DETAILED ACTION
This action is in response to amendments received on 3/26/2026. Claims 22-41 were previously pending. Claims 22, 25, 30, 32 and 37 have been amended and claims 23-24 canceled. A complete action on the merits of claims 22 and 25-41 follows below.
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 .
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 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.
Response to Amendment
It is acknowledged that Applicant amended the independent claims to add the previously indicated allowable subject matter; however, upon further consideration and interference search a double patenting issue as well as a new reference has been found. The Non-Final rejection dated 01/16/2026 has been withdrawn and a new Non-Final is hereby issued.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Walton (US Pub. No. 2005/0159735) in view of Baust (US Pub. No. 2012/0059364) and further in view of Vancelette (US Pub. No. 2008/0125764).
Regarding Claim 22, Walton teaches a cryoablation apparatus (Figs. 1 and 11) comprising:
a [cryoballoon], provided with a circulating cold carrier medium therein (“a closed-in tip section at the distal end of the catheter tube” [0021]), and adapted for contacting a human tissue and performing cryoablation on the human tissue; a catheter 300/920 (Figs. 1 and 11), connected to the [cryoballoon] tip, having an inlet end and an outlet end adapted for transporting the cold carrier medium into and out of the cryoballoon (at the proximal end coupled to inlet tube 306 and outlet tube 308 to transport the cold carrier medium into and out of the distal tip [0047] and Fig. 1, also see [0080]-[0081] and Fig. 11);
a storage tank 200/914, provided with the cold carrier medium stored therein ([0044], Fig. 1 and [0075], Fig. 11); a delivery pipeline (306 in Fig. 1, the delivery pipeline shown in Fig. 11, but not numbered), having one end communicated with the storage tank 200/914 and another end communicated with the inlet end of the catheter 300/920 (Figs. 1 and 11); a recovery pipeline (308 in Fig. 1, the return line shown in Fig. 11, but not numbered), having one end communicated with the storage tank and another end communicated with the outlet end of the catheter 300/920 (through the bypass loop 407 shown in Fig. 1 and a similar bypass loop in Fig. 11, which is not numbered);
a refrigeration assembly (precooling assembly provided on the left side in Figs. 1 and 11 comprising a precool compressor 100/972, and precool heat exchanger 114/922), connected in series with the delivery pipeline (at section 114/922), and adapted for cooling the cold carrier medium in the delivery pipeline ([0045] and [0080]); a first cold energy exchanger 114/922, mounted on the delivery pipeline (Figs. 1 and 11) and used for cooling the cold carrier medium flowing through the first cold energy exchanger by heat exchange ([0045] and [0080]); a cold energy generator 100/972 ([0048] and [0080]), for generating cold energy and providing the cold energy to the first cold energy exchanger; and a bypass pipe (marked 407 in Fig. 1, similarly shown in Fig. 11, but not numbered) communicated with the delivery pipeline and the recovery pipeline to allow the delivery pipeline and the recovery pipeline to form a precooling looping path connecting the storage tank 200/914 and the first cold energy exchanger 114/922 in series, wherein the bypass pipe 407 is communicated with the delivery pipeline via a first [three-way] valve (bypass valve 406 is discussed to be a two-way valve), although it is in communication with three-way valve 506 thus the opening and closing of both valves 406 and 506 controls the path as discussed in [0064]-[0065], please note that a similar configuration exist in Fig. 11, Walton does not teach the bypass pipe is in communication with the delivery pipeline via a three-way valve;
In the same field of invention, Vancelette teaches the bypass pipe is in communication with a delivery pipeline (at least one of 224a-h) via a first three-way valve 202/302 ([0026]-[0027] in Fig. 3 and [0032]-[0033] in Fig. 4).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a three-way valve coupling the bypass line to the delivery line instead of the two-way valve disclosed in order to easier control the flow path between the recovery line to the bypass and delivery line as it is known in the art to use two-way or three-way valves for coupling two or three lines together.
Furthermore, Walton does not teach the tip comprising a cryoballoon.
