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 .
Priority: the current application has the effective filing date of 05/17/2022 according to the priority chain on the record.
Drawings
The drawings are objected to because drawing figures 5A, 5B, 6 and 8 are blurry. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
With regard to the term “about”, it is interpreted according to the Applicant’s Specification, pg.6 lines 7-14.
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, 5-16, 18, 20 and 22-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. US 2016/0114164 A1 (hereinafter “Zhang”).
Regarding claim 1, Zhang discloses a method of treating a subject with an electronic device for neuromodulation (Abstract: deliver neural stimulation pulses to the ventral nerve root and dorsal nerve root: implantable pulse generator), comprising:
placing a lead in a vertebral vein of the subject (Figs.7-8: neural stimulation leads 716, 816, see [0051-0052]),
placing at least one electrode ([0051] “Electrodes on each lead are placed operationally in position with respect to the nerve root(s) to stimulate the neural target(s) and elicit the desired effect(s).” and also see [0052 electrodes 816A and 816B]) within the vertebral vein adjacent to an autonomic nerve (ventral nerve root is an autonomic root), wherein the at least one electrode is coupled to the lead (Figs. 7-8 and [0051-0052]); and
modulating a cardiovascular system of the subject by supplying a predetermined amount of an electrical stimulation energy to the autonomic nerve ([0051-0052] stimulate ventral nerve roots on contralateral sides of the spinal cord; also see [0030] “Sympathetic modulation (inhibition or activation of sympathetic activity) treats a variety of cardiovascular disease with abnormal sympathetic activity. The neural stimulation is capable of being implemented in treatments for pain, heart failure, arrhythmia, angina, and the like”).
Regarding claim 5, Zhang discloses the method of claim 1, wherein the electronic device is implantable. (implantable pulse generator, according to [0051-0052])
Regarding claim 6, Zhang discloses the method of claim 5, further comprising placing a pulse generator that is coupled to the lead. (pulse generator 715)
Regarding claim 7, Zhang discloses the method of claim 5, wherein the electrical stimulation energy is continuous or titrated. ([0088] titrated signal, see “Various embodiments modulate the stimulation intensity by modulating the amplitude of the neural stimulation signal, the frequency of the neural stimulation signal, the duty cycle of the neural stimulation signal, the duration of a stimulation signal, the waveform of the neural stimulation signal, the polarity of the neural stimulation signal, or any combination thereof.”)
Regarding claim 8, Zhang discloses the method of claim 5, wherein the electrical stimulation energy is delivered at a magnitude of stimulation to avoid incidental stimulation of muscle. (this is implicitly taught by adjusting stimulation intensity, see [0071: 2ns to last sentence] “Electronic repositioning can be performed as part of an automatic process, where a device cycles through available electrode combinations (and stimulation intensity) until the desired efficacy is realized.” Also see [0088] “Various “closed loop” systems vary the intensity of the neural stimulation, as generally illustrated by the stimulation intensity module 1865, based on the sensed physiology signal received by the feedback circuit according to a preprogrammed therapy to provide a desired affect…”)
Regarding claim 9, Zhang discloses the method of claim 6, wherein the modulating the cardiovascular system of the subject comprises inhibiting an activity of the autonomic nerve via a closed loop system function of the pulse generator when a ventricular arrhythmia is detected from the subject. ([0075, 0088] closed loop system and closed loop control of the treatment using autonomic balance indicators/ABIs)
Regarding claim 10, Zhang discloses the method of claim 6, wherein the modulating the cardiovascular system of the subject comprises activating an activity of the autonomic nerve via a closed loop system function of the pulse generator when a thoracic impedance of the subject increases. (see rejection to claim 9 above, [0075, 0088] closed loop control using detect physiological data, this includes measured transthoracic impedance discussed in [0086-0087])
Regarding claim 11, Zhang discloses the method of claim 5, wherein the at least one electrode is located longitudinally along a distal aspect of the lead. (see Fig. 9 electrode 916 located at the distal aspect of lead 914)
Regarding claim 12, Zhang discloses the method of claim 5, wherein the electrode is positioned with a directional bias in around the lead diameter. (as shown in Figs. 15B, see [0069])
Regarding claim 13, Zhang discloses the method of claim 5, where the electrode is directed toward the autonomic nerve. (See rejection to claim 1 above, and also as shown in Figs. 9-10B electrode guided to wrap around ventral nerve)
Regarding claim 14, Zhang discloses the method of claim 5, wherein the lead (Fig.9: 914) comprises a guidewire lumen (Fig.9: catheter 917; [0057]).
