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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/9/2026 has been entered.
Applicant' s arguments, filed 3/9/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 3/9/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 3, 5, 7, 13, 15-17, 19-21, 23-27, 29, 35-36, 44, and 51-74 are the currently pending claims hereby under examination. Claims 2, 4, 6, 8-12, 14, 18, 22, 28, 30-34, 37-43, and 45-50 have been canceled. Claims 1, 3, 5, 7, 13, 15-17, 19-21, 24, 27, 29, 35, 36, and 44 have been amended. Claims 51-74 have been newly added.
Information Disclosure Statement
The information disclosure statement filed 03/09/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, under the Foreign Patent Documents section, citation number 4 (“20170108550 KR A 2017-09-27 Lee et al.”) is not in the English language, was not accompanied by an English translation, was not accompanied by an English Abstract, and was not accompanied by a concise explanation of their relevance. The first two pages of the reference appear as unreadable text/image as if the entire refence has been scaled down to fit within two pages. This references has not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
The written description identifies “frame 132” as the printed circuit board shown in FIG. 6, which mechanically supports and electrically connects controller 134 and generator elements 136, 142, 148, and 152. However, FIG. 6 does not appear to label a frame 132. Instead, FIG. 6 appears to label the horizontal support/printed-circuit-board structure as 135. Appropriate correction is required to clarify whether the structure labeled 135 in FIG. 6 is intended to correspond to frame 132, or whether another correction to the drawing or written description is intended.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0061] appears to incorrectly identify the housing attachment feature as “attachment feature 32”, while FIG. 3A appears to identify the exterior housing attachment feature as 33A. The inconsistency creates ambiguity because reference numerals 32A-32D are otherwise used to identify energy outputs or modes, including impact/vibratory energy 32A, thermal energy 32B, electrical stimulus 32C, and pressure energy 32D in both the written description and figures (FIGS. 4A-4D). Appropriate correction is required to clarify the reference numeral corresponding to the housing attachment feature.
Claim Objections
Claims 26, 44, 58-59, 61, 65, 66, 67, 71, and 73 are objected to because of the following informalities:
In claim 26, lines 5-7: “a beating heart of the living body movements of the living body; and breathing of the living body” contains a grammatical or punctuation error and should be amended to clarify the listed sources of the measurements of electrical activity;
In claim 44, line 34: “the power source” lacks proper antecedent basis and should be amended to recite “a power source”;
In claim 58, line 2: “output the thermal” lacks proper antecedent basis and should be “output the thermal energy”;
In claim 59, line 7: “positioned on tissue contact surface” lacks proper antecedent basis and should be “positioned on the tissue contact surface”;
In claim 61, line 4: “from the power” lacks proper antecedent basis and appears to be incomplete, and should be amended to “the power source”;
In claim 65, line 4: “at lease a portion” appears to be a typographical error and should be “at least a portion”;
In claim 65, line 20: “linearly activated piston” appears to be a typographical error and should be “linearly actuated piston”;
In claim 66, line 3: “when housing is removably attached to the body” lacks proper antecedent basis and should be “when the housing is removably attached to the body”;
In claim 67, line 1: “comprising sensor is operable” contains a grammatical error and should be amended to “comprising a sensor that is operable”;
In claim 71, line 6: “the electrical contact plates” lacks proper antecedent basis and should be “electrical contact plates”; and
In claim 73, line 2: “in the signal direction an optical stimulus” contains a grammatical error and should be amended to recite “in the signal direction as an optical stimulus”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 35, 55, and 58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 35 recites “wherein the electrothermal device is spaced apart from the physiologic tissue and operable to output the thermal energy to the physiologic tissue through the tissue contact surface” (lines 1-4). The specification does not reasonably convey that Applicant was in possession of an electrothermal device spaced apart from the physiologic tissue and configured to output thermal energy to the physiologic tissue through an intervening tissue contact surface. The specification describes generator elements as extending toward and contacting the physiologic tissue, stating that “portions of each generator element 36, 42, 48, and/or 52 may extend distally from housing 33 to contact the physiologic tissue (e.g., skin 2)” (Instant Application, ¶[0061]). The specification further describes the thermal generator element 42 as including electrical resistor 43 and heat reflecting groove 44, and states that “thermal signal 32B may be output in signal direction SD as an amount of heat transferred to skin 2 by resistor 43” (Instant Application, ¶[0068]). These disclosures support thermal energy being generated and transferred to the skin by the thermal generator element, but do not describe the electrothermal device itself as being spaced apart from the physiologic tissue while transferring thermal energy through a separate tissue contact surface. Although the specification expressly describes spacing for a pressure generator embodiment, namely that “[a] face of the piezoelectric speaker may be spaced apart from the physiologic tissue to define an air gap and the pressure energy comprises a sonic energy output toward the physiologic tissue through the air gap with the speaker” (Instant Application, ¶[0007]), that disclosure is limited to the pressure/piezoelectric speaker embodiment and does not reasonably convey possession of an analogous spaced-apart electrothermal device. Accordingly, the originally filed disclosure does not provide adequate written-description support for the claimed electrothermal device spaced apart from the physiologic tissue. (See also FIG. 4B) Claim 55 recites “wherein the housing comprises a tapered exterior shape that tapers in the signal direction along a length of the housing” (lines 1-2). The specification does not reasonably convey that Applicant was in possession of a housing having an overall tapered exterior housing profile that tapers in the signal direction along a length of the housing. The specification describes housing 33 as including attachment feature 32 configured to secure each generator 31 in a communication bay, where attachment feature 32 may include threads engageable with an interior surface of bays 25 (¶[0061], FIG. 3A). The specification also describes housing 233 as comprising exterior surfaces with attachment features, including roughened areas, grooves, or ridges, engageable with interior surfaces of an opening formed in wearable body 533 (¶[0117]). These disclosures may support localized exterior attachment or engagement features, such as threads, grooves, ridges, roughened areas, or protrusions on the housing exterior, but they do not describe or clearly depict the housing itself as having an overall tapered/radiused exterior housing profile that tapers in the signal direction along a length of the housing. FIGS. 3A and 13A may be understood as depicting localized exterior attachment features rather than the housing body itself tapering along the signal direction. The other depicted housing embodiments appear to show smooth, generally parallel sides rather than an overall tapered exterior housing profile. Accordingly, the originally filed disclosure does not provide adequate written-description support for the claimed tapered exterior shape of the housing.
Claim 58 recites “wherein the electrothermal device is spaced apart from the physiologic tissue and operable to output the thermal through the tissue contact surface” (lines 1-2). The specification does not reasonably convey that Applicant was in possession of an electrothermal device spaced apart from the physiologic tissue and configured to output thermal energy through an intervening tissue contact surface. As discussed above, the specification describes generator elements as extending distally from the housing to contact the physiologic tissue (Instant Application, ¶[0061]) and describes the thermal generator element as transferring heat to skin 2 by resistor 43 (Instant Application, ¶[0068]). The specification separately provides an express spaced-apart/gap disclosure for a pressure or sonic embodiment involving a piezoelectric speaker face spaced apart from the physiologic tissue to define an air gap (Instant Application, ¶[0007]), but does not provide a corresponding disclosure for an electrothermal device spaced apart from the tissue and outputting thermal energy through a tissue contact surface. Accordingly, the originally filed disclosure does not provide adequate written-description support for claim 58. (See also FIG. 4B)
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 1, 3, 5, 7, 13, 15-17, 19-21, 23-27, 29, 35-36, 44, and 51-74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1 recites “a body graspable with a hand of a user” and “a housing that is removably attached to the body” (lines 2-3). The scope of the claim is unclear because the claim requires the body and housing to be distinct structures, while also requiring the housing to include the generator elements, tissue contact surface, controller, and frame, and further requiring the plurality of generator elements to be maintained against the physiologic tissue “with the housing and the body”. The specification describes an energy transceiver including “a body 20” and further describes body 20 as containing elements of the energy transceiver and being composed of a flexible biocompatible base material conformable against a curvature of skin (Instant Application, ¶[0052], ¶[0053]). The specification also describes generator 31 as including housing 33 and describes portions of generator elements extending distally from housing 33 to contact physiologic tissue (Instant Application, ¶[0060], ¶[0061]). However, the claim does not clearly identify the structural boundary between the claimed body and the claimed housing, or whether the claimed housing corresponds to housing 33 alone, generator 31, or another structural assembly that includes generator and tissue-contacting structures. The removable attachment relationship is also unclear because the specification discloses attachment features such as threads and snap-fit connections, which suggest removable attachment, but also describes adhesive attachment, which may suggest permanent or semi-permanent attachment (Instant Application, ¶[0057], ¶[0061]). Accordingly, the metes and bounds of the claimed “body”, “housing”, and “removably attached” relationship are unclear. The Examiner is interpreting the “body”, for purposes of prior-art examination, as a structural portion of the apparatus configured to be grasped by a hand of a user and associated with the housing during use, and is interpreting the “housing” as a structure that contains or supports at least a portion of one or more energy-generating elements and includes or is associated with a tissue-facing interface. The Examiner is further interpreting “removably attached” as attached in a manner that permits separation without destruction of the components.
Claims 1, 3, 5, 7, 13, 15-17, 19-21, 23-27, 29, 35-36, and 51-56 are rejected by virtue of their dependence from claim 1.
Claims 44 and 65 have the same issue as claim 1 above (see lines 2-3 and 2-3 respectively) and are being interpreted in the same manner.
Claims 57-64 are rejected by virtue of their dependence from claim 44.
Claims 66-74 are rejected by virtue of their dependence from claim 65.
Claim 1 recites “a tissue contact surface” (line 7). The scope of the limitation is unclear because it is not clear whether the claimed “tissue contact surface” requires a single, distinct structural surface of the apparatus interposed between the plurality of generator elements and the physiologic tissue, or whether the term broadly refers to the tissue-facing interface region of the apparatus through which energy is delivered to the physiologic tissue. The specification describes embodiments in which portions of multiple generator elements may extend distally from the housing and directly contact the physiologic tissue, stating that “portions of each generator element 36, 42, 48, and/or 52 may extend distally from housing 33 to contact the physiologic tissue (e.g., skin 2)” (Instant Application, ¶[0061]). The specification further describes the thermal generator element 42 as including electrical resistor 43 and heat reflecting groove 44, with “thermal signal 32B” being output “as an amount of heat transferred to skin 2 by resistor 43” (Instant Application, ¶[0068]). These disclosures indicate that the generator elements may separately deliver their respective energy types at their own tissue-facing portions, rather than through a single common structural surface interposed between all generator elements and the tissue. The specification also describes other embodiments in which energy is delivered through an intervening path or medium, including the pressure generator embodiment in which “[a] face of the piezoelectric speaker may be spaced apart from the physiologic tissue to define an air gap and the pressure energy comprises a sonic energy output toward the physiologic tissue through the air gap with the speaker” (Instant Application, ¶[0007]). Thus, the specification appears to use the tissue-contact concept to describe the tissue-facing region or manner of energy transfer to the physiologic tissue, which may include direct contact by individual generator elements, contact through a housing, patch, layer, adhesive, or other material, or transfer through an air gap or other intervening medium, rather than clearly identifying a single common structural surface required to be interposed between each generator element and the tissue. Accordingly, the metes and bounds of “tissue contact surface” are unclear. The Examiner is interpreting “tissue contact surface”, for purposes of prior-art examination, as the tissue-facing interface region of the apparatus through which energy is transferred to the physiologic tissue, including a surface of an individual generator element, housing, patch, layer, adhesive, or other intervening medium that contacts or faces the physiologic tissue.
Claims 44 and 65 have the same “a tissue contact surface” issue as claim 1 above (see lines 7 and 7 respectively) and are being interpreted in the same manner.
Claim 29 recites “The apparatus of claim 28” (line 1). However, claim 28 has been canceled. As such, the metes and bounds of claim 29 are unclear because there is no active base claim from which claim 29 properly depends. The Examiner is interpreting claim 29, for purposes of prior-art examination, as intended to depend from claim 1.
Claim 55 recites “wherein the housing comprises a tapered exterior shape that tapers in the signal direction along a length of the housing” (lines 1-2). The scope of the limitation is unclear because it is not clear whether the claim requires the overall exterior profile of the housing to taper in the signal direction along a length of the housing, or whether localized exterior attachment features, such as tapered ridges, threads, grooves, or protrusions, are intended to satisfy the limitation. The specification describes housing 33 as including attachment feature 32 configured to secure each generator 31 in a communication bay, where attachment feature 32 may include threads engageable with an interior surface of bays 25 (Instant Application, ¶[0061], FIG. 3A). The specification also describes housing 233 as comprising exterior surfaces with attachment features, including roughened areas, grooves, or ridges, engageable with interior surfaces of an opening formed in wearable body 533 (Instant Application, ¶[0117]). FIGS. 3A and 13A may be understood as depicting threads, ridges, or protrusions on the exterior of the housing, but the specification describes these structures as attachment features rather than clearly defining the housing itself as having an overall tapered exterior shape. Accordingly, the claim is indefinite because the metes and bounds of the claimed “tapered exterior shape” are unclear. The Examiner is interpreting, for purposes of prior-art examination, “wherein the housing comprises a tapered exterior shape that tapers in the signal direction along a length of the housing” as requiring that the housing include either an overall tapered exterior housing profile or an exterior surface feature/profile, including a tapered, radiused, ridged, threaded, grooved, protruding, or other engagement/fitment feature, that tapers or changes contour along the signal direction over at least a portion of the housing length.
Claim 56 recites “wherein the electrothermal device is operable with the tissue contact surface to evenly output the thermal energy to the physiologic tissue” (lines 1-2). The scope of the limitation is unclear because the term “evenly” is a term of degree and the claim does not identify an objective boundary for determining how uniform the thermal output must be in order to be considered “evenly” output. The specification does not appear to provide an objective standard, measurement technique, tolerance, thermal distribution profile, or comparison baseline for determining whether thermal energy is evenly output to the physiologic tissue. Accordingly, the metes and bounds of “evenly output” are unclear. The Examiner is interpreting “evenly output”, for purposes of prior-art examination, as distributing thermal energy across the tissue contact surface or physiologic tissue in a substantially uniform manner relative to the thermal output area.
Claim 63 recites “wherein: the tissue contact surface comprises a circular area; and the electrothermal device is operable with the tissue contact surface to evenly output the thermal energy across the circular area” (lines 1-4). The scope of the limitation is unclear because the term “evenly” is a term of degree and the claim does not identify an objective boundary for determining how uniform the thermal output must be across the circular area. The specification does not appear to provide an objective standard, measurement technique, tolerance, thermal distribution profile, or comparison baseline for determining whether thermal energy is evenly output across the circular area. Accordingly, the metes and bounds of “evenly output” are unclear. The Examiner is interpreting “evenly output”, for purposes of prior-art examination, as distributing thermal energy across the circular area in a substantially uniform manner relative to the circular thermal output area.
Claim 65 recites “at least a portion of the first generator element being spaced apart from the second generator element in the signal direction” (lines 28-29). The scope of the claim is unclear because the phrase “in the signal direction” appears to require spacing along the direction in which energy is output toward the physiologic tissue, while the specification describes generator-element spacing using radial/concentric arrangements around the communication axis. The specification describes the generator elements as arranged coaxially with communication axis z-z so that energy is output toward the physiologic tissue “in signal direction SD” (Instant Application, ¶[0062]). The specification also describes circular thermal elements arranged coaxially with communication axis z-z and electrical contacts “spaced apart in a radial pattern coaxial with communication axis z-z” (Instant Application, ¶[0068]-[0070]), and an annular thermal generator surrounding an impact/vibratory generator (Instant Application, ¶[0106]). Accordingly, it is unclear whether the claim requires axial spacing along the signal direction, radial spacing around the signal direction, or merely spacing between elements that each output energy in the signal direction. The Examiner is interpreting “at least a portion of the first generator element being spaced apart from the second generator element in the signal direction”, for purposes of prior-art examination, as meaning that at least a portion of the first generator element is spaced apart from the second generator element in a direction transverse or perpendicular to the signal direction, consistent with the specification’s disclosure of generator elements arranged coaxially around the communication axis and spaced radially or laterally relative to one another while outputting energy in signal direction SD.
Claims 66-74 are rejected by virtue of their dependence from claim 65.
Claim 71 recites “the electrical contact plates contact the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue” (lines 6-7). The scope of the claim is unclear because claim 71 recites a third generator element operable to output electrical energy, but does not introduce electrical contact plates as part of the third generator element or otherwise identify which electrical contact plates are being referenced. Accordingly, the metes and bounds of “the electrical contact plates” are unclear. The Examiner is interpreting “the electrical contact plates”, for purposes of prior-art examination, as electrical contact plates of the third generator element.
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.
Claim 29 is 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.
Claim 29 recites “The apparatus of claim 28” (line 1). Claim 28 has been canceled. Claim 29 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form because claim 29 refers to a canceled claim and therefore does not further limit an active claim. The Examiner is interpreting claim 29, for purposes of prior-art examination, as intended to depend from claim 1.
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, 5, 7, 21, 23-27, 29, 35-36, 44, 51-53, 56-58, 61-63, 65, 67-71, and 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales.
Regarding claim 1, Toth teaches that an apparatus comprises: a housing (Toth, Fig. 2c, 13-15, [0448]: "The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280", this expressly discloses a module with a housing and further shows the PCB frame forming part of that housing); a body graspable with a hand of a user (Toth, ¶[0079]: “the patch interface may include a stimulating device… arranged along the substrate so as to interface with the skin of the subject”; ¶[0181]: “a feedback component… may include or be included in a wristwatch (e.g. a biometric watch, a smart watch, etc.)… feedback components may be used to convey signals, or metrics relating to the physiologic and/or physical signals”; Toth teaches a substrate/patch structure configured to interface with the skin, wherein the substrate/patch corresponds to the claimed body and the module corresponds to the claimed housing; the substrate/patch is a physical wearable structure that can be handled and positioned during application to the user’s body, and Toth’s wristwatch embodiment further confirms that Toth’s wearable device structures are of a size and form factor that can be grasped, donned, adjusted, or positioned by a user’s hand, thereby teaching a body graspable with a hand of a user); and a housing that is removably attached to the body (Toth, ¶[0314]: “...may include swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc”, Toth teaches that the module may be swapped out or replaced during the monitoring procedure, thereby showing that the module is removable from the patch-based system; ¶[0446]: “the module 235 includes multiple module interconnects 240a, b… configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects 230a, b… [which] may include snap elements, magnetic elements, etc”, Toth further teaches that the module includes interconnects configured to mate with corresponding patch interconnects using snap or magnetic elements, thereby showing a removable attachment between the module and the patch/substrate ); the housing comprising: at least a portion of a plurality of generator elements operable to output a plurality of different energy types in a signal direction toward a physiologic tissue (Toth, [0488]: "The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301", this is an example of a vibrational generator element within a module delivering energy toward tissue; [0489]: "The module 1415 includes one or more heater bands 1405... in the adjacent tissues upon engagement", thermal generator example within a module; [0489]: "the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source", this identifies multiple thermal/ultrasonic generator modalities that can be included in a module); a controller comprising a printed circuit board operable to activate one or more generator elements of the plurality of generator elements by directing electricity to the one or more generator elements from a power source (Toth, ¶[0521]: “includes a controller/microcircuit 2051”, Toth teaches controller circuitry; ¶[0450]: “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)”, Toth teaches that microcircuits may be stacked or embedded into PCBs; ¶[0462]: “The module 601 includes… a controller, a power supply, power management circuit”, Toth teaches a controller, power source, and power-management circuitry; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”, teaching electronics that control and power the generator element; under the broadest reasonable interpretation, a controller comprising a printed circuit board encompasses a PCB-based controller assembly in which controller circuitry is mounted on, soldered to, stacked on, embedded into, mechanically supported by, or electrically integrated with a PCB, with the PCB providing electrical routing between the controller circuitry, power source, and generator elements. This interpretation is consistent with the Instant Application’s use of “comprise” with respect to PCB-based structures, where it states that “frame 132 may comprise a printed circuit board (or ‘PCB’) operable to mechanically support and electrically connect controller 134 and the plurality of generator elements” and further states that “controller 134 and elements 136, 142, 148, and 152 may be soldered onto frame 132 to electrically connect and mechanically fasten them to a common platform” (Instant Specification, ¶[0099])); a frame that mechanically connects the controller and the plurality of generator elements to the housing (Toth, Fig. 2c; ¶[0448]: “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280”, showing that the printed circuit board forms part of the housing structure; ¶[0021]: “a printed circuit board (PCB) including one or more microcircuits”, and ¶[0521]: “includes a controller/microcircuit 2051”, establishing that the controller is implemented as a microcircuit included on the PCB; ¶[0450]: “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)”, showing that both microcircuits, corresponding to controller circuitry, and transducers, corresponding to generator elements, may be mechanically supported by or integrated into the PCB; Toth therefore teaches a PCB that mechanically supports both the controller and the generator elements and forms part of the housing, thereby functioning as a frame that mechanically connects the controller and the plurality of generator elements to the housing. BRI is consistent with the Instant Specification ¶[0099] as shown above); the plurality of generator elements comprising: a thermal stimulus generator element operable with an electrothermal device to output a thermal energy of the plurality of different energy types in the signal direction as a thermal stimulus recognizable by temperature receptors of the physiologic tissue (Toth, ¶[0079]: “a stimulating device selected from… a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… a combination thereof”; ¶[0489]: “one or more heater bands 1405”; ¶[0489]: “one or more thermoelectric units, a Peltier device”; under the broadest reasonable interpretation of “operable with an electrothermal device", Toth teaches the claimed thermal stimulus generator element because the thermal stimulus generator element may be the electrothermal structure itself or a broader thermal stimulation assembly that operates with an electrothermal device; Toth teaches thermoregulating devices, heating coils, heater bands, thermoelectric units, and Peltier devices that output thermal energy; the thermoelectric unit, Peltier device, heating coil, and heater bands are electrothermal devices because they use electricity to generate heating or cooling; Toth’s disclosure of thermal elements for application to adjacent tissue teaches outputting thermal energy toward the physiologic tissue, and such heating or cooling would be recognizable by temperature receptors in the tissue).
Also regarding claim 1, Toth partially teaches that a tissue contact surface is operable to transfer the plurality of different energy types to the physiologic tissue when maintained against the physiologic tissue by external forces applied to the body with the hand. Specifically, Toth teaches stimulation elements arranged “to interface with the skin of the subject” (Toth, ¶[0079]), and further teaches applying an external force to the patch via a thumb to bias device elements into engagement with the skin, stating that “upon pressure application… (e.g. a thumb, an applicator, etc.), the electrode features may be biased towards the skin… during the monitoring session” (Toth, ¶[0262]) and that the electrode features “may be forced into engagement with an adjacent tissue surface via a bias force… as may be applied by a thumb over top thereof” (Toth, ¶[0496]). Toth further teaches that “once engaged with the skin, the electrode features may remain in place for the duration of the monitoring procedure” (Toth, ¶[0262]). These disclosures establish that Toth teaches applying an external hand force to maintain or bias device elements against physiologic tissue during engagement with the tissue. Although Toth describes the hand-applied biasing force in the context of electrode features, Toth also teaches stimulation elements arranged to interface with the skin, including thermal and vibratory elements, and a person of ordinary skill in the art would have understood that applying pressure to the device body similarly enhances coupling between the device and the skin for such energy-generating elements, as increased contact improves energy transfer across the interface. However, Toth does not clearly teach that the module housing itself includes the tissue contact surface operable to transfer the plurality of different energy types to the physiologic tissue.
