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 Amendments under 37 CFR 1.132 filed 04/15/2026 is sufficient to overcome the rejection of claim 1, 13, and 19 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2).
Acknowledgement is made to newly added claims 21-23 and canceled claims 10-11 and 17.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/15/2026, with respect to the rejection(s) of claim(s) 1, 13, and 19 under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Suzuki (US 20170304591 A1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 13-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2), further in view of Suzuki (US 20170304591 A1).
Regarding claim 1, Lane teaches a cryoablation shaft comprising: a working fluid circuit (Fig 13; coolant injection tube 830 enclosing a coolant injection lumen 835); a vacuum circuit (Fig 13; a vacuum port 840, a vacuum return tube 845, a primary vacuum return lumen 850, a secondary vacuum return lumen 855); an insulated portion, wherein the vacuum circuit runs through the insulated portion (Fig 15; [0083] The space 910 effectively provides such insulation, which may be fine-tuned by applying varying levels of vacuum through the return lumen 855); and an expansion chamber (Fig 13; cooling chamber 870) extending distally to the insulated portion (Fig 13); a guidewire lumen extending through a length of the cryoablation shaft (Fig 13; guidewire lumen 822), the guidewire lumen configured for insertion of a guidewire ([0075] a guidewire port 815 for the insertion of a guidewire (not shown) into guidewire tube 820), a supply tube (Fig 13; coolant injection tube 830), the supply tube having a distal outlet in the expansion chamber, wherein fluid from the working fluid circuit travels distally down the cryoablation shaft through supply tube and expands in the expansion chamber ([0081] Upon flowing through the coaxial injection tube 830, coolant enters the chamber 870 through the injection orifice 905 located in the distal half of inner balloon 860); a return tube surrounding the supply tube (Fig 13; [0081] Coolant then flows out of the chamber 870 through the primary vacuum return lumen 850); and an insulating shaft surrounding the return tube (Fig 15; [0083] The space 910 effectively provides such insulation, which may be fine-tuned by applying varying levels of vacuum through the return lumen 855).
Lane fails to fully teach the guidewire lumen comprising: a metallic tube; and a polymer sleeve configured to surround at least a portion of the metallic tube; a first compressive wrap configured to seal the polymer sleeve to the metallic tube at a distal end of the polymer sleeve; and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve.
However, Musbach teaches the guidewire lumen comprising: a metallic tube (micromachined hypotube 174) ([Pg 8 Para 3] the micromachined hypotube 10 may be formed of a metallic material such as stainless steel or a nickel-titanium alloy such as Nitinol or other metallic or polymeric shape-memory material); and a polymer sleeve (134) configured to surround at least a portion of the metallic tube ([Pg 15 Para 3] inner polymeric liner 172 that defines guidewire lumen 168). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the guidewire lumen comprising: a metallic tube; and a polymer sleeve configured to surround at least a portion of the metallic tube. Doing so would allow the polymeric lining to seal the tube for prevention of unwanted particles.
Further, Suzuki teaches a first compressive wrap configured to seal the polymer sleeve to the metallic tube (Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping) at a distal end of the polymer sleeve ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping); and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve (Fig 2; joining at the proximal end) ((Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Lane in view of Musbach to include a first compressive wrap configured to seal the polymer sleeve to the metallic tube at a distal end of the polymer sleeve; and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve. Doing so allows the polymer sleeve to be adhered to the metal tube for protection and ease of application.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the compressive wrap at a distal end of the polymer sleeve, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 2, Lane teaches the cryoablation shaft of claim 1, wherein the guidewire lumen is concentrically located within the supply tube, wherein the supply tube is concentrically located within the return tube, wherein at least a portion of the return tube is concentrically located within the insulating shaft ([0073] a guidewire port 815, a guidewire tube 820 enclosing a guidewire lumen 822; Fig 13, 14).
Regarding claim 3, Lane teaches the cryoablation shaft of claim 2, wherein fluid from the working fluid circuit travels distally down the cryoablation shaft through an annular space defined between the return tube and the guidewire lumen ([0073] Fig 13, 14).
Regarding claim 4, Lane teaches cryoablation shaft of claim 1, but fails to fully teach the metallic tube comprising any of nitinol and stainless steel.
