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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-30 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,966,782 and over claims 1-72 of U.S. Patent No. 10,716,618. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 10,966,782 and U.S. Patent No. 10,716,618 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tullis et al., (hereinafter ‘Tullis,’ U.S. Pat. 7,918,852) in view of Behl et al., (hereinafter ‘Behl,’ U.S. Pat. 7,195,629).
Regarding claim 1, Tullis (Fig. 2) discloses a system for performing radiofrequency neurotomy on a target nerve of a patient, the system comprising: a radiofrequency probe assembly (supply electrode assembly 36) configured to connect to a radiofrequency generator (22), the radiofrequency probe assembly (36) comprising a radiofrequency probe (col. 5, ll. 54-58); and a radiofrequency neurotomy needle (cannula 28 in Fig. 2; col. 5, ll. 41-43; cannula 28 is best suited to pierce and penetrate skin and tissue) comprising: a first hub (46); a cannula (28) fixedly attached to the first hub (46), the cannula (28) comprising a lumen (lumen of body 29) that accepts the radiofrequency probe (Fig. 5); a tip (58) at a distal end of the radiofrequency neurotomy needle that is conductive (col. 6, ll. 14-23, cannula 28 has a generally tubular body 29 including electrically conductive outer tube 54 and inner tube 48) and is shaped to pierce tissue of the patient (col. 5, ll. 41-43). Tullis discloses wherein, when the radiofrequency probe is accepted in the lumen of the cannula and is in the deployed position (Figs. 2 and 5), an electrode is formed that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated (col. 5, ll. 54-58).
Tullis is silent regarding a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, wherein, when the radiofrequency probe is accepted in the lumen of the cannula and the plurality of filaments are in the deployed position, the tip and the plurality of filaments together form an electrode that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated, and wherein the plurality of filaments are advanceable from the retracted position to the deployed position without concurrent advancement of the radiofrequency probe relative to the radiofrequency neurotomy needle.
However, in the same field of endeavor, Behl taches a similar radiofrequency probe (50) and a plurality of filaments (52) that are conductive and are movable between a retracted position and a deployed position (Fig. 2). Behl further teaches a second hub (distal slider 58) interconnected to the plurality of filaments (52); and an actuator (rotatable portion 72) interconnected to the second hub (58), wherein rotation of the actuator (72) relative to the first hub (stationary portion 70) in a first direction causes the second hub (58) to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position (col. 12, ll. 62-67, “In this way, rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52 … as best illustrated in FIG. 3.”), wherein, when the radiofrequency probe is accepted in the lumen of the cannula and the plurality of filaments are in the deployed position, the tip and the plurality of filaments together form an electrode that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated (col. 13, ll. 14-18, “When fully deployed, a distal electrode array 52, as shown in FIGS. 2 and 3, is in electrical contact with the distal conductor 86 so that the array and conductor form an integrated electrode array of the type illustrated in FIG. 1.” See Fig. 5 for probe 50, distal conductor 84). Further, Behl teaches wherein the plurality of filaments (52) are advanceable from the retracted position to the deployed position without concurrent advancement of the radiofrequency probe relative to the radiofrequency neurotomy needle (as best illustrated in Fig. 2, slider 58 is advanced to deploy electrode array 52, without concurrent advancement of the radiofrequency probe 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system as taught by Tullis to incorporate a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, wherein, when the radiofrequency probe is accepted in the lumen of the cannula and the plurality of filaments are in the deployed position, the tip and the plurality of filaments together form an electrode that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated, and wherein the plurality of filaments are advanceable from the retracted position to the deployed position without concurrent advancement of the radiofrequency probe relative to the radiofrequency neurotomy needle, as taught by Behl, in order to provide radiofrequency energy to targeted regions of tissue and produce tissue lesions having a variety of geometries to accommodate the targeted region (col. 2, ll. 23-28), thereby increasing overall control, accuracy and efficiency.
