DETAILED ACTION
Applicant’s arguments, filed 12/18/2025, 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.
Claims 1, 3-8, 10-13, and 15-20 are the current claims hereby under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
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:
“visual unit” first recited in claim 1.
The identified structure for the corresponding claim limitations are as follows:
“visual unit” is identified as “The LED array 110 can receive 422 the visual command 422 and generate 424 visual stimulation” (Paragraph 00040) and “The LED array 110 can include one or more LEDS and hardware, firmware, and/or software configured to drive the LEDs to emit light …” (Paragraph 00025).
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 11 and 19 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.
Regarding claims 11 and 19, the claims state that the tactile stimulation is sufficient to cue the patient to volitionally reduce the dystonic muscle contraction of the patient. However, claims 1 and 16 from which they depend, state that the tactile stimulation is generated and is sufficient to interrupt dystonic sensorimotor pathways to non-volitionally reduce the dystonic muscle contraction of the patient. It is unclear how much tactile stimulation is required to “sufficiently” cue the patient volitionally versus non-volitionally. Is there a difference in the tactile stimulation between volition and non-volitional cues or are they the same? There is no definition of “sufficient” in the disclosure, and it is unclear how much tactile stimulation is required to meet a sufficient, non-volitional tactile stimulation versus a sufficient, volitional tactile stimulation. For examination purposes, any stimulation to non-volitionally cue the patient and any stimulation to require a volitional reduction in muscle contraction will be required to meet the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-7, 10-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brokaw (US 9974478), Dosen et. al. (“Online Tremor Suppression Using Electromyography and Low-Level Electrical Stimulation”), hereinafter Dosen, and Kurzweil (US 20080287770),
Regarding claim 1, Brokaw discloses a system for the treatment of dystonic symptoms, the system comprising:
one or more surface-electromyogram (EMG) sensors (Fig. 6, EMG electrodes 0605) configured to:
attach to a patient (Fig. 6, EMG electrodes 0605);
sense surface-EMG data indicative of muscle contraction of the patient (Col 20, lines 46-52; wherein muscle activity includes muscle contraction; Col 28, lines 26-28 and Col 56, line 67 – Col 57, line 13, wherein tremors are defined by muscle contraction and the sensors measure variables of tremor); and
transmit, to a controller, the surface-EMG data (Col 23, lines 5-10; transceiver);
a controller comprising computer-memory and one or more processors, the computer memory storing instructions (Col 22, lines 63-66) that, when executed by the processor, cause the controller to:
receive, from the surface-EMG sensors, the surface-EMG data (Col 23, lines 5-10);
identify at least one parameter of the surface-EMG data (Col 41, line 62 - Col 42, line 1), wherein the at least one parameter is a voltage value indicative of the muscle contraction of the patient (Col 20, lines 46-57);
compare the parameter to a corresponding dystonia-threshold-value (Col 41, line 62 - Col 42, line 1), wherein the dystonia-threshold-value is a voltage value indicative of a dystonic muscle contraction (Col 20, lines 52-54, EMG sensors measure parameters in voltages; therefore, the threshold values set would also be measured or taken as a voltage) of the patient and wherein the dystonia-threshold-value is individualized for the patient based on calibration data comprising resting and active EMG measurements (Col 30, lines 41-61);
responsive to a determination that the parameter is greater than the corresponding dystonia-threshold-value:
issue a tactile-engagement command to a tactile unit (Col 43, lines 1-3; Col 45, line 63 – Col 46, line 3) wherein the tactile unit is a tactor array comprising a plurality of vibrotactile transducers (Col 43, lines 42-45; Col 46, lines 3-8; Examiner notes that the small vibrational motor(s) taught in Brokaw read on the claimed “tactor” and “vibrotactile transducers” of the instant application. Additionally, one or more vibrational motors are taught, and could be arranged in such a way to be an “array”; therefore, reading on the claim of a “tactor array”).
