Mount kitchen sinkDETAILED ACTION
This action is pursuant to claims filed on 5/11/2024. Claims 1-11 are pending. A first action on the merits of claims 1-11 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 Objections
Claims 1-11 are objected to because they recite “J-T slots” which is an acronym for “Joule Thompson slot.” The acronym should be introduced or defined upon the first use and then the acronym can be used throughout the claims. Using the acronym, without first introducing the definition of the acronym, can lead to confusion.
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, 2, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Berzak et al. (hereinafter ‘Berzak’, US 20060079867 A1).
Regarding independent claim 1, Berzak discloses a cryoablation needle having dual J-T slots, comprising: a vacuum wall and J-T slots (Fig. 17), wherein
the vacuum wall comprises: a needle rod (outer wall of cryoprobe 200 in Fig. 17) and an inner tube (inner tube forming chamber 184 and which surrounds 182 in Fig. 17)-;
the needle rod is provided with a needle tip at a distal end (the needle tip is the distal end of 190 in Fig. 17);
the inner tube penetrates through the needle rod, and a cavity is formed between the inner tube and the needle rod (the inner tube forms the chamber 184 in Fig. 17), the cavity being capable of forming a vacuum (this is a functional limitation and capable of forming a vacuum since there is an open chamber which when can form a vacuum when negative pressure is introduced);
in an axis direction of the vacuum wall, a first preset distance exists between a distal end of the inner tube and the distal end of the needle rod (there is a distance between the very distal end of rod 200 and the end of the tube forming chamber 184 as seen in Fig. 17); the distal end of the inner tube is an end of the inner tube close to the needle tip (the distal end of chamber 184 is the end close to the tip as seen in Fig. 17);
the J-T slots comprise: a first J-T slot (JT slot 192 in Fig. 17) and a second J-T slot (JT slot 182 in Fig. 17);
the first J-T slot and the second J-T slot penetrate through the inner tube (182 and 192 penetrate through the inner tube as seen in Fig. 17);
in areas in which the vacuum wall is distributed in the axis direction of the vacuum wall, an area in which the cavity is located is a vacuum insulation area (chamber 184 forms the vacuum insulation area in Fig. 17; [0201]: module 180 is isolated and insulated from other modules – the claim, as written and broadly interpreted, states the “vacuum insulation area” is simply a location of the cavity and is not provided any particular structure. Thus, since the module 180 that forms chamber 184 is both insulated and isolated from the other treatment areas, the limitation is met), and an area in which the first preset distance exists is a target area (area 194 is the area of the first preset distance and is the target area in Fig. 17);
a distal end of the first J-T slot is located in the target area (end of JT slot 196 is in the target area in Fig. 17); the distal end of the first J-T slot is an end of the first J-T slot close to the needle tip (the distal end of JT slot 196 is an end near the needle tip in Fig. 17);
a distal end of the second J-T slot is located in the vacuum insulation area (distal end of JT slot 186 is in chamber 184 as seen in Fig. 17); the distal end of the second J-T slot is an end of the second J-T slot close to the needle tip (186 is closer to the needle tip as seen in Fig. 17);
a refrigerant is introduced into only one of the first J-T slot and the second J-T slot at a time ([0201]: each treatment module of probe 200 is designed to be independently controlled in heating and cooling. Control is preferably effected by controlling a supply of gas delivered to each module. Thus, modules 180 and 190 may be cooled at selected times and in selected degrees, each independently of the others);
in the axis direction of the vacuum wall, a second preset distance exists between the distal end of the first J-T slot and the needle tip (distance between 196 and needle tip in Fig. 17), and the second preset distance at least ensures that an ice ball formed by freezing is wrapped around the needle tip ([0168]: ice ball created at tip during cryoablation; this is also a functional limitation and when the needle tip is cooled, it is inherent that an ice ball would result around the needle tip); and
in the axis direction of the vacuum wall, a third preset distance exists between the distal end of the second J-T slot and a distal end of the vacuum insulation area (there is a distance between the end of the chamber 184 and the distal tip 186 in Fig. 17), and the third preset distance at least ensures that the refrigerant directly returns from the inside of the vacuum insulation area after being sprayed from the second J-T slot ([0089]: gas refrigerant is supplied inside the chamber 184 through JT orifice 186 and directly exhausted out of exhaust conduit 188), the distal end of the vacuum insulation area being an end of the vacuum insulation area close to the needle tip (distal end of chamber 184 is closest to the tip as seen in Fig. 17).
