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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 23rd, 2026, has been entered.
Response to Amendment
The amendment filed January 23rd, 2026, has been entered. Claims 1, 10-12, & 20-23 are amended. Claims 3, 7, & 13 are canceled. Claims 1-2, 4-6, 8-12, & 14-23 remain pending; claims 20 & 23 are withdrawn from further consideration
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-6, 8-12, 14-19, & 21-22 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
Applicant's election with traverse of the invention originally claimed (apparatus claims 1-2, 4-6, 8-12, 14-19, & 21-22) in the reply filed on January 23rd, 2026, is acknowledged. The traversal is on the ground(s) that “the justification for the restriction stated in the office action does not asset that examining claims 20 & 23 with the other claims in this application would be a serious burden on examination. A restriction requirement is justified only if the claims in an application would raise a serious burden on examination. It is not sufficient that the claims in an application are directed to independent or distinct inventions”. This is not found persuasive because the invention of the newly submitted method claims 20 & 23 and the invention of the original apparatus claims 1-2, 4-6, 8-12, 14-19, & 21-22 are related as process and apparatus for its practice, the apparatus 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 or other tissue wall; and the process as claimed can be practiced by another and materially different apparatus, such as a catheter that does not contain a guidewire and a guidewire lumen and does not contain an exit port in a radially outer surface of the catheter shaft, e.g. an apparatus where the telescopic needle assembly extends along the same axis as the catheter shaft entirely. Further, the invention of the original apparatus claims 1-2, 4-6, 8-12, 14-19, & 21-22 is classified in A61B18/1477, while the newly submitted method claims 20 & 23 are classified in A61B 5/4836 and restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the disclosed inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search quarries); and/or the prior art applicable to one invention would not likely be applicable to the other invention.
The requirement is still deemed proper and is therefore made FINAL; accordingly, claims 20 & 23 are withdrawn.
Claim Objections
Claim 12 is objected to because of the following informalities: “the needle” 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 11-12, 14-19, & 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites the limitation “the hollow needle protrudes from the sharp distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position”. The specification describes the hollow needle guide 101 and the distal end of the hollow needle guide 103 in paragraph [0243], this paragraph explicitly states “the device 100 further includes a needle guide 101, which has a distal end 103 (also referred to herein as a “needle guide distal end”) that is blunt”; therefore the claim contains subject matter of “the sharp distal end of the hollow needle guide” that is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Dependent claims 12, 14-19, & 22 are rejected by virtue of their dependency on independent claim 11.
Claim 21 recites the limitation “wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm” The specification describes the third section/hollow needle guide 101 and the distal end of the third section/hollow needle guide 103 in paragraph [0243], this paragraph explicitly states “the device 100 further includes a needle guide 101, which has a distal end 103 (also referred to herein as a “needle guide distal end”) that is blunt”; therefore the claim contains subject matter of “the sharp distal end of the third section” that is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 11-12, 14-19, & 21-22 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 11 recites the limitation “the hollow needle protrudes from the sharp distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position”; there is insufficient antecedent basis for the limitation “the sharp distal end of the hollow needle guide” in the claim; claim 11 introduces wherein the hollow needle includes a sharp distal end, however, claim 11 does not introduce the hollow needle guide also including a sharp distal end, and further it is unclear if the hollow needle guide includes a sharp distal end or if only the hollow needle includes a sharp distal end (see above 112(a) rejection of claim 11). The examiner further notes that claim 11 additionally recites “advancing the hollow needle from a distal end of the hollow needle guide and puncturing”; it is unclear if the “a distal end of the hollow needle guide” is the same or different that the “sharp distal end of the hollow needle guide”, as introduced in claim 11, which renders the claim indefinite. For examination purposes, the examiner is considering the sharp distal end of the hollow needle to protrude from a distal end of the hollow needle guide. Claims 12, 14-19, & 22 are rejected by virtue of their dependency on independent claim 11.
