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 Invention I and Subspecies 1A, 2A, and 3A in the reply filed on July 27, 2026 is acknowledged. Claims 1-2 and 4-15 are pending under examination.
Specification
The disclosure is objected to because of the following informalities:
In the specification, silicone and silicon appear to be used interchangeably. In [0026], “silicone casing” is used. In [0028], “the base layer 110 may be formed of silicone” is used. In [0044], “silicon tubing” is used. In [0061], “silicone tubing” is used while “silicon cuff” is used. Applicant is asked to confirm or deny whether the use of silicone and silicon should both be used or if only one is being used.
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.
Claims 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2014/0046407) in view of Tyulmankov et al. (US 2019/0151657).
In re claim 1, Ben-Ezra discloses a neuromodulation device [1937, 1942] comprising:
a flexible layer comprising a non-conductive material (fig 57: 2132, 2134; [1942, 1943]: electrode housing and insulating elements are made of an elastic, insulating material),
the layer being positioned in at least a partially tubular shape ([1258]: “cuff is configured to be placed at least partially around (typically entirely around) a nerve or other tubular body tissue”);
at least one cathodic band (fig 12C: 146, cathode) comprising at least one conductive cathodic contact housed by the layer (fig 57: 2146; [1949]: “conductive surfaces of the electrode contact surface”; [1950]); and
an anodic band (fig 12C: 144, anode) comprising at least one anodic contact housed by the layer (fig 57: 2148; [1950]);
wherein the device is configured to receive a wireless signal to power and activate the at least one cathodic contact and the at least one anodic contact ([1619]: stimulator is used to wirelessly communicate with the electrode device; [1939]: the electrode device contains electrode contact surfaces).
Ben-Ezra lacks:
wherein the device is configured to receive a wireless signal to power and activate the at least one cathodic contact and the at least one anodic contact in a coordinated reset cycle.
Tyulmankov teaches a system for providing electrical stimulation to a patient by providing a time-ordered arrangement of stimulation instances [0005] using a lead with electrodes that can be a cuff lead [0033]. A processor can select which of the electrodes on the lead are assigned as a cathode, anode, or unused [0054]. A remote control can be used to wirelessly communicate with an implantable pulse generator [0038], which delivers electrical stimulation energy to the leads based on the stimulation parameter sets [0036]. The stimulation can be provided asynchronously to produce a coordinated reset result [0069] by using multiple stimulation fields that each have their own stimulation parameter set [0070].
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 Ben-Ezra by having the device receive a wireless signal to activate specific electrodes and provide stimulation in a coordinated reset cycle as taught by Tyulmankov, as having the electrodes activated in a coordinated reset cycle would improve efficacy, reduce power consumption and undesired side effects [0069], and prevent undesired neural synchronization [0070].
In re claim 2, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the layer houses the at least one cathodic contact and the at least one anodic contact such that a contact surface of the at least one cathodic contact and a contact surface of the at least one anodic contact are flush with a surface of the layer ([1950]: “insulating elements 2134 are generally flush with the faces of the electrode contact surfaces”).
In re claim 4, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the neuromodulation device comprises a length of about 12.5 millimeters (mm) to 30 mm ([0320]: “the entire length of the cuff is between 1 and 40 mm”).
In re claim 5, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the layer comprises silicone ([1942, 1943]: housing and insulating elements comprise silicone).
In re claim 6, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the layer, the at least one cathodic band, and the at least one anodic band are comprised of corrosion resistant and biocompatible materials ([01628]: “platinum/iridium cuff electrode assembly”; [1942, 1943]: housing and insulating elements are comprised of silicone; Note: both platinum iridium and silicone are known to be biocompatible and corrosion resistant and are known to be used in cuff electrodes).
In re claim 9, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the at least one cathodic contact and the at least one anodic contact comprise platinum iridium ([1628]: first sentence; Note: platinum/iridium is a known material used for electrodes).
Claims 7 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2014/0046407) in view of Tyulmankov et al. (US 2019/0151657) in view of Guiraud et al. (US 2024/0335665).
In re claim 7, the proposed combination lacks
wherein the at least one cathodic band and the at least one anodic band are comprised of a non-conductive material.
Guiraud teaches a neural stimulation device [0001] that uses a cuff-type neural electrode that has three rings, each of which has four electrical contacts (fig. 1; [0066]: “the four contacts are separate”; Note: the electrical contacts on the rings can be separate from each other so non-conductive material would have to separate them so they can all be independently controlled without affecting each other).
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 the proposed combination by having multiple electrical contacts disposed around the bands with having non-conductive material separating them as taught by Guirad, as having non-conductive material separate the electrical contacts along the bands would allow for each contact to apply stimulation at a precise location along the nerve instead of stimulation being applied along the entire length of the band.
