DETAILED ACTION
This action is pursuant to claims filed on 4/16/2026. Claims 1-6, 8-10, 12-18, and 20-23 are pending, claims 7, 11, and 19 have been cancelled by the Applicant. A final action on the merits of claims 1-6, 8-10, 12-18, and 20-23 is as follows.
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 .
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-4, 6, 8-9, 12-15, and 17-18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Yang et al. (hereinafter ‘Yang’, CN 210019628 U).
Regarding independent claim 1, Yang discloses a cryoablation system ([Page 1 of translation]: the invention is a split-type cryoablation device) comprising:
a working gas circuit (gas intake and return passages in Figs. 1-17; [Page 4 of translation]: intake passages 5 and 22 connected to JT groove 16; return passages are 17, 247, 23, and 6);
a vacuum chamber isolated from the working gas circuit ([Page 5 of translation]: vacuum chamber 14 connected to vacuum chamber 15 which communicates with vacuum passage 21 and vacuum hose 4 – there are walls and tubing separating the vacuums from the gas circuit, thus it is isolated as seen in Figs. 2 and 3);
a shaft (shaft 1 in Figs. 1 and 2), the shaft comprising:
an insulated zone along a proximal length of the shaft (insulated zone is the section where the portion of the vacuum chamber 14 is located in Fig. 3), comprising a shaft portion of the vacuum chamber (portion of the vacuum chamber 14 in Figs. 2 and 3) and an insulated portion of the working gas circuit (the portion of passages 16 and 17 that are surrounded by vacuum insulation 14 in Figs. 2 and 3 are insulated by the vacuum chamber), wherein the shaft portion of the vacuum chamber surrounds and is isolated from the insulated portion of the working gas circuit (vacuum chamber 14 surrounds the portions 16 and 17 and is isolated by tube 12 as seen in Fig. 2); and
a working gas expansion chamber distal to the insulated zone (expansion zone 3 of the shaft on the distal end in Fig. 3), wherein the working gas expansion chamber comprises an expansion portion of the working gas circuit ([Page 6 of translation]: the JT groove 16 expels the cold medium in the cutter head 3 and then it returns through passage 17 – JT groove are a standard structure in the art that deploy a cooling medium to expand and cool the tip before returning through the return passage);
a handle comprising (socket body 26 in Fig. 8), a handle portion of the vacuum chamber (portion 21 of the vacuum chamber in Fig. 8), and a handle portion of the working gas circuit (portions of 22 and 23 that are in the socket body 26 as well as passages 5 and 6 where they connect to the socket body 26 in Fig. 8); and
a shaft-handle connector (shaft handle connector is parts 113 and 13 in Figs. 3 and 8), wherein a proximal end of the shaft connects to the shaft-handle connector (proximal end of shaft connects to part 113 in Figs. 3 and 8), wherein the shaft-handle connector is configured to removably attach the proximal end of the shaft to a distal end of the handle (the proximal end of the saft and the distal end of the handle are connected as seen in Fig. 8; [Page 9 of translation]: the plug structure provides for separation and connection between all of the channels and passages; [Pages 6 and 7 of translation]: the portions 113 and 13 have a threaded connection - thus are capable of being screwed and unscrewed from each other which allows the outer body 111 of the shaft to be removed; [Page 8 of translation]: part 24 of piece 13 inserts into body 26 and locks with part 27 for installation and fixing as seen in Fig. 8 – this is a removable part for removing the plug and entire shaft).
wherein the shaft can be removed from the handle while maintaining isolation between the handle portion of the vacuum chamber and the handle portion of the working gas circuit ([Page 9 of translation]: the plug structure provides for separation and connection between all of the channels and passages – when the plug is removed, the shaft and handle are separated and the handle portion of the vacuum chamber and the handle portion of the working gas circuit are still separated from each other and thus isolated from each other; the claim does not provide any specific structure to maintaining isolation between the handle vacuum chamber and gas circuit and since the handle vacuum chamber and gas circuits are separate entities that do not move upon removal of the plug, they are interpreted as maintaining their original isolation).
