DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
4. Regarding Claim 1, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Specifically, the applicant makes a generic statement that the prior art fails to teach the new amendments found in Claim 1. They broadly state that the combination of Donovan, Johnson, and Arthurs fails to teach all the limitations found in Claim 1, since these were the references used to reject the previously recited claim 2 (whose language is now found in claim 1) and claim 10. However, they fails to explain why these references fail to teach all the limitations.
5. The applicant also broadly states that there is no teaching, suggestion, or motivation to combine the references. In response to said argument, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine the references Donovan, Johnson, and Arthurs has to do with providing the benefit of flexibility to the device.
6. Therefore, the previous rejections regarding the limitations found in the newly amended claims 1, 15, and 19 stand.
Claim Rejections - 35 USC § 112
7. Claims 1, 15, and 19 were previously rejected under 35 U.S.C. 112(b) as being indefinite. The claims have been amended to overcome these rejections. Therefore, the rejections have been withdrawn.
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites identical claim language found in Claim 1, which Claim 10 depends from. Therefore, it does not further limit Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
10. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claims 1, 3-4, 6-7, 10, 12-16, and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan U.S. 2021/0290289 (publication date 09/23/2021; herein referred to as “Donovan”) and in view of Johnson U.S. 2024/0108361 (earliest filing date 10/4/22; herein referred to as “Johnson”) and Arthurs U.S. 2018/0110531 (herein referred to as “Arthurs”).
12. Regarding Claim 1, Donovan teaches a medical device for forming a channel into a bone (Fig. 3; para 0034, “target treatment location within bone”), comprising:
a. an introducer cannula (Fig. 3 and 3A, ref num 112) having a hypotube disposed in a longitudinal direction (Fig. 3A, ref num 118), the distal hypotube having an introducer lumen disposed therethrough (para 0082, “the central lumen of the hypotube 118”);
b. a curved cannula (Fig. 3, ref num 210) having an elongated tube (Fig. 3, ref num 212), the elongated tube having a curved cannula lumen disposed therethrough (para 0089, “The central lumen of the curved cannula 212”), the elongated tube having a proximal straight tube portion (Fig. 3I, ref num 224) and a distal curved tube portion (Fig. 3I, ref num 225), the elongated tube configured to be received into the introducer lumen of the introducer cannula (para 0090, “the distal tip 222 of the curved cannula 212 does not extend out of the open distal tip 122 of the introducer cannula 112 when the curved cannula assembly 210 is fully inserted therein”); and
c. a stylet (Fig. 3K, ref num 214) having an elongated shaft (Fig. 3K, ref num 218), the elongated shaft having a proximal straight portion (Fig. 3K, ref num 318) and a distal curved portion (Fig. 3K, ref num 227), the elongated shaft configured to be received into the curved cannula lumen (para 0089, “facilitate insertion of the J-stylet 214 into and along a central lumen of the curved cannula 212”);
d. wherein the distal curved portion of the stylet is relieved from a generally cylindrical shape of the stylet (Figs. 3L and 3M, shape of ref num 227; para 0093, “the curved distal end portion 227 comprises a springboard or a platform section 229 having a “D-shaped” cross-sectional profile”).
Donovan fails to teach the distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft at an outer curvature side of the distal curved portion.
Johnson teaches a device of analogous art (Figs. 2, 3, 4A), wherein the device comprises a stylet having a distal curved portion (Fig. 4C, ref num 244 having distal curved portion, Fig. 3, ref num 260). The distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft at an outer curvature side of the distal curved portion (Fig. 10C and 10D, ref nums 271, 273; para 0087). The cutouts provide flexibility to the curved distal portion of the stylet when advanced to the target area (para 0084, 0087). 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 Donovan to have a plurality of slots formed on the outer curvature side of the distal curved portion in order to increase flexibility of the stylet.
Donovan as modified teaches the distal curved portion of the stylet having a slit (Johnson, Fig. 11C, ref num 265; para 0091, “the tamp 244 can include an opening 265 in the proximal end of the tip 262”), but fails to explicitly teach the slit is formed along a length direction of the elongated shaft separating a flexible curved section at an outer curvature side of the distal curved portion and a flexible extension at the inner curvature side of the distal curved portion.