However, Musbach teaches, the metallic tube comprising any of nitinol and stainless steel ([Pg 8 Para 3]; the micromachined hypotube 10 may be formed of a metallic material such as stainless steel or a nickel-titanium alloy such as Nitinol or other metallic or polymeric shape-memory material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the metallic tube comprising any of nitinol and stainless steel. Doing so would allow the tube to be made of a durable material that is suitable.
Regarding claim 5, Lane teaches the cryoablation shaft of claim 1, but fails to teach the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate.
However, Musbach teaches the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate ([Pg 14; Para 4]; The polymeric liner 148 can be made of any suitable polymeric material. Examples of suitable materials include polyethylene, polyurethane, elastomeric polyamides, block polyamide/ethers (such as PEBAX®), silicones, co-polymers, thermoplastic polymers such as a co-polyester thermoplastic elastomer). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate. Doing so allows for a flexible material to seal the tube.
Regarding claim 6, Lane teaches the cryoablation shaft of claim 1, but fails to fully teach wherein at least a portion of the metallic tube comprises slots, and wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots.
However, Musbach teaches wherein at least a portion of the metallic tube comprises slots (Fig 1; [Pg 7 Para 3] One or more slots 22 are disposed along the length of the micromachined hypotube 10), and wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots ([Pg 3 Para 3] An outer sheath is disposed proximal to the inflatable balloon covering at least the distal region of the elongate hypotube such that the outer sheath seals the plurality of slots so that the hypotube lumen may be used for inflating and deflating the inflatable balloon). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include wherein at least a portion of the metallic tube comprises slots, and wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots. Doing so would allow for the metal tube to bend for accommodation to insertion and to seal the slots so no unwanted particles could enter.
Regarding claim 13, Lane teaches a distal tip (Fig 13; distal tip 883); and wherein the guidewire lumen is configured to extend through a length of the cryoablation shaft (Fig 13; guidewire lumen 822); wherein the guidewire lumen is configured for insertion of a guidewire ([0075] a guidewire port 815 for the insertion of a guidewire (not shown) into guidewire tube 820).
Lane fails to fully teach a guidewire lumen for a cryoablation shaft comprising: a metallic tube, wherein at least a portion of the metallic tube comprises slots; a polymer sleeve wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots; and wherein the metallic tube is configured to be joined to the distal tip at a distal end of the cryoablation shaft using a metal-to-metal joining processes.
However, Musbach teaches a guidewire lumen for a cryoablation shaft comprising: a metallic tube (micromachined hypotube 174) ([Pg 8 Para 3] the micromachined hypotube 10 may be formed of a metallic material such as stainless steel or a nickel-titanium alloy such as Nitinol or other metallic or polymeric shape-memory material), wherein at least a portion of the metallic tube comprises slots (Fig 1; [Pg 7 Para 3] One or more slots 22 are disposed along the length of the micromachined hypotube 10); a polymer sleeve (134) wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots ([Pg 3 Para 3] An outer sheath is disposed proximal to the inflatable balloon covering at least the distal region of the elongate hypotube such that the outer sheath seals the plurality of slots so that the hypotube lumen may be used for inflating and deflating the inflatable balloon); and wherein the metallic tube is configured to be joined to the distal tip at a distal end of the cryoablation shaft using a metal to metal joining processes ([Pg 21 Para 3] the hypotube lumen 310 may be sized to accommodate a guidewire (not shown). In a fixed wire configuration, it is contemplated that a distal portion of the hypotube lumen 310 include a plug or other structure to seal the interior of the hypotube lumen 310. In an over-the-wire configuration, it is contemplated that the hypotube lumen 310 may include sealing structure (not shown) adapted to permit a guidewire to pass through the sealing structure yet be at least substantially fluid tight against the guidewire). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include a guidewire lumen for a cryoablation shaft comprising: a metallic tube, wherein at least a portion of the metallic tube comprises slots; a polymer sleeve wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots; and wherein the metallic tube is configured to be joined to the distal tip at a distal end of the cryoablation shaft using a metal-to-metal joining processes. Doing so allows for the metal tube to bend for accommodation to insertion and to seal the slots so no unwanted particles could enter; a compressive wrap configured to seal the polymer sleeve to the metallic tube.
Further, Suzuki teaches a first compressive wrap configured to seal the polymer sleeve to the metallic tube (Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping) at a distal end of the polymer sleeve ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping); and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve (Fig 2; joining at the proximal end) ((Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Lane in view of Musbach to include a compressive wrap configured to seal the polymer sleeve to the metallic tube. Doing so allows the polymer sleeve to be adhered to the metal tube for protection and ease of application.