Claim 21 recites the limitation “wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm”; there is insufficient antecedent basis for the limitation “the sharp distal end of the third section” in the claim; claim 1 introduces the first section having a sharp distal end, however, claim 1 does not introduce the third section also including a sharp distal end, and further it is unclear if the third section includes a sharp distal end or if only the first section includes a sharp distal end (see above 112(a) rejection of claim 21), which renders the claim indefinite. For examination purposes, the examiner is considering the sharp distal end of the first section to protrude from the distal end of the 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, 5-6, 8, 10-12, 15-17, & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. (US 20160338724 A1), hereinafter “Sinelnikov”, in view of Abe et al. (US 6200313 B1), hereinafter “Abe”.
Regarding claim 1, Sinelnikov discloses a vascular catheter, comprising: a catheter shaft comprising an exit port in a radially outer surface of the catheter shaft ([0227] & [0228]; Figure 33—element 471; the examiner is considering the exit portion to be the opening shown in the radially outer surface of the catheter shaft 471 communicating with needle lumen 473), and a needle assembly lumen ([0227] & [0228]; Figure 33—element 473); a guidewire lumen ([0026], [0158], [0227], [0228], & [0230]; Figure 33 & 34A—element 489), and a telescopic needle assembly, where the telescopic needle assembly is the only telescopic needle assembly in the catheter shaft ([0227] & [0228]; Figures 32 & 33—elements 465 & 467), 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, the telescopic needle assembly is configured to puncture vascular tissue when transitioned to the second position ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the deployable needle 465 is configured to be deployed and advanced through a vessel wall, and a probe 467 may be advanced out of the distal end of the deployable needle 465 to pass through the target tissue; the examiner is considering the second position to be the deployed position, as shown in Figures 32 & 33), the telescopic needle assembly comprising: a first section, a second section co-axial to each other and protruding from the exit port while the telescopic needle assembly is in the second position ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the examiner is considering the first section to be the deployable needle 465 and the second section to be the probe 467); wherein the first section is hollow and has a sharp distal end configure to puncture a vein wall ([0227] & [0228]; Figures 32 & 33—elements 465 & 466); wherein the first section has a distal portion which extends through the exit port when transitioning from the first position to the second position ([0227] & [0228]; Figures 32 & 33—elements 465 & 466; the examiner is considering the distal section to be the distal portion of the deployable needle 465 including sharp tip 466 that is configured to be deployed out of lumen/exit port 473); wherein the second section moves from within the first section to protruding from the sharp distal end of the first section as the telescopic needle assembly advances to the second position ([0227] & [0228]; Figures 32 & 33—element 467; the second section/probe 467 is configured to be advanced out of the distal end 466 of the first section 465), wherein the second section comprises one or more electrodes ([0227] & [0228]; Figures 32 & 33—element 468; the second section 467 may comprise an RF electrode 468), 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 ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the deployable needle 465 is configured to be deployed and advanced through a vessel wall, and a probe 467 may be advanced out of the distal end of the deployable needle 465 to pass through the target tissue; the examiner is considering the second position to be the deployed position, as shown in Figures 32 & 33), and wherein the second section comprises a distal end with a blunt tip ([0227] & [0228]; Figures 32 & 33—element 467; the second section 467 is a blunt tipped probe).
Sinelnikov 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 hollow guide that receives the first section and the first selection slides relative to the third section as the telescopic needle assembly moves from the first position to the second position; 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; wherein the third section exit the exit port as the telescopic needle assembly transitions from the first position to the second position.
Abe teaches a catheter comprising an exit port ([Col. 3, lines 12-24] & [Col. 3, lines 43-56]; Figures 1 & 3—elements 2 & 11) and a telescopic needle assembly configured to transition from a first position to a second position ([Col. 7, lines 30-63]; Figure 11—element 80); the telescopic needle assembly comprising: a first section that is hollow and has a sharp distal end configure to puncture a wall and a second section comprising one or more electrodes, the first section and the second section protruding from the exit port while the telescopic needle assembly is in the second position ([Col. 7, lines 30-63]; Figure 11—elements 82 & 84); the telescopic needle assembly comprising a third section co-axial to the first section and second section and protruding from the exit port while the telescopic needle assembly is in the second position; wherein the third section is a hollow guide that receives the first section and the first selection slides relative to the third section as the telescopic needle assembly moves from the first position to the second position; 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; wherein the third section exits the exit port as the telescopic needle assembly transitions from the first position to the second position ([Col. 7, lines 30-63]; Figure 11—element 81).
