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 .
Response to Amendment
The amendment filed June 17th, 2025 has been entered. Claims 1-2, 4, 9-11, 14, & 18-19 are amended. Claims 3, 7, & 13 are canceled. Claims 20-23 are new. Claims 1-2, 4-6, 8-12, & 14-23 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-6, 8-12, & 14-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Election/Restrictions
Newly submitted claims 20 & 23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of the newly submitted claims and the invention originally claimed are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another materially different process. (MPEP § 806.05(e)). In this case the invention as claimed can be used to practice another and materially different process such as delivering the catheter to a treatment site over a guidewire and using the telescopic needle assembly to electrosurgically puncture and dilate a vessel wall; and the process as claimed can be practiced by another materially different apparatus, such as with a catheter apparatus that does not contain a guidewire lumen and does not contain an exit port in a radially outer surface of the catheter shaft.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20 & 23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 11 is objected to because of the following informalities: “the elongated delivery device” (lines 25 & 32-33) should be –the delivery device—; as introduced in claim 11. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “the needle” (line 14) should be –the hollow needle—; as introduced in claim 11. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: “the needle” (line 1) should be –the hollow needle—; as introduced in claim 11. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 10, 12, & 21 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.
Claim 10 recites the limitation “an electrode advancer configured to extend the telescopic needle assembly and one or more electrodes through the exit port”; it is unclear if “one or more electrodes”, as recited in claim 10, as the same as or in addition to the “one or more electrodes”, as introduced in claim 1, which renders the claim indefinite. For examination purposes the examiner is considering “one or more electrodes”, as recited in claim 10, as the same as “one or more electrodes”, as introduced in claim 1.
Claim 12 recites the limitations “the second section" and “the third section” in lines 1-2. There is insufficient antecedent basis for these limitation in the claim. Further it is unclear how the “second section” and the “third section” are related to the components of the device, as introduced in independent claim 11, which renders the claim indefinite. For examination purposes, the examiner is considering “the second section” to be the hollow needle and “the third section” to be the delivery device.
Claim 21 recites “wherein the first section protrudes from the sharp distal end of the needle of the first section by no more than 2 mm”. First, there is insufficient antecedent basis for the limitation “the needle of the first section” in the claim. Second, it is unclear how the first section protrudes from the sharp distal end of the needle of the first section, more specifically, it is unclear how the first section protrudes from itself (e.g. from its own sharp distal end), which renders the claim indefinite, for examination purposes the examiner is considering the first section to protrude from third section by no more than 2 mm.
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.
Claims 1-2, 4-5, 10-12, 14-15, 19, & 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Blakstvedt et al. (US 20090227952 A1), hereinafter “Blakstvedt”, in view of Fischell et al. (previously presented-US 20160242661 A1), hereinafter “Fischell”.
Regarding claim 1, Blakstvedt discloses a vascular catheter, comprising: a catheter shaft ([0032]; Figure 1—element 12) comprising an exit port in a radially outer surface of the catheter shaft ([0032] & [0034]; Figures 1, 1A, 5A, & 5B—elements 22/30; with said exit port being the lateral port through which penetrator 30 and device 22 are advanceable, as shown in figures 1-1A & 5A-5B), and a needle assembly lumen ([0032] & [0034]; Figures 1, 1A, 5A, & 5B—elements 12, 22, & 30; with said needle assembly lumen being the interior lumen of the catheter 12 containing needle assembly 22/30); a guidewire lumen ([0034]; Figure 1A—element 25), and a telescopic needle assembly ([0032]; Figures 1, 1A, & 5B-5D—elements 22 & 30), where the telescopic needle assembly is the only telescopic needle assembly in the catheter shaft ([0032]; Figures 1, 1A, & 5B-5D—elements 22 & 30), the telescopic needle assembly configurable from a first position to a second position, wherein the telescopic needle assembly is within the catheter shaft in the first position and in the second position extends from the exit port ([0049]; Figures 5A-5D—elements 22 & 30; the examiner is considering the first position to be the position when the telescopic needle assembly 