the tactile unit configured to:
receive the tactile-engagement command (Col 43, lines 1-3);
generate a tactile stimulation for the patient wherein the plurality of vibrotactile transducers of the tactile array vibrate against the skin of the patient to deliver the tactile stimulation (Col 43, line 42 – 65; Col 45, line 63 – Col 46, line 8);
While Brokaw discloses that the system may be used with other assistance devices that may correct movement (Col 27, lines 2-24; Col 28, lines 24-30), Brokaw fails to disclose wherein the system estimates a source location of the dystonic muscle contraction and the vibrational motors deliver the tactile stimulation at the source location to non-volitionally reduce the dystonic muscle contraction. Additionally, while Brokaw discloses a harness worn by the patient that contains all components within the harness (Col 32, lines 24-30), Brokaw fails to disclose that the components are attached via pockets.
However, Dosen teaches a tremor suppression tool using electromyography wherein EMG data is captured to detect presence of tremor (Section IIB, paragraphs 1-2) wherein the processing was performed for each muscle group independently and a stimulation was delivered (Section IIB, paragraph 2; Section IV, paragraph 1; Examiner interprets the processing for each muscle group independently is locating the source of the muscle contraction). Dosen discusses this method is useful to reduce muscle fatigue and patient discomfort (Section I, paragraph 6). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw to detect tremors of a muscle group and deliver a stimulation to that location of Dosen to reduce muscle fatigue and patient discomfort.
Kurzweil teaches a harness with pockets (Fig. 12, pocket 18; Paragraph 0041), and indicates this is useful to hold the sensors in place (Paragraph 0080). Additionally, there are only a finite number of identified and predictable solutions to secure components to a harness, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw and Dosen to incorporate the harness with pockets of Kurzweil to hold the sensors in place.
Regarding claim 6, Brokaw as modified further discloses wherein the surface-EMG sensors are configured to be worn on the patient's forearm (Fig 6, EMG sensors 0605; Col 32, lines 42 – 47).
Regarding claim 7, Brokaw as modified further discloses wherein the surface-EMG sensors are configured to sense surface-EMG data indicative of muscle contractions in at least one of the group consisting of Flexor Carpi Ulnaris, Palmaris Longus, Extensor Digitorum, and Extensor Carpi Radialis (Fig 6, EMG sensors 0605; The sensors are configured to sense EMG data by being placed over one of the muscles claimed).
Regarding claim 10, Brokaw as modified further discloses wherein the system is configured to deliver a visual stimulation to the patient (Col 45, lines 26-31) when the patient is experiencing dystonic symptoms (Col 9, lines 18-38, “measuring … continuously”).
Regarding claim 11, Brokaw as modified further discloses wherein the system is configured to deliver the tactile stimulation to the patient (Col 45, line 63 – Col 46, line 3) when the patient is experiencing dystonic symptoms (Col 9, lines 18-38, “measuring … continuously”), wherein the tactile stimulation is sufficient to cue the patient to volitionally reduce dystonic muscle contraction of the patient (Col 43, line 65 – Col 44, line 9).
Regarding claim 12, Brokaw as modified further discloses the system further comprising at least one battery in energetic communication with at least the controller (Col 22, line 63 – Col 23, line 1).
Regarding claim 13, Brokaw as modified does not explicitly teach wherein the visual stimulation comprises illumination of a light-emitting diode (LED).
However, in Col 45, lines 28-20, Brokaw points to a visual stimulation that, “may comprise a single or series of blinking or flashing lights.” Light-emitting diodes (LEDs) are known to those of ordinary skill in the art, and the visual stimulation could comprise an LED. It would have been obvious to use LEDs as a visual stimulation as they are more energy efficient than other types of lights, thereby consuming less energy from the battery.