Arthurs teaches a device of analogous art (Fig. 1) comprising a stylet (Fig. 1, 6A, ref num 3), such that a distal portion of the stylet comprises a slit that is formed along a length direction of the shaft (shaft = ref num 31; Fig. 6B, ref num 41; para 0045). The slit separates two sides of the distal portion (see Fig. 6B). The slit is provided in order to allow for the distal portion of the stylet to flex/expand has it is inserted and retracted out of the bone (para 0045). 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 Donovan to have a longitudinal slit separating an outer curved side and an inner curved side of the distal curved portion of the stylet in order to provide more flexibility to the distal portion of the stylet while being manipulated at the target site.
13. Regarding Claim 3, Donovan teaches the distal curved portion of the stylet has a section of reduced thickness formed by removing material from at least a region of the distal curved portion (Fig. 3L, 3M, ref num 229; para 0093, “The thickness (e.g., vertical cross-sectional dimension) of the springboard or platform section 229, the predefined set angulation or radius of curvature, and the starting and ending points of the springboard or platform section 229 along the length of the curved distal end portion 227 may be varied to provide J-stylets having different rigidity and bending characteristics for different levels of vertebrae or different densities of bone”; para 0094; The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985)).
14. Regarding Claim 4, Donovan teaches the section of reduced thickness is 40%-80% of the full circumferential thickness of the elongated shaft (para 0094, “a thickness (e.g., a maximum vertical cross-sectional dimension from an upper surface of the springboard or platform section 229 to a lower-most point on a lower surface of the curved distal end portion) is between 40% and 85% (e.g., between 40% and 60%, between 50% and 70%, between 50% and 75%, between 60% and 70%, between 65% and 80%, between 70% and 85%, overlapping ranges thereof, or any value within the recited ranges) of the thickness (e.g., diameter) of the adjacent regions of the curved distal end portion (e.g., the regions just proximal and just distal of the length of the springboard or platform section 229)…”).
15. Regarding Claim 6, Donovan teaches the distal curved portion of the stylet has a section of reduced thickness (para 0093-0094).
Donovan fails to teach the distal curved portion has a radiused or sloped transition section between the section of reduced thickness and a distal channeling tip.
Johnson teaches a device of analogous art (Figs. 2, 3, 4A), wherein the device comprises a stylet having a distal curved portion (Fig. 4C, ref num 244 having distal curved portion, Fig. 3, ref num 260). The distal curved portion has a section of reduced thickness (Fig. 5, ref num 263; para 0074, “the curvable portion 264 has a smaller thickness 263 in the plane of the bend as compared to the portions of the tip 262 and the shaft 266”), further that the distal curved portion has a radiused or sloped transition section between the section of reduced thickness and a distal channeling tip (see Fig. 5 and Figs. 8A-8E; para 0084, “the curvable portion 264 has a uniform thickness along a length of the curvable portion 264… except for relatively short region(s) adjacent the tip 262 or the shaft 266 or both the tip and shaft…”). These variations of thickness and shape result in varying degrees of flexibility (para 0084). 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 Donovan to have a radiused transition section of the distal curved portion since it is an obvious matter of design choice to make the different portions of the distal curved portion whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
16. Regarding Claim 7, Donovan teaches the distal curved portion of the stylet has a section of reduced thickness (para 0093-0094).
Donovan fails to teach the section of reduced thickness is not uniform from a proximal end to a distal end of the distal curved portion and tapers along a length of the distal curved portion.
Johnson teaches the section of reduced thickness is not uniform from a proximal end to a distal end of the distal curved portion tapers along a length of the distal curved portion (Fig. 8E, ref num 264; para 0084, “the curvable portion 264 has a variable thickness along the length of the curvable region, as illustrated in FIG. 8E. In FIG. 8E, the thickness of the curvable portion 264 decreases from the distal end to the proximal end of the curvable portion”). These variations of thickness and shape result in varying degrees of flexibility (para 0084). 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 Donovan to have a nonuniform reduced thickness of the distal curved portion since it is an obvious matter of design choice to make the different portions of the distal curved portion whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
17. Regarding Claim 10, Donovan as modified teaches the distal curved portion of the stylet having a slit (Johnson, Fig. 11C, ref num 265; para 0091, “the tamp 244 can include an opening 265 in the proximal end of the tip 262”), but fails to explicitly teach the slit is formed along a length direction of the elongated shaft separating a flexible curved section at an outer curvature side of the distal curved portion and a flexible extension at the inner curvature side of the distal curved portion.