22 & 30 is in the retracted position within catheter 12 body, as shown in figure 5A, and the second position to be the position when the telescopic needle assembly extended out of the catheter body, as shown in figures 5B-5D), the telescopic needle assembly is configured to puncture vascular tissue when transitioned to the second position ([0034] & [0049]), the telescopic needle assembly comprising: a first section ([0032], [0034], & [0049]; Figure 1A, 5A, 5B—element 30), a second section ([0032], [0038], [0040], [0044], & [0049]; Figure 1, 1A, 3-3C, 5C, & 5D—element 22), co-axial to each other and protruding from the exit port while the telescopic needle assembly is in the second position ([0032] & [0049]; Figure 1, 1A, 5C, & 5D—elements 22 & 30); wherein the first section is hollow and has a sharp distal end configure to puncture a vein wall ([0032], [0034], & [0049]; Figure 1A, 5A, 5B—element 30); wherein the first section has a distal portion which extends through the exit port transitions from the first position to the second position ([0049]; Figures 5A & 5B—element 30); wherein the second section protrudes from the sharp distal end of the first section while the telescopic needle assembly is in or is advancing to the second position ([0049]; Figures 5C & 5D—element 22), and wherein the second section comprises an outer surface with one or more electrodes ([0035], [0037], [0040], [0044]; Figure 3—element 22; the second section/device 22 may have an energy emitting distal tip, for example a radiofrequency electrode may be located on the distal tip), and wherein the first section, the second section exit the exit port as the telescopic needle assembly transitions from the first position to the second position ([0049]; Figures 5A-5D—elements 22 & 30).
Blakstvedt does not disclose the telescopic needle assembly comprising: a third section co-axial to each other and protruding from the exit port while the telescopic needle assembly is in the second position; wherein the third section is a guide for the first section; wherein the first section is fully covered by the third section while the telescopic needle assembly is in the first position and the first section protrudes from a distal end of the third section while the telescopic needle assembly is in or is advancing to the second position; the third section exit the exit port as the telescopic needle assembly transitions from the first position to the second position.
Fischell teaches a catheter comprising an exit port ([0176]; Figure 1—elements 13 & 15) and a telescopic needle assembly configured to transition from a first position to a second position ([0176]-[0179]; Figure 1—elements 20 & 30); the telescopic needle assembly comprising: a hollow sharp first section ([0176]-[0178]; Figures 1 & 3—element 20), and a third section co-axial to each other and protruding from the exit port while the telescopic needle assembly is in the second position ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30); wherein the third section is a guide for the first section ([0179], [0186], & [0191]; Figures 1-3—element 30); wherein the first section is fully covered by the third section while the telescopic needle assembly is in the first position and the first section protrudes from a distal end of the third section while the telescopic needle assembly is in or is advancing to the second position ([0191], [0196], [0200], & [0203]); the third section exits the exit port as the telescopic needle assembly transitions from the first position to the second position ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the telescopic needle assembly, as disclosed by Blakstvedt, to further include a third section that is a guide for the first section, as taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly includes a first section that is configured to penetrate tissue to reach a target site for positioning an electrode tip ([0034], [0044], & [0049]). As disclosed by Fischell, the telescopic needle assembly includes a first section that is configured to penetrate tissue to reach a target site for positioning an electrode tip, the telescopic needle assembly may also include a third section that acts as a guide tube for the first section; the guide tube structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section ([0018], [0090], [0108], [0118], [0188], [0203], [0229]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the telescopic needle assembly, as disclosed by Blakstvedt, to further include a third section that is a guide for the first section, as taught by Fischell, as such a modification would provide for a guide tube that structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section.
Regarding claim 2, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt further discloses a telescoping relationship with the first section and the second section ([0049]; Figures 5C & 5D—elements 22 & 30).
Blakstvedt does not disclose wherein the third section is in the telescoping relationship with the first section and the second section.