Regarding claim 14, Lane teaches the guidewire lumen of claim 13, wherein the guidewire lumen is concentrically located within a supply tube of the cryoablation shaft, wherein the supply tube is concentrically located within a return tube of the cryoablation shaft, wherein at least a portion of the return tube is concentrically located within an insulating shaft of the cryoablation shaft ([0073] a guidewire port 815, a guidewire tube 820 enclosing a guidewire lumen 822; Fig 13, 14).
Regarding claim 15, Lane teaches the guidewire lumen of claim 13, but fails to fully teach the metallic tube comprising any of nitinol and stainless steel.
However, Musbach teaches guidewire lumen of claim 13, the metallic tube comprising any of nitinol and stainless steel ([Pg 8 Para 3]; the micromachined hypotube 10 may be formed of a metallic material such as stainless steel or a nickel-titanium alloy such as Nitinol or other metallic or polymeric shape-memory material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the metallic tube comprising any of nitinol and stainless steel. Doing so would allow the tube to be made of a durable material that is suitable.
Regarding claim 16, Lane teaches the guidewire lumen of claim 13, but fails to fully teach the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate.
However, Musbach teaches guidewire lumen of claim 13, the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate ([Pg 14; Para 4]; The polymeric liner 148 can be made of any suitable polymeric material. Examples of suitable materials include polyethylene, polyurethane, elastomeric polyamides, block polyamide/ethers (such as PEBAX®), silicones, co-polymers, thermoplastic polymers such as a co-polyester thermoplastic elastomer). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the polymer sleeve comprising any of polyether block amide and polyethylene terephthalate. Doing so for a flexible material to seal the tube.
Regarding claim 19, Lane teaches a cryoablation shaft comprising: a working fluid circuit (Fig 13; coolant injection tube 830 enclosing a coolant injection lumen 835); a vacuum circuit (Fig 13; a vacuum port 840, a vacuum return tube 845, a primary vacuum return lumen 850, a secondary vacuum return lumen 855); an insulated portion (Fig 15; [0083] The space 910 effectively provides such insulation, which may be fine-tuned by applying varying levels of vacuum through the return lumen 855), wherein the vacuum circuit runs through the insulated portion (Fig 13); and an expansion chamber (Fig 13; cooling chamber 870); a guidewire lumen (Fig 13; guidewire lumen 822) extending through a length of the cryoablation shaft, the guidewire lumen configured for insertion of a guidewire ([0075] a guidewire port 815 for the insertion of a guidewire (not shown) into guidewire tube 820); a supply tube (Fig 13; coolant injection tube 830), the supply tube having a distal outlet in the expansion chamber, wherein fluid from the working fluid circuit travels distally down the cryoablation shaft through supply tube and expands in the expansion chamber ([0081] Upon flowing through the coaxial injection tube 830, coolant enters the chamber 870 through the injection orifice 905 located in the distal half of inner balloon 860); a return tube surrounding the supply tube (Fig 13; [0081] Coolant then flows out of the chamber 870 through the primary vacuum return lumen 850); and an insulating shaft surrounding the return tube (Fig 15; [0083] The space 910 effectively provides such insulation, which may be fine-tuned by applying varying levels of vacuum through the return lumen 855); wherein the guidewire lumen (822) is concentrically located within the supply tube (830), wherein the supply tube is concentrically located within the return tube (845), wherein the return tube is concentrically located within the insulating shaft (855) ([0073] a guidewire port 815, a guidewire tube 820 enclosing a guidewire lumen 822; Fig 13, 14).
Lane fails to fully teach the guidewire lumen comprising: a metallic tube wherein at least a portion of the metallic tube comprises slots; and a polymer sleeve configured to surround at least a portion of the metallic tube, wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots; a first compressive wrap configured to seal the polymer sleeve to the metallic tube at a distal end of the polymer sleeve; and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve.
