DETAILED ACTION
After further review, pending claims 1-6, 9, and 11-29 have been rejected under 35 U.S.C. 102. Claims 7-8 have been rejected under 35 U.S.C. 103. Please see rejections below. Accordingly, the Action filed 01/02/2026 has been withdrawn.
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 .
Information Disclosure Statement
The Information Disclosure Statements filed 03/16/2026 have been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see page 8, filed 03/12/2026, with respect to claim objections have been fully considered and are persuasive. The claim objections have been obviated by amendments to the claims. The previously-held claim objections have been withdrawn. However, new claim objections are now made below. Please see claim objections below.
Applicant’s arguments, see pages 8-10, filed 03/12/2026 with respect to 35 U.S.C. 102 and 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see prior art rejections below.
Claim Interpretation
The Examiner notes that “virtual electrode” appears to be a term of the art, as demonstrated by Meadows, et al. (US 2003/0120323). Meadows teaches that a “virtual” electrode comprises an electrode that appears to be at a certain physical location, but really is not physically located at the apparent location (Par. [0018]). Meadows further teaches that rather, the virtual electrode results from the vector combination of electrical fields from two or more electrodes that are activated simultaneously (Par. [0018]). “Virtual electrode” is interpreted herein as it is defined by Meadows in Par. [0018].
The Examiner notes that the term “skeletonized” is defined by the Applicant in the instant specification at Par. [0039]. Par. [0039] states “As used herein, the term “skeletonized” can refer to a substrate that is formed as peninsulas that surround only the locations where electrodes, traces, and contacts for connectors are printed, without the dead space of traditional substrates”. This definition provided by the Applicant is relied upon for interpretation of the term “skeletonized” herein.
Claim Objections
Claim 5 objected to because of the following informalities:
Lines 3-4: “between the at least one of the plurality of electrodes and tissue and the at least one of the plurality of electrode contacts” should be changed to “between the at least one of the plurality of electrodes, tissue, and the at least one of the plurality of electrodes contacts”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 11-24, and 28-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “tissue” in line 3, whereas tissue was already introduced in a claim that claim 5 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different tissue. Consider changing to “the tissue”.
Claim 5 recites the limitation "the at least one of the plurality of electrodes contacts" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the at least the portion of the plurality of electrodes" in line 12. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that there was a previous mention of “a portion” of the array.
Claim 11 recites the limitation "the at least the portion of the plurality of electrodes" in line 15. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that there was a previous mention of “a portion” of the array.
Claim 11 recites the limitation "the at least the portion of the plurality of electrodes" in line 16. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that there was a previous mention of “a portion” of the array.
Claim 15 recites the limitation “at least one flexible electrode pad” in line 3, whereas an at least one flexible electrode pad was already introduced in a claim that claim 15 depends from (claim 11). It is unclear whether the Applicant intended to claim the same or a different at least one flexible electrode pad. Consider changing to “the at least one flexible electrode pad”.
Claim 16 recites the limitation “connections and electrodes” in line 5, whereas connections and electrodes were already introduced in claim 16. It is unclear whether the Applicant intended to claim the same or a different connections and electrodes. Consider changing to “the connections and electrodes”.
The limitation “electrical connections” renders claim 17 (line 2) indefinite. It is unclear whether these electrical connections are different or the same as the connections recited in claim 16, from which claim 17 depends.
Claim 23 recites the limitation "the array" in line 11. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the conductive traces are exposed connector connections terminating at exposed connector connections” renders claim 28 indefinite. It is unclear whether or not the 2nd instance of “exposed connector connections” is the same or different from the 1st instance of “exposed connector connections”. It is also unclear how the connections terminate at themselves. Please provide appropriate corrections or explanation.
*All other claims are rejected due to their dependency on a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 12-15 do not depend from a claim that was previously set forth. Claims 12-15 are all written to depend from claim 10, which has been canceled. Examiner has examined these claims as if they were intended to depend from claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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, 9, and 11-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Clements, et al. (US 2020/0138313 – cited on IDS).
