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 November 19th, 2025 has been entered. Claims 1, 5, 7, & 19 are amended. Claims 1-23 remain pending; claims 9-18 & 22 are withdrawn from further consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-8, 19-21, & 23 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6, 8, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Razavi (US 20110306970 A1), hereinafter “Razavi”.
Regarding claim 1, Razavi discloses a cryoablation probe assembly comprising: a handle ([0019]; Figure 2—element 15; the examiner is considering the proximal end 15 of the catheter 9 to be the handle); a cryoablation probe supported by the handle ([0018]; Figures 1B-3—element 9; the catheter 9 may be a cryoablation catheter); a sheath coaxially positioned around the cryoablation probe ([0017], [0037], & [0043]; Figures 1A-3—element 7; Figure 4—element 407), the sheath having a body defining a distal face ([0017] & [0037]; Figures 1A, 2, & 7—element 4; Figure 4—element 404 the distal face being the distal end 4/404 of the sheath 7/407), a central lumen ([0017] & [0037]; Figures 4—element 401) and a plurality of channel extending from the distal face and through the body of the sheath, each of the plurality of channels including an opening at the distal face ([0017], [0018], [0022], [0037], & [0038]; Figure 4—elements 402 & 403; each channel may have an opening at the distal end of the sheath); and a fluid port in communication with the plurality of channels of the sheath, the fluid port configured to direct a fluid along the plurality of channels to the opening of each of the plurality of channels ([0038] & [0043]; the channels may may be attached proximally to a system for the delivery and control of irrigation distally; the examiner is considering the proximal attachment of the channels to be the fluid port), wherein the plurality of channels delivers the fluid, via the opening of each of the plurality of channels ([0018], [0019], [0021], & [0038]; the channels may be used for suction and/or irrigation), to a plurality of positions along the cryoablation probe ([0022], [0025], & [0030]; Figures 1A-3—elements 7 & 9; the catheter/cryoablation probe 9 is configured to be introduced/deployed within the lumen of the sheath 7, as the catheter/cryoablation probe 9 is movable/insertable within the sheath 7 it is the examiners position that the plurality of channels would be capable of delivering fluid to a plurality of positions along the cryoablation probe).
Regarding claim 3, Razavi discloses all of the limitations of claim 1, as described above.
Razavi further discloses wherein the plurality of channels collectively span 360 degrees of the distal face ([0037] & [0038]; Figure 4—elements 402, 403, & 404).
Regarding claim 4, Razavi discloses all of the limitations of claim 1, as described above.
Razavi further discloses a fluid source connected to the fluid port ([0019], [0038], & [0041]; the proximal end of the channels are coupled to a system for the delivery and control of irrigation (e.g. a pump or a syringe)).
Regarding claim 5, Razavi discloses all of the limitations of claim 1, as described above.
Razavi further wherein the opening of each of the plurality of channels at the distal face are equally spaced ([0037] & [0038]; Figure 4—elements 402, 403, & 404; the opening of the plurality of channels 402 & 404 at the distal face are portrayed as being equally spaced).
Regarding claim 6, Razavi discloses all of the limitations of claim 1, as described above.
Razavi further wherein the sheath is configured to slide with respect to the cryoablation probe ([0022] & [0025]; Figures 1A-3—elements 7 & 9; the catheter/cryoablation probe 9 is configured to be introduced/deployed within the lumen of the sheath 7).
Regarding claim 8, Razavi discloses all of the limitations of claim 1, as described above.
Razavi further disclose wherein the fluid port is in fluid communication with the central lumen ([0023], [0037], [0038], & [0043]; the central lumen that receives the catheter/cryoablation probe may also be irrigated and/or suctioned).