Fischell further teaches wherein the third section is in the telescoping relationship with the first section ([0191], [0196], [0200], & [0203]; Figures 1-3—elements 20 & 30).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the telescoping relationship with the first section and second section, as disclosed by Blakstvedt, to include the third section in the telescoping relationship with the sections, as further taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Fischell, the telescopic needle assembly includes a first section that is configured to penetrate tissue to reach a target site for positioning an electrode tip, the telescopic needle assembly may also include a telescoping third section that acts as a guide tube for the first section; the guide tube structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section ([0018], [0090], [0108], [0118], [0188], [0203], [0229]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the telescoping relationship with the first section and second section, as disclosed by Blakstvedt, to include the third section in the telescoping relationship with the sections, as further taught by Fischell, as such a modification would provide for a guide tube that structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section.
Regarding claim 4, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt further discloses wherein the one or more electrodes comprise a first electrode ([0035], [0037], [0040], [0044]; Figure 3—element 22; the second section/device 22 may have an energy emitting distal tip, for example a radiofrequency electrode may be located on the distal tip).
Blakstvedt does not disclose wherein the one or more electrodes comprise the first electrode and a second electrode positioned and adapted to be operated in a bipolar mode.
Fischell further teaches a telescopic needle assembly comprising one or more electrodes ([0177]), wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode ([0047] & [0064]; the energy delivery can utilize bipolar montages where the anode and cathode are located on the same tip or monopolar montages where the energy travels between an electrode on the tip and a return electrode located elsewhere).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode, as disclosed by Blakstvedt, to include a second electrode, wherein the first electrode and the second electrode positioned and adapted to be operated in a bipolar mode, as further taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly may include a radio frequency electrode for delivering RF energy to target tissue ([0040] & [0044]). As disclosed by Fischell, the telescopic needle assembly may include a bipolar or monopolar electrode arrangement for delivering RF energy to target tissue ([0047], [0064], & [0135]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first electrode, as disclosed by Blakstvedt, to include a second electrode, wherein the first electrode and the second electrode positioned and adapted to be operated in a bipolar mode, as further taught by Fischell, as providing a bipolar electrode arrangement on a telescopic needle assembly for delivering RF energy to tissue is a known and suitable alternative in the art for providing a monopolar electrode arrangement and such a modification would produce the predictable result of providing a suitable electrode arrangement for delivering RF energy to tissue.
Regarding claim 5, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt further discloses further comprising a marker configured to indicate radial orientation ([0034]; Figures 1 & 1A—element 13).
Regarding claim 10, as best understood in view of the 112(b) rejection above, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt further discloses an electrode advancer configured to extend the telescopic needle assembly and one or more electrodes through the exit port ([0034], [0035], [0038], & [0049]).
Regarding claim 11, Blakstvedt discloses a vascular catheter, comprising: a catheter shaft ([0032]; Figure 1—element 12) comprising an exit port in a radially outer surface of the catheter shaft ([0032] & [0034]; Figures 1, 1A, 5A, & 5B—elements 22/30; with said exit port being the lateral port through which penetrator 30 and device 22 are advanceable, as shown in figures 1-1A & 5A-5B), and a needle assembly lumen having an opening at the exit port ([0032] & [0034]; Figures 1, 1A, 5A, & 5B—elements 12, 22, & 30; with said needle assembly lumen being the interior lumen of the catheter 12 containing needle assembly 22/30); a guidewire lumen ([0034]; Figure 1A—element 25), and a telescopic needle assembly ([0032]; Figures 1, 1A, & 5B-5D—elements 22 & 30), and a telescopic needle assembly, where the telescopic needle assembly is the only telescopic needle assembly in the catheter ([0032]; Figures 1, 1A, & 5B-5D—elements 22 & 30), and the telescopic needle assembly is configured to advance from a first position within the needle assembly lumen of the catheter shaft to a second position protruding from the exit port into a vein in which the telescopic needle assembly is positioned ([0049]; Figures 5A-5D—elements 22 & 30; the examiner is considering the first position to be the position when the telescopic needle assembly 22 & 30 is in the retracted