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.
Election/Restrictions
3. Applicant's election with traverse of Species A in the reply filed on 03/02/2026 is acknowledged. The traversal is on the ground(s) that the species should refer to different embodiments of the invention, not by identifying claims. This is found persuasive; therefore, the previous restriction is withdrawn.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turovskiy U.S. 2024/0206941 (herein referred to as “Turovskiy”).
6. Regarding Claim 1, Turovskiy teaches a medical system comprising:
a. a flexible elongated tool (Fig. 1, ref num 16) in which a lumen extends (Figs. 3A, 3B, ref num 19, which is part of tool ref num 16, defines a lumen, ref num 27), the lumen defined by an inner wall of the elongated tool (see Fig. 3B, ref num 19 has an inner wall; abstract, “interior wall of the occlusion element”); and
b. a flexible stylet (Fig. 3B, ref num 42/24; para 0047, “a flexible tube 42”) configured to extend within the lumen (see Figs. 3A and 3B, ref num 42/24 extends through lumen defined by ref num 19) and contact the inner wall of the elongated tool at a plurality of points (see Fig. 3B, ref num 24 contacts inner wall of ref num 19 at a plurality of points; para 0021, “the direct heating element contacts the interior surface of the occlusion element”; para 0050, “the direct heating element 24 contacts an inner surface of the occlusion element 19”), wherein energy conducted through the stylet is transmitted at the plurality of points to the elongated tool (para 0050, “the direct heating element 24 is heated to transfer heat through the occlusion element”; para 0054, “direct heating element 24 is electrically connected to the energy generator 26”; par 0045, “thermal energy from the direct heating element 24”).
7. Regarding Claim 2, Turovskiy teaches at least a portion of the flexible stylet extends away from a central axis of the lumen (Fig. 3A, central axis is defined by ref num 16; see Fig. 3B, ref num 24 extends away from central axis).
8. Regarding Claim 3, Turovskiy teaches the flexible stylet has an unexpanded configuration (Fig. 3A, ref num 24 is unexpanded) and expanded configuration (see Fig. 3B, ref num 24 is expanded), a diameter of the stylet being larger in the expanded configuration that the unexpanded configuration (it is obvious that the diameter of ref num 24 in Fig. 3B is larger than in Fig. 3A), and wherein the flexible stylet contacts the plurality of points in the expanded configuration (see Fig. 3B, in the expanded configuration, ref num 24 contacts the plurality of points on the inner wall of ref num 19).
9. Regarding Claim 4, Turovskiy teaches the flexible stylet exerts forces on the inner wall at the plurality of points (para 0050, “the pre-shaped control member 50 moves toward its pre-formed shape, such as a spiral/helical shape, which in turn causes the direct heating element 24 to have a shape set by the pre-formed shape of the control member 50. As best seen in FIG. 3B, for example, in one embodiment the direct heating element 24 has a helical/spiral shape in the expanded state such that the direct heating element 24 contacts an inner surface of the occlusion element 19”; this indicates there is a force exerted on the inner wall).
10. Regarding Claim 5, Turovskiy teaches the flexible stylet includes a stylet shaft (Fig. 3a and 3B, ref num 24) that has a helical shape (para 0050, “in one embodiment the direct heating element 24 has a helical/spiral shape”) with an outer diameter larger than an inner diameter of the tool when outside of the lumen (see Fig. 3B, diameter of the helical configuration of ref num 24 has an outer diameter that is larger than the diameter defined by ref num 16).
11. Regarding Claim 8, Turovskiy teaches a straightening member (Figs. 3A-3C; para 0050, “guidewire”) configurated to extend within an elongated passage in the stylet (see Fig. 3C, ref num 50 extends through ref num 42/24) wherein withdrawing the straightening member from a portion of the stylet causes the portion of the stylet to revert to a preformed shape (para 0050, “the guidewire is withdrawn. Without the guidewire, the pre-shaped control member 50 moves toward its pre-formed shape, such as a spiral/helical shape, which in turn causes the direct heating element 24 to have a shape set by the pre-formed shape of the control member 50”).
12. Regarding Claim 9, Turovskiy teaches the preformed shape is a helical shape (para 0050).
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 6, 12-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy and in view of Ge U.S. 2016/0317212 (herein referred to as “Ge”).
15. Regarding Claim 6, Turovskiy teaches the flexible stylet includes a stylet shaft (Fig. 3a and 3B, ref num 24) that has a helical shape (para 0050, “in one embodiment the direct heating element 24 has a helical/spiral shape”).
