DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
It is noted that the status identifiers for claims 3 and 12 are incorrectly indicated as “Previously Presented” and not properly marked-up with changes set forth below.
Claim 3 includes change of the limitation “sEMG signal amplitude” to “sEMG activity”
Claim 12 includes change of dependency of claim 10 to claim 11.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 8-13 and 15-20 have been renumbered as 7-18. For the purpose of examination, renumbered claims have been used.
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.
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: “electrostimulation unit” in claims 1-3, 8-11, and 16-20.
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. The specification discloses controller circuitry or electrodes (see [0145], [0153]-[0156] of the USPGPub. version of the specification for example).
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 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.
Claims 1-20 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.
Regarding claims 1-20, the specification does not include amended claimed range of “800 Hz and 8kHz”, which was part of preliminary amendment on 3/28/25. The specification discloses high-frequency stimulation ranges including, for example:
500 to 10,000 Hz at [0008]-[0010],
500 to 15,000 Hz, more preferably 1-10 kHz, and more preferably 2-6 kHz at [0056], and
additional aspect statements reciting 500 to 15,000 Hz and related ranges at [0178]-[0180], [0195], [0200], [0202]-[0203]
However, the specification does not include amended claimed range of “800 Hz and 8kHz”. As such, claim 1 and its dependent claims thereof includes new matter since as-filed specification and claims fail to provide appropriate written description support for the amended claimed range of “800 Hz and 8kHz”.
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 1-18 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 claim 1, it is unclear what the relationship is between “target nerve or branch thereof” and “the head of a patient fibula near the peroneal nerve.” Claim 1 recites “at least one electrostimulation electrode” being located “near a target never or branch thereof” and also being placed “over the head of a patient fibula near the peroneal nerve or branch thereof.” Therefore, it is unclear if the claimed target nerve is limited to the peroneal nerve or encompasses other nerves.
Additionally, it is unclear if “signal induces” is referring to “a first high-frequency electrostimulation signal”. If so, consistent terminology should be used.
The term “near” in claim 1 is a relative term which renders the claim indefinite. The term “near” 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. Applicant should clarify this claim language to address this 112(b) rejection.
Claim 1 recites the limitation "the head" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 2-18 have been rejected for the same issues identified in claim 1 set forth above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-13, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Rosenbluth et al. (Pub. No.: US 2019/0001129 A1); hereinafter referred to as “Rosenbluth”.
Regarding claim 1, Rosenbluth discloses a system for treating a patient having one or more symptoms associated with at least one of Restless Legs Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD) (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) using applied high-frequency electrostimulation (e.g. see [0028], [0129]), the system comprising: at least one electrostimulation electrode (e.g. see figure 1 element 102) configured for location at a first external target body location on a leg near a target nerve or a branch thereof (e.g. see [0052], [0066]-[0068]); and an electrostimulation unit (e.g. see figure 1 element 100) coupled to the at least one electrostimulation electrode for generating and applying to the target nerve or branch thereof (e.g. see [0052], [0066]-[0068]) a first high-frequency electrostimulation signal, having a frequency within a range of 800 Hertz (Hz) and 8 kilohertz (kHz) (e.g. see “1000 Hz, about 2500 Hz, about 5000 Hz” in [0028], [0129]) and controlled such that, when the at least one electrostimulation electrode is in place over the head of a patient fibula near the peroneal nerve or the branch thereof (e.g. see [0052], [0066]-[0068]), signal induces at least one of a foot dorsiflexion or continuous tonic motor activation of a tibialis anterior muscle (Note: In terms of device claims, the examiner is searching the device not intended use limitations (this limitation). Because the device is capable of stimulating the same nerve (e.g. see [0052], [0066]-[0068]) with high frequency electrical stimulation (e.g. see [0028], [0129]), the device of the prior art is capable of and/or configured to induce the claimed patient responses); and onboard power management circuitry (e.g. see figure 7 elements 750, 797, [0120]) coupled to the electrostimulation unit for powering the electrostimulation unit via a battery (e.g. see figure 7 element 750, [0121], [0124], [0232]).
Regarding claim 2, Rosenbluth discloses the electrostimulation unit is wearable, external, and non-implantable (e.g. see figure 1 element 100); and the electrostimulation unit is configured for generating and applying the first high-frequency (e.g. see [0028], [0129]) electrostimulation signal to produce tonic sEMG activity indicative of the foot dorsiflexion or continuous tonic motor activation, in response to the electrostimulation signal (Note: In terms of device claims, the examiner is searching the device not intended use limitations (this limitation). Because the device is capable of stimulating the same nerve (e.g. see [0052], [0066]-[0068]) with high frequency electrical stimulation (e.g. see [0028], [0129]), the device of the prior art is capable of and/or configured to induce the claimed patient responses).
