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 .
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.
Claims 66, 70-74, 81-85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/106843 by Li.
Regarding Claim 66, Li discloses a system (abstract) comprising:
a plurality of skin surface electrodes configured to contact a skin surface of a patient (e.g. ¶¶ 9,22,50,62,140, Fig. 2, Fig. 14, and Fig. 18: multi-electrode array stimulators, such as 102/202, for “focal and precise stimulation”, including transcutaneous spinal cord stimulation);
a sensor configured to contact the skin surface of a patient (e.g. ¶¶ 45-46, 140-142, 145-146, Fig. 18-21: vital sign sensors 224, EMG sensors 226, brain recording sensors 222, heart rate, PPG, SpO2, blood pressure, etc.);
a signal processing device coupled to the plurality of skin surface electrodes or the sensor (e.g. ¶¶ 129,131,136,144,150: FPGA, controller, or processing device), the signal processing device configured to change stimulation settings of the plurality of skin surface electrodes based on measurements from the sensor (e.g. ¶ 140: “The vital sign sensor 224 is important, as spinal cord stimulation also modulates sympathetic and parasympathetic nerves that travel along with the spinal cord. Once an abnormal physiological signal is sensed, the stimulation parameters may be adapted or ceased. In another application, the spinal cord stimulation system can be used to regulate high blood pressure (BP) and the patent's BP can be sensed accordingly as a feedback control”; Also see ¶¶ 53,81,122,128,140-142: all feedback/sensing signals are used in stimulation control); and
a multi-channel stimulator comprising at least one stimulation channel for each of the plurality of skin surface electrodes (e.g. ¶¶ 13-15,39-41,124-125,128,130,136,179-180, Fig. 14, Fig. 16: the stimulator is a multi-channel stimulator, e.g. 64 electrodes with 64 channels, with control of each channel),
wherein the plurality of skin surface electrodes is capable of being positioned to selectively stimulate at least one biological target, enhancing and focalizing an electrical field or a tangential electrical field, or a derivative of the electrical field or the tangential electric field, at the biological target (e.g. abstract, ¶ 125: “In addition to the optimization algorithm, the key to a highly spatially focused direct current stimulation is enabling precise control of currents in each stimulation channel. Thus, the optimization algorithm detailed above may be used to its highest precision by providing a hardware platform as shown in stimulation system 100 of FIG. 14 that has the capability to enable this precision: a high channel-count stimulator with precise output current parameters for each channel and seemingly immediate dynamic updates to those parameters in real-time“; ¶181: “high intensity and focal accuracy within safety the safety limit by applying a parameter that assigns a weight to a directional intensity and focality associated with said transcutaneous stimulation”; Also see, ¶¶ 16,18,28,49-51,54-57,68,73-75,92-94,96-101,122,124-125,156,166,181, Fig. 5C: the focality of stimulation is optimized via the E-field of each channel, e.g. by controlling the directional intensity of the E-field of each channel independently).
Regarding Claim 70, Li teaches the system of claim 66, wherein the at least one sensor comprises electromyography sensors configured to detect muscle activation during stimulation or to detect reflex signals (e.g ¶¶ 140-142: EMG sensors to sense flexor and extensor muscle movement and postures during the system operation).
Regarding Claim 71, Li teaches the system of claim 66, wherein the at least one sensor is configured to detect an electromyography parameter, a skin temperature, a heart rate, a blood oxygenation (e.g. ¶ 140: SpO2).
Regarding Claim 72, Li teaches the system of claim 66, wherein the plurality of skin surface electrodes comprises electrodes capable of being arranged in a longitudinal direction and electrodes arranged in a transverse direction relative to the patient's spinal cord and/or at least one ganglion root (this intended use is explicitly met as shown in Fig. 2 for electrodes 32 in an array over the back of the patient that are used for transcutaneous spinal cord stimulation, see e.g. ¶ 16).
Regarding Claim 73, Li teaches the system of claim 66, wherein the plurality of skin surface electrodes is capable of being positioned on the patient's skin to target the patient's spinal cord (this intended use is explicitly met as shown in Fig. 2 for electrodes 32 in an array over the back of the patient that are used for transcutaneous spinal cord stimulation, see e.g. ¶ 16).
Regarding Claim 74, Li teaches the system of claim 66, wherein the electrical field, the tangential electric field, or the derivative of the electrical field is minimized in other locations (e.g. abstract, ¶¶ 12,15,50,132,147,156,199: directional focal treatment that targets any location, avoids other locations, and does not cause tissue damage).
