DETAILED ACTION
Currently, claims 2, 4, 6-10, 12, 14, and 16-20 are being examined, while the remaining claims have been cancelled/withdrawn.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 3, 2025 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the [RF probe] curved distal portion comprising a first electrode disposed at a distal tip of the curved distal portion and a second electrode disposed at a starting location of a radius of curvature of the curved distal portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Objections
Claim 9 is objected to because of the following informalities: In line 2, -the- should be inserted before “radiofrequency”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 12, 14, and 16-20 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.
Claim 12 is found to be indefinite because Examiner is unsure of the scope of the “radiofrequency probe” limitation, which does not appear to be tied to any other components in the claim (i.e., its relationship to the “cannula” and “stylet” is no longer claimed). Appropriate correction is required.
Claim 12 recites the limitation "a basivertebral nerve" in line 17 (including lined out portions). The antecedent basis for this limitation is confusing, since it’s already been recited.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 2, 4, 6-10, 12, 14, and 16-20 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 Pellegrino, U.S. 2004/0064137 (hereinafter Pellegrino-2).
Regarding claims 2, 9, 12, and 19, Pellegrino discloses (note figs. 10A-E and 17) a system comprising: a cannula (230) having a curved distal portion configured to be inserted into a vertebral body at a pedicle insertion site (note fig. 10E); a sharp stylet (note paragraph 123) configured to be inserted within the cannula and selectively removed therefrom; and a bipolar radiofrequency ablation probe (‘250’ - note paragraph 124) configured to be inserted through the cannula when the stylet is not present, wherein the radiofrequency ablation probe comprises a curved distal portion (note fig. 17), the curved distal portion comprising a first electrode (274) disposed at a distal tip of the curved distal portion and a second electrode (276) necessarily disposed ‘at’ a starting location of a radius of curvature of the curved distal portion (according to Merriam-Webster dictionary, “at” has been defined as “a function word to indicate presence or occurrence in, on, or near”), wherein the curved distal portion has a length and the radius of curvature capable of positioning the first electrode beyond a midline of the vertebral body and the second electrode on a same side of the midline as the pedicle insertion site (e.g., depending on the size of the patient), wherein the length and radius of curvature of the curved distal portion are capable of positioning the first electrode and the second electrode on opposite sides of a basivertebral nerve within the vertebral body (e.g., depending on the size of the patient) and at a substantially same anterior-posterior depth relative to a posterior wall of the vertebral body; wherein the radiofrequency ablation probe is configured to deliver energy between the first electrode and the second electrode to ablate at least a portion of the basivertebral nerve within the vertebral body. However, Pellegrino fails to explicitly disclose a temperature sensor on the probe that is configured to monitor a temperature within the vertebral body during energy delivery. However, Pellegrino-2 teaches (note embodiment depicted in figs. 28A-B) an energy delivery probe having a temperature sensor thereon (note paragraphs 246-247) that is configured to monitor a temperature within the vertebral body during energy delivery. It is well known in the art that the use of this temperature-based feedback configuration (note paragraph 202) would result in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the apparatus of Pellegrino to comprise a temperature sensor on the probe that is configured to monitor a temperature within the vertebral body during energy delivery (as taught by Pellegrino-2), in order to increase safety and efficiency. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 4 and 14, Pellegrino discloses (see above) a system wherein one of the electrodes of the first electrode and the second electrode is an active electrode and the other electrode is a return electrode (note paragraph 124).
Regarding claims 6 and 16, Pellegrino discloses (see above) the claimed invention except for the specific probe diameter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the probe size accordingly, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 7 and 17, Pellegrino discloses (see above) a system that is capable of performing the claimed function. As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 8 and 18, Pellegrino discloses (see above) a system necessarily comprising a radiofrequency generator electrically coupled to the radiofrequency ablation probe.
Regarding claims 10 and 20, Pellegrino discloses (see above) a system wherein the stylet necessarily comprises a sharp distal tip adapted to penetrate through cortical bone and into cancellous bone of the vertebral body (note paragraph 123).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Regarding Applicant’s arguments concerning Pellegrino, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met by Pellegrino as they are currently written, due to the breadth of limitations such as “at” as well as their reliance on functional language (see modified rejections above). As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, Examiner asserts that the claims are still met by the cited references, as can be seen above.
Conclusion
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