Regarding claim 1, Clements teaches (Figs. 1 and 6, # 100 – electrode patch, i.e. electrode pad) an electrode pad configured to adhere to a patient's skin and provide transcutaneous stimulation to a portion of tissue (Par. [0025] – electrode patch configured to interface with a subject’s skin; Par. [0054]; Par. [0060] – Additionally, the electrode patch 100 described herein is configured to operate (e.g., apply stimulus and/or record activity) more reliably and with higher resolution at the same anatomical structure (e.g. targeting the median nerve in a patient's wrist, as shown in FIG. 6); Par. [0160]), the electrode pad comprising:
(Fig. 1, # 102) a flexible substrate (Par. [0054] – the electrode patch 100 includes a flexible substrate 102);
(Fig. 1, # 104 – electrode array, 106 – electrodes) a plurality of electrodes arranged in an array on or within the flexible substrate, wherein each of the plurality of electrodes is configured to apply at least a stimulation waveform (Par. [0055-0056]; Par. [0060] – The electronics module can be configured to apply stimulation and/or record electrical activity independently via each electrode 106.); and
(Fig. 1, # 106, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector) conductive traces applied to the flexible substrate and coupled to each of the plurality of electrodes such that each of the plurality of electrodes is independently addressable through a single external cable (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.; Par. [0154] – Examiner notes this paragraph indicates a cable upstream of the connector),
wherein (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.),
and wherein two or more of the plurality of electrodes are configured to form a virtual electrode with a synchronized stimulation timing (Par. [0115] – Adjacent electrodes can be stimulated together with fine-tuned percentages of current delivery through each for high precision tuning of current delivery to mimic an intermediate virtual electrode.).
Therefore, claim 1 is unpatentable over Clements, et al.
Regarding claim 2, Clements teaches the electrode pad of claim 1, further comprising (Fig. 3A, # 102 – flexible substrate, 108 – adhesive layer) an adhesive layer that covers at least a portion of the flexible substrate and the conductive traces without covering the plurality of electrodes (Par. [0058] - the electrode patch 100 can further include an adhesive layer 108).
Therefore, claim 2 is unpatentable over Clements, et al.
Regarding claim 3, Clements teaches the electrode pad of claim 1, wherein (Fig. 6, # 100) the portion of tissue comprises at least a portion of a spinal cord, one or more spinal nerves, or one or more peripheral nerves (Par. [0060] – Additionally, the electrode patch 100 described herein is configured to operate (e.g., apply stimulus and/or record activity) more reliably and with higher resolution at the same anatomical structure (e.g. targeting the median nerve in a patient's wrist, as shown in FIG. 6); Examiner notes that median nerve is considered a peripheral nerve).
Therefore, claim 3 is unpatentable over Clements, et al.
Regarding claim 4, Clements teaches the electrode pad of claim 1, wherein (Figs. 7A-B, 105 and 107) the flexible substrate comprises the one or more slits or cutouts (Par. [0059]).
Therefore, claim 4 is unpatentable over Clements, et al.
Regarding claim 5, Clements teaches the electrode pad of claim 1, wherein (Fig. 1, # 104, 106) 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 and the at least one of the plurality of electrodes contacts (Par. [0055] – the electrode array includes a plurality of electrodes 106; Par. [0061] – In some implementations, the plurality of electrodes 106 are arranged in a grid. For example, the grid has a square, rectangular, or hexagonal shape.).
Therefore, claim 5 is unpatentable over Clements, et al.
Regarding claim 6, Clements teaches the electrode pad of claim 1, further comprising (Fig. 1, # 120 – peripheral region, 130 – snapping connector) a connector to couple the plurality of electrodes to the single cable (Par. [0060] – Each of the traces 118 extends between one of the electrodes 106 (e.g., the electrode contact described above) and the peripheral region 120. Accordingly, an electronics module (described below) can be coupled to the electrode patch 100 at the peripheral region 120.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.; Par. [0154] – Examiner notes this paragraph indicates a cable connected to the connector).
Therefore, claim 6 is unpatentable over Clements, et al.
Regarding claim 9, Clements teaches the electrode pad of claim 1 further comprising one or more light emitters arranged on or in the flexible substrate, each configured to provide photobiomodulation therapy to surrounding tissue (Par. [0108] – an electrode might be replaced by an light emitter such as a light emitting diode (LED) able to optically stimulate tissue, for example through natural or optogenetic techniques.).
Therefore, claim 9 is unpatentable over Clements, et al.
Regarding claim 11, Clements teaches a system (Title; Abstract – Systems, devices, and methods for interfacing with biological tissue) comprising:
(Figs. 1 and 6, # 100 – electrode patch, i.e. electrode pad) at least one flexible electrode pad (Par. [0025] – electrode patch configured to interface with a subject’s skin; Par. [0054]; Par. [0060] – Additionally, the electrode patch 100 described herein is configured to operate (e.g., apply stimulus and/or record activity) more reliably and with higher resolution at the same anatomical structure (e.g. targeting the median nerve in a patient's wrist, as shown in FIG. 6); Par. [0160]), (Fig. 1, # 102 – flexible substrate, 104 – electrode array, 106 – electrodes) each comprising a plurality of electrodes arranged on or within a flexible substrate in an array (Par. [0054] – the electrode patch 100 includes a flexible substrate 102; Par. [0055-0056]; Par. [0060] – The electronics module can be configured to apply stimulation and/or record electrical activity independently via each electrode 106.) and (Fig. 1, # 106, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector) connected by conductive traces such that each of the plurality of electrodes is independently addressable through a single external cable (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.; Par. [0154] – Examiner notes this paragraph indicates a cable upstream of the connector), wherein (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.),
wherein two or more of the plurality of electrodes are configured to form a virtual electrode with a synchronized stimulation timing (Par. [0115] – Adjacent electrodes can be stimulated together with fine-tuned percentages of current delivery through each for high precision tuning of current delivery to mimic an intermediate virtual electrode.);
(Fig. 10A, # 150) a stimulator connected to the flexible electrode pad 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 (Pars. [0066-0068]); and
(Fig. 15, # 200, 202, 206, 214) a controller 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 for the portion of the plurality of electrodes based on a user input (Par. [0066] – the electronics module can be a computing device (e.g., computing device 200 of FIG. 15); Pars. [0074-0075] – computing device 200 typically includes at least one processing unit 206; Par. [0076] – computing device 200 may also have input device(s) 214 such as a keyboard, mouse, touch screen, etc.; Par. [0079]; Par. [0115]; Par. [0178] – A software-based user interface such as a graphical user interface would allow visualization of recorded signals, allowing on-the-fly analysis and, if necessary, adjustment of the electrode positioning, current delivery, signal processing, and other experimental parameters).
Therefore, claim 11 is unpatentable over Clements, et al.
Regarding claim 12, Clements teaches the system of claim 10 (it’s believed this claim and claims 13-15 were intended to depend from claim 11), 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 (Pars. [0077-0078]; Par. [0171] – in the determination of optimal stimulation parameters, a variety of stimulation can be quickly and automatically delivered at low intensities during simultaneous measurement of evoked activity. Only after determining optimal stimulation patterns would “full strength” stimulation be used. This would make procedures less painful, which can be particularly important in situations where the patient is a child or infant.).
Therefore, claim 12 is unpatentable over Clements, et al.
Regarding claim 13, Clements teaches the system of claim 10, further comprising (Fig. 2, # 122) one or more ground electrodes connected to the stimulator (Par. [0060] – in some implementations, as shown in FIG. 2, the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.)).
Therefore, claim 13 is unpatentable over Clements, et al.
Regarding claim 14, Clements teaches the system of claim 10, 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 (Par. [0108] – Similarly a photodiode or infrared (IR) sensor may be used to measure an optical property of the underlying tissue. Chemical, acoustic, ultrasonic, magnetic, mechanical, radiofrequency (RF), and a variety of other modes may be similarly used to interact with the tissue. Any interaction might be defined as but not limited to monitoring, measuring, or stimulating tissue).
Therefore, claim 14 is unpatentable over Clements, et al.
Regarding claim 15, Clements teaches the system of claim 10, further comprising (Figs. 1-2 and 11-13, # 120 – peripheral region, i.e., flexible hub) 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 (Par. [0060]; Par. [0064]).
Therefore, claim 15 is unpatentable over Clements, et al.
