DETAILED ACTION
A complete action on the merits of claims 1-20 follows below.
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 .
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 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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 5-6 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vilims (US Patent No. 7,945,331) in view of Lipani (US Pub. No. 2012/0215218).
Regarding Claim 1, Vilims teaches a method to treat sacroiliac joint pain (“it may also be advantageous to denervate the L5 dorsal ramus as well as the L4 medial branch since there is some innervation to the SI joint from both of these additional nerve structures” Col. 15, ll. 56-60 and Col. 14, ll. 60-Col. 15, ll. 38) the method comprising inserting at least one ablation electrode into a patient to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the lumbar vertebrae L3, L4, or L5 or any of the sacral vertebrae (Col. 15, ll. 56-60); and applying pulses to the at least one ablation electrode to ablate the at least one spinal nerve (Col. 4, ll. 45-59 and Col. 15, ll. 61-Col. 16, ll. 29), although teaches “In terms of the types of electrical impulses provided to the electrodes 22, these electrical impulses may be continuous or variable over time, and may vary based upon voltage, amperage, and alternate current frequency” in Col. 9, ll. 58-62, does not specify wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV.
In the same field of nerve stimulation/ablation, Lipani teaches programming the pulse generator after modeling the spinal cord stimulation for the best results such as “Pulse width is usually set to between 100 to 400 microseconds, but for such modeling, the pulse width is also a variable, which affects the area of coverage” in [0080] and “If the parameters that are used do not reduce the pain, the pulse duration is increased, the voltage is increased (up to the limit of the pulse generator, typically 1000 V), and/or the pulsation continues every 10 seconds until the pain is reduced” in [0091].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to program the pulse generator of Vilims with the parameters disclosed by Lipani to generate each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV as Lipani teaches.
Regarding Claim 2, Vilims teaches wherein the at least one spinal nerve comprises at least one sacral lateral branch nerve (“to denervation of the sacral lateral branches, it may also be advantageous to denervate the L5 dorsal ramus as well as the L4 medial branch since there is some innervation to the SI joint from both of these additional nerve structures” Col. 15, ll. 56-60).
Regarding Claim 5, Vilims in view of Lipani teaches wherein at least a plurality of the pulses each have a duration of no more than 100 microseconds ([0080] of Lipani).
Regarding Claim 6, Vilims in view of Lipani teaches wherein at least a plurality of the pulses are separated from each other by no more than 20 milliseconds ([0080] of Lipani).
Regarding Claim 9, Vilims in view of Lipani teaches wherein the pulses are multiphasic ([0079] and claim 13 of Lipani).
Regarding Claim 10, Vilims teaches wherein the at least one nerve comprises a plurality of the nerves and inserting the at least one ablation electrode comprises inserting the at least one ablation electrode at different positions along the plurality of the nerves (Fig. 23 shows a plurality of electrodes positioned at a plurality of nerves).
Regarding Claim 11, Vilims teaches wherein the at least one ablation electrode comprises a plurality of monelectrode ablation electrodes (Fig. 23 shows a plurality of electrodes).
Regarding Claim 12, Vilims teaches wherein applying the pulses comprises applying the pulses to at least one set of the monoelectrode ablation electrodes, wherein each of the at least one set comprises at least one first monoelectrode ablation electrode that is an active electrode and at least one second monoelectrode ablation electrode that is a return electrode (Fig. 23 and Col. 5, ll. 8-40).
Regarding Claim 13, Vilims teaches wherein the at least one ablation electrode comprises at least one multipolar ablation electrode (Fig. 23 and Col. 5, ll. 8-40).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Vilims in view of Lipani as applied above and further in view of Long (US Pub. No. 2016/0310211).
Regarding Claims 3-4, Vilims in view of Lipani teaches applying irreversible electroporation to the target tissue wherein each of the pulses has a voltage of at least 1000 volts ( of Lipani), but not 2 kV or 3kV as claimed.
In the same field of irreversible electroporation Long teaches “A DC voltage for electroporation can be applied to the catheter electrodes. The DC voltage is applied in brief pulses sufficient to cause irreversible electroporation can be in the range of 0.5 kV to 10 kV and more preferably in the range 1 kV to 4 kV, so that an appropriate threshold electric field is effectively achieved in the renal nerve tissue to be ablated” in [0061].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to apply irreversible electroporation pulses in the range of 1kV to 4kV so that an appropriate threshold electric field is effectively achieved in the targeted nerve as Long teaches.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Vilims in view of Lipani as applied above and further in view of Viswanathan (US Pub. No. 2020/0205892).
Regarding Claim 7, Vilims in view of Lipani teaches the invention as applied above and although teaches wherein the pulses are arranged in a plurality of pulse bursts, do not teach wherein each of the pulse bursts comprises a plurality of the pulses, wherein the pulse bursts are separated from each other by at least 3 microseconds.
In the same field of invention, Viswanathan teaches “Pulse waveforms for electroporation energy delivery as disclosed herein may enhance the safety, efficiency and effectiveness of energy delivery to tissue by reducing the electric field threshold associated with irreversible electroporation, thus yielding more effective ablative lesions with a reduction in total energy delivered. In some embodiments, the voltage pulse waveforms disclosed herein may be hierarchical and have a nested structure. For example, the pulse waveform may include hierarchical groupings of pulses having associated timescales” in [0053] and as seen in Figs. 7-9 as well as “the pulse (600) is separated from a neighboring pulse by a time interval (602), also sometimes referred to as a first time interval. The first time interval can be about 3 microseconds” in [0165].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to apply irreversible electroporation pulses in a nested structure (arranged in plurality of pulse bursts, each of the pulse bursts comprises a plurality of the pulses, wherein the pulse bursts) that are separated from each other by at least 3 microseconds in order to yield a more effective ablative lesions with a reduction in total energy delivered.