Regarding claim 2, Berzak discloses the cryoablation needle having the dual J-T slots according to claim 1, further comprising: a switching assembly ([0209]: assembly 250 in Fig. 19 controlled by control module 320; [0201]: the control that controls the supply of gas into each module is the switching assembly because the claim does not provide structure for the switching assembly), wherein the switching assembly is connected to the first J-T slot and the second J-T slot separately ([0201]: the control is independent and allows for module 180 and module 190, and additional modules if present, to be operated to cool, or to heat, at selected times and in selected degrees, each independently of the others; [0207-[0209]: the control module controls the delivery of gas to each JT slot by controlling the cooling gas control valves 314 which and each JT slot comprises its own valve as seen in Fig. 19 – thus the control module is separately connected to each JT slot through the control valves) and the switching assembly is configured to switch the refrigerant between the first J-T slot and the second J-T slot ([0201]: control is preferably effected by controlling a supply of gas delivered to each module – gas is delivered through the J-T slots, thus the switching assembly controls the refrigerant between the JT slots).
Regarding claim 10, Berzak discloses the cryoablation needle having the dual J-T slots according to claim 1, comprising: a first refrigerant intake channel, a second refrigerant intake channel, a freezing valve and a pre-purging valve (components highlighted in Fig. 19 below – each channel and valve is not provided a structure or function in the claim and thus the channels and valves are assigned accordingly; these names are not common names for specific structures in the art and based on the specification of the instant application, these are simply arbitrary names given based off of when the refrigerant is delivered and do not constitute a specific structure), wherein
the first refrigerant intake channel is connected to the first J-T slot (first intake channel is connected to the first JT slot as highlighted below);
the second refrigerant intake channel is connected to the second J-T slot (the second intake channel is connected to the second JT slot highlighted below);
the freezing valve is arranged on the first refrigerant intake channel (the freezing valve is connected to the first intake as highlighted below); and
the pre-purging valve is arranged on the second refrigerant intake channel (the pre-purging valve is connected to the second intake as highlighted below).
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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) 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Berzak as applied to claim 2/1 and described above, in view of Holroyd (US 4146030 A).
Regarding claim 3, Berzak discloses the cryoablation needle having the dual J-T slots according to claim 2, wherein the switching assembly comprises: an adjusting cavity, a freezing channel, a pre-purging channel and sealing pieces (adjusting cavity is the space around the valves of the sealing members highlighted below, other components highlighted in Fig. 19 below; [0205]: the probes in the system of Fig. 19 can be those shown in Fig. 17 – the claim does not provide for specific structure or function of each piece and thus the channels and valves are assigned accordingly; these names are not common names for specific structures in the art and based on the specification of the instant application, these are simply arbitrary names given based off of when the refrigerant is delivered and do not constitute a specific structure), wherein
the freezing channel and the pre-purging channel are in communication with the adjusting cavity separately (the freezing and pre-purging channels are in separate communication with separate valves in the adjusting cavity as shown in Fig. 19 below);
the freezing channel is further in communication with the first J-T slot (the freezing channel is in communication with the first JT slot as highlighted below);
the pre-purging channel is further in communication the second J-T slot (the pre-purging channel is in communication with the second JT slot highlighted below);
the adjusting cavity is further in communication with a refrigerant intake channel for introducing the refrigerant (the adjusting cavity is in communication with a refrigerant intake channel as highlighted below; [0207]: the cooling gas is supplied by source 302 which is connected to the valves by a conduit as seen in Fig. 19);
the sealing pieces are arranged in the adjusting cavity (sealing pieces 314 in the adjusting cavity as seen in Fig. 19 and highlighted below), and the sealing pieces at least comprise: a first adjusting portion (valve 314 going to the first JT slot in Fig. 19) and a second adjusting portion (valve 314 going to second JT slot in Fig. 19) in the adjusting cavity;
the sealing piece of the first adjusting position directly or indirectly separates the freezing channel from the refrigerant intake channel ([0207]-[0209]: the valves 314 control the flow of cooling gas to the treatment modules – thus they open or close based on the need of gas in each module, thus directly separating the freezing channel from the refrigeration intake channel); and
the sealing piece of the second adjusting position directly or indirectly separates the pre-purging channel from the refrigerant intake channel ([0207]-[0209]: the valves 314 control the flow of cooling gas to the treatment modules – they open or close based on the need of gas in each module, thus directly separating the pre-purging channel from the refrigeration intake channel).