Arthurs teaches a device of analogous art (Fig. 1) comprising a stylet (Fig. 1, 6A, ref num 3), such that a distal portion of the stylet comprises a slit that is formed along a length direction of the shaft (shaft = ref num 31; Fig. 6B, ref num 41; para 0045). The slit separates two sides of the distal portion (see Fig. 6B). The slit is provided in order to allow for the distal portion of the stylet to flex/expand has it is inserted and retracted out of the bone (para 0045). 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 Donovan to have a longitudinal slit separating an outer curved side and an inner curved side of the distal curved portion of the stylet in order to provide more flexibility to the distal portion of the stylet while being manipulated at the target site.
18. Regarding Claim 12, Donovan fails to teach the flexible extension extends along a full length of the flexible curved section.
Arthurs teaches the slit that forms the extension along a length of the distal portion of the stylet (Fig. 6B, ref num 41). It would have been an obvious matter of design choice to change the length of the extension along the flexible curved section of the distal portion of the stylet, since such a modification would have involved a mere change in the size of a component. 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).
19. Regarding Claim 13, Donovan fails to teach a cutout is formed at the outer curvature of the distal curved portion at a proximal end of the distal curved portion.
Johnson teaches a cutout is formed at the outer curvature of the distal curved portion at a proximal end of the distal curved portion (Fig. 5, 7A, ref num 265; para 0078, “the curvable portion 264 curves away from the cutout 265”). These variations of thickness and shape result in varying degrees of flexibility (para 0084). 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 Donovan to have a cutout in the distal curved portion at the proximal end, since it is an obvious matter of design choice to make the different portions of the distal curved portion whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
20. Regarding Claim 14, Donovan teaches a distal open tip of the curved cannula (Fig. 3I, ref num 222; para 0089, “an open distal tip 222 of the distal polymeric shaft portion”) is a beveled tip (para 0075, “Any of the access tools may have beveled or otherwise sharp tips or they may have blunt or rounded, atraumatic distal tips”).
21. Regarding Claim 15, Donovan teaches a medical device for accessing and treating tissue within a vertebral body (Fig. 3; para 0034), comprising:
a. an introducer cannula (Fig. 3 and 3A, ref num 112) having an introducer lumen disposed therethrough (para 0082, “the central lumen of the hypotube 118”);
b. a curved cannula (Fig. 3, ref num 210) having an elongated tube (Fig. 3, ref num 212), the elongated tube having a curved cannula lumen disposed therethrough (para 0089, “The central lumen of the curved cannula 212”) and having a proximal straight tube portion (Fig. 3I, ref num 224) and a distal curved tube portion (Fig. 3I, ref num 225), the elongated tube configured to be received into the introducer lumen of the introducer cannula (para 0090, “the distal tip 222 of the curved cannula 212 does not extend out of the open distal tip 122 of the introducer cannula 112 when the curved cannula assembly 210 is fully inserted therein”); and
c. a stylet (Fig. 3K, ref num 214) having an elongated shaft (Fig. 3K, ref num 218), the elongated shaft having a proximal straight portion (Fig. 3K, ref num 318) and a distal curved portion (Fig. 3K, ref num 227), the elongated shaft configured to be received into the curved cannula lumen (para 0089, “facilitate insertion of the J-stylet 214 into and along a central lumen of the curved cannula 212”);
d. a radiofrequency probe configured to be advanced through the curved cannula lumen to a target treatment location (Fig. 3HH, ref num 501; para 0112, “a treatment device 501 (e.g., a flexible bipolar radiofrequency probe) may be inserted through the curved cannula 212… to the target treatment location”);
e. a radiofrequency energy generator connected to the radiofrequency probe (Fig. 4, ref num 400; para 0125) and configured to provide radiofrequency energy to the radiofrequency probe to treat the tissue (para 0125);
f. wherein the distal curved portion of the stylet is relieved from a generally cylindrical shape of the stylet (Figs. 3L and 3M, shape of ref num 227; para 0093, “the curved distal end portion 227 comprises a springboard or a platform section 229 having a “D-shaped” cross-sectional profile”).
Donovan fails to teach the distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft at an outer curvature side of the distal curved portion.
Johnson teaches a device of analogous art (Figs. 2, 3, 4A), wherein the device comprises a stylet having a distal curved portion (Fig. 4C, ref num 244 having distal curved portion, Fig. 3, ref num 260). The distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft at an outer curvature side of the distal curved portion (Fig. 10C and 10D, ref nums 271, 273; para 0087). The cutouts provide flexibility to the curved distal portion of the stylet when advanced to the target area (para 0084, 0087). 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 Donovan to have a plurality of slots formed on the outer curvature side of the distal curved portion in order to increase flexibility of the stylet.
