Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“connection means” in claim 18
“fastening means” in claims 20 and 33
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9-10, 12-14, 26, 28-29, 31 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim term “resilient structure made of a low resistance conductive material” in claims 7 and 26 is a relative claim term which renders each claim indefinite. The terms “resilient” and “low resistance” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, the Specification [0065] recites “the plurality of contact pads 300 is made of a low resistance conductive material, such as copper, aluminum, gold, nickel, other metallic material, or any combination thereof”; it is the Examiner’s best guess that the listed metallic materials (or functional equivalent) satisfy “resilient structure made of a low resistance conductive material” in the claim; the Applicant is required to amend the claim for clarity.
The claim term “low reference voltage” in claims 9-10, 12, 28-29 and 31 is a relative claim term which renders each claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, the Specification [0059] recites “the ultra-low current is delivered to each of the acupoints for stimulation by coupling the pulse stimulation signal and a low reference voltage to the patient. Preferably, the low reference voltage has a ground (GND) voltage potential.” It is the Examiner’s best guess that ‘ground voltage potential’ (or functional equivalent) satisfy “low reference voltage” in the claim; the Applicant is required to amend the claim for clarity.
Regarding claims 13 and 14, the phrase "preferably" renders each claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 33, the claim recites “fastening means for applying a tension to hold the TENS device tightly on the head”; the claim term “tightly” is a relative claim term which renders each claim indefinite. The term “tightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, this claim feature is interpreted as applying tension to hold the TENs device against the head/scalp.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 15-16, 23-26, 32 and 34-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang US 2020/0306536 A1 (hereinafter “Wang”).
Regarding claim 1, Wang discloses a head-mount transcutaneous electrical nerve stimulation (TENS) device (Abstract and Fig. 9: head mount device with housing 7) adapted to stimulate acupoints of a user transcutaneously when being worn on the head of the user (Abstract and [0005-0006], electrical and heat stimulation onto the user’s head/scalp), comprising:
one or more frames arranged to have a contour matching an anatomical shape of the head (helmet or hat like housing 7, as shown in Fig.9 and [0035: 1st-2nd sentence]);
a plurality of contacts (device electrode assembly, exemplary as shown in Figs. 4-8) arranged on an inner surface of the one or more frames for contacting the acupoints on the head (see [0036] and Fig. 9: assemblies 2, 3, 4 and 5 are mounted on the interior of housing 7, adapted to contact the user’s scalp);
a pulse width modulation (PWM) generator (pulse generating circuitry 8) configured to generate a pulse stimulation signal and couple the pulse stimulation signal to the plurality of contacts for stimulating the acupoints ([0034-0035, 0040-0041] electrodes output stimulating electrical pulse to contacted acupoints on the scalp); and
one or more thermal pads (Figs. 6-7: heating elements) arranged on the inner surface of the one or more frames (Fig.9 mounted in the interior of housing 7) for applying thermal treatment to at least one of the acupoints. ([0032-0033, 0044] heat element or heat conducting area outputting radiation to contacted acupoints on the scalp)
Note: Wang discloses individual electrode assemblies, such as in Figs. 4-8 and [0030-0034, 0036], each assembly is taken to contact “one group” of acupoints in this office action.
Regarding claim 2, Wang discloses the head-mount TENS device of claim 1, wherein the plurality of contacts comprises a first group of contacts configured for contacting Baihui (GV-20) and Sishencong (EX-HN1) acupoints of the user. ([0036, 0038] electrode assemblies adapted also see Fig. 10 and [0039] “the device as shown in FIG. 10 can be an array of electrode or an array of electrode with heating/IR radiation means covering the skin on top of the brain with the stimulation pulse frequency between 25˜100 Hz, preferably between 35˜45 Hz.”, the area shown covers acupoints Baihui and SiShencong)
Regarding claim 3, Wang discloses the head-mount TENS device of claim 1, wherein the plurality of contacts comprises a second group of contacts configured for contacting Fengchi (GB-20) acupoints of the user. (see [0006, 0038] electrode assemblies adapted to be placed over acupoint Fengchi)
Regarding claim 4, Wang discloses the head-mount TENS device of claim 1, wherein the plurality of contacts comprises a third contact configured for contacting Shenting (GV-24) acupoint of the user. (see Fig. 10 and [0006, 0040-0041] electrode assemblies adapted to be placed over acupoint Shenting)
Regarding claim 5, Wang discloses the head-mount TENS device of claim 1, wherein the plurality of contacts comprises: a first group of contacts configured for contacting Baihui (GV-20) and Sishencong (EX- HN1) acupoints of the user; a second group of contacts configured for contacting Fengchi (GB-20) acupoints of the user; and a third contact configured for contacting Shenting (GV-24) acupoint of the user. (See Figs. 4-8 and [0030-0034, 0036] regarding electrode assemblies, and see Fig. 10 and [0006, 0036, 0038, 0040] mentions the recited acupoints.)
