The limitation “wherein transitioning the lead includes at least a portion of the plurality of electrodes are orienting in the same direction” is grammatically incorrect. It should read something similar to the following: wherein transitioning the lead to an extended configuration includes orienting at least a portion of the plurality of electrodes in the same direction.
The exact language proposed is a suggestion, Applicant is welcome to amend the language differently so long as the sentence is grammatically correct.
Appropriate correction is required.
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 1-6, 8-13, 15, 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dhuldhoya et al. (US 2023/0338734).
In re claim 1, Dhuldhoya discloses an electrophysiology lead system (fig 49A), comprising:
a lead (fig 10A: 1010) comprising a longitudinal body (1010, the longitudinal body of the lead extending away from the energy delivery element, 1002),
a substrate (1006), and
an electrode (1004),
the electrode being configured to deliver or record an electrical signal [0148],
the electrode configured to include a nonuniform thickness (non-elected) or a discontinuity (fig 68G; [0307]: “interrupted ring shape”),
the lead including an extended configuration ([0177]: “expanded configuration”) and a compressed configuration ([0177]: “delivery configuration”),
the substrate being normally biased toward the extended configuration ([0177]: “the expanded configuration may be achieved… allowing the component to expand to its biased configuration”),
the electrode being configured to be compressed when the lead is in the compressed configuration ([0307]: “constrain or compress round window electrodes for delivery”),
the electrode being configured so that the substrate urges the electrode toward the extended configuration ([0307]: the electrodes are “introduced in a compressed state and may expand to make contact with the walls”), and
the electrode including a thickness between 2 microns and 200 microns ([0323]: “the electrode array may have a thickness between… 0.01mm and 0.3mm”. Examiner notes that 0.01mm to 0.3mm converts to 10 microns to 300 microns)
In re claim 2, Dhuldhoya discloses
wherein the nonuniform thickness comprises an indentation extending partly through the thickness of the electrode (non-elected), or
wherein the discontinuity comprises a void in the electrode extending completely through the thickness of the electrode (fig 68G; [0307]: “interrupted ring shape”)
In re claim 3, Dhuldhoya discloses wherein the normal bias of the substrate is a function of elasticity, shape-memory behavior, thermal change, phase change, polymeric change, or volumetric change ([0177]: to change the array from the compressed state to the expanded state, liquid could be infused, volumetric change, or allowing the array to expand back to its biased configuration, shape-memory behavior).
In re claim 4, Dhuldhoya discloses
wherein the substrate includes a guide to direct the lead into the compressed configuration ([0287]: “energy delivery element is compressible along backbone into a compressed or folded configuration”; Note: Applicant states the guide can be a spine [0069]) in response to the lead being directed into a lumen; ([0289: the change to folded configuration occurs by passive or active tab manipulation; [0239]: the delivery system can be a catheter which the electrode array is inserted into).
In re claim 5, Dhuldhoya discloses
wherein the lead includes a plurality of electrodes including the first electrode (fig 10A: 1010), and
wherein each of the plurality of electrodes are oriented in a same direction when the lead is in the extended configuration (fig 10A: 1004; [0253]: the electrodes are arranged linearly and extend going through the substrate attached to the lead).
In re claim 6, Dhuldhoya discloses wherein the substrate includes an anchor configured to mechanically couple the lead to a biological tissue [0299].
In re claim 8, see above (In re claim 1 and In re claim 4) and the following limitation:
A method for electrically coupling a lead and a neural tissue ([0143]: the electrode array is adapted to attach to tissue and configured to apply electrical stimulation)
In re claim 9, see above (In re claim 2).
In re claim 10, see above (In re claim 3).
In re claim 11, see above (In re claim 4).
In re claim 12, see above (In re claim 5) and the following limitation:
wherein transitioning the lead includes at least a portion of the plurality of electrodes are orienting in the same direction (fig 40: the electrodes are orienting up when the lead is in the compressed configuration; fig 41: the electrodes are pushed out and down when the lead transitions to the expanded configuration).
In re claim 13, see above (In re claim 6).
In re claim 15, see above (In re claim 1) and the following limitation:
the electrode including a plurality of bending zones (Dhuldhoya: [0307]: the separate sides of the irregular ring-shaped electrode due to the void space between them) configured to be flexed in the compressed configuration and relaxed as the substrate moves toward the extended configuration (Dhuldhoya: [0307]).
In re claim 17, see above (In re claim 3).
In re claim 18, see above (In re claim 4).
In re claim 19, see above (In re claim 5).
In re claim 20, see above (In re claim 6).
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.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dhuldhoya et al. (US 2023/0338734) in view of Xu et al. (US 2016/0199638).
In re claim 7, Dhuldhoya lacks comprising a radiopaque marker coupled to the substrate.
Xu teaches an implantable lead which has a substrate and electrically conductive material used for stimulating a cochlear nerve (abstract). The substrate includes a radiopaque material [0039].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dhuldhoya with disposing a radiopaque material on the substrate as taught by Xu, as radiopaque materials are known markers used to serve as a reference for medical imaging which would allow the medical practitioner to easily determine where the lead is located.
In re claim 14, see above (In re claim 7).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dhuldhoya et al. (US 2023/0338734) in view of Abercrombie, II et al. (US 2022/0039720).
In re claim 16, Dhuldhoya discloses wherein the plurality of bending zones includes
an indentation extending partly through the thickness of the electrode (non-elected), or
a void in the electrode extending completely through the thickness of the electrode.
Dhuldhoya lacks:
voids in the electrode extending completely through the thickness of the electrode.
Abercrombie, II teaches a medical device that has a flexible substrate with flexible electrodes [0087]. Abercrombie, II teaches that the electrodes can include differently shaped perforations or apertures through the thickness of one or more of the electrode layers which would increase bendability [0133].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Dhuldhoya with the electrodes having multiple perforations as taught by Abercrombie, II as having perforations on an electrode increases bendability which would allow for the entire structure to compress more during delivery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cadwell (US 11,185,684) teaches a system for deploying an electrode array that has an array of electrodes attached to a substrate which is initially compressed during positioning of the lead and then uncompressed once the lead is in the desired position (abstract). A guidewire is used to keep the electrode array at the desired position until the cannula is removed and then it enables the substrate to spread (col 16, ln 25-33).
Vetter et al. (US 2018/0353753) teaches a flexible medical electrode array (abstract). The electrode array can include a plurality of wings in the overall array with empty space between them which increases the flexibility and maneuverability of the array (fig 9; [0069]).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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