In the same field of cryoablation, Baust teaches “cryotherapy catheter generally includes a treatment member at its distal end, such as an inflatable balloon having a cooling chamber inside. To deliver the cryotherapy, the inflatable balloon may be introduced at a treatment site inside a patient, and the balloon positioned and then inflated” in [0012] and shows a balloon at the distal tip of the catheter in Fig. 11.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a cryoballoon at the distal end of the catheter 300 in order to allow for releasing of the cryogenic fluid into the chamber to “cool the chamber (e.g. through the Joule-Thompson effect), and correspondingly, with the balloon's outer surface, which may be in contact with tissue that is to be ablated” as Baust teaches in [0012] and as the use of cryoballoon in cryoablation is known and widely used in the art.
Claims 25-33 are rejected under 35 U.S.C. 103 as being unpatentable over Walton in view of Baust and Vancelette as applied above and further in view of Babkin (US Pub. No. 2010/0256621).
Regarding Claim 25, Walton in view of Baust teaches a warming step (“recent studies have suggested that the cooling rate and subsequent warming rate can affect the percentage of tissue cells destroyed in a cryoablation procedure” [0016] and “the device uses a warming feature within the cryogenic medical system to maintain a determined size of iceball formation, control treatment times, and allow for probe detachment, tissue thawing, and heating” in [0032] and “After freezing for the desired time, the injection valve was closed, stopping the cryogen flow, and warm saline was utilized to rapidly thaw the probe” [0151] of Baust); however, neither teach or show the the refrigeration assembly further comprises a second cold energy exchanger having a hot fluid channel mounted on the delivery pipeline and a cold fluid channel mounted on the recovery pipeline, wherein cold energy exchange occurs between the cold fluid channel and the hot fluid channel to precool the cold carrier medium flowing through the hot fluid channel, and wherein the hot fluid channel is connected between the storage tank and the first cold energy exchanger.
In the same field of invention, Babkin teaches the refrigeration assembly 32 (Fig. 8) further comprises a second cold energy exchanger 504 having a hot fluid channel mounted on the delivery pipeline 38 and a cold fluid channel (through valve 313) mounted on the recovery pipeline, wherein cold energy exchange occurs between the cold fluid channel (passing through liquid pump 31) and the hot fluid channel (the bypass passing through valve 500 to heating unit 504) to precool the cold carrier medium flowing through the hot fluid channel, and wherein the hot fluid channel is connected between the storage tank 30 and the first cold energy exchanger 32 (Fig. 8). Babkin further teaches “heating the distal section of the cryoprobe. Warming the distal section of the cryoprobe may serve to thaw an ice structure, to facilitate probe removal, or to provide a surgical application such as but not limited to electrocautery, coagulation or heat based ablation” in [0061].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a rewarming looping path passing through a heating unit 504 bypassing the refrigerator in order to raise the temperature to a desired range to warm the frozen tissue during or after the ablation procedure as Babkin’621 teaches in [0061]-[0064].
Regarding Claim 26, Walton teaches wherein the refrigeration assembly further comprises a cold storage device 512, mounted on the recovery pipeline (the extension of return line 308 as seen in Fig. 1), communicated with the first cold energy exchanger via the bypass pipe 407 (in thermal communication), and adapted for storing cold energy coming from the first cold energy exchanger (after it returns from the catheter).
Regarding Claim 27, Walton teaches wherein the refrigeration assembly further comprises a heat-insulation device (console 916 in Fig. 8); wherein the first cold energy exchanger, the second cold energy exchanger, the cold storage device, and a cold energy output end of the cold energy generator are located inside the heat-insulation chamber (Fig. 11 shows “the interactive components in the console of the present invention” [0040], which is very similar to the embodiment of Fig. 1 and thus examiner takes the position that the components of Fig. 1 are also provided in a similar console as claimed in claim 13 of Walton);
However, does not specifically teach the console having a heat-insulation chamber adapted for reducing or eliminating heat conduction to the exterior thereof. This limitation is known from the teachings of Baust in [0057] “the container 6 takes the form of a vacuum insulated dewar 6. Any size or shape of insulated vessel, however, may be utilized as the dewar 6. The dewar 6 stores liquid cryogen and interconnects a supply line 11 and return line 12 to a probe or catheter (not shown) to form a closed system 30. The dewar 6 may be made of material such as stainless steel, cryo-compatible plastic, or any other material known for providing an insulated vessel”.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the console include a heat-insulation chamber adapted for reducing or eliminating heat conduction to the exterior thereof in order to keep the internal components cooled and reduce or eliminate heat conduction to the exterior thereof.