Regarding claim 6, Wang discloses the head-mount TENS device of claim 2, wherein the first group of contacts comprises a first contact pad positioned for contacting the Baihui (GV-20) acupoints, and four adjacent contact pads positioned around the first contact pad for contacting the Sishencong (EX-HN1) acupoints. (see Fig. 10 and [0039] “the device as shown in FIG. 10 can be an array of electrode or an array of electrode with heating/IR radiation means covering the skin on top of the brain with the stimulation pulse frequency between 25˜100 Hz, preferably between 35˜45 Hz.”, the area shown covers acupoints Baihui and SiShencong)
Regarding claim 7, Wang discloses the head-mount TENS device of claim 1, wherein each individual contact of the plurality of contacts has a resilient structure made of a low resistance conductive material. (Fig.6 and [0032] discusses an individual electrode assembly comprising a conductive material made of a metal, this is taken to encompass “a resilient structure made of a low resistance conductive material” in this claim)
Regarding claim 15, Wang discloses the head-mount TENS device of claim 1, wherein the one or more thermal pads (heating elements or heat conductive surface as shown in Fig. 6; see [0032]) are configured to deliver heat to the at least one of the acupoints of the user and areas proximate to the at least one of the acupoints. ([0024-0025, 0043] heating element to acupuncture sites)
Regarding claim 16, Wang discloses the head-mount TENS device of claim 15, wherein each of the one or more thermal pads comprises a winding ([0025] “IR radiation elements can be tungsten wire…”, this is taken to encompass “winding” in the claim) of a thermally conductive material [0032] “heating element or a heat conducting area (e.g. a metal piece)”) for delivering thermal energy to the at least one of the acupoints and the areas proximate ([0043] heating element to acupuncture sites and areas proximate) to the at least one of the acupoints with a temperature ranging between 360C and 400C. ([0024] 35-55 degree)
Regarding claim 23, Wang discloses a transcutaneous electrical nerve stimulation (TENS) device (Abstract and Fig. 9: head mount device with housing 7) adapted to stimulate acupoints of a user transcutaneously (Abstract and [0005-0006], electrical and heat stimulation onto the user’s head/scalp), comprising:
a head article (helmet or hat like housing 7, as shown in Fig.9 and [0035: 1st-2nd sentence]);
a plurality of contacts (device electrode assembly, exemplary as shown in Figs. 4-8) hidden within the head article for contacting the acupoints on the head (see [0036] and Fig. 9: assemblies 2, 3, 4 and 5 are mounted on the interior of housing 7, adapted to contact the user’s scalp);
a pulse width modulation (PWM) generator (pulse generating circuitry 8) configured to generate a pulse stimulation signal and couple the pulse stimulation signal to the plurality of contacts for stimulating the acupoints ([0034-0035, 0040-0041] electrodes output stimulating electrical pulse to contacted acupoints on the scalp); and
one or more thermal pads (Figs. 6-7: heating elements) hidden within the head article (Fig.9 mounted in the interior of housing 7) for applying thermal treatment to at least one of the acupoints. ([0032-0033, 0044] heat element or heat conducting area outputting radiation to contacted acupoints on the scalp)
Claims 24-26 are rejected by Wang, under the same rationale as discussed to claims 5-7 above.
Claim 32 is rejected by Wang, under the same rationale as discussed to claim 15 above.
Regarding claim 34, Wang discloses the TENS device of claim 23, wherein the head article is a helmet, a hat, a headband, a crown, a headgear, a headwear, a hood, or any combination thereof. ([0035: 2nd sentence] “helmet or hat like housing 7”)
Regarding claim 35, this claim is rejected by Wang, under the same rationale as discussed to claim 1 above.
Claims 36 and 37 are rejected by Wang, under the same rationale as discussed to claims 5 and 6 above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-10, 17-21 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1 and 23 above, and in view of Kesinger et al. US 2019/0021665 A1 (hereinafter “Kesinger”).
Regarding claim 8, Wang teaches the head-mount TENS device of claim 7 comprising a plurality skin contacting device electrode assemblies having a contact pad (i.e. contact surface) for contacting the skin against the head at the acupoints (Figs.9-10), but does not disclose wherein each individual contact comprises a spring and a contact pad, wherein the spring is arranged to press the contact pad against the head.