Regarding claim 2, Tullis in view of Behl teach all of the limitations of the system according to claim 1. Tullis discloses wherein: the radiofrequency probe assembly (36) is separate from the radiofrequency neurotomy needle (28); and the radiofrequency probe (36) is insertable by a user of the system into the lumen of the cannula of the radiofrequency neurotomy needle (Figs. 2 and 5).
Regarding claim 3, Tullis in view of Behl teach all of the limitations of the system according to claim 2. Tullis discloses wherein the radiofrequency neurotomy needle (28) further comprises a fitting in fluid communication with the lumen of the cannula (coupling assembly 44 and associated parts), wherein the fitting is attachable to a fluid delivery device for delivery of fluid through the lumen to a region of tissue around the tip (syringe 32), and wherein the fitting permits the radiofrequency probe (36) to be inserted through the fitting and into the cannula after delivery of fluid through the lumen (col. 16, ll. 39-47, “If therapeutic fluids are needed after the penetration state 38, system 20 is placed into the medication state 40 by preferably press fitting a leading end of the syringe 32 against the collar 74 and into the bore 72 for slightly pressurized injection of the therapeutic fluid into the through-bore 57 of cannula body 29. After the medication state 40, the syringe 32 is preferably removed from the hub 46 and the supply electrode assembly 36 is connected thus designating the operation state 42 of the tool 24.”).
Regarding claim 4, Tullis in view of Behl teach all of the limitations of the system according to claim 1. Tullis discloses wherein a distal end of the radiofrequency probe (36) comprises a temperature measurement device (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36).
Regarding claim 5, Tullis in view of Behl teach all of the limitations of the system according to claim 4. Tullis discloses wherein the temperature measurement device (120) is proximate to the tip of the radiofrequency neurotomy needle (28) when the radiofrequency probe (36) is present in the lumen of the cannula (Figs. 2 and 5).
Regarding claim 6, Tullis in view of Behl teach all of the limitations of the system according to claim 1. Tullis discloses wherein: the cannula (28) comprises a conductive tube (54); the system further comprises an additional conductive tube (48) in the lumen of the cannula (Fig. 6), the additional conductive tube defining an additional lumen into which the radiofrequency probe is received (Fig. 6); and the radiofrequency energy emitted by the radiofrequency probe (36) is conducted through the additional conductive tube (col. 6, ll. 14-23, cannula 28 has a generally tubular body 29 including electrically conductive outer tube 54 and inner tube 48; col. 5, ll. 54-58, “supply electrode assembly 36 is attached to the cannula 28 for the conduction of energy to the nerve tissue targeted for denervation.”).
In view of the prior modification of Tullis in view of Behl, Behl teaches the radiofrequency energy emitted by the radiofrequency probe is conducted through and transmitted by the plurality of filaments and the tip to the target volume (col. 13, ll. 14-18).
Regarding claim 7, Tullis in view of Behl teach all of the limitations of the system according to claim 1. In view of the prior modification of Tullis in view of Behl, the combination teaches wherein the plurality of filaments and the tip are in physical contact when the plurality of filaments are in the deployed state (see Tullis, Fig. 5 for supply electrode assembly 36 fully inserted into lumen 29 of cannula 28, thereby providing physical contact between all components). See rejection of claim 2 above for obviousness rationale.
Regarding claim 8, Tullis in view of Behl teach all of the limitations of the system according to claim 1. In view of the prior modification of Tullis in view of Behl, Behl teaches wherein the actuator (72) comprises a helical track (first threaded channel 74), and wherein rotation of the actuator (72) causes the second hub (58) to move linearly relative to the first hub (stationary portion 70) without rotating relative to the first hub (col. 12, ll. 4-66, “The rotatable portion 72 has a first threaded channel 74 which receives the threaded end 60 of the distal array slider 58. … rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52.”).
Regarding claim 9, Tullis in view of Behl teach all of the limitations of the system according to claim 1, but are silent regarding wherein the cannula comprises a 16-gauge or smaller sized tube. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the cannula comprises a 16-gauge or smaller sized tube, 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.