However, Musbach teaches the guidewire lumen comprising: a metallic tube (micromachined hypotube 174) ([Pg 8 Para 3] the micromachined hypotube 10 may be formed of a metallic material such as stainless steel or a nickel-titanium alloy such as Nitinol or other metallic or polymeric shape-memory material) wherein at least a portion of the metallic tube comprises slots (Fig 1; [Pg 7 Para 3] One or more slots 22 are disposed along the length of the micromachined hypotube 10); and a polymer sleeve (134) configured to surround at least a portion of the metallic tube ([Pg 15 Para 3] inner polymeric liner 172 that defines guidewire lumen 168), wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots ([Pg 3 Para 3] An outer sheath is disposed proximal to the inflatable balloon covering at least the distal region of the elongate hypotube such that the outer sheath seals the plurality of slots so that the hypotube lumen may be used for inflating and deflating the inflatable balloon). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include the guidewire lumen comprising: a metallic tube wherein at least a portion of the metallic tube comprises slots; and a polymer sleeve configured to surround at least a portion of the metallic tube, wherein the polymer sleeve is configured to form a seal around the portion of the metallic tube comprising the slots. Doing so allows for the metal tube to bend for accommodation to insertion and to seal the slots so no unwanted particles could enter.
Further, Suzuki teaches a first compressive wrap configured to seal the polymer sleeve to the metallic tube (Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping) at a distal end of the polymer sleeve ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping); and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve (Fig 2; joining at the proximal end) ((Fig 5; [0046] A portion where the proximal shaft 30 and the distal shaft 40 overlap with each other is covered with a shrinkable tube 61 that shrinks by being heated) ([0040] As the proximal shaft 30 is made of a metallic material and the distal shaft 40 is made of a resin material, the joining strength between the proximal shaft 30 and the distal shaft 40 if joint is made by crimping is lower than when forming a joint between resins by crimping).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Lane in view of Musbach to include a first compressive wrap configured to seal the polymer sleeve to the metallic tube at a distal end of the polymer sleeve; and a second compressive wrap configured to seal the polymer sleeve to the metallic tube at a proximal end of the polymer sleeve. Doing so allows the polymer sleeve to be adhered to the metal tube for protection and ease of application.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the compressive wrap at a distal end of the polymer sleeve, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 7-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2), further in view of Suzuki (US 20170304591 A1), further in view of Dobak (US 5758505 A).
Regarding claim 7, Lane teaches the cryoablation shaft of claim 1, further comprising a distal tip configured to seal a distal end of the expansion chamber at a distal tip of the cryoablation shaft (Fig 13; distal tip 883), but fails to fully teach wherein the distal tip comprises metal.
However, Dobak teaches wherein the distal tip comprises metal ([26] a metal plug can be installed in the tip of the outer tube or catheter, for applying cooling through the extreme distal tip of the catheter. Alternatively, a relatively narrow metal strip can be mounted in a side wall of the catheter, near the distal tip, for applying cooling to a narrow strip of tissue). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include wherein the distal tip comprises metal. Doing so allows for the tip to apply cooling for effective treatment.
Regarding claim 8, Lane teaches the cryoablation shaft of claim 7, but fails to fully teach wherein a distal end of the metallic tube is joined to a proximal end of the distal tip using a metal-to-metal joining process.
However, Musbach teaches wherein a distal end of the metallic tube is joined to a proximal end of the distal tip using a metal-to-metal joining process ([Pg 21 Para 2] the hypotube lumen 310 may be sized to accommodate a guidewire (not shown). In a fixed wire configuration, it is contemplated that a distal portion of the hypotube lumen 310 include a plug or other structure to seal the interior of the hypotube lumen 310. In an over-the-wire configuration, it is contemplated that the hypotube lumen 310 may include sealing structure (not shown) adapted to permit a guidewire to pass through the sealing structure yet be at least substantially fluid tight against the guidewire). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include wherein a distal end of the metallic tube is joined to a proximal end of the distal tip using a metal-to-metal joining process. Doing so allows for a strong connection between the tip and tube for it to be fluid tight against the guidewire.
Regarding claim 9, Lane teaches the cryoablation shaft of claim 7, but fails to fully teach wherein the distal tip defines a central channel, wherein the central channel is configured to receive the guidewire, wherein a proximal end of the central channel of the distal tip is joined to a distal end of the metallic tube.