position within catheter 12 body, as shown in figure 5A, and the second position to be the position when the telescopic needle assembly extended out of the catheter body, as shown in figures 5B-5D; it is the examiner position that the telescopic needle assembly would be capable of protruding into a vein), wherein the telescopic needle assembly includes: a hollow needle ([0032], [0034], & [0049]; Figure 1A, 5A, 5B—element 30); and a delivery device within the hollow needle and coaxial to the needle ([0032], [0038], [0040], [0044], & [0049]; Figure 1, 1A, 3-3C, 5C, & 5D—element 22), wherein the hollow needle includes a sharp distal end from which extends the delivery device while the telescopic needle assembly is in or advances to the second position ([0032], [0034], & [0049]; Figures 1A & 5B-5D—element 30); wherein the telescopic needle assembly is configured to advance from the first position to the second position by a sequence including: the hollow needle and the elongated delivery device are sheathed, advancing the hollow needle from a distal end and puncturing, with the sharp distal end, a wall of the vein within which the telescopic needle assembly is positioned, and advancing the delivery device from the hollow needle into tissue surrounding the vein ([0049]; Figures 5A-5D—elements 22 & 30; Figure 5A portrays the hollow needle 30 and the elongated delivery device 22 being sheathed; Figure 5B portrays the advancement of the hollow needle 30 for puncturing, it is the examiner position that the hollow needle would be capable of puncturing a wall of the vein with the sharp distal end, Figures 5C & 5D portrays the advancement of the delivery device 22 from the hollow needle into tissue, it is the examiner position that the delivery device would be capable of advancing into tissue surrounding a vein), wherein one or more electrodes are carried by the elongated delivery device ([0035], [0037], [0040], [0044]; Figure 3—element 22; the second section/device 22 may have an energy emitting distal tip, for example a radiofrequency electrode may be located on the distal tip).
Blakstvedt does not disclose wherein the telescopic needle assembly includes: a hollow needle guide; the hollow needle within and coaxial to the hollow needle guide; wherein the hollow needle is fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from a distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position; wherein the telescopic needle assembly is configured to advance from the first position to the second position by the sequence including: advancing the hollow needle guide through the exit port while the hollow needle and the elongated delivery device are sheathed within the hollow needle guide, advancing the hollow needle from a distal end of the hollow needle guide.
Fischell teaches a catheter comprising an exit port ([0176]; Figure 1—elements 13 & 15) and a telescopic needle assembly configured to transition from a first position to a second position ([0176]-[0179]; Figure 1—elements 20 & 30); the telescopic needle assembly comprising: a hollow needle including a sharp distal ([0176]-[0178]; Figures 1 & 3—element 20), a hollow needle guide ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30); the hollow needle within and coaxial to the hollow needle guide ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30); wherein the hollow needle is fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from a distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position ([0191], [0196], [0200], & [0203]); wherein the telescopic needle assembly is configured to advance from the first position to the second position by the sequence including: advancing the hollow needle guide through the exit port while the hollow needle is sheathed within the hollow needle guide ([0179], [0190], [0191], [0196], & [0199]), advancing the hollow needle from a distal end of the hollow needle guide (0191], [0196], [0199], & [0203]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the telescopic needle assembly, as disclosed by Blakstvedt, to further include a hollow needle guide coaxial to the hollow needle, as taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly includes a hollow needle that is configured to penetrate tissue to reach a target site for positioning an electrode tip ([0034], [0044], & [0049]). As disclosed by Fischell, the telescopic needle assembly includes a hollow needle that is configured to penetrate tissue to reach a target site for positioning an electrode tip, the telescopic needle assembly may also include a hollow needle guide for supporting the hollow needle; the hollow needle guide structurally supports the hollow needle, allows the hollow needle to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the hollow needle ([0018], [0090], [0108], [0118], [0188], [0203], [0229]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the telescopic needle assembly, as disclosed by Blakstvedt, to further include a hollow needle guide coaxial to the hollow needle, as taught by Fischell, as such a modification would provide for a hollow needle guide that structurally supports the hollow needle, allows the hollow needle to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the hollow needle.