Regarding Claim 28, Walton in view of Baust teaches wherein the heat-insulation device is a box mounted with a vacuumizing device 400 communicated with the heat-insulation chamber ([0046] and Fig. 8 showing a box-like housing, also see [0057] and Fig. 1 of Baust).
Regarding Claim 29, Walton in view of Baust teaches wherein the heat-insulation device is a box with the heat-insulation chamber thereof filled with heat insulation substance (Fig. 8 of Walton and Fig. 1 of Baust).
Regarding Claim 30, Walton in view of Baust teaches a rewarming looping path (“recent studies have suggested that the cooling rate and subsequent warming rate can affect the percentage of tissue cells destroyed in a cryoablation procedure” [0016] and “the device uses a warming feature within the cryogenic medical system to maintain a determined size of iceball formation, control treatment times, and allow for probe detachment, tissue thawing, and heating” in [0032] and “After freezing for the desired time, the injection valve was closed, stopping the cryogen flow, and warm saline was utilized to rapidly thaw the probe” [0151] of Baust); however, neither teach or show the rewarming looping path for transporting the cold carrier medium in the storage tank to the inlet end of the catheter of the cryoablation apparatus as claimed.
In the same field of invention, Babkin teaches a rewarming looping path (passing through valve 500 and heating unit 504 in Fig. 8) for transporting the cold carrier medium in the storage tank 30 to the inlet end of the catheter of the cryoablation apparatus ([0063] and Fig. 8 of Babkin).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a rewarming looping path passing through a heating unit 504 bypassing the refrigerator in order to raise the temperature to a desired range to warm the frozen tissue during the ablation procedure as Babkin teaches in [0061]-[0064].
Regarding Claim 31, Walton in view of Baust and Babkin teaches wherein the rewarming looping path comprises a rewarming pipe, and wherein an inlet end of the rewarming pipe is connected by a second three-way valve (valve 500 of Babkin) to a side of the delivery pipeline that is located upstream of the first cold energy exchanger (Fig. 8 of Babkin).
Regarding Claim 32, Walton in view of Baust and Babkin teaches further comprising a rewarming looping path (passing through valve 500 and heating unit 504 in Fig. 8 of Babkin) for transporting the cold carrier medium in the storage tank to the inlet end of the catheter of the cryoablation apparatus after heating the cold carrier medium ([0063] and Fig. 8 of Babkin).
Regarding Claim 33, Walton in view of Baust and Babkin teaches wherein the rewarming looping path comprises a rewarming pipe (passing through valve 500 and heating unit 504 in Fig. 8 of Babkin) with a heating device 504 connected in series (Fig. 8 of Babkin), and wherein an inlet end of the rewarming pipe is connected by a second three-way valve 500 to an upstream side of an inlet to the hot fluid channel ([0063] and Fig. 8 of Babkin).
Claims 37-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babkin in view of Vancelette.
Regarding Claim 37, Babkin teaches a cryoablation method comprising (abstract):
a precooling step, in which a cold carrier medium is circulated through a cold energy generator for cooling ([0010]), a precooling looping path connecting a storage tank and a first cold energy exchanger 32 in series (through valve 502 as seen in Fig. 8);
an ablating step, in which the precooled cold carrier medium is re-circulated through the cold energy generator for re-cooling and then is transported to a target tissue of a human body, so that cold energy exchange occurs between the cold carrier medium and the target tissue to cool the target tissue for cryoablation of the target tissue ([0042]-[0048] and Fig. 8);
a recovering step, in which the cold carrier medium after cold energy exchange with the target tissue is transported out of the human body and into a storage tank 30 ([0048]); and
a rewarming step ([0021]), in which the transportation of the cooled cold carrier medium into the human body is stopped, and the target tissue is rewarmed (“heating the distal section of the cryoprobe. Warming the distal section of the cryoprobe may serve to thaw an ice structure, to facilitate probe removal, or to provide a surgical application such as but not limited to electrocautery, coagulation or heat-based ablation” [0061]);
however, does not teach the cold energy generator for cooling by using a bypass pipe that is communicated with a delivery pipeline and a recovery pipeline to allow the delivery pipeline and the recