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 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 1-5, 10-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deem et al (8,504,147) in view of the teaching of Heggeness (6,699,242).
Regarding claim 1, Deem et al disclose a method for nerve ablation (Abstract, for example) comprising inserting at least one ablation electrode (Figure 4, catheter 22 having electrodes 30 and 32) into a vertebral body of a patient and applying pulses to the ablation electrode to ablate (i.e. irreversibly electroporate) the nerve. The pulses have a voltage and duration within applicant’s claimed range (col. 9, lines 10-17,for example). Deem et al disclose the use of the device to treat various types of nerves in the vertebra, but fail to expressly disclose the treatment of basivertebral nerves. The examiner maintains that one of ordinary skill in the art would recognize that the breadth of nerves disclosed by Deem et al would obviously also encompass basivertebral nerves.
To show the teaching of various different nerves including basivertebral nerves with ablative energy, attention is directed to Heggeness who disclose an electrosurgical system for the ablation of nerves in the spinal column (Abstract, for example), and specifically disclose the ablation of various intraosseous nerves and basivertebral nerves (col. 3, lines 35-37, for example).
To have used the Deem et al device and associated method to ablate basivertebral nerves would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Deem et al disclose the treatment of various different nerve sites and further since Heggeness specifically teach that basivertebral nerves may be a target for nerve ablation in a similar ablation procedure.
Regarding claims 2 and 3, Deem et al disclose a range of voltages inclusive of 2kV and 3kV (col. 9, lines 10-17). Regarding claims 4 and 5, Deem et al disclose a similar range for pulse duration (col. 9, lines 10-17). Regarding claims 10-12, Deem et al disclose the use of monopolar and bipolar electrodes (col. 7, lines 50-55, for example). Regarding claim 13, Heggeness teach accessing the nerves through the pedicle (col. 10, lines 15-34, for example).
Regarding claim 14, Deem et al again disclose a method for nerve ablation comprising inserting an ablation electrode into a vertebral body and applying pulses of a duration and electric field within applicant’s claimed range as addressed with respect to claim 1 above. Again, Deem et al fail to expressly disclose the treatment of basivertebral nerves, but Heggeness provides the relative teaching of treating basivertebral nerves in a similar ablation procedure as addressed with respect to claim 1 above. The motivation for combining these references is the same as addressed with respect to claim 1 above.
Regarding claims 15 and 16, see again Deem et al at column 9, lines 10-17. Regarding claims 18-20, see above discussion of claims 10-12 and column 7, lines 50-55 of deem et al.
Claims 6, 7, 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Deem et al (8,504,147) in view of the teaching of Heggeness (6,699,242) and further in view of the teaching of McKay (2014/0121656).
Regarding claims 6, 7, 9 and 17, Deem et al teach that the pulses may be of a variety of waveforms and may have varying separation between pulses (i.e. col. 8, lines 21-31), but fails to disclose the specific values recited in these claims.
McKay disclose another device for ablating nerves (para. [0010], for example) using a plurality of pulses to treat tissue. In particular, McKay teach of using busts of pulses (para. [0071]) having a pulse interval between pulses within applicant’s range. McKay also disclose the use of various different phasic waveforms including biphasic waveforms (para. [0071]).
To have provided the Deem et al system, as modified by the teaching of Heggeness, with the specific waveforms of the claims would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since McKay disclose such waveforms used in a similar system to ablate nerve tissue.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Deem et al (8,504,147) in view of the teaching of Heggeness (6,699,242) and further in view of the teaching of Viswanathan et al (10,322,286).
Deem et al fail to disclose the specific use of monophasic pulses to treat tissue. The examiner maintains that Deem et al disclose a variety of different waveforms, and the use of biphasic and monophasic waveforms are generally known as obvious alternatives. To that end, Viswanathan et al is cited to teach the known use of either biphasic or monophasic waveforms (col. 3, lines 24-33, for example) to ablate nerve tissue.
To have used monophasic waveforms to deliver pulsed energy to ablate nerve tissue in the Deem et al method, as modified by the teaching of Heggeness, would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Viswanathan et al fairly teach that it is known to use either biphasic or monophasic pulses to ablate nerve tissue.
Response to Arguments
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Applicant asserts that the Deem disclosure of the range of voltages is orders of magnitude and is not as within the specific maximum/minimum values of the instant claims. While it is agreed that Deem discloses a very wide range of values, applicant’s claimed ranges are no less broad. Claim 1, for example, recites pulses that “have a voltage of at least 2 kV. There is no upper limit associated with the claim limitation which would make that particular range more broad than that of the Deem disclosure. Additionally, claim 1 recites a pulse duration “of no more than 500 microseconds”, which has no lower limit for the duration making that range also broader than that disclosed by Deem. The examiner maintains that applicant’s disclosure fails to disclose any specific range for voltage or pulse duration, but rather generalized open-ended values that would include a very wide range of options. There is no criticality or sufficient specificity in applicant’s specification for the use of a specific, narrow range that would be appropriate for treating the basivertebral nerve. It is noted that the prior art of record is replete with various different types of devices for performing irreversible electroporation on various different types of tissue and discloses numerous different ranges for the parameters (i.e. voltage, pulse duration, pulse delay, etc.). One of ordinary skill in the art would recognize from the vast disclosed ranges that these values may obviously be derived without the need for undue experimentation to arrive at acceptable/optimal values for the procedure being performed. Regarding claim 5, applicant argues that Deem discloses a minimum value of 10 microseconds, which is larger than the claimed limitation of a duration of no more than 1 microsecond. The examiner maintains it would be within the purview of the skilled artisan to arrive at the value of 1 microsecond, particularly given the large disclosed range of Deem and the large disclosed range in applicant’s own specification. While Deem does not disclose 1 microsecond within the disclosed range of pulse durations, it is close enough to the disclosed range that one of ordinary skill in the art would obviously consider such a value. It is noted that both Deem et al (7,653,438) and Azamian et al (8,568,399) disclose sub-microsecond pulse durations in other RF devices for ablating nerve tissue.
Regarding claims 6, 7, 9 and 17, applicant asserts the McKay reference is non-analogous prior art. The examiner disagrees. McKay is directed to a device that provides pulsed RF energy for the ablation of nerves, similar to the Deem et al and Heggeness references. That McKay may disclose the resection and cutting of tissue does not deflect from the teaching that the device is also used for nerve ablation with pulsed energy, the pulses having a pulse separation within applicant’s claimed range. Again, applicant has disclosed very broad ranges for the pulse parameters, and the prior art contains many references which disclose various parameters for irreversible and reversible electroporation with values across a very wide range for treatment of tissues. The examiner maintains that one of ordinary skill in the art would glean from McKay that the specific pulse separation values would be obvious for use in any device that uses pulsed RF energy to ablate tissue.
As such, the examiner maintains the rejections of record remain tenable.
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 MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL PEFFLEY/
Primary Examiner
Art Unit 3794
/M.F.P/May 25, 2026
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