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
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claim Objections
Claims 5 and 7 are objected to because of the following informalities:
Claim 5, lines 2 reads “comprise” should read “comprises”.
Claim 7, lines 2 reads "comprise" should read “comprises”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (US 20130268020 A1) and in view of Capogrosso et al. (US 20200391030 A1), hereinafter Capogrosso.
Regarding claim 1, Rosenberg teaches a spinal cord machine interface (SCMI) device (para. 0018 (spinal cord stimulation (SCS) system… includes an implantable medical lead having one or more electrode arrays)), comprising:
an intraspinal probe (Fig. 6, element 10 – implantable lead), comprising at least one implantable shank (Fig. 6, element 50 – distal end) including a sensing electrode array (Fig. 7, elements 70A, 70B, 70D, & 70E) and a stimulating electrode array (Fig. 7, element 70C, para. 0008 (electrode array includes a first pair of small electrodes and a large electrode. The first pair of small electrodes acts as both sensing electrodes and stimulation electrodes. The large electrode only acts as a stimulation electrode)); and
detect action potentials from an efferent portion of a patient's spinal cord using the sensing electrode array (para. 0018 (SCS system configured to enable sensing of nerve firings… each electrode array 15 has the characteristic of high signal to noise ratio to sense the low-amplitude, high-frequency signal on the nervous system in order to extract signal (firing pattern) characteristics)), and
to stimulate an afferent portion of the patient's spinal cord using the stimulating electrode array (para. 0037 (SCS system 5 disclosed herein utilizes a segmented ring electrode array 15 to provide SCS to the spinal column), 0022 (the lead distal end in the thoracic vertebra region, afferent portion of the spinal cord)).
Rosenberg does not teach an application specific integrated circuit (ASIC) and a functional map linking specific regions of the spinal cord to their respective sensory and motor functions.
Capogrosso teaches a spinal cord machine interface (SCMI) device (Fig. 1, element 22 – neuromodulation lead), comprising:
a stimulating electrode array (para. 0153 (a specific subset of electrodes of an electrode array that is placed in the vicinity of the spinal cord to perform epidural electrical stimulation)); and
an application specific integrated circuit (ASIC) (Fig. 1, element 14 – processor), and
a functional map linking specific regions of the spinal cord to their respective sensory and motor functions (Fig. 2, para. 0153 (By already knowing the connection the placement of the electrodes vis-a-vis the spinal cord and the afferent sensory neurons, the necessary muscles or muscle groups needed for a specific movement can be addressed), abstract (functional mapping module configured and arranged such that based on stimulation related basic data and stimulation related response data and transfer data a digital characteristic functional map is generated and/or provided…the provided neurostimulation and its response may be analyzed on the basis of the functional map and that on the basis of this analysis a placement analysis of a placement of the electrode is provided)).
Rosenberg and Capogrosso are considered to be analogous to the claimed invention because they are in the same field of applying spinal stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg to incorporate the teachings of Capogrosso and provide an ASIC and a functional map linking specific regions of the spinal cord to their respective sensory and motor functions. Providing an ASIC allows for a circuit to perform the signal stimulation when needed, which helps reduce the consumption of the pulse generator’s stimulation module taught in Rosenberg. The addition of the functional map would improve the targeting and precision of the stimulation from the electrode array, which reduces stimulation of unintended tissue.
Regarding claim 2, Rosenberg (in view of Capogrosso) teaches the SCMI device of claim 1, in which the sensing electrode array comprises a plurality of two-dimensional (2D) flat electrodes (para. 0042 (flat electrodes 15 on a paddle lead) arranged in a 2D matrix in a first direction and a second direction (Fig. 8, para. 0044 (the electrode array(s) 15 of the paddle lead 10 may additionally be split along its longitudinal axis by a longitudinally extending space 120 such that there are lateral divisions of the electrode 15 in addition to longitudinal divisions of the electrode 15)).
Regarding claim 3, Rosenberg (in view of Capogrosso) teaches the SCMI device of claim 2, in which the plurality of 2D flat electrodes are coated with a conductive material, comprising titanium nitride (TiN), gold (Au), and/or platinum (Pt) (para. 0029 (electrodes 70A-70E are made of platinum)).
Claim 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Capogrosso and in further view of Saini et al. (US 9867978 B1), hereinafter Saini.