Regarding claim 2, Yang discloses the cryoablation system of claim 1, wherein the shaft comprises a supply tube extending along a portion of a length of the shaft (supply/JT groove 16), wherein the supply tube is surrounded by an return tube along a portion of a length of the supply tube (supply 16 is surrounded by the return 17 as seen in Fig. 2; [Page 6 of translation]: the return air gap 17 is between the module 12 and the JT slot structure 16 – thus it surrounds the supply 16), wherein the return tube is surrounded by an insulating shaft along the insulated zone of the shaft (return tube 17 is surrounded by insulating shaft 11 of the vacuum insulation portion 14 in Figs. 2 and 3; [Page 6 of translation]: shaft 11 is made of outer tube body 111 and outer tube connecting portion 112 which are directly/integrally connected as seen in Fig. 3), wherein the shaft-handle connector is configured to form a seal around an outer surface the insulating shaft ([Page 6 of translation]: the connecting tube portion 12 is sandwiched between the outer tube fixing member 113 and the plugging body 13; [Page 7 of translation]: the fixing member 113 is a screw nut connecting the pipe 112 and the transition pipe portion and the portion is made of a bell mouth shape such that the assembly can be tightly tightened t by the threads to achieve better connection strength and sealing performance – this claim limitation is written functionally rather than claiming a seal; thus, the two pieces are capable of being tightened sufficiently by the threads to form a seal around an outer surface of 112 which is a part of the insulating shaft 11 as the wedge shaped portion of 13 compresses 112 against the wall of 113 in Fig. 3).
Regarding claim 3, Yang discloses the cryoablation system of claim 2, wherein the shaft-handle connector comprises a first connector piece (first connector piece 113) and a second connector piece (second connector piece 13), wherein a protrusion of the second connector piece is configured to extend within a cavity defined within the first connector piece (protrusion of 13, which is interpreted as the entirety of the most distal half of piece 13 including all internal components, wedges into and threadedly engages with receiving portion of piece 113 in Fig. 3).
Regarding claim 4, Yang discloses the cryoablation system of claim 3, wherein an inner surface of the protrusion of the second connector piece of the shaft-handle connector is configured to form a seal around an outer surface of the return tube ([Page 7 of translation]: the squeeze tube 122 squeezes the inner pipe 121, which forms the outer surface of the return passage 17 in Fig. 3, seals such that the returned gas flowing through the tube assembly 12 does not lead to the vacuum gap 14 – the squeeze tube 122 is an inner surface of the protrusion of the second connector because it is inside of the protrusion and is thus a part of it as stated in the interpretation of the protrusion above).
Regarding claim 6, Yang discloses the cryoablation system of claim 1, wherein an inner surface of the handle is configured to form a seal around an outer surface of the shaft-handle connector ([Page 9 of translation]: seal 242 on outside of plug body 13 in Fig. 8 that seals against an inner surface of the handle portion 26).
Regarding claim 8, Yang discloses the cryoablation system of claim 1, wherein the shaft-handle connector comprises a connector portion of the vacuum chamber (connector portion of vacuum chamber 15 in Fig. 3), wherein the shaft-handle connector defines one or more openings (vent hole 132 in Fig. 8) in fluid communication with the connector portion of the vacuum chamber and is configured to connect to a vacuum chamber portion of the handle ([Page 5 pf translation]: the vent hole 132may be any number of vent holes that communicates with the vacuum chamber 115 and the vacuum passage 21).
Regarding claim 9, Yang discloses the cryoablation system of claim 1, wherein the shaft-handle connector defines one or more openings through which a return portion of the working gas circuit runs between the handle and the shaft-handle connector (air return hole 241 in Fig. 8; [Page 8 of translation]: the air return gap 17, the air return cavity 247, and the air return hole 241 communicate with the air return channel 23 in this order).
