DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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.
Claims 1, 5, 7-10,24-26, 29 and 32 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Godara et al. (US 2020/0330152).
Regarding claim 1 and 29, Godara discloses a method of ablating tissue within a vertebral body with a system (fig.1, see also [0059]) including an access cannula (100) including a cannula hub (106), a drill (130) including a drill hub (132), and a first probe (140a) and a second probe (140b) of different lengths [0052] and each including a probe hub (probe handle [0052]), the method comprising: providing access to within the vertebral body with the access cannula (vertebral body 202, [0056], [0059]-[0060]); directing a distal end of a shaft (distal end of bone drill shaft 134) of the drill beyond a distal end of the access cannula (fig.6c) to form a first tissue path of a first path length or a second tissue path of a second path length greater than the first path length, wherein the drill hub (132) is spaced from the cannula hub (106) and a proximal portion of the drill shaft is exposed (fig.1, fig.6b-c, handle 132 is spaced from hub 106 so markings 138 are exposed); determining whether a first indicia of a first color (first marking 138a defines a first color; see [0069]; [0110]) or a second indicia of a second color (second marking 138b defines a second color; see also [0069] and [0110]) is in registration with the cannula hub of the access cannula [0069] and [0110], wherein the first indicia and the second indicia are longitudinally sized and positioned on the proximal portion of the drill shaft to be associated with a respective one of the first path length and the second path length for receiving a respective one of the first probe and the second probe [0062]-[0063]; correlating one of the first color (fig.1) and the second color (fig.1, the defined second color) that is in registration with the cannula hub (fig.6c; 106) of the access cannula with a corresponding color (fig.6c, see also [0068]-[0069]) of complementary indicia associated with a respective one of the first probe and the second probe (fig.4; second probe 140b); selecting one of the first probe and the second probe based on the correlated one of the first color and the second color (fig.4, fig.6c-d, see also [0068]-[0069]); removing (fig.6c, the physician withdrawn drill 130 from the cannula, see also [0068]) the drill from the access cannula (fig.1, cannula 100); directing the selected one of the first probe (first probe 140a) and the second probe (second probe 140b) through the access cannula and into the formed first tissue path or the formed second tissue path; and operating the selected one of the first probe (first probe 14a) and the second probe to ablate the tissue adjacent the formed first tissue path or the formed second tissue path ([0056] and [0068]).
Regarding claim 5 and 32, Godara discloses further comprising: correlating a distal margin (fig. 6c, second marking 138b defines a distal margin) of the second indicia (Fig. 6c, second marking 138b) as being in registration with the cannula hub (fig. 4, fig. 6c, the user advances drill 130 such that the defined distal margin of probe selection marking 138b cooperates with a feature of cannula* 100 and observes the marking 138b to identify the corresponding probe 140; [0062]; [0064]; [0068]; selecting the second probe (fig. 4, fig. 6d, the user selects the corresponding probe 140b; [0052] and [0068]); and directing the second probe (Fig. 4, probe 140b) through the access cannula (fig. 1, cannula 100) and into the formed second tissue path (fig. 4, fig. 6d, the physician inserts and positions the probe 140 such that the probe shaft 144 extends distal of cannula shaft104; [0068]).