Kesinger, another prior art reference in the analogous art, discloses a head-worn apparatus 21 comprising a plurality of electrode hubs 25, wherein each individual contact comprises a spring and a contact pad ([0119] mechanical biasing mechanism, e.g. coil spring, spring member or the like), wherein the spring is arranged to press the contact pad against the head ([0119] “biasing force provided by the mechanical biasing mechanism [i.e. spring member] can be sufficient to cause the electrode member 26c to move outwardly to its initial position until a patient's head is contacting the electrode member 26c.”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang in view of Kesinger to further include a spring and a contact pad in view of Kesinger, the motivation for doing so is to mechanically press the device electrode assemblies against the skin to ensure contact for adequate stimulation (Kesinger: [0119] tight fit).
Regarding claim 9, Wang further teaches the head-mount TENS device of claim 8, wherein the contact pad is a circular plate (as shown in Figs.4-7, circular pads) electrically connected to the PWM generator (power supply electronics and control 8) for coupling the pulse stimulation signal or to a low reference voltage. (Wang: Fig. 7 and [0033])
Regarding claim 10, Wang further discloses the head-mount TENS device of claim 8, wherein the contact pad comprises a first zone and a second zone (Figs.6-7: anode, i.e. + side is taken to encompass “first zone”, and cathode, i.e. – side is taken to encompass “second zone”), wherein: the first zone and the second zone are separated by an insulating material (Figs. 6-7: heating element in the middle is an insulating material, see [0032]); and the first zone is electrically connected to the PWM generator for coupling the pulse stimulation signal and the second zone is electrically connected to the low reference voltage ([0030] “One electrode will function as cathode (or connects to the hot wire of the current source) and another electrode will function as anode (or connects to the neutral wire).”).
Regarding claim 17, Wang discloses the head-mount TENS device of claim 1 comprising a frame (housing 7) comprising a plurality of electrode assemblies (as shown in Figs. 4-9: assemblies 2-5) covering a plurality of regions over a user’s head including covering areas in the frontal region (2), the parietal region (3) and the occipital region (4) as shown in annotated Fig. 9 below:
PNG
media_image1.png
559
492
media_image1.png
Greyscale
Since Wang’s device is embodied in a helmet or a hat like housing 7 ([0035: 2nd sentence]), Wang does not wherein the one or more frames comprises an upper frame at least partially covering a frontal region and a parietal region of the head, and a lower frame at least partially covering an occipital region of the head. However, it would have been an obvious design choice to modify Wang’s helmet housing with one or more frames that holds respective electrode/stimulating assembles 2-4 with respect to the frontal, parietal and occipital regions in the head; the frame would serve the same purpose as the disclosed helmet for supporting assemblies with respect to intended treatment regions as shown in Fig. 9 above.
Alternatively, Kesinger, another prior art reference in the analogous art, discloses a head-worn apparatus, comprising a plurality of electrode hubs 25, held by a upper frame 23 (vertical frame from forehead to back of head) and a lower frame 23a (horizontal frame from left to right ear; see Fig. 6 and [0110-0111]) with respect to different regions on the head, including the frontal area (Fig.6: 26a), parietal area (Fig.6: 26b and 26c), and occipital area (Fig. 6:25). It would have been obvious to a person of ordinary skill in the art at the time of invention to replace Wang’s helmet housing with Kesinger’s frame (Fig. 6), the motivation for doing so is because the frame provides the added advantage of allowing stimulation units to be moved/adjusted relative to the frame, this way the placement of the stimulation units can be adjusted so as to accommodate different treatment regions and/or different size heads (Kesinger: [0121]).