Regarding independent claim 12, Yang discloses a cryoablation system comprising:
a working gas circuit (gas intake and return passages in Figs. 1-17; [Page 4 of translation]: intake passages 5 and 22 connected to JT groove 16; return passages are 17, 247, 23, and 6);
a vacuum chamber isolated from the working gas circuit ([Page 5 of translation]: vacuum chamber 14 connected to vacuum chamber 15 which communicates with vacuum passage 21 and vacuum hose 4 – there are walls and tubing separating the vacuums from the gas circuit, thus it is isolated as seen in Figs. 2 and 3);
a shaft (shaft 1 in Figs. 1 and 2), the shaft comprising along a length of the shaft:
an insulated zone along a proximal length of the shaft (insulated zone is the section where the portion of the vacuum chamber 14 is located in Fig. 3), comprising a vacuum chamber shaft portion (portion of the vacuum chamber 14 in Figs. 2 and 3) and an insulated portion of the working gas circuit (the portion of passages 16 and 17 that are surrounded by vacuum insulation 14 in Figs. 2 and 3 are insulated by the vacuum chamber), wherein the vacuum chamber shaft portion surrounds and is isolated from the insulated portion of the working gas circuit (vacuum chamber 14 surrounds the portions 16 and 17 and is isolated by tube 12 as seen in Fig. 2); and
a working gas expansion chamber distal to the insulated zone (expansion zone 3 of the shaft on the distal end in Fig. 3), wherein the working gas expansion chamber comprises an expansion portion of the working gas circuit ([Page 6 of translation]: the JT groove 16 expels the cold medium in the cutter head 3 and then it returns through passage 17 – JT groove are a standard structure in the art that deploy a cooling medium to expand and cool the tip before returning through the return passage); and
a shaft-handle connector (shaft handle connector is parts 113 and 13 in Figs. 3 and 8), wherein a proximal end of the shaft connects to the shaft-handle connector (proximal end of shaft connects to part 113 in Figs. 3 and 8), wherein the shaft-handle connector is configured to removably attach the proximal end of the shaft to a distal end of a handle (the proximal end of the saft and the distal end of the handle are connected as seen in Fig. 8; [Page 9 of translation]: the plug structure provides for separation and connection between all of the channels and passages; [Pages 6 and 7 of translation]: the portions 113 and 13 have a threaded connection - thus are capable of being screwed and unscrewed from each other; [Page 8 of translation]: part 24 of piece 13 inserts into body 26 and locks with part 27 for installation and fixing as seen in Fig. 8 – this is not an integral connection and can thus be removed if necessary), wherein the shaft-handle connector further comprises:
a working gas connector structure (portion of line 16 that runs through the connector and portions of return cavities 17 and 247 that run through connector in Figs. 3 and 8) configured to make a sealed connection to a working gas supply passage in the handle (seal 242 allows for a sealed connection between supply line 5 and 16 as seen in Fig. 8; seal 242 is explained on page 9 of the translation) and a working gas exhaust passage in the handle ([Page 9 of translation]: seal 135 provides a seal to prevent leakage of returning medium and orifice 241 is the return hole; [Page 8 of translation]: the air return gap 17, the air return cavity 247, and the air return hole 241 communicate with the air return channel 23 in this order);
a vacuum connector structure configured to make a sealed connection to a vacuum chamber portion of the handle (seal 134 in Fig. 8 that seals in front of the vacuum chamber orifice 132 and seal 135 behind the orifice in Fig. 8; [Page 8 of translation]: the connection point with the plug body 13 is on the front side of the sealing ring 134, and the vacuum passage 21 and the vent hole 132 are on the rear side of the sealing ring 134. Furthermore, it can ensure that air in the air does not enter the vacuum channel To play a better sealing role; [Page 5 of translation]: vacuum gap 15 communicates with the vacuum passage 21, and a vacuum hose 4 is connected to a rear end of the vacuum passage 21); and
wherein the shaft-handle connector comprises a connector portion of the vacuum chamber (connector portion of the vacuum chamber is portion 15 in Fig. 3) isolated from a connector portion of the working gas circuit (portion 15 surrounds 122 as seen in Fig. 3; [Page 7 of translation]: tube 122 ensures that returning gas does not leak into the vacuum chamber).
