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
Applicant’s amendments to the Claims have overcome the claim objections and most of the 112(b) rejections previously set forth in the Non-Final Rejection mailed October 28th, 2025.
Response to Arguments
Applicant’s arguments, see pages 10-15, filed February 12th, 2026, with respect to the rejection(s) of claim(s) 1, 13 & 23-24 under 35 U.S.C. 103 have been fully considered and are persuasive based on the previous interpretations of the current prior art of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of the current prior art of record and/or newly found prior art that teaches the newly disclosed claim limitations. Regarding Applicant’s arguments that the current prior art of record fail to teach the newly disclosed claim limitations, the Examiner respectfully disagrees as outlined in the updated rejections, below.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1, line 11: “cryogenic fluid” should read --the cryogenic fluid--.
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 11, 21-22 & 24-25 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.
Regarding claim 11, the claim recites “the first reinforcing structure and the second reinforcing” in lines 1-2 and it is unclear which reinforcing structures this is referring to, the “first reinforcing tubular structure” & “second reinforcing tubular structure” of claim 1, from which claim 11 depends, or if these are different reinforcing structures. For examination purposes, the limitation will be interpreted as “the first reinforcing tubular structure and the second reinforcing tubular structure”.
Claim 21 recites the limitation “the reinforcing structure” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 is also rejected by virtue of its dependency on claim 21.
Regarding claim 24, the claim recites “cryogenic fluid” in line 10 and it is unclear if this is the same cryogenic fluid as the cryogenic fluid recited in line 2 or is a different cryogenic fluid. For examination purposes, these are the same cryogenic fluid and the limitation will be interpreted as “the cryogenic fluid”. Other recitations of “cryogenic fluid” will be interpreted similarly, see Claim Objections section for each occurrence and corrections.
Claim 25 is rejected by virtue of its dependency on claim 24.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-17 & 21-22 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Skorich et al. (U.S. 2020/0085485, cited in IDS), herein referred to as “Skorich”.
Regarding claim 13, Skorich teaches a method of making a cryogenic probe ([0049]: methods of fabricating cryogenic probes … the embodiments discussed below are exemplary in nature and may be reconfigured without departing from the scope and spirit of the present invention), the method comprising:
providing an elongated, generally cylindrical shaft (insulated tube 106 & insulated conduit 170) comprising
a flexible thermoplastic body (malleable shaft 104; [0053]: the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics)) housed within the elongated, generally cylindrical shaft ([0050]: a flexible or malleable elongated shaft 104 extending through an insulated tube 106),
a supply conduit (supply hypotube 136) extending through the flexible thermoplastic body (see Fig. 2), the supply conduit being configured to convey cryogenic fluid ([0052]: a distal end of the supply line 114 may be fluidically coupled, via a fluid tight seal, to a fluid supply conduit such as a supply hypotube 136), and
an exhaust conduit (exhaust conduit 105) extending through the flexible thermoplastic body (see Fig. 2), the exhaust conduit being configured to convey spent cryogenic fluid ([0053]: a fluid exhaust conduit 105, which may convey the exhaust stream from the ablation tip 102), and
a pair of tubular reinforcing structures each separately circumscribing one of the supply conduit ([0053]: the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance) and the exhaust conduit ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., copper, aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance; see Figs. 7 & 15 where the malleable shaft 104 circumscribes the exhaust conduit 105 such that an inner liner of malleable shaft 104 circumscribes the exhaust conduit),
wherein the thermoplastic body conforms to a shape of the supply conduit and a shape of the exhaust conduit ([0053]: the interior of the malleable shaft 104 may form a fluid exhaust conduit 105; [0056]: the malleable shaft 104 may circumscribe the hypotube 136; wherein the malleable shaft 104 forming the exhaust conduit 105 is seen as conforming to a shape of the exhaust conduit & the malleable shaft circumscribing the hypotube 136/supply conduit is seen as conforming to a shape of the supply conduit);
Regarding claim 14, Skorich teaches attaching a handle (handle 108) proximally on the elongated, generally cylindrical shaft ([0050]: the insulated tube 106 may be substantially rigid and fixedly mounted to the handle housing 108 in order to shield portions of the malleable shaft 104 from direct contact with its immediate surroundings (including adjacent tissue when inserted into a mammalian body)).
