DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Claim Objections
Claims 29 and 35 are objected to because of the following informalities: In claim 29, lines 5 and 6, -first- should be inserted before “treatment region”; In claim 35, line 2, “include” should be replaced with -includes-. Appropriate correction is required.
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 30-33 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.
Claims 30 and 32 both recite ‘removably securing’ the stylet and the cannula. However, there does not appear to be sufficient support for this specific claim limitation in the specification (e.g., it only refers to these components ‘having mating proximal ends’). Appropriate correction is required.
Claim 33 recites the limitation “wherein the preformed curved distal end region of the cannula and the curvable distal end region of the stylet are configured to assume a sufficiently straight configuration to allow the cannula and the stylet to be passed through the trocar and are configured to regain a curvature after exiting the distal end opening of the trocar”. However, there does not appear to be sufficient support for this specific claim limitation in the specification (e.g., the cannula is inserted/straightened with a different stylet). Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 38 and 40 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. Appropriate correction is required.
Claim 38 recites the limitations "the first electrode" and “the second electrode” in line 1. There is insufficient antecedent basis for these limitations in the claim.
Claim 40 recites the limitation "the BVN" in lines 4 and 8. The antecedent basis for this limitation is confusing, since it’s unclear which of the previously-recited “BVN’s” is being referred to. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 24, 25, and 29-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pellegrino, U.S. 2010/0185161 (hereinafter Pellegrino) in view of Sherar, U.S. 2014/0031715 (hereinafter Sherar).
Regarding claim 24, Pellegrino discloses (note figs. 1-2; paragraph 13) a method of ablating a basivertebral nerve (BVN), the method comprising: inserting a first bipolar radiofrequency probe (100 – note paragraph 82) into a first cancellous bone region of a first vertebral body at a first vertebral level of the patient; advancing a distal end portion of the first bipolar radiofrequency probe to a first treatment region within the first cancellous bone region of the first vertebral body (note figs. 4A-F); and delivering radiofrequency energy from a single radiofrequency generator through the first bipolar radiofrequency probe to ablate the BVN in the first vertebral body (note paragraphs 67 and 82). However, Pellegrino fails to explicitly disclose ablating a BVN at multiple vertebral levels simultaneously, by inserting a second bipolar radiofrequency probe into a second vertebral body, and delivering radiofrequency energy from a single radiofrequency generator through both the radiofrequency probes. Sherar teaches (note abstract) a similar method of ablating intravertebral nerves, wherein multiple intravertebral nerves at different vertebral levels may be ablated simultaneously, through the use of multiple RF probes that deliver energy from a single radiofrequency generator (note figs. 9A-B; paragraph 83). It is well known in the art that this simultaneous ablation of multiple targets would result in increased efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the method of Pellegrino to comprise the steps of inserting a second bipolar radiofrequency probe into a second vertebral body, and delivering radiofrequency energy from a single radiofrequency generator through both the radiofrequency probes simultaneously, in order to increase efficiency.
Regarding claim 25, Pellegrino in view of Sherar teaches (see above) a method wherein the first vertebral level and the second vertebral level are each selected from the group consisting of L3, L4, L5, and S1 (note Pellegrino - paragraph 103).
Regarding claim 29, Pellegrino in view of Sherar teaches (see above) a method wherein the operation of inserting the first bipolar radiofrequency probe into the first cancellous bone region of the first vertebral body comprises advancing a trocar (20) through the patient's skin toward the first vertebral body, advancing a cannula (50) having a lumen and a preformed curved distal end region beyond a distal end opening of the trocar into the first vertebral body to create a curved path to the treatment region, and advancing the first bipolar radiofrequency probe through the lumen of the cannula to the treatment region.
Regarding claim 30, Pellegrino in view of Sherar teaches (see above) a method wherein the operation of advancing the cannula further comprises providing within the lumen of the cannula a stylet (60) having a curvable distal end region and a distal tip that protrudes beyond a distal opening of the cannula and ‘removably securing’ the stylet within the lumen of the cannula (note Pellegrino - paragraphs 75-77).