Grant teaches that “the wearable device 110… includes a haptic output device 112 that is connected to a wearable member 114 via a flexible mounting 115,” wherein “the wearable member 114 may be any member or article that is configured to be worn by the user” (Grant, ¶[0032]) and “the flexible mounting includes a flexible casing, and the haptic output device is carried by the flexible casing” (Grant, ¶[0008]). Grant further teaches that “the flexible casings 415 may be... connected via a hook and loop-type fastener (e.g., VELCRO®),” thereby providing a removable attachment between the casing and the wearable member (Grant, ¶[0047]). Additionally, “the haptic output device 112 is connected to the flexible mounting 115 so that the haptic output device 112 comes into contact with the user's skin when the wearable device 110 is placed on the user” (Grant, ¶[0034]). Accordingly, Grant teaches a wearable haptic housing or flexible casing/mount that contains an energy-generating element, namely the haptic output device, is removably attached to a body, namely the wearable member, and includes a tissue-contacting surface via the haptic output device it contains. Thus, Grant provides evidence that, in a wearable haptic device, it was known to configure a removable casing/housing to carry the energy-generating haptic output device and position that output device at the tissue-contacting interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Toth in view of Grant by configuring Toth’s removable module housing to include a tissue-contacting generator/contact arrangement as taught by Grant. The combination would have been possible because Toth already teaches a wearable patch/module system having a removable module housing, generator elements, and hand-applied force for maintaining device elements against tissue, while Grant teaches a compatible wearable haptic structure in which a flexible casing carries a haptic output device and positions that haptic output device to contact the user’s skin. A person of ordinary skill in the art would have been motivated to configure Toth’s removable module housing to include a tissue-contacting generator/contact surface as taught by Grant in order to have improved direct transfer of generated stimulus energy to the user’s skin, while preserving the modular removable attachment between the housing and body. The benefit of the combination would have been improved mechanical coupling between the generator and physiologic tissue, more reliable transfer of the energy to the user, and continued modularity for attachment, replacement, or adjustment of the stimulation structure.
Also regarding claim 1, the modified Toth partially teaches that each generator element of the plurality of generator elements being independently operable with the controller, when the plurality of generator elements are maintained against the physiologic tissue with the housing and the body, to communicate with different nerve receptors associated with the physiologic tissue by outputting a different portion of an energy signal in the signal direction toward the physiologic tissue with one energy type of the plurality of different energy types. Specifically, the modified Toth identifies generator modalities within a module housing and when the housing and body are held against the skin as discussed above, these different modalities would communicate with different nerve receptors because tactile/vibratory stimulation is recognized by mechanoreceptors and thermal stimulation is recognized by thermoreceptors in the skin. However, it does not expressly disclose independent operation of multiple generator elements with the controller.
Singhal teaches independent control of thermal and vibratory patterns as separate stimulus dimensions delivered to the same site (Singhal, Fig. 6, 13-15, p. 90, Abstract: "The thermal patterns varied with respect to the direction, rate, and duration of the change in skin temperature and for the vibration inputs the number of pulses was varied", p. 90, 'I': "Tactile sensory acuity and the perceived intensity of tactile stimuli can be influenced by the temperature of the device contacting the skin", supporting that thermal and vibratory components are independently operable to stimulate distinct sensory pathways).
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 further modified the modified Toth in view of Singhal to provide controller-mediated independent operation of multiple generator elements within the module housing, because Toth teaches onboard controller and power-management circuits while Singhal provides exemplars of independently varied thermal and vibratory patterns, yielding predictable benefits of flexible multimodal control, user-specific tuning, and improved perceptual outcomes.
Also regarding claim 1, the modified Toth partially teaches the limitation requiring the plurality of generator elements comprising: an impact or vibratory stimulus generator element operable with a linearly actuated piston to output an impact or vibratory energy of the plurality of different energy types in the signal direction as a mechanical stimulus recognizable by touch receptors of the physiologic tissue. Specifically, the modified Toth teaches “a tactile stimulating component, a vibratory stimulating element” (Toth, ¶[0079]), wherein the “module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301” (Toth, ¶[0488]) and the “modules may include a vibrating actuator (e.g. an eccentric motor, an electroactive material actuator, etc.)” (Toth, ¶[0184]). Additionally, Toth teaches that the device is “configured to apply energy 1325 (in this case tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.)” and that “the transducer 1305 may be a motor with an unbalanced shaft, a stroking actuator, etc.” (Toth, ¶[0488]). Thus, Toth teaches an impact or vibratory stimulus generator element configured to output tactile, vibrational, stroking, and poking mechanical energy toward the subject, where such tactile, vibrational, stroking, and poking energy would be recognizable by touch receptors of the physiologic tissue. However, the modified Toth does not specifically teach that the impact or vibratory stimulus generator element is operable with a linearly actuated piston.
Gonzales teaches “a vibromechanical stimulator with a tactile effector portion as a solenoid 46 with its electrical connection 48 and a solenoid piston 62”, wherein the “solenoid piston 62 acting as a tactile effector is in a retracted position and upon energizing solenoid 46, solenoid piston 62 will be forced out aperture 60 through housing face 58" (Gonzales, FIG. 3; col. 12, ll. 59-65). Gonzales further teaches that “the orientation is to place housing face 58 against the surface of the wearer’s skin” and that “the vibromechanical stimulators will come into contact with the surface of the wearer’s skin when the stimulators are energized" (Gonzales, FIG. 4; col. 12-13, ll. 65-11). Gonzales also teaches that “projection of any of the solenoid pistons 62 impinge against the wearer’s skin and convey a tactual stimulation to the wearer." (Gonzales, FIG. 4; col. 12-13, ll. 65-11). Thus, Gonzales teaches a linearly actuated piston, namely solenoid piston 62, that outputs mechanical/tactual stimulation toward physiologic tissue.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Gonzales such that the impact or vibratory stimulus generator element is operable with a linearly actuated piston. The combination would have been possible because the modified Toth already teaches a tactile/vibratory transducer configured to apply “tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.” to the subject, including a “stroking actuator,” while Gonzales teaches a known vibromechanical stimulator using a solenoid piston that moves from a retracted position through a housing face to impinge against the wearer’s skin and convey tactual stimulation. A person of ordinary skill in the art would have been motivated to use Gonzales’s solenoid piston as the stroking or poking actuator of the modified Toth because the solenoid piston provides a predictable mechanism for generating localized impact, poking, stroking, or vibratory tactile stimulation in the signal direction toward the physiologic tissue. The benefit of the combination would have been improved localized mechanical stimulation, direct and repeatable delivery of tactile energy to the tissue, and a known electrically actuated structure for producing the stroking and poking mechanical energy already contemplated by Toth.
Also regarding claim 1, the modified Toth does not teach the limitation requiring the plurality of generator elements comprising: the impact or vibratory stimulus generator element being spaced apart from the thermal stimulus generator element. Rather, the modified Toth identifies vibratory and thermal transducers in a module housing but does not expressly disclose the specific spatial arrangement in which the impact or vibratory stimulus generator element is spaced apart from the thermal stimulus generator element.
Singhal teaches the Peltier device and coin vibration motor are physically separated by the annular geometry. It teaches an annular TEC with a centrally located coin motor that necessarily forms a gap between their side surfaces (Singhal, Fig. 1, Fig. 2; p. 91, 'II': Singhal describes a device including a thermoelectric cooler/module (TEC) using the Peltier effect and a vibratory actuator centrally embedded within the TEC assembly. The thermal generator structure surrounds the vibratory generator such that a gap is formed between the outer surface of the vibratory module and the inner structure of the TEC (Singhal, Fig. 1-3).
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 further modified the modified Toth in view of Singhal and Gonzales such that the impact or vibratory stimulus generator element is spaced apart from the thermal stimulus generator element. The combination would have been possible because Toth provides a module housing with a PCB portion and components “optionally stacked/embedded into PCBs” (Toth, Fig. 2c; ¶[0448]; ¶[0450]), Singhal teaches a compact haptic/thermal placement arrangement in which a mechanical/vibratory output element is positioned in a central region of an annular electrothermal element, thereby physically spacing the mechanical/vibratory element from the thermal element while both remain oriented to deliver stimulus energy toward the user’s tissue (Singhal, Fig. 1; p. 91, 'II': “The thermoelectric module was an annular Peltier device, with an outer diameter of 24 mm, a 9.8 mm hole at the center... A coin vibration motor... was placed at the center of the Peltier device”), and Gonzales teaches a linearly actuated piston that provides a tactile/mechanical output toward the wearer’s skin. A person of ordinary skill in the art would have recognized that applying Singhal’s known compact haptic/thermal placement arrangement to the modified Toth, with Gonzales’s linearly actuated piston serving as the mechanical/tactile output structure of the impact or vibratory stimulus generator element, would have resulted in the impact or vibratory stimulus generator element being spaced apart from the thermal stimulus generator element. The benefit of this combination would have been improved thermal isolation between modalities to reduce cross-talk, compact co-location of generators, simplified electrical routing via PCB interconnects, and stable mechanical positioning within the housing to ensure reliable energy delivery to physiologic tissue.
Also regarding claim 1, the modified Toth does not teach the limitation requiring the electrothermal device being positioned between the printed circuit board and the tissue contact surface. Rather, the modified Toth teaches a module housing having a printed circuit board and generator elements, including thermal generator elements, as shown above. Specifically, Toth teaches that “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280” (Toth, ¶[0448]) and that “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)” may be included in the module (Toth, ¶[0450]). Toth further teaches thermal generator elements, including “one or more heater bands 1405” and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). However, the modified Toth does not expressly teach that the electrothermal device is positioned between the printed circuit board and the tissue contact surface.
Singhal teaches such positioning of a thermoelectric device at the tissue-contacting side of a haptic/thermal device. In particular, Singhal teaches that “[a] multisensory display was built to provide thermal and vibratory cues to the skin” and that “[t]he display consisted of a thermoelectric cooler (TEC)… mounted on a heat sink” (Singhal, p. 91, 'II'). Singhal further teaches that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” and that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, 'II'). Thus, Singhal teaches an electrothermal device, namely the thermoelectric cooler/Peltier device, positioned at the tissue-contacting interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the electrothermal device is positioned between the printed circuit board and the tissue contact surface. The combination would have been possible because the modified Toth already teaches a compact module housing having a printed circuit board forming part of the housing and components, including microcircuits, sensors, and transducers, optionally stacked or embedded into PCBs, while Singhal teaches a thermoelectric/Peltier device positioned at the skin-contacting interface for delivering thermal cues to the skin. A person of ordinary skill in the art would have recognized that, when incorporating Singhal’s skin-facing thermoelectric/Peltier arrangement into the modified Toth module, the electrothermal device would have been positioned at the tissue-contacting/output side of the housing to deliver thermal energy directly to the tissue, while Toth’s printed circuit board would have been positioned behind the electrothermal device as the support and electrical-routing side of the compact module. This PCB-supported architecture would have yielded the claimed arrangement in which the electrothermal device is positioned between the printed circuit board and the tissue contact surface. The benefit of the combination would have been direct and efficient thermal transfer to the physiologic tissue, improved perceptibility of the thermal stimulus, and a compact layered structure in which the electrothermal device is positioned at the tissue-contacting side for thermal delivery while the printed circuit board and controller are positioned behind the electrothermal device to provide support, electrical routing, and control of the thermal generator.
Regarding claim 3, the modified Toth teaches that the electrothermal device comprises a thermoelectric device operable to output the thermal stimulus as a hot or cold stimulus by creating a temperature differential responsive to the electricity (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device, a tactile stimulating component, a vibratory stimulating element, a combination thereof, or the like arranged along the substrate so as to interface with the skin of the subject”; ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues”; ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range”; ¶[0415]: “a component for providing a Seebeck effect, Peltier effect, and/or Thomson effect in the adjacent tissues upon engagement”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source”; ¶[0489]: “thermocouples 1406 coupled to an electronics unit 1420 including a power source, a microcircuit, etc. via one or more electronic interconnects 1408”; Toth teaches a thermoelectric/Peltier device that is electrically driven by a processor/electronics unit and is operable to heat and/or cool adjacent tissue, thereby outputting the claimed thermal stimulus as a hot or cold stimulus by creating a temperature differential responsive to electricity).
Regarding claim 5, the modified Toth teaches that the electrothermal device comprises an electrical resistor operable to output the thermal stimulus as a hot stimulus by generating heat responsive to the electricity (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device, a tactile stimulating component, a vibratory stimulating element, a combination thereof, or the like arranged along the substrate so as to interface with the skin of the subject”; ¶[0427]: “the processor may be configured to drive one or more thermal, electromagnetic, electrical, and/or tactile stimulatory components in one or more of the patches/devices to coordinate a stress test on the subject”; ¶[0489]: “The module 1415 includes one or more heater bands 1405 or RF heating circuits, and thermocouples 1406 coupled to an electronics unit 1420 including a power source, a microcircuit, etc. via one or more electronic interconnects 1408”; ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or Substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. heat or cool the tissues 1401”; Toth teaches an electrothermal heating element, including a heating coil and heater bands, electrically driven by a processor/electronics unit and power source to heat adjacent tissue. Under the broadest reasonable interpretation, a heating coil/heater band is an electrical resistive heating element that generates heat responsive to applied electricity, corresponding to the claimed electrical resistor operable to output the thermal stimulus as a hot stimulus by generating heat responsive to the electricity).
Regarding claim 7, the modified Toth teaches that the plurality of generator elements comprise an electrical stimulus generator element (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device, a tactile stimulating component, a vibratory stimulating element, a combination thereof, or the like arranged along the substrate so as to interface with the skin of the subject”; ¶[0540]: “the temporally applied patch 2201 may include one or more energy or stimulus delivery elements, a thermal regulating unit, an electrical stimulator, a light source, a tactile stimulator, etc. in order to stress the subject near to the ocular circuits”; ¶[0541]: “the groin applied patch 2205 may include one or more energy or stimulus delivery elements, a vibratory stimulating element, a tactile stimulating element, an electrical stimulator, a thermal regulating unit, etc. in order to stimulate one or more neural structures in the groin of the subject 25”; Toth teaches a plurality of stimulus delivery/generator elements including an electrical stimulator, corresponding to the claimed electrical stimulus generator element); the electrical stimulus generator element comprising electrical contact plates (Toth, FIGS. 20a-20l; ¶[0454]: “The patch 301 includes a plurality of electrodes 303a-e for interfacing with a subject”; ¶[0455]: “The patch 306 includes a bipolar electrode arrangement 307a, b for interfacing with a subject”; ¶[0465]: “The patch 801 includes a plurality of electrodes 805a-b for interfacing with a subject. The electrodes 805a-b are arranged in a very tight bipolar arrangement suitable for obtaining a bipolar electrical reading from the surface of a subject with a very small profile”; ¶[0248]: “the substrate may be patterned with one or more electrical traces configured to connect one or more electrodes with one or more connectors in an interconnect”; Toth teaches conductive electrode structures arranged at the subject interface and connected to electrical traces/interconnects. Under the broadest reasonable interpretation, the electrodes/bipolar electrode arrangement are electrical contact plates because they are conductive contact structures for interfacing electrically with the subject); operable to output an electrical energy of the plurality of different energy types in the signal direction by converting the electricity into an electrical stimulus (Toth, ¶[0455]-[0456]: “a stimulation device” may be “coupled with a stimulatory component (e.g. … an electrical stimulation component …)”; ¶[0528]: “a stimulator 2095 coupled to the substrate 2091”; ¶[0295]: “A module… may include a power source… a processor”; ¶[0296]: “The microcircuit may include one or more of… a power management system”; ¶[0079]: “an electrical stimulator… arranged along the substrate so as to interface with the skin of the subject”; Toth teaches a powered electrical stimulation component/stimulator coupled to the substrate and module electronics, and arranged to interface with the skin. Thus, the electrical stimulator converts electricity supplied by the power source and controlled by the module electronics into electrical stimulus energy directed from the substrate/contact interface toward the skin, corresponding to outputting electrical energy in the signal direction toward the physiologic tissue); recognizable by electricity-sensitive receptors of the physiologic tissue (Toth, ¶[0540]: “Such stimulation may be advantageous to interact and/or stimulate one or more neural structures, nerves, and/or receptors such as near to or within a carotid sinus, a carotid body, a vagus nerve plexus, a baroreceptor, a chemoreceptor, a cutaneously innervated region of tissue, or the like located in the neck of the subject 25”; ¶[0541]: “the groin applied patch 2205 may include one or more energy or stimulus delivery elements, a vibratory stimulating element, a tactile stimulating element, an electrical stimulator, a thermal regulating unit, etc. in order to stimulate one or more neural structures in the groin of the subject 25”; Toth teaches electrical stimulation used to stimulate neural structures, nerves, and receptors in physiologic tissue. Under the broadest reasonable interpretation, receptors stimulated by an electrical stimulator through skin-contact electrodes are electricity-sensitive receptors of the physiologic tissue); and the electrical contact plates contact the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue (Toth, ¶[0249]: “the patch may include an adhesive layer coupled with the substrate for making contact with the subject”; ¶[0249]: “The thin adhesive layer may be formulated in combination with one or more salts, so as to impart Suitable ionic/electrical conductivity to communicate electrically between one or more aspects of the patch and the skin surface of the subject”; ¶[0262]: “Upon pressure application to the electrode by an external entity (e.g. a thumb, an applicator, etc.), the electrode features may be biased towards the skin, thus penetrating the stratum corneum and enhancing the electrical connection thereto during the monitoring session”; ¶[0263]: “The initial engagement of the electrode features with the skin may assist in lowering the local impedance of the stratum corneum, so as to improve contact between the electrode and the body”; ¶[0454]: “The patch 301 includes a plurality of electrodes 303a-e for interfacing with a subject”; Toth teaches that the patch/substrate contact surface is maintained against the subject/skin, and that the electrode contact structures contact or electrically communicate with the skin when the patch is engaged/pressed against the tissue, corresponding to the claimed electrical contact plates contacting the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue).
Regarding claim 21, the modified Toth teaches that the apparatus comprises an optical stimulus generator element (Toth, ¶[0481]: “The module 1160 includes an optical source 1165 for emitting energy towards 1172 a subject”; ¶[0304]: “one or more modules may include a signal source for imparting an energy signal (e.g. electrostatic, electromagnetic, magnetic, vibrational, thermal, optical, etc.) into the body of the subject”; ¶[0066]: “The processor may be configured to provide a feedback signal to the feedback mechanism based upon the analysis of the sleep state of the subject. The feedback mechanism may include a transducer, a loudspeaker, tactile actuator, a visual feedback means, a light source, a buzzer, a combination thereof, or the like to interact with the subject”; Toth teaches an optical source/light source in the module architecture for emitting optical energy and interacting with the subject, corresponding to the claimed optical stimulus generator element); operable with a semiconductor device (Toth, ¶[0305]: “the optical sensor may be used in combination with one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; Toth identifies light emitting diodes and laser diodes as optical emitters. Under the broadest reasonable interpretation, light emitting diodes and laser diodes are semiconductor devices operable as optical emitters); to output an optical energy of the plurality of different energy types in the signal direction (Toth, ¶[0481]: “The module 1160 includes an optical source 1165 for emitting energy towards 1172 a subject”; ¶[0481]: “One or more layers of the patch 1140 may be transparent to the radiation, so as to facilitate interaction of the module 1160 with an adjacent subject”; ¶[0304]: “one or more modules may include a signal source for imparting an energy signal (e.g. electrostatic, electromagnetic, magnetic, vibrational, thermal, optical, etc.) into the body of the subject”; Toth teaches that the module optical source emits energy toward the subject through transparent patch layers and that optical energy is one of the energy signal types imparted into the body, corresponding to outputting optical energy in the signal direction toward physiologic tissue or the user); by converting the electricity into an optical stimulus (Toth, ¶[0462]: “The module 601 includes one or more of interconnects, sensors, optical source(s), optical detector(s), a radio, an antenna, a sensor communication circuit, a signal conditioning circuit, a processor, a memory device, a controller, a power supply, power management circuit, and/or energy harvesting circuit”; ¶[0305]: “the optical sensor may be used in combination with one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; Toth teaches module-level electronics, power supply, controller, and power management circuitry associated with optical source(s), and identifies electrically driven optical emitters such as LEDs and laser diodes. Thus, Toth teaches converting electricity supplied by the module electronics into optical stimulus output); recognizable by eyes of the user (Toth, ¶[0399]: “a light source and/or display for providing one or more visual cues, optical stresses, incident light profiles, light scans, optical stress tests, etc. into the eye or eyes of the subject”; ¶[0066]: “The feedback mechanism may include a transducer, a loudspeaker, tactile actuator, a visual feedback means, a light source, a buzzer, a combination thereof, or the like to interact with the subject”; Toth teaches light/visual feedback and optical stresses provided into the eye or eyes of the subject, corresponding to optical stimulus recognizable by the eyes of the user).
Regarding claim 23, the modified Toth teaches that the semiconductor device comprises an LED (Toth, ¶[0305]: “the optical sensor may be used in combination with one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; Toth expressly identifies light emitting diodes as optical emitters. Because claim 23 depends from claim 21’s semiconductor-device optical stimulus generator, Toth’s light emitting diode corresponds to the claimed LED semiconductor device).
Regarding claim 24, the modified Toth teaches that the apparatus comprises a sensor that is proximate to the tissue contact surface (Toth, ¶[0017]: “According to aspects there is provided an interface (i.e. a patch in accordance with the present disclosure) for monitoring a physiologic and/or physical signal from a subject, including a substrate, an adhesive coupled to the substrate formulated for attachment to the skin of a subject, and one or more sensors and/or electrodes each in accordance with the present disclosure coupled to the substrate, arranged, configured, and dimensioned to interface with the subject”; ¶[0078]: “The patch interface may include a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto”; ¶[0249]: “the patch may include an adhesive layer coupled with the substrate for making contact with the subject”; Toth teaches a patch/interface having an adhesive/substrate tissue-contacting surface and a sensor coupled to that substrate and arranged to interface with the subject. Thus, the sensor is proximate to the tissue contact surface); and operable to detect physiological signals associated with the physiologic tissue (Toth, ¶[0078]: “The patch interface may include a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto”; ¶[0070]: “a patch interface for monitoring neural activity… including a substrate with a surface… and a plurality [of] microelectrodes… electrically coupled with the interconnect and/or the microcircuit”; ¶[0527]: “The patch 2080 includes a region 2083 coupled to the substrate 2081 configured to monitor local neural traffic (e.g. skin SNA, PNA, somatosensory response, etc.), from an adjacent tissue surface, a perfusion sensor 2085 in accordance with the present disclosure, a temperature sensor 2087, and/or a heat transfer sensor 2089 each in accordance with the present disclosure”; Toth teaches sensors and electrode regions coupled to the substrate and configured to monitor physiologic parameters, neural activity, local neural traffic, perfusion, temperature, and heat transfer from adjacent tissue, corresponding to detecting physiological signals associated with the physiologic tissue).
Regarding claim 25, the modified Toth teaches that the sensor is operable to detect physiological signals comprising measurements of electrical activity associated with the physiologic tissue (Toth, ¶[0529]: “one or more sensors, physiologic sensors, electrodes, electrophysiological sensors, environmental sensors, kinematic sensors, kinetic sensors, proprioceptive sensors, analyte sensors, perfusion sensors, galvanic skin response sensors, bioimpedance sensing”; ¶[0531]: “monitoring macroscopic electrophysiologic fields, local electrical potentials, bioimpedance of adjacent tissues”; ¶[0532]: “signals monitored locally by one or more electrodes in the array”; ¶[0062]: “The EKG device configured to measure an electrophysiological signal pertaining to cardiac function of the subject so as to produce an EKG signal”; Toth teaches electrophysiological sensors and electrodes that monitor electrophysiologic fields, local electrical potentials, bioimpedance, local electrode signals, and EKG signals, corresponding to physiological signals comprising measurements of electrical activity associated with physiologic tissue).
Regarding claim 26, the modified Toth teaches that the physiologic tissue is part of a living body (Toth, ¶[0066]: "The processor may be configured to provide a feedback signal to the feedback mechanism… to interact with the subject, the user, the doctor, the nurse, the partner", this confirms the device is used on a subject i.e., a living body); and the measurements of electrical activity are detectable with the sensor when produced by one or more of: a beating heart of the living body movements of the living body; and breathing of the living body (Toth, ¶[0062]: "The EKG device configured to measure an electrophysiological signal pertaining to cardiac function of the subject so as to produce an EKG signal", this teaches detection of electrical activity produced by a beating heart; ¶[0399]: "a sensor (such as but not limited to an EMG, micro electrode array on a contact, ERG, etc.)", EMG measures electrical activity of muscles associated with movement, thus detecting electrical activity produced by body movements; ¶[0164]: "clinically relevant data than may be obtained... includ[ing] cardiorespiratory assessment... breath/gait synchronization", connoting electrical signals (EKG) are analyzed in contexts that include breathing; ¶[0469]: "The stretchable conducting elements... configuration may be advantageous for assessing movement under the patch (e.g. due to muscle movement, breathing, etc.) in conjunction with one or more physiologic signals...", describing stretchable conductors whose impedance (electrical property) changes with stretch to assess breathing in conjunction with electrophysiological signals).