Regarding claim 10, Tullis in view of Behl teach all of the limitations of the system according to claim 1. Tullis discloses wherein the cannula (28) comprises: a tube that comprises a conductive material (48); and an insulating coating or sleeve (52) (Fig. 6).
Regarding claim 11, Tullis in view of Behl teach all of the limitations of the system according to claim 1. Tullis (Fig. 6) teaches wherein: the cannula (28) comprises a conductive material (54) and an insulating coating or sleeve (56) ; an additional conductive tube (48) is within the cannula, the additional conductive tube defining an additional lumen into which the radiofrequency probe is received (as best illustrated in Figs. 2 and 5); a distal end of the radiofrequency probe (36, 118) comprises a temperature measurement device that is proximate to the tip of the radiofrequency neurotomy needle when the radiofrequency probe is received in the additional conductive tube (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36).
In view of the prior modification of Tullis in view of Behl, Behl teaches the actuator (72) comprises a helical track (first threaded channel 74); and rotation of the actuator (72) causes the second hub (58) to move linearly relative to the first hub (70) without rotating relative to the first hub (col. 12, ll. 4-66, “The rotatable portion 72 has a first threaded channel 74 which receives the threaded end 60 of the distal array slider 58. … rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52.”).
Tullis in view of Behl are silent regarding wherein the cannula comprises a 16-gauge or smaller sized tube. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the cannula comprises a 16-gauge or smaller sized tube, 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.
In view of the modification of Tullis in view of Behl, the combination provides the radiofrequency energy emitted by the radiofrequency probe is conducted through the additional conductive tube and transmitted by the plurality of filaments and the tip (Tullis, col. 6, ll. 14-23, cannula 28 has a generally tubular body 29 including electrically conductive outer tube 54 and inner tube 48; col. 5, ll. 54-58, “supply electrode assembly 36 is attached to the cannula 28 for the conduction of energy to the nerve tissue targeted for denervation.”). See rejection of claim 1 for obviousness rationale.
Regarding claim 12, Tullis in view of Behl teach all of the limitations of the system according to claim 11. Tullis discloses wherein: the radiofrequency probe assembly (36) is separate from the radiofrequency neurotomy needle (28); the radiofrequency probe (36) is insertable by a user of the system into the lumen of the cannula of the radiofrequency neurotomy needle (Figs. 2 and 5); the radiofrequency neurotomy needle (28) further comprises a fitting in fluid communication with the lumen of the cannula (coupling assembly 44 and associated parts); the fitting is attachable to a fluid delivery device for delivery of fluid through the lumen to a region of tissue around the tip (syringe 32), and the fitting permits the radiofrequency probe to be inserted through the fitting and into the cannula after delivery of fluid through the lumen (col. 16, ll. 39-47, “If therapeutic fluids are needed after the penetration state 38, system 20 is placed into the medication state 40 by preferably press fitting a leading end of the syringe 32 against the collar 74 and into the bore 72 for slightly pressurized injection of the therapeutic fluid into the through-bore 57 of cannula body 29. After the medication state 40, the syringe 32 is preferably removed from the hub 46 and the supply electrode assembly 36 is connected thus designating the operation state 42 of the tool 24.”).
Regarding claim 13, Tullis in view of Behl teach all of the limitations of the system according to claim 1. In view of the prior modification of Tullis in View of Behl, Tullis discloses the method comprising: introducing the radiofrequency neurotomy needle (28) into the patient. In view of the prior modification of Tullis in View of Behl, Behl teaches deploying the system, the plurality of filaments in the retracted position; moving the tip of the radiofrequency neurotomy needle to a target position relative to the target volume; rotating the actuator relative to the first hub to advance the plurality of filaments to the deployed position; and with the radiofrequency probe assembly connected to the radiofrequency generator and the radiofrequency probe accepted in the lumen of the cannula, causing the radiofrequency generator to deliver radiofrequency energy to the radiofrequency probe that is transmitted by the tip and the plurality of filaments to the target volume, thereby ablating the target nerve of the patient to relieve pain (see Fig. 2; see col. 12, ll. 62-67, “In this way, rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52 … as best illustrated in FIG. 3.” Also see col. 13, ll. 14-18, “When fully deployed, a distal electrode array 52, as shown in FIGS. 2 and 3, is in electrical contact with the distal conductor 86 so that the array and conductor form an integrated electrode array of the type illustrated in FIG. 1.” See Fig. 5 for probe 50, distal conductor 84). See rejection of claim 2 for obviousness rationale.