Regarding claim 12, as best understood in view of the 112(b) rejection above, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt further discloses wherein the second section surrounds the third section and the third section extends outward from the second section ([0049]; Figures 5B-5D—elements 22 & 30).
Regarding claim 14, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt further discloses wherein the one or more electrodes comprises a first electrode ([0035], [0037], [0040], [0044]; Figure 3—element 22; the second section/device 22 may have an energy emitting distal tip, for example a radiofrequency electrode may be located on the distal tip).
Blakstvedt does not disclose wherein the one or more electrodes comprises the first electrode and a second electrode positioned and adapted to be operated in a bipolar mode.
Fischell further teaches a telescopic needle assembly comprising one or more electrodes ([0177]), wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode ([0047] & [0064]; the energy delivery can utilize bipolar montages where the anode and cathode are located on the same tip or monopolar montages where the energy travels between an electrode on the tip and a return electrode located elsewhere).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode, as disclosed by Blakstvedt, to include a second electrode, wherein the first electrode and the second electrode positioned and adapted to be operated in a bipolar mode, as further taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly may include a radio frequency electrode for delivering RF energy to target tissue ([0040] & [0044]). As disclosed by Fischell, the telescopic needle assembly may include a bipolar or monopolar electrode arrangement for delivering RF energy to target tissue ([0047], [0064], & [0135]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first electrode, as disclosed by Blakstvedt, to include a second electrode, wherein the first electrode and the second electrode positioned and adapted to be operated in a bipolar mode, as further taught by Fischell, as providing a bipolar electrode arrangement on a telescopic needle assembly for delivering RF energy to tissue is a known and suitable alternative in the art for providing a monopolar electrode arrangement and such a modification would produce the predictable result of providing a suitable electrode arrangement for delivering RF energy to tissue.
Regarding claim 15, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt further discloses further comprising a marker configured to indicate radial orientation ([0034]; Figures 1 & 1A—element 13).
Regarding claim 19, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt further discloses an electrode advancer configured to extend the telescopic needle assembly and the one or more electrodes through the exit port ([0034], [0035], [0038], & [0049]).
Regarding claim 21, as best understood in view of the 112(b) rejection above, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt does not disclose wherein the first section protrudes from the sharp distal end of the needle of the first section by no more than 2 mm.
Fischell further teaches wherein the first section protrudes from the sharp distal end of the needle of the first section by no more than 2 mm ([0090], [0203], [0318]; Figure 3—element “L1”; as best understood in view of the 112(b) rejection above, the examiner is considering the first section to protrude from the third section by no more than 2 mm; the penetration depth L1, which is the distance from the distal end of the third section 30 to the distal end of the first section 20 may be adjusted or limited; the first section 20 may penetrate to a preset distance between 2 to 6mm; it is the examiners position that the first section can protrude from the distal end of the third section by exactly 2mm, as 2mm is within the range of 2 to 6mm).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the telescopic needle assembly, as disclosed by Blakstvedt, to include the third section and the penetration depth of the first section, as further taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly includes a first section that is configured to penetrate tissue to reach a target site for positioning an electrode tip ([0034], [0044], & [0049]). As disclosed by Fischell, the telescopic needle assembly includes a first section that is configured to penetrate tissue to reach a target site for positioning an electrode tip, the telescopic needle assembly may also include a third section for supporting the first section; the third section structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section, the penetration depth of the first section may typically be between 2 and 6mm as this distance will minimize injury to non-target tissue ([0018], [0090], [0108], [0118], [0188], [0203], [0229], & [0318]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the telescopic needle assembly, as disclosed by Blakstvedt, to include the third section and the penetration depth of the first section, as further taught by Fischell, as such a modification would provide for a third section that structurally supports the first section, allows the first section to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the first section to between 2-6 mm which can prevent injury to non-target tissue.
Regarding claim 22, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt does not disclose wherein the needle protrudes from the distal end of the hollow needle guide by no more than 2 mm.
