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 Objections
Claims 5 and 18 are objected to because of the following informalities:
Claim 5 should read “…between the at least one of the plurality of electrodes and tissue and the at least one of the plurality of electrodes contacts.”
Claim 18 reads “…the flexible substrate is cit..” The spelling should be corrected to “cut.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 16, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2010/0228113 granted to Solosko et al (hereinafter “Solosko”).
In reference to claim 16, Solosko discloses a method comprising: printing [e.g. 0004 “the traces, which may be printed or etched…”] a first conductive layer, comprising a plurality of electrodes, traces, and connections, on a flexible substrate using conductive ink [e.g. 0056: “A printed polyester circuit layer 106 conducts signals from the electrodes to the contacts 103 of electro-mechanical connector 102. In this embodiment, the circuit 107 is printed on both sides of the polyester film. The side facing electro-mechanical connector 102 is printed with conductive silver ink that is connected via printed thru-holes to the silver/silver chloride biomedical electrodes 108 on the patient side”]; printing a dielectric layer [e.g. 0056: “..The side facing electro-mechanical connector 102 is printed with conductive silver ink…”] covering a portion of the conductive ink to insulate the traces, but leave connections and electrodes exposed [e.g. 0057: “The support substrate 109 provides the required dielectric barrier between electrodes. It may be the same nominal thickness as the hydrogel pads 111. Alternatively, it may also be a little thinner to push the hydrogel pads 111 gently through openings 113 of a retention seal 112”]; placing an adhesive layer on top of the dielectric layer [e.g. 0060: “the retention seal 112 is a thin, flexible, breathable layer…coated on one side with medical grade pressure sensitive adhesive…”]; and cutting [e.g. 0035: “…hydrogel is a piece cut from a pre-cured sheet..”] the substrate into a shape of an electrode pad, wherein the substrate is further cut such that one or more electrodes in the array are able to move independently from others of the plurality of electrodes [e.g. 0061: “The four large holes 113 through this layer are the windows through which the hydrogel makes contact with the skin. These holes also define the center-to-center spacing of the four electrodes…”], wherein the plurality of electrodes is arranged in an array [e.g. 0001: “..multi-electrode biomedical patch…”].
In reference to claim 17, Solosko discloses further comprising placing a connector on the substrate to form electrical connections with the traces [e.g. 0004: “The traces, which may be printed or etched, provide electrical connection between the electrode and the monitoring device via the electro-mechanical connector”].
In reference to claim 19, Solosko discloses further comprising placing an isolated hydrogel section at least on top of each electrode [e.g. 0058: “…hydrogel pads 111…”].
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 1-7 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No 2018/0296834 granted to John et al (hereinafter “John”) in view of U.S. Patent Application Publication No 2014/0371566 granted to Raymond et al (hereinafter “Raymond”).
In reference to claim 1, John discloses an electrode pad [e.g. electrode pad 18] configured to adhere to a patient's skin and provide transcutaneous stimulation to a portion of tissue [e.g. 0149: “…back sides of the TENS electrodes can be provided with a material such as Velcro® (or adhesive)…”], the electrode pad comprising: a flexible substrate [e.g. 0149: “…an array substrate material includes a foam core…” (examiner is interpreting the substrate to be flexible since it is described as being able to wrapped around a user’s leg)]; a plurality of electrodes arranged in an array [e.g. 0148: “…electrode array shown in Fig. 6A…”] on or within the flexible substrate [e.g. 0149: “…an array substrate material includes a foam core and has Velcro® material on its surface. The electrodes are secured to the array's surface at customized positions”], wherein each of the plurality of electrodes is configured to apply a stimulation waveform [e.g. 0147 “…electrode pads which may be programmably assigned values such as on, off, anode, or cathode…electrode combinations can be selected until desired nerve recruitment is successful…”]; and conductive traces applied to the flexible substrate and coupled to each of the plurality of electrodes [e.g. 0148: “The conduits that conduct the electrical signals to the pads, can be realized as conductive traces or can be wires that are attached to the array and routed along a non-conductive set of pathways…”] such that each of the plurality of electrodes is independently addressable through a single external cable [e.g. Figure 6A: cable 91f]. John, however, fails to describe wherein the flexible substrate is at least partially skeletonized and/or comprises one or more slits or cutouts configured to allow at least a portion of the array to conform to a surface. Raymond discloses this as “a conforming patient contact assembly 100 allowing each of the patient contact elements 101 to move independently from each other thus providing optimal contact with the patient’s skin surface” [e.g. 0034]. Further, the claimed element of “slits or cutouts” can be seen in “Figure 4”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of John, to include a substrate that is partially skeletonized or comprising slits as taught by Raymond, since such a modification would provide the predictable results of allowing the electrode pad to better conform to a user especially in areas of the human anatomy that may require more flexibility.