Regarding claim 19, Razavi discloses a cryoablation probe assembly comprising: a handle ([0019]; Figure 2—element 15; the examiner is considering the proximal end 15 of the catheter 9 to be the handle); a cryoablation probe supported by the handle ([0018]; Figures 1B-3—element 9; the catheter 9 may be a cryoablation catheter); a sheath coaxially positioned around the cryoablation probe ([0017], [0037], & [0043]; Figures 1A-3—element 7; Figure 4—element 407), the sheath having a body defining a distal face ([0017] & [0037]; Figures 1A, 2, & 7—element 4; Figure 4—element 404 the distal face being the distal end 4/404 of the sheath 7/407), a central lumen ([0017] & [0037]; Figures 4—element 401) and a plurality of channels extending from the distal face and through the body of the sheath, each of the plurality of channels including an opening at the distal face ([0017], [0018], [0022], [0037], & [0038]; Figure 4—elements 402 & 403; each channel may have an opening at the distal end of the sheath); wherein the sheath is configured to slide with respect to the cryoablation probe ([0022], [0025], & [0030]; Figures 1A-2—elements 7 & 9; the catheter/cryoablation probe 9 is configured to be introduced/deployed within the lumen of the sheath 7); a fluid port in communication with the plurality of channels of the sheath, the fluid port configured to direct a fluid along the plurality of channels to the opening of each of the plurality of channels ([0038]; the channels may may be attached proximally to a system for the delivery and control of irrigation distally; the examiner is considering the proximal attachment of the channels to be the fluid port); and a fluid source connected to the fluid port ([0019], [0038], & [0041]; the proximal end of the channels are coupled to a system for the delivery and control of irrigation (e.g. a pump or a syringe)) and in fluid communication with the central lumen ([0023], [0037], [0038], & [0043]; the central lumen that receives the catheter/cryoablation probe may also be irrigated and/or suctioned), wherein the sheath slides with respect to the cryoablation probe such that the plurality of channels deliver the fluid, via the opening of each of the plurality of channels, to a plurality of positions along the cryoablation probe ([0022], [0025], & [0030]; Figures 1A-3—elements 7 & 9; the catheter/cryoablation probe 9 is configured to be introduced/deployed within the lumen of the sheath 7, as the catheter/cryoablation probe 9 is movable/insertable within the sheath 7 it is the examiners position that the plurality of channels would be capable of delivering fluid to a plurality of positions along the cryoablation probe).
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 2 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Razavi in view of Coen et al. (US 20020198520 A1), hereinafter “Coen”.
Regarding claim 2, Razavi discloses all of the limitations of claim 1, as described above.
Razavi does not disclose wherein the plurality of channels includes at least four channels.
Coen teaches an ablation assembly comprising an ablation probe ([0028]; Figures 1-3—element 80), a sheath coaxially positioned around the ablation probe ([0028]; Figures 1-3—element 20) and comprising a central lumen ([0028] & [0039]; Figures 6A-6C—element 95) and a plurality of channels configured to deliver fluid via opening at a distal face of the sheath ([0039]; Figures 6A-6C—element 140 & 142), wherein the plurality of channels includes at least four channels ([0039]; Figures 6A-6C—elements 140 & 142; Figures 6B portrays 6 fluid channels 140/142).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of channels, as disclosed by Razavi, to include wherein the plurality of channels includes at least four channels, as taught by Coen, as both references and the claimed invention are directed toward irrigation sheaths comprising a plurality of fluid channels. As disclosed by Razavi, the sheath may comprise one or more fluid channels, for example two fluid channels, to deliver irrigation distally over the catheter located within the sheath ([0002], [0036], [0037], [0038]). As disclosed by Coen, the sheath may comprise one or more fluid channels and exit ports in order to perfuse various fluids, including irrigation fluids, in a substantially distal direction over the catheter located within the sheath, for example the sheath may comprise six fluid channels and exit ports ([0009] & [0039]). 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 plurality of channels, as disclosed by Razavi, to include wherein the plurality of channels includes at least four channels, as taught by Coen, as such a modification would provide for a suitable and known number of fluid channels in an irrigation sheath that produces the predictable result of delivering irrigation fluids in a substantially distal direction over the catheter located within the sheath, and further the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the plurality of channels includes at least four channels, 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 20, Razavi discloses all of the limitations of claim 19, as described above.
Razavi does not disclose wherein the plurality of channels includes at least four channels.
Coen teaches an ablation assembly comprising an ablation probe ([0028]; Figures 1-3—element 80), a sheath coaxially positioned around the ablation probe ([0028]; Figures 1-3—element 20) and comprising a central lumen ([0028] & [0039]; Figures 6A-6C—element 95) and a plurality of channels configured to deliver fluid via opening at a distal face of the sheath ([0039]; Figures 6A-6C—element 140 & 142), wherein the plurality of channels includes at least four channels ([0039]; Figures 6A-6C—elements 140 & 142; Figures 6B portrays 6 fluid channels 140/142).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of channels, as disclosed by Razavi, to include wherein the plurality of channels includes at least four channels, as taught by Coen, as both references and the claimed invention are directed toward irrigation sheaths comprising a plurality of fluid channels. As disclosed by Razavi, the sheath may comprise one or more fluid channels, for example two fluid channels, to deliver irrigation distally over the catheter located within the sheath ([0002], [0036], [0037], [0038]). As disclosed by Coen, the sheath may comprise one or more fluid channels and exit ports in order to perfuse various fluids, including irrigation fluids, in a substantially distal direction over the catheter located within the sheath, for example the sheath may comprise six fluid channels and exit ports ([0009] & [0039]). 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 plurality of channels, as disclosed by Razavi, to include wherein the plurality of channels includes at least four channels, as taught by Coen, as such a modification would provide for a suitable and known number of fluid channels in an irrigation sheath that produces the predictable result of delivering irrigation fluids in a substantially distal direction over the catheter located within the sheath, and further the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the plurality of channels includes at least four channels, 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Razavi in view of Bales et al. (US 5312332 A), hereinafter “Bales”.