Regarding claim 15, Brokaw as modified further discloses wherein the parameter is indicative of a one or more of a type, intensity, or periodicity of the muscle contraction on the patient (Fig. 15, variables calculated from the EMG data in box 1550, including frequency, amplitude, and power).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Brokaw, Dosen, and Kurzweil as applied to claims 1 and 6 above, and further in view of Blum (20230277109).
Regarding claims 3 and 8, Brokaw as modified fails to disclose wherein the harness comprises a sleeve wearable on the patient's arm and sense muscle contractions in each of Flexor Carpi Ulnaris, Palmaris Longus, Extensor Digitorum, and Extensor Carpi Radialis.
However, Blum discloses an alternate EMG sensing arrangement including a harness that comprises a sleeve wearable on the patient's arm (Figs. 1-4), wherein the sensors are arranged over the claimed muscle groups of the arm and configured to sense data therefrom. Blum discloses that by providing electrodes in a sleeve made from stretchable fabric, good contact between the electrodes and the subject’s skin is maintained during measurement (Paragraph 0039). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw, Dosen, and Kurzweil to incorporate the sleeve of Blum to ensure good contact of the electrodes to the skin.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brokaw, Dosen, and Kurzweil as applied to claim 1 above, and in further view of Cao (“Soft Robotic Glove with Integrated sEMG Sensing for Disabled People with Hand Paralysis” – previously cited), hereinafter Cao.
Regarding claim 4, Brokaw fails to teach wherein the harness comprises a glove wearable on the patient's hand.
However, Cao discloses an alternate EMG sensor arrangement wherein the harness comprises a glove wearable on the patient's hand (Fig. 1). Cao discloses that having EMG sensors on a glove allowed the device to measure movement and angle of each individual finger. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw, Dosen, and Kurzweil to incorporate the glove of Cao to measure individual finger movements.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Brokaw, Dosen, and Kurzweil as applied to claim 1 above, and further in view of Vasanth (US 20220338810).
Regarding claim 5, Brokaw as modified fails to explicitly disclose wherein the EMG sensors comprise graphene and a silver electrode.
However, Vasanth teaches a wearable device wherein biosensor electrodes, which can be adapted to monitor muscular activity such as EMG (Paragraph 0052), are silver/silver chloride and include graphene-based materials for improved conductivity and long-term monitoring (Paragraph 0053). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw, Dosen, and Kurzweil to incorporate the silver/silver chloride and graphene based EMG electrode of Vasanth for improved conductivity and long-term monitoring.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brokaw and Dosen.
Regarding claim 16, Brokaw discloses a non-transitory, computer-readable media storing instructions that, when executed by a processor (Col 9, lines 42-45; Col 6, lines 30-40, wherein the processing device includes coordinated application(s), program(s), or software installed to perform the analysis), cause a controller of the processor to:
receive, from one or more surface-EMG sensors, surface-EMG data indicative of muscle contraction of a patient (Col 23, lines 5-10; Col 20, lines 46-52; wherein muscle activity includes muscle contraction; Col 28, lines 26-28 and Col 56, line 67 – Col 57, line 13, wherein tremors are defined by muscle contraction and the sensors measure variables of tremor);
identify at least one parameter of the surface-EMG data (Col 41, line 62 - Col 42, line 1), wherein the at least one parameter is a voltage value indicative of the muscle contraction of the patient (Col 20, lines 46-57);
compare the parameter to a corresponding dystonia-threshold-value (Col 41, line 62 - Col 42, line 1), wherein the dystonia-threshold-value is a voltage value indicative of a dystonic muscle contraction (Col 20, lines 52-54, EMG sensors measure parameters in voltages; therefore, the threshold values set would also be measured or taken as a voltage) of the patient and wherein the dystonia-threshold value is individualized for the patient based on calibration data comprising resting and active EMG measurements (Col 30, lines 41-61); and
responsive to a determination that the parameter is greater than the corresponding dystonia-threshold-value:
issue a tactile-engagement command to a tactile unit (Col 43, lines 1-3; Col 45, line 63 – Col 46, line 3) wherein the tactile unit is a tactor array comprising a plurality of vibrotactile transducers (Col 43, lines 42-45; Col 46, lines 3-8; Examiner notes that the small vibrational motor(s) taught in Brokaw read on the claimed “tactor” and “vibrotactile transducers” of the instant application. Additionally, one or more vibrational motors are taught, and could be arranged in such a way to be an “array”; therefore, reading on the claim of a “tactor array”), the tactile unit generates a tactile stimulation for the patient wherein the plurality of vibrotactile transducers of the tactile array vibrate against the skin of the patient to deliver the tactile stimulation at the location of the dystonic muscle contraction (Col 43, line 42 – 65; Col 45, line 63 – Col 46, line 8).
