DETAILED ACTION
This action is in response to amendments received on 4/8/2026. Claims 1-20 were previously pending. Claims 1, 10-11, 14, 18 and 20 have been amended. 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 1-5 and 10-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan (US Pub. No. 2021/0113239) in view of Pakhomov (US Pub. No. 2020/0147371).
Regarding Claim 1, Donovan teaches a method to treat sacroiliac joint pain, the method comprising inserting at least one ablation electrode into a patient ([0008] and [0072]) 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 ([0008], [0012]-[0016], [0026], [0065]); and applying pulses to the at least one ablation electrode to ablate the at least one spinal nerve ([0008]-[0009], [0019]-[0022] and [0065]);
although Donovan teaches electroporation ablation of the nerve, does not specifically teach, wherein each of the pulses has a duration of no more than 300 microseconds and at least some of the pulses have a voltage of at least 1 kV.
In the same field of invention, Pakhomov teaches “intense nanosecond pulsed electric filed (nsPEF) may be used for cell activation, nanoelectroporation and excitation of electrically cells, including in particular nerves such as ventricular cardiomyocytes and peripheral nerve fibers, for membrane electroporation, and/or for killing cells” in [0007], “a controller; an applicator comprising a set of electrodes adapted to be placed in proximity to the biological tissue; and one or more pulse generator, wherein each pulse generator is configured to generate a sub-microsecond pulse (e.g., having a duration of 1000 ns or less); wherein the controller is configured to apply a train of sub-microsecond pulses at a frequency of greater than 0.1 megahertz (e.g., 0.2 MHz or greater, 0.5 MHz or greater, 1 MHz or greater, etc.)” [0012], “methods and apparatuses described herein may therefore also be used for defibrillation, peripheral nerve and deep brain stimulation, and tissue or cell ablation (e.g., cancer ablation)” in [0052], “Any appropriate tissue may be treated, including, but not limited to: skin, liver, kidney, neuronal (brain, spine, peripheral), lung, muscle, adipose, respiratory, gastrointestinal, bladder, reproductive, etc. tissue, including tumorous tissue. The nanosecond pulses at low electric field (e.g., low voltage) and high (e.g., megahertz) frequency described herein may be used to manipulate biological functions and treat diseases. Responses to such electrical stimulation may include a variety of bio-effects, including but not limited to: nerve and muscle excitation, activation of immune (or otherwise stimulating an immune response) and endocrine cells, cell differentiation, electroporation, necrotic and apoptotic cell death. Thus, the use of nanosecond pulses at low electric field and megahertz frequency may be used in virtually any indication in which electrical stimulation may be applied” [0077] and “pulse generators configured as described herein may limit the burst duration and minimum pulse duration, but could deliver up to about 3 kV”, also see [0014]-[0017], [0062]-[0071].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to control the application of energy of Donovan to deliver a plurality of short pulsed electric field ablation energy to the target tissue especially for electroporating the spinal tissue in the ranges claimed as they appear to be a workable range for benefiting better results in treatment in view of the teachings of Pakhomov.
Regarding Claim 2, Donovan teaches wherein the at least one spinal nerve comprises at least one sacral lateral branch nerve (“Creating specific lesion shapes may allow clinicians to efficiently ablate a basivertebral nerve trunk within specific vertebral bodies (e.g., cervical, thoracic, lumbar, sacral vertebrae)” [0008]).
Regarding Claim 3, Donovan in view of Willis teaches wherein each of the pulses has a voltage of at least 2 kV ([0126] of Willis).
Regarding Claim 4, Donovan in view of Willis teaches wherein each of the pulses has a voltage of at least 3 kV ([0126] of Willis).
Regarding Claim 5, Donovan in view of Willis teaches wherein at least a plurality of the pulses each have a duration of no more than 100 microseconds ([0126], [0129] and [0141] of Willis).
Regarding Claim 10, Donovan teaches wherein the at least one spinal nerve comprises a plurality of the spinal 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 spinal nerves ([0065]-[0072] and Figs. 5A-D).
Regarding Claim 11, Donovan teaches wherein the at least one ablation electrode comprises a plurality of monoelectrode ablation electrodes (“nerve locator device may include a bipolar pair of stimulation electrodes or monopolar electrodes. In some implementations, the nerve locator features may be implemented on the access tools or treatment devices themselves as opposed to a separate stand-alone device” [0073] and “Radiofrequency treatment probes may include multiple electrodes configured to act as monopolar, or unipolar, electrodes or as pairs of bipolar electrodes” [0122]).
Regarding Claim 12, Donovan 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 (“The first radiofrequency energy delivery device and the second radiofrequency energy delivery device each include at least two electrodes” [0014], Figs. 5A-D, also see [0073] and [0122]).
Regarding Claim 13, Donovan teaches wherein the at least one ablation electrode comprises at least one multipolar ablation electrode ([0014] and [0073]).
Regarding Claim 14, Donovan teaches a method to treat sacroiliac joint pain ([0008] and [0072]), 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 ([0008], [0012]-[0016], [0026], [0065]); and applying pulses to the at least one ablation electrode to ablate the at least one spinal nerve ([0008]-[0009], [0019]-[0022] and [0065]);
although Donovan teaches electroporation ablation of the nerve, does not specifically teach, wherein each of the pulses has a duration of no more than 300 microseconds and at least some of the pulses generate an electric field of at least 3 kV/cm.