Regarding claim 14, Tullis in view of Behl teach all of the limitations of the system according to claim 13. Tullis teaches wherein: the radiofrequency neurotomy procedure is a spinal radiofrequency neurotomy procedure; the patient is human; and the target nerve is positioned along the spine of the patient (col. 5, ll. 12-15, “system 20 may be used for selective denervation and tissue destruction procedures that may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain.”).
Regarding claim 15, Tullis in view of Behl teach all of the limitations of the system according to claim 13. Tullis discloses wherein: a distal end of the radiofrequency probe comprises a temperature measurement device; and the method further comprises permitting the temperature measurement device to sense a temperature at or near the tip of the radiofrequency neurotomy needle (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36; col. 10, ll. 46-49, “The temperature signal may be used as input signal for a feedback control loop to regulate the characteristics of the RF signal output by console 22.”).
Regarding claim 16, Tullis in view of Behl teach all of the limitations of the system according to claim 15. Tullis discloses further comprising inserting the radiofrequency probe into the lumen of the cannula (Figs. 2 and 5), said inserting taking place after said introducing the radiofrequency neurotomy needle into the patient and prior to said causing the radiofrequency generator to deliver radiofrequency energy to the radiofrequency probe (cannula 28 in Fig. 2; col. 5, ll. 41-43; cannula 28 is best suited to pierce and penetrate skin and tissue; col. 16, ll. 48-61; as broadly claimed, the cannula must first pierce the tissue prior to treatment).
Regarding claim 17, Tullis in view of Behl teach all of the limitations of the system according to claim 15. Tullis discloses wherein the radiofrequency neurotomy needle (28) further comprises a fitting (coupling assembly 44 and associated parts), the method further comprising: attaching a fluid delivery device (syringe 32) to the fitting; and causing the fluid delivery device (syringe 32) to deliver fluid through the radiofrequency neurotomy needle (28) to a region of tissue around the tip, wherein said inserting the radiofrequency probe into the lumen of the cannula comprises inserting the radiofrequency probe through the fitting after said causing the fluid delivery device to deliver fluid through the radiofrequency neurotomy needle (col. 16, ll. 39-47, “If therapeutic fluids are needed after the penetration state 38, system 20 is placed into the medication state 40 by preferably press fitting a leading end of the syringe 32 against the collar 74 and into the bore 72 for slightly pressurized injection of the therapeutic fluid into the through-bore 57 of cannula body 29. After the medication state 40, the syringe 32 is preferably removed from the hub 46 and the supply electrode assembly 36 is connected thus designating the operation state 42 of the tool 24.”).
Regarding claim 18, Tullis (Fig. 2) discloses a system for performing radiofrequency neurotomy on a target nerve of a patient, the system comprising: a radiofrequency probe assembly (supply electrode assembly 36) configured to connect to a radiofrequency generator (22), the radiofrequency probe assembly (36) comprising a radiofrequency probe (col. 5, ll. 54-58); and a radiofrequency neurotomy needle (cannula 28 in Fig. 2; col. 5, ll. 41-43; cannula 28 is best suited to pierce and penetrate skin and tissue) that comprises :a first hub (46); a cannula (28) that is conductive and is fixedly attached to the first hub (46) (col. 6, ll. 14-23, cannula 28 has a generally tubular body 29 including electrically conductive outer tube 54 and inner tube 48); a tip (58) shaped to pierce tissue of the patient (col. 5, ll. 41-43), the tip (58) and the cannula (28) being a single unitary structure (Fig. 2); a tube (48) that is conductive and comprises a lumen that accepts the radiofrequency probe (Figs. 2 and 5), wherein a portion of the tube is housed by the cannula (28). Tullis discloses wherein, when the radiofrequency probe is accepted in the lumen of the tube: the radiofrequency probe is configured to emit radiofrequency energy that is conducted through the tube (col. 10, ll. 8-11, “supply electrode 118 serves as the component that completes the conductive path from control console 22 through plug 112 and cable 114, to the first active contact 62 of the cannula 28.” Also see col. 16, ll. 48-61), and an electrode is formed that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated (col. 5, ll. 54-58).