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 Sinelnikov, to include the third section co-axial to the first section and second section and protruding from the exit port while the telescopic needle assembly is in the second position, as taught by Abe, as both references and the claimed invention are directed toward electrosurgical devices comprising telescopic needles for accessing and treating a target tissue area. As disclosed by Sinelnikov, the telescopic needle assembly can include a deployable puncture needle and a high-frequency treatment device, such that upon actuation of the telescopic needle the deployable needle is advanced from within the catheter and is punctures through a target tissue wall and the high-frequency treatment device is advanced out of the needle to deliver treatment to the target tissue ([0227] & [0228]). As disclosed by Abe, the telescopic needle assembly can include a guide tube, a puncture needle, and a high-frequency treatment device, the telescopic needle assembly may be held in a retracted position within the catheter and upon actuation of the telescopic needle the guide tube may be advanced out of the catheter so as to abut against the target tissue wall, the puncture needle may be advanced out of the guide tube to penetrate through the target tissue wall to a depth where high-frequency treatment is needed, and the high-frequency treatment device may be protruded out of the puncture needle to deliver high-frequency energy to the target tissue, the telescopic needle configuration permits carrying out high-frequency treatment in the target tissue region in a safe and secure manner ([Col. 5, lines 15-37], [Col. 7, lines 30-64], & [Col. 8, lines 24-36]). 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 Sinelnikov, to include the third section co-axial to the first section and second section and protruding from the exit port while the telescopic needle assembly is in the second position, as taught by Abe, as such a modification would aid in guiding the needle and the high-frequency treatment device to and through the target tissue wall and further would permit carrying out high-frequency treatment in the target tissue region in a safe and secure manner.
Regarding claim 2, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov further discloses a telescoping relationship with the first section and the second section ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the first section/needle 465 is configured to be deployed and advanced through a vessel wall, and the second section/probe 467 may be advanced out of the distal end of the first section/needle 465 to pass through the target tissue).
Sinelnikov does not disclose the third section is in a telescoping relationship with the first section and the second section.
Abe further teaches the third section is in a telescoping relationship with the first section and the second section ([Col. 7, lines 30-63]; Figure 11—element 81).
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 including the first section and the second section, as disclosed by Sinelnikov, to include the third section is in a telescoping relationship with the first section and the second section, as further taught by Abe, as both references and the claimed invention are directed toward electrosurgical devices comprising telescopic needles for accessing and treating a target tissue area. As disclosed by Sinelnikov, the telescopic needle assembly can include a deployable puncture needle and a high-frequency treatment device, such that upon actuation of the telescopic needle the deployable needle is advanced from within the catheter and is punctures through a target tissue wall and the high-frequency treatment device is advanced out of the needle to deliver treatment to the target tissue ([0227] & [0228]). As disclosed by Abe, the telescopic needle assembly can include a guide tube, a puncture needle member, and a high-frequency treatment device, the telescopic needle assembly may be held in a retracted position within the catheter and upon actuation of the telescopic needle the guide tube may be advanced out of the catheter so as to abut against the target tissue wall, the puncture needle may be advanced out of the guide tube to penetrate through the target tissue wall to a depth where high-frequency treatment is needed, and the high-frequency treatment device may be protruded out of the puncture needle to deliver high-frequency energy to the target tissue, the telescopic needle configuration permits carrying out high-frequency treatment in the target tissue region in a safe and secure manner ([Col. 5, lines 15-37], [Col. 7, lines 30-64], & [Col. 8, lines 24-36]). 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 including the first section and the second section, as disclosed by Sinelnikov, to include the third section is in a telescoping relationship with the first section and the second section, as further taught by Abe, as such a modification would aid in guiding the needle and the high-frequency treatment device to and through the target tissue wall and further would permit carrying out high-frequency treatment in the target tissue region in a safe and secure manner.