While Brokaw discloses that the system may be used with other assistance devices that may correct movement (Col 27, lines 2-24; Col 28, lines 24-30), Brokaw fails to disclose wherein the system estimate a source location of the dystonic muscle contraction and the vibrational motors deliver the tactile stimulation at the source location to non-volitionally reduce the dystonic muscle contraction.
However, Dosen teaches a tremor suppression tool using electromyography wherein EMG data is captured to detect presence of tremor (Section IIB, paragraphs 1-2) wherein the processing was performed for each muscle group independently and a stimulation was delivered (Section IIB, paragraph 2; Section IV, paragraph 1; Examiner interprets the processing for each muscle group independently is locating the source of the muscle contraction). Dosen discusses this method is useful to reduce muscle fatigue and patient discomfort (Section I, paragraph 6). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Brokaw to detect tremors of a muscle group and deliver a stimulation to that location of Dosen to reduce muscle fatigue and patient discomfort.
Regarding claim 17, Brokaw as modified further discloses wherein, responsive to a determination that the parameter is greater than the corresponding dystonia-threshold-value, issue a visual-engagement command to a visual unit (Col 43, lines 1-3) to generate a visual stimulation for the patient (Col 45, lines 26-31; Col 43, line 43– Col 44, line 42);
Regarding claim 18, Brokaw as modified further discloses wherein the instructions cause delivery of the visual stimulation to the patient (Col 45, lines 26-31) when the patient is experiencing dystonic symptoms (Col 9, lines 18-38, “measuring … continuously”).
Regarding claim 19, Brokaw as modified further discloses wherein the instructions cause delivery of the tactile stimulation to the patient (Col 45, line 63 – Col 46, line 3) when the patient is experiencing dystonic symptoms (Col 9, lines 18-38, “measuring … continuously”), wherein the tactile stimulation is sufficient to cue the patient to volitionally reduce dystonic muscle contraction of the patient (Col 43, line 65 – Col 44, line 9).
Regarding claim 20, Brokaw as modified further discloses wherein the parameter is indicative of a one or more of a type, intensity, or periodicity of the muscle contraction on the patient (Fig. 15, variables calculated from the EMG data in box 1550, including frequency, amplitude, and power).
Response to Arguments
Applicant’s arguments, see page 8, filed 12/18/2025, with respect to the claim objections have been fully considered and are persuasive. Applicant has amended the claims per suggestion of the Examiner. The objection of the claims has been withdrawn.
Applicant's arguments, see page 9, filed 12/18/2025, with respect to the 35 U.S.C. §112(b) rejections have been fully considered but they are not persuasive. Examiner has clarified the ambiguity between sufficient “volitional” and “non-volitional” tactile stimulations above.
Applicant’s arguments, see 9, filed 12/18/2025, with respect to the 35 U.S.C. §112(d) rejections have been fully considered and are persuasive. Applicant has amended the claims to remove the limitations that fails to limit the claims from which they were dependent on. The rejection of the claims has been withdrawn.
Applicant’s arguments, see page 10, filed 12/18/2025, with respect to the rejection(s) of claim(s) 1, 3-8, 10-13, and 15-20 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Brokaw in view of Dosen and Kurzweil.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791