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However, Berzak shows two sealing valves and is silent to the exact structure of the switch.
Holroyd teaches a cryosurgical instrument that has a unitary in-line valve assembly that allows for the valves to be contained in the instrument itself without making the instrument large, heavy, or upsetting to balance ([Abstract]). The valve assembly can be controlled by a fingertip to route refrigerant through the instrument’s tip to operate the instrument in various modes ([Abstract]). The valve assembly taught by Holroyd is a switching mechanism that controls the flow of refrigerant from a source through to separate lines. There are three modes of operation. The first is OFF where valve balls 3 and 6 in Fig. 13 are seated ([Col 14, lines 51-61]). The second mode of operation allows refrigerant to flow through valve structure 346 because the balls 3 and 4 are unseated while balls 5 and 6 are unseated ([Col 14, lines 62-68]). The last mode is of operation allows refrigerant to flow through the valve structure 354 because balls 3 and 4 are seated while balls 5 and 6 are unseated ([Col 15, lines 4-17]). While the modes provide a slightly different end result for the tip (i.e. freezing vs. defrosting), the end result is due to the conduit size and the effect in the tip, not the opening and closing mechanism of the valve ([Col 14, line 51]-[Col 15, line 17]). Although the valve assemblies can assume slightly different forms depending on how the refrigerant needs to be routed through the instrument, the assembly can be of unitary in-line construction and when compared to systems which require multiple valves, it is relatively simple, inexpensive, rugged, and reliable ([Col 3, lines 38-51]). Converting the valve assembly of Berzak to an inline system as taught by Holroyd would be of ordinary skill in the art. A valve system similar to that shown in Fig. 13 can be used as it controls the flow of refrigerant to an end effector through two different valves through a simple joy stick and rod mechanism. This would simply take the place of the two valve system of Berzak. The sealing ball 3 would in turn become the sealing piece because in one mode it directly prevents flow through channel 346 as it is seated against it and in another mode of operation it indirectly prevents flow through the second channel 354 because it is unseated and channel 346 is open, and fluid will inherently take the shortest path of least resistance. Thus, ball 3 indirectly prevents flow through channel 354 because in the unseated position, it allows refrigerant to flow through channel 346 eliminating some of the flow through channel 354. 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 a unitary in-line valve system like that of Holroyd with the valve system of Berzak to control the flow of refrigerant through the two separate channels such that the two valves or Berzak are replaced with a single, inline valve assembly that can fit in a slim instrument handle that is also inexpensive, reliable, and has a long use life ([Col 3, lines 38-51]).
Regarding claim 4, the Berzak/Holroyd combination discloses the cryoablation needle having the dual J-T slots according to claim 3, wherein the sealing piece is a sealing ball (Holroyd [Col 14, lines 10-68]: seal 3 is a ball).