Regarding claims 4-5, Rosenberg (in view of Capogrosso) teaches the SCMI device of claim 1, and the stimulating electrode array (Fig. 7, element 70C) arranged in a 2D matrix in a first direction and a second direction (Fig. 8, element 70C, para. 0044 (another embodiment, the electrode array(s) 15 of the paddle lead 10 may additionally be split along its longitudinal axis by a longitudinally extending space 120 such that there are lateral divisions of the electrode 15 in addition to longitudinal divisions of the electrode 15)).
Rosenberg does not teach the stimulating electrode array comprising a plurality of three-dimensional (3D) electrodes in which the plurality of 3D electrodes comprise a conductive region surrounding an electrode post.
Saini teaches a stimulating electrode array comprises a plurality of three-dimensional (3D) electrodes (col. 1, lines 13-14 (a three-dimensional, electrically isolated multi-electrode array (MEA)), col. 1, lines 39-41 (The MEMS electrodes may be used to provide electrical stimulation and to measure electrical activity)), in which the plurality of 3D electrodes comprise a conductive region surrounding an electrode post (Fig. 1B, element 106 – conductive interface layer, col. 3, lines 32-33 (each electrode 102 includes a conductive interface layer 106)).
Rosenberg, Capogrosso, and Saini are all considered to be analogous to the claimed invention because they are in the same field of applying electrode arrays for electrical stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg’s stimulating array to incorporate the teachings of Saini listed above, and provide 3D electrodes comprising a conductive region surrounding an electrode post. The addition of 3D electrodes enables more versatile shaping of electric fields and more precise spatial targeting than two-dimensional electrode arrays. The addition of the conductive region improves electrical coupling between the electrode and the target region.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Capogrosso and in further view of Saini and Zhou (US 20070092750 A1).
Regarding claim 6, Rosenberg (in view of Capogrosso and Saini) teaches the SCMI device of claim 4, comprising the claimed features listed above. Rosenberg does not teach in which the plurality of 3D electrodes are coated in a conductive material, comprising titanium (Ti)/Au (Ti/Au), Ti/Pt (Ti/Pt), Ti/Pt iridium (Ir) (Ti/Ptr), Ti/Pt/Ir, Ti/Pt/Ir oxide (Ox) (Ti/Pt/TrOx), Ti/Ir, Ti/Ti nitride (N) (Ti/TiN), Ti/Pt/TiN, and/or Ti/IrOx.
Zhou teaches a plurality of electrodes coated in a conductive material, comprising titanium (Ti)/Au (Ti/Au), Ti/Pt (Ti/Pt), Ti/Pt iridium (Ir) (Ti/Ptr), Ti/Pt/Ir, Ti/Pt/Ir oxide (Ox) (Ti/Pt/TrOx), Ti/Ir, Ti/Ti nitride (N) (Ti/TiN), Ti/Pt/TiN, and/or Ti/IrOx (abstract (an electrode surface coating… comprising one or more of the following metals titanium, niobium, tantalum, ruthenium, rhodium, iridium, palladium, or gold)).
Rosenberg, Capogrosso, Saini, and Zhou are all considered to be analogous to the claimed invention because they are in the same field of using electrode arrays. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg (in view of Saini) 3D electrodes, to incorporate the teachings of Zhou listed above, and provide electrodes coated in a conductive material. It is well known in the art to coat electrodes with a conductive material, such as titanium and gold, to create a durable and conductive electrode surface.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg and in view of Capogrosso and in further view of Saini and Kim et al. (US 20160208110 A1), hereinafter Kim.
Regarding claims 7-9, Rosenberg (in view of Capogrosso and Saini) teaches the SCMI device of claim 4, comprising the claimed features listed above. Rosenberg does not teach in which the plurality of 3D electrodes comprise a plurality of nanopatterned electrodes, in which the plurality of nanopatterned electrodes comprises black silicon (BSi) having a predetermined shape, in which the predetermined shape comprises silicon grass or needle-like morphology.
Kim teaches the plurality of 3D electrodes comprise a plurality of nanopatterned electrodes (Fig. 8C, para. 0036 (an electrode 60 layer is deposited over the nanofeatures)), in which the plurality of nanopatterned electrodes comprises black silicon (BSi) (para. 0035 (nanofeatures 22 are formed on the substrate 12 using a well-known “black silicon” method)) having a predetermined shape, in which the predetermined shape comprises silicon grass or needle-like morphology (Fig. 8D & 8E, para. 0036 (To pattern the electrode layer 60, photolithographic techniques such as those illustrated in FIGS. 8D and 8E may be employed)).