Regarding claim 13, Yang discloses the cryoablation system of claim 12, wherein the shaft comprises a supply tube extending along a portion of a length of the shaft (supply/JT groove 16), wherein the supply tube is surrounded by an return tube along a portion of a length of the supply tube (supply 16 is surrounded by the return 17 as seen in Fig. 2; [Page 6 of translation]: the return air gap 17 is between the module 12 and the JT slot structure 16 – thus it surrounds the supply 16), wherein the return tube is surrounded by an insulating shaft along the insulated zone of the shaft (return tube 17 is surrounded by insulating shaft 11 of the vacuum insulation portion 14 in Figs. 2 and 3; [Page 6 of translation]: shaft 11 is made of outer tube body 111 and outer tube connecting portion 112 which are directly/integrally connected as seen in Fig. 3), wherein the shaft-handle connector is configured to form a seal around an outer surface of the insulating shaft ([Page 6 of translation]: the connecting tube portion 12 is sandwiched between the outer tube fixing member 113 and the plugging body 13; [Page 7 of translation]: the fixing member 113 is a screw nut connecting the pipe 112 and the transition pipe portion and the portion is made of a bell mouth shape such that the assembly can be tightly tightened t by the threads to achieve better connection strength and sealing performance – this claim limitation is written functionally rather than claiming a seal; thus, the two pieces are capable of being tightened sufficiently by the threads to form a seal around an outer surface of 112 which is a part of the insulating shaft 11 as the wedge shaped portion of 13 compresses 112 against the wall of 113 in Fig. 3).
Regarding claim 14, Yang discloses the cryoablation system of claim 13, wherein the shaft-handle connector comprises a first piece (first connector piece 113) and a second piece (second connector piece 13), wherein a protrusion of the second piece is configured to extend within a cavity defined within the first piece (protrusion of 13, which is interpreted as the entirety of the most distal half of piece 13 including all internal components, wedges into and threadedly engages with receiving portion of piece 113 in Fig. 3).
Regarding claim 15, Yang discloses the cryoablation system of claim 14, wherein an inner surface of the protrusion of the second piece of the shaft-handle connector is configured to form a seal around an outer surface of the return tube ([Page 7 of translation]: the squeeze tube 122 squeezes the inner pipe 121, which forms the outer surface of the return passage 17 in Fig. 3, seals such that the returned gas flowing through the tube assembly 12 does not lead to the vacuum gap 14 – the squeeze tube 122 is an inner surface of the protrusion of the second connector because it is inside of the protrusion and is thus a part of it as stated in the interpretation of the protrusion above).
Regarding claim 17, Yang discloses the cryoablation system of claim 12, wherein the shaft-handle connector comprises a connector portion of the vacuum chamber (connector portion of vacuum chamber 15 in Fig. 3), wherein the shaft-handle connector defines one or more openings (vent hole 132 in Fig. 8) in fluid communication with the connector portion of the vacuum chamber and is configured to connect to a vacuum chamber portion of the handle ([Page 5 pf translation]: the vent hole 132may be any number of vent holes that communicates with the vacuum chamber 115 and the vacuum passage 21).
Regarding claim 18, Yang discloses the cryoablation system of claim 12, wherein the shaft-handle connector defines one or more openings through which a return portion of the working gas circuit runs between the handle and the shaft-handle connector (air return hole 241 in Fig. 8; [Page 8 of translation]: the air return gap 17, the air return cavity 247, and the air return hole 241 communicate with the air return channel 23 in this order).
Regarding claim 21, Yang discloses the cryoablation system of claim 18, wherein the one or more openings are in fluid communication with the insulated portion of the working gas circuit such that after expansion in the expansion chamber the working gas circuit returns through the shaft and exits through the working gas exhaust via the one or more openings in the shaft-handle connector ([Page 8 of translation]: the air return gap 17, the air return cavity 247, and the air return hole 241 communicate with the air return channel 23 in this order; [Page 6 of translation]: the J-T groove structure 16 can be used to convey the cold medium to the head structure, and then return cold medium through the air return gap 17, and finally discharged).
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.
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) 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claims 3 and 14, respectively, in view of Parmer et al. (hereinafter ‘Parmer’, US 20110178584 A1).
Regarding claim 5, Yang discloses the cryoablation system of claim 3, wherein the second connector piece of the shaft-handle connector comprises an interior space (interior space in which supply tube 16 is disposed) and an inner surface of the interior space is configured to form a seal around an outer surface of the supply tube (the portion 24 of the second piece 13 touches the proximal end of the supply 16 as seen in Fig. 3; [Page 8 of translation]: the JT groove structure 16 passes through the tube assembly 12 and connects to joint structure 24 in turn to connect to the air intake passage 22 as seen in Fig. 8).
However, while the pieces appear to touch, Yang is silent to whether piece 24 is sealed to supply 16.