Regarding claim 15, Skorich teaches wherein providing the elongated, generally cylindrical shaft comprises extruding the flexible thermoplastic body ([0053]: the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics)); and
wherein extruding the flexible thermoplastic body is operative to conform the flexible thermoplastic body to the shape of the supply conduit and the shape of the exhaust conduit ([0053]: the interior of the malleable shaft 104 may form a fluid exhaust conduit 105 … the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics); [0056]: the malleable shaft 104 may circumscribe the hypotube 136; wherein the malleable shaft 104 forming the exhaust conduit 105 is seen as conforming to a shape of the exhaust conduit & the malleable shaft circumscribing the hypotube 136/supply conduit is seen as conforming to a shape of the supply conduit).
Regarding claim 16, Skorich teaches wherein extruding the flexible thermoplastic body comprises forming at least one auxiliary lumen extending generally longitudinally through the flexible thermoplastic body ([0070]: It is also within the scope of this exemplary insert 400 to include one or more conduits for routing thermocouple leads (not shown) or sensor leads (not shown) so as to provide real-time information regarding temperature and/or pressure within one or more of the conduits 420, 430 and air pockets 410; [0088]: the invention described herein is not limited to any precise embodiment and that changes may be made to such embodiments without departing from the scope of the invention).
Regarding claim 17, Skorich discloses wherein the exhaust conduit is disposed generally centrally within the flexible thermoplastic body (see Figs. 7 & 15).
Regarding claim 21, Skorich discloses wherein at least one of the supply conduit and the exhaust conduit comprises the reinforcing structure ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., copper, aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance … the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance).
Regarding claim 22, Skorich discloses wherein the reinforcing structure comprises a generally tubular braid reinforcement ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., copper, aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance … the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance).
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 1-5, 7-8, 11-12 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Skorich in view of Arless et al. (U.S. Pub. No. 2010/0057063, previously cited), herein referred to as “Arless”.
Regarding claim 1, Skorich discloses a cryogenic probe (Abstract: Cryosurgical devices; [0049]: the embodiments discussed below are exemplary in nature and may be reconfigured without departing from the scope and spirit of the present invention) comprising:
a distal ablation tip (ablation tip 102) configured to reverse flow of a cryogenic fluid directed thereto ([0060]: A countercurrent flow may be established by lower pressure cryogenic fluid flowing through the cavity 200 and around the hypotube 136 and continuing into and through the malleable shaft 104 to circumscribe the hypotube, thereby providing precooling to the cryogenic fluid flowing through the hypotube as Joule-Thompson expansion within the ablation tip 102 continues. Though not required, a vacuum or low-pressure purge may be drawn on the exhaust line 116 (see FIG. 1) to hasten the flow of expanded cryogenic fluid through the malleable shaft 104, through the exhaust adapter 140, and into the exhaust line; wherein the cavity 200 within the ablation tip is where the cryogenic fluid flows into and out of & therefore has a reversed flow); and
an elongated, generally cylindrical shaft (insulated tube 106 & insulated conduit 170) extending proximally from and connected to the distal ablation tip ([0050]: an ablation tip 102 connected to a flexible or malleable elongated shaft 104 extending through an insulated tube 106; wherein the tip 102 is connected to insulated tube 106 & insulated conduit 170 via malleable elongated shaft 104);
wherein the elongated, generally cylindrical shaft comprises:
a flexible thermoplastic body housed within the elongated, generally cylindrical shaft (a flexible or malleable elongated shaft 104; [0053]: the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics); [0050]: a flexible or malleable elongated shaft 104 extending through an insulated tube 106),
a supply conduit (supply hypotube 136) extending through the flexible thermoplastic body (see Fig. 2) and in communication with a nozzle in the distal ablation tip ([0059]: the distal termination of the hypotube 136 comprises a nozzle 206 through which cryogenic fluid may be expelled; see Fig. 15 where the nozzle 106 is within tip 102), the supply conduit being configured to convey cryogenic fluid distally to the nozzle of the distal ablation tip ([0052]: a distal end of the supply line 114 may be fluidically coupled, via a fluid tight seal, to a fluid supply conduit such as a supply hypotube 136; [0059]: the distal termination of the hypotube 136 comprises a nozzle 206 through which cryogenic fluid may be expelled),
a first reinforcing tubular structure circumscribing the supply conduit and interposing the supply conduit and the flexible thermoplastic body ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., copper, aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance; [0056]: the malleable shaft 104 may circumscribe the hypotube 136).