Regarding claim 5, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov further discloses a marker configured to indicate radial orientation ([0193], [0227], & [0228]; a fiducial marker may be positioned on the catheter to interact with the imaging ultrasound waves to provide a distinguishable aiming artifact that identifies a relative position to the direction of delivery of ablation energy).
Regarding claim 6, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov further discloses a stimulation electrode for delivering a nerve stimulation signal ([0164]; the catheter may comprise one or more stimulation electrodes to assess proximity to a nerve).
Regarding claim 8, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov further discloses a base electrode on an outer surface of the catheter ([0164] & [0228]; Figure 33—element 471; the catheter may comprise one or more stimulation electrodes to assess proximity to a nerve).
Regarding claim 10, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov further discloses an electrode advancer configured to extend the telescopic needle assembly and the one or more electrodes through the exit port ([0139] & [0227]; Figure 12G—element 544; the examiner is considering the handle 544 to be the electrode advancer, as the handle may facilitate the manipulations of the ablation catheter).
Regarding claim 11, as best understood in view of the 112(a) & 112(b) rejections above, Sinelnikov discloses a vascular catheter, comprising: a catheter shaft comprising an exit port in a radially outer surface of the catheter shaft ([0227] & [0228]; Figure 33—element 471; the examiner is considering the exit portion to be the opening shown in the radially outer surface of the catheter shaft 471 communicating with needle lumen 473), and a needle assembly lumen having an opening at the exit port ([0227] & [0228]; Figure 33—element 473); a guidewire lumen ([0026], [0158], [0227], [0228], & [0230]; Figure 33 & 34A—element 489), and a telescopic needle assembly configured to advance from a first position within the needle assembly lumen of the catheter shaft to a second position and a second position in which the telescopic needle assembly protrudes from the exit port into a vein in which the telescopic needle assembly is positioned ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the deployable needle 465 is configured to be deployed and advanced through a vessel wall, and a probe 467 may be advanced out of the distal end of the deployable needle 465 to pass through the target tissue; the examiner is considering the second position to be the deployed position, as shown in Figures 32 & 33), wherein the telescopic needle assembly includes: a hollow needle; and a delivery device within the hollow needle and coaxial to the hollow needle ([0227] & [0228]; Figures 32 & 33—elements 465 & 467; the examiner is considering the hollow needle to be the deployable needle 465 and the delivery device to be the probe 467), 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 ([0227] & [0228]; Figures 32 & 33—element 466); 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 delivery device are sheathed ([0227] & [0228]; the examiner is considering the hollow needle and delivery device to be sheathed when they are undeployed), advancing the hollow needle and puncturing, with the sharp distal end, a wall of the vein within which the telescopic needle assembly is positioned ([0227] & [0228]; Figures 32 & 33—element 465 & 466; the hollow needle 465 is advanced and has a sharp tip 466 that is configured to advance through a vessel wall), and advancing the delivery device from within the hollow needle, beyond the sharp distal end and into tissue surrounding the vein, wherein the delivery device includes a blunt tip at a distal end of the delivery device ([0227] & [0228]; Figures 32 & 33—element 467; the delivery device 467 is advanced out of the hollow needle 465; the delivery device 467 is a blunt tipped probe), and wherein one or more electrodes are carried by the delivery device ([0227] & [0228]; Figures 32 & 33—element 468; the second section 467 may comprise an RF electrode 468).
Sinelnikov 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 and the delivery device are fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from the sharp 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 delivery device are sheathed within the hollow needle guide, advancing the hollow needle from a distal end of the hollow needle guide.