Regarding claim 3, Rosenbluth discloses the electrostimulation unit is configured for generating and applying the first high-frequency electrostimulation (e.g. see [0028], [0129]) signal to modulate phasic sEMG activity in response to the electrostimulation signal (e.g. see [0192], [0264], [0270], [0304], [0306]. Note: This claim only requires high frequency stimulation to modulate phasic EMG activity. There is no claimed sensing of the phasic activity).
Regarding claim 4, Rosenbluth discloses at least one parameter setting of the first high-frequency electrostimulation signal (e.g. see [0028], [0129]) is specified for treating the at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS), based at least in part on an observed surface electromyographic (sEMG) signal (e.g. see [0264], [0270], [0306]).
Regarding claim 5, Rosenbluth discloses at least one parameter setting of first high-frequency (e.g. see [0028], [0129]) electrostimulation signal is specified for treating the at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS), based at least in part on patient feedback, to be less than at least one of a pain threshold or a distraction threshold (e.g. see [0143]).
Regarding claim 6, Rosenbluth discloses at least one parameter setting of the first high-frequency electrostimulation signal is configured for treating the at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) to permit being specified differently based on an indication of whether the patient is, or is expected to be, one of awake or asleep (e.g. see [0264]).
Regarding claim 8, Rosenbluth discloses the electrostimulation unit includes or is coupled to controller circuitry (e.g. see figure 7 element 797) that is configured to store (e.g. see figure 7 element 770) indications of sEMG activity respectively corresponding to different settings of at least one parameter of the first high- frequency electrostimulation signal for treating at least one of RLS or PLMD (e.g. see [0264], [0270], [0306]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS).
Regarding claim 9, Rosenbluth discloses the electrostimulation unit includes or is coupled to controller circuitry that is configured to select at least one parameter setting for treating at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) of the first high-frequency electrostimulation signal based on a comparison of sEMG activity at different settings (e.g. see [0264], [0270], [0306]).
Regarding claim 10, Rosenbluth discloses the electrostimulation unit includes or is coupled to controller circuitry (e.g. see figure 7 element 797) that is configured to record (e.g. see figure 7 element 770) an indication of baseline sEMG activity obtained without providing the first high-frequency electrostimulation signal to the patient (e.g. see [0272]. Note: [0272] discloses “a patient's baseline eye muscle movement parameter such as blink time can be compared with parameters/times of the patient while on or after therapy for comparison. Some embodiments could involve, for example: video eye tracking or blinking (such as via a camera, including a web camera, tablet or smartphone camera, or a wearable device that includes a camera, e.g., headwear such as a cap, glasses such as a modified Google Glass, and the like); electro-oculography eye muscle recording based on the dipole of the eye; EMG of muscles on the head that control blinking, such as the orbicularis oculi and levator palpebrae superioris muscle”).
Regarding claim 11, Rosenbluth discloses the controller circuitry is configured to characterize a neurostimulation responsiveness for treating at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) of the patient based at least in part on a change in observed sEMG activity in the patient from the baseline sEMG activity (e.g. see [0192], [0264], [0270], [0304], [0306]), in response to the first high-frequency electrostimulation signal (e.g. see [0028], [0129]).
Regarding claim 12, Rosenbluth discloses the controller circuitry is configured to characterize a neurostimulation responsiveness for treating at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) based at least in part on a pain threshold (e.g. see [0143]), determined using one or more parameter settings of the first high- frequency electrostimulation signal (e.g. see [0028], [0129]).
Regarding claim 13, Rosenbluth discloses at least one sEMG signal electrode configured to be located in association with at least one muscle innervated by the target nerve of the same patient to which the first high-frequency electrostimulation signal is delivered by the at least one electrostimulation electrode for treating at least one of RLS or PLMD (e.g. see [0192], [0264], [0270], [0304], [0306]).
Regarding claim 16, Rosenbluth discloses an arrangement of a plurality of electrodes, wherein the electrostimulation unit includes or is coupled to controller circuitry that is configured to select one or more electrodes from the plurality of electrodes based at least in part on observed sEMG activity indicative of at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) treatment efficacy in response to a test electrostimulation signal delivered to the patient via different ones of the plurality of electrodes, and use the selected one or more electrodes to apply a therapeutic electrostimulation signal to the patient (e.g. see [0251]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth in view of Wurth et al. (Pub. No.: US 2018/0280700 A1); hereinafter referred to as “Wurth”.