Regarding Claim 81, Li teaches the system of claim 66, wherein the signal processing device is further configured to execute a real-time signal analysis to change a stimulation signal (e.g. ¶ 14-15,125-126,128: real-time signal analysis).
Regarding Claim 82, Li teaches the system of claim 66, wherein the multi-channel stimulator being configured to receive parameters of the changed stimulation signal from the signal processing device and deliver the changed stimulation signal according to the parameters at each stimulation channel through its corresponding electrode (e.g. ¶ 122, 128: the electrodes also provide feedback of the stimulation).
Regarding Claim 83, Li teaches the system of claim 66, wherein the multi-channel stimulator is configured to treat spinal cord injury (e.g. ¶ 142: paralysis treatment).
Regarding Claim 84, Li teaches the system of claim 66, wherein the multi-channel stimulator modulates spinal cord networks/circuits to improve and/or facilitate spinal cord recovery (e.g. ¶ 142: paralysis treatment).
Regarding Claim 85, Li teaches the system of claim 66, wherein the multi-channel stimulator modulates spinal cord networks/circuits to regulate the motor function (e.g. ¶ 142: paralysis treatment).
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Li, as evidenced by US 2020/0093400 by Hamner and US 2014/0336722 by Rocon De Lima.
Regarding Claim 75, Li teaches the system of claim 66, wherein the plurality of skin surface electrodes is associated with at least one IMU that is configured to monitor movement of the patient's limbs and/or the patient's trunk (e.g. ¶ 142: accelerometer to measure movement; as evidenced by Hamner, ¶ 92, and Rocon De Lima, ¶25, accelerometers are understood to meet “IMU” in the art).
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 67-68 are rejected under 35 U.S.C. 103 as being unpatentable over Li, as applied to Claim 66, in view of US 2005/0131465 by Freeman.
Regarding Claim 67, Li teaches the system of claim 66, wherein the at least one sensor comprises one or more light emitter and one or more photodetectors in contact with the skin surface of the patient (e.g. ¶ 140: PPG and SpO2 sensors have a light emitter and a photodetector), yet does not explicitly disclose that the light emitter is an infrared LED.
However, it is well known in the art to utilize at least one infrared LED in oximetry, in order to measure blood oxygen saturation, and one example of this is taught by Freeman (e.g. ¶ 41, 61: oximetry with read and NIR LEDs that are detected, the difference in their signals forming the basis of detection of blood oxygenation). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an infrared LED (and a red LED) in the PPG or oximeter of a device according to the teachings of Li, as is well known in the art and taught by Freeman, in order to predictably measure blood oxygenation.
Regarding Claim 68, Li as modified in Claim 67 teaches the system of claim 66, wherein the light emitting diodes are configured to emit light at various wavelengths, each wavelength being associated with a different penetration depth and a different muscle unit (e.g. Freeman, ¶ 41, 61, noting that different wavelengths of light have different optical penetration depths).
Claims 69 is rejected under 35 U.S.C. 103 as being unpatentable over Li, as applied to Claim 66, in view of US 2008/0288020 by Einav.
Regarding Claim 69, Li The system of claim 66, wherein the signal processing device is configured to dynamically vary a stimulation amplitude and stimulation locations, based on measurements from the at least one sensor such that the stimulation amplitude, amplitude, frequency, and/or pulse width delivered by at least one of the plurality of skin surface electrodes is maximized (e.g. ¶¶ 8,14-15,19,50,125: dynamic adjustment of directional intensity), yet does not explicitly disclose doing so while remaining under a motor threshold level.
However, Einav teaches an analogous neuromuscular stimulation system which uses equivalently sub-threshold and supra-threshold stimulation in rehabilitating patients with motor control problems (e.g. abstract, ¶2,145). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate maintaining sub-threshold stimulation under a motor threshold level in a device according to the teachings of Li, as taught by Einav, in order to predictably provide NMES as part of rehabilitating patients with motor control problems.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Li, as applied to Claim 66, in view of US 8,165,685 by Knutson.
Regarding Claim 76, Li teaches the system of claim 66, wherein the at least one sensor is a motion/position sensors disposed electrically connected to the plurality of skin surface electrodes (e.g. ¶ 142: EMG sensors and accelerometers 226 are deployed to limb muscles to sense flexor and extensor muscle movements and posture, for the feedback that drives stimulation), yet fails to teach that the motion sensors include a bend sensor disposed in a flexible hub.
However, Knutson teaches an analogous NMES system for treating paralysis, and having bend sensors integrated in a flexible wearable article, such as a glove, sock, or sleeve, for sensing the position or muscle contraction of a body part, such as an arm, a leg, a finger, in order to provide feedback for the NMES (e.g. abstract, 1:10-14,3:36-67,6:59—7:8, Fig. 1, Fig. 4). These flexible wearable articles that are electically connected to the stimulation in a feedback loop (e.g. see Fig. 1), would read on the claimed flexible hub. Therefore, it would have it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate bend sensors in a flexible wearable item, such as a limb sleeve or glove or sock, in a device according to the teachings of Li, as taught by Knutson, in order to predictably provide feedback on muscle movements and posture.
Regarding Claim 77, Li as modified in Claim 76 teaches the system of claim 76, wherein the flexible hub is further configured to be in contact with the patient (as discussed in Claim 76, the clothing item is for contact with the body of the patient).
Regarding Claim 79, Li as modified in Claim 76 teaches the system of claim 76, wherein the bend sensor is further configured to measure posture or movement (as discussed in Claim 76, the bend sensor measures posture and movement).
Regarding Claim 80, Li as modified in Claim 76 teaches the system of claim 76, further comprising electrical connectors each configured to connect the hub to external electronics (e.g. Knutson, Fig. 1: the clothing article 12 with the bend sensor is electrically connected to electronics 14 and 16, ie. the processing circuits of the combination with Li, that are “external” to the clothing, via multiple wires and connections, see 4:36-40, Fig. 4). Li as modified in Claim 76 does not explicitly teach that the connections are detachable. However, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make the electrical connections of the sensing clothing article detachable in a device according to the teachings of the combination, as it has been held that: a) the separation of elements, where removability would be desirable, is a design consideration within the skill of the art (In re Dulberg, 283 F.2d 522, 129 USPQ 348 (CCPA 1961)-MPEP 2144.04.V.C), and b) constructing a formerly integral structure in various elements involves only routine skill in the art (Nerwin v. Erlicnrnan, 168 USPQ 177, 179).
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Li/Knutson, as applied to Claim 76, and further in view of US 2014/0336722 by Rocon De Lima.
Regarding Claim 78, Li as modified in Claim 76 teaches the system of claim 76, yet does not explicitly disclose wherein the bend sensor comprises an inertial measurement unit. However, Rocon De Lima teaches an analogous neurostimulation device which utilizes inertial sensors to measure flexion/extension angle as feedback for the neurostimulation (e.g. abstract, ¶ 9,25,140). Therefore, it would have it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate inertial sensors to measure bend in the combination, as taught by Rocon De Lima, in order to predictably measure flexion/extension angles.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 66 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,167,918. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 9 of the issued patent clearly anticipates Claim 66.
Regarding Claim 66, Claim 1 of the issued patent teaches a system comprising:
a plurality of skin surface electrodes configured to contact a skin surface of a patient (Claim 66: a plurality of electrodes configured to be in contact with a skin surface of a patient);
at least one sensor configured to contact the skin surface of a patient (Claim 66: a bend sensor disposed in the hub and configured to measure a curvature of the hub; a signal processing device electrically coupled to the plurality of electrodes and the bend sensor);
a signal processing device coupled to the plurality of skin surface electrodes and/or the at least one sensor, the signal processing device configured to change stimulation settings of the plurality of skin surface electrodes based on measurements from the at least one sensor (Claim 66: he signal processing device being configured to change stimulation settings of the plurality of electrodes based on the curvature of the hub, wherein a curvature signal from the hub is used to dynamically restrict stimulation intensity); and
a multi-channel stimulator comprising at least one stimulation channel for each of the plurality of skin surface electrodes (Claim 66: a multi-channel stimulator comprising at least one stimulation channel for each of the plurality of electrodes),
wherein the plurality of skin surface electrodes is positioned to selectively stimulate at least one biological target, enhancing and focalizing an electrical field or a tangential electrical field, or a derivative of the electrical field or the tangential electric field, at the biological target (Claim 66: he multi-channel stimulation is configured to enhance and focalize the electrical field or the tangential electrical field, or the derivative of an electrical field or a tangential electrical field at the selected target or targets and minimize the electrical field, the tangential electric field, or the derivative of the electrical field in other locations).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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