Regarding claim 16, Clements teaches a method (Abstract – methods for interfacing with biological tissue; Par. [0056] – manufacturing process; Par. [0140] – method of manufacture) comprising:
(Figs. 1-2, # 102 – flexible substrate, 106 – electrodes, 118 – traces, 120) printing a first conductive layer, comprising a plurality of electrodes, traces, and connections, on a flexible substrate using conductive ink (Par. [0056] – In these implementations, the electrode contacts and/or traces are formed from conductive inks such as silver (Ag) or silver chloride (AgCl) ink; Par. [0060] – the traces 118 are formed from conductive inks);
(Fig. 3B, # 110 – intermediate layer, i.e. dielectric layer) printing a dielectric layer covering a portion of the conductive ink to insulate the traces, but leave connections and electrodes exposed (Par. [0058] – the intermediate layer 110 can be an elastic material and/or material that increases patient comfort. For example, the intermediate layer 110 can be made of compressible-foam, rubber or silicone.; The Examiner notes that these materials are known to act as dielectrics);
(Fig. 3B, # 108 – adhesive layer) placing an adhesive layer on top of the dielectric layer (Par. [0058]); and
(Figs. 1 and 3B, # 100 – electrode patch, i.e. electrode pad) cutting the substrate into a shape of an electrode pad (Par. [0054]),
(Fig. 1, # 104, 106) wherein the plurality of electrodes is arranged in an array (Par. [0054-0055] – the electrode array 104 includes a plurality of electrodes 106), and
wherein two or more of the plurality of electrodes are configured to form a virtual electrode with a synchronized stimulation timing (Par. [0115] – Adjacent electrodes can be stimulated together with fine-tuned percentages of current delivery through each for high precision tuning of current delivery to mimic an intermediate virtual electrode.).
Therefore, claim 16 is unpatentable over Clements, et al.
Regarding claim 17, Clements teaches the method of claim 16, further comprising (Figs. 1-2, # 102, 106 – electrodes, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector) placing a connector on the substrate to form electrical connections with the traces (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.).
Therefore, claim 17 is unpatentable over Clements, et al.
Regarding claim 18, Clements teaches the method of claim 16, wherein (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.).
Therefore, claim 18 is unpatentable over Clements, et al.
Regarding claim 19, Clements teaches the method of claim 16, further comprising (Fig. 3B, # 106B – hydrogel) placing an isolated hydrogel section at least on top of each electrode (Par. [0056] – the hydrogel 106B, which is moldable or castable, is provided onto the electrode contact 106A).
Therefore, claim 19 is unpatentable over Clements, et al.
Regarding claim 20, Clements teaches the method of claim 16, further comprising placing (Fig. 3B, # 110) a foam layer between the substrate and the adhesive layer (Par. [0058] – the electrode patch 100 can further include an adhesive layer 108 and/or an intermediate layer 110 … the intermediate layer 110 can be made of compressible-foam).
Therefore, claim 20 is unpatentable over Clements, et al.
Regarding claim 21, Clements teaches the method of claim 16, further comprising (Fig. 3B, # 106A – electrode contact, i.e. first conductive layer, 106B – hydrogel, i.e. second conductive layer) printing a second conductive layer after printing the first conductive layer to form three dimensional patterns on at least one of the plurality of electrodes (Par. [0056] – the hydrogel 106B, which is moldable or castable, is provided onto the electrode contact 106A; Par. [0105] – The electrodes can have various geometries, including two-dimensional (2D) and three-dimensional (3D) geometries).
Therefore, claim 21 is unpatentable over Clements, et al.
Regarding claim 22, Clements teaches the method of claim 16, wherein the (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.).
Therefore, claim 22 is unpatentable over Clements, et al.