Parmer teaches a device for remodeling target tissue including a handpiece, treatment tip, and a source of coolant which is supplied and removed through lines in the device, similar to the cryoprobe of Kollner ([0011]). The handle includes coolant delivery and return channels that mate and seal to delivery and coolant channels on the applicatory tip ([0018]). The utilization of seals in the connector aid in the prevention of leaking coolant ([0101]). It would be of routine skill in the art to modify the connection between the supply line 16 and portion 24 such that the outside of the line 16 is sealed to the portion 24 as doing so is merely a change in the size of the components. Furthermore, preventing coolant leakage between these two pieces is an obvious benefit as it would prevent coolant from entering undesirable spaces. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sizes of the supply line 16 or the portion 24 in order to form a seal in order to prevent coolant leakages as taught by Parmer.
Regarding claim 16, Yang discloses the cryoablation system of claim 14, wherein the second piece of the shaft-handle connector comprises an interior space (interior space in which supply tube 16 is disposed) and an inner surface of the interior space is configured to form a seal around an outer surface of the supply tube (the portion 24 of the second piece 13 touches the proximal end of the supply 16 as seen in Fig. 3; [Page 8 of translation]: the JT groove structure 16 passes through the tube assembly 12 and connects to joint structure 24 in turn to connect to the air intake passage 22 as seen in Fig. 8).
However, while the pieces appear to touch, Yang is silent to whether piece 24 is sealed to supply 16.
Parmer teaches a device for remodeling target tissue including a handpiece, treatment tip, and a source of coolant which is supplied and removed through lines in the device, similar to the cryoprobe of Kollner ([0011]). The handle includes coolant delivery and return channels that mate and seal to delivery and coolant channels on the applicatory tip ([0018]). The utilization of seals in the connector aid in the prevention of leaking coolant ([0101]). It would be of routine skill in the art to modify the connection between the supply line 16 and portion 24 such that the outside of the line 16 is sealed to the portion 24 as doing so is merely a change in the size of the components. Furthermore, preventing coolant leakage between these two pieces is an obvious benefit as it would prevent coolant from entering undesirable spaces. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sizes of the supply line 16 or the portion 24 in order to form a seal in order to prevent coolant leakages as taught by Parmer.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 in view of Dobak et al. (hereinafter ‘Dobak’, US 6530234 B1) and in further view of Birdsall et al. (hereinafter ‘Birdsall’, US 20150148791 A1)
Regarding claim 10, Yang discloses the cryoablation system of claim 1 as described above.
However, Yang is silent to the cryoablation system further comprises a pre-cooler gas circuit isolated from the working gas circuit and the vacuum circuit, wherein the handle comprises a handle portion of the pre-cooler gas circuit.
Dobak teaches a precooling system of J-T cryosurgical devices ([Col 3, lines 14-20]). The cooling power is an important design parameter of a cryosurgical instrument. With greater cooling power, more rapid temperature decreases occur, and lower temperatures can be maintained at the probe tip during freezing. This ultimately leads to greater tissue destruction. The power of a J-T cryosurgical device is a function of the enthalpy difference of the primary refrigerant and the mass flow rate. Pre-cooling certain refrigerants will increase the enthalpy difference available for cooling power and increases the average mass flow rate by making the gas more dense ([Col 3, lines 21-31]). Dobak further teaches that this pre-cooling can be done in the handle for ease of handling and maximum efficiency ([Col 6, lines 1-8]). Dobak pre-cools the medium through pre-cooling heat exchangers that promotes colling of the cryogen ([Col 6, lines 43-64]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the pre-cooling apparatus in the handle of Yang in order to further decrease the temperature of the cooling medium to provide greater cooling power to the device.
However, the Yang/Dobak combination is silent to the pre-cooler gas circuit is configured to supply a pre-cooler gas from a high-pressure cryogenic gas source to the handle, the pre-cooler gas circuit comprising a pre-cooler Joule-Thomson orifice where the pre-cooler gas enters a pre-cooler expansion chamber.
Birdsall teaches a cytotherapeutic system for neuromodulation ([Abstract]). Birdsall further teaches that the system can pre-cool the refrigerant to increase the cooling potential of said refrigerant, similar to Dobak ([0110]). The pre-cooling module can pre-cool the primary refrigerant by supplying secondary refrigerant through a secondary supply tube such that when the secondary refrigerant exits the secondary supply tube into an expansion chamber, a Joules-Thomson effect is realized and cools the space around the primary supply tube ([0275]). The substitution of one known element (the pre-cooling Joules Thomson orifice taught by Birdsall) for another (the pre-cooling heat exchanger taught by Dobak) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the pre-cooling J-T orifice shown in Birdsall would have yielded predictable results, namely, pre-cooling the primary refrigerant of the Yang/Dobak combination to increase the cooling potential of the primary refrigerant.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Kollner et al. (hereinafter ‘Kollner’, US 3794039 A).