Donovan as modified teaches the distal curved portion of the stylet having a slit (Johnson, Fig. 11C, ref num 265; para 0091, “the tamp 244 can include an opening 265 in the proximal end of the tip 262”), but fails to explicitly teach the slit is formed along a length direction of the elongated shaft separating a flexible curved section at an outer curvature side of the distal curved portion and a flexible extension at the inner curvature side of the distal curved portion.
Arthurs teaches a device of analogous art (Fig. 1) comprising a stylet (Fig. 1, 6A, ref num 3), such that a distal portion of the stylet comprises a slit that is formed along a length direction of the shaft (shaft = ref num 31; Fig. 6B, ref num 41; para 0045). The slit separates two sides of the distal portion (see Fig. 6B). The slit is provided in order to allow for the distal portion of the stylet to flex/expand has it is inserted and retracted out of the bone (para 0045). 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 Donovan to have a longitudinal slit separating an outer curved side and an inner curved side of the distal curved portion of the stylet in order to provide more flexibility to the distal portion of the stylet while being manipulated at the target site.
22. Regarding Claim 16, Donovan teaches the radiofrequency probe is a flexible bipolar probe (Fig. 3HH, ref num 501; para 0115, “The treatment device 501 may be an RF energy delivery device. The RF energy delivery device may include a bipolar pair of electrodes at a distal end portion of the device”; para 0112, “a treatment device 501 (e.g., a flexible bipolar radiofrequency probe)…”).
23. Regarding Claims 19 and 20, Donovan teaches a medical device for forming a channel into a bone (Fig. 3; para 0034, “target treatment location within bone”), comprising:
a. an introducer cannula (Fig. 3 and 3A, ref num 112) having a hypotube disposed in a longitudinal direction (Fig. 3A, ref num 118), the distal hypotube having an introducer lumen disposed therethrough (para 0082, “the central lumen of the hypotube 118”);
b. a curved cannula (Fig. 3, ref num 210) having an elongated tube (Fig. 3, ref num 212), the elongated tube having a curved cannula lumen disposed therethrough (para 0089, “The central lumen of the curved cannula 212”), the elongated tube having a proximal straight tube portion (Fig. 3I, ref num 224) and a distal curved tube portion (Fig. 3I, ref num 225), the elongated tube configured to be received into the introducer lumen of the introducer cannula (para 0090, “the distal tip 222 of the curved cannula 212 does not extend out of the open distal tip 122 of the introducer cannula 112 when the curved cannula assembly 210 is fully inserted therein”); and
c. a stylet (Fig. 3K, ref num 214) having an elongated shaft (Fig. 3K, ref num 218), the elongated shaft having a proximal straight portion (Fig. 3K, ref num 318) and a distal curved portion (Fig. 3K, ref num 227), the elongated shaft configured to be received into the curved cannula lumen (para 0089, “facilitate insertion of the J-stylet 214 into and along a central lumen of the curved cannula 212”).
Donovan fails to teach the distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft (claim 19) at an outer curvature side of the distal curved portion (claim 20).
Johnson teaches a device of analogous art (Figs. 2, 3, 4A), wherein the device comprises a stylet having a distal curved portion (Fig. 4C, ref num 244 having distal curved portion, Fig. 3, ref num 260). The distal curved portion of the stylet has a plurality of slots formed perpendicular to the length direction of the elongated shaft at an outer curvature side of the distal curved portion (Fig. 10C and 10D, ref nums 271, 273; para 0087). The cutouts provide flexibility to the curved distal portion of the stylet when advanced to the target area (para 0084, 0087). 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 Donovan to have a plurality of slots formed on the outer curvature side of the distal curved portion in order to increase flexibility of the stylet.
Donovan as modified teaches the distal curved portion of the stylet having a slit (Johnson, Fig. 11C, ref num 265; para 0091, “the tamp 244 can include an opening 265 in the proximal end of the tip 262”), but fails to explicitly teach the slit is formed along a length direction of the elongated shaft separating a flexible curved section at an outer curvature side of the distal curved portion and a flexible extension at the inner curvature side of the distal curved portion, such that the flexible extension extends along a partial length of the flexible curved section (claim 20).