Regarding claim 15, Zhang discloses the method of claim 14, further comprises inserting the guidewire lumen (catheter 917) at least one centimeter into the vertebral vein; and advancing the lead over the guidewire. (see [0068])
Regarding claim 16, Zhang discloses a system for treating a subject with an electronic device for neuromodulation (see Abstract). This claim is rejected by Zhang under the same rationale as discussed to claims 1 and 6 above. comprising:
Regarding claim 18, Zhang discloses the system of claim 16, wherein a frequency of the electrical stimulation energy ranges from about 0.9Hz to about 10kHz. ([0041])
Regarding claim 20, Zhang discloses the system of claim 16, wherein the electronic device is implantable. (implantable pulse generator; see [0071-0072])
Regarding claim 22, Zhang discloses the system of claim 20, wherein the lead comprises a tapered distal tip with a bend for positioning in the vertebral vein and ensuring contact with the autonomic nerve. (see Figs. 9, 10B, 11A, 12 and 13A all show a tapered distal tip with a bend)
Regarding claim 23, Zhang discloses the system of claim 20, wherein the lead comprises up to about 20 electrodes. (see Fig. 7 lead 716 showing “up to about 20 electrodes”)
Regarding claim 24, Zhang discloses the system of claim 20, where the lead is configured to exert a bias force to retain a distal top of the lead substantially immobile. (varying stiffness along the length of the shaft and distal portion, see [0066])
Regarding claim 25, Zhang discloses the system of claim 20, wherein the lead is configured to detect an electrical energy corresponding to a ventricular contraction, a thoracic impedance, or a combination thereof. ([0077] detecting ventricular contractions; [0086-0087] detecting transthoracic impedance)
Regarding claim 26, Zhang discloses the system of claim 20, wherein the pulse generator is configured to detect ventricular arrhythmias based on a rate of a ventricular activity and a direction of activation. ([0042, 0087])
Regarding claim 27, Zhang discloses the system of claim 20, wherein the pulse generator is a battery powered pulse generator. ([0077: last sentence] battery)
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 2-4, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims 1 and 16 above, and in view of Boveja US 10,149,626 B2.
Regarding claims 2-4, Zhang discloses the method of claim 1, but does not disclose wherein the method comprises inducing an arrhythmia, identifying a site of origin based on the arrhythmia, and guiding an ablation based on the arrhythmia.
Bojeva, another prior art reference in analogous art discloses that in a typical ablation procedure, patient’s clinical arrhythmia is induce, as such that the source of the arrhythmia is identified to guide the ablation procedure (see Background/Summary). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to combine Zhang and Bojeva so as to utilize the implanted IPG to clinically induce arrhythmia, without introducing another device, such that ablation procedure can be carried out accordingly.
Regarding claims 17 and 19, Zhang disclose the system of claim 16, but does not disclose wherein the system is guiding a cardiac ablation procedure and wherein the amplitude of electrical stimulation ranges from about 2-20mA.
To claim 17, Bojeva, another prior art reference in analogous art discloses that in a typical ablation procedure, patient’s clinical arrhythmia is induce, as such that the source of the arrhythmia is identified to guide the ablation procedure (see Background/Summary). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to combine Zhang and Bojeva so as to utilize the implanted IPG to clinically induce arrhythmia, without introducing another device, such that ablation procedure can be carried out accordingly.
To claim 19, neither Zhang nor Bojeva discloses wherein the amplitude of electrical stimulation from about 2-20mA. However, it would have been obvious to a person of ordinary skill in the art to try various amplitude ranges so as to effectively induce clinical arrhythmia.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 16 above.
Regarding claim 21, Zhang discloses the system of claim 20, but does not disclose wherein a diameter of the lead ranges from about 0.6mm to about 2.5mm. Zhang discloses the implantable device comprising a lead adapted to be implanted to stimulate the autonomic nerve, such as shown in Figs. 4 and 7-8 and [0048, 0051-0052]. It would have been a design choice to adjust the lead to have a diameter to the appropriate range, e.g. from about 0.6mm to about 2.5mm in order to reach the intended implantation site as taught in Zhang.
Conclusion
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.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 26, 2026
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