DETAILED ACTION
Currently, claims 51 and 52 are pending, while the remaining claims have been cancelled.
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on January 14, 2026 has been entered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed provisional application, U.S. Provisional Application No. 61/100,553, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, this application fails to disclose the method steps pertaining to the ‘locking member’ and the ‘rotatable element’.
The Examiner notes that support for the instant claims has been found in U.S. Application No. 12/566,895. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 9/25/2009, this being the filing date of U.S. Application No. 12/566,895.
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 51-52 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pellegrino, U.S. 2004/0064137 (hereinafter Pellegrino) in view of Kraft, U.S. 2003/0225364 (hereinafter Kraft) and Tindel, U.S. 5,807,237 (hereinafter Tindel).
Regarding claim 51, Pellegrino discloses (note fig. 13; paragraphs 82-86) a method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: inserting an arrangement (including an instrument) through a pedicle of a vertebral body and into a cancellous portion thereof, wherein a distal portion of the arrangement is configured to be curved or straightened (note paragraph 84); producing a pathway through the bone region toward the basivertebral nerve, wherein the arrangement includes an instrument (101) defining a proximal portion, a distal portion, and a lumen; advancing an active element (301) to a treatment location ‘adjacent’ to the BVN (note fig. 12); and delivering energy to the active element and applying bipolar RF energy to ablate at least a portion of the BVN (note paragraphs 23 and 188). However, Pellegrino fails to explicitly disclose a procedure utilizing a straight outer introducer (having a central channel and a distal opening) for delivering the arrangement into the vertebrae. Furthermore, Pellegrino fails to explicitly disclose a procedure utilizing an arrangement that can be curved and straightened, wherein the instrument from the arrangement comprises a distal deflectable section. Kraft teaches (note fig. 3; paragraphs 67-68) a similar a procedure utilizing a straight outer introducer (101), having a central channel and a distal opening, for delivering an arrangement (‘105’ and ‘106’) into the bone. Furthermore, Kraft teaches (note fig. 4a) a procedure utilizing an arrangement that can be curved and straightened (note paragraphs 69 and 83), wherein the instrument from the arrangement comprises a distal deflectable section. It is well known in the art that these different configurations for delivering a device into bone are widely considered to be interchangeable. 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 procedure of Pellegrino to utilize the introducer and curveable arrangement from Kraft. This is because this modification would have merely comprised a simple substitution of interchangeable ‘bone delivery’ configurations in order to produce a predictable result (see MPEP 2143). While Pellegrino in view of Kraft teaches (see above) a method that utilizes an instrument comprising a distal deflectable section, this combination of references fails to expressly teach an instrument further comprising a proximal locking member. Tindel teaches (note figs. 2-4) a procedure that utilizes an instrument comprising a distal deflectable section (see fig. 4), as well as a proximal locking member (‘20’ – note col. 5, line 7) for securing the instrument to an outer introducer (30) during insertion/advancement (note figs. 3a-b). It is well known in the art that this locking member configuration would minimize unwanted movements between the components, thereby resulting 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 further modified the procedure of Pellegrino to utilize the proximal locking member from Tindel in order to increase safety and efficiency. While this embodiment of Pellegrino fails to explicitly disclose applying bipolar RF energy between two electrodes of a single bipolar RF probe, a different embodiment of Pellegrino teaches (note fig. 25) applying bipolar RF energy between two electrodes of a single bipolar RF probe (note paragraphs 175-176). It is well known in the art that these different bipolar energy-delivery configurations (i.e., single probe with multiple electrodes thereon vs multiple probes with individual electrodes thereon) are widely considered to be interchangeable (as can be seen by the different embodiments disclosed in Pellegrino). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have further modified the procedure of Pellegrino to comprise applying bipolar RF energy between two electrodes of a single bipolar RF probe. This is because this modification would have merely comprised a simple substitution of interchangeable bipolar energy-delivery configurations in order to produce a predictable result (see MPEP 2143). It should be noted that any remaining method steps would have necessarily been met through the routine use of this modified device.
Regarding claim 52, Pellegrino discloses (note fig. 13; paragraphs 82-86) a method of ablating a basivertebral nerve in a vertebral body of a patient, the method comprising: inserting an arrangement (including an instrument) through a pedicle of a vertebral body and into a cancellous portion thereof, wherein a distal portion of the arrangement is configured to be curved or straightened (note paragraph 84); producing a pathway through the bone region toward the basivertebral nerve, wherein the arrangement includes an instrument (101) defining a proximal portion, a distal portion, and a lumen; advancing an active element (301) to a treatment location ‘adjacent’ to the BVN (note fig. 12); and delivering energy to the active element and applying bipolar RF energy to ablate at least a portion of the BVN (note paragraphs 23 and 188). However, Pellegrino fails to explicitly disclose a procedure utilizing a straight outer introducer (having a central channel and a distal opening) for delivering the arrangement into the vertebrae. Furthermore, Pellegrino fails to explicitly disclose a procedure utilizing an arrangement that can be curved and straightened, wherein the instrument from the arrangement comprises a distal deflectable section. Kraft teaches (note fig. 3; paragraphs 67-68) a similar a procedure utilizing a straight outer introducer (101), having a central channel and a distal opening, for delivering an arrangement (‘105’ and ‘106’) into the bone. Furthermore, Kraft teaches (note fig. 4a) a procedure utilizing an arrangement that can be curved and straightened (note paragraphs 69 and 83), wherein the instrument from the arrangement comprises a distal deflectable section. It is well known in the art that these different configurations for delivering a device into bone are widely considered to be interchangeable. 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 procedure of Pellegrino to utilize the introducer and curveable arrangement from Kraft. This is because this modification would have merely comprised a simple substitution of interchangeable ‘bone delivery’ configurations in order to produce a predictable result (see MPEP 2143). While Pellegrino in view of Kraft teaches (see above) a method that utilizes an instrument comprising a distal deflectable section, this combination of references fails to expressly teach an instrument further comprising a proximal rotatable element. Tindel teaches (note figs. 2-4) a procedure that utilizes an instrument comprising a distal deflectable section (see fig. 4) that is controlled by a proximal rotatable element (24). It is well known in the art that any of a wide variety of actuator configurations could be used interchangeably for actuating the deflectable section of the instrument. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have further modified the procedure of Pellegrino to utilize the proximal rotatable actuating element from Tindel. This is because this modification would have merely comprised a simple substitution of interchangeable actuator configurations in order to produce a predictable result (see MPEP 2143). While this embodiment of Pellegrino fails to explicitly disclose applying bipolar RF energy between two electrodes of a single bipolar RF probe, a different embodiment of Pellegrino teaches (note fig. 25) applying bipolar RF energy between two electrodes of a single bipolar RF probe (note paragraphs 175-176). It is well known in the art that these different bipolar energy-delivery configurations (i.e., single probe with multiple electrodes thereon vs multiple probes with individual electrodes thereon) are widely considered to be interchangeable (as can be seen by the different embodiments disclosed in Pellegrino). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have further modified the procedure of Pellegrino to comprise applying bipolar RF energy between two electrodes of a single bipolar RF probe. This is because this modification would have merely comprised a simple substitution of interchangeable bipolar energy-delivery configurations in order to produce a predictable result (see MPEP 2143). It should be noted that any remaining method steps would have necessarily been met through the routine use of this modified device, due to the breadth of limitations such as “rotated position,” “distal deflectable section,” and “relative to the opening”.
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
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794