an exhaust conduit (exhaust conduit 105) extending through the flexible thermoplastic body (see Fig. 2), the exhaust conduit being configured to convey spent cryogenic fluid proximally from the distal ablation tip ([0053]: a fluid exhaust conduit 105, which may convey the exhaust stream from the ablation tip 102); and
wherein the thermoplastic body conforms to a shape of the supply conduit and a shape of the exhaust conduit ([0053]: the interior of the malleable shaft 104 may form a fluid exhaust conduit 105; [0056]: the malleable shaft 104 may circumscribe the hypotube 136; wherein the malleable shaft 104 forming the exhaust conduit 105 is seen as conforming to a shape of the exhaust conduit & the malleable shaft circumscribing the hypotube 136/supply conduit is seen as conforming to a shape of the supply conduit).
while the supply conduits and exhaust conduits are capable of fluid flow in either direction, Skorich fails to explicitly disclose a second tubular reinforcing structure circumscribing the exhaust conduit and interposing the supply conduit and the exhaust conduit.
However, Arless discloses a cryogenic probe ([0035]: cryogenic probe 100) comprising a second tubular reinforcing structure (probe chamber 230, Fig. 2) circumscribing the exhaust conduit and interposing the supply conduit and the exhaust conduit ([0039]: probe chamber 230 may be filled with an insulating or thermally reflective material; see Arless Fig. 2 where the probe chamber 230 comprising an insulating or thermally reflective material circumscribes the exhaust conduit/central return line and is interposing the supply conduit/injection coil 210 and the return line & in this combination, the fluid flow directions of the supply/exhaust conduits are swapped).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryogenic probe of Skorich to have a second tubular reinforcing liner and the supply and exhaust conduit positioning as taught by Arless, for the purpose of maximizing the thermal transmission between the inner injection coil and the outer portion of the probe and maximizing thermal conductivity with, for example, insulating cores and increased contact surfaces, it may also enlarge or increase the thermally transmittive area at the distal end of the catheter or probe (the tip region) and the liquid gas refrigerant or cryogen may stay in liquid form from entry into the tip region until exit from the tip area while the flow is continuous and controlled, in a predictable (designed) path in the cooling zone of the catheter or probe (Arless: [0034]).
Regarding claim 2, Skorich in view of Arless discloses wherein the exhaust conduit is disposed generally centrally within the flexible thermoplastic body (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see Fig. 1).
Regarding claim 3, Skorich fails to disclose wherein the supply conduit is generally helically shaped; and wherein the generally helically shaped supply conduit is disposed radially around the generally centrally disposed exhaust conduit.
However, Arless discloses the supply conduit (inner injection coil 110) is generally helically shaped (see Fig. 1); and wherein the generally helically shaped supply conduit is disposed radially around the generally centrally disposed exhaust conduit (return line 120, see Fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the conduits of Skorich to the helical arrangement of Arless for the purpose enabling the windings of the coil to be placed as closely as possible so as to maximize thermal conductivity but with some space to allow for probe flexibility (Arless: [0057]).
Regarding claim 4, Skorich in view of Arless disclose wherein the exhaust conduit is generally concentrically disposed within the supply conduit (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see Fig. 1).
Regarding claim 5, Skorich in view of Arless discloses wherein the supply conduit is generally concentrically disposed within the flexible thermoplastic body (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see Fig. 1).