Turovskiy fails to teach the helical shape is configured to engage threads along the inner wall of the tool.
Ge teaches a medical system of analogous art (Figs. 2A-2D and 3), wherein the system comprises an elongated tool (Fig. 2A, ref num 4) and a stylet configured to extend within a lumen of the tool (Fig. 2A-2B, ref num 1; para 0037, “As illustrated in FIG. 2A, probe 10 is in the un-deployed state where individual struts 12 are confined by outer sheath 4 to a generally cylindrical configuration”). The stylet is configured to engage threads along an inner wall of the tool (Fig. 2E-eG, ref num 4 has threads, ref num 16, which ref num 12 engages with along inner wall of ref num 4; para 0039-0040). This prevents unwanted twisting of the stylet as it is advanced through the tool (para 0039-0040). 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 Turovskiy to have threads along the inner wall of the tool in order to prevent twisting of the stylet within the tool.
16. Regarding Claim 12, Turovskiy fails to teach the stylet includes an expandable basket portion that can be inserted into the tool in a low profile configuration and transition to an expanded profile configuration wherein a plurality of splines of the expandable basket portion contact the inner wall of the tool.
Ge teaches a system of analogous art (Figs. 2A-2B and 3), wherein the system comprises a stylet (Fig. 2A, ref num 1) that can be inserted into the tool in a low profile configuration (para 0037, “As illustrated in FIG. 2A, probe 10 is in the un-deployed state where individual struts 12 are confined by outer sheath 4 to a generally cylindrical configuration”) and transition to an expanded profile configuration (Figs. 2B-2D). While Ge does not teach the plurality of splines of the expandable basket portion contacting the inner wall of the tool when in the expanded profile, Ge does teach that the splines are biased against in the inner wall of the tool (para 0037, “Individual struts 12 are resiliently biased against the inner wall of outer sheath 4”). Ge also teaches that the individual shape of the expandable portion may be controlled by the tool (para 0038), and that any shape of the expandable portion may be desired (para 0037). 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 Turovskiy to include an expandable basket portion to be inserted in the tool, since it would have been an obvious matter of design choice to make the different portions of the stylet whatever form or shape was desired or expedient, such as an expandable basket. 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 13, Turovskiy fails to teach the splines are separated by slits cut in a nitinol tube.
Ge teaches the splines are separated by slits cut in a nitinol tube (para 0057, “One example of a nickel-titanium alloy suitable for use to form struts 12 is nitinol”). This is a conductive material to achieve the desired result (para 0057). 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 Turovskiy to have the splines separated by slits cut in a nitinol tube, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
18. Regarding Claim 14, Turovskiy fails to teach the splines include an array of wires.
Ge teaches the splines include an array of wires (para 0053, “cathode cage 1… may be connected to each cathode strut via cathode strut wires 54”). This provides the desired energy to the stylet (para 0053). 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 Turovskiy to include an array of wires, as this provides the desired energy to the stylet.
19. Regarding Claim 15, Turovskiy fails to teach an actuator coupled to a cap on the expandable basket portion, wherein pushing the cap or pulling the cap with the actuator causes the transition of the expandable basket portion between the low and expanded profile configurations.
Ge teaches a cap on the expandable basket portion (Fig. 2B, ref num 14), and an actuator (Figs. 2K-2M, ref num 18), such that pushing the cap or pulling the cap with the actuator causes the transition of the expandable basket portion between the low and expanded profile configurations (para 0038, “each strut 12 can be individually extended or retracted by pushing axially towards or away from the cathode tip 14 on each individual strut 12. In another embodiment, as will be described in more detail below, outer sheath 4 may include actuators for individually moving each strut 12”; para 0041, “Each actuator 18 may be attached to one of struts 12. When an actuator 18 slides within a groove 20, the respective strut 12 bends either radially outwards or inwards, depending on the direction of movement of the actuator 18”). This controls the profile configurations of the stylet (para 0038, 0041). 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 Turovskiy to control the profile configurations of the stylet.
20. Regarding Claim 16, Turovskiy fails to teach the stylet includes a cannulated shaft and a plurality of curved tines configured to contact the inner wall of the tool, wherein the plurality of curved tines are movable relative to the cannulated shaft.
