DETAILED ACTION
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 (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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Godara et al. (US 2007/0027449) in view of Underwood et al. (US 2007/0112346) and in further view of Burbank et al. (US 2003/0023239).
Regarding claim 17, Godara discloses a method of performing a rhizotomy on a medial branch of a dorsal ramus sensory nerve innervating a facet joint between two vertebrae (see [0124]-[0125], [0127], Fig. 12), the method comprising: providing an electrocautery probe having a distal end with a distal tip (see electrocautery probe 100 having a distal end 104 with a conductive distal tip 118, Figs. 1A and 12; [0036] and [0038]) creating an incision in a body of a patient (see insertion of probe 100 via an introducer comprising an cannula and sharpened obturator for piercing skin that creates an incision through which the probe passes through, the incision being positioned on the back of the patient; [0081] and [0126]); directing the distal end of the electrocautery probe through the incision (see insertion of probe 100 through the incision caused by using the introducer, [0126]); navigating the distal tip of the electrocautery probe via medical imaging (see “insertion step may be facilitated with the use of fluoroscopic imaging techniques”, [0126]) to a lateral mass of a vertebra at a location adjacent a medial branch of the dorsal ramus sensory nerve (see nerves located substantially adjacent to the articular process of the lumbar vertebra, [0125]-[0127]); delivering medication to the medial branch of the dorsal ramus sensory nerve (see [0066]); delivering energy from the distal tip of the probe over a surface area along the lateral mass to direct the energy over the surface area to cauterize the medial branch of the dorsal ramus sensory nerve (see formation of lesion in the target area via energy delivery by the distal end of the probe, damaging to the nerves, [0003], [0102], [0127]). However, Godara fails to specifically teach creating the incision in the body of the patient with the distal tip of the electrocautery probe; or while delivering energy, moving the distal tip of the probe over the surface area along the lateral mass to direct the energy over the surface area to cauterize of the medial branch of the dorsal ramus sensory nerve.
Underwood teaches an electrosurgical method for treating spinal tissue (see Abstract) comprising translating the instrument forwards and backwards according to preset limits while energizing the working end to ablate tissue surrounding the working end (see [0130]-[0131]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the energy delivery as taught by Godara to have further included moving the distal tip of the probe over the surface area along the lateral mass to direct the energy over the surface area and while delivering energy, moving the distal tip of the probe in a plurality of directions to direct the energy over the second surface area in light of Underwood, the motivation being to provide the additional benefit of increasing the volume of tissue treated during energy delivery to ensure all of the targeted tissue is treated (see Underwood: [0130]-[0131]). However, Godara in view of Underwood fails to teach creating the incision in the body of the patient with the distal tip of the electrocautery probe.
Burbank teaches use of an electrocautery probe (see Figs. 1 and 21A) wherein the skin of the patient is breached to gain access to the surgical site either using a scalpel or other surgical instrument to make an initial incision in the skin and alternatively, access through the skin may be achieved without such an initial incision by pressing the energized tissue-cutting electrode of the device against an exterior site on the patient's skin proximate to the surgical site (see [0055]). Burbank further teaches using high frequency electrical power through the electrical conductor to energize the tissue-cutting electrode for the tissue incision (see [0055]-[0056]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the manner of creating an incision as taught by Godara in view of Underwood to instead include creating the incision in the body of the patient with the distal tip of the electrocautery probe in light of Burbank, since one of ordinary skill in the art could have readily made the substitution in light of Burbank, and further since the modification would have been a matter of simple substitution to one of ordinary skill in the art for the same purpose of creating an incision in the skin of the patient for accessing the target surgical site.
Regarding claim 18, Godara further discloses wherein the electrocautery probe is provided with a lumen, and the medication is delivered through the lumen (see lumen through which the anesthetic/treatment compound is delivered from to the aperture, [0066]).
Regarding claims 19 and 21, Godara further discloses wherein the medication includes a local anesthetic (see anesthetic, [0066]).
Regarding claim 23, Godara in view of Underwood and Burbank further teaches the limitations of claim 23 under the same rationale as that applied in the rejection of claim 17 above.
Claims 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Godara in view of Underwood, Burbank, and in further view of Schepis et al. (US 2020/0038096).
Regarding claims 20 and 22, Godara in view of Underwood and Burbank teaches the limitations of claims 19 and 21, however Godara in view of Underwood and Burbank fails to specifically teach wherein the medication comprises at least one of novocaine, bupivacaine, and methylprednisolone.
Schepis teaches a method for facet joint nerve modulation (see Abstract), wherein the method includes injecting Bupivacaine as a local anesthetic at the stimulation site (see [0004] and [0157]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Godara in view of Underwood and Burbank to have included at least Bupivacaine as the medication in light of Schepis, the motivation being to reduce the discomfort caused by the lesion (see Schepis [0004]).
Response to Arguments
Applicant’s arguments with respect to the rejected claims 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. Specifically, the current arguments do not address the new combination of prior art references set forth in the current office action to address the newly added limitations being argued.
Allowable Subject Matter
Claims 14-16 and 24 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Godara et al. (US 2007/0027449), Nolan et al. (US 2024/0307105), and Underwood et al. (US 2007/0112346), fails to reasonably teach or suggest while delivering energy, moving the distal tip of the probe in X and Y directions transverse to the Z-axis over a first surface area along the first lateral mass to direct the energy over the first surface area to cauterize a first medial branch of the dorsal ramus sensory nerve when considered in combination with the additional requirements of the claim. The closest prior art generally teaches moving the distal tip of the probe while moving the distal tip of the probe in a back and forth or in a linear path, however fails to specifically teach movement in X and Y directions transverse to the Z-axis extending through the electrocautery probe as required by the claim.
Conclusion
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 SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794