Regarding claim 7, Skorich in view of Arless discloses wherein the supply conduit and the exhaust conduit are disposed in the flexible thermoplastic body in a generally parallel and spaced apart arrangement (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see spacing in Fig. 1)
Regarding claim 8, Skorich discloses wherein the elongated, generally cylindrical shaft further comprises at least one auxiliary lumen extending generally longitudinally through the flexible thermoplastic body ([0070]: It is also within the scope of this exemplary insert 400 to include one or more conduits for routing thermocouple leads (not shown) or sensor leads (not shown) so as to provide real-time information regarding temperature and/or pressure within one or more of the conduits 420, 430 and air pockets 410; [0088]: the invention described herein is not limited to any precise embodiment and that changes may be made to such embodiments without departing from the scope of the invention).
Regarding claim 11, Skorich discloses wherein the first reinforcing structure and the second reinforcing comprises at least one of stainless steel, nylon, high density polyethylene, polyethylene terephthalate, carbon fibers, and poly para-aramid ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., copper, aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance … the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance).
Regarding claim 12, Skorich discloses a cryogenic surgical system comprising:
the cryogenic probe of claim 1 (cryoprobe 100); and
a cryogenic module configured to be operatively coupled to the cryogenic probe to supply the cryogenic fluid to the cryogenic probe ([0051]: In this fashion, the cryoprobe 100 may be rendered disposable and configured to interface with multiple or repeated use components such as, without limitation, cryogenic fluid tanks, cryogenic fluid recyclers, and medical equipment operative to display temperature readings).
Regarding claim 23, Skorich discloses a cryogenic probe (Abstract: Cryosurgical devices; [0049]: the embodiments discussed below are exemplary in nature and may be reconfigured without departing from the scope and spirit of the present invention) comprising:
a distal ablation tip (ablation tip 102) configured to reverse flow of a cryogenic fluid directed thereto ([0060]: A countercurrent flow may be established by lower pressure cryogenic fluid flowing through the cavity 200 and around the hypotube 136 and continuing into and through the malleable shaft 104 to circumscribe the hypotube, thereby providing precooling to the cryogenic fluid flowing through the hypotube as Joule-Thompson expansion within the ablation tip 102 continues. Though not required, a vacuum or low-pressure purge may be drawn on the exhaust line 116 (see FIG. 1) to hasten the flow of expanded cryogenic fluid through the malleable shaft 104, through the exhaust adapter 140, and into the exhaust line; wherein the cavity 200 within the ablation tip is where the cryogenic fluid flows into and out of & therefore has a reversed flow); and
an elongated, generally cylindrical shaft (insulated tube 106 & insulated conduit 170) extending proximally from and connected to the distal ablation tip ([0050]: an ablation tip 102 connected to a flexible or malleable elongated shaft 104 extending through an insulated tube 106; wherein the tip 102 is connected to insulated tube 106 & insulated conduit 170 via malleable elongated shaft 104);
wherein the elongated, generally cylindrical shaft comprises
a flexible thermoplastic body (a flexible or malleable elongated shaft 104; [0053]: the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics)) housed with the elongated, generally cylindrical shaft ([0050]: a flexible or malleable elongated shaft 104 extending through an insulated tube 106),
a supply conduit (supply hypotube 136) extending through the flexible thermoplastic body (see Fig. 2), the supply conduit being configured to convey the cryogenic fluid distally to the distal ablation tip ([0052]: a distal end of the supply line 114 may be fluidically coupled, via a fluid tight seal, to a fluid supply conduit such as a supply hypotube 136),
a first reinforcing structure circumscribing the supply conduit and circumscribed by the flexible thermoplastic body ([0053]: the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance; see Figs. 7 & 15 where an outer layer on the supply conduit/hypotube 136 would circumscribe the supply conduit/hypotube 136 and is circumscribed by the flexible thermoplastic body/malleable shaft 104);
an exhaust conduit (exhaust conduit 105) extending through the flexible thermoplastic body (see Fig. 2), the exhaust conduit being configured to convey the cryogenic fluid proximally from an internal cavity of the distal ablation tip ([0053]: a fluid exhaust conduit 105, which may convey the exhaust stream from the ablation tip 102); and
a second reinforcing structure circumscribing the exhaust conduit and circumscribed by the flexible thermoplastic body ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube); see Figs. 7 & 15 where an inner layer of the flexible thermoplastic body/malleable shaft 104 circumscribes the exhaust conduit 105 and is circumscribed by the flexible thermoplastic body/malleable shaft 104);
wherein a nozzle (nozzle 206) proximate the distal ablation tip interposes the helical supply conduit and the exhaust conduit ([0059]: the distal termination of the hypotube 136 comprises a nozzle 206 through which cryogenic fluid may be expelled and flow into the portion of the cavity 200 unoccupied by the hypotube; see Fig. 15 where the nozzle 206 is proximate tip 105 & lies on terminal end of hypotube 136 such that it is interposing the supply conduit/hypotube 136 and the exhaust conduit 105 (as in, the cryogenic fluid flows from the hypotube 136 to exhaust conduit 105 by passing through the nozzle 106 such that it is interposing the two conduits)).