Regarding claim 7, Razavi discloses all of the limitations of claim 1, as described above.
Razavi does not disclose wherein the handle includes a first end and a second end and the sheath extends through both of the first end and the second end.
Bales discloses a surgical device comprising a handle ([Col. 7, lines 14-26]; Figures 1B & 6C—elements 102 & 114), a probe supported by the handle ([Col. 13, line 60 – Col. 14, line 29]; Figure 6C—element 689), and a sheath ([Col. 13, lines 16-50], [col. 13, lines 25-32]; Figure 1B & 6C—element 500/600/610), wherein the handle includes a first end and a second end and the sheath extends through both of the first end and the second end ([Col. 7, lines 14-26], [Col. 7, line 51 – Col. 8, line 6]; Figure 1B-2, & 6C—elements 102, 114, & 600/610; with the first end being the distal end of the handle 102/114 and the second end being the proximal end of the handle 102/114; sheath 600/610 is shown as extending through the first and second end of the handle 102/114)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the handle, as disclosed by Razavi, to include wherein the handle includes a first end and a second end and the sheath extends through both of the first end and the second end, as taught by Bales, as both references and the claimed invention are directed toward surgical devices comprising handles and coaxial sheaths. As disclosed by Bales, the sheath may be inserted into a slit valve at the proximal end of the handle and through the handle to the distal end of the device, the handle configuration allows for the insertion and removal of multiple different tools during a procedure ([Col. 4, line 36 – Col. 5, line 2] & [Col. 7, lines 25-35]). 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 handle, as disclosed by Razavi, to include wherein the handle includes a first end and a second end and the sheath extends through both of the first end and the second end, as taught by Bales, as such a modification would provide for a suitable and known handle configuration that allows for the insertion and removal of surgical devices therefrom.
Claims 21 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Razavi in view of Baust (US 20140275767 A1), hereinafter “Baust”.
Regarding claim 21, Razavi discloses all of the limitations of claim 1, as described above.
Razavi does not disclose an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath.
Baust discloses cryoablation probe ([0026]; Figures 2 & 3—element 102), a sheath comprising a central lumen and positioned coaxially about the cryoablation probe ([0026]; Figures 2 & 3—element 103), and an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath ([0028] & [0030]; Figures 2 & 3—element 112).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the sheath, as disclosed by Razavi, to include an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath, as taught by Baust, as both references and the claimed invention are directed to cryoablation devices comprising sheaths. As disclosed by Baust, the sheath may include heating elements that comprise electrically conductive wires integrated within the sheath in order to prevent freezing between the sheath and the tissue and reduce the damage to non-target tissue areas ([0030]). 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 sheath, as disclosed by Razavi, to include an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath, as taught by Baust, as such a modification would prevent freezing between the sheath and the tissue and reduce the damage to non-target tissue areas during cryoablation.
Regarding claim 23, Razavi discloses all of the limitations of claim 19, as described above.
Razavi does not disclose an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath.
Baust discloses cryoablation probe ([0026]; Figures 2 & 3—element 102), a sheath comprising a central lumen and positioned coaxially about the cryoablation probe ([0026]; Figures 2 & 3—element 103), and an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath ([0028] & [0030]; Figures 2 & 3—element 112).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the sheath, as disclosed by Razavi, to include an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath, as taught by Baust, as both references and the claimed invention are directed to cryoablation devices comprising sheaths. As disclosed by Baust, the sheath may include heating elements that comprise electrically conductive wires integrated within the sheath in order to prevent freezing between the sheath and the tissue and reduce the damage to non-target tissue areas ([0030]). 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 sheath, as disclosed by Razavi, to include an electrical heating element positioned within the sheath and around the central lumen, wherein the electrical heating element is configured to heat the sheath, as taught by Baust, as such a modification would prevent freezing between the sheath and the tissue and reduce the damage to non-target tissue areas during cryoablation.
Conclusion
Accordingly, claims 1-8, 19-21, & 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794