Abe teaches a catheter comprising an exit port ([Col. 3, lines 12-24] & [Col. 3, lines 43-56]; Figures 1 & 3—elements 2 & 11) and a telescopic needle assembly configured to transition from a first position to a second position ([Col. 7, lines 30-63]; Figure 11—element 80); the telescopic needle assembly comprising: a hollow needle and a delivery device comprising one or more electrodes ([Col. 7, lines 30-63]; Figure 11—elements 82 & 84); the telescopic needle assembly includes: a hollow needle guide; the hollow needle within and coaxial to the hollow needle guide; wherein the hollow needle and the delivery device are fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from the sharp 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 delivery device are sheathed within the hollow needle guide, advancing the hollow needle from a distal end of the hollow needle guide ([Col. 7, lines 30-63]; Figure 11—element 81).
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 including the hollow needle and delivery device, as disclosed by Sinelnikov, to include a hollow needle guide; the hollow needle within and coaxial to the hollow needle guide; wherein the hollow needle and the delivery device are fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from the sharp distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position, as taught by Abe, as both references and the claimed invention are directed toward electrosurgical devices comprising telescopic needles for accessing and treating a target tissue area. As disclosed by Sinelnikov, the telescopic needle assembly can include a deployable puncture needle and a high-frequency treatment device, such that upon actuation of the telescopic needle the deployable needle is advanced from within the catheter and is punctures through a target tissue wall and the high-frequency treatment device is advanced out of the needle to deliver treatment to the target tissue ([0227] & [0228]). As disclosed by Abe, the telescopic needle assembly can include a hollow needle guide tube, a puncture needle, and a high-frequency treatment device, the telescopic needle assembly may be held in a retracted position within the catheter and upon actuation of the telescopic needle the hollow guide tube may be advanced out of the catheter so as to abut against the target tissue wall, the puncture needle may be advanced out of the hollow guide tube to penetrate through the target tissue wall to a depth where high-frequency treatment is needed, and the high-frequency treatment device may be protruded out of the puncture needle to deliver high-frequency energy to the target tissue, the telescopic needle configuration permits carrying out high-frequency treatment in the target tissue region in a safe and secure manner ([Col. 5, lines 15-37], [Col. 7, lines 30-64], & [Col. 8, lines 24-36]). 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 including the hollow needle and delivery device, as disclosed by Sinelnikov, to include a hollow needle guide; the hollow needle within and coaxial to the hollow needle guide; wherein the hollow needle and the delivery device are fully within the hollow needle guide while the telescopic needle assembly is in the first position and the hollow needle protrudes from the sharp distal end of the hollow needle guide while the telescopic needle assembly is in or advances to the second position, as taught by Abe, as such a modification would aid in guiding the needle and the high-frequency treatment device to and through the target tissue wall and further would permit carrying out high-frequency treatment in the target tissue region in a safe and secure manner.
Regarding claim 12, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov does not disclose wherein the hollow needle guide surrounds the hollow needle, and the needle extends outward from the hollow needle guide.
Abe further teaches wherein the hollow needle guide surrounds the hollow needle, and the needle extends outward from the hollow needle guide ([Col. 7, lines 30-63]; Figure 11—elements 81 & 82).
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 including the hollow needle and delivery device, as disclosed by Sinelnikov, to include the hollow needle guide, wherein the hollow needle guide surrounds the hollow needle, and the needle extends outward from the hollow needle guide, as further taught by Abe, as both references and the claimed invention are directed toward electrosurgical devices comprising telescopic needles for accessing and treating a target tissue area. As disclosed by Sinelnikov, the telescopic needle assembly can include a deployable puncture needle and a high-frequency treatment device, such that upon actuation of the telescopic needle the deployable needle is advanced from within the catheter and is punctures through a target tissue wall and the high-frequency treatment device is advanced out of the needle to deliver treatment to the target tissue ([0227] & [0228]). As disclosed by Abe, the telescopic needle assembly can include a hollow needle guide tube, a puncture needle, and a high-frequency treatment device, the telescopic needle assembly may be held in a retracted position within the catheter and upon actuation of the telescopic needle the hollow guide tube may be advanced out of the catheter so as to abut against the target tissue wall, the puncture needle may be advanced out of the hollow guide tube to penetrate through the target tissue wall to a depth where high-frequency treatment is needed, and the high-frequency treatment device may be protruded out of the puncture needle to deliver high-frequency energy to the target tissue, the telescopic needle configuration permits carrying out high-frequency treatment in the target tissue region in a safe and secure manner ([Col. 5, lines 15-37], [Col. 7, lines 30-64], & [Col. 8, lines 24-36]). 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 including the hollow needle and delivery device, as disclosed by Sinelnikov, to include the hollow needle guide, wherein the hollow needle guide surrounds the hollow needle, and the needle extends outward from the hollow needle guide, as further taught by Abe,, as such a modification would aid in guiding the needle and the high-frequency treatment device to and through the target tissue wall and further would permit carrying out high-frequency treatment in the target tissue region in a safe and secure manner.