Regarding claim 27, the modified Toth teaches that the sensor is operable to detect a temperature of the physiologic tissue (Toth, ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues... an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0527]: “The patch 2080 includes… a temperature sensor 2087, and/or a heat transfer sensor 2089 each in accordance with the present disclosure”; ¶[0527]: “The temperature sensor 2087 may be configured to analyze changes in the temperature of a Volume of tissue under the patch 2080”; Toth teaches a sensor configured to detect adjacent tissue temperature and changes in temperature of tissue under the patch, corresponding to the sensor being operable to detect a temperature of the physiologic tissue); and the controller is operable to cause the thermal stimulus generator element to output the thermal energy responsive to the temperature (Toth, ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range (e.g. to perform one or more temperature sweeps, to maintain a particular temperature, etc.), an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0528]: “The feedback sensor 2097 configured to convey a feedback signal to the circuit, processor, etc. during use”; ¶[0528]: “The feedback signal used by an associated processor, etc. to more precisely control the stimulus, confirm delivery of the stimulus, adjust the amplitude of the stimulus, etc.”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches that the processor/controller drives the Peltier thermal generator over a temperature range using tissue-temperature feedback, and further teaches using sensor feedback to control or adjust stimulus delivery. Thus, the controller causes the thermal stimulus generator element to output thermal energy responsive to the detected temperature).
Regarding claim 29 (interpreted as depending from claim 1 and not the canceled claim 28), the modified Toth does not fully teach that the housing comprises a cylindrical shape made from an insulating material operable to limit outputs of the thermal energy in directions away from the physiologic tissue. Rather, Toth teaches a module housing having a round/dome-shaped profile, teaches that the circuit board may constitute at least a portion of the housing, and teaches insulating or isolating structures in the patch/module architecture, but Toth does not expressly teach that the dome-shaped housing itself is made from an insulating material operable to limit thermal energy output away from the physiologic tissue (Toth, FIG. 2a; FIG. 7; ¶[0040]: “According to aspects, there is provided a module for monitoring one or more physiologic and/or electrophysiological signals from a subject, including a housing, a circuit board including one or more microcircuits, and a module interconnect coupled to one or more of the microcircuits configured for placement and coupling of the device onto a patch interface in accordance with the present disclosure”; ¶[0041]: “the circuit board may constitute at least a portion of the housing”; ¶[0041]: “In aspects, the housing may be shaped like a dome”; Toth teaches a module housing coupled to the patch interface, with the figures showing a round module profile and the text expressly teaching a dome-shaped housing; Under the broadest reasonable interpretation, the round/dome-shaped module housing teaches or at least suggests a housing comprising a cylindrical shape; ¶[0248]: “The substrate may be patterned with one or more electrical traces… the electrical traces may be isolated from one or more regions of the adhesive layer (e.g. with a dielectric overcoat, via a passivation layer, etc.)”, teaches use of dielectric/passivation layers to provide electrical insulation within the body of the device; ¶[0283]: “the module may include a housing… providing a sealed cavity in which other components of the module may reside”, supports a surrounding enclosure that contains energy sources and aids in limiting unintended outputs to non-target directions). Additionally, Toth teaches that the module (which includes the housing) “may include an insulating layer so as to limit heat transfer between the skin site and the surrounding environment” (Toth, ¶[0415]. However, Toth does not expressly teach that the cylindrical housing itself is made from the insulating material.
Grant teaches surrounding a stimulus-output component with a casing made from flexible rubber or plastic material (Grant, ¶[0047]: “The flexible casing 415 may be made from any suitable flexible material. Such as a flexible rubber or plastic material, such as an elastomeric plastic material”; ¶[0047]: “the flexible casing 415 surrounds the body of the ERM actuator 412”). Grant therefore teaches a polymeric casing surrounding a stimulus-output component, which would have suggested forming or lining Toth’s housing with an insulating polymeric material around the stimulus-output components.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Grant such that Toth’s generally round/dome-shaped module housing is formed from or lined with a flexible rubber/plastic polymeric casing material. Toth teaches a skin-contact patch/module apparatus having a module housing that contains device components and is coupled to a patch interface, but Toth is silent regarding the material of the dome-shaped housing portion. It also teaches using a material to insulate the surrounding environment from the thermal stimulator. Grant is directed to wearable haptic output devices and teaches that a casing surrounding a haptic output actuator may be made from flexible rubber or plastic, such as an elastomeric plastic material. A person of ordinary skill in the art would have looked to Grant’s casing material as a known, suitable housing/casing material for a wearable stimulus-output component because both Toth and Grant involve compact body-worn devices that house stimulus-output components intended to be maintained against or near the user’s body. Using Grant’s flexible rubber/plastic casing material in Toth would have predictably provided a comfortable, durable, protective, and conformable housing/casing for the module components. Further, when used around Toth’s thermal stimulus generator, the rubber/plastic polymeric housing material would have predictably limited thermal energy transfer through non-tissue-facing portions of the housing, thereby helping direct or confine the thermal stimulus toward the tissue-contact side. The benefit would have been improved wearable comfort, protection of internal components, reduced off-target heating away from the physiologic tissue, and more predictable delivery of the thermal stimulus toward the tissue.
Regarding claim 35, the modified Toth teaches or at least suggests that the electrothermal device is spaced apart from the physiologic tissue (Toth, FIG. 14; ¶[0489]: “The module 1415 includes one or more heater bands 1405 or RF heating circuits”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device”; Toth’s FIG. 14 depicts the heater bands 1405/electrothermal structures located in module 1415 at a position spaced apart from skin surface 1402, thereby teaching an electrothermal device spaced apart from the physiologic tissue); and operable to output the thermal energy to the physiologic tissue through the tissue contact surface (Toth, ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. are configured to apply energy to the adjacent tissues 1401”; Toth teaches that the spaced electrothermal structures in the FIG. 14 module remain operable to heat, cool, or apply thermal energy to the adjacent tissue, thereby teaching output of thermal energy toward the physiologic tissue through the intervening skin-facing/tissue-contacting interface).
Regarding claim 36, the modified Toth teaches that a portion of the impact or vibratory energy is transferred to the physiologic tissue with the impact or vibratory stimulus generator element when the linearly actuated piston is activated (As set forth in the rejection of claim 1, the modified Toth includes the linearly actuated piston of the impact or vibratory stimulus generator element. Toth, ¶[0420]: “the device/patch/module may include a vibratory stimulatory component, configured so as to provide a tactile stress state to an adjacent region of tissue”; ¶[0420]: “the stimulatory component may be arranged to provide one or more tactile forms of stimulation to the tissues (e.g. indentation like tactile stimulus, stretch like stimulus, hair follicle deflection, skin shear, vibration, or pain (noxious mechanical stimulation)”; ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”; Toth teaches that an activated, powered vibratory/tactile transducer transfers vibrational or tactile energy to adjacent tissue); and a portion of the thermal energy is concurrently transferred to the physiologic tissue with the thermal stimulus generator element when the electrothermal device is activated (Toth, ¶[0414]: “the patch may include a thermal stimulatory component arranged in the patch so as to control a thermal state of an adjacent tissue upon engagement”; ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues”; ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range”; ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. heat or cool the tissues 1401”; Toth teaches that an activated electrothermal/thermal stimulus generator transfers thermal energy to adjacent physiologic tissue; ¶[0427]: “the processor may be configured to drive one or more thermal, electromagnetic, electrical, and/or tactile stimulatory components in one or more of the patches/devices to coordinate a stress test on the subject”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches a controller/processor configured to drive one or more selected stimulation components, including thermal and tactile/mechanical stimulation components, thereby suggesting coordinated operation of thermal and tactile/mechanical stimulation components in the modified apparatus).
However, to the extent Toth does not expressly teach outputting the mechanical stimulus together simultaneously with the thermal stimulus, Singhal teaches the same combined-output relationship in a thermo-tactile display (Singhal, Abstract: “The present experiment measured thermal pattern identification in the presence of concurrent vibrotactile feedback on the thenar eminence on the hand”; Singhal, §II, Experimental Design: “Vibrotactile stimulation was delivered at the same site concurrently with the thermal stimuli”; Singhal teaches outputting vibrotactile/mechanical stimulation together with thermal stimulation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that a portion of the impact or vibratory energy is transferred to the physiologic tissue with the impact or vibratory stimulus generator element when the linearly actuated piston is activated, and a portion of the thermal energy is concurrently transferred to the physiologic tissue with the thermal stimulus generator element when the electrothermal device is activated. A person of ordinary skill in the art would have recognized that Toth’s controller-driven tactile/mechanical and thermal stimulus components could be operated together according to Singhal’s concurrent thermo-tactile operation to provide combined mechanical and thermal stimulation. The combination would have been possible because Toth already provides the apparatus having controller-driven mechanical/vibratory and thermal stimulus components, and Singhal teaches delivering vibrotactile stimulation concurrently with thermal stimulation in a thermo-tactile display. The benefit would have been coordinated multimodal stimulation using the already-established mechanical and thermal generator elements of the modified Toth apparatus.
Regarding claim 44, Toth teaches that an apparatus comprises: a body graspable with a hand of a user (Toth, ¶[0079]: “the patch interface may include a stimulating device… arranged along the substrate so as to interface with the skin of the subject”; ¶[0181]: “a feedback component… may include or be included in a wristwatch (e.g. a biometric watch, a smart watch, etc.)… feedback components may be used to convey signals, or metrics relating to the physiologic and/or physical signals”; Toth teaches a substrate/patch structure configured to interface with the skin, wherein the substrate/patch corresponds to the claimed body and the module corresponds to the claimed housing; the substrate/patch is a physical wearable structure that can be handled and positioned during application to the user’s body, and Toth’s wristwatch embodiment further confirms that Toth’s wearable device structures are of a size and form factor that can be grasped, donned, adjusted, or positioned by a user’s hand, thereby teaching a body graspable with a hand of a user); and a housing (Toth, Fig. 2c, 13-15, [0448]: "The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280", this expressly discloses a module with a housing and further shows the PCB frame forming part of that housing) that is removably attached to the body (Toth, ¶[0314]: “...may include swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc”, Toth teaches that the module may be swapped out or replaced during the monitoring procedure, thereby showing that the module is removable from the patch-based system; ¶[0446]: “the module 235 includes multiple module interconnects 240a, b… configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects 230a, b… [which] may include snap elements, magnetic elements, etc”, Toth further teaches that the module includes interconnects configured to mate with corresponding patch interconnects using snap or magnetic elements, thereby showing a removable attachment between the module and the patch/substrate ); the housing comprising: at least a portion of a plurality of generator elements operable to output a plurality of different energy types in a signal direction toward a physiologic tissue (Toth, [0488]: "The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301", this is an example of a vibrational generator element within a module delivering energy toward tissue; [0489]: "The module 1415 includes one or more heater bands 1405... in the adjacent tissues upon engagement", thermal generator example within a module; [0489]: "the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source", this identifies multiple thermal/ultrasonic generator modalities that can be included in a module); a controller operable to activate one or more generator elements of the plurality of generator elements (Toth, ¶[0521]: “includes a controller/microcircuit 2051”, Toth teaches controller circuitry; ¶[0450]: “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)”, Toth teaches that microcircuits may be stacked or embedded into PCBs; ¶[0462]: “The module 601 includes… a controller, a power supply, power management circuit”, Toth teaches a controller, power source, and power-management circuitry; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”, teaching electronics that control and power the generator element); a frame that mechanically connects the controller and the plurality of generator elements to the housing (Toth, Fig. 2c; ¶[0448]: “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280”, showing that the printed circuit board forms part of the housing structure; ¶[0021]: “a printed circuit board (PCB) including one or more microcircuits”, and ¶[0521]: “includes a controller/microcircuit 2051”, establishing that the controller is implemented as a microcircuit included on the PCB; ¶[0450]: “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)”, showing that both microcircuits, corresponding to controller circuitry, and transducers, corresponding to generator elements, may be mechanically supported by or integrated into the PCB; Toth therefore teaches a PCB that mechanically supports both the controller and the generator elements and forms part of the housing, thereby functioning as a frame that mechanically connects the controller and the plurality of generator elements to the housing. BRI is consistent with the Instant Specification ¶[0099]: “frame 132 may comprise a printed circuit board (or ‘PCB’) operable to mechanically support and electrically connect controller 134 and the plurality of generator elements” and “controller 134 and elements 136, 142, 148, and 152 may be soldered onto frame 132 to electrically connect and mechanically fasten them to a common platform”); a sensor operable to detect physiological signals associated with the physiologic tissue (Toth, ¶[0527]: “The patch 2080 includes… a temperature sensor 2087, and/or a heat transfer sensor 2089 each in accordance with the present disclosure” and “The temperature sensor 2087 may be configured to analyze changes in the temperature of a Volume of tissue under the patch 2080”, Toth teaches temperature and heat-transfer sensors associated with tissue under the patch monitoring a physiological signal related to skin temperature); a transceiver operable to send and receive data over a network (Toth, ¶[0023]: "the device may include a three dimensional antenna coupled to the microcircuits (i.e. coupled with a transceiver, transmitter, radio, etc. included within the microcircuits). In aspects, the antenna may be printed onto or embedded into the housing", this teaches a transceiver; ¶[0160]: “Each module may be configured to communicate with one or more patches, additional modules, an analysis device, and/or a host device, etc. Such communication may be performed wirelessly” and "the host device may be configured to coordinate information exchange to/from each module and/or patch... for the subject, a user, a network, an electronic health record (EHR), a database (e.g. as part of a data management center, an EHR, a social network, etc.)", this shows networked communication for the system); the controller being operable with the transceiver to activate the one or more generator elements of the plurality of generator elements responsive to the physiological signals (Toth, ¶[0160]: “the host device may be configured to coordinate information exchange to/from each module and/or patch, and to generate one or more physiologic signals, physical signals, environmental signals, kinetic signals, diagnostic signals, alerts, reports, recommendation signals, commands, combinations thereof, or the like”; ¶[0297]: “The processor may switch between states based on conditions determined via the sensors, a recharge unit, a calibration unit, a host device, etc.”; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”; because Toth already teaches, as mapped above, a controller/electronics unit operable to activate generator elements and a transceiver/radio operable to exchange data with a host device/network, Toth’s disclosure of host-device information exchange, generated commands, and processor state switching based on conditions determined via sensors/host device, and control/power of the transducer; Because Toth teaches sensors detecting physiologic information, wireless information exchange between the module/patch and a host device/network, generation of commands based on such information exchange, processor state switching based on conditions determined via sensors or a host device, and electronics controlling or powering the transducer, Toth teaches or at least suggests controller operation with the transceiver to activate the generator element responsive to physiological signals); the plurality of generator elements comprising: a thermal stimulus generator element operable with an electrothermal device to output a thermal energy of the plurality of different energy types in the signal direction by converting a second flow of electricity from the power source into a thermal stimulus recognizable by temperature receptors of the physiologic tissue (Toth, ¶[0079]: “a stimulating device selected from… a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… a combination thereof”; ¶[0489]: “one or more heater bands 1405”; ¶[0489]: “one or more thermoelectric units, a Peltier device”; ¶[0462]: “The module 601 includes… a controller, a power supply, power management circuit”; under the broadest reasonable interpretation of “operable with an electrothermal device”, Toth teaches the claimed thermal stimulus generator element because the thermal stimulus generator element may be the electrothermal structure itself or a broader thermal stimulation assembly that operates with an electrothermal device; Toth teaches thermoregulating devices, heating coils, heater bands, thermoelectric units, and Peltier devices that output thermal energy; the thermoelectric unit, Peltier device, heating coil, and heater bands are electrothermal devices because they convert electrical energy into heating or cooling; Toth’s power supply and power management circuitry provide electrical power to the module components, and the electrothermal devices convert such electricity into thermal energy; Toth’s disclosure of thermal elements for application to adjacent tissue teaches outputting thermal energy toward the physiologic tissue, and such heating or cooling would be recognizable by temperature receptors in the tissue).
Also regarding claim 44, Toth partially teaches that a tissue contact surface is operable to transfer the plurality of different energy types to the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue by external forces applied to the body with the hand.
Specifically, Toth teaches stimulation elements arranged “to interface with the skin of the subject” (Toth, ¶[0079]), and further teaches applying an external force to the patch via a thumb to bias device elements into engagement with the skin, stating that “upon pressure application… (e.g. a thumb, an applicator, etc.), the electrode features may be biased towards the skin… during the monitoring session” (Toth, ¶[0262]) and that the electrode features “may be forced into engagement with an adjacent tissue surface via a bias force… as may be applied by a thumb over top thereof” (Toth, ¶[0496]). Toth further teaches that “once engaged with the skin, the electrode features may remain in place for the duration of the monitoring procedure” (Toth, ¶[0262]). These disclosures establish that Toth teaches applying an external hand force to maintain or bias device elements against physiologic tissue during engagement with the tissue. Although Toth describes the hand-applied biasing force in the context of electrode features, Toth also teaches stimulation elements arranged to interface with the skin, including thermal and vibratory elements, and a person of ordinary skill in the art would have understood that applying pressure to the device body similarly enhances coupling between the device and the skin for such energy-generating elements, as increased contact improves energy transfer across the interface. However, Toth does not clearly teach that the module housing itself includes the tissue contact surface operable to transfer the plurality of different energy types to the physiologic tissue.
Grant teaches that “the wearable device 110… includes a haptic output device 112 that is connected to a wearable member 114 via a flexible mounting 115,” wherein “the wearable member 114 may be any member or article that is configured to be worn by the user” (Grant, ¶[0032]) and “the flexible mounting includes a flexible casing, and the haptic output device is carried by the flexible casing” (Grant, ¶[0008]). Grant further teaches that “the flexible casings 415 may be... connected via a hook and loop-type fastener (e.g., VELCRO®),” thereby providing a removable attachment between the casing and the wearable member (Grant, ¶[0047]). Additionally, “the haptic output device 112 is connected to the flexible mounting 115 so that the haptic output device 112 comes into contact with the user's skin when the wearable device 110 is placed on the user” (Grant, ¶[0034]). Accordingly, Grant teaches a wearable haptic housing or flexible casing/mount that contains an energy-generating element, namely the haptic output device, is removably attached to a body, namely the wearable member, and includes a tissue-contacting surface via the haptic output device it contains. Thus, Grant provides evidence that, in a wearable haptic device, it was known to configure a removable casing/housing to carry the energy-generating haptic output device and position that output device at the tissue-contacting interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Toth in view of Grant by configuring Toth’s removable module housing to include a tissue-contacting generator/contact arrangement as taught by Grant. The combination would have been possible because Toth already teaches a wearable patch/module system having a removable module housing, generator elements, and hand-applied force for maintaining device elements against tissue, while Grant teaches a compatible wearable haptic structure in which a flexible casing carries a haptic output device and positions that haptic output device to contact the user’s skin. A person of ordinary skill in the art would have been motivated to configure Toth’s removable module housing to include a tissue-contacting generator/contact surface as taught by Grant in order to have improved direct transfer of generated stimulus energy to the user’s skin, while preserving the modular removable attachment between the housing and body. The benefit of the combination would have been improved mechanical coupling between the generator and physiologic tissue, more reliable transfer of the energy to the user, and continued modularity for attachment, replacement, or adjustment of the stimulation structure.
Also regarding claim 44, the modified Toth partially teaches that each generator element of the plurality of generator elements being independently operable with the controller, when the plurality of generator elements are maintained against the physiologic tissue with the housing and the body, to communicate with different nerve receptors associated with the physiologic tissue by outputting a different portion of an energy signal in the signal direction toward the physiologic tissue with one energy type of the plurality of different energy types. Specifically, the modified Toth identifies generator modalities within a module housing and when the housing and body are held against the skin as discussed above, these different modalities would communicate with different nerve receptors because tactile/vibratory stimulation is recognized by mechanoreceptors and thermal stimulation is recognized by thermoreceptors in the skin. However, it does not expressly disclose independent operation of multiple generator elements with the controller.
Singhal teaches independent control of thermal and vibratory patterns as separate stimulus dimensions delivered to the same site (Singhal, Fig. 6, 13-15, p. 90, Abstract: "The thermal patterns varied with respect to the direction, rate, and duration of the change in skin temperature and for the vibration inputs the number of pulses was varied", p. 90, 'I': "Tactile sensory acuity and the perceived intensity of tactile stimuli can be influenced by the temperature of the device contacting the skin", supporting that thermal and vibratory components are independently operable to stimulate distinct sensory pathways).
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 further modified the modified Toth in view of Singhal to provide controller-mediated independent operation of multiple generator elements within the module housing, because Toth teaches onboard controller and power-management circuits while Singhal provides exemplars of independently varied thermal and vibratory patterns, yielding predictable benefits of flexible multimodal control, user-specific tuning, and improved perceptual outcomes.
Also regarding claim 44, the modified Toth partially teaches the limitation requiring the plurality of generator elements comprising: an impact or vibratory stimulus generator element operable with a linearly actuated piston to output an impact or vibratory energy of the plurality of different energy types in the signal direction by converting a first flow of electricity from the power source into a mechanical stimulus recognizable by touch receptors of the physiologic tissue. Specifically, the modified Toth teaches “a tactile stimulating component, a vibratory stimulating element” (Toth, ¶[0079]), wherein the “module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301” (Toth, ¶[0488]) and the “modules may include a vibrating actuator (e.g. an eccentric motor, an electroactive material actuator, etc.)” (Toth, ¶[0184]). Toth further teaches that the device is “configured to apply energy 1325 (in this case tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.)” and that “the transducer 1305 may be a motor with an unbalanced shaft, a stroking actuator, etc.” (Toth, ¶[0488]). Toth also teaches that “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315” (Toth, ¶[0488]). Toth further teaches that the module includes “a controller, a power supply, power management circuit” (Toth, ¶[0462]), thereby tying the electronics unit and transducer operation to electrical power supplied within the module. Thus, Toth teaches an impact or vibratory stimulus generator element configured to receive electrical power from the module power source/power-management circuitry and convert that electrical power into tactile, vibrational, stroking, and poking mechanical energy toward the subject, where such tactile, vibrational, stroking, and poking energy would be recognizable by touch receptors of the physiologic tissue. However, the modified Toth does not specifically teach that the impact or vibratory stimulus generator element is operable with a linearly actuated piston.
Gonzales teaches “a vibromechanical stimulator with a tactile effector portion as a solenoid 46 with its electrical connection 48 and a solenoid piston 62”, wherein the “solenoid piston 62 acting as a tactile effector is in a retracted position and upon energizing solenoid 46, solenoid piston 62 will be forced out aperture 60 through housing face 58” (Gonzales, FIG. 3; col. 12, ll. 59-65). Gonzales further teaches that “the orientation is to place housing face 58 against the surface of the wearer’s skin” and that “the vibromechanical stimulators will come into contact with the surface of the wearer’s skin when the stimulators are energized” (Gonzales, FIG. 4; col. 12, l. 65-col. 13, l. 11). Gonzales also teaches that “projection of any of the solenoid pistons 62 impinge against the wearer’s skin and convey a tactual stimulation to the wearer” (Gonzales, FIG. 4; col. 12, l. 65-col. 13, l. 11). Thus, Gonzales teaches a linearly actuated piston, namely solenoid piston 62, that is electrically energized and converts electrical input into movement of the piston to output mechanical/tactual stimulation toward physiologic tissue.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Gonzales such that the impact or vibratory stimulus generator element is operable with a linearly actuated piston to convert a first flow of electricity from the power source into impact or vibratory mechanical energy. The combination would have been possible because the modified Toth already teaches a tactile/vibratory transducer controlled and powered by module electronics and configured to apply “tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.” to the subject, including a “stroking actuator,” while Gonzales teaches a known electrically energized vibromechanical stimulator using a solenoid piston that moves from a retracted position through a housing face to impinge against the wearer’s skin and convey tactual stimulation. A person of ordinary skill in the art would have been motivated to use Gonzales’s solenoid piston as the stroking or poking actuator of the modified Toth because the solenoid piston provides a predictable electrically actuated mechanism for converting electrical energy into localized impact, poking, stroking, or vibratory tactile stimulation in the signal direction toward the physiologic tissue. The benefit of the combination would have been improved localized mechanical stimulation, direct and repeatable delivery of tactile energy to the tissue, and a known electrically actuated structure for producing the stroking and poking mechanical energy already contemplated by Toth.