In the same field of invention, Pakhomov teaches “intense nanosecond pulsed electric filed (nsPEF) may be used for cell activation, nanoelectroporation and excitation of electrically cells, including in particular nerves such as ventricular cardiomyocytes and peripheral nerve fibers, for membrane electroporation, and/or for killing cells” in [0007], “a controller; an applicator comprising a set of electrodes adapted to be placed in proximity to the biological tissue; and one or more pulse generator, wherein each pulse generator is configured to generate a sub-microsecond pulse (e.g., having a duration of 1000 ns or less); wherein the controller is configured to apply a train of sub-microsecond pulses at a frequency of greater than 0.1 megahertz (e.g., 0.2 MHz or greater, 0.5 MHz or greater, 1 MHz or greater, etc.)” [0012], “methods and apparatuses described herein may therefore also be used for defibrillation, peripheral nerve and deep brain stimulation, and tissue or cell ablation (e.g., cancer ablation)” in [0052], “Any appropriate tissue may be treated, including, but not limited to: skin, liver, kidney, neuronal (brain, spine, peripheral), lung, muscle, adipose, respiratory, gastrointestinal, bladder, reproductive, etc. tissue, including tumorous tissue. The nanosecond pulses at low electric field (e.g., low voltage) and high (e.g., megahertz) frequency described herein may be used to manipulate biological functions and treat diseases. Responses to such electrical stimulation may include a variety of bio-effects, including but not limited to: nerve and muscle excitation, activation of immune (or otherwise stimulating an immune response) and endocrine cells, cell differentiation, electroporation, necrotic and apoptotic cell death. Thus, the use of nanosecond pulses at low electric field and megahertz frequency may be used in virtually any indication in which electrical stimulation may be applied” [0077] and “pulse generators configured as described herein may limit the burst duration and minimum pulse duration, but could deliver up to about 3 kV”, also see [0049], [0120].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to control the application of energy of Donovan to deliver a plurality of short pulsed electric field ablation energy to the target tissue especially for electroporating the spinal tissue in the ranges claimed as they appear to be a workable range for benefiting better results in treatment in view of the teachings of Pakhomov.
Regarding Claim 15, Donovan in view of Pakhomov teaches wherein each of the pulses generates an electric field of at least 3.5 kV/cm ([0049] and [0120] of Pakhomov).
Regarding Claim 16, Donovan in view of Pakhomov teaches wherein at least a plurality of the pulses each have a duration of no more than 100 microseconds (Pakhomov teaches “equal or less than 1 microsecond duration”, see [0014]-[0017]).
Regarding Claim 18, Donovan teaches wherein the at least one ablation electrode comprises a plurality of monoelectrode ablation electrodes (“nerve locator device may include a bipolar pair of stimulation electrodes or monopolar electrodes. In some implementations, the nerve locator features may be implemented on the access tools or treatment devices themselves as opposed to a separate stand-alone device” [0073] and “Radiofrequency treatment probes may include multiple electrodes configured to act as monopolar, or unipolar, electrodes or as pairs of bipolar electrodes” [0122]).
Regarding Claim 19, Donovan 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 (“The first radiofrequency energy delivery device and the second radiofrequency energy delivery device each include at least two electrodes” [0014], Figs. 5A-D, also see [0073] and [0122]).
Regarding Claim 20, Donovan teaches wherein the at least one ablation electrode comprises at least one multipolar ablation electrode ([0014] and [0073]).
Claims 6-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan in view of Pakhomov as applied above and further in view of Viswanathan (US Pub. No. 2020/0205892).
Regarding Claims 6-7 and 17, Donovan in view of Pakhomov teaches the invention as applied above and although Pakhomov teaches applying a plurality of pulses, but not specifically wherein at least a plurality of the pulses are separated from each other by an intra-pulse duration of no more than 20 milliseconds and/or 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 waveform may include a first level of a hierarchy of the pulse waveform in the form of a first set of pulses, each pulse having a pulse time duration, a first time interval separating successive pulses. A second level of the hierarchy of the pulse waveform includes a plurality of first sets of pulses as a second set of pulses, a second time interval separating successive first sets of pulses, the second time interval being at least three times the duration of the first time interval” in [0015] and “The pulse width and the time interval t.sub.1 between pulses can both be in the range of microseconds to hundreds of microseconds, including all values and sub ranges in between. In some embodiments, the time interval t.sub.2 can be at least three times larger than the time interval t.sub.1” in [0166] and “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]; thereby the second time interval, which is the spacing between two sets of pulses have an intra-pulse duration of no more than 20 milliseconds and/or 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 as claimed.
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 and/or the spacing between two sets of pulses have an intra-pulse duration of no more than 20 milliseconds in order to yield a more effective electroporation treatment with a reduction in total energy delivered.
Regarding Claim 8, Donovan in view of Pakhomov and further in view of Viswanathan teaches wherein the pulses are monophasic ([0040] and Fig. 8 of Viswanathan).
Regarding Claim 9, Donovan in view of Pakhomov and further in view of Viswanathan teaches wherein the pulses are multiphasic ([0041] and Fig. 9 of Viswanathan)
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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