Regarding claim 18, Wang in view of Kesinger would disclose the head-mount TENS device of claim 17, wherein the upper frame and the lower frame are adjustably connected together using connection means. (See modification to claim 17 rejection above. Furthermore, see Kesinger Fig. 6: interconnecting straps 23a and [0110])
Regarding claim 19, Wang in view of Kesinger would disclose the head-mount TENS device of claim 18, wherein the connection means comprises straps or belts for providing a flexibility to adjust the contour for matching the anatomical shape of the head. (See modification to claim 17 rejection above. Furthermore, see Kesinger Fig. 6: interconnecting straps 23a, also see [0083, 0110] rigid frame and contouring/elastic straps that conform to the shape of a patient’s head)
Regarding claim 20, Wang in view of Kesinger would disclose the head-mount TENS device of claim 17 further comprising fastening means for applying a tension on the upper frame and the lower frame toward the acupoints. (See modification to claim 17 rejection above. Furthermore, see Kensinger: [0074] “The headgear 3 can have structure (e.g. a chin strap that can be buckled or otherwise attachable to the headgear 3) and/or other configuration (e.g. elasticity of the headgear structure) to apply a force on the user's head when the headgear 3 is worn on the user's head to ensure a tight fit on the user's head and/or a quality electrical connection. The tight fit can help with electrode placement and positioning, for example.” and [0115] “The force exerted to have the headgear 3 worn on the patient's head and fit thereon can function to also apply a force via the patient's head”)
Regarding claim 21, Wang in view of Kesinger would disclose head-mount TENS device of claim 20, wherein the fastening means comprises a chin strap fastened around the user's chin and two transverse straps extending from the upper frame to the lower frame, wherein the chin strap and each of the transverse straps are connected to form a Y-shaped configuration around an otic region for securing the head-mount TENS device in position on the head. (See modification to claim 20 rejection above. Kensinger: [0074] discloses using a chin strap for tight fit. Kesinger does not explicitly disclose the chin strap having two transverse straps and forming a Y-shaped configuration as recited in the claim, but this configuration would have been an obvious design choice to a person of ordinary skill in the art at the time of invention because the Y-shaped straps around the otic region is widely use in head worn devices, including helmets, for relative stability to ensure the head-worn device doesn’t shift/slide during head movements.)
Claims 27-29 are rejected by Wang in view of Kesinger under the same rationale as discussed to claims 8-10 above.
Claims 11, 12, 30, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 7 and 23 above, and in view of Sullivan et al. US 2017/0165485 A1 (hereinafter “Sullivan”).
Regarding claim 11, Wang teaches the head-mount TENS device of claim 7 comprising a plurality skin contacting device electrode assemblies having a contact pad (i.e. contact surface) for contacting the skin against the head at the acupoints (Figs.9-10), but does not disclose wherein the individual contact comprises a spring and a contact pad having plural pin electrodes, wherein the spring is arranged to press the plural pin electrodes through the hair of the user against the head.
Sullivan, another prior art reference, discloses a head worn device comprising a frame carrying a plurality of electrode pads with respect to different regions on a user’s scalp, as shown in Fig. 2. Sullivan further discloses that individual contact electrode has a spring and a contact pad having plural pin electrodes ([0076] spring-loaded electrode pins, see Figs. 5A-6B), wherein the spring is arranged to press the plural pin electrodes through the hair of the user against the head ([0076] “the spring-loaded electrode…comply with varying contours of the head, thereby improving the electrical contact with the scalp through hair”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang in view of Sullivan to further include a spring and pin electrode in view of Sullivan, the motivation for doing so is to mechanically press the device electrode assemblies against the skin to ensure contact for adequate stimulation (Sullivan: [0076, 0078])
Regarding claim 12, Wang in view of Sullivan further discloses the head-mount TENS device of claim 11, wherein at least one pin electrode of the plural pin electrodes (see modification to claim 11 rejection above, Sullivan Figs. 51-6B) is electrically connected to the PWM generator for coupling the pulse stimulation signal, and at least one other pin electrode of the plural pin electrodes is electrically connected to a low reference voltage (this is taught in Wang: Fig. 7 and [0033]).
Claims 30 and 31 are rejected by Wang in view of Sullivan under the same rationale as discussed to claims 11 and 12 above.
Regarding claim 33, Wang discloses the TENS device of claim 23 further comprising a plurality skin contacting device electrode assemblies having a contact pad (i.e. contact surface) for contacting the skin against the head at the acupoints (Figs.9-10), but does not disclose fastening means for applying a tension to hold the TENS device tightly on the head.
Sullivan, another prior art reference, discloses a head worn device comprising a frame carrying a plurality of electrode pads with respect to different regions on a user’s scalp, as shown in Fig. 2. Sullivan further discloses that individual contact electrode has a spring and a contact pad having plural pin electrodes ([0076] spring-loaded electrode pins, see Figs. 5A-6B), wherein the spring is arranged to press the plural pin electrodes through the hair of the user against the head ([0076] “the spring-loaded electrode…comply with varying contours of the head, thereby improving the electrical contact with the scalp through hair”). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang in view of Sullivan to further include a spring and pin electrode in view of Sullivan, the motivation for doing so is to mechanically press the device electrode assemblies against the skin to ensure contact for adequate stimulation (Sullivan: [0076, 0078] tension/tight fit)
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claim 1 above, and in view of Molsberger US 2017/0136235 A1.