Also regarding claim 44, the modified Toth does not teach the limitation requiring the plurality of generator elements comprising: the impact or vibratory stimulus generator element being spaced apart from the thermal stimulus generator element. Rather, the modified Toth identifies vibratory and thermal transducers in a module housing but does not expressly disclose the specific spatial arrangement in which the impact or vibratory stimulus generator element is spaced apart from the thermal stimulus generator element.
Singhal teaches the Peltier device and coin vibration motor are physically separated by the annular geometry. It teaches an annular TEC with a centrally located coin motor that necessarily forms a gap between their side surfaces (Singhal, Fig. 1, Fig. 2; p. 91, 'II': Singhal describes a device including a thermoelectric cooler/module (TEC) using the Peltier effect and a vibratory actuator centrally embedded within the TEC assembly. The thermal generator structure surrounds the vibratory generator such that a gap is formed between the outer surface of the vibratory module and the inner structure of the TEC (Singhal, Fig. 1-3).
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 further modified the modified Toth in view of Singhal and Gonzales such that the impact or vibratory stimulus generator element is spaced apart from the thermal stimulus generator element. The combination would have been possible because Toth provides a module housing with a PCB portion and components “optionally stacked/embedded into PCBs” (Toth, Fig. 2c; ¶[0448]; ¶[0450]), Singhal teaches a compact haptic/thermal placement arrangement in which a mechanical/vibratory output element is positioned in a central region of an annular electrothermal element, thereby physically spacing the mechanical/vibratory element from the thermal element while both remain oriented to deliver stimulus energy toward the user’s tissue (Singhal, Fig. 1; p. 91, 'II': “The thermoelectric module was an annular Peltier device, with an outer diameter of 24 mm, a 9.8 mm hole at the center... A coin vibration motor... was placed at the center of the Peltier device”), and Gonzales teaches a linearly actuated piston that provides a tactile/mechanical output toward the wearer’s skin. A person of ordinary skill in the art would have recognized that applying Singhal’s known compact haptic/thermal placement arrangement to the modified Toth, with Gonzales’s linearly actuated piston serving as the mechanical/tactile output structure of the impact or vibratory stimulus generator element, would have resulted in the impact or vibratory stimulus generator element being spaced apart from the thermal stimulus generator element. The benefit of this combination would have been improved thermal isolation between modalities to reduce cross-talk, compact co-location of generators, simplified electrical routing via PCB interconnects, and stable mechanical positioning within the housing to ensure reliable energy delivery to physiologic tissue.
Also regarding claim 44, the modified Toth does not teach the limitation requiring the electrothermal device being positioned between the controller and the tissue contact surface.
Rather, the modified Toth teaches a module housing having a printed circuit board and generator elements, including thermal generator elements, as shown above. Specifically, Toth teaches that “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280” (Toth, ¶[0448]) and that “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)” may be included in the module (Toth, ¶[0450]). Toth further teaches thermal generator elements, including “one or more heater bands 1405” and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). However, the modified Toth does not expressly teach that the electrothermal device is positioned between the controller and the tissue contact surface.
Singhal teaches such positioning of a thermoelectric device at the tissue-contacting side of a haptic/thermal device. In particular, Singhal teaches that “[a] multisensory display was built to provide thermal and vibratory cues to the skin” and that “[t]he display consisted of a thermoelectric cooler (TEC)… mounted on a heat sink” (Singhal, p. 91, 'II'). Singhal further teaches that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” and that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, 'II'). Thus, Singhal teaches an electrothermal device, namely the thermoelectric cooler/Peltier device, positioned at the tissue-contacting interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the electrothermal device is positioned between the controller and the tissue contact surface. The combination would have been possible because the modified Toth already teaches a compact module housing having PCB-supported or PCB-embedded controller/electronics components and thermal generator elements, while Singhal teaches a thermoelectric/Peltier device positioned at the skin-contacting interface for delivering thermal cues to the skin. A person of ordinary skill in the art would have recognized that, when incorporating Singhal’s skin-facing thermoelectric/Peltier arrangement into the modified Toth module, the electrothermal device would have been positioned at the tissue-contacting side of the housing to deliver thermal energy directly to the tissue, while Toth’s controller/electronics structure would have been positioned behind the electrothermal device because Toth teaches a compact module architecture in which microcircuits, sensors, and transducers may be stacked or embedded into PCBs and the PCB forms part of the module housing. This stacked/PCB-supported architecture would have placed the controller/electronics on the support side of the module and the electrothermal device at the output/tissue-contacting side, thereby yielding the claimed arrangement in which the electrothermal device is positioned between the controller and the tissue contact surface. The benefit of the combination would have been direct and efficient thermal transfer to the physiologic tissue, improved perceptibility of the thermal stimulus, and a compact layered structure in which the electrothermal device is positioned at the tissue-contacting side for thermal delivery while the controller is positioned behind the electrothermal device to provide support, electrical routing, and control of the thermal generator.
Regarding claim 51, the modified Toth teaches that the apparatus is operable to output the mechanical stimulus independently of the thermal stimulus when the housing is removably attached to the body (Toth, ¶[0427]: “the processor may be configured to drive one or more thermal, electromagnetic, electrical, and/or tactile stimulatory components in one or more of the patches/devices to coordinate a stress test on the subject”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches that the processor/controller may drive “one or more” selected stimulatory components, including tactile/mechanical and thermal components. Because Toth teaches that one or more components may be driven, Toth at least suggests that the mechanical/vibratory component may be driven independently of the thermal component).
Regarding claim 52, the modified Toth teaches or at least suggests that the apparatus is operable to output the mechanical stimulus together with the thermal stimulus when the housing is removably attached to the body (Toth, ¶[0427]: “the processor may be configured to drive one or more thermal, electromagnetic, electrical, and/or tactile stimulatory components in one or more of the patches/devices to coordinate a stress test on the subject”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches a controller/processor configured to drive one or more selected stimulation components, including thermal and tactile/mechanical stimulation components, thereby suggesting coordinated operation of thermal and tactile/mechanical stimulation components in the modified apparatus when the housing is removably attached to the body).
However, to the extent Toth does not expressly teach outputting the mechanical stimulus together simultaneously with the thermal stimulus, Singhal teaches the same combined-output relationship in a thermo-tactile display (Singhal, Abstract: “The present experiment measured thermal pattern identification in the presence of concurrent vibrotactile feedback on the thenar eminence on the hand”; Singhal, §II, Experimental Design: “Vibrotactile stimulation was delivered at the same site concurrently with the thermal stimuli”; Singhal teaches outputting vibrotactile/mechanical stimulation together with thermal stimulation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the apparatus is operable to output the mechanical stimulus together with the thermal stimulus when the housing is removably attached to the body. A person of ordinary skill in the art would have recognized that Toth’s controller-driven tactile/mechanical and thermal stimulus components could be operated together according to Singhal’s concurrent thermo-tactile operation to provide combined mechanical and thermal stimulation. The combination would have been possible because Toth already provides the apparatus having controller-driven mechanical/vibratory and thermal stimulus components, and Singhal teaches delivering vibrotactile stimulation concurrently with thermal stimulation in a thermo-tactile display. The benefit would have been coordinated multimodal stimulation using the already-established mechanical and thermal generator elements of the modified Toth apparatus.
Regarding claim 53, the modified Toth does not fully teach that an exterior surface of the housing is axially receivable in an opening of the body in the signal direction to removably attach the housing to the body. Rather, the modified Toth teaches a removable module/housing that mates with and is physically/electrically coupled to a corresponding patch/body interface in a direction normal to the skin when the patch is applied to the user. Toth teaches that the module interconnect is “sized and dimensioned to interface with a corresponding interconnect included within the patch interface” to form an operable interconnection, that magnetic elements physically and/or electrically couple the module to the patch interface when aligned, that the module is configured and dimensioned to mate with the patch and interface with the subject therethrough, and that the modules are hot swappable with the patch interface (Toth, ¶[0044]: “the module interconnect included within the module may be sized and dimensioned to interface with a corresponding interconnect included within the patch interface, wherein to form an operable interconnection between the patch interface and the module”; ¶[0045]: “the magnetic elements arranged so as to physically and/or electrically couple the module to the patch interface when the magnetic elements are aligned with the ferromagnetic regions”; ¶[0046]: “a module in accordance with the present disclosure configured and dimensioned to mate with the patch, and to interface with the subject there through”; ¶[0047]: “the modules being hot swappable with the patch interface”). Toth further teaches an example in which module interconnects mesh with corresponding patch interconnects, which necessarily requires the module to be moved into and out of engagement with the patch interface along the mating axis (Toth, FIG. 12a-c; ¶[0483]: “FIG.12a shows a module 1215 in accordance with the present disclosure configured and dimensioned to mate with the patch 1201”; ¶[0483]: “The module 1215 includes a module interconnect 1217 a,b arranged to mesh with the corresponding patch interconnect 1211 a,b”). Because the patch is applied to the user’s skin and the module mates with the tissue-facing patch interface to interface with the subject therethrough, this mating/removal axis is normal to the skin and corresponds to the claimed signal direction, since the stimulus signal is directed toward the skin/physiologic tissue. Thus, the modified Toth teaches that the housing/module is axially receivable in the signal direction to removably attach the housing to the body, but does not expressly teach that the axial receipt occurs in an opening of the body.
Grant teaches the missing opening/receiving structure in a wearable haptic device. Grant teaches that a wearable device includes a haptic output device connected to a wearable member by a flexible mounting (Grant, ¶[0032]: “The wearable device 110… includes a haptic output device 112 that is connected to a wearable member 114 via a flexible mounting 115”). Grant further teaches a flexible casing/mounting that surrounds or partially contains the haptic output device and is connected to the wearable member (Grant, ¶[0047]: “the flexible casing 415 surrounds the body of the ERM actuator 412”; ¶[0047]: “The flexible casing 415 may then be connected to or embedded in a wearable member 414”). In particular, Grant’s FIG. 6 shows the haptic output device/actuator received within a surrounding opening or cavity of the flexible mounting, and Grant describes this embodiment as including “the ERM actuator 412 partially contained within a flexible mounting 615” (Grant, FIG. 6; ¶[0051]: “FIG. 6 illustrates an embodiment that includes the ERM actuator 412 partially contained within a flexible mounting 615”). Thus, Grant teaches a wearable body/mounting structure having an opening or cavity that receives and holds an exterior portion of a haptic output device, while Toth supplies the axial tissue-normal mating direction.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Grant such that an exterior surface of Toth’s housing/module is axially receivable in an opening of the body in the signal direction to removably attach the housing to the body. The modified Toth already teaches a removable module/housing configured and dimensioned to mate with a corresponding tissue-facing patch/body interface, including aligned interconnects that mesh and physically/electrically couple the module to the patch interface. This mating/removal occurs along the tissue-normal direction, which corresponds to the signal direction toward the physiologic tissue, but Toth does not expressly characterize the receiving structure as an opening in the body. Grant’s FIG. 6 and ¶[0051] teach a wearable haptic body/mounting structure in which the actuator is partially contained within the flexible mounting, thereby showing an opening or cavity in the body/mounting that receives the exterior of the haptic output device. A person of ordinary skill in the art would have recognized that Toth’s removable module-to-body interface could be implemented using Grant’s opening/cavity receiving structure to provide mechanical capture of the module housing in addition to Toth’s magnetic/interconnect alignment. Although Toth’s magnetic elements align and physically/electrically couple the module to the patch interface, Grant’s opening/cavity structure would have provided additional lateral support, controlled insertion depth, resistance to shear or accidental dislodgement during use, and repeatable seating of the housing relative to the body while preserving Toth’s axial signal-direction mating relationship. The benefit would have been improved mechanical retention and repeatable seating of the removable housing, reduced lateral shifting or shear loading at the interconnects, protection of the coupled interface during body-worn use, and reliable maintenance of the stimulus-output orientation in the signal direction toward the physiologic tissue.
Regarding claim 56, the modified Toth does not expressly teach that the electrothermal device is operable with the tissue contact surface to evenly output the thermal energy to the physiologic tissue.
Rather, as set forth above with respect to claim 1, the modified Toth teaches a module/housing having thermal generator elements, including electrothermal devices, configured to output thermal energy toward physiologic tissue. Specifically, Toth teaches thermal generator elements, including “one or more heater bands 1405” and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). Toth further teaches stimulation elements arranged “so as to interface with the skin of the subject” (Toth, ¶[0079]). However, it does not expressly teach that the electrothermal device operates with the tissue contact surface to evenly output the thermal energy to the physiologic tissue.
Singhal teaches the missing even-output/tissue-contact thermal delivery feature. In particular, Singhal teaches a skin-contacting thermoelectric/Peltier thermal display having a defined contact area for delivering thermal cues to the skin. Singhal teaches that “[a] multisensory display was built to provide thermal and vibratory cues to the skin” and that “[t]he display consisted of a thermoelectric cooler (TEC)… mounted on a heat sink” (Singhal, p. 91, Sec. II). Singhal further teaches that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” and that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, Sec. II). Thus, Singhal teaches operating a thermoelectric/Peltier device with a tissue-contacting surface having a defined skin-contact area so that thermal energy is delivered across the contacted skin region. Under the broadest reasonable interpretation, delivering thermal energy through a defined skin-contacting Peltier contact area teaches or at least suggests operating the electrothermal device with the tissue contact surface to evenly output the thermal energy to the physiologic tissue, because the thermal output is applied through the skin-contacting surface over the contact area rather than merely from an isolated point source.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the electrothermal device is operable with the tissue contact surface to evenly output the thermal energy to the physiologic tissue. The combination would have been possible because the modified Toth already teaches electrothermal generator elements, including heater bands, thermoelectric units, and a Peltier device, arranged to interface with skin, while Singhal teaches a thermoelectric/Peltier device having a defined skin-contacting area for delivering thermal cues to the skin. A person of ordinary skill in the art would have recognized that, when incorporating Singhal’s skin-facing thermoelectric/Peltier arrangement into the modified Toth module, the electrothermal device would have been operated with the tissue contact surface so that the contacted surface distributes the thermal output across the intended skin-contact region. The benefit of the combination would have been predictable, comfortable, and perceptible thermal stimulation over the intended tissue-contact area, improved thermal coupling between the electrothermal device and the physiologic tissue, and reduced localized hot or cold spots while preserving the compact PCB-supported multimodal arrangement set forth in the rejection of claim 1.
Regarding claim 57, the modified Toth teaches that the physiological signals comprise a temperature of the physiologic tissue (Toth, ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues”; ¶[0415]: “an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0527]: “The patch 2080 includes… a temperature sensor 2087, and/or a heat transfer sensor 2089 each in accordance with the present disclosure”; ¶[0527]: “The temperature sensor 2087 may be configured to analyze changes in the temperature of a Volume of tissue under the patch 2080”; Toth teaches a sensor configured to detect adjacent tissue temperature and changes in temperature of tissue under the patch, corresponding to physiological signals comprising a temperature of the physiologic tissue); and the controller is operable to cause the electrothermal device to output the thermal energy responsive to the temperature (Toth, ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range (e.g. to perform one or more temperature sweeps, to maintain a particular temperature, etc.), an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0528]: “The feedback sensor 2097 configured to convey a feedback signal to the circuit, processor, etc. during use”; ¶[0528]: “The feedback signal used by an associated processor, etc. to more precisely control the stimulus, confirm delivery of the stimulus, adjust the amplitude of the stimulus, etc.”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches that the processor/controller drives the Peltier thermal generator over a temperature range using tissue-temperature feedback, and further teaches using sensor feedback to control or adjust stimulus delivery. Thus, the controller causes the electrothermal device to output thermal energy responsive to the detected temperature).
Regarding claim 58, the modified Toth teaches or at least suggests that the electrothermal device is spaced apart from the physiologic tissue (Toth, FIG. 14; ¶[0489]: “The module 1415 includes one or more heater bands 1405 or RF heating circuits”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device”; Toth’s FIG. 14 depicts the heater bands 1405/electrothermal structures located in module 1415 at a position spaced apart from skin surface 1402, thereby teaching an electrothermal device spaced apart from the physiologic tissue); and operable to output the thermal energy through the tissue contact surface (Toth, ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. are configured to apply energy to the adjacent tissues 1401”; Toth teaches that the spaced electrothermal structures in the FIG. 14 module remain operable to heat, cool, or apply thermal energy to the adjacent tissue, thereby teaching output of thermal energy toward the physiologic tissue through the intervening skin-facing/tissue-contacting interface).
Regarding claim 61, the modified Toth teaches that the apparatus comprises an optical stimulus generator element comprising a semiconductor device (Toth, ¶[0305]: “the optical sensor may be used in combination with one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; ¶[0462]: “The module 601 includes one or more of interconnects, sensors, optical source(s), optical detector(s)… a controller, a power supply, power management circuit”; Toth teaches optical sources/emitters, including light emitting diodes and laser diodes, in the module electronics, corresponding to semiconductor optical stimulus generator devices); operable to output an optical energy of the plurality of different energy types by converting a fifth flow of electricity from the power source into an optical stimulus recognizable by eyes of the user (Toth, ¶[0304]: “one or more modules may include a signal source for imparting an energy signal (e.g. electrostatic, electromagnetic, magnetic, vibrational, thermal, optical, etc.) into the body of the subject”; ¶[0305]: “one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; ¶[0399]: “a light source and/or display for providing one or more visual cues, optical stresses, incident light profiles, light scans, optical stress tests, etc. into the eye or eyes of the subject”; Toth teaches electrically powered optical emitters, including LEDs/laser diodes, that output optical energy/light as a visual cue or optical stress recognizable by the eyes of the subject); and the semiconductor device is proximate to the tissue contact surface (Toth, ¶[0481]: “The module 1160 includes an optical source 1165 for emitting energy towards 1172 a subject”; ¶[0481]: “One or more layers of the patch 1140 may be transparent to the radiation, so as to facilitate interaction of the module 1160 with an adjacent subject”, Toth teaches an optical source in the module/housing positioned to emit optical energy toward an adjacent subject through transparent subject-facing layers. Because the optical source is located within the module/housing and arranged to transmit optical energy through the subject-facing output interface, Toth teaches the semiconductor optical emitter proximate to the tissue-contacting/output interface.).
Regarding claim 62, the modified Toth teaches that the thermal energy is transferred to the physiologic tissue through the tissue contact surface (Toth, ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues”; ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. are configured to apply energy to the adjacent tissues 1401”; Toth teaches that electrothermal structures heat, cool, or apply thermal energy to adjacent tissue. In the modified Toth arrangement set forth above regarding claim 44, the housing/output-device arrangement includes a tissue contact surface maintained against the physiologic tissue to transfer energy to the tissue. The thermal energy is therefore transferred to the physiologic tissue through the tissue contact surface of the modified housing/output-device arrangement. Toth further supports this limitation because the electrothermal structures are configured to apply thermal energy through the skin-facing/tissue-contacting interface region to the adjacent tissue).
Regarding claim 63, the modified Toth does not expressly teach that the tissue contact surface comprises a circular area; and the electrothermal device is operable with the tissue contact surface to evenly output the thermal energy across the circular area. Rather, as discussed above regarding claim 62, Toth teaches electrothermal structures configured to heat, cool, or apply thermal energy to adjacent physiologic tissue, including a Peltier device, thermoelectric unit, heater bands, and RF heating circuits (Toth, ¶[0415], ¶[0489]). However, Toth does not expressly teach that the tissue-contacting thermal output region comprises a circular area across which the thermal energy is evenly output.
Singhal teaches the missing circular thermal-output configuration. In particular, Singhal teaches a multisensory thermo-tactile display including a thermoelectric/Peltier thermal device positioned at the skin-contacting interface, stating that “[t]he display consisted of a thermoelectric cooler (TEC)… mounted on a heat sink” and that “[t]he thermoelectric module was an annular Peltier device, with an outer diameter of 24 mm, a 9.8 mm hole at the center... giving a contact area with the skin of 377 mm2” (Singhal, p. 91, Sec. II). Singhal further teaches that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, Sec. II). Thus, Singhal teaches a circular/annular skin-contacting thermal area provided by a thermoelectric/Peltier device, with the electrothermal device operating with that skin-contacting area to deliver thermal energy across the defined contact area. A person of ordinary skill in the art would understand that such a Peltier device is intended to have an even output of thermal energy across the surface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the tissue-contacting thermal output region comprises a circular area and the electrothermal device operates with that region to evenly output thermal energy across the circular area. The combination would have been possible because the modified Toth already teaches electrothermal structures, including a Peltier device and thermoelectric unit, configured to apply thermal energy to adjacent tissue, while Singhal teaches a known skin-contacting annular/circular Peltier configuration having a defined skin-contact area for delivering thermal cues. A person of ordinary skill in the art would have recognized that incorporating Singhal’s annular/circular Peltier skin-contact arrangement into the modified Toth thermal output structure would provide a defined circular thermal-output area at the tissue-facing side of the device. The benefit would have been predictable and spatially distributed thermal stimulation over a defined skin-contact area, improved perceptibility of the thermal cue, and reduced localized thermal concentration while preserving the compact multimodal output arrangement set forth in the rejection of claim 44.
Regarding claim 65, Toth teaches that an apparatus comprises: a body graspable with a hand of a user (Toth, ¶[0079]: “the patch interface may include a stimulating device… arranged along the substrate so as to interface with the skin of the subject”; ¶[0181]: “a feedback component… may include or be included in a wristwatch (e.g. a biometric watch, a smart watch, etc.)… feedback components may be used to convey signals, or metrics relating to the physiologic and/or physical signals”; Toth teaches a substrate/patch structure configured to interface with the skin, wherein the substrate/patch corresponds to the claimed body and the module corresponds to the claimed housing; the substrate/patch is a physical wearable structure that can be handled and positioned during application to the user’s body, and Toth’s wristwatch embodiment further confirms that Toth’s wearable device structures are of a size and form factor that can be grasped, donned, adjusted, or positioned by a user’s hand, thereby teaching a body graspable with a hand of a user); and a housing (Toth, Fig. 2c, 13-15, ¶[0448]: “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280”, this expressly discloses a module with a housing and further shows the PCB frame forming part of that housing) that is removably attached to the body (Toth, ¶[0314]: “…may include swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc”, Toth teaches that the module may be swapped out or replaced during the monitoring procedure, thereby showing that the module is removable from the patch-based system; ¶[0446]: “the module 235 includes multiple module interconnects 240a, b… configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects 230a, b… [which] may include snap elements, magnetic elements, etc”, Toth further teaches that the module includes interconnects configured to mate with corresponding patch interconnects using snap or magnetic elements, thereby showing a removable attachment between the module and the patch/substrate); the housing comprising: at least a portion of a plurality of generator elements operable to output a plurality of different energy types in a signal direction toward a physiologic tissue (Toth, ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”, this is an example of a vibrational generator element within a module delivering energy toward tissue; ¶[0489]: “The module 1415 includes one or more heater bands 1405... in the adjacent tissues upon engagement”, thermal generator example within a module; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source”, this identifies multiple thermal/ultrasonic generator modalities that can be included in a module); and a controller operable to activate one or more generator elements of the plurality of generator elements (Toth, ¶[0521]: “includes a controller/microcircuit 2051”, Toth teaches controller circuitry; ¶[0450]: “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)”, Toth teaches that microcircuits may be stacked or embedded into PCBs; ¶[0462]: “The module 601 includes… a controller, a power supply, power management circuit”, Toth teaches a controller, power source, and power-management circuitry; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”, teaching electronics that control and power the generator element); the plurality of generator elements comprising: a second generator element operable with an electrothermal device to output a thermal energy of the plurality of different energy types in the signal direction as a thermal stimulus recognizable by temperature receptors of the physiologic tissue (Toth, ¶[0079]: “a stimulating device selected from… a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… a combination thereof”; ¶[0489]: “one or more heater bands 1405”; ¶[0489]: “one or more thermoelectric units, a Peltier device”; under the broadest reasonable interpretation of “operable with an electrothermal device”, Toth teaches the claimed second generator element because the second generator element may be the electrothermal structure itself or a broader thermal stimulation assembly that operates with an electrothermal device; Toth teaches thermoregulating devices, heating coils, heater bands, thermoelectric units, and Peltier devices that output thermal energy; the thermoelectric unit, Peltier device, heating coil, and heater bands are electrothermal devices because they use electricity to generate heating or cooling; Toth’s disclosure of thermal elements for application to adjacent tissue teaches outputting thermal energy toward the physiologic tissue, and such heating or cooling would be recognizable by temperature receptors in the tissue).