Regarding claim 15, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov further discloses a marker configured to indicate radial orientation ([0193], [0227], & [0228]; a fiducial marker may be positioned on the catheter to interact with the imaging ultrasound waves to provide a distinguishable aiming artifact that identifies a relative position to the direction of delivery of ablation energy).
Regarding claim 16, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov further discloses a stimulation electrode for delivering a nerve stimulation signal ([0164]; the catheter may comprise one or more stimulation electrodes to assess proximity to a nerve).
Regarding claim 17, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov further discloses a base electrode on an outer surface of the catheter ([0164] & [0228]; Figure 33—element 471; the catheter may comprise one or more stimulation electrodes to assess proximity to a nerve).
Regarding claim 19, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov further discloses an electrode advancer configured to extend the telescopic needle assembly and the one or more electrodes through the exit port ([0139] & [0227]; Figure 12G—element 544; the examiner is considering the handle 544 to be the electrode advancer, as the handle may facilitate the manipulations of the ablation catheter).
Claims 4, 9, 14, & 18 rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov in view of Abe and Edwards et al. (previously presented-US 5558673 A), hereinafter “Edwards”.
Regarding claim 4, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov does not disclose wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode.
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) 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 comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode ([Col. 8, lines 22-30]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the one or more electrodes, as disclosed by Sinelnikov, to include wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode, as taught by Edwards, as both references and the claimed invention are directed toward needle assemblies for puncturing and ablating tissue comprising one or more electrodes. As disclosed by Sinelnikov, the one or more electrodes may comprise an RF electrode for ablating tissue ([0227]). As disclosed by Edwards, the one or more electrodes may comprise a single electrode configured to be operated in a monopolar fashion for delivering a precise amount of RF energy to a small amount of target tissue or alternatively the one or more electrodes may comprise multiple electrodes that are configured to be energized in a bipolar fashion which allows for quicker treatment of a large target tissue area ([Col. 8, lines 22-46]). 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 one or more electrodes, as disclosed by Sinelnikov, to include wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode, as taught by Edwards, as providing a bipolar electrode configuration would allow for quicker treatment of a large target tissue area.
Regarding claim 9, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov 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 ([0227]).
Sinelnikov 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) 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 comprises 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 one or more electrodes comprising a first electrode, as disclosed by Sinelnikov, to further include the one or more electrodes comprising 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 one or more electrodes comprising a first electrode, as disclosed by Sinelnikov, to further include the one or more electrodes comprising 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 14, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov does not disclose wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode.
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) 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 comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode ([Col. 8, lines 22-30]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the one or more electrodes, as disclosed by Sinelnikov, to include wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode, as taught by Edwards, as both references and the claimed invention are directed toward needle assemblies for puncturing and ablating tissue comprising one or more electrodes. As disclosed by Sinelnikov, the one or more electrodes may comprise an RF electrode for ablating tissue ([0227]). As disclosed by Edwards, the one or more electrodes may comprise a single electrode configured to be operated in a monopolar fashion for delivering a precise amount of RF energy to a small amount of target tissue or alternatively the one or more electrodes may comprise multiple electrodes that are configured to be energized in a bipolar fashion which allows for quicker treatment of a large target tissue area ([Col. 8, lines 22-46]). 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 one or more electrodes, as disclosed by Sinelnikov, to include wherein the one or more electrodes comprise a first electrode and a second electrode positioned and adapted to be operated in a bipolar mode, as taught by Edwards, as providing a bipolar electrode configuration would allow for quicker treatment of a large target tissue area.