Regarding claim 23, Clements teaches (Figs. 1 and 6, # 100 – electrode patch, i.e. electrode pad) a pad configured to adhere to a patient's skin and provide transcutaneous stimulation to a portion of tissue (Par. [0025] – electrode patch configured to interface with a subject’s skin; Par. [0054]; Par. [0060] – Additionally, the electrode patch 100 described herein is configured to operate (e.g., apply stimulus and/or record activity) more reliably and with higher resolution at the same anatomical structure (e.g. targeting the median nerve in a patient's wrist, as shown in FIG. 6); Par. [0160]), the pad comprising:
(Fig. 1, # 102) a flexible substrate (Par. [0054] – the electrode patch 100 includes a flexible substrate 102);
one or more light emitters arranged on or within the flexible substrate, wherein each of the one or more light emitters is configured to provide photobiomodulation therapy to at least surrounding tissue (Par. [0108] – an electrode might be replaced by an light emitter such as a light emitting diode (LED) able to optically stimulate tissue, for example through natural or optogenetic techniques.); and
(Fig. 1, # 106, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector) conductive traces applied to the flexible substrate and coupled to each of the one or more light emitters such that each of the one or more light emitters is independently addressable through a single external cable (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.; Par. [0108]; Par. [0154] – Examiner notes this paragraph indicates a cable upstream of the connector),
wherein (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.).
Therefore, claim 23 is unpatentable over Clements, et al.
Regarding claim 24, Clements teaches the pad of claim 23, wherein the portion of tissue comprises a spinal cord (Par. [0102]; Par. [0189-0190] – Intra-operative neural monitoring (IONM) is used to reduce the risk of nerve damage to patients undergoing sensitive and invasive procedures involving the brain and spinal cord).
Therefore, claim 24 is unpatentable over Clements, et al.
Regarding claim 25, Clements teaches a system (Title; Abstract – Systems, devices, and methods for interfacing with biological tissue) comprising:
(Figs. 1 and 6, # 100 – electrode patch, i.e. electrode pad) at least one flexible electrode pad (Par. [0025] – electrode patch configured to interface with a subject’s skin; Par. [0054]; Par. [0060] – Additionally, the electrode patch 100 described herein is configured to operate (e.g., apply stimulus and/or record activity) more reliably and with higher resolution at the same anatomical structure (e.g. targeting the median nerve in a patient's wrist, as shown in FIG. 6); Par. [0160]), (Fig. 1, # 102 – flexible substrate, 104 – electrode array, 106 – electrodes) each comprising a plurality of electrodes arranged on or within a flexible substrate in an array (Par. [0054] – the electrode patch 100 includes a flexible substrate 102; Par. [0055-0056]; Par. [0060] – The electronics module can be configured to apply stimulation and/or record electrical activity independently via each electrode 106.) and (Fig. 1, # 106, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector) connected by conductive traces such that each of the plurality of electrodes is independently addressable through a single external cable (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.; Par. [0154] – Examiner notes this paragraph indicates a cable upstream of the connector),
wherein the at least one flexible electrode pad is configured to be placed on a patient's spine for transcutaneous spinal stimulation (Abstract – electrode patch configured to interface with a subject’s skin; Par. [0102]; Par. [0189-0190] – Intra-operative neural monitoring (IONM) is used to reduce the risk of nerve damage to patients undergoing sensitive and invasive procedures involving the brain and spinal cord).
Therefore, claim 25 is unpatentable over Clements, et al.
Regarding claim 26, Clements teaches the system of claim 25, wherein (Figs. 7A-B, # 105 and 107) 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 (Par. [0059] – As shown in FIGS. 7A and 7B, the electrode patch 100 can include at least one elongate cutout 105 (FIG. 7A) or at least one cutout 107 (FIG. 7B). The elongate cutout 105 and/or cutouts 107 can be provided in the flexible substrate and/or the intermediate layer of the electrode patch. The cutouts act as relief cuts, increasing flexibility or conformability of the electrode patch 100.).
Therefore, claim 26 is unpatentable over Clements, et al.
Regarding claim 27, Clements teaches the system of claim 25, wherein two or more of the plurality of electrodes are configured to form a virtual electrode with a synchronized stimulation timing (Par. [0115] – Adjacent electrodes can be stimulated together with fine-tuned percentages of current delivery through each for high precision tuning of current delivery to mimic an intermediate virtual electrode.).
Therefore, claim 27 is unpatentable over Clements, et al.
Regarding claim 28, Clements teaches the system of claim 25, wherein (Fig. 1, # 106, 118 – traces, 120 – peripheral region; Fig. 11, # 120, 130 – connector; Fig. 12-13, # 136 – pins) the conductive traces are exposed connector connections terminating at exposed connector connections with a conductive pin within an external connector (Par. [0060] – Additionally, the electrodes 106 can be independently addressable. For example, the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100.; Par. [0064] – The connectors can be used to operably couple the electrode patch to the electronics module (described below). These connectors provide for both mechanical and electrical coupling. FIG. 11 illustrates a snapping connector 130 that aligns with the peripheral region 120 of the electrode patch.).