Regarding claim 7, Godara discloses a method of ablating tissue (fig.4, 6a-d,see also [0059]) within a vertebral body (fig. 5, vertebral body or bone 202, see also [0056]) with a system (assembly 120, probe 140, and drill bit 130 define a system) including an access cannula (cannula 100) including a cannula hub (hub 106), a drill (drill 130) comprising a drill hub (handle 132), and a first probe (first probe 140a) and a second probe (second probe 140b) of different lengths (first probe 140a and second probe 140b have different lengths, see also [0052]) and each including a probe hub (each probe 140 is comprised of a probe handle 142; [0052]), the method comprising: providing access to within the vertebral body (Fig. 5, vertebral body 202) with the access cannula (fig. 5, fig. 6a, inserting and advancing introducer assembly 120 to a target location within a patient's body; [0056]; [0059]-[0060]); directing a distal end (fig. 1, shaft 134 defines a distal end) of a shaft (shaft 134) of the drill (drill 130) beyond a distal end (cannula 100 defines a distal end) of the access cannula (cannula 100) to form a first tissue path of a first path length or a second tissue path of a second path length greater than the first path length (fig. 1, fig. 5, figs. 6a-6c, the user advances bone drill 130 from the position of fig. 6b to the position of fig. 6c such that probe selection marking 138a lines up with the proximal end of cannula 100 such that the distal margin 214 of probe ablation zone corresponding to the probe indicated by probe selection marking 138a is forms a first path with a first length or such that probe selection marking 138b cooperates with a feature of cannula 100 to define a distal margin 214 of probe ablation zone 210 corresponding to a probe indicated by probe selection marking 138b to form a second path with a second length, the second length longer than the first length; [0062]-[0063]), wherein the drill hub (fig. 1, handle 132) is spaced from the cannula hub (fig. 1, hub 106) and a proximal portion (fig. 1, shaft 134 defines a proximal portion) of the drill shaft (Fig. 1, shaft 134) is exposed (fig. 1, fig. 6b, fig. 6c, handle 132 is spaced from hub 106 so markings 138 are exposed); determining whether a first indicia (fig. 1, first marking 138a) of a first color (fig. 1, first marking 138a defines a first color; [0069]; [0110]) or a second indicia (fig. 1, second marking 138b) of a second color (fig. 1, second marking 138b defines a second color; [0069]; [0110]) on the proximal portion (Fig. 1, the defined proximal portion) of the drill shaft (Fig. 1, shaft 134) is in registration with the cannula hub (fig. 1, the user advances drill 130 until a selection marking 138a, 138b cooperates with hub 106; [0061]-[0062]; [0068]) of the access cannula (fig. 1, cannula 100); correlating one of the first color (fig. 1, the defined first color) or the second color (fig. 1, the defined second color) with a corresponding color of complementary indicia (fig. 1, fig. 4, figs. 6c-6d, markings 138 are color coded such that each probe selection marking corresponds with a color coding associated with each probe (probe identifier 143; [0069]) associated with a respective one of the first probe (fig. 4, first probe 140a) and the second probe (fig. 4, second probe 140b), wherein a distal margin (fig. 6c, fig. 6d, first distal margin 214) of the first indicia (fig. 1, figs. 6b-6d, first marking 138a) being in registration with the cannula hub (fig. 6b, hub 106) provides for a proximal emitter (fig. 4, fig. 6d, first active tip 146) of the first probe (fig. 4, first probe 140a) to be exposed beyond the distal end (fig. 1, the defined distal end) of the access cannula (Fig. 1, Fig. 4, Figs. 6b-6d, first marking 138a provides for first active tip 146 to extend distal of cannula shaft 104; [0068]) and a distal end (fig. 4, first probe 140a defines a distal end) of the first probe (fig. 4, first probe 140a) to be positioned at an end of the first tissue path (fig. 6c, the distal end of first probe 140a is positioned at an end of the path formed by drill 130) with a first probe hub (fig. 4, fig. 6d, first probe handle 142) engaging the cannula hub (fig. 4, fig. 6d, first probe handle 142 engages hub 106), and wherein the second probe (Fig. 4, Fig. 6d, second probe 140b) has a length such that a proximal emitter (fig. 4, fig. 6d, second active tip 146) of the second probe (fig. 4, fig. 6d, second probe 140b) would not be exposed beyond the distal end (Fig. 1, fig. 6d, the defined distal end) of the access cannula (fig. 1, fig. 6b, cannula 100) based on a distal end (fig. 4, second probe 140b defines a distal end) of the second probe (fig. 6d, second probe 140b) engaging the tissue at the end of the first tissue path (fig. 4, figs. 6b-6d, the second probe 140b would not be exposed beyond the distal end of cannula 100 based on engaging tissue at the end of the path formed based on first marking 138a; [0062]-[0063]); selecting (fig. 4, figs. 6c-6d, the physician selects the corresponding probe 140; [0068]-[0069]) one of the first probe (Fig. 4, first probe 140a) and the second probe (fig. 4, second probe 140b) based on the correlated one of the first color (the defined first color) and the second color (the defined second color); removing (fig. 6c, the physician withdraws drill 130 from the cannula; [0068]) the drill (fig. 6c, drill 130) from the access cannula (cannula 100); directing the selected one of the first probe (Fig. 4, first probe 140a) and the second probe (Fig. 4, second probe 140b) through the access cannula (cannula 100) and into the formed first tissue path or the formed second tissue path (the physician inserts and positions the selected probe 140 such that probe shaft 144 extends distal of cannula shaft 104 and into the formed path; [0068]); and operating the selected one of the first probe (first probe 140a) and the second probe (second probe 140b) to ablate the tissue adjacent the formed first tissue path or the formed second tissue path (energy delivered from active tip 146 ablates material proximal and distal of active tip 146; [0056]; [0068]).