Regarding claim 7, Rosenbluth discloses adjusting the first high-frequency electrostimulation signal in response to the EMG signal (e.g. see [0264], [0270], [0306]) but is silent as to the EMG signal is tonic EMG activity. Wurth teaches it is known to use such a modification as set forth in [0050] to provide a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient (e.g. see [0020]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use tonic EMG as the feedback component for stimulation as taught by Wurth in the system/method of Rosenbluth, since said modification would provide the predictable results of a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient.
Regarding claim 14, Rosenbluth discloses the at least one electrostimulation electrode locatable at a first external target body location on a leg near a target nerve or a branch thereof comprises: at least one first electrostimulation electrode configured for location at a first external target body location on a right leg of the patient near a right target nerve or a branch thereof; and at least one second electrostimulation electrode configured for location at a second external target body location on a left leg of the patient near a left target nerve or a branch thereof; wherein the electrostimulation unit generates the first high-frequency electrostimulation signal for delivery to the right target nerve or branch thereof for treating at least one of RLS or PLMD using the at least one first electrostimulation electrode and generates a second high-frequency pulsed electrostimulation signal for delivery to the left target nerve or branch thereof using the at least one second electrostimulation electrode (e.g. see figure 1 elements 100, 102. Note: The electrodes of Rosenbluth are configured to and/or capable of being placed on the left and right legs of a patient) but is silent as to producing or modulating tonic surface electromyographic (sEMG) activity in at least one muscle innervated by the right target nerve and to producing or modulating tonic surface electromyographic (sEMG) activity in at least one muscle innervated by the left target nerve. Wurth teaches it is known to use such a modification as set forth in [0050] to provide a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient (e.g. see [0020]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use tonic EMG as the feedback component for stimulation as taught by Wurth in the system/method of Rosenbluth, since said modification would provide the predictable results of a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient.
Regarding claim 17, Rosenbluth discloses adjusting the first high-frequency electrostimulation signal in response to the EMG signal (e.g. see [0264], [0270], [0306]) but is silent as to adjusting based at least in part on a modulation of phasic sEMG activity in an observed sEMG signal. Wurth teaches it is known to use such a modification as set forth in [0050] to provide a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient (e.g. see [0020]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use phasic EMG as a feedback component for stimulation as taught by Wurth in the system/method of Rosenbluth, since said modification would provide the predictable results of a PNS (Peripheral Nervous System) module that may be used to locally steer and direct stimulation signals to specific peripheral nervous structures in order to trigger a specific movement and/or refine existing movements, refine and/or complete motion and/or movement capabilities of the patient being equipped with the system, and complete flexion or extension, lifting, turning or the like of including but not limited to toes, fingers, arms, feet, legs or any extremities of the patient.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth in view of Cadwell (Pub. No.: US 2014/0148725 A1).
Regarding claim 15, Rosenbluth discloses the claimed invention except for the electrostimulation unit is configured to repeatedly deliver pulses of the first high-frequency electrostimulation signal for treating at least one of RLS or PLMD in a ramped manner of increasing energy levels toward a target energy level. Cadwell teaches that it is known to use such a modification as set forth in figure 10 element 762, [0100]-[0102] to reduce the number of electrical stimulations delivered to a patient or measurements that are required (e.g. see [0003]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use ramped stimulation as taught by Cadwell in the system/method of Rosenbluth, since said modification would provide the predictable results of reducing the number of electrical stimulations delivered to a patient or measurements that are required.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth in view of Bouton et al. (Pub. No.: US 2015/0290451 A1); hereinafter referred to as “Bouton”.
Regarding claim 18, Rosenbluth discloses the electrostimulation unit is coupled to the at least one electrostimulation electrode for both delivering the first high-frequency electrostimulation signal (e.g. see [0028], [0129]) to the patient for treating at least one of RLS or PLMD (e.g. see [0264]. Note: “rapid back and forth movement of legs” will read on a symptom of RLS) and for detecting a responsive sEMG signal from the patient, for indicating efficacy of treating at least one of RLS or PLMD (e.g. see [0192], [0264], [0270], [0304], [0306]) but is silent as to using the same at least one electrostimulation electrode. Bouton teaches it is known to use such a modification as set forth in [0045] to provide sensed EMG data that may also be analyzed in deciding whether to reposition the neuromuscular electrodes to turn off individual electrodes within the electrogel disc array (e.g. see [0045]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the same electrodes for sensing and stimulation as taught by Bouton in the system/method of Rosenbluth, since said modification would provide the predictable results of sensed EMG data that may also be analyzed in deciding whether to reposition the neuromuscular electrodes to turn off individual electrodes within the electrogel disc array.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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