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.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 1, 15, and 19, as well as Claims 2-14, 16-18, and 20 based on their dependencies to the previous claims, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 recites the limitation "the distal hypotube" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites “a hypotube, but fails to recite “a distal hypotube”, rendering the claim indefinite. Proper correction is required.
6. Claim 15 recites the limitation "the elongated tube" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 fails to previously recites “an elongated tube”, rendering the claim indefinite. Proper correction is required.
7. Claim 15 also recites the limitation "the curved cannula lumen" in lines 8 and 9. There is insufficient antecedent basis for this limitation in the claim. Claim 15 fails to previously recites “an curved cannula lumen”, rendering the claim indefinite. Proper correction is required.
8. Claim 19 recites the limitation "the distal hypotube" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 19 previously recites “a hypotube, but fails to recite “a distal hypotube”, rendering the claim indefinite. Proper correction is required.
Claim Rejections - 35 USC § 102
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1, 3-5, and 14-16 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donovan U.S. 2021/0290289 (publication date 09/23/2021; herein referred to as “Donovan”).
11. 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”).
12. Regarding Claim 3, Donovan teaches the distal curved portion of the stylet has a section of reduced thickness (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).
13. 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)…”).
14. Regarding Claim 5, Donovan teaches the section of reduced thickness if formed by removing material from at least a region of the distal curved portion (see Fig. 3M, ref num 229 shows the removed material in the curved portion, ref num 227; para 0093-0094).
15. 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”).
16. 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 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”).
17. 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)…”).
Claim Rejections - 35 USC § 103
18. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
19. Claims 2, 6-9, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan and in view of Johnson U.S. 2024/0108361 (earliest filing date 10/4/22; herein referred to as “Johnson”).
20. Regarding Claim 2, 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.
21. Regarding Claim 6, Donovan teaches 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.
22. Regarding Claim 7, 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.
Johnson teaches the section of reduced thickness is not uniform from a proximal end to a distal end 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.
23. Regarding Claims 8 and 9, Donovan fails to teach the reduced thickness tapers from the proximal end to the distal end of the distal curved portion (claim 8) OR the reduced thickness tapers from the distal end to the proximal end of the distal curved portion (claim 9).
Johnson teaches the reduced thickness tapers from the proximal end to the distal end of the distal curved portion OR the reduced thickness tapers from the distal end to the proximal end of the distal curved portion (Fig. 8E; 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… increasing thickness from the distal end to the proximal end”). 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.
24. 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.
25. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan and in view of Arthurs U.S. 2018/0110531 (herein referred to as “Arthurs”).
26. 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.
27. Regarding Claims 11 and 12, Donovan fails to teach the flexible extension extends along a partial length of the flexible curved section OR 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).
28. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Donovan and in view of Arthurs and Johnson.
29. 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.
Conclusion
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794