Tullis is silent regarding a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, wherein, when the radiofrequency probe is accepted in the lumen of the tube and the plurality of filaments are in the deployed position: the radiofrequency probe is configured to emit radiofrequency energy that is conducted through the tube; and the tip and the plurality of filaments together form an electrode that transmits said radiofrequency energy emitted by the radiofrequency probe and conducted through the tube to a target volume in which the target nerve is situated.
However, in the same field of endeavor, Behl taches a similar radiofrequency probe (50) and a plurality of filaments (52) that are conductive and are movable between a retracted position and a deployed position (Fig. 2). Behl further teaches a second hub (distal slider 58) interconnected to the plurality of filaments (52); and an actuator (rotatable portion 72) interconnected to the second hub (58), wherein rotation of the actuator (72) relative to the first hub (stationary portion 70) in a first direction causes the second hub (58) to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position (col. 12, ll. 62-67, “In this way, rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52 … as best illustrated in FIG. 3.”), wherein, when the radiofrequency probe is accepted in the lumen of the tube and the plurality of filaments are in the deployed position, the tip and the plurality of filaments together form an electrode that transmits radiofrequency energy emitted by the radiofrequency probe to a target volume in which the target nerve is situated (col. 13, ll. 14-18, “When fully deployed, a distal electrode array 52, as shown in FIGS. 2 and 3, is in electrical contact with the distal conductor 86 so that the array and conductor form an integrated electrode array of the type illustrated in FIG. 1.” See Fig. 5 for probe 50, distal conductor 84). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system as taught by Tullis to incorporate a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, wherein, when the radiofrequency probe is accepted in the lumen of the tube and the plurality of filaments are in the deployed position: the radiofrequency probe is configured to emit radiofrequency energy that is conducted through the tube; and the tip and the plurality of filaments together form an electrode that transmits said radiofrequency energy emitted by the radiofrequency probe and conducted through the tube to a target volume in which the target nerve is situated, as taught by Behl, in order to provide radiofrequency energy to targeted regions of tissue and produce tissue lesions having a variety of geometries to accommodate the targeted region (col. 2, ll. 23-28), thereby increasing overall control, accuracy and efficiency.
Regarding claim 19, Tullis in view of Behl teach all of the limitations of the system according to claim 18. In view of the prior modification of Tullis in view of Behl, Behl teaches wherein the plurality of filaments (52) are advanceable from the retracted position to the deployed position without concurrent advancement of the radiofrequency probe relative to the radiofrequency neurotomy needle (as best illustrated in Fig. 2, slider 58 is advanced to deploy electrode array 52, without concurrent advancement of the radiofrequency probe 50).
Regarding claim 20, Tullis in view of Behl teach all of the limitations of the system according to claim 18. In view of the prior modification of Tullis in view of Behl, the combination teaches wherein the plurality of filaments and the tip are in physical contact when the plurality of filaments are in the deployed state (see Tullis, Fig. 5 for supply electrode assembly 36 fully inserted into lumen 29 of cannula 28, thereby providing physical contact between all components). See rejection of claim 2 above for obviousness rationale.
Regarding claim 21, Tullis in view of Behl teach all of the limitations of the system according to claim 18. Tullis discloses wherein: the radiofrequency probe assembly (36) is separate from the radiofrequency neurotomy needle (28); and the radiofrequency probe (36) is insertable by a user of the system into the lumen of the tube (Figs. 2 and 5).
Regarding claim 22, Tullis in view of Behl teach all of the limitations of the system according to claim 21. Tullis discloses wherein a distal end of the radiofrequency probe (36) comprises a temperature measurement device (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36), and wherein the temperature measurement device is proximate to the tip of the radiofrequency neurotomy needle (28) when the radiofrequency probe (36) is accepted in the lumen of the tube (Figs. 2 and 5).