In reference to claim 2, John discloses an electrode pad but fails to describe comprising an adhesive layer that covers at least a portion of the flexible substrate and the conductive traces without covering the plurality of electrodes. Raymond describes in Figure 4 “patient contact elements 101 may hold adhesive [e.g. 0028]”. As can be seen in Figure 4, not all contact elements have the adhesive. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of John, to include an adhesive layer that covers part of the substrate as taught by Raymond, since such a modification would provide the predictable results of allowing the electrode pad to better conform to a user especially in areas of the human anatomy that may require more flexibility.
In reference to claim 3, John discloses wherein the portion of tissue comprises at least a portion of a spinal cord, one or more spinal nerves, or one or more peripheral nerves [e.g. 0003: “This invention relates generally stimulation of peripheral nerves…”].
In reference to claim 4, John discloses an electrode pad but fails to describe where the flexible substrate comprises one or more slits or cutouts. Raymond discloses the claimed element of “slits or cutouts” in “Figure 4”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of John, to include a substrate that is partially skeletonized or comprising slits as taught by Raymond, since such a modification would provide the predictable results of allowing the electrode pad to better conform to a user especially in areas of the human anatomy that may require more flexibility.
In reference to claim 5, John discloses wherein at least one of the plurality of electrodes comprises a pattern designed to spread electric field evenly or to reduce impedance between the at least one of the plurality of electrodes and tissue the at least one of the plurality of electrodes contacts [e.g. 0148: “…When a grid is used, an interface can be provided that allows the user to shape or locate the electrical stimulation in customizable and intuitive manners. For example, the user may cause the stimulation field to become spatially biased either medially, laterally, proximally or distally…”].
In reference to claim 6, John discloses further comprising a connector to couple the plurality of electrodes to the single cable [e.g. accessory port 98].
In reference to claim 7, John discloses an electrode pad but fails to describe one or more components configured to measure a bending moment of the array, an orientation angle of the array, a linear acceleration of the array, and/or a radial acceleration of the array. Raymond describes “This shape change actuation of the spine 202 may be accomplished by mechanical, electrical or other means, such as by using a material that is mechanically responsive to an electrical current, or a material that is under mechanical tension or compression when laying flat and that automatically returns to its resting state in the arced shape, or else through another equivalent means” [e.g. 0029]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of John to include a measure of bending of the array as taught by Raymond, since such a modification would provide the predictable results of allowing for a wider range of movement for each patient contact element.
In reference to claim 11, John discloses an electrode pad [e.g. electrode pad 95] configured to adhere to a patient's skin and provide transcutaneous stimulation to a portion of tissue [e.g. 0149: “…back sides of the TENS electrodes can be provided with a material such as Velcro® (or adhesive)…”], the electrode pad comprising: a flexible substrate [e.g. 0149: “…an array substrate material includes a foam core…” (examiner is interpreting the substrate to be flexible since it is described as being able to wrapped around a user’s leg)]; a plurality of electrodes arranged in an array [e.g. 0148: “…electrode array shown in Fig. 6A…”] on or within the flexible substrate [e.g. 0149: “…an array substrate material includes a foam core and has Velcro® material on its surface. The electrodes are secured to the array's surface at customized positions”], wherein each of the plurality of electrodes is configured to apply a stimulation waveform [e.g. 0147 “…electrode pads which may be programmably assigned values such as on, off, anode, or cathode…electrode combinations can be selected until desired nerve recruitment is successful…”]; and conductive traces applied to the flexible substrate and coupled to each of the plurality of electrodes [e.g. 0148: “The conduits that conduct the electrical signals to the pads, can be realized as conductive traces or can be wires that are attached to the array and routed along a non-conductive set of pathways…”] such that each of the plurality of electrodes is independently addressable through a single external cable [e.g. Figure 6A: cable 91f]; a stimulator [e.g. stimulator 12] connected to the flexible electrode pad [e.g. array 14] through the single external cable configured to provide a stimulation to at least a portion of the plurality of electrodes based on addresses associated with the at least the portion of the plurality of electrodes [e.g. 0106: “…a user connects an electrode array 14 into stimulator 12 (FIG. 1B) to realize a mechanical and electrical connection between the two system components…”]; and a controller [e.g. Figure 2: controller 40] coupled to the stimulator comprising a processor configured to select the portion of the plurality of electrodes and to alter one or more parameters of the stimulation [e.g. Figure 2: stimulation 48] for the portion of the plurality of electrodes based on a user input [e.g. user interface 44, paragraph 0079 “…the device 12 is configured to operate interactively with a user in order to define stimulation parameter settings which are assigned qualitative meanings such as “threshold”, “comfortable”, “strong”, “very strong” and “uncomfortable”. For example, a user can press buttons to indicate these attributes during a calibration routine where the intensity of stimuli are adjusted”]. John, however, fails to describe wherein the flexible substrate is at least partially skeletonized and/or comprises one or more slits or cutouts configured to allow at least a portion of the array to conform to a surface. Raymond discloses this as “a conforming patient contact assembly 100 allowing each of the patient contact elements 101 to move independently from each other thus providing optimal contact with the patient’s skin surface” [e.g. 0034]. Further, the claimed element of “slits or cutouts” can be seen in “Figure 4”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of John, to include a substrate that is partially skeletonized or comprising slits as taught by Raymond, since such a modification would provide the predictable results of allowing the electrode pad to better conform to a user especially in areas of the human anatomy that may require more flexibility.