But Skorich fails to disclose wherein the supply conduit is a helical supply conduit,
while the supply conduits and exhaust conduits are capable of fluid flow in either direction, Skorich fails to explicitly disclose the exhaust conduit being circumscribed by the helical supply conduit.
However, Arless discloses a cryogenic probe ([0035]: cryogenic probe 100) wherein the supply conduit is a helical supply conduit (inner injection coil 110; [0035]: an inner injection coil 110 which may be made of, for example, a formed tube containing a narrow bore 111 for which the refrigerant may pass through),
the exhaust conduit (return line 120) being circumscribed by the helical supply conduit ([0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120); see Fig. 1).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryogenic probe of Skorich to have the helical supply conduit and supply and exhaust conduit positioning as taught by Arless, for the purpose of maximizing thermal conductivity with, for example, insulating cores and increased contact surfaces, it may also enlarge or increase the thermally transmittive area at the distal end of the catheter or probe (the tip region) and the liquid gas refrigerant or cryogen may stay in liquid form from entry into the tip region until exit from the tip area while the flow is continuous and controlled, in a predictable (designed) path in the cooling zone of the catheter or probe; and enabling the windings of the coil to be placed as closely as possible so as to maximize thermal conductivity but with some space to allow for probe flexibility (Arless: [0034], [0057]).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Skorich as applied to claim 13, above, and further in view of Arless.
Regarding claim 18, Skorich fails to disclose wherein the supply conduit is generally helically shaped; and wherein the generally helically shaped supply conduit is disposed radially around the generally centrally disposed exhaust conduit.
However, Arless discloses wherein the supply conduit (inner injection coil 110) is generally helically shaped (see Fig. 1); and wherein the generally helically shaped supply conduit is disposed radially around the generally centrally disposed exhaust conduit (return line 120, see Fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the conduits of Skorich to the helical arrangement of Arless for the purpose enabling the windings of the coil to be placed as closely as possible so as to maximize thermal conductivity but with some space to allow for probe flexibility (Arless [0057]).
Regarding claim 19, Skorich in view of Arless discloses wherein the exhaust conduit is generally concentrically disposed within the supply conduit (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see Fig. 1).
Regarding claim 20, Skorich in view of Arless discloses wherein the supply conduit and the exhaust conduit are disposed in the flexible thermoplastic body in a generally parallel and spaced apart arrangement (Arless: [0035]: After the refrigerant travels through the inner injection coil 110, it exits the probe though the return line 120; see spacing in Fig. 1)
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Skorich in view of Babkin et al. (U.S. Pub. No. 20190076179, previously cited), herein referred to as “Babkin”.