Fischell further teaches wherein the needle protrudes from the distal end of the hollow needle guide by no more than 2 mm ([0090], [0203], [0318]; Figure 3—element “L1”; the penetration depth L1, which is the distance from the distal end of the hollow needle guide 30 to the distal end of the hollow needle 20 may be adjusted or limited; the hollow needle 20 may penetrate to a preset distanced between 2 to 6mm; it is the examiners position that the needle can protrude from the distal end of the hollow needle guide by exactly 2mm, as 2mm is within the range of 2 to 6mm).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the telescopic needle assembly, as disclosed by Blakstvedt, to include the hollow needle guide and the penetration depth of the hollow needle, as further taught by Fischell, as both references and the claimed invention are directed toward vascular catheters comprising telescopic needle assemblies. As disclosed by Blakstvedt, the telescopic needle assembly includes a hollow needle that is configured to penetrate tissue to reach a target site for positioning an electrode tip ([0034], [0044], & [0049]). As disclosed by Fischell, the telescopic needle assembly includes a hollow needle that is configured to penetrate tissue to reach a target site for positioning an electrode tip, the telescopic needle assembly may also include a hollow needle guide for supporting the hollow needle; the hollow needle guide structurally supports the hollow needle, allows the hollow needle to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the hollow needle, the penetration depth of the hollow needle may typically be between 2 and 6mm as this distance will minimize injury to non-target tissue ([0018], [0090], [0108], [0118], [0188], [0203], [0229], & [0318]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the telescopic needle assembly, as disclosed by Blakstvedt, to include the hollow needle guide and the penetration depth of the hollow needle, as further taught by Fischell, as such a modification would provide for a hollow needle guide that structurally supports the hollow needle, allows the hollow needle to be reliably advanced into the wall of a target vessel, serves to center the catheter within the vessel, and aids in adjusting and limiting the depth of penetration of the hollow needle to between 2-6 mm which can prevent injury to non-target tissue.
Claims 6, 8, & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Blakstvedt in view of Fischell and Gelfand et al. (previously presented-US 20130310823 A1), hereinafter “Gelfand”.
Regarding claim 6, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt does not disclose a stimulation electrode for delivering a nerve stimulation signal.
Gelfand teaches a vascular catheter ([0187], [0188], & [0200]; Figure 7 –element 448) comprising a needle assembly for ablating tissue ([0196] & [0200]; Figures 6 & 7—element 441), the vascular catheter further comprising a stimulation electrode for delivering a nerve stimulation signal ([0189], [0190]; the vascular catheter may comprise an electrode positioned at a distal region which may provide electrical nerve stimulation).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the vascular catheter, as disclosed by Blakstvedt, to include a stimulation electrode for delivering a nerve stimulation signal, as taught by Gelfand, as both references and the claimed invention are directed toward vascular catheters comprising needle ablation assemblies. As disclosed by Blakstvedt, the vascular catheter comprises an electrode for ablating tissue ([0050]). As disclosed by Gelfand, the vascular catheter may comprise an electrode to provide electrical nerve stimulation, such that changes in physiological parameters prior to and after ablation can indicate the effectiveness of ablation ([0041], [00189], [0190]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the vascular catheter, as disclosed by Blakstvedt, to include a stimulation electrode for delivering a nerve stimulation signal, as taught by Gelfand, as such a modification would allow for changes in physiological paraments prior to and after ablation to be monitored to indicate the effectiveness of ablation.
Regarding claim 8, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt does not disclose a base electrode on an outer surface of the catheter.
Gelfand teaches a vascular catheter ([0187], [0188], & [0200]; Figure 7 –element 448) comprising a needle assembly for ablating tissue ([0196] & [0200]; Figures 6 & 7—element 441), the vascular catheter further comprising a base electrode on an outer surface of the catheter ([0189], [0190]; the vascular catheter may comprise an electrode positioned at a distal region which may provide electrical nerve stimulation).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the vascular catheter, as disclosed by Blakstvedt, to include a base electrode, as taught by Gelfand, as both references and the claimed invention are directed toward vascular catheters comprising needle ablation assemblies. As disclosed by Blakstvedt, the vascular catheter comprises an electrode for ablating tissue ([0050]). As disclosed by Gelfand, the vascular catheter may comprise an electrode on the distal end to provide electrical nerve stimulation, such that changes in physiological parameters prior to and after ablation can indicate the effectiveness of ablation ([0041], [00189], [0190]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the vascular catheter, as disclosed by Blakstvedt, to include a base electrode, as taught by Gelfand, as such a modification would allow for changes in physiological paraments prior to and after ablation to be monitored to indicate the effectiveness of ablation.
Regarding claim 16, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt does not disclose a stimulation electrode for delivering a nerve stimulation signal.
Gelfand teaches a vascular catheter ([0187], [0188], & [0200]; Figure 7 –element 448) comprising a needle assembly for ablating tissue ([0196] & [0200]; Figures 6 & 7—element 441), the vascular catheter further comprising a stimulation electrode for delivering a nerve stimulation signal ([0189], [0190]; the vascular catheter may comprise an electrode positioned at a distal region which may provide electrical nerve stimulation).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the vascular catheter, as disclosed by Blakstvedt, to include a stimulation electrode for delivering a nerve stimulation signal, as taught by Gelfand, as both references and the claimed invention are directed toward vascular catheters comprising needle ablation assemblies. As disclosed by Blakstvedt, the vascular catheter comprises an electrode for ablating tissue ([0050]). As disclosed by Gelfand, the vascular catheter may comprise an electrode to provide electrical nerve stimulation, such that changes in physiological parameters prior to and after ablation can indicate the effectiveness of ablation ([0041], [00189], [0190]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the vascular catheter, as disclosed by Blakstvedt, to include a stimulation electrode for delivering a nerve stimulation signal, as taught by Gelfand, as such a modification would allow for changes in physiological paraments prior to and after ablation to be monitored to indicate the effectiveness of ablation.
Regarding claim 17, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt does not disclose a base electrode on an outer surface of the catheter.
Gelfand teaches a vascular catheter ([0187], [0188], & [0200]; Figure 7 –element 448) comprising a needle assembly for ablating tissue ([0196] & [0200]; Figures 6 & 7—element 441), the vascular catheter further comprising a base electrode on an outer surface of the catheter ([0189], [0190]; the vascular catheter may comprise an electrode positioned at a distal region which may provide electrical nerve stimulation).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the vascular catheter, as disclosed by Blakstvedt, to include a base electrode, as taught by Gelfand, as both references and the claimed invention are directed toward vascular catheters comprising needle ablation assemblies. As disclosed by Blakstvedt, the vascular catheter comprises an electrode for ablating tissue ([0050]). As disclosed by Gelfand, the vascular catheter may comprise an electrode on the distal end to provide electrical nerve stimulation, such that changes in physiological parameters prior to and after ablation can indicate the effectiveness of ablation ([0041], [00189], [0190]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the vascular catheter, as disclosed by Blakstvedt, to include a base electrode, as taught by Gelfand, as such a modification would allow for changes in physiological paraments prior to and after ablation to be monitored to indicate the effectiveness of ablation.
Claims 9 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Blakstvedt in view of Fischell and Edwards et al. (previously presented-US 5558673 A), hereinafter “Edwards”.
Regarding claim 9, Blakstvedt in view of Fischell disclose all of the limitations of claim 1, as described above.
Blakstvedt further discloses wherein the one or more electrodes comprises a first electrode, and wherein the vascular catheter is configured to provide a first ablation energy to the first electrode ([0040] & [0044]).
Blakstvedt does not disclose wherein the one or more electrodes comprises a second electrode, and wherein the vascular catheter is configured to provide a second ablation energy to the second electrode, wherein the first ablation energy and the second ablation energy are independent of one another.