Regarding claim 13, Wang discloses the head-mount TENS device of claim 1, Wang discloses that the electrical power levels is in the range of 0.5-50 milli-amps (equivalent to 500 µA- 50000 µA); but does not disclose wherein the pulse stimulation signal has an ultra-low current of not more than 20 µA, and preferably the ultra-low current is between 1 µA and 8 µA.
(Note: This claim is rejected under 35 USC 112(b), the limitations following “preferably” is not given patentable weight.)
Molsberger, another prior art reference in the analogous art field of electro-acupuncture apparatus and methods for headache treatment (Abstract, [0010]), includes a direct current delivery device (i.e. electrode to acupuncture points; [0046]) connected to a power source, the electrode outputs current at the range of 2.5-5 μA ([0074: second sentence] “Particularly preferable ranges for the current intensity are from 10-800 μA, …2.5-5 μA (variant B)”. Also see [0077]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang in view of Molsberger to apply electrical power levels in the low range of 2.5-5 μA, because Molsberger has shown that a wide range of electrical power levels can be used when applying electrodes to acupuncture points in the head/scalp (Wang: [0003]; Molsberger: [0010, 0020, 0074, 0077]).
Regarding claim 14, Wang modified discloses the head-mount TENS device of claim 13, Wang teaches outputting current in the range of 2-100Hz, Wang does not explicitly disclose wherein the pulse stimulation signal is a square wave with a pulse frequency of 50 Hz to 200 Hz, and preferably the pulse frequency is between 96 Hz and 100 Hz. However, since Wang discloses pulse width modulation and outputting power in the broader range of 2-100Hz, it would have been obvious an obvious design choice to a person of ordinary skill in the art at the at the time of invention to modulate the output stimulation signal to output a square wave signal in the power range to 50-200 Hz; because Wang provides support in [0039] to modulate the stimulation signal to a “varieties of wave shape/pattern (e.g. sinusoidal wave, [square] wave, continued, discontinued, varying amplitude, symmetrical wave or unsymmetrical wave etc.).” (Note: This claim is rejected under 35 USC 112(b), the limitations following “preferably” is not given patentable weight.)
Claims 22 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1 and 23 above, and in view of Longinotti-Buitoni et al. US 2014/0070957 A1 (hereinafter “Long”).
Regarding claim 22, Wang discloses the head-mount TENS device of claim 1, further comprising: a current sensor (Fig.2: feedback current) for detecting an electric current flowing through the user via the plurality of contacts ([0028]); and a processor (Fig.2: microprocessor) configured to monitor and adjust the PWM generator continuously based on the electric current detected by the current sensor ([0028] “current feedback to regulate the microprocessor output to voltage converter and current source to generate the stimulate pulses at the current level set by the keypad”). Wang also discloses thermal pads for radiating the treated areas (Fig.2: heating elements, and Fig. 6 and [0032]) and wherein the temperature is controlled by the control interface ([0113] “The heat level should be the level not causing damage to the skin (e.g. temperature within 40-60 degree) and can be controlled by a control interface”) , but does not disclose one or more temperature sensors for obtaining temperature readings of areas proximate to the one or more thermal pads, and the processor configured to monitor and adjust the one or more thermal pads continuously based on the temperature detected by the one or more temperature sensors.
However, since Wang discloses that the temperature of the scalp is controlled to be within 40-60 degree ([0113]), it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang to include a temperature sensor for temperature feedback such that the processor can monitor and adjust the heating element.
Alternatively, Long, a prior art reference in the field of wearable therapeutic garment teaches device comprising a plurality of sensors (temperature, heart rate motion, etc.; [0191]), stimulating elements (e.g. heating element, electrodes, TENS; [0124, 0187]), processor (14) and wireless communication (1). Long discloses the TENS element stimulating acupuncture points in conjunction with the heating element providing heat ([0187]). Furthermore, wherein temperature sensor are provided to detect skin temperature, such that the processor can perform temperature control application to adjust the heat provided ([0184]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang to include a skin temperature sensor in view of Long; the motivation for doing so is to for detecting temperature as feedback for the processor to control the heating element based on detected temperature (Long: [0187] Wang: [0113]).
Claim 38 is rejected by Wang in view of Long, under the same rationale as discussed to claim 22 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wang US 2022/0054856 and US 2023/0110636 discloses a method and system for providing noninvasive therapeutic and heating elements to acupoints.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
January 27, 2026