Therefore, claim 28 is unpatentable over Clements, et al.
Regarding claim 29, Clements teaches the system of claim 28, wherein (Figs. 11-13, # 130, 136) the external connector comprises a mechanical feature configured to hold at least one contact (Par. [0064]).
Therefore, claim 29 is unpatentable over Clements, et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Clements, et al. (US 2020/0138313 – cited on IDS) in view of John, et al. (US 2018/0296834 – cited on IDS).
Regarding claim 7, Clements teaches the electrode pad of claim 1, as indicated hereinabove. Clements does not explicitly teach the limitation of instant claim 7, that is wherein the electrode pad is further comprising 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.
John, directed to analogous art, teaches systems and methods for providing stimulation, using electrode arrays, of peripheral targets such as targets in the lower limbs (Title; Abstract). John also teaches the limitation of instant claim 7, that is wherein (Figs. 1A-B and 2, # 8 – system, 12 – device, 14 – housing, 46 – monitoring module) the electrode pad is further comprising 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 (Par. [0081] – In a preferred embodiment the system 8 includes a position, motion, and/or muscle activity sensor as part of the monitoring module 46 (e.g., an accelerometer and/or level detector), to detect movement, posture, and/or changes in patient position. A three-axis (x, y, z) accelerometer, such as may be realized using a semiconductor chip, is used to measure the device or band orientation due to the effect of static gravity on each axis (i.e., x, y, z) as well as acceleration due to user motion along one or more axes. A gyroscope sensor is provided to measure rotation.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented John’s position and motion sensor into Clements’ electrode pad because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would desire implementing such sensors in order to control (e.g., stop or halt) stimulation or notify the patient when continued stimulation may present an undesirable risk to the patient (see Pars. [0085-0086] of John). For instance, it may be advantageous to weaken/shut off stimulation when the orientation of the wearable device transitions from horizontal to vertical (e.g., due to standing after lying down) (see Pars. [0085-0086] of John).
Therefore, claim 7 is unpatentable over Clements, et al. and John, et al.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Clements, et al. (US 2020/0138313 – cited on IDS) in view of Kraft, et al. (US 4,819,657 – cited on IDS).
Regarding claim 8, Clements teaches the electrode pad of claim 1, as indicated hereinabove. Clements does teach that it is contemplated that descriptions of electrodes or arrays of electrodes might also apply towards other structures able to measure from or interact with tissue (Par. [0108]). Clements further teaches that chemical, acoustic, ultrasonic, magnetic, mechanical, radiofrequency (RF), and a variety of other modes may be similarly used to interact with the tissue (Par. [0108]). However, Clements does not explicitly teach the limitation of instant claim 8, that is 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, directed to analogous art, teaches an automatic allergy testing system that includes an electrode capable of testing up to eight different allergies (Title; Abstract). Kraft also teaches the limitation of instant claim 8, that is wherein (Fig. 1, # 12 – electrode) 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 (Col. 1, line 57-Col. 2, line 3 – a new and unique electrode which can be used in allergy testing and that allows the allergen to be transcutaneously delivered to the patient without fracturing the skin; Col. 2, lines 59-68 – Electrode 12 may be placed at any convenient place on a patient 22, such as the back as shown in FIG. 1 or the arm or other areas in which it is desired to perform an allergy test).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Kraft’s allergy testing electrode into Clements’ electrode pad because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill would have desired implementing such an allergy testing electrode into Clements’ electrode pad because Clements suggests other uses of the electrodes in the electrode pad (see Par. [0108] of Clements). One of ordinary skill in the art would have also desired implementing Kraft’s allergy testing electrode due to its non-invasive technique of using an electrode for transcutaneously delivering an allergen to the patient for allergy testing (see Col. 1, line 57-Col. 2, line 3 of Kraft).
Therefore, claim 8 is unpatentable over Clements, et al. and Kraft, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
Prosecution Insights