Rosenberg, Capogrosso, Saini, and Kim are all considered to be analogous to the claimed invention because they are in the same field of using electrode arrays. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg’s stimulating array to incorporate the teachings of Kim listed above, and provide nanopatterned electrodes comprising black silicon having a needle-like morphology. It is well known in the art to modify electrodes with a nanopatterned, doing so enhances electric field concentration and improved focusing of electrical pulsing. Additionally, it is well known to apply a black silicon method to electrodes, to create a needle-like morphology (Kim, para. 0036).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg and in view of Capogrosso and in further view of Moffitt et al. (US 9216282 B2), hereinafter Moffitt and Haggers (US 20090306491 A1).
Regarding claim 10, Rosenberg (in view of Capogrosso) teaches the SCMI device of claim 1, comprising the claimed features listed above.
Rosenberg teaches an intraspinal sensing module and an intraspinal stimulation module (para. 0043 (sensing module 56 and stimulation module 57) hermetically sealed in the housing or can 58 the pulse generator 20)) and detecting action potentials (para. 0018 (SCS system configured to enable sensing of nerve firings… each electrode array 15 has the characteristic of high signal to noise ratio to sense the low-amplitude, high-frequency signal on the nervous system in order to extract signal (firing pattern) characteristics), (0020 (pulse generator 20 is configured to both sense nerve electrical signals and deliver electrical stimulation via the lead 10)).
Rosenberg does not teach an ASIC comprising a control module coupled to the intraspinal sensing module and the intraspinal stimulation module; a receiving module; and a transmitting module, in which the action potentials detected by the intraspinal sensing module are transmitted to an external actuator to carry out a brain-initiated task.
Capogrosso teaches an ASIC (Fig. 1, element 14 – processor).
Capogrosso does not teach the ASIC comprising a control module coupled to the intraspinal sensing module and the intraspinal stimulation module; a receiving module; and a transmitting module, in which the action potentials detected by the intraspinal sensing module are transmitted to an external actuator to carry out a brain-initiated task.
Moffit teaches a control module (Fig. 10, element 204 – processor, col. 7 lines 18-20 (processor 204 is generally included to control the timing and electrical characteristics of the stimulation));
a receiving module (col. 7 lines 34-38 (processor 204 is coupled to a receiver 202 which is coupled to the antenna 218)); and
a transmitting module transmitting to an external device (col. 7, lines 44-45 (The telemetry unit 206 can be a device that is worn on the skin of the user), col. 7, lines 51-54 (programming unit 208 can provide signals or information to the telemetry unit via a wireless or wired connection)).
Moffitt does not teach an external actuator to carry out a brain-initiated task.
Haggers teaches an external actuator to carry out a brain-initiated task (para. 0013 ([neurostimulation device] is adaptable to communicate with an external device… can be an actuator)), 0054 (devices can be configured to allow the user to directly interface with an… external device through nerve impulse detection and stimulation), Fig. 10B)).
Rosenberg, Capogrosso, Moffitt, and Haggers are all considered to be analogous to the claimed invention because they are in the same field of using electrodes to provide spinal stimulation.
Rosenberg teaches an intraspinal sensing module and an intraspinal stimulation module within an implantable pulse generator, to allow for the detection of neural firings (para. 0043, 0020). Capogrosso teaches an ASIC (Fig. 1, element 14 – processor). Moffitt teaches an implantable pulse generator that is able to house the antenna, receiver, and processor (col. 6 lines 56-60). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg’s implantable pulse generator to incorporate the teachings of Capogrosso and Moffitt listed above, and provide a control module that is coupled to the electrical components to sense action potentials occurring from the electrode arrays. Doing so provides stimulation control within the electrical components, to enable efficient processing for the detection of action potentials.
Moffitt also teaches a transmitting module that is able to provide signals to an external device, that is worn on the user’s skin (col. 7, lines 44-45). Haggers teaches an external actuator that communicates with the neurostimulation device through radio frequency, to perform a task based on neural impulse detection and stimulation (para. 0054).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rosenberg to incorporate the teachings of Moffitt and Haggers listed above, to provide an external actuator to carry out a brain-initiated task. Doing so would allow the external actuator to respond to the detected neural activity, which ensures that the patient is able to respond from the spinal stimulation implanted device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant' s disclosure. Rapoport et al. (US 9867978 B1), is another example of 3D electrodes arranged in a 2D matrix. Jin et al. (US 20210370053 A1) is another example of a nanopillar electrode array, with needle-like morphology. Avery et al. (US 3724467 A) and Van et al. (WO 2024081829 A1) are additional examples of electrical stimulation to the afferent portion of the spinal cord.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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