Regarding claim 5, the Berzak/Holroyd combination discloses the cryoablation needle having the dual J-T slots according to claim 3, further comprising: a sealing piece adjusting apparatus (Holroyd Fig. 13: adjusting apparatus comprising rod 346 and the cavity where it resides) wherein the sealing piece adjusting apparatus is configured to adjust the sealing piece to be switched between the first adjusting position and the second adjusting position (Holroyd [Col 14, lines 10-68]: the rod 346 is adjusted inside of the bore to adjust the sealing ball 3 between the seated and unseated positions).
Regarding claim 6, the Berzak/Holroyd combination discloses the cryoablation needle having the dual J-T slots according to claim 5, wherein the sealing piece adjusting apparatus comprises: a pull wire (rod 76 in Holroyd Fig. 13; [Col 14, lines 10-21]: the rod can be moved in one direction or the other – thus they can pull) and a pull wire channel (passage 362 is the channel in which the rod 76 is housed in Holroyd Fig. 13), wherein
a distal end of the pull wire is connected to the sealing piece (Holroyd [Col 14, lines 25-38]: rod 346 is connected to valve ball 3);
the pull wire penetrates through the pull wire channel (rod 346 penetrates through the wire channel as seen in Holroyd Fig. 13); and
the pull wire is capable of being controlled to move along the pull wire channel, to drive the sealing piece to be switched between the first adjusting position and the second adjusting position (Holroyd [Col 14, line 10]-[Col 15, line 3]: the rod pushes and pulls the valve ball to the seated and unseated positions).
The claim is silent to the thickness and materials of the pull wire and it is the examiner’s opinion that the push rod of Holroyd is equivalent to the claimed “pull wire” because the rod of Holroyd can be pulled and is a round, slender piece of material that resembles a wire in Fig. 13.
However, Holroyd is silent to the rod being a wire.
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 utilize a “pull wire” over a “rod”, since applicant has not disclosed that pull wire specifically solves any stated problem or is for any particular purpose other than pulling the ball seal and it appears that the invention would perform equally as well with a rod since the rod of Holroyd pushes and pulls the valve balls. Furthermore, a thicker pull wire would easily be capable of pushing valve balls as required by Holroyd and Holroyd appears to already disclose a thick wire as seen in Fig. 13.
Regarding claim 7, the Berzak/Holroyd combination discloses the cryoablation needle having the dual J-T slots according to claim 6, further comprising: a guiding piece (joystick 210 in Holroyd Fig. 13), wherein the guiding piece is connected to a proximal end of the pull wire (joystick 210 is connected to the proximal end of rod 346 through ball 4 and rod 76 – the claim as broadly recited does not require a direct connection); and
the guiding piece is capable of being controlled to drive the pull wire to move along the pull wire channel, to drive the sealing piece to be switched between the first adjusting position and the second adjusting position (Holroyd [Col 14, line 10]-[Col 15, line 3]: the stick 210 controls the rod to push and pull the valve ball to the seated and unseated positions).
Allowable Subject Matter
Claims 8, 9, and 11 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.
Regarding claims 8 and 11, Holroyd teaches a spring that can move synchronously with the distal end of the pull wire (spring attached to ball 3 in Holroyd Fig. 13). However, both Berzak and Holroyd are silent to a clamping piece that is capable of entering and exiting a clamped position which limits the spring’s movement by keeping it in a deformation state when clamped and allowing the spring to restore its natural state when released. Furthermore, no such clamping piece was found through a thorough and comprehensive search. While springs with clamps exist, no spring and clamp system was found that would be operable in a ball valve or similar system. Thus, since the system of Holroyd operates without a clamp, there would be no obvious reason to combine a clamp with the valve assembly of the Berzak/Holroyd combination. Therefore, the claims 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 because no prior art found discloses, teaches, or suggests the subject matter of claims 8 and 11.
Claim 9 is objected to due to its dependance on claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Edward (US 3536075 A) discloses a cryosurgical instrument with a valve 73 that directs the flow of refrigerant through two different channels as seen in Figs. 2 and 5. This could also be combined with Berzak to reject claims 3 and 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794