Arthurs teaches a device of analogous art (Fig. 1) comprising a stylet (Fig. 1, 6A, ref num 3), such that a distal portion of the stylet comprises a slit that is formed along a length direction of the shaft (shaft = ref num 31; Fig. 6B, ref num 41; para 0045). The slit separates two sides of the distal portion (see Fig. 6B). There is also a flexible extension that extends along a partial length of the flexible curved section (see Fig. 6B, top portion of ref num 41). The slit is provided in order to allow for the distal portion of the stylet to flex/expand has it is inserted and retracted out of the bone (para 0045). 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 Donovan to have a longitudinal slit separating an outer curved side and an inner curved side of the distal curved portion of the stylet in order to provide more flexibility to the distal portion of the stylet while being manipulated at the target site.
24. Regarding Claim 21, Donovan fails to teach the plurality of slots is formed in the flexible curved section.
Johnson teaches the plurality of slots (Fig. 10D, ref num 273) is formed in the flexible curved section (see Fig. 10D). The cutouts provide flexibility to the curved distal portion of the stylet when advanced to the target area (para 0084, 0087). 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 Donovan to have a plurality of slots formed on flexible curved section in order to increase flexibility of the stylet.
25. Regarding Claim 22, Donovan fails to teach the flexible extension is disposed circumferentially opposite the plurality of slots about the elongated shaft.
Johnson teaches a flexible extension (Fig. 8A-10B, ref num 261) that may be arranged on either side of the plurality of slots (para 0081, “this direction of bending or curving has been found to create a smooth tunnel. It will be understood, however, that the curvable portion 264 can be designed to bend in the other direction so that the offset is toward the outside of the bend”). This produces the same expected result of increasing the flexibility of the device (para 0081). 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 Donovan to have the flexible extension disposed circumferentially opposite the plurality of slots in order to increase the flexibility of the device.
26. Regarding Claim 23, Donovan teaches the distal curved portion of the stylet includes a distal channeling tip (Fig. 3L, ref num 228) and a section of reduced thickness disposed proximal to the distal channeling tip (Fig. 3L, ref num 229), the section of reduced thickness having a cross-section circumference profile less than a full cross-section circumference profile of the distal channeling tip (para 0093, “The thickness (e.g., vertical cross-sectional dimension) of the springboard or platform section 229, the predefined set angulation or radius of curvature, and the starting and ending points of the springboard or platform section 229 along the length of the curved distal end portion 227 may be varied to provide J-stylets having different rigidity and bending characteristics for different levels of vertebrae or different densities of bone”; para 0094).
27. Regarding Claim 24, Donovan teaches the distal curved tube portion of the curved cannula has a first preformed curvature (Fig. 3I, ref num 225) in an unconstrained configuration (para 0091, “the distal end portion 225 is pre-curved (e.g., shape-set) to have a predetermined curve in a “resting” unconstrained configuration”) and is configured to bend when received in the introduced lumen (see Figs. 3P and 3Q; para 0098), wherein the distal curved portion of the stylet has a second preformed curvature in an unconstrained configuration (see Fig. 3K, 3L, ref num 227) and is configured to bend when received in at least one of the curved cannula lumen or bone tissue (see Fig. 3N and 3O).
28. Regarding Claim 25, Donovan teaches the section of reduced thickness defines a larger gap between an outer cross-sectional dimension of the distal curved portion of the stylet and an inner diameter of the curved cannula lumen than a gap between adjacent portions of the distal curved portion of the stylet and the inner diameter of the curved cannula lumen (see Fig. 3L and 3M, ref num 229 defines a large gap between outer dimension of ref num 227 and inner diameter of ref num 218).
29. Regarding Claim 26, Donovan teaches the radiofrequency probe is configured to be advanced through the curved cannula lumen after the stylet has been withdrawn from the curved cannula lumen (Fig. 3HH, ref num 501; para 0112, “a treatment device 501 (e.g., a flexible bipolar radiofrequency probe) may be inserted through the curved cannula 212 (after removal of the straight stylet 314 if used)…”), and wherein the radiofrequency probe includes a bipolar pair of electrodes at a distal end portion of the radiofrequency probe (para 0115, “The treatment device 501 may be an RF energy delivery device. The RF energy delivery device may include a bipolar pair of electrodes at a distal end portion of the device”).
Conclusion
30. THIS ACTION IS MADE FINAL. 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.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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