Also regarding claim 65, Toth partially teaches that a tissue contact surface is operable to transfer the plurality of different energy types to the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue by external forces applied to the body with the hand.
Specifically, Toth teaches stimulation elements arranged “to interface with the skin of the subject” (Toth, ¶[0079]), and further teaches applying an external force to the patch via a thumb to bias device elements into engagement with the skin, stating that “upon pressure application… (e.g. a thumb, an applicator, etc.), the electrode features may be biased towards the skin… during the monitoring session” (Toth, ¶[0262]) and that the electrode features “may be forced into engagement with an adjacent tissue surface via a bias force… as may be applied by a thumb over top thereof” (Toth, ¶[0496]). Toth further teaches that “once engaged with the skin, the electrode features may remain in place for the duration of the monitoring procedure” (Toth, ¶[0262]). These disclosures establish that Toth teaches applying an external hand force to maintain or bias device elements against physiologic tissue during engagement with the tissue. Although Toth describes the hand-applied biasing force in the context of electrode features, Toth also teaches stimulation elements arranged to interface with the skin, including thermal and vibratory elements, and a person of ordinary skill in the art would have understood that applying pressure to the device body similarly enhances coupling between the device and the skin for such energy-generating elements, as increased contact improves energy transfer across the interface. However, Toth does not clearly teach that the module housing itself includes the tissue contact surface operable to transfer the plurality of different energy types to the physiologic tissue.
Grant teaches that “the wearable device 110… includes a haptic output device 112 that is connected to a wearable member 114 via a flexible mounting 115,” wherein “the wearable member 114 may be any member or article that is configured to be worn by the user” (Grant, ¶[0032]) and “the flexible mounting includes a flexible casing, and the haptic output device is carried by the flexible casing” (Grant, ¶[0008]). Grant further teaches that “the flexible casings 415 may be... connected via a hook and loop-type fastener (e.g., VELCRO®),” thereby providing a removable attachment between the casing and the wearable member (Grant, ¶[0047]). Additionally, “the haptic output device 112 is connected to the flexible mounting 115 so that the haptic output device 112 comes into contact with the user's skin when the wearable device 110 is placed on the user” (Grant, ¶[0034]). Accordingly, Grant teaches a wearable haptic housing or flexible casing/mount that contains an energy-generating element, namely the haptic output device, is removably attached to a body, namely the wearable member, and includes a tissue-contacting surface via the haptic output device it contains. Thus, Grant provides evidence that, in a wearable haptic device, it was known to configure a removable casing/housing to carry the energy-generating haptic output device and position that output device at the tissue-contacting interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Toth in view of Grant by configuring Toth’s removable module housing to include a tissue-contacting generator/contact arrangement as taught by Grant. The combination would have been possible because Toth already teaches a wearable patch/module system having a removable module housing, generator elements, and hand-applied force for maintaining device elements against tissue, while Grant teaches a compatible wearable haptic structure in which a flexible casing carries a haptic output device and positions that haptic output device to contact the user’s skin. A person of ordinary skill in the art would have been motivated to configure Toth’s removable module housing to include a tissue-contacting generator/contact surface as taught by Grant in order to have improved direct transfer of generated stimulus energy to the user’s skin, while preserving the modular removable attachment between the housing and body. The benefit of the combination would have been improved mechanical coupling between the generator and physiologic tissue, more reliable transfer of the energy to the user, and continued modularity for attachment, replacement, or adjustment of the stimulation structure.
Also regarding claim 65, the modified Toth partially teaches that each generator element of the plurality of generator elements being independently operable with the controller, when the plurality of generator elements are maintained against the physiologic tissue with the housing and the body, to communicate with different nerve receptors associated with the physiologic tissue by outputting a different portion of an energy signal in the signal direction toward the physiologic tissue with one energy type of the plurality of different energy types. Specifically, the modified Toth identifies generator modalities within a module housing and when the housing and body are held against the skin as discussed above, these different modalities would communicate with different nerve receptors because tactile/vibratory stimulation is recognized by mechanoreceptors and thermal stimulation is recognized by thermoreceptors in the skin. However, it does not expressly disclose independent operation of multiple generator elements with the controller.
Singhal teaches independent control of thermal and vibratory patterns as separate stimulus dimensions delivered to the same site (Singhal, Fig. 6, 13-15, p. 90, Abstract: “The thermal patterns varied with respect to the direction, rate, and duration of the change in skin temperature and for the vibration inputs the number of pulses was varied”, p. 90, 'I': “Tactile sensory acuity and the perceived intensity of tactile stimuli can be influenced by the temperature of the device contacting the skin”, supporting that thermal and vibratory components are independently operable to stimulate distinct sensory pathways).
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 further modified the modified Toth in view of Singhal to provide controller-mediated independent operation of multiple generator elements within the module housing, because Toth teaches onboard controller and power-management circuits while Singhal provides exemplars of independently varied thermal and vibratory patterns, yielding predictable benefits of flexible multimodal control, user-specific tuning, and improved perceptual outcomes.
Also regarding claim 65, the modified Toth partially teaches the limitation requiring the plurality of generator elements comprising: a first generator element operable with a linearly activated piston to output a first energy of the plurality of different energy types in the signal direction as a mechanical stimulus recognizable by touch receptors of the physiologic tissue. (For purposes of examination in view of the apparent typographical error, “linearly activated piston” is being treated as “linearly actuated piston” as set forth in the objection above.) Specifically, the modified Toth teaches “a tactile stimulating component, a vibratory stimulating element” (Toth, ¶[0079]), wherein the “module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301” (Toth, ¶[0488]) and the “modules may include a vibrating actuator (e.g. an eccentric motor, an electroactive material actuator, etc.)” (Toth, ¶[0184]). Additionally, Toth teaches that the device is “configured to apply energy 1325 (in this case tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.)” and that “the transducer 1305 may be a motor with an unbalanced shaft, a stroking actuator, etc.” (Toth, ¶[0488]). Thus, Toth teaches a first generator element configured to output tactile, vibrational, stroking, and poking mechanical energy toward the subject, where such tactile, vibrational, stroking, and poking energy would be recognizable by touch receptors of the physiologic tissue. However, the modified Toth does not specifically teach that the first generator element is operable with a linearly actuated piston.
Gonzales teaches “a vibromechanical stimulator with a tactile effector portion as a solenoid 46 with its electrical connection 48 and a solenoid piston 62”, wherein the “solenoid piston 62 acting as a tactile effector is in a retracted position and upon energizing solenoid 46, solenoid piston 62 will be forced out aperture 60 through housing face 58” (Gonzales, FIG. 3; col. 12, ll. 59-65). Gonzales further teaches that “the orientation is to place housing face 58 against the surface of the wearer’s skin” and that “the vibromechanical stimulators will come into contact with the surface of the wearer’s skin when the stimulators are energized” (Gonzales, FIG. 4; col. 12, l. 65-col. 13, l. 11). Gonzales also teaches that “projection of any of the solenoid pistons 62 impinge against the wearer’s skin and convey a tactual stimulation to the wearer” (Gonzales, FIG. 4; col. 12, l. 65-col. 13, l. 11). Thus, Gonzales teaches a linearly actuated piston, namely solenoid piston 62, that outputs mechanical/tactual stimulation toward physiologic tissue.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Gonzales such that the first generator element is operable with a linearly actuated piston. The combination would have been possible because the modified Toth already teaches a tactile/vibratory transducer configured to apply “tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.” to the subject, including a “stroking actuator,” while Gonzales teaches a known vibromechanical stimulator using a solenoid piston that moves from a retracted position through a housing face to impinge against the wearer’s skin and convey tactual stimulation. A person of ordinary skill in the art would have been motivated to use Gonzales’s solenoid piston as the stroking or poking actuator of the modified Toth because the solenoid piston provides a predictable mechanism for generating localized impact, poking, stroking, or vibratory tactile stimulation in the signal direction toward the physiologic tissue. The benefit of the combination would have been improved localized mechanical stimulation, direct and repeatable delivery of tactile energy to the tissue, and a known electrically actuated structure for producing the stroking and poking mechanical energy already contemplated by Toth.
Also regarding claim 65, the modified Toth does not teach the limitation requiring at least a portion of the first generator element being spaced apart from the second generator element in the signal direction. (As set forth in the rejection under 35 U.S.C. 112(b) above, for purposes of examination, the Examiner interprets "in the signal direction" as requiring that at least a portion of the first generator element is spaced apart from the second generator element in a direction transverse or perpendicular to the signal direction.) Rather, the modified Toth identifies vibratory and thermal transducers in a module housing but does not expressly disclose the specific spatial arrangement in which at least a portion of the first generator element is spaced apart from the second generator element in a direction transverse or perpendicular to the signal direction.
Singhal teaches the Peltier device and coin vibration motor are physically separated in a transverse or radial arrangement relative to the skin-contacting output direction. Specifically, Singhal teaches an annular TEC with a centrally located coin motor that necessarily forms a gap between the side surfaces of the thermal element and the vibratory element (Singhal, Fig. 1, Fig. 2; p. 91, 'II': Singhal describes a device including a thermoelectric cooler/module (TEC) using the Peltier effect and a vibratory actuator centrally embedded within the TEC assembly). The thermal generator structure surrounds the vibratory generator such that a gap is formed between the outer surface of the vibratory module and the inner structure of the TEC (Singhal, Fig. 1-3). Thus, Singhal teaches a first generator element, namely the central vibratory actuator, laterally or radially spaced apart from a second generator element, namely the annular Peltier/TEC, while both elements are arranged to output stimulus energy toward the user’s tissue in the signal direction.
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 further modified the modified Toth in view of Singhal and Gonzales such that at least a portion of the first generator element is spaced apart from the second generator element in a direction transverse or perpendicular to the signal direction. The combination would be possible because Toth provides a module housing with a PCB portion and components “optionally stacked/embedded into PCBs” (Toth, Fig. 2c; ¶[0448]; ¶[0450]), which accommodates the annular thermoelectric arrangement with a central mechanical/vibratory output region taught by Singhal (Singhal, Fig. 1; p. 91, 'II': “The thermoelectric module was an annular Peltier device, with an outer diameter of 24 mm, a 9.8 mm hole at the center... A coin vibration motor... was placed at the center of the Peltier device”), and the linearly actuated piston of Gonzales that provides a tactile/mechanical output toward the wearer’s skin. A person of ordinary skill in the art would have recognized from Singhal that, in a compact haptic/thermal output device, a mechanical/vibratory output element may be placed in a central region of an annular electrothermal element so that the mechanical and thermal generator elements are radially or laterally spaced apart while both remain oriented to deliver stimulus energy toward the user’s tissue. Applying that known spatial arrangement to the modified Toth, with Gonzales’s linearly actuated piston serving as the mechanical/tactile output structure of the first generator element, would have resulted in at least the piston or actuator portion of the first generator element being radially or laterally spaced apart from the surrounding second generator element while both generator elements deliver their respective stimulus energies toward the physiologic tissue in the signal direction. The benefit of this combination would be improved thermal isolation between modalities to reduce cross-talk, compact co-location of generators, simplified electrical routing via PCB interconnects, and stable mechanical positioning within the housing to ensure reliable energy delivery to physiologic tissue.
Also regarding claim 65, the modified Toth does not teach the limitation requiring the second generator element being proximate to the tissue contact surface.
Rather, the modified Toth teaches a module housing having generator elements, including thermal generator elements, as shown above. Specifically, Toth teaches thermal generator elements, including “one or more heater bands 1405” and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). However, the modified Toth does not expressly teach that the second generator element is proximate to the tissue contact surface.
Singhal teaches such positioning of a thermoelectric device at the tissue-contacting side of a haptic/thermal device. In particular, Singhal teaches that “[a] multisensory display was built to provide thermal and vibratory cues to the skin” and that “[t]he display consisted of a thermoelectric cooler (TEC)… mounted on a heat sink” (Singhal, p. 91, 'II'). Singhal further teaches that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” and that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, 'II'). Thus, Singhal teaches a second generator element, namely the thermoelectric cooler/Peltier device, positioned proximate to the tissue contact surface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the second generator element is proximate to the tissue contact surface. The combination would have been possible because the modified Toth already teaches a module housing having thermal generator elements, while Singhal teaches a thermoelectric/Peltier device positioned at the skin-contacting interface for delivering thermal cues to the skin. A person of ordinary skill in the art would have recognized that, when incorporating Singhal’s skin-facing thermoelectric/Peltier arrangement into the modified Toth module, the second generator element would have been positioned at or proximate to the tissue-contacting/output side of the housing to deliver thermal energy directly to the tissue. The benefit of the combination would have been direct and efficient thermal transfer to the physiologic tissue, improved perceptibility of the thermal stimulus, and a compact structure in which the second generator element is positioned proximate to the tissue contact surface for thermal delivery.
Regarding claim 67, the modified Toth teaches that the apparatus comprises a sensor operable to detect physiological signals associated with the physiologic tissue (Toth, ¶[0527]: “The patch 2080 includes… a temperature sensor 2087, and/or a heat transfer sensor 2089 each in accordance with the present disclosure”; ¶[0527]: “The temperature sensor 2087 may be configured to analyze changes in the temperature of a volume of tissue under the patch 2080”; ¶[0056]: “an EKG device... configured to measure local electrophysiological signals in adjacent tissues”; ¶[0059]: “an electroencephalogram (EEG) device... configured to measure local electrophysiological signals associated with brain activity in adjacent tissues”; Toth teaches sensors that detect temperature, heat-transfer, EKG, and EEG/electrophysiological signals associated with adjacent tissue, corresponding to physiological signals associated with the physiologic tissue).
Regarding claim 68, the modified Toth teaches that the physiological signals comprise a temperature of the physiologic tissue (Toth, ¶[0415]: “an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0527]: “The patch 2080 includes... a temperature sensor 2087, and/or a heat transfer sensor 2089”; ¶[0527]: “The temperature sensor 2087 may be configured to analyze changes in the temperature of a volume of tissue under the patch 2080”; Toth teaches sensing adjacent tissue temperature and changes in the temperature of tissue under the device); and the controller is operable to cause the second generator element to output the thermal energy responsive to the temperature (Toth, ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range... an embedded temperature sensor arranged so as to provide feedback of the adjacent tissue temperature”; ¶[0528]: “The feedback sensor 2097 configured to convey a feedback signal to the circuit, processor, etc. during use”; ¶[0528]: “The feedback signal used by an associated processor, etc. to more precisely control the stimulus, confirm delivery of the stimulus, adjust the amplitude of the stimulus, etc.”; Toth teaches processor/controller-based control of a thermal/Peltier stimulus using tissue-temperature feedback, thereby causing the second thermal generator element to output thermal energy responsive to the detected tissue temperature).
Regarding claim 69, the modified Toth teaches that the electrothermal device comprises a thermoelectric device operable to output the thermal stimulus as a hot or cold stimulus by creating a temperature differential (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device...”; ¶[0415]: “A Peltier device may be incorporated into the device so as to heat and/or cool the adjacent tissues”; ¶[0415]: “The processor may be programmed so as to drive the Peltier device over a predetermined temperature range”; ¶[0415]: “a component for providing a Seebeck effect, Peltier effect, and/or Thomson effect in the adjacent tissues upon engagement”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device”; Toth teaches a thermoelectric/Peltier electrothermal device driven by the processor/electronics and configured to heat or cool adjacent tissue, thereby outputting the thermal stimulus as a hot or cold stimulus by creating a temperature differential).
Regarding claim 70, the modified Toth teaches or at least suggests that the electrothermal device comprises an electrical resistor operable to output the thermal stimulus as a hot stimulus by generating heat (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from… a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… arranged along the substrate so as to interface with the skin of the subject”; ¶[0489]: “The module 1415 includes one or more heater bands 1405 or RF heating circuits”; ¶[0489]: “The thermoelectric unit may be configured to heat, cool, or substantially maintain the temperature of an adjacent tissue 1401 during use”; ¶[0489]: “the thermoelectric unit, heater bands 1405, etc. are configured to apply energy to the adjacent tissues 1401”; Toth teaches electrically powered heating structures, including a heating coil and heater bands, that generate heat and apply thermal energy to adjacent tissue. Under the broadest reasonable interpretation, a heating coil or heater band is an electrical resistive heating element that outputs a hot thermal stimulus by generating heat responsive to applied electricity).
Accordingly, because claim 65 is rejected over Toth in view of Grant, Singhal, and Gonzales as set forth above, and because Toth further teaches an electrical resistive heating structure operable to generate heat and output a hot thermal stimulus to adjacent tissue, claim 70 is rejected over Toth in view of Grant, Singhal, and Gonzales.
Regarding claim 71, the modified Toth teaches that the plurality of generator elements comprise a third generator element operable to output an electrical energy of the plurality of different energy types in the signal direction as an electrical stimulus recognizable by electricity-sensitive receptors of the physiologic tissue (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator... arranged along the substrate so as to interface with the skin of the subject”; ¶[0540]: “the temporally applied patch 2201 may include one or more energy or stimulus delivery elements... an electrical stimulator... in order to stress the subject near to the ocular circuits”; ¶[0541]: “the groin applied patch 2205 may include one or more energy or stimulus delivery elements... an electrical stimulator... in order to stimulate one or more neural structures in the groin of the subject 25”; Toth teaches an electrical stimulator as one of multiple stimulus delivery/generator elements, and further teaches that the electrical stimulation is used to stimulate neural structures, corresponding to an electrical stimulus recognizable by electricity-sensitive receptors of the physiologic tissue); and the electrical contact plates contact the physiologic tissue when the tissue contact surface is maintained against the physiologic tissue (Toth, FIGS. 20a-20l; ¶[0454]: “The patch 301 includes a plurality of electrodes 303a-e for interfacing with a subject”; ¶[0455]: “The patch 306 includes a bipolar electrode arrangement 307a, b for interfacing with a subject”; Toth teaches conductive electrodes/bipolar electrodes at the subject-facing interface. Under the broadest reasonable interpretation, the electrodes/bipolar electrodes are electrical contact plates, and the electrodes interface with, and therefore contact, the subject when the device is maintained against the physiologic tissue).
Regarding claim 73, the modified Toth teaches that the apparatus comprises an optical stimulus generator element operable with a semiconductor device to output an optical energy of the plurality of different energy types in the signal direction as an optical stimulus recognizable by eyes of the user (Toth, ¶[0462]: “The module 601 includes one or more of interconnects, sensors, optical source(s), optical detector(s), a radio, an antenna, a sensor communication circuit, a signal conditioning circuit, a processor, a memory device, a controller, a power supply, power management circuit, and/or energy harvesting circuit”; ¶[0305]: “the optical sensor may be used in combination with one or more optical emitters (e.g. light emitting diodes, laser diodes, bulbs, etc.)”; ¶[0399]: “a light source and/or display for providing one or more visual cues, optical stresses, incident light profiles, light scans, optical stress tests, etc. into the eye or eyes of the subject”; ¶[0066]: “The feedback mechanism may include a transducer, a loudspeaker, tactile actuator, a visual feedback means, a light source, a buzzer, a combination thereof, or the like to interact with the subject”; Toth teaches module-level optical sources/emitters, including light emitting diodes and laser diodes, powered and controlled by module electronics. Light emitting diodes and laser diodes correspond to semiconductor devices that convert electricity into optical energy, and Toth further teaches using light/visual output to provide visual cues or optical stresses into the eye or eyes of the subject, corresponding to an optical stimulus recognizable by eyes of the user).
Regarding claim 74, the modified Toth teaches or at least suggests that the apparatus is operable to output the mechanical stimulus independently of the thermal stimulus when the housing is removably attached to the body (Toth, ¶[0427]: “the processor may be configured to drive one or more thermal, electromagnetic, electrical, and/or tactile stimulatory components in one or more of the patches/devices to coordinate a stress test on the subject”; ¶[0462]: “The module 601 includes one or more of… a processor, a memory device, a controller, a power supply, power management circuit”; Toth teaches a controller/processor configured to drive one or more selected stimulation components, including thermal and tactile/mechanical stimulation components, thereby teaching selective operation of the mechanical stimulus independently of the thermal stimulus in the modified apparatus when the housing is removably attached to the body).
However, to the extent Toth does not expressly teach outputting the mechanical stimulus concurrently with the thermal stimulus, Singhal teaches the same combined-output relationship in a thermo-tactile display (Singhal, Abstract: “The present experiment measured thermal pattern identification in the presence of concurrent vibrotactile feedback on the thenar eminence on the hand”; Singhal, §II, Experimental Design: “Vibrotactile stimulation was delivered at the same site concurrently with the thermal stimuli”; Singhal teaches outputting vibrotactile/mechanical stimulation concurrently with thermal stimulation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Singhal such that the apparatus is operable to output the mechanical stimulus independently of or concurrently with the thermal stimulus when the housing is removably attached to the body. A person of ordinary skill in the art would have recognized that Toth’s controller-driven tactile/mechanical and thermal stimulus components could be selectively operated alone or together according to Singhal’s concurrent thermo-tactile operation to provide flexible single-mode or multimodal stimulation. The combination would have been possible because Toth already provides the apparatus having controller-driven mechanical/vibratory and thermal stimulus components, and Singhal teaches delivering vibrotactile stimulation concurrently with thermal stimulation in a thermo-tactile display. The benefit would have been selectable operation using the already-established mechanical and thermal generator elements of the modified Toth apparatus, including independent mechanical stimulation when thermal stimulation is unnecessary and coordinated mechanical/thermal stimulation when combined tactile and thermal communication is desired.
Claims 13, 15-17, 20, 60, 64, 66, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales, and further in view of Law et al. (US-20170080255-A1), hereto referred as Law.
The modified Toth teaches claim 1 as shown above.
The modified Toth teaches claim 44 as shown above.
The modified Toth teaches claim 65 as shown above.
Regarding claim 13, the modified Toth teaches or at least suggests that the plurality of generator elements comprise a pressure stimulus generator element (Toth, ¶[0417]: “the patch may include a Sonography component, configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source”; Toth teaches an ultrasound/sonography component within the patch/module architecture, corresponding to a pressure-energy stimulus source because ultrasound is acoustic pressure energy delivered to adjacent tissue); operable to output a pressure energy of the plurality of different energy types in the signal direction (Toth, ¶[0304]: “one or more modules may include a signal source for imparting an energy signal (e.g. electrostatic, electromagnetic, magnetic, vibrational, thermal, optical, etc.) into the body of the subject”; ¶[0417]: “configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “an ultrasound source”; Toth teaches a module signal source and ultrasound/sonography component for providing ultrasonic energy into or to adjacent tissue upon engagement with the skin, corresponding to outputting pressure energy in a signal direction toward the physiologic tissue); recognizable by pressure receptors of the physiologic tissue (Toth, ¶[0577]: “varying a pressure applied to one or more nerves in the subject, stimulating the nerves, and monitoring afferent nerve activity during such changes”; ¶[0540]: “Such stimulation may be advantageous to interact and/or stimulate one or more neural structures, nerves, and/or receptors”; Toth teaches that pressure applied to tissue stimulates nerves and produces afferent nerve activity, and further teaches stimulation of neural structures, nerves, and/or receptors. Under the broadest reasonable interpretation, pressure-responsive nerves/receptors in physiologic tissue that respond to applied pressure correspond to pressure receptors of the physiologic tissue); and the pressure stimulus generator element is proximate to the tissue contact surface (Toth, ¶[0417]: “the patch may include a Sonography component, configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0079]: “the patch interface may include a stimulating device selected from… a tactile stimulating component, a vibratory stimulating element, a combination thereof, or the like arranged along the substrate so as to interface with the skin of the subject”; ¶[0249]: “the patch may include an adhesive layer coupled with the substrate for making contact with the subject”; Toth teaches that the patch/module component is arranged at the patch interface/substrate for engagement with the skin and that the sonography component provides ultrasonic signals to adjacent tissue upon skin engagement, corresponding to the pressure stimulus generator element being proximate to the tissue contact surface).
Also regarding claim 13, Toth does not expressly teach that the pressure stimulus generator element comprises an electromechanical transducer or that the pressure stimulus generator element outputs the pressure energy by converting the electricity into a pressure stimulus. Rather, the modified Toth teaches a wearable patch/module architecture that includes an ultrasound source within the module and a sonography component configured to provide ultrasonic signals to adjacent tissue upon engagement with the skin. Toth also teaches module-level electronics, including a controller, power supply, and power management circuitry, for powering and controlling module components (Toth, ¶[0417]; ¶[0462]; ¶[0489]). However, it does not expressly identify the ultrasound source/sonography component as an electromechanical transducer that converts electricity into a pressure stimulus.