Regarding claim 23, Tullis in view of Behl teach all of the limitations of the system according to claim 22. Tullis discloses wherein the radiofrequency neurotomy needle (28) further comprises a fitting in fluid communication with the lumen of the tube (coupling assembly 44 and associated parts), wherein the fitting is attachable to a fluid delivery device (syringe 32) for delivery of fluid through the lumen to a region of tissue around the tip, and wherein the fitting permits the radiofrequency probe (36) to be inserted through the fitting and into the tube after delivery of fluid through the lumen (col. 16, ll. 39-47, “If therapeutic fluids are needed after the penetration state 38, system 20 is placed into the medication state 40 by preferably press fitting a leading end of the syringe 32 against the collar 74 and into the bore 72 for slightly pressurized injection of the therapeutic fluid into the through-bore 57 of cannula body 29. After the medication state 40, the syringe 32 is preferably removed from the hub 46 and the supply electrode assembly 36 is connected thus designating the operation state 42 of the tool 24.”).
Regarding claim 24, Tullis (Fig. 2) discloses a system for performing radiofrequency neurotomy on a target nerve of a patient, the system comprising: a radiofrequency probe assembly (supply electrode assembly 36) comprising: a radiofrequency probe (col. 5, ll. 54-58) that comprises a temperature measurement device (temperature sensor 120) at a distal end of the radiofrequency probe (Fig. 17); and a cable (114) connectable to a radiofrequency generator (22); and a radiofrequency neurotomy needle (cannula 28 in Fig. 2; col. 5, ll. 41-43; cannula 28 is best suited to pierce and penetrate skin and tissue) comprising: a first hub (46); a tip (58) that is conductive (col. 6, ll. 14-23, cannula 28 has a generally tubular body 29 including electrically conductive outer tube 54 and inner tube 48) and is shaped to pierce tissue of the patient (col. 5, ll. 41-43); a cannula (28) attached to the first hub (46), the cannula being configured to accept the radiofrequency probe therein such that the distal end of the radiofrequency probe is proximate to the tip (Fig. 2 and 5). Tullis discloses wherein, when the radiofrequency probe (36) is accepted in the cannula of the radiofrequency neurotomy needle (28) and emits radiofrequency energy, an electrode is formed that transmits radiofrequency energy emitted by the radiofrequency probe to target tissue in which the target nerve is situated to ablate the target tissue (col. 5, ll. 54-58); and the temperature measurement device (120) of the radiofrequency probe measures temperature at the target tissue (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36; col. 10, ll. 46-49, “The temperature signal may be used as input signal for a feedback control loop to regulate the characteristics of the RF signal output by console 22.”).
Tullis is silent regarding a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, and when the plurality of filaments are in the deployed position: the tip and the plurality of filaments together form an electrode that transmits the radiofrequency energy emitted by the radiofrequency probe to target tissue in which the target nerve is situated to ablate the target tissue.