In re claim 10, the proposed combination lacks
wherein the at least one cathodic band comprises at least three cathodic contacts, and the at least one anodic band comprises at least three anodic contacts.
Guiraud teaches a neural stimulation device [0001] that uses a cuff-type neural electrode that has three rings, each of which has four electrical contacts (fig. 1). The electrical contacts can be assigned as anodic, cathodic, or unused [0025]. Multiple contacts in one ring can be assigned with an anodic function (fig 1: TLR configuration, both outer rings have all four contacts as anodic contacts). The inner ring can have eight electrical contacts, each of which can be successively defined as a cathode [0053].
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 the proposed combination with having each band have multiple contacts that can be assigned as anodic or cathodic as taught by Guiraud, as having multiple contacts would allow the contacts to be distributed along a nerve so that the stimulation can be delivered to the nerve more precisely. Additionally, each contact being able to be assigned as a cathode or anode would allow for more precise current steering.
In re claim 11, the proposed combination yields (all mapping directed to Ben-Ezra) wherein the coordinated reset cycle comprises activating one of the at least three cathodic contacts and one of the at least three anodic contacts ([1957]: control unit can drive a cathode electrode contact and an anode electrode contact).
In re claim 12, the proposed combination yields (all mapping directed to Ben-Ezra), wherein the one cathodic contact and the one anodic contact are activated simultaneously [1808] or sequentially (optional).
In re claim 13, the proposed combination lacks wherein a pattern of the coordinated reset cycle comprises activating another one of the at least three cathodic contacts and another one of the at least three anodic contacts.
Tyulmankov teaches using electrical stimulation to produce a coordinated reset [0069] by using a series of stimulation fields, wherein each field is generated by a different subset of electrodes [0070]. Each of the electrodes can be defined as an anode or cathode [0047].
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 the proposed combination by having a pattern of the coordinated reset cycle comprise activating different electrodes, which can be assigned as cathodes or anodes, as taught by Tyulmankov, as activating different cathodes or anodes in a series of stimulation fields can cause asynchronous stimulation which can improve efficacy and reduce power consumption and undesired side effects during stimulation [0069].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2014/0046407) in view of Tyulmankov et al. (US 2019/0151657) in view of Subramanian (US 2022/0226641).
In re claim 8, the proposed combination lacks wherein, when positioned in a tubular shape, the layer comprises a diameter of about 2.0 millimeters (mm) to 2.5 mm.
Subramanian teaches an electrical stimulation lead that has a cuff with electrodes on it (abstract). The cuff body can have an inner diameter of 1 to 3 mm [0057] that the nerve is meant to go between [0051].
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 the proposed combination with having the cuff have the specified diameter range as taught by Subramanian, as this diameter range would allow for the targeted nerves to fit within the cuff body.
Additionally, it would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited values/ranges in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2014/0046407) in view of Tyulmankov et al. (US 2019/0151657) in view of Ayal et al. (US 2015/0057728).
In re claim 14, the proposed combination lacks
wherein the at least one cathodic band comprises a first cathodic band and a second cathodic band disposed on opposite sides of the anodic band.
Ayal teaches an apparatus for applying current to a nerve (abstract) that uses a nerve cuff [0288] that has alternating anodes and cathodes (fig 19: 842, anodes, and 841, cathodes; [0453]).
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 the proposed combination with having alternating cathodic and anodic regions as taught by Ayal, as alternating cathodic and anodic regions is a known technique for targeting nerve fibers of a specific diameter. Additionally, different configurations of cathodic, anodic, or passive electrode regions can be used and one of ordinary skill could choose to use different a different configuration.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2014/0046407) in view of Tyulmankov et al. (US 2019/0151657) in view of McLaughlin et al. (US 2020/0215335).
In re claim 15, the proposed combination lacks wherein the layer is positioned around a nerve, the layer having a Young’s Modulus of 1 to 10 GPa.
McLaughlin teaches an implantable stimulation device with an attached electrode array used for neurostimulation [0002] that has a non-conductive flexible substrate that can be formed of silicone [0008]. The electrode array can be in the form of a nerve cuff [0042]. The flexible substrate can have a Young’s Modulus between 1 MPa and 5 GPa.
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 Ben-Ezra with having the layer have a Young’s Modulus between the specified range as taught by McLaughlin, as having a flexible, soft elastomer material used for the layer will have a lower modulus and rigidity which can reduce the risk of damaging nerves or tissue [0069].
Additionally, it would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited values/ranges in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bolea et al. (US 2008/0177366) teaches a stimulator arrangement for a nerve using a cuff with a plurality of electrodes (abstract). The electrodes on the cuff can be monopolar, bipolar, or tripolar with different configurations including anode-cathode-anode and cathode-anode-cathode [0090].
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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