Law teaches ultrasonic transducer elements that are electrically and mechanically supported in a compact device architecture (Law, ¶[0061]: “adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz... Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g., PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies”; ¶[0073]: “...may include a circuit board... configured to couple to at least one transducer element. The circuit board may be configured to mechanically support and electrically couple elements of the phased array”; ¶[0082]: “…the transducer (e.g., peizo or any other competent material)”). Law therefore teaches an electromechanical ultrasonic transducer that is electrically coupled to a circuit board and operable to convert electrical drive into ultrasonic pressure energy.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view Law to implement Toth’s ultrasound source/sonography component as Law’s electrically coupled ultrasonic electromechanical transducer. A person of ordinary skill in the art would have recognized that Toth’s ultrasound source could be predictably implemented using Law’s ultrasonic transducer elements because ultrasonic transducers were known components for converting electrical drive signals into acoustic pressure energy. The combination would have been possible because Toth already provides a module architecture with controller, power supply, power management, and interconnect circuitry for powering and controlling module components, and Law teaches ultrasonic transducer elements mechanically supported and electrically coupled by a circuit board. The benefit would have been predictable delivery of controlled pressure/ultrasonic stimulus energy toward physiologic tissue using a compact, electrically controllable transducer located proximate to the tissue contact surface, thereby improving integration, control accuracy, and reliability of the multimodal stimulus module.
Regarding claim 15, the modified Toth teaches or at least suggests that the electromechanical transducer comprises a piezoelectric material (Toth, ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0488]: “the transducer 1305 may be piezoelectric material”; Toth teaches a module-integrated transducer that may be formed from piezoelectric material); operable to output mechanical energy by converting electricity into mechanical motion(Toth, ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”; ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0462]: “The module 601 includes one or more of… a controller, a power supply, power management circuit”; Toth teaches that the transducer is powered/controlled by module electronics and generates vibrational energy for transfer into the subject. Under the broadest reasonable interpretation, generating vibrational energy using a powered piezoelectric transducer corresponds to converting electricity into mechanical motion);
Also regarding claim 15, the modified Toth does not teach that the transducer is operable to output the pressure energy at a location that is spaced apart from the physiologic tissue. Rather, the modified Toth teaches a piezoelectric transducer configured to generate vibrational energy for transfer into the subject, but does not expressly characterize that piezoelectric mechanical output as the claimed pressure energy of the pressure stimulus generator element at a spaced-apart location from the tissue.
Law demonstrates that a piezoelectric ultrasonic transducer may be used to output acoustic/pressure energy from a location spaced apart from the subject-facing surface. Law teaches ultrasonic transducer elements configured to deliver energy at pressure/acoustic frequencies and identifies piezoelectric material as the vibrating material of the transducer (Law, ¶[0061]: “In general, these apparatuses are particularly well adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz. Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g. PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies…”; ¶[0082]: “For example, the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Law therefore teaches that a piezoelectric material in an ultrasonic transducer mechanically vibrates in response to electrical drive to output acoustic/pressure energy.
Law further teaches that the ultrasonic transducer elements may be mounted to an intervening PCB substrate/matching layer through which the ultrasound signals are transmitted toward the subject (Law, ¶[0014]-[0015]: “a printed circuit board (PCB) substrate configured as a matching layer, onto which a front side of each ultrasound transducer element of the array of ultrasound transducer elements is mounted for transmission of the emitted ultrasound signals through the PCB substrate”). Law further teaches “emitting ultrasound signals through the PCB substrate between 100 kHz and 1 MHz” after attaching the ultrasound applicator device to the subject’s head (Law, ¶[0025]). Accordingly, Law teaches a pressure/ultrasound transducer located behind an intervening PCB/matching-layer interface, such that the transducer is spaced apart from the subject-facing surface while still outputting sonic/ultrasonic mechanical pressure energy toward the subject through the intervening interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law to configure the electromechanical transducer as a piezoelectric material operable to output the claimed pressure energy by converting electricity into mechanical motion at a location spaced apart from the physiologic tissue. A person of ordinary skill in the art would have recognized that Toth’s disclosed piezoelectric transducer and ultrasound source could be implemented as Law’s electrically driven ultrasonic piezoelectric transducer because piezoelectric ultrasonic transducers were known structures for converting electrical drive into mechanical vibration/acoustic pressure output. The combination would have been possible because Toth already provides a module architecture with controller, power supply, power management, and electronics for driving transducers, while Law teaches ultrasound transducer elements arranged on a substrate such as a PCB and using a vibrating piezoelectric material to output acoustic/pressure energy. The benefit would have been predictable electronically controlled pressure/ultrasonic output from a compact piezoelectric element located proximate to, but spaced apart from, the physiologic tissue while preserving compact module integration, controlled energy transmission, and PCB-based mechanical and electrical support.
Regarding claim 16, the modified Toth does not fully teach that a face of the piezoelectric material is spaced apart from the physiologic tissue to define a gap between the face and the physiologic tissue; and the pressure energy comprises a sonic or ultrasonic energy output from the location toward the physiologic tissue through the gap. Rather, the modified Toth, as shown above regarding claim 15, teaches a module-supported piezoelectric transducer configured to generate vibrational energy for transfer into the subject, wherein the transducer may be controlled and/or powered by module electronics and may comprise piezoelectric material (Toth, ¶[0488]). However, Toth does not expressly disclose that a face of the piezoelectric material is spaced apart from the physiologic tissue to define a gap between the face and the physiologic tissue, or that the pressure energy output through that gap comprises sonic or ultrasonic energy.
Law demonstrates that a piezoelectric pressure/ultrasonic transducer may be arranged so that ultrasonic energy is output from the transducer toward the subject through an air gap or air-coupled interface. Specifically, Law teaches “a printed circuit board (PCB) substrate configured as a matching layer, onto which a front side of each ultrasound transducer element of the array of ultrasound transducer elements is mounted for transmission of the emitted ultrasound signals through the PCB substrate” (Law, ¶[0014]-[0015]). Law further teaches “emitting ultrasound signals through the PCB substrate between 100 kHz and 1 MHz” after attaching the ultrasound applicator device to the subject’s head (Law, ¶[0025]). Additionally, Law teaches that “an air-coupled transducer may efficiently transmit the ultrasound through the skin to the user,” explains that “air has a very low density” and that the impedance mismatch between “air and skin” may cause some ultrasound energy to reflect off the skin, and teaches that a matching layer may be placed on the user to optimize energy transmission (Law, ¶[0180]). Accordingly, Law teaches or at least suggests that the face/front side of an ultrasound transducer element may be spaced from the physiologic tissue by an air gap or air-coupled interface, while sonic or ultrasonic pressure energy is output from the transducer location toward the physiologic tissue through that gap/interface.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law such that a face of the piezoelectric material is spaced apart from the physiologic tissue to define a gap between the face and the physiologic tissue, and such that the pressure energy comprises sonic or ultrasonic energy output from the location toward the physiologic tissue through the gap. A person of ordinary skill in the art would have recognized that Toth’s powered piezoelectric transducer could be implemented using Law’s air-coupled ultrasonic transducer arrangement because Law provides a known structure for transmitting ultrasonic pressure energy from an ultrasonic transducer toward a subject through an air-coupled interface, with optional matching material to improve transmission at the air/skin interface. The combination would have been possible because Toth already provides the module architecture, controller, power supply, power management, and electronics for driving the transducer, while Law supplies a known spaced ultrasonic implementation in which ultrasound is transmitted toward the subject through an air gap or air-coupled interface. The benefit would have been predictable sonic or ultrasonic pressure-energy delivery from the modified Toth piezoelectric transducer at a location spaced from the physiologic tissue, while preserving controlled energy transmission, compact module integration, and PCB-based mechanical and electrical support.
Regarding claim 17, the modified Toth teaches that the electromechanical transducer comprises a piezoelectric material (Toth, ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0488]: “the transducer 1305 may be piezoelectric material (e.g. polymer, ceramic, etc.)”; Toth teaches a module-supported transducer that may be formed from piezoelectric material); operable to output energy from the location (Toth, ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0488]: “The transducer 1305 may be controlled and/or powered by an electronics unit 1320 included in the module 1315”; Toth teaches that the powered piezoelectric transducer outputs vibrational energy from its module location for transfer into the subject).
Also regarding claim 17, the modified Toth does not expressly teach that the electromechanical transducer comprises an array of piezoelectric materials or that such an array is operable to output the pressure energy from the location. Rather, the modified Toth teaches a compact patch/module architecture with onboard electronics for powering and controlling a module-supported transducer, including a transducer that may be piezoelectric material and that outputs energy from the module location for transfer into the subject (Toth, ¶[0462]; ¶[0488]). As discussed above for claim 15, the modified Toth does not expressly teach the claimed pressure-energy implementation of the piezoelectric transducer, and it also does not expressly teach that the piezoelectric transducer is an array.
Law teaches the missing array structure and pressure-energy function. Law teaches ultrasonic transducer elements adapted for delivering energy at sonic/ultrasonic frequencies (Law, ¶[0061]: “In general, these apparatuses are particularly well adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz... Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g. PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies…”). Law further teaches a phased array in which a circuit board mechanically supports and electrically couples multiple transducer elements (Law, ¶[0073]: “Any of the apparatuses described herein may include a circuit board... configured to couple to at least one transducer element. The circuit board may be configured to mechanically support and electrically couple elements of the phased array”). Law also identifies the vibrating transducer material as piezoelectric or other competent material (Law, ¶[0082]: “For example, the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Law therefore teaches an array of piezoelectric transducer materials operable to output sonic/ultrasonic pressure energy from the transducer location.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law such that the electromechanical transducer comprises an array of piezoelectric materials operable to output the pressure energy from the location. A person of ordinary skill in the art would have recognized that Toth’s module-supported piezoelectric transducer could be implemented using Law’s PCB-supported phased-array piezoelectric ultrasound transducer elements because Law provides a known arrayed implementation for electrically controlled pressure-energy delivery. The combination would have been possible because Toth already provides a module architecture with electronics, controller, power supply, and power-management circuitry for driving transducer components, and Law teaches that a circuit board can mechanically support and electrically couple the elements of a phased array. The benefit would have been improved control over the pressure-energy output, including increased output capability, spatial control, beamforming or directional control, and reliable PCB-based electrical and mechanical integration within the multimodal module.
Regarding claim 20, the modified Toth teaches or at least suggests that the electromechanical transducer comprises one of: an ultrasound transducer; a piezoelectric material; an electroacoustic transducer; and a linearly actuated diaphragm (Toth, ¶[0417]: “the patch may include a Sonography component, configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “the module 1415 may include one or more thermoelectric units, a Peltier device, an RF heating circuit, an ultrasound source”; ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0488]: “the transducer 1305 may be piezoelectric material (e.g. polymer, ceramic, etc.)”; Toth teaches an ultrasound source/sonography component and also teaches a module transducer that may be piezoelectric material. These teachings correspond to at least the claimed alternatives of an ultrasound transducer and a piezoelectric material).
Also regarding claim 20, the modified Toth does not expressly teach that the ultrasound source/sonography component or piezoelectric material is the same electromechanical transducer of the pressure stimulus generator element discussed in claim 13, namely the component that outputs pressure energy by converting electricity into a pressure stimulus. Rather, as discussed above for claim 13, Toth teaches a wearable patch/module architecture that includes an ultrasound source and a sonography component configured to provide ultrasonic signals to adjacent tissue upon engagement with the skin. Toth also teaches a module-supported transducer that may be piezoelectric material and that is controlled and/or powered by module electronics (Toth, ¶[0417]; ¶[0488]; ¶[0489]). However, the modified Toth does not expressly identify the pressure stimulus generator element as an electromechanical transducer implemented as an ultrasound transducer or piezoelectric material.
Law teaches the missing relationship. Law teaches ultrasonic transducer elements adapted for delivering energy at ultrasound frequencies and identifies the vibrating material of the transducer as piezoelectric or other competent material (Law, ¶[0061]: “In general, these apparatuses are particularly well adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz. Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g. PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies…”; ¶[0082]: “For example, the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Law therefore teaches that the electromechanical pressure transducer may be implemented as an ultrasound transducer and/or as a piezoelectric material.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law such that the electromechanical transducer comprises at least an ultrasound transducer or piezoelectric material. A person of ordinary skill in the art would have recognized that Toth’s ultrasound source/sonography component and piezoelectric transducer could be implemented using Law’s electrically driven ultrasonic piezoelectric transducer because such transducers were known structures for converting electrical drive into acoustic pressure energy. The combination would have been possible because Toth already provides a module architecture having controller, power supply, power management, and electronics for driving transducer components, and Law teaches ultrasound transducer elements arranged on a substrate such as a PCB with piezoelectric vibrating material. The benefit would have been predictable electronically controlled pressure-stimulus output using a known compact electromechanical ultrasound/piezoelectric transducer structure.
Regarding claim 60, the modified Toth teaches that the plurality of generator elements comprise a pressure stimulus generator element (Toth, ¶[0417]: “the patch may include a Sonography component, configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “the module 1415 may include... an ultrasound source”; Toth teaches an ultrasound/sonography component in the patch/module architecture, corresponding to a pressure stimulus generator element because ultrasound is acoustic pressure energy delivered to adjacent tissue); operable to output a pressure energy of the plurality of different energy types (Toth, ¶[0304]: “one or more modules may include a signal source for imparting an energy signal (e.g. electrostatic, electromagnetic, magnetic, vibrational, thermal, optical, etc.) into the body of the subject”; ¶[0417]: “configured to provide an ultrasonic signal to and/or receive a Sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “an ultrasound source”; Toth teaches a module signal source and ultrasound/sonography component for providing ultrasonic energy to adjacent tissue, corresponding to outputting pressure energy); recognizable by pressure receptors of the physiologic tissue (Toth, ¶[0577]: “varying a pressure applied to one or more nerves... and monitoring afferent nerve activity during such changes”; ¶[0540]: “Such stimulation may be advantageous to interact and/or stimulate one or more neural structures, nerves, and/or receptors”; Toth teaches pressure-based stimulation of nerves and stimulation of neural structures, nerves, and/or receptors. Under the broadest reasonable interpretation, Toth’s ultrasonic/acoustic pressure output to adjacent tissue is a pressure stimulus recognizable by pressure-responsive receptors of the physiologic tissue); and proximate to the tissue contact surface (Toth, ¶[0417]: “the patch may include a sonography component, configured to provide an ultrasonic signal to and/or receive a sonographic signal from an adjacent tissue upon engagement with the skin”; ¶[0489]: “the module 1415 may include... an ultrasound source”; ¶[0079]: “the patch interface may include a stimulating device selected from... a tactile stimulating component, a vibratory stimulating element... arranged along the substrate so as to interface with the skin of the subject”; Toth teaches an ultrasound/sonography pressure stimulus component configured to provide ultrasonic signals to adjacent tissue when the patch/module structure is engaged with the skin. Because the tissue contact surface is the skin-engaging interface, the sonography/ultrasound component configured to transmit ultrasonic pressure energy to the adjacent tissue in that engaged condition is proximate to the tissue contact surface).
Also regarding claim 60, the modified Toth does not expressly teach that the pressure stimulus generator element comprises an electromechanical transducer operable to output the pressure energy by converting a fourth flow of electricity from the power source into a pressure stimulus. Rather, Toth teaches a wearable patch/module architecture that includes an ultrasound source and a sonography component configured to provide ultrasonic signals to adjacent tissue upon engagement with the skin, and also teaches module electronics including a controller, power supply, and power management circuitry for powering and controlling module components (Toth, ¶[0417]; ¶[0462]; ¶[0489]). However, Toth does not expressly identify the ultrasound source/sonography component as an electromechanical transducer that converts electricity from the power source into a pressure stimulus.
Law teaches the missing electromechanical transducer relationship. Law teaches ultrasonic transducer elements configured for delivering energy at ultrasound frequencies and mechanically/electrically supported by a circuit board (Law, ¶[0061]: “adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz... Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g. PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies”; ¶[0073]: “The circuit board may be configured to mechanically support and electrically couple elements of the phased array”; ¶[0082]: “the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Thus, Law teaches an electromechanical ultrasonic transducer that is electrically driven and converts electrical energy into mechanical vibration/acoustic pressure energy.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law to implement Toth’s ultrasound source/sonography pressure stimulus component as Law’s electrically driven ultrasonic electromechanical transducer. A person of ordinary skill in the art would have recognized that Toth’s ultrasound source could be predictably implemented using Law’s ultrasonic transducer elements because ultrasonic transducers were known components for converting electrical drive signals into acoustic pressure energy. The combination would have been possible because Toth already provides a module architecture with a controller, power source, power management, and interconnect circuitry for powering and controlling module components, while Law teaches ultrasonic transducer elements mechanically supported and electrically coupled by a circuit board. The benefit would have been predictable delivery of controlled pressure/ultrasonic stimulus energy toward physiologic tissue using a compact, electrically controllable transducer located proximate to the tissue contact surface, thereby improving integration, control accuracy, and reliability of the multimodal stimulus module.
Regarding claim 64, the modified Toth does not fully teach that an exterior surface of the housing is axially receivable in an opening of the body in the signal direction to removably attach the housing to the body. Rather, the modified Toth teaches a removable module/housing that mates with and is physically/electrically coupled to a corresponding patch/body interface in a direction normal to the skin when the patch is applied to the user. Toth teaches that the module interconnect is “sized and dimensioned to interface with a corresponding interconnect included within the patch interface” to form an operable interconnection, that magnetic elements physically and/or electrically couple the module to the patch interface when aligned, that the module is configured and dimensioned to mate with the patch and interface with the subject therethrough, and that the modules are hot swappable with the patch interface (Toth, ¶[0044]: “the module interconnect included within the module may be sized and dimensioned to interface with a corresponding interconnect included within the patch interface, wherein to form an operable interconnection between the patch interface and the module”; ¶[0045]: “the magnetic elements arranged so as to physically and/or electrically couple the module to the patch interface when the magnetic elements are aligned with the ferromagnetic regions”; ¶[0046]: “a module in accordance with the present disclosure configured and dimensioned to mate with the patch, and to interface with the subject there through”; ¶[0047]: “the modules being hot swappable with the patch interface”). Toth further teaches an example in which module interconnects mesh with corresponding patch interconnects, which necessarily requires the module to be moved into and out of engagement with the patch interface along the mating axis (Toth, FIGS. 12a-12c; ¶[0483]: “FIG.12a shows a module 1215 in accordance with the present disclosure configured and dimensioned to mate with the patch 1201”; ¶[0483]: “The module 1215 includes a module interconnect 1217 a,b arranged to mesh with the corresponding patch interconnect 1211 a,b”). Because the patch is applied to the user’s skin and the module mates with the tissue-facing patch interface to interface with the subject therethrough, this mating/removal axis is normal to the skin and corresponds to the claimed signal direction, since the stimulus signal is directed toward the skin/physiologic tissue. Thus, the modified Toth teaches that the housing/module is axially receivable in the signal direction to removably attach the housing to the body, but does not expressly teach that the axial receipt occurs in an opening of the body.
Grant teaches the missing opening/receiving structure in a wearable haptic device. Grant teaches that a wearable device includes a haptic output device connected to a wearable member by a flexible mounting (Grant, ¶[0032]: “The wearable device 110… includes a haptic output device 112 that is connected to a wearable member 114 via a flexible mounting 115”). Grant further teaches a flexible casing/mounting that surrounds or partially contains the haptic output device and is connected to the wearable member (Grant, ¶[0047]: “the flexible casing 415 surrounds the body of the ERM actuator 412”; ¶[0047]: “The flexible casing 415 may then be connected to or embedded in a wearable member 414”). In particular, Grant’s FIG. 6 shows the haptic output device/actuator received within a surrounding opening or cavity of the flexible mounting, and Grant describes this embodiment as including “the ERM actuator 412 partially contained within a flexible mounting 615” (Grant, FIG. 6; ¶[0051]: “FIG. 6 illustrates an embodiment that includes the ERM actuator 412 partially contained within a flexible mounting 615”). Thus, Grant teaches a wearable body/mounting structure having an opening or cavity that receives and holds an exterior portion of a haptic output device, while Toth supplies the axial tissue-normal mating direction.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Grant such that an exterior surface of Toth’s housing/module is axially receivable in an opening of the body in the signal direction to removably attach the housing to the body. The modified Toth already teaches a removable module/housing configured and dimensioned to mate with a corresponding tissue-facing patch/body interface, including aligned interconnects that mesh and physically/electrically couple the module to the patch interface. This mating/removal occurs along the tissue-normal direction, which corresponds to the signal direction toward the physiologic tissue, but Toth does not expressly characterize the receiving structure as an opening in the body. Grant’s FIG. 6 and ¶[0051] teach a wearable haptic body/mounting structure in which the actuator is partially contained within the flexible mounting, thereby showing an opening or cavity in the body/mounting that receives the exterior of the haptic output device. A person of ordinary skill in the art would have recognized that Toth’s removable module-to-body interface could be implemented using Grant’s opening/cavity receiving structure to provide mechanical capture of the module housing in addition to Toth’s magnetic/interconnect alignment. Although Toth’s magnetic elements align and physically/electrically couple the module to the patch interface, Grant’s opening/cavity structure would have provided additional lateral support, controlled insertion depth, resistance to shear or accidental dislodgement during use, and repeatable seating of the housing relative to the body while preserving Toth’s axial signal-direction mating relationship. The benefit would have been improved mechanical retention and repeatable seating of the removable housing, reduced lateral shifting or shear loading at the interconnects, protection of the coupled interface during body-worn use, and reliable maintenance of the stimulus-output orientation in the signal direction toward the physiologic tissue.
Also regarding claim 64, the modified Toth does not fully teach that an electrical connection is established between the controller and the power source when the exterior surface of the housing is axially received in the opening of the body.
The modified Toth teaches that the module is configured and dimensioned to mate with the patch and interface with the subject therethrough, that the module interconnect is sized and dimensioned to interface with a corresponding patch interconnect to form an operable interconnection, and that the module interconnects mesh with corresponding patch interconnects (Toth, ¶[0046]: “a module in accordance with the present disclosure configured and dimensioned to mate with the patch, and to interface with the subject there through”; ¶[0044]: “the module interconnect included within the module may be sized and dimensioned to interface with a corresponding interconnect included within the patch interface, wherein to form an operable interconnection between the patch interface and the module”; FIG. 12a; ¶[0483]: “FIG.12a shows a module 1215 in accordance with the present disclosure configured and dimensioned to mate with the patch 1201”; ¶[0483]: “The module 1215 includes a module interconnect 1217 a,b arranged to mesh with the corresponding patch interconnect 1211 a,b”). Because the patch is the tissue-facing structure applied to the user’s skin and the module mates with the patch to interface with the subject therethrough, the FIG. 12a patch/module mating relationship provides the axial receipt relationship in the signal direction, and Grant supplies the opening/receiving structure as discussed above. However, although Toth teaches a module including a controller and a power supply (Toth, ¶[0462]: “The module 601 includes… a controller, a power supply, power management circuit”), Toth does not fully teach a controller in the housing electrically connected to a power source in the body when the housing is axially received in the body opening.
Worthington teaches the missing electrical-connection relationship. Worthington teaches that a body-side power source supplies power through the body assembly and that electronics in a removable assembly establish electrical connection upon attachment. Worthington teaches that the “electric motor (42) is powered by power pack (44)” in the handle assembly/body (Worthington, ¶[0058]), and that the removable shaft assembly includes a circuit board that may include a microcontroller because “shaft circuit board (134) may include a microcontroller” (Worthington, ¶[0073]). Worthington further teaches that, during axial attachment, “tapered attachment members (150) are received within dovetail receiving slots (154) along an installation axis (IA),” and that “shaft electrical connector (152) is electrically coupled with handle electrical connector (156)” (Worthington, ¶[0076]). Thus, Worthington teaches that an electrical connection is established between electronics of a removable assembly and a body-side power/electrical system when the removable assembly is received by the body.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Worthington such that an electrical connection is established between the controller and a power source in the body when the exterior surface of the housing is axially received in the opening of the body. The modified Toth already teaches a removable module/housing that mates with a tissue-facing patch/body interface through corresponding interconnects, and the modified Toth in view of Grant teaches the housing being axially received in an opening of the body in the signal direction. Worthington teaches a modular electrical architecture in which a removable assembly having electronics/microcontroller structure establishes an electrical connection with a body-side powered system when the removable assembly is received by the body along an installation axis. A person of ordinary skill in the art would have recognized that Worthington’s body-side power and mating electrical connector arrangement could be used in the modified Toth/Grant device so that the controller in the removable housing is electrically connected to a power source in the body upon receipt of the housing in the body opening. The combination would have been possible because Toth already teaches removable modules, mating interconnects, controller electronics, and hot-swappable module replacement, while Worthington teaches establishing electrical connection between a removable assembly and a body-side powered system during axial attachment. The benefit would have been reduced size, weight, and cost of each swappable housing/module by avoiding duplication of the power source in each removable housing, reliable power delivery to the controller only when the housing is properly seated in the body opening, and preservation of Toth’s modular replacement and hot-swapping functionality.