In reference to claim 12, John discloses wherein the processor is configured to alter the one or more parameters of the stimulation based on an algorithm intended to stimulate with a high focality and intensity [e.g. 0148: “Using an interface that allows a user to customize the field may allow for improved recruitment of a target nerve. This feature can be accomplished using algorithms provided within the routing module 54. This interface can also be used to adjust the region of overlap created by interferential stimulation waveforms”].
In reference to claim 13, John discloses further comprising one or more ground electrodes connected to the stimulator [e.g. 0176: “The electrode 136 is understood to represent a monopolar, bipolar, tripolar, paddle electrode, or other configuration which can provide stimulation/sensing, and can include a ground, but is simplified to avoid cluttering of the figure.”].
In reference to claim 14, John discloses further comprising one or more sensors configured to be placed on or around a patient's body, wherein the sensor comprises one or more of an inertial measurement unit, a bend sensor, an electromyogram (EMG) sensor, and a near-infrared spectrum (NIRS) sensor [e.g. 0185: “…other relevant measure as obtained from sensed data of one or more sensors (or otherwise). Sensors may be implanted, external to the patient, or may be inserted vaginally or anally to obtain physiological or other data in an acute manner. In an embodiment, the method also includes recording thigh muscle EMG to ensure minimal spillover.”].
In reference to claim 15, John discloses further comprising a flexible hub configured to be placed between the plurality of electrodes and the single external cable to route electrical stimulation to an appropriate at least one flexible electrode pad [e.g. connection port 80, paragraph 0135: “…connected directly to a common contact 82 of port 80. The stimulus generator is configured to deliver distinct waveforms to the different electrodes 90a-90d using fixed circuitry and where conductive traces 91 are connected to specific contacts of the port 80.”].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over John in view of Raymond and further in view of U.S. Patent No 4,819,657 granted to Kraft et al (hereinafter “Kraft”). John as modified by Raymond discloses an electrode pad but fails to describe wherein one or more of the plurality of electrodes is functionalized to detect a chemical and/or biological signature of inflammation and/or an allergic reaction in tissue in contact with the one or more of the plurality of electrodes. Kraft describes “there is provided an allergy testing system for use in conjunction with an electrode which senses the instantaneous skin temperature in the area of an allergic reaction and provides an electric signal manifesting the sensed temperature” [e.g. column 2: lines 21-26]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the electrode pad as taught by John and Raymond to include an allergy testing system as taught by Kraft, since such a modification would provide the predictable results of being able to detect a chemical or biological reaction.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Solosko in view of Raymond. Solosko discloses a method of making an electrode array but fails to describe wherein the flexible substrate is cut in a skeletonized pattern such that one or more electrodes in the array are able to move independently from others of the plurality of electrodes. Raymond discloses this as “a conforming patient contact assembly 100 allowing each of the patient contact elements 101 to move independently from each other thus providing optimal contact with the patient’s skin surface” [e.g. 0034]. Further, the claimed element of “slits or cutouts” can be seen in “Figure 4”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Solosko, to include a substrate that is partially skeletonized or comprising slits as taught by Raymond, since such a modification would provide the predictable results of allowing the electrode pad to better conform to a user especially in areas of the human anatomy that may require more flexibility.
Allowable Subject Matter
Claims 9, 10, 20, and 21 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.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796