However, Musbach teaches wherein the distal tip defines a central channel, wherein the central channel is configured to receive the guidewire, wherein a proximal end of the central channel of the distal tip is joined to a distal end of the metallic tube ([Pg 21 Para 2] the hypotube lumen 310 may be sized to accommodate a guidewire (not shown). In a fixed wire configuration, it is contemplated that a distal portion of the hypotube lumen 310 include a plug or other structure to seal the interior of the hypotube lumen 310. In an over-the-wire configuration, it is contemplated that the hypotube lumen 310 may include sealing structure (not shown) adapted to permit a guidewire to pass through the sealing structure yet be at least substantially fluid tight against the guidewire). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include wherein the distal tip defines a central channel, wherein the central channel is configured to receive the guidewire, wherein a proximal end of the central channel of the distal tip is joined to a distal end of the metallic tube. Doing so allows for the guide wire to be in the center channel for effective guiding of the device.
Regarding claim 20, Lane teaches the cryoablation shaft of claim 19, further comprising a distal tip configured to seal a distal end of the expansion chamber at a distal tip of the cryoablation shaft (Fig 13; distal tip 883), but fails to fully teach wherein the distal tip comprises metal.
However, Doback teaches wherein the distal tip comprises metal ([26] a metal plug can be installed in the tip of the outer tube or catheter, for applying cooling through the extreme distal tip of the catheter. Alternatively, a relatively narrow metal strip can be mounted in a side wall of the catheter, near the distal tip, for applying cooling to a narrow strip of tissue). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include wherein the distal tip comprises metal. Doing so allows for the tip to apply cooling for effective treatment.
Claim(s) 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2), further in view of Suzuki (US 20170304591 A1), further in view of Duong (US 20140276706 A1).
Regarding claim 12, Lane teaches the cryoablation shaft of claim 1, wherein the guidewire lumen may form a curve ([0037] An inextensible guide wire 21 extends from the handle to the tip 10c for exerting tension via a take up wheel 22 that is turned by lever 24 to curve the tip of the catheter and steer it through various branch points along the route through a vessel to the intended treatment site), but fails to fully teach having a smallest radius of curvature of less than or equal to 30 mm.
However, Duong teaches having a smallest radius of curvature of less than or equal to 30 mm ([0103] The catheter body 306, along with the distal section 308 described below, is capable of bending around a contour having an angle of less than ninety degrees, having a bend radius of less than 0.50 inch). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include having a smallest radius of curvature of less than or equal to 30 mm. Doing so allows for bending to accommodate insertion and movement while applying treatment.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to having a smallest radius of curvature of less than or equal to 30 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 18, Lane teaches the cryoablation shaft of claim 1, wherein the guidewire lumen may form a curve ([0037] An inextensible guide wire 21 extends from the handle to the tip 10c for exerting tension via a take up wheel 22 that is turned by lever 24 to curve the tip of the catheter and steer it through various branch points along the route through a vessel to the intended treatment site), but fails to fully teach having a smallest radius of curvature of less than or equal to 30 mm.
However, Duong teaches having a smallest radius of curvature of less than or equal to 30 mm ([0103] The catheter body 306, along with the distal section 308 described below, is capable of bending around a contour having an angle of less than ninety degrees, having a bend radius of less than 0.50 inch).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane to include having a smallest radius of curvature of less than or equal to 30 mm. Doing so allows for bending to accommodate insertion and movement while applying treatment.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to having a smallest radius of curvature of less than or equal to 30 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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane (US 20060030843 A1) in view of Musbach (WO 2007070235 A2), further in view of Suzuki (US 20170304591 A1), further in view of Datta (US 20090088697 A1).
Regarding claim 21, Lane teaches cryoablation shaft of claim 1, but fails to teach the first compressive wrap comprising a filament wrapped around the polymer sleeve and the metallic tube of the guidewire lumen.
However, Datta teaches the first compressive wrap comprising a filament wrapped around the polymer sleeve and the metallic tube of the guidewire lumen ([0034] The compression coil 44 is made of any suitable metal, such as stainless steel) ([0032] The single lumen 18 permits the lead wires 40, the device 46, the sensor cable 74, and the puller wire 42 surrounded by the compression coil 44 to float freely within the catheter body). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lane in view of Suzuki to include the first compressive wrap comprising a filament (compression coil) wrapped around the polymer sleeve and the metallic tube of the guidewire lumen. Doing so provides consistent force to secure the sleeve to the metal tube.
Further, it would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to use a compressive coil, since applicant has not disclosed that compressive wrap comprising a filament solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a compressive coil, as a compressive coil and compressive wrap comprising a filament are equivalent in the art as they both yield the same expected result of providing a compressive seal.
Allowable Subject Matter
10. Claims 22 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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