Ge teaches a system of analogous art (Figs. 2A-2B and 3), wherein the system comprises a stylet (Fig. 2A, ref num 1) that includes a cannulated shaft and a plurality of curved tines (Fig. 2B, ref num 12 and 3). The plurality of curved tines are movable relative to the cannulated shaft (Fig. 2B-2D, ref num 12 are movable relative to ref num 3). While Ge does not teach the plurality of tines contacting the inner wall of the tool when in the expanded profile, Ge does teach that the tines are biased against in the inner wall of the tool (para 0037, “Individual struts 12 are resiliently biased against the inner wall of outer sheath 4”). Ge also teaches that the individual shape of the expandable portion may be controlled by the tool (para 0038), and that any shape of the expandable portion may be desired (para 0037). 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 Turovskiy to include a plurality of curved tines to be inserted in the tool, since it would have been an obvious matter of design choice to make the different portions of the stylet whatever form or shape was desired or expedient, such as having a plurality of tines. 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.
21. Regarding Claim 21, Turovskiy fails to teach the stylet includes a cannulated shaft and straight tines that are movable relative to a cannulated shaft to flare out distally from the cannulated shaft.
Ge teaches a system of analogous art (Figs. 2A-2B and 3), wherein the system comprises a stylet (Fig. 2A, ref num 1) that includes a cannulated shaft and a plurality of tines (Fig. 2B, ref num 12 and 3). The plurality of tines are movable relative to the cannulated shaft to flare out distally (Fig. 2B-2D, ref num 12 are movable relative to ref num 3). Ge also teaches that the individual shape of the expandable portion may be controlled by the tool (para 0038), and that any shape of the expandable portion may be desired (para 0037). 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 Turovskiy to include a plurality of straight tines to be inserted in the tool, since it would have been an obvious matter of design choice to make the different portions of the stylet whatever form or shape was desired or expedient, such as having a plurality of tines . 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. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy and in view of Woloszko U.S. 7,070,596 (herein referred to as “Woloszko”).
23. Regarding Claim 7, Turovskiy fails to teach the elongated tool includes a needle.
Woloszko teaches a system of analogous art (Figs. 26A-32B), wherein the tool includes a needle (Col. 44, line 63, “introducer needle 928”). The needle provides the same expected result of having the stylet extend through it in order to guide the stylet to the desired target location (Col. 7, lines 3-22). 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 Turovskiy to have the tool include a needle as this produces the same expected result of guiding the stylet to the target location.
24. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy.
25. Regarding Claim 11, Turovskiy fails to teach the stylet includes a brush portion with multiple bristles that extend from a shaft of the stylet into contact with the inner wall of the tool. But since Turovskiy teaches the stylet includes a portion that comes into a plurality of contact points along the inner wall of the tool (see Fig. 3B, ref num 24 contacts inner wall of ref num 19 at a plurality of points; para 0021, “the direct heating element contacts the interior surface of the occlusion element”; para 0050, “the direct heating element 24 contacts an inner surface of the occlusion element 19”), then it would have been an obvious matter of design choice to make the different portions of the stylet whatever form or shape was desired or expedient, such as a brush with bristles. 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.
25. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy and Ge, and further in view of Koop U.S. 2022/0015826 (herein referred to as “Koop”).
26. Regarding Claims 17 and 18, Turovskiy as modified fails to teach the cannulated shaft is moveable distally relative to the tines (claim 17); and the tines are extendable distally of the cannulated shaft or are extendable through openings along a longitudinal length of the cannulated shaft (claim 18).
Koop teaches a system of analogous art (Fig. 1A, 1B), wherein a stylet includes a cannulated shaft and tines (Fig. 1A, ref num 16, Fig. 1B, ref num 14). The cannulated shaft is moveable distally relative to the tines (para 0056, “The flexible shaft 16 may be moved distally to deploy the plurality of tines 14 from the lumen 28”), such that the tines are extendable distally of the cannulated shaft (see Fig. 1B). This facilitates the deployment of tines to the target site (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Turovskiy in order to facilitate the deployment of the tines to the target site.
27. Regarding Claims 22 and 23, Turovskiy as modified fails to teach the cannulated shaft is moveable distally relative to the tines (claim 17); and the tines are extendable distally of the cannulated shaft or are extendable through openings along a longitudinal length of the cannulated shaft (claim 18).
Koop teaches a system of analogous art (Fig. 1A, 1B), wherein a stylet includes a cannulated shaft and tines (Fig. 1A, ref num 16, Fig. 1B, ref num 14). The cannulated shaft is moveable distally relative to the tines (para 0056, “The flexible shaft 16 may be moved distally to deploy the plurality of tines 14 from the lumen 28”), such that the tines are extendable distally of the cannulated shaft (see Fig. 1B). This facilitates the deployment of tines to the target site (para 0056). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Turovskiy in order to facilitate the deployment of the tines to the target site.
Conclusion
28. 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