However, in the same field of endeavor, Behl taches a similar radiofrequency probe (50) and a plurality of filaments (52) that are conductive and are movable between a retracted position and a deployed position (Fig. 2). Behl further teaches a second hub (distal slider 58) interconnected to the plurality of filaments (52); and an actuator (rotatable portion 72) interconnected to the second hub (58), wherein rotation of the actuator (72) relative to the first hub (stationary portion 70) in a first direction causes the second hub (58) to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position (col. 12, ll. 62-67, “In this way, rotation of the rotatable part 72 of handle 68 will simultaneously advance the distal slider 58 to deploy the distal electrode array 52 … as best illustrated in FIG. 3.”). Behl teaches when the plurality of filaments are in the deployed position: the tip and the plurality of filaments together form an electrode that transmits the radiofrequency energy emitted by the radiofrequency probe to target tissue in which the target nerve is situated to ablate the target tissue (col. 13, ll. 14-18, “When fully deployed, a distal electrode array 52, as shown in FIGS. 2 and 3, is in electrical contact with the distal conductor 86 so that the array and conductor form an integrated electrode array of the type illustrated in FIG. 1.” See Fig. 5 for probe 50, distal conductor 84). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system as taught by Tullis to incorporate a plurality of filaments that are conductive and are movable between a retracted position and a deployed position; a second hub interconnected to the plurality of filaments; and an actuator interconnected to the second hub, wherein rotation of the actuator relative to the first hub in a first direction causes the second hub to move axially to advance the plurality of filaments to the deployed position and rotation of the actuator relative to the first hub in a second direction that is opposite the first direction causes the second hub to move axially to retract the plurality of filaments to the retracted position, and when the plurality of filaments are in the deployed position: the tip and the plurality of filaments together form an electrode that transmits the radiofrequency energy emitted by the radiofrequency probe to target tissue in which the target nerve is situated to ablate the target tissue., as taught by Behl, in order to provide radiofrequency energy to targeted regions of tissue and produce tissue lesions having a variety of geometries to accommodate the targeted region (col. 2, ll. 23-28), thereby increasing overall control, accuracy and efficiency.
Regarding claim 25, Tullis in view of Behl teach all of the limitations of the system according to claim 24. Tullis discloses wherein when the radiofrequency probe (36) is accepted into the cannula (28) (Figs. 2 and 5), the distal end of the radiofrequency probe is proximate to the tip of the radiofrequency neurotomy needle cannula (Figs. 2 and 5).
Regarding claim 26, Tullis in view of Behl teach all of the limitations of the system according to claim 24. Tullis discloses wherein when the radiofrequency probe (36) is accepted into the cannula (28), the distal end of the radiofrequency probe (36) is in the tip of the radiofrequency neurotomy needle (Figs. 2 and 5).
Regarding claim 27, Tullis in view of Behl teach all of the limitations of the system according to claim 24. Tullis discloses wherein the temperature measurement device comprises a thermocouple (see Fig. 17 for temperature sensor 120, thermocouple wires 126, 128 within supply electrode 118 of supply electrode assembly 36).
Regarding claim 28, Tullis in view of Behl teach all of the limitations of the system according to claim 24. In view of the prior modification of Tullis in view of Behl, Behl teaches wherein the plurality of filaments (52) are advanceable from the retracted position to the deployed position without concurrent advancement of the radiofrequency probe relative to the radiofrequency neurotomy needle (as best illustrated in Fig. 2, slider 58 is advanced to deploy electrode array 52, without concurrent advancement of the radiofrequency probe 50).
Regarding claim 29, Tullis in view of Behl teach all of the limitations of the system according to claim 28. Tullis teaches various components may be inserted into cannula (28). Therefore, it is contemplated that the radiofrequency probe (36) is insertable into the cannula (28) of the radiofrequency neurotomy needle (28) after deployment of the plurality of filaments, as insertion of various components may be repeated, including after deployment of the plurality of filaments.
Regarding claim 30, Tullis in view of Behl teach all of the limitations of the system according to claim 29. Tullis discloses wherein the radiofrequency neurotomy needle (28) further comprises: a lumen (29) within the cannula (28); and a fitting in fluid communication with the lumen (coupling assembly 44 and associated parts), the fitting being configured to attach to a fluid delivery device (syringe 32) for delivery of fluid through the lumen to a region of tissue around the tip, the fitting further being configured to permit the radiofrequency probe to be inserted through the fitting and into the cannula after delivery of fluid through the lumen (col. 16, ll. 39-47, “If therapeutic fluids are needed after the penetration state 38, system 20 is placed into the medication state 40 by preferably press fitting a leading end of the syringe 32 against the collar 74 and into the bore 72 for slightly pressurized injection of the therapeutic fluid into the through-bore 57 of cannula body 29. After the medication state 40, the syringe 32 is preferably removed from the hub 46 and the supply electrode assembly 36 is connected thus designating the operation state 42 of the tool 24.”).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/C.A.D./Examiner, Art Unit 3794