Regarding claim 31, Pellegrino in view of Sherar teaches (see above) a method further comprising removing the stylet from the cannula (note Pellegrino – paragraph 79).
Regarding claim 32, Pellegrino in view of Sherar teaches (see above) a method wherein the preformed curved distal end region of the cannula and the curvable distal end region of the stylet remain ‘removably secured’ during advancement beyond the distal end opening of the trocar (note Pellegrino – paragraph 77).
Regarding claim 33, Pellegrino in view of Sherar teaches (see above, as best understood) a method wherein the preformed curved distal end region of the cannula and the curvable distal end region of the stylet are configured to assume a sufficiently straight configuration to allow the cannula and the stylet to be passed through the trocar and are configured to regain a curvature after exiting the distal end opening of the trocar (note Pellegrino – paragraphs 74-75).
Regarding claim 34, Pellegrino in view of Sherar teaches (see above) a method wherein the operation of advancing the trocar through the patient's skin toward the first vertebral body comprises inserting a straight stylet (40) through the trocar until a distal tip of the straight stylet protrudes beyond the distal end opening of the trocar.
Regarding claim 35, Pellegrino in view of Sherar teaches (see above) a method wherein at least one of the first and second bipolar radiofrequency probes include a sensor (note Pellegrino – paragraph 84).
Regarding claim 36, Pellegrino in view of Sherar teaches (see above) a method wherein at least one of the first and second bipolar radiofrequency probes defines a fluid delivery catheter (note Pellegrino – paragraph 83).
Regarding claim 37, Pellegrino in view of Sherar teaches (see above) a method wherein the first treatment region is anterior to an entry point of the BVN into the first vertebral body and within a trunk region of the BVN in the first vertebral body (note Pellegrino – fig. 4F).
Regarding claim 38, Pellegrino in view of Sherar teaches (see above) a method wherein the first electrode and the second electrode of the first bipolar radiofrequency probe are positioned proximal of a junction of the BVN in the first vertebral body (note Pellegrino – fig. 4F).
Regarding claim 39, Pellegrino in view of Sherar teaches (see above) a method wherein the first bipolar radiofrequency probe and the second bipolar radiofrequency probe are provided as a kit (note Pellegrino – paragraph 102).
Regarding claim 40, Pellegrino in view of Sherar teaches (see above) a method wherein the operation of advancing the distal end portion of the first bipolar radiofrequency probe to the first treatment region within the first cancellous bone region of the first vertebral body comprises positioning a first electrode and a second electrode of the first bipolar radiofrequency probe immediately adjacent the BVN of the patient (note Pellegrino – fig. 17), and wherein the operation of advancing the distal end portion of the second bipolar radiofrequency probe to the second treatment region within the second cancellous bone region of the second vertebral body comprises positioning a first electrode and a second electrode of the second bipolar radiofrequency probe immediately adjacent the BVN of the patient (note Pellegrino – fig. 17).
Claims 26-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pellegrino in view of Sherar as applied to claims 24, 25, and 29-40 above, and further in view of Pellegrino, U.S. 2004/0064137 (hereinafter Pellegrino-2).
Regarding claims 26-28, Pellegrino in view of Sherar teaches (see above) a method of ablating a BVN at multiple vertebral levels simultaneously. However, this combination of references fails to expressly teach the specifically-claimed ablation parameters, including frequency, temperature, and duration. Pellegrino-2 teaches (note abstract) a similar method of BVN ablation, wherein energy is delivered at a frequency of 400-600 kHz (note paragraph 222) in order to heat target tissue to a temperature of 80-100 degrees Celsius for a specific duration of 5-15 minutes (note paragraphs 188, 190, and 196). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have further modified the procedure of Pellegrino to comprise delivering energy at a frequency of 400-600 kHz in order to heat target tissue to a temperature of 80-100 degrees Celsius for a specific duration of 5-15 minutes. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2001/0047167 (Heggeness).
U.S. 2009/0275995 (Truckai).
U.S. 2004/0162559 (Arramon).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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