Regarding independent claim 20, Yang discloses a method of operating a cryoablation system comprising:
providing a cryoablation system ([Page 1 of translation]: the invention is a split-type cryoablation device is provided), the cryoablation system comprising:
a working gas circuit (gas intake and return passages in Figs. 1-17; [Page 4 of translation]: intake passages 5 and 22 connected to JT groove 16; return passages are 17, 247, 23, and 6);
a first catheter assembly (assembly formed by shaft 1, connector 13, and handle 2 in Figs. 2/3/8) comprising a first shaft (first shaft 1 in Figs. 2/3/8) and a first shaft-handle connector (handle connector 13), the first shaft comprising a first working gas expansion chamber (gas expansion chamber 3 in Fig. 3);
a handle (handle 2 in Fig. 8) comprising a handle portion of the working gas circuit (portions of 22 and 23 that are in the socket body 26 as well as passages 5 and 6 where they connect to the socket body 26 in Fig. 8); and
wherein a proximal end of the first shaft connects to the first shaft-handle connector (proximal end of shaft connects to part 113 in Figs. 3 and 8), wherein the first shaft-handle connector removably attaches the proximal end of the first shaft to a distal end of the handle (the proximal end of the saft and the distal end of the handle are connected as seen in Fig. 8; [Page 9 of translation]: the plug structure provides for separation and connection between all of the channels and passages; [Pages 6 and 7 of translation]: the portions 113 and 13 have a threaded connection - thus screw and unscrew from each other);
detaching the first catheter assembly from the handle ([Page 1 of translation]: the solution solves the technical problem of how to realize the separation and connection of the vacuum sandwich passage, the air inlet passage, the air return passage, and the electric wire line through a single plug-in operation at the same time; [Page 9 of translation]: the embodiments can achieve the separation and connection of the vacuum passage, the intake passage, and the return passage at the same time through one plug).
Thus, Yang discloses separating and connect the first catheter assembly from the handle.
Yang discloses connecting a catheter assembly as described on pages 1 and 9 of the translation. However, Yang does not explicitly state a second catheter assembly is then connected.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the first catheter assembly for attachment to the handle, 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.
Kollner teaches an apparatus for cryosurgery that delivers coolant through a supply line that is vaporized and returned through the return line ([Abstract]). The device has a distal tube end 4 and a handle side12 as seen in Fig. 1. The tube 4 has a threaded section 11 for detachably connecting to grip member 12 ([Col 2, lines 53-64]). This threaded connection facilitates the exchangeability of the tip of the probe which is advantageous because if the tip of the probe is damaged or if a different length or thickness is required, it can be replaced ([Col 2, lines 53-64]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a duplicated catheter assembly as described above to use as a replacement for the first catheter assembly in the case that the first assembly is damaged and needs to be replaced.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1, in view of Sprain et al. (hereinafter ‘Sprain’, US 20230190356 A1).
Regarding claim 22, Yang discloses the cryoablation system according to claim 1 as described above.
However, Yang is silent to the shaft-handle connector comprising a valve, the valve having an open state in which the working gas circuit flows from the handle to the shaft through a conduit of the shaft-handle connector and a closed state in which the working gas circuit cannot flow from the handle to the shaft through a conduit of the shaft-handle connector.
Sprain teaches a coupler for use in connecting a source of pressurized cryomedia to a surgical tool ([0004]). The coupler can include a valve which is configured to open upon connection of the first connector with the second connector in a sealing engagement ([0089]). Upon opening the valve, the first conduit is brought into fluid communication with the second conduit to allow the passage of fluid only when the sealing engagement is made ([0089]). Utilizing a valve in the shaft-handle connector of Yang would be of routine skill in the art and would maintain the operability of Yang. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a valve in the shaft-handle connector of Yang which would ensure fluid only flows once a proper sealing engagement is made between the shaft-handle connector and the handle of the device.