Regarding claim 18, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov 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 ([0227]).
Sinelnikov 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 is independent of the second ablation energy.
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) 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 comprises 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 one or more electrodes comprising a first electrode, as disclosed by Sinelnikov, to further include the one or more electrodes comprising 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 one or more electrodes comprising a first electrode, as disclosed by Sinelnikov, to further include the one or more electrodes comprising 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.
Claims 21 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov in view of Abe and Fischell et al. (previously presented-US 20160242661 A1), hereinafter “Fischell”.
Regarding claim 21, as best understood in view of the 112(a) & 112(b) rejections above, Sinelnikov in view of Abe disclose all of the limitations of claim 1, as described above.
Sinelnikov in view of Abe do not disclose wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm.
Fischell teaches an ablation catheter comprising a telescopic needle assembly comprising a third section that acts as a guide ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30) and a first section that comprises a sharp distal end ([0176]-[0178]; Figures 1 & 3—element 20), wherein the first section protrudes from the sharp distal end of the third section 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 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 6 mm; it is the examiners position that the first section can protrude from the distal end of the third section by exactly 2 mm, as 2 mm is within the range of 2 to 6 mm).
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 section protruding from the third section, as disclosed by Sinelnikov in view of Abe, to include wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm, as taught by Fischell, as all references and the claimed invention are directed toward ablation 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 and a third section for supporting and guiding 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 first section protruding from the third section, as disclosed by Sinelnikov in view of Abe, to include wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm, as taught by Fischell, as such a modification would provide for a penetration depth that aids in preventing injury to non-target tissue. The examiner further notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the first section protrudes from the sharp distal end of the third section by no more than 2 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 22, Sinelnikov in view of Abe disclose all of the limitations of claim 11, as described above.
Sinelnikov in view of Abe do not disclose wherein the hollow needle protrudes from the distal end of the hollow needle guide by no more than 2 mm.
Fischell teaches an ablation catheter comprising a telescopic needle assembly comprising a hollow needle guide ([0176], [0179], [0186], & [0200]; Figures 1 & 3—element 30) and a needle comprising sharp distal end ([0176]-[0178]; Figures 1 & 3—element 20), 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 needle guide 30 to the distal end of the needle 20 may be adjusted or limited; the needle 20 may penetrate to a preset distance between 2 to 6 mm; it is the examiners position that the needle can protrude from the distal end of the needle guide by exactly 2 mm, as 2 mm is within the range of 2 to 6 mm).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the hollow needle protruding from the hollow needle guide, as disclosed by Sinelnikov in view of Abe, to include wherein the hollow needle protrudes from the distal end of the hollow needle guide by no more than 2 mm, as taught by Fischell, as all references and the claimed invention are directed toward ablation catheters comprising telescopic needle assemblies. As disclosed by Fischell, the telescopic needle assembly includes a needle that is configured to penetrate tissue to reach a target site for positioning an electrode tip and a hollow needle guide for supporting and guiding the needle; the penetration depth of the needle may typically be between 2 and 6 mm 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 hollow needle protruding from the hollow needle guide, as disclosed by Sinelnikov in view of Abe, to include wherein the hollow needle protrudes from the distal end of the hollow needle guide by no more than 2 mm, as taught by Fischell, as such a modification would provide for a penetration depth that aids in preventing injury to non-target tissue. The examiner further notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the hollow needle protrudes from the distal end of the hollow needle guide by no more than 2 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Accordingly, claims 1-2, 4-6, 8-12, 14-19, & 21-22 are rejected; claims 20 & 23 are withdrawn from further consideration.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