Regarding claim 66, the modified Toth does not fully teach that an electrical connection is established between the controller and a power source when the housing is removably attached to the body; and the electrical connection is disrupted when the housing is removed from the body. Rather, the modified Toth teaches a removable module/housing and patch/body interface having complementary electrically conducting interconnects that conduct current upon attachment (Toth, ¶[0282]: “In the case of an electrically conducting interconnect, each patch and module interconnect may include complimentary electrically conducting connectors, configured and dimensioned so as to conduct current there between upon attachment”; ¶[0446]: “The module 235 includes multiple module interconnects 240a, b... configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects 230a, b”; ¶[0314]: “swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc.”). However, it does not expressly teach the specific separated power arrangement in which the electrical connection established by removable attachment is between a housing-side controller and a body-side power source.
Worthington teaches the missing modular electrical connection/disconnection relationship. Worthington teaches a body assembly and a releasably attachable shaft assembly, where “first and second electrical contacts are configured to electrically couple together to establish an electrical connection therebetween when the shaft assembly is attached to the body assembly” (Worthington, Abstract). Worthington further teaches that the body assembly includes a power source, stating that “Electric motor (42) is powered by a power source shown in the form of a power pack (44) removably coupled to a proximal portion of handle assembly body (20)” and that “Power pack (44) includes one or more batteries” (Worthington, ¶[0058]). Worthington also teaches electronics in the removable assembly, stating that “Electrical connector (132) is configured to electrically couple annular conductors (128) with a shaft circuit board (134), shown schematically in FIG. 4, which may be mounted to shaft chassis (80) and include a microcontroller” (Worthington, ¶[0073]). Worthington further teaches that the electrical connection is made during attachment, stating that “[d]uring attachment of shaft assembly (14) to handle assembly (12)... shaft electrical connector (152) is electrically coupled with handle electrical connector (156)” (Worthington, ¶[0076]). Thus, Worthington teaches that attaching a removable assembly to a body establishes an electrical connection between removable-assembly electronics/controller circuitry and body-side powered circuitry, and that removal of the removable assembly would disrupt that connection because the mating electrical contacts are no longer electrically coupled.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Worthington such that an electrical connection is established between the controller and a power source when the housing is removably attached to the body, and the electrical connection is disrupted when the housing is removed from the body. The modified Toth already teaches a removable module/housing, a body/patch interface, and complementary electrically conducting interconnects that conduct current upon attachment. Worthington teaches a known modular power-interface architecture in which a removable assembly having controller/microcontroller circuitry electrically couples to a body-side power source through mating electrical connectors when the removable assembly is attached. A person of ordinary skill in the art would have recognized that Worthington’s attach-to-connect and remove-to-disconnect electrical architecture could be used in the modified Toth apparatus to supply power across the removable housing/body interface while preserving the removable-module functionality already taught by Toth. The combination would have been possible because both systems use removable modular assemblies with mating electrical connectors, and the modification would have merely applied Worthington’s known connector/power-source arrangement to Toth’s removable module/body interface. The benefit would have been reliable electrical connection during use, automatic electrical disconnection when the housing is removed, simplified module replacement, and the ability to locate the power source in the body while maintaining controller-driven operation of the removable housing.
Regarding claim 72, the modified Toth does not fully teach that the plurality of generator elements comprise a fourth generator element comprising an electromechanical transducer operable to output a pressure energy of the plurality of different energy types in the signal direction as a pressure stimulus recognizable by pressure receptors of the physiologic tissue, with the electromechanical transducer proximate to the tissue contact surface. Rather, the modified Toth teaches a wearable patch/module architecture that includes a transducer, an ultrasound source, and a sonography component configured to provide ultrasonic signals or vibrational energy to adjacent tissue (Toth, ¶[0417]: “the patch may include a sonography component, configured so as to provide an ultrasonic signal to adjacent tissues upon engagement with the skin”; ¶[0488]: “The module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301”; ¶[0489]: “the module 1415 may include... an ultrasound source”). Toth also teaches module-level electronics, including a controller, power supply, and power management circuitry, for powering and controlling module components (Toth, ¶[0462]). Further, because Toth places the transducer/ultrasound source in the module that forms part of the energy-output structure maintained at the tissue-facing side of the apparatus, Toth at least suggests the pressure-output transducer being proximate to the tissue contact surface/interface. However, Toth does not expressly identify the ultrasound source/sonography component as the claimed fourth generator element comprising an electromechanical transducer that converts electricity into a pressure stimulus recognizable by pressure receptors of the physiologic tissue.
Law teaches the missing electromechanical pressure-transducer implementation. Law teaches ultrasonic transducer elements that are electrically and mechanically supported in a compact device architecture (Law, ¶[0061]: “In general, these apparatuses are particularly well adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz. Thus the sizes and configuration (including spacing and arrangement on the substrate, e.g., PCB) of the ultrasound transducer elements may be adapted specifically for operation over this range of ultrasound frequencies”; ¶[0073]: “The circuit board may be configured to mechanically support and electrically couple elements of the phased array”; ¶[0082]: “For example, the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Law therefore teaches an electromechanical ultrasonic transducer electrically coupled to circuitry and operable to convert electrical drive into ultrasonic/acoustic pressure energy. Law further teaches that the ultrasound transducer elements are positioned relative to the tissue-facing output side of the apparatus so that ultrasound is emitted toward the subject, including “a printed circuit board (PCB) substrate configured as a matching layer, onto which a front side of each ultrasound transducer element of the array of ultrasound transducer elements is mounted for transmission of the emitted ultrasound signals through the PCB substrate” (Law, ¶[0014]-[0015]) and “emitting ultrasound signals through the PCB substrate” after attaching the ultrasound applicator device to the subject (Law, ¶[0025]). Thus, Law teaches an electromechanical ultrasonic transducer electrically coupled to circuitry and located proximate to the tissue-facing output surface/interface so that ultrasonic/acoustic pressure energy is transmitted from the transducer toward the physiologic tissue.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law to implement Toth’s ultrasound source/sonography component as Law’s electrically coupled ultrasonic electromechanical transducer, such that the fourth generator element is operable to output pressure energy in the signal direction as a pressure stimulus recognizable by pressure receptors of the physiologic tissue and is proximate to the tissue contact surface. A person of ordinary skill in the art would have recognized that Toth’s ultrasound source/sonography component could be predictably implemented using Law’s ultrasonic transducer elements because ultrasonic transducers were known components for converting electrical drive signals into acoustic pressure energy. The combination would have been possible because Toth already provides a module architecture with controller, power supply, power management, and interconnect circuitry for powering and controlling module components, and Law teaches ultrasonic transducer elements mechanically supported and electrically coupled by a circuit board. The benefit would have been predictable delivery of controlled pressure/ultrasonic stimulus energy toward physiologic tissue using a compact, electrically controllable transducer positioned near the tissue-facing output surface/interface of the modified Toth module so that pressure energy is effectively transmitted toward the tissue.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales, and further in view of Law et al. (US-20170080255-A1), hereto referred as Law, and further in view of Sawada et al. (US-20070293762-A1), hereto referred as Sawada.
The modified Toth teaches claim 1 as shown above.
Regarding claim 19, the modified Toth does not expressly teach that the array of piezoelectric materials comprises a radial array that is coaxial with and surrounds the impact or vibratory stimulus generator. Rather, Toth teaches a vibratory stimulus generator and a piezoelectric transducer within the module/patch architecture, as shown above, but Toth does not disclose a radial array of piezoelectric materials, does not disclose the array as coaxial with the impact or vibratory stimulus generator, and does not disclose the array surrounding the impact or vibratory stimulus generator.
As discussed above for claim 17, Toth teaches a compact module architecture with a module-supported piezoelectric transducer and onboard electronics, but Toth does not expressly teach an array of piezoelectric materials. Law teaches the arrayed piezoelectric pressure-energy implementation by disclosing ultrasonic transducer elements mechanically supported and electrically coupled by a circuit board as a phased array (Law, ¶[0073]: “Any of the apparatuses described herein may include a circuit board... configured to couple to at least one transducer element. The circuit board may be configured to mechanically support and electrically couple elements of the phased array”; ¶[0061]: “In general, these apparatuses are particularly well adapted for delivering energy, using frequencies of between about 20 kHz and about 2 MHz”; ¶[0082]: “For example, the material that vibrates in the transducer (e.g. peizo or any other competent material)”). Law therefore teaches the array of piezoelectric materials operable to output pressure energy, as applied in claim 17. Law does not expressly require the array to be radial, coaxial with, or surrounding the impact or vibratory stimulus generator.
Sawada teaches the missing radial piezoelectric-array geometry (Sawada, ¶[0003]: “This ultrasonic transducer includes a radial array type that arrays a plurality of piezoelectric elements in a cylindrical arrangement”; Sawada teaches a radial array of piezoelectric elements in a cylindrical arrangement, corresponding to a radial array arranged around a common axis).
Singhal further teaches a compact concentric thermo-tactile geometry in which a central vibratory generator is located within a surrounding annular structure (Singhal, p. 91, §II.B, ¶1: “The thermoelectric cooler (TEC) had an outer diameter of 25 mm and consisted of an annulus with a 9.8 mm hole at the center… A coin vibration motor… was placed at the center of the Peltier device”; Singhal teaches a central vibratory stimulus generator and a surrounding coaxial annular geometry, showing that multimodal haptic components may be arranged coaxially around a central vibration motor).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Law, Sawada, and Singhal such that the array of piezoelectric materials comprises a radial array that is coaxial with and surrounds the impact or vibratory stimulus generator. A person of ordinary skill in the art would have recognized that Law’s piezoelectric array implementation could be arranged in Sawada’s known radial/cylindrical array geometry and placed coaxially around the central impact or vibratory stimulus generator in the manner suggested by Singhal’s concentric thermo-tactile arrangement. The combination would have been possible because Toth provides the compact module/housing architecture and onboard electronics, Law provides PCB-supported electrically coupled piezoelectric array elements, Sawada provides the radial/cylindrical piezoelectric array layout, and Singhal provides the coaxial arrangement of a surrounding annular structure around a central vibration motor. The benefit would have been symmetric circumferential pressure-energy output around the central impact or vibratory stimulus generator, improved directional balance and spatial uniformity, compact integration of multiple stimulus modalities, and reduced mechanical interference with the central vibratory component.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales, and further in view of Worthington et al. (US-20190290308-A1), hereto referred as Worthington.
The modified Toth teaches claim 44 as shown above.
Regarding claim 54, the modified Toth does not fully teach that an electrical connection is established between the controller and a power source in the body when the exterior surface of the housing is axially received in the opening of the body.
As set forth in the rejection of claim 53, Toth teaches the axial receipt aspect because FIG. 12a depicts module 1215 aligned with and moved into mating engagement with patch 1201 along the patch/module mating axis, while Grant supplies the opening/receiving structure of the body. Furthermore, the modified Toth teaches that the module is configured and dimensioned to mate with the patch and interface with the subject therethrough, that the module interconnect is sized and dimensioned to interface with a corresponding patch interconnect to form an operable interconnection, and that the module interconnects mesh with corresponding patch interconnects (Toth, FIG. 12a; ¶[0046]: “a module in accordance with the present disclosure configured and dimensioned to mate with the patch, and to interface with the subject there through”; ¶[0044]: “the module interconnect included within the module may be sized and dimensioned to interface with a corresponding interconnect included within the patch interface, wherein to form an operable interconnection between the patch interface and the module”; ¶[0483]: “FIG.12a shows a module 1215 in accordance with the present disclosure configured and dimensioned to mate with the patch 1201”; ¶[0483]: “The module 1215 includes a module interconnect 1217 a,b arranged to mesh with the corresponding patch interconnect 1211 a,b”). Because the patch is the tissue-facing structure applied to the user’s skin and the module mates with the patch to interface with the subject therethrough, the FIG. 12a patch/module mating axis is normal to the skin and corresponds to the claimed signal direction toward the physiologic tissue. Toth further teaches an electrically conducting interconnect interface that conducts current when the removable module/housing is attached to the corresponding patch/body interface (Toth, ¶[0282]: “one or more interconnects may be configured for electrically conducting interconnection, inductively coupled interconnection, capacitively coupled interconnection, between the module and a corresponding patch”; ¶[0282]: “In the case of an electrically conducting interconnect, each patch and module interconnect may include complimentary electrically conducting connectors, configured and dimensioned so as to conduct current there between upon attachment”). Toth also teaches that the module may include the power source and processor together in the module/housing (Toth, ¶[0281]: “a module may include a power source, a housing, one or more interconnects, signal conditioning circuitry, communication circuitry, a processor, a transceiver, a transducer, one or more sensors, an antenna, a buzzer, a button, a light source, and/or the like”). Thus, Toth teaches axial receipt of the removable housing/module in the signal direction and electrical connection upon attachment of the removable module/housing to the patch/body interface. As set forth in the rejection of claim 1, the modified Toth further includes the controller in the housing. However, Toth describes the power source and processor together in the module/housing and therefore does not expressly teach the claimed separated arrangement in which the controller is in the housing and the power source is in the body.
Worthington teaches the missing separated controller/power-source modular electrical architecture. Worthington teaches a body assembly and releasably attachable shaft assembly, where electrical contacts establish an electrical connection when the shaft assembly is attached to the body assembly (Worthington, Abstract: “A surgical instrument includes a body assembly, a shaft assembly that releasably attaches to the body assembly”; “The first and second electrical contacts are configured to electrically couple together to establish an electrical connection therebetween when the shaft assembly is attached to the body assembly”). Worthington maps to the missing claim elements as follows: the handle assembly body corresponds to the claimed body and includes the power source (Worthington, ¶[0058]: “Electric motor (42) is powered by a power source shown in the form of a power pack (44) removably coupled to a proximal portion of handle assembly body (20). Power pack (44) includes one or more batteries…”); the removable shaft assembly corresponds to the claimed housing and includes the controller/microcontroller (Worthington, ¶[0073]: “Electrical connector (132) is configured to electrically couple annular conductors (128) with a shaft circuit board (134), shown schematically in FIG. 4, which may be mounted to shaft chassis (80) and include a microcontroller”); and the electrical connection is established during axial receipt/attachment of the removable assembly (Worthington, ¶[0076]: “During attachment of shaft assembly (14) to handle assembly (12)… tapered attachment members (150) are received within dovetail receiving slots (154) along an installation axis (IA)”; “shaft electrical connector (152) is electrically coupled with handle electrical connector (156)”). Worthington’s installation-axis attachment reinforces the timing requirement because the electrical connection is established as the removable assembly is received along the attachment axis. Thus, Worthington teaches a removable assembly having a controller/microcontroller that electrically connects to body/handle-side powered circuitry through mating connectors when the removable assembly is attached.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Worthington such that an electrical connection is established between the controller in Toth’s removable housing and a power source in the body when the exterior surface of the housing is axially received in the opening of the body. The modified Toth already teaches a removable housing/module, a body/patch interface, and an electrically conducting interface formed between the module and patch/body upon assembly, but Toth describes the power source as being in the module/housing. Worthington teaches a known alternative modular power architecture in which a removable assembly having a controller/microcontroller is mechanically seated in a body/handle and electrically connected to body-side powered circuitry through mating electrical connectors. Worthington is analogous art under both the field-of-endeavor and reasonably-pertinent analyses. As to field of endeavor, both the modified Toth apparatus and Worthington concern handheld or body-associated medical devices having detachable modular assemblies configured to interface with a patient and to establish electrical connection through a removable module/body interface. As to reasonable pertinence, Worthington is reasonably pertinent to the problem faced by a person of ordinary skill in the art because Toth itself contemplates hot-swappable removable modules and electrically conducting interconnects, and the remaining design problem is how to efficiently supply power through a removable module/body interface while maintaining detachable attachment and reliable electrical connection. Worthington directly addresses that modular power-interface problem by using a body/handle power source, electronics in an interchangeable removable assembly, and electrical contacts that establish connection when the removable assembly is attached. Worthington further supports the separability rationale because it teaches that different interchangeable shaft assemblies may be used with the same handle assembly while shaft-side electrical components maintain electrical communication with the handle circuit board (Worthington, ¶[0075]: “various other types of interchangeable shaft assemblies having end effectors configured for various types of surgical procedures may be used in combination with handle assembly (12)”; ¶[0071]: “various other electrical components that require electrical communication with handle circuit board (46) of handle assembly (12)”). Thus, a person of ordinary skill in the art would have recognized that, in Toth’s modular and hot-swappable device, the power source could predictably be located either in each removable module, as Toth expressly describes, or in the reusable supporting body/base with power supplied to the removable module through the mating electrical interface, as taught by Worthington. Applying Worthington’s body-side power and mating electrical connector arrangement to the modified Toth apparatus would have predictably allowed Toth’s controller in the removable housing to receive power through the body opening/attachment interface when the housing is seated, while preserving Toth’s hot-swappable removable-module architecture. The combination would have been possible because the modified Toth already includes complementary module/body interconnects forming an electrically conducting interface upon assembly, and Worthington teaches corresponding handle/shaft electrical connectors that electrically connect a removable assembly circuit board to handle-side electronics associated with the handle/body power pack when the removable assembly is attached. The benefit would have been reducing the size, weight, and cost of each hot-swappable removable housing, allowing a larger, rechargeable, or more serviceable power source to remain in the reusable body, avoiding duplication of batteries across multiple interchangeable housings, supplying power only when the housing is properly seated, and simplifying replacement or swapping of the removable housing without separately managing a battery in each housing.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales, and further in view of Reif et al. (US-20190094088-A1), hereto referred as Reif.
The modified Toth teaches claim 44 as shown above.
Regarding claim 55, under the Examiner’s interpretation set forth in the §112(b) rejection above, the modified Toth teaches or at least suggests that the housing comprises a tapered exterior shape that tapers in the signal direction along a length of the housing. The modified Toth teaches a removable module/housing configured and dimensioned to mate with a tissue-facing patch/body interface along the signal direction. In particular, Toth teaches that the module is configured and dimensioned to mate with the patch and interface with the subject therethrough, and that module interconnects mesh with corresponding patch interconnects (Toth, FIG. 12a; ¶[0046]: “a module in accordance with the present disclosure configured and dimensioned to mate with the patch, and to interface with the subject there through”; ¶[0483]: “FIG.12a shows a module 1215 in accordance with the present disclosure configured and dimensioned to mate with the patch 1201”; ¶[0483]: “The module 1215 includes a module interconnect 1217 a,b arranged to mesh with the corresponding patch interconnect 1211 a,b”). Toth also teaches module interconnects configured to mate with corresponding patch interconnects, including snap elements and magnetic elements (Toth, ¶[0446]). Under the Examiner’s interpretation, Toth’s meshing and mating interconnect structures at least suggest exterior engagement/fitment features of the removable module/housing that change contour along the patch/module mating direction, which corresponds to the signal direction when the module is received toward the tissue-facing patch/body interface.
While Toth’s meshing interconnect structures suggest exterior engagement/fitment features that change contour along the signal direction, Toth does not expressly teach a specifically tapered exterior housing profile along the length of the housing. Reif teaches the missing specific geometry in a wearable module/receptacle arrangement analogous to Toth’s module/patch arrangement. Reif’s DED component corresponds to the claimed housing because it is a removable electronics module releasably attached to and detached from a receiving structure, and Reif’s SAS component corresponds to the claimed body because it is a receiving docking structure associated with a wearable substrate that receives and retains the DED component. Reif teaches that the SAS may be permanently or detachably associated with footwear, a garment, or an object and configured as a docking component having a predetermined conformation for detachably receiving a mating DED component, and that discrete SAS and DED components have complementary mechanical and electrical configurations for convenient and high-fidelity mating (Reif, ¶[0021]: “the SAS may be permanently or detachably associated with footwear, a garment or an object with which the sensor assembly is associated and may be configured as a docking component having a predetermined conformation for detachably receiving a mating DED component”; ¶[0021]: “Discrete SAS and DED components that can be operably coupled to and also detached from one another have complementary mechanical and electrical configurations for facilitating convenient and high fidelity mating of the components”). Reif further teaches that the DED core device is detachably and stably mounted in an SAS receipt cavity by complementary contours and a secure press-fit, with the receptacle side walls expressly being tapered or radiused, and with the DED core device having an enlarged exterior rim, chamfered side-wall surfaces, and a smaller DED body received toward the receptacle base wall (Reif, ¶[0068]: “the upper and side wall contours of receipt cavity 70 correspond generally to outer contours of a DED body... to provide detachable yet stable mounting of DED core device 90 in receipt cavity 70”; ¶[0068]: “Exterior surfaces of side walls 61, 62, 63, 64 may be tapered or radiused, as shown, toward a central location”; ¶[0070]: “Exterior surface 91... has a perimeter larger than that of DED body 100, forming an enlarged rim extending peripherally of side walls 92, 93, 94, 95”; ¶[0070]: “Side walls 92, 93, 94 95 are illustrated as being generally flat with chamfered surfaces interfacing with exterior surface 91”; ¶[0071]: “DED core body 100 comprises side walls having a configuration that is complementary to and matches side walls of the SAS receptacle receipt cavity 70, providing a secure press-fit of DED core body 100 in SAS receipt cavity 70”). Because Reif expressly teaches that the SAS and DED components have complementary mechanical configurations for high-fidelity mating (Reif, ¶[0021]), that the SAS receipt cavity side walls are tapered or radiused (Reif, ¶[0068]), and that the DED core body side walls are complementary to and match the SAS receptacle receipt cavity side walls (Reif, ¶[0071]), Reif teaches or at least suggests that the DED core body side walls are correspondingly tapered or radiused to match the receptacle geometry. Thus, when Reif’s DED core device is inserted into the SAS receipt cavity toward the base wall and corresponding sensor/terminal interface, the DED module housing has an exterior profile that is larger at the enlarged rim away from the receptacle/base interface and smaller at the complementarily tapered or radiused body received closer to the base wall. Under the Examiner’s interpretation, Reif’s enlarged rim, chamfered side walls, complementary press-fit body, and receipt-cavity geometry teach or at least suggest the claimed tapered exterior shape that tapers in the signal direction along a length of the housing.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Reif such that the housing comprises a tapered exterior shape that tapers in the signal direction along a length of the housing. Reif is analogous art because it is in the same field of endeavor as the claimed apparatus and Toth’s wearable patch/module system, namely wearable body-associated electronic devices having removable modules that electrically and mechanically couple to body-worn or garment-associated sensor structures. Reif is also reasonably pertinent to the problem addressed by claim 55 because it addresses how to detachably receive, align, press-fit, and electrically couple a removable electronics module within a receiving docking component, which is the same module-retention and seating problem presented by Toth’s removable module/housing and patch/body interface. A person of ordinary skill in the art seeking to improve the axial guidance, consistent seating depth, retention, and electrical/mechanical coupling of Toth’s removable module housing within the patch/body interface would have found in Reif a known wearable sensor module docking architecture that directly addresses these problems. Reif teaches complementary SAS and DED housing components that detachably receive one another, provide convenient and high-fidelity mating, use complementary and/or locking mechanical configurations, and provide detachable yet stable mounting and a secure press-fit between the DED core body and SAS receipt cavity. A person of ordinary skill in the art would have recognized that applying Reif’s known enlarged-rim, chamfered-wall, tapered/radiused, complementary press-fit docking geometry to Toth’s removable module housing would have predictably improved insertion guidance, repeatable seating, resistance to rocking or lateral shifting, retention of the module in the body/patch interface, and alignment of electrical contacts during use. The combination would have been possible because Toth already provides a removable module/housing and tissue-facing patch/body interface, and Reif provides a compatible wearable sensor module docking architecture for detachably and securely mounting an electronics module in a receiving component associated with a garment, footwear, body surface, or other wearable sensor substrate. The benefit would have been improved guided insertion, repeatable seating, secure retention, and stable electrical/mechanical coupling of the removable module housing during use.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US-20150335288-A1), hereto referred as Toth, and further in view of Grant et al. (US-20150287293-A1), hereto referred as Grant, and further in view of Singhal et al. (Singhal, Anshul, and Lynette A Jones. “Perceptual Interactions in Thermo-Tactile Displays.” 2017 IEEE World Haptics Conference (WHC). IEEE, 2017. 90–95. Web.), hereto referred as Singhal, and further in view of Gonzales et al. (US-6326901-B1), hereto referred as Gonzales, and further in view of Stivoric et al. (US-20140275812-A1), hereto referred as Stivoric.