Regarding claim 8, Godara discloses the method of claim 7, Medtronic further disclosing wherein a proximal margin (fig. 1, fig. 6b, first marking 138a defines a first proximal margin) of the first indicia (fig. 1, fig. 6b, first marking 138a) being in registration with the cannula hub (fig. 1, fig. 6b, fig. 6c, hub 106) provides for the distal end (fig. 4, the defined distal end) of the first probe (fig. 4, first probe 140a) being spaced apart from the end (fig. 6c, the defined end) of the first tissue path (fig. 6c, the defined first path) with the first probe hub (fig. 4, fig. 6d, the first probe handle 142) engaging the cannula hub (Fig. 1, fig. 4, figs. 6b-6d, the defined first proximal margin being in registration with the hub 106 provides for the distal end of the first probe 140a being spaced apart from the end of the first tissue path with the handle engaging hub 106; [0062]-[0064]), wherein a distal margin (fig. 1, second marking 138b defines a second distal margin) of the second indicia (fig. 1, second marking 138b) being in registration with the cannula hub (fig. 1, hub 106) provides for the distal end (fig. 4, the defined distal end) of the second probe (fig. 4, second probe 140b) being at an end of the second tissue path (figs, 6c-6d, the defined second path) with a second probe hub (fig. 4, second probe handle 142) engaging the cannula hub (fig. 1, fig. 4, figs. 6b-6d, the defined second distal margin being in registration with the hub 106 provides for the distal end of the second probe 140b being at the end of the defined second path with the handle 142 engaging the hub 106; [0062]-[0064]), and wherein a proximal margin (fig. 1, second marking 138b defines a second proximal margin) of the second indicia (fig. 1, second marking 138b) being in registration with the cannula hub (fig. 1, hub 106) provides for the distal end (Fig. 4, the defined distal end) of the second probe (fig. 4, second probe 140b) being spaced apart from the end of the second tissue path (figs. 6c-6d, the defined second path) with the second probe hub (Fig. 4, second probe handle 142) engaging the cannula hub (fig. 1, fig. 4, figs. 6c-6d, the defined second proximal margin being in registration with the hub 106 provides for the distal end of the second probe 140b being spaced apart from the end of the second path with the handle 142 engaging the hub 106; [0062]-[0064]).
Regarding claim 9, Godara discloses the method of claim 7wherein the step of determining whether the first indicia (fig. 1, first marking 138a) of the first color (the defined first color) or the second indicia (fig. 1, second marking 138b) of the second color (the defined color) is in registration with the cannula hub (fig. 1, hub 106) is performed after a step of confirming the distal end (fig. 1, the defined distal end) of the drill shaft (fig. 1, shaft 134) on imaging (fig. 1, figs. 6b-6d, the physician observes the marking 138 to identify the corresponding probe 140 following mapping the distal tip of the drill 130 using imaging; [0062]; [0065]; [0068]-[0069]).