Regarding claim 23, the Yang/Sprain combination discloses the system according to claim 22 as described above. The combination further teaches wherein the valve is configured to switch from the open state to the closed state when the shaft and the shaft-handle connector are removed from the handle ([0089] of Sprain: the valve is only open when a sealing engagement is made, thus when the connector is removed from the handle, the valve closes).
Response to Arguments
Applicant’s arguments, see page 7, filed 4/16/2026, with respect to the 112b rejections of claims 1-19 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 1-19 have been withdrawn.
Applicant's arguments filed 4/16/2026 regarding the rejection of claim 1 have been fully considered but they are not persuasive. The applicant argues that the shaft-handle connector 113 does not removably attach the proximal end of the shaft to the distal end of the handle because if 113 is removed, the shaft would remain connected to the handle. However, this is not persuasive because 113 is merely one part of the shaft-handle connector. The other part of the shaft-handle connector is plug 13. As detailed on page 9 of the translation of Yang, the plug structure 13 provides for separation and connection between all of the channels and passages. The claim is not specific to how the shaft-handle connector connects to both the shaft and the handle. Thus, because the plug 13 is part of the shaft-handle connector and can separate the shaft and all of its components from the handle, the shaft handle connector is capable of detaching the shaft from the handle. Additionally, this removal maintains the isolation of the handle working gas circuit and the handle vacuum chamber because they are not connected upon removal of the plug 13. They simply remain as separate channels and thus remain isolated. The claim does not specify any structure that provides for this isolation or how it is achieved, thus the channels not being connected is interpreted as maintaining the isolation of the gas circuit and the vacuum from each other.
Therefore, the rejection to claim 1 remains.
Applicant's arguments filed 4/16/2026 regarding the rejection of claim 12 have been fully considered but they are not persuasive. Again, the applicant argues that the shaft-handle connector is only portion 113. This is an incorrect reading of the Office Action. The shaft-handle connector comprises portions 113 and plug 13 as described in the office action. The connector is not solely portion 113 as argued. The plug 13 contains a portion of line 16 as seen in Figs. 3 and 8. Plug 13 provides for the sealed connection to the working gas supply passage in the handle and a working gas exhaust passage in the handle as described above. The applicant has claimed these structures broadly. The “working gas connector structure” is simply interpreted as the portion of the structure of the working gas circuit that is present in the shaft-handle connector. The portions of the line 16 and cavities 17 and 247 are the portions of the working gas circuit that are present in the shaft-handle connector (which is plug 13 in combination with portion 113) and make sealed connections to the working has supply in the handle as seen in Fig. 8 and explained on page 9 of the translation.
Therefore, the rejection of claim 12 is maintained.
The applicant does not challenge the specific references as applied to claims 5, 10, and 16. Therefore, the rejections are maintained.
Regarding claim 20, the applicant initially argues that plugging and unplugging the plug body 13 is not the same as removing the first catheter assembly from the handle. This is not persuasive. The plug body 13 attaches the shaft to the handle. As detailed on page 9 of the translation of Yang, the plug structure 13 provides for separation and connection between all of the channels and passages. Unplugging, which is synonymous with detaching, the plug 13 from the handle detaches the shaft, or first catheter assembly, from the handle. Therefore, Yang discloses detaching a first catheter assembly from the handle.
Applicant additionally argues that the tip of Kollner is not analogous to the catheter assembly of Yang and thus the second catheter assembly is not taught. This is not persuasive. A duplication of parts rejection was utilized to duplicate the first catheter assembly of Yang, such that there were two catheter assemblies comprising the same parts as described above. The duplication of parts rejection was not challenged in the Applicant’s arguments. Kollner is simply used to teach that switching one catheter assembly for another is a known method in the art. It would be obvious for one of ordinary skill in the art to utilize a duplicated catheter assembly of Yang as described above as a replacement for the first catheter assembly in the case that the first assembly is damaged and needs to be replaced. Therefore, the claim language is taught because a duplication of parts is used to teach the second catheter assembly and Kollner is used to teach replacing a first part for a second part.
Therefore, the rejection to claim 20 is maintained.
The rejections to the dependent claims 1-6, 8-10, and 13-18 are maintained because they are dependent upon rejected independent claims and their rejections are not specifically challenged by the applicant.
New claims 21-23 are rejected as described above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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