The modified Toth teaches claim 44 as shown above.
Regarding claim 59, the modified Toth teaches that the plurality of generator elements comprise an electrical stimulus generator element comprising electrical contact plates (Toth, ¶[0079]: “the patch interface may include a stimulating device selected from an electrical stimulator... arranged along the substrate so as to interface with the skin of the subject”; FIGS. 20a-20l: depicting both micro and macro electrodes; ¶[0454]: “The patch 301 includes a plurality of electrodes 303a-e for interfacing with a subject”; ¶[0455]: “The patch 306 includes a bipolar electrode arrangement 307 a,b for interfacing with a subject”; Toth teaches an electrical stimulator and conductive electrodes/bipolar electrodes at the subject interface, corresponding to electrical contact plates of an electrical stimulus generator element); operable to output an electrical energy of the plurality of different energy types by converting a third flow of electricity from the power source into an electrical stimulus recognizable by electricity-sensitive receptors of the physiologic tissue (Toth, ¶[0455]-[0456]: “a stimulation device” may be “coupled with a stimulatory component (e.g. ... an electrical stimulation component ...)”; ¶[0528]: “a stimulator 2095 coupled to the substrate 2091”; ¶[0295]: “A module... may include a power source... a processor”; ¶[0540]: “Such stimulation may be advantageous to interact and/or stimulate one or more neural structures, nerves, and/or receptors...”; Toth teaches a powered electrical stimulation component coupled to the substrate and arranged to interface with skin, thereby converting electricity from the module power source into electrical stimulus energy recognizable by neural structures/receptors of the physiologic tissue).
Also regarding claim 59, the modified Toth does not fully teach that the electrical contact plates are positioned on the tissue contact surface. Rather, the modified Toth teaches electrodes/contact plates at a subject-facing patch/substrate interface (Toth, FIGS. 20a-20l; ¶[0454]: “The patch 301 includes a plurality of electrodes 303a-e for interfacing with a subject”; ¶[0455]: “The patch 306 includes a bipolar electrode arrangement 307a, b for interfacing with a subject”). However, to the extent Toth’s patch/substrate is relied upon as the body rather than the housing/tissue contact surface in the independent claim rejection, Toth does not expressly teach the contact plates positioned on the tissue contact surface of the housing/output-device arrangement.
Stivoric teaches the missing placement of electrical contact plates on a skin-contacting surface of a wearable device housing. Specifically, Stivoric teaches that “bottom portion 440 includes, on a bottom side thereof, a raised platform 430” and that “GSR sensors 465, preferably comprising electrodes formed of a material such as conductive carbonized rubber, gold or stainless steel” are affixed to the raised platform (Stivoric, ¶[0109]). Stivoric further teaches that “the individual GSR sensors 465, i.e., the electrodes, are electrically isolated from one another” and that “[b]y being affixed to raised platform 430, heat flux sensor 460 and GSR sensors 465 are adapted to be in contact with the wearer’s skin when armband sensor device 400 is worn” (Stivoric, ¶[0109]). Stivoric also teaches electrical connection between the skin-contact electrodes and internal electronics, stating that “[e]lectrical coupling between heat flux sensor 460, GSR sensors 465, and PCB 445 may be accomplished in one of various known methods,” including wiring molded into bottom portion 440 of computer housing 405 or passed through thru-holes in the housing (Stivoric, ¶[0110]). Thus, Stivoric teaches conductive electrode/contact-plate structures located on a raised skin-contacting surface of a device housing and electrically coupled to internal PCB electronics.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Toth in view of Stivoric such that the electrical stimulus generator element includes conductive electrical contact plates positioned on the tissue contact surface of the housing/output-device arrangement. As set forth above regarding claim 44, the modified Toth/Grant arrangement uses a housing/output-device structure having a tissue contact surface for transferring stimulus energy to physiologic tissue. A person of ordinary skill in the art would have recognized that, in that modified housing-based structure, Toth’s electrical stimulator would require conductive tissue-facing contact structures at the tissue contact surface in order to deliver electrical stimulus to the physiologic tissue. Stivoric teaches a known wearable-device configuration in which conductive electrodes, formed of materials such as conductive carbonized rubber, gold, or stainless steel, are affixed to a raised skin-contacting surface of a device housing and electrically coupled to internal PCB electronics. It would therefore have been a predictable implementation of Toth’s electrical stimulation function in the modified Toth/Grant housing arrangement to use Stivoric’s housing-mounted conductive electrode/contact-plate structure at the tissue contact surface. The combination would have been possible because the modified Toth already includes a module/housing, power source, controller, and electrical stimulation component, while Stivoric supplies a known housing-mounted conductive electrode structure for contacting skin and coupling to internal electronics. The benefit would have been reliable electrical coupling between the electrical stimulus generator and the physiologic tissue, predictable delivery of electrical stimulus energy through conductive contact plates at the tissue contact surface, and integration of the electrical tissue interface into the same housing/output structure used to deliver the other stimulus energies.
Response to Arguments
Objections
Applicant's arguments filed 03/09/2026, page 17, regarding the previous Objections of claims 48, 49, and 50 have been fully considered and are persuasive. The previous Objections have been withdrawn. However, there are new objections to claims 26, 44, 58, 61, 65, 66, 67, 71, and 73 as shown above.
35 U.S.C. §112(b)
Applicant's arguments filed 03/09/2026, page 17, regarding the previous 112(b) Rejections of claims 12, 15-16, 27, 40, and 50 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn. However, there are new 112(b) rejections to claims 1, 3, 5, 7, 13, 15-17, 19-21, 23-27, 29, 35-36, 44, and 51-74 as shown above.
35 U.S.C. §112(d)
Applicant's arguments filed 03/09/2026, page 17-18, regarding the previous 112(d) Rejections of claims 12 and 15-16 have been fully considered and are persuasive. The previous 112(d) rejections have been withdrawn. However, there are new rejections of claim 29 as shown above.
35 U.S.C. §103
Applicant's arguments filed 03/09/2026, pages 18-20, regarding the previous 103 Rejections of claims1, 2-3, 5-7, 10-13, 15-17, 19-21, 23-40, and 42-50 have been fully considered but are either 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 (that is, there are new grounds of rejection) or the arguments were not persuasive.
Specifically, Applicant argues:
Applicant’s Argument: Applicant argues that independent claim 1 has been amended to recite limitations regarding a body, a housing, a tissue contact surface, and a plurality of generator elements that are not disclosed by Toth, Singhal, or any other art of record, individually or in combination.
Examiner’s Response: Applicant’s argument is not persuasive. The rejection has been updated under the broadest reasonable interpretation of the amended claim language and relies on Toth in combination with Grant, Singhal, and Gonzales.
Toth teaches a patch/module system in which the module corresponds to the claimed housing and the patch/substrate corresponds to the claimed body. Toth teaches that “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280” (Toth, ¶[0448]), that Toth teaches “swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc.” (Toth, ¶[0314]), and that “the module 235 includes multiple module interconnects 240a, b… configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects 230a, b,” which “may include snap elements, magnetic elements, etc.” (Toth, ¶[0446]). Toth further teaches generator elements, controller circuitry, power-management circuitry, and PCB-supported components within the module structure, including “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)” (Toth, ¶[0450]) and a module including “a controller, a power supply, power management circuit” (Toth, ¶[0462]). To the extent Toth does not clearly teach that the module housing itself includes the tissue contact surface operable to transfer the plurality of different energy types to physiologic tissue, Grant teaches that “the flexible mounting includes a flexible casing, and the haptic output device is carried by the flexible casing” (Grant, ¶[0008]) and that “the haptic output device 112 is connected to the flexible mounting 115 so that the haptic output device 112 comes into contact with the user’s skin when the wearable device 110 is placed on the user” (Grant, ¶[0034]). Thus, the rejection does not rely on Toth alone for every newly amended structural feature, but instead relies on the combined teachings as set forth in the rejection above.
Applicant’s Argument: Applicant argues that Toth’s Fig. 2c discloses a printed circuit board as a bottom portion of housing 265 and that Toth does not describe components 270, how they work, or how they are mechanically supported relative to one another.
Examiner’s Response: Applicant’s argument is not persuasive because Toth is not limited to the isolated view of Fig. 2c. Toth expressly teaches that “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280” (Toth, ¶[0448]). Toth further teaches that components 270 may include “microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.” (Toth, ¶[0450]). Toth also teaches a controller/microcircuit because Toth states that the device “includes a controller/microcircuit 2051” (Toth, ¶[0521]) and teaches module structures including “a controller, a power supply, power management circuit” (Toth, ¶[0462]). Under the broadest reasonable interpretation, the PCB functions as the claimed frame because it mechanically supports and electrically integrates controller circuitry and generator/transducer components while forming part of the module housing. Applicant’s focus on Fig. 2c alone does not address these additional teachings of Toth relied upon in the present rejection.
Further, under the broadest reasonable interpretation, “a controller comprising a printed circuit board” encompasses a PCB-based controller assembly in which controller circuitry is mounted on, soldered to, stacked on, embedded into, mechanically supported by, or electrically integrated with a PCB, with the PCB providing electrical routing between the controller circuitry, power source, and generator elements. This interpretation is consistent with the instant specification’s description of PCB-based structures, where the specification describes a PCB-based frame that mechanically supports and electrically connects the controller and generator elements, with the controller and generator elements soldered onto the frame to electrically connect and mechanically fasten them to a common platform.
Applicant’s Argument: Applicant argues that Toth and Singhal are silent with respect to “a body graspable with a hand of a user” and “a housing that is removably attached to the body.”
Examiner’s Response: Applicant’s argument is not persuasive because the claim does not require the apparatus to be a handheld device or to be continuously held by the user’s hand during operation. Rather, the claim requires a body “graspable with a hand of a user,” which broadly encompasses a physical wearable structure that can be held, positioned, donned, adjusted, or applied by a user’s hand. Toth teaches such a body because Toth describes a patch/substrate structure at the skin interface, stating that “the patch interface may include a stimulating device… arranged along the substrate so as to interface with the skin of the subject” (Toth, ¶[0079]). Toth further confirms that its wearable structures are of a hand-manipulable size and form factor by teaching that “a feedback component… may include or be included in a wristwatch (e.g. a biometric watch, a smart watch, etc.)” (Toth, ¶[0181]). Thus, under the broadest reasonable interpretation, Toth’s patch/substrate corresponds to the claimed body because it is a physical wearable structure that can be grasped, handled, positioned, or applied by a user’s hand.
Toth also teaches the claimed housing and removable attachment to the body. Toth states that “The module 260 includes a housing 265” (Toth, ¶[0448]), and separately teaches “swapping the module with a new module, swapping the module out without interrupting the monitoring procedure, removing the module and corresponding patch from the subject, etc.” (Toth, ¶[0314]). Toth further explains the removable relationship between the module and the patch/substrate by teaching module interconnects “configured, dimensioned, and arranged so as to mate with the corresponding patch interconnects” and that such interconnects “may include snap elements, magnetic elements, etc.” (Toth, ¶[0446]). Thus, when the patch/substrate is read as the claimed body and the module housing is read as the claimed housing, Toth teaches a housing removably attached to the body through mating snap or magnetic interconnect structures.
Applicant’s Argument: Applicant argues that Toth and Singhal do not teach “a tissue contact surface operable to transfer the plurality of different energy types to the physiologic tissue when maintained against the physiologic tissue by external forces applied to the body with the hand.”
Examiner’s Response: Applicant’s argument is not persuasive because Toth teaches applying an external hand force to bias device elements into engagement with tissue. In particular, Toth teaches that “upon pressure application… (e.g. a thumb, an applicator, etc.), the electrode features may be biased towards the skin” and that such biasing may occur “during the monitoring session” (Toth, ¶[0262]). Toth further teaches that electrode features “may be forced into engagement with an adjacent tissue surface via a bias force… as may be applied by a thumb over top thereof” (Toth, ¶[0496]). Although Toth describes this hand-applied force in the context of electrode features, Toth also teaches stimulation elements arranged “to interface with the skin of the subject” (Toth, ¶[0079]), including thermal and vibratory elements. A person of ordinary skill in the art would have understood that, where stimulation elements are likewise arranged to interface with the skin, applying pressure to the device body similarly improves coupling between the device and skin for energy-generating elements because increased contact improves energy transfer across the tissue interface. To the extent Toth does not clearly teach that the module housing itself includes the tissue contact surface, Grant teaches a wearable haptic casing/flexible mounting carrying a haptic output device that comes into contact with the user’s skin, as Grant teaches that “the flexible mounting includes a flexible casing, and the haptic output device is carried by the flexible casing” (Grant, ¶[0008]) and that “the haptic output device 112… comes into contact with the user’s skin when the wearable device 110 is placed on the user” (Grant, ¶[0034]).
Applicant’s Argument: Applicant argues that Toth fails to describe the recited energy generator elements and further argues that Singhal fails to describe the recited energy generator elements and their configuration.
Examiner’s Response: Applicant’s argument is not persuasive. Toth teaches multiple generator modalities, including “a tactile stimulating component, a vibratory stimulating element” and “a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… a combination thereof” (Toth, ¶[0079]). Toth further teaches a module including a transducer configured to generate vibrational energy for transfer into the subject because “the module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301” (Toth, ¶[0488]). Toth also teaches thermal generator structures including “one or more heater bands 1405” and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). Accordingly, Toth teaches the general thermal and impact/vibratory generator element framework.
Applicant’s argument regarding Singhal is also not persuasive because the rejection does not rely on Singhal to teach every recited generator element or the entire apparatus structure. Rather, Singhal is relied upon for the narrower teachings of independently varied thermal and vibratory stimulus dimensions, a skin-facing thermoelectric/Peltier device, and an annular Peltier/central vibration motor arrangement in which the thermal and vibratory elements are physically spaced apart. Singhal teaches that “[t]he thermal patterns varied with respect to the direction, rate, and duration of the change in skin temperature and for the vibration inputs the number of pulses was varied” (Singhal, p. 90, Abstract), that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” (Singhal, p. 91, Sec. II), and that “[a] coin vibration motor… was placed at the center of the Peltier device” (Singhal, p. 91, Sec. II). The present rejection further relies on Gonzales for the specific linearly actuated piston structure and Grant for the tissue-contacting housing arrangement. Thus, Singhal need not independently disclose every recited generator element in the claimed combination.
Applicant’s Argument: Applicant argues that Toth and Singhal do not teach “an impact or vibratory stimulus generator element operable with a linearly actuated piston.”
Examiner’s Response: Applicant’s argument is addressed by the updated rejection. Toth teaches an impact or vibratory stimulus generator element to a significant extent because Toth teaches “a tactile stimulating component, a vibratory stimulating element” (Toth, ¶[0079]), a transducer configured to generate vibrational energy because “the module 1315 includes a transducer 1305 configured to generate vibrational energy 1325 for transfer 1330 into the subject 1301” (Toth, ¶[0488]), and application of “tactile stimulus, vibrational energy, stroking, poking, circular movement, etc.” (Toth, ¶[0488]). Toth further teaches that “the transducer 1305 may be a motor with an unbalanced shaft, a stroking actuator, etc.” (Toth, ¶[0488]). However, the Examiner acknowledges that Toth does not specifically teach that the impact or vibratory stimulus generator element is operable with a linearly actuated piston. Gonzales is relied upon for this missing feature. Gonzales teaches “a vibromechanical stimulator with a tactile effector portion as a solenoid 46 with its electrical connection 48 and a solenoid piston 62,” wherein the “solenoid piston 62 acting as a tactile effector is in a retracted position and upon energizing solenoid 46, solenoid piston 62 will be forced out aperture 60 through housing face 58” (Gonzales, col. 12, ll. 59-65). Gonzales further teaches that “projection of any of the solenoid pistons 62 impinge against the wearer’s skin and convey a tactual stimulation to the wearer” (Gonzales, col. 12, l. 65-col. 13, l. 11). It would have been prima facie obvious to further modify the modified Toth in view of Gonzales by using Gonzales’s solenoid piston as the stroking or poking actuator of Toth because it provides a known, predictable electrically actuated mechanism for producing localized impact, poking, stroking, or vibratory tactile stimulation toward tissue.
Applicant’s Argument: Applicant argues that Toth and Singhal do not teach “a thermal stimulus generator element operable with an electrothermal device.”
Examiner’s Response: Applicant’s argument is not persuasive. Under the broadest reasonable interpretation of “operable with an electrothermal device,” the thermal stimulus generator element may be the electrothermal structure itself or a broader thermal stimulation assembly that operates with an electrothermal device. Toth teaches “a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device… a combination thereof” (Toth, ¶[0079]), “one or more heater bands 1405” (Toth, ¶[0489]), and “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). The thermoelectric unit, Peltier device, heating coil, and heater bands are electrothermal devices because they use electricity to generate heating or cooling. Toth’s thermal elements for application to adjacent tissue teach outputting thermal energy toward physiologic tissue, and such heating or cooling would be recognizable by temperature receptors in the tissue.
Applicant’s Argument: Applicant argues that Toth and Singhal do not teach “the electrothermal device being positioned between the printed circuit board and the tissue contact surface.”
Examiner’s Response: Applicant’s argument is addressed by the updated combination. The Examiner agrees that Toth does not expressly teach this specific positional relationship. However, Toth teaches a module housing having PCB-supported components, controller electronics, and thermal generator elements because “The module 260 includes a housing 265, a portion of which is provided by a printed circuit board 280” (Toth, ¶[0448]), “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.)” may be included in the module (Toth, ¶[0450]), and Toth teaches “one or more thermoelectric units, a Peltier device” (Toth, ¶[0489]). Singhal teaches a thermoelectric/Peltier device positioned at the skin-contacting interface for delivering thermal cues to the skin because Singhal teaches that “[a] multisensory display was built to provide thermal and vibratory cues to the skin” (Singhal, p. 91, Sec. II), that “[t]he thermoelectric module was an annular Peltier device… giving a contact area with the skin of 377 mm2” (Singhal, p. 91, Sec. II), and that “[t]he base of the thumb is in contact with the Peltier module and hand rests on a surface” (Singhal, p. 91, Sec. II). It would have been prima facie obvious to further modify the modified Toth in view of Singhal such that the electrothermal device is positioned at the tissue-contacting side of the housing while the PCB/controller structure is positioned behind the electrothermal device to support, route power to, and control the thermal generator. This yields the claimed arrangement in which the electrothermal device is positioned between the printed circuit board and the tissue contact surface, with the benefit of direct and efficient thermal transfer to physiologic tissue and a compact layered support/control structure.
Applicant’s Argument: Applicant argues that the prior art fails to teach the claimed generator elements in combination with the other claim limitations.
Examiner’s Response: Applicant’s argument is not persuasive because the updated rejection expressly addresses the claimed combination. Toth provides the patch/module architecture, removable module housing, PCB/controller/frame structure, thermal and vibratory generator teachings, and hand-applied force teaching (Toth, ¶[0079], ¶[0262], ¶[0314], ¶[0446], ¶[0448], ¶[0450], ¶[0462], ¶[0488], ¶[0489], ¶[0521]). Grant provides the known wearable haptic casing/flexible mounting arrangement in which a removable casing carries a haptic output device positioned at the tissue-contacting interface (Grant, ¶[0008], ¶[0032], ¶[0034], ¶[0047]). Singhal provides independent control of thermal and vibratory stimulus dimensions and the annular Peltier/central vibration motor arrangement, including spacing between thermal and vibratory elements and a skin-facing thermoelectric device (Singhal, p. 90, Abstract; p. 90, Sec. I; p. 91, Sec. II; Fig. 1). Gonzales provides the linearly actuated piston used to generate tactile stimulation (Gonzales, col. 12, l. 59-col. 13, l. 11). The combination is supported by articulated reasons to combine, including improved tissue coupling, reliable transfer of generated stimulus energy, modularity, independent multimodal control, thermal isolation, compact co-location, and predictable use of known haptic/thermal actuator structures for their established purposes.
Applicant’s Argument: Applicant argues that the cited art does not provide a teaching, suggestion, or motivation to modify Toth’s housing, components, and printed circuit board to arrive at the amended limitations.
Examiner’s Response: Applicant’s argument is not persuasive. The rejection is not based on bodily incorporation of each reference into Toth, but on the predictable use of known wearable haptic and thermal actuator arrangements for their established purposes. Toth already teaches a removable patch/module system with PCB-supported controller and transducer components, thermal and vibratory stimulation elements, and hand-applied force for engagement with tissue (Toth, ¶[0079], ¶[0262], ¶[0314], ¶[0446], ¶[0448], ¶[0450], ¶[0462], ¶[0488], ¶[0489], ¶[0521]). Grant teaches a wearable haptic casing carrying an output device at the skin-contacting interface (Grant, ¶[0008], ¶[0034], ¶[0047]). Singhal teaches independently controlled thermal and vibratory stimuli with a skin-facing Peltier structure and central vibration motor (Singhal, p. 90, Abstract; p. 91, Sec. II). Gonzales teaches a solenoid piston tactile effector for delivering tactual stimulation to skin (Gonzales, col. 12, l. 59-col. 13, l. 11). The stated reasons to combine are improved tissue coupling, direct energy transfer, independent multimodal control, compact co-location, thermal isolation, and predictable localized tactile output. Accordingly, the rejection provides articulated reasoning with rational underpinning for the proposed modifications.
Applicant’s Argument: Applicant requests withdrawal of the § 103 rejection of independent claim 44 for reasons similar to those presented for claim 1.
Examiner’s Response: Applicant’s argument is not persuasive. Claim 44 recites limitations similar to claim 1 regarding the body, removable housing, tissue contact surface, independently operable generator elements, impact/vibratory stimulus generator element, thermal stimulus generator element, spacing between generator elements, and tissue-contacting arrangement. Those limitations are addressed above and in the rejection of claim 44. To the extent claim 44 further recites a sensor operable to detect physiological signals associated with the physiologic tissue, a transceiver operable to send and receive data over a network, and controller operation with the transceiver to activate generator elements responsive to physiological signals, Toth teaches physiological sensing, controller circuitry, communication/network functionality, and control of device components responsive to collected physiological information as set forth in the rejection of claim 44. Accordingly, Applicant’s arguments do not overcome the rejection of claim 44.
Applicant’s Argument: Applicant argues that new claims 51-74, including new independent claim 65, are patentable over the art of record because claim 65 includes limitations like those of amended claims 1 and 44.
Examiner’s Response: Applicant’s argument is not persuasive. To the extent claim 65 recites limitations corresponding to amended claims 1 and/or 44, those limitations are addressed above and in the rejection of claim 65. The Examiner has considered claim 65 separately, and the rejection identifies where the applied references teach or render obvious each limitation of claim 65. Accordingly, the filing of new claim 65 does not overcome the applied prior art.
Applicant’s Argument: Applicant requests withdrawal of the § 103 rejection because independent claims 1 and 44, and their respective dependent claims, are allegedly patentable over the art of record.
Examiner’s Response: Applicant’s request is not persuasive at least with respect to independent claims 1, 44, and 65 because the amended and newly presented independent claim limitations are taught or would have been obvious over the applied references for the reasons set forth above and in the rejections. The rejection of claim 1 has been updated to address the amended limitations and Applicant’s arguments, including the body/housing relationship, tissue-contacting housing structure, independently operable generator elements, linearly actuated piston, spacing between impact/vibratory and thermal stimulus generator elements, and the electrothermal device positioned between the printed circuit board and the tissue contact surface. The corresponding limitations of claims 44 and 65 are addressed in their respective rejections. Because Applicant has not presented separate arguments for the dependent claims apart from their dependence from the independent claims, the dependent claims remain rejected for the reasons stated in the present Office Action.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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