Regarding claim 10, Godara discloses the method of claim 7, wherein the first probe is packaged in a first probe kit and the second probe is packaged in a second probe kit, the method further comprising opening a singular one of the first probe kit and the second probe kit based on the correlated one of the first color and the second color such that the second probe kit remains usable in a subsequent ablation procedure ([0049], see also [0236]).
Regarding claim 24, Godara discloses the method of claim 1, wherein the step of determining whether the first indicia of the first color or the second indicia of the second color is in registration with the cannula hub is performed after the step of directing the distal end of the shaft of the drill beyond the distal end of the access cannula to form the first tissue path or the second tissue path.
Regarding claim 25, Godara discloses the method of claim 1, further comprising confirming, on imaging, a position of the distal end of the drill shaft, wherein step of determining whether the first indicia (fig. 1, first marking 138a) of the first color (the defined first color) or the second indicia (fig. 1,second marking 138b) of the second color (the defined color) is in registration with the cannula hub (fig. 1, hub 106) is performed after a step of confirming the distal end (fig. 1, the defined distal end) of the drill shaft (fig. 1, shaft 134) on imaging (fig. 1, figs. 6b-6d, the physician observes the marking 138 to identify the corresponding probe 140 following mapping the distal tip of the drill 130 using imaging, see also [0062]-[0065] and [0068]-[0069]).
Regarding claim 26, Godara discloses the method of claim 1, wherein the first probe is packaged in a first probe kit and the second probe is packaged in a second probe kit, the method further comprising opening a singular one of the first probe kit and the second probe kit based on the correlated one of the first color and the second color such that the second probe kit remains usable in a subsequent ablation procedure ([0049], see also [0236]).
Claim Rejections - 35 USC § 103
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.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Godara et al. (US 2020/0330152) in view of Elfar (US 2015/0031991).
Regarding claim 27-28, Godara discloses the system of claim 11. Godara does not explicitly disclose wherein the first indicia and the second indicia are elongate, linear, and longitudinally inset along a side of the proximal portion of the drill shaft.
Elfar is in the field of a medical needle that provides depth of penetration information ([0003]) and teaches a system (fig. 35, marker needle 3500), wherein the first indicia fig. 35, first indicator; [0102]) and the second indicia (fig. 35, second indicator; [0102]) are elongate, linear, and longitudinally inset (fig. 35, indicators are elongate, linear, and recessed into the shaft 3503; [0102]) along a side of the proximal portion (fig. 35, shaft 3503 defines a proximal portion) of the drill shaft (fig. 35, indicators are positioned along a side of the shaft 3503). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Godara to include recessed indicators as taught by Elfar in order to maximize visibility to a user.
Allowable Subject Matter
Claim 2-4, 6, 30-31 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: During the search of the prior art, the Examiner has failed to identify any reference which that, either alone or in combination discloses, suggests or renders obvious of correlating a proximal margin of the first indicia as being in registration with the cannula hub with the first indicia partially visible; selecting the first probe; and directing the first probe through the access cannula and into the formed first tissue path such that the distal end of the first probe is spaced apart from an end of the first tissue path with the first probe hub engaging the cannula hub or correlating a proximal margin of the first indicia as being in registration with the cannula hub with the first indicia not visible; selecting the second probe; and directing the second probe through the access cannula and into the formed second tissue path such that the distal end of the second probe is at an end of the second tissue path with a second probe hub engaging the cannula hub or correlating a thin portion of the drill shaft between the first indicia and the second indicia as being in registration with the cannula hub with the first indicia not visible; selecting the second probe; and directing the second probe through the access cannula and into the formed second tissue path and correlating a proximal margin of the second indicia as being in registration with the cannula hub; selecting the second probe; and directing the second probe through the access cannula and into the formed second tissue path such that the distal end of the second probe is spaced apart from the end of the second tissue path with the second probe hub engaging the cannula hub while also teaching each and every limitation set forth in independent claims.
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Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