Edwards teaches a needle assembly configured to ablate tissue ([Col. 4, lines 56-65] & [Col. 7, line 66 – Col. 8, line 22]; Figure 4, & 10-12—element 34) and comprising one or more electrodes thereon ([Col. 7, line 66 – Col. 8, line 22]; Figures 10-12—element 96), wherein the one or more electrodes comprises a first electrode and wherein the vascular catheter is configured to provide a first ablation energy to the first electrode ([Col. 7, line 66 – Col. 8, line 22]; Figure 10—elements 96) and wherein the one or more electrodes comprise a second electrode ([Col. 7, line 66 – Col. 8, line 22]; Figure 10—elements 96), and wherein the vascular catheter is configured to provide a second ablation energy to the second electrode, wherein the first ablation energy and the second ablation energy are independent of one another ([Col. 7, line 66 – Col. 8, line 22]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode, as disclosed by Blakstvedt, to further include a second electrode that is configured to receive a second ablation energy independent of the first ablation energy, as taught by Edwards, as both references and the claimed invention are directed toward needle assemblies for puncturing and ablating tissue. As disclosed by Edwards, the needle may comprise multiple electrodes that are independently connected to the power supply, such that each electrode may be energized independent of any other electrode which allows for less energy to be applied to each electrode for a longer period of time and allows for more total energy to be applied to target tissue ([Col. 7, line 66 – Col. 8, line 22]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first electrode, as disclosed by Blakstvedt, to further include a second electrode that is configured to receive a second ablation energy independent of the first ablation energy, as taught by Edwards, as such a modification would provide for an electrode configuration that allows: electrodes to be energized independent of any other electrode, less energy to be applied to each electrode for a longer period of time, and more total energy to be applied to target tissue.
Regarding claim 18, Blakstvedt in view of Fischell disclose all of the limitations of claim 11, as described above.
Blakstvedt further discloses wherein the one or more electrodes comprises a first electrode, and wherein the vascular catheter is configured to provide a first ablation energy to the first electrode ([0040] & [0044]).
Blakstvedt does not disclose wherein the one or more electrodes comprises a second electrode, and wherein the vascular catheter is configured to provide a second ablation energy to the second electrode, wherein the first ablation energy and the second ablation energy are independent of one another.
Edwards teaches a needle assembly configured to ablate tissue ([Col. 4, lines 56-65] & [Col. 7, line 66 – Col. 8, line 22]; Figure 4, & 10-12—element 34) and comprising one or more electrodes thereon ([Col. 7, line 66 – Col. 8, line 22]; Figures 10-12—element 96), wherein the one or more electrodes comprises a first electrode and wherein the vascular catheter is configured to provide a first ablation energy to the first electrode ([Col. 7, line 66 – Col. 8, line 22]; Figure 10—elements 96) and wherein the one or more electrodes comprise a second electrode ([Col. 7, line 66 – Col. 8, line 22]; Figure 10—elements 96), and wherein the vascular catheter is configured to provide a second ablation energy to the second electrode, wherein the first ablation energy and the second ablation energy are independent of one another ([Col. 7, line 66 – Col. 8, line 22]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode, as disclosed by Blakstvedt, to further include a second electrode that is configured to receive a second ablation energy independent of the first ablation energy, as taught by Edwards, as both references and the claimed invention are directed toward needle assemblies for puncturing and ablating tissue. As disclosed by Edwards, the needle may comprise multiple electrodes that are independently connected to the power supply, such that each electrode may be energized independent of any other electrode which allows for less energy to be applied to each electrode for a longer period of time and allows for more total energy to be applied to target tissue ([Col. 7, line 66 – Col. 8, line 22]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first electrode, as disclosed by Blakstvedt, to further include a second electrode that is configured to receive a second ablation energy independent of the first ablation energy, as taught by Edwards, as such a modification would provide for an electrode configuration that allows: electrodes to be energized independent of any other electrode, less energy to be applied to each electrode for a longer period of time, and more total energy to be applied to target tissue.
Conclusion
Accordingly, claims 1-2, 4-6, 8-12, 14-23 are rejected.
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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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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