Regarding claim 24, Skorich discloses a cryogenic probe (Abstract: Cryosurgical devices; [0049]: the embodiments discussed below are exemplary in nature and may be reconfigured without departing from the scope and spirit of the present invention) comprising:
a distal ablation tip (ablation tip 102) configured to reverse flow of a cryogenic fluid directed thereto ([0060]: A countercurrent flow may be established by lower pressure cryogenic fluid flowing through the cavity 200 and around the hypotube 136 and continuing into and through the malleable shaft 104 to circumscribe the hypotube, thereby providing precooling to the cryogenic fluid flowing through the hypotube as Joule-Thompson expansion within the ablation tip 102 continues. Though not required, a vacuum or low-pressure purge may be drawn on the exhaust line 116 (see FIG. 1) to hasten the flow of expanded cryogenic fluid through the malleable shaft 104, through the exhaust adapter 140, and into the exhaust line; wherein the cavity 200 within the ablation tip is where the cryogenic fluid flows into and out of & therefore has a reversed flow); and
an elongated, generally cylindrical shaft (insulated tube 106 & insulated conduit 170) extending proximally from and connected to the distal ablation tip ([0050]: an ablation tip 102 connected to a flexible or malleable elongated shaft 104 extending through an insulated tube 106; wherein the tip 102 is connected to insulated tube 106 & insulated conduit 170 via malleable elongated shaft 104);
wherein the elongated, generally cylindrical shaft comprises
a flexible thermoplastic body (a flexible or malleable elongated shaft 104; [0053]: the malleable shaft 104 and adapter 140 may be fabricated from a single or multilayer construction of various metals and polymers that include, without limitation, aluminum, copper, stainless steel, and thermoplastics (including extruded thermoplastics)) housed within the elongated, generally cylindrical shaft ([0050]: a flexible or malleable elongated shaft 104 extending through an insulated tube 106),
a supply conduit (supply hypotube 136) extending through the flexible thermoplastic body (see Fig. 2), the supply conduit being configured to convey cryogenic fluid distally to the distal ablation tip ([0052]: a distal end of the supply line 114 may be fluidically coupled, via a fluid tight seal, to a fluid supply conduit such as a supply hypotube 136),
a first reinforcing tubular structure circumscribing the supply conduit ([0053]: the hypotube 136 and supply adapter 134 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube) and one or more outer layers for strength (e.g., aluminum, stainless steel, braided yarn), flexibility abrasion resistance, and/or appearance);
an exhaust conduit (exhaust conduit 105) extending through the flexible thermoplastic body (see Fig. 2), the exhaust conduit being configured to convey the cryogenic fluid proximally from the distal ablation tip ([0053]: a fluid exhaust conduit 105, which may convey the exhaust stream from the ablation tip 102); and
a second reinforcing tubular structure circumscribing the exhaust conduit ([0053]: the malleable shaft 104 and adapter 140 may comprise an inner layer for chemical compatibility (e.g., an extruded polymeric tube); see Figs. 7 & 15 where the malleable shaft 104 circumscribes the exhaust conduit 105 such that an inner liner of the malleable shaft 104 would also circumscribe the exhaust conduit);
wherein a nozzle (nozzle 206) interposes the supply conduit and the exhaust conduit ([0059]: the distal termination of the hypotube 136 comprises a nozzle 206 through which cryogenic fluid may be expelled and flow into the portion of the cavity 200 unoccupied by the hypotube; see Fig. 15 where the nozzle 206 is proximate tip 105 & lies on terminal end of hypotube 136 such that it is interposing the supply conduit/hypotube 136 and the exhaust conduit 105 (as in, the cryogenic fluid flows from the hypotube 136 to exhaust conduit 105 by passing through the nozzle 106 such that it is interposing the two conduits));
but Skorich fails to disclose:
wherein the supply conduit and the exhaust conduit are within the flexible thermoplastic body in a non-concentric orientation.
However, Babkin discloses wherein the supply conduit and the exhaust conduit are within the flexible thermoplastic body in a non-concentric orientation (see each individual inlet fluid transfer tube 422 and each individual outlet fluid transfer tube 424 such that the entirety of the tubes are in a parallel configuration but not a coaxial/concentric configuration in Fig. 5B).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryogenic probe of Skorich to have the supply and exhaust conduit positioning as taught by Babkin, for the purpose of providing a substantial increase in the heat exchange area between the cryogen and tissue. Depending on the number of tubes used, cryo-instruments can increase the contact area several times over previous designs having similarly sized diameters with single shafts/tubes (Babkin: [0130]).
Regarding claim 25, Skorich in view of Babkin discloses an auxiliary lumen extending through the flexible thermoplastic body (Skorich: [0070]: It is also within the scope of this exemplary insert 400 to include one or more conduits for routing thermocouple leads (not shown) or sensor leads (not shown) so as to provide real-time information regarding temperature and/or pressure within one or more of the conduits 420, 430 and air pockets 410; [0088]: the invention described herein is not limited to any precise embodiment and that changes may be made to such embodiments without departing from the scope of the invention).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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