Claims 8 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vilims in view of Lipani as applied above and further in view of Davalos (US Pub. No. 2018/0161086).
Regarding Claim 8, Vilims in view of Lipani teaches the invention as applied, but does not teach wherein the pulses are monophasic. In the same field of irreversible electroporation of nerve stimulation, Davalos teaches “It is to be recognized that, in various embodiments, the individual electric pulses can be monophasic while in other embodiments, the individual electric pulses can be biphasic” in [0109]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to program the pulse generator of Vilims to supply individual electric pulses in monophasic for specific treatment as Davalos teaches.
Regarding Claim 14, Vilims teaches a method to treat sacroiliac joint pain (“it may also be advantageous to denervate the L5 dorsal ramus as well as the L4 medial branch since there is some innervation to the SI joint from both of these additional nerve structures” Col. 15, ll. 56-60 and Col. 14, ll. 60-Col. 15, ll. 38), the method comprising inserting at least one ablation electrode into a patient to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the sacral vertebrae or the lumbar vertebrae L3, L4, or L5 (Col. 15, ll. 56-60); and
applying pulses to the at least one ablation electrode to ablate the at least one nerve, (Col. 4, ll. 45-59 and Col. 15, ll. 61-Col. 16, ll. 29), although teaches “In terms of the types of electrical impulses provided to the electrodes 22, these electrical impulses may be continuous or variable over time, and may vary based upon voltage, amperage, and alternate current frequency” in Col. 9, ll. 58-62, does not specify wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses generate an electric field of at least 3 kV/cm.
In the same field of nerve stimulation/ablation, Lipani teaches programming the pulse generator after modeling the spinal cord stimulation for the best results such as “Pulse width is usually set to between 100 to 400 microseconds, but for such modeling, the pulse width is also a variable, which affects the area of coverage” in [0080], “To damage the cells, the field should generally be greater than 680 volts per cm (typically 1000 volts per cm), the pulse duration should be 0.5-10 millisec (typically 1.0 millisec) separated by 10 sec to minimize the likelihood of Joule heating” [0090] and “If the parameters that are used do not reduce the pain, the pulse duration is increased, the voltage is increased (up to the limit of the pulse generator, typically 1000 V), and/or the pulsation continues every 10 seconds until the pain is reduced” in [0091].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to program the pulse generator of Vilims with the parameters disclosed by Lipani to generate each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV as Lipani teaches;
However, Lipani teaches applying irreversible electroporation to ablate the nerve with the electric field of 1kv/cm and not 3kv/cm as claimed.
In the same field of irreversible electroporation of nerve stimulation, Davalos teaches “the electroporation-based therapy is provided at a higher energy than conventional electroporation-based therapies. In an exemplary embodiment, the amplitude of the pulses of the electroporation-based therapy exceeds 2000 V/cm, including an amplitude of about 2200 V/cm, or 2500 V/cm, such as about 3000 V/cm” in [0069].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to apply a higher energy such as 3000 v/cm for better results in the ablation procedure.
Regarding Claim 15, Vilims in view of Lipani and Davalos teaches wherein each of the pulses generates an electric field of at least 3.5 kV/cm ([0069] of Davalos).
Regarding Claim 16, Vilims in view of Lipani and Davalos teaches wherein at least a plurality of the pulses each have a duration of no more than 100 microseconds ([0080] of Lipani and [0015], [0035] and [0066] of Davalos).
Regarding Claim 17, Vilims in view of Lipani and Davalos teaches wherein at least a plurality of the pulses are separated from each other by no more than 20 milliseconds ([0080] of Lipani and [0015], [0035] and [0066] of Davalos).
Regarding Claim 18, Vilims in view of Lipani and Davalos teaches wherein the plurality of ablation electrodes comprises a plurality of monoelectrode ablation electrodes (Fig. 23 of Vilims).
Regarding Claim 19, Vilims in view of Lipani and Davalos teaches wherein applying the pulses comprises applying the pulses to at least one set of the monoelectrode ablation electrodes, wherein each of the at least one set comprises at least one first monoelectrode ablation electrode that is an active electrode and at least one second monoelectrode ablation electrode that is a return electrode (Fig. 23 and Col. 5, ll. 8-40 of Vilims and also see “each probe 22 includes either a monopolar electrode or bipolar electrodes having two electrodes separated by an insulating sleeve. In one embodiment, if the probe includes a monopolar electrode, the amount of exposure of the active portion of the electrode can be adjusted by retracting or advancing an insulating sleeve relative to the electrode” [0167] of Davalos).
Regarding Claim 20, Vilims in view of Lipani and Davalos teaches wherein the plurality of ablation electrodes comprises at least one multipolar ablation electrode comprising a plurality of the ablation electrodes (Fig. 23 and Col. 5, ll. 8-40 of Vilims and also see “each probe 22 includes either a monopolar electrode or bipolar electrodes having two electrodes separated by an insulating sleeve. In one embodiment, if the probe includes a monopolar electrode, the amount of exposure of the active portion of the electrode can be adjusted by retracting or advancing an insulating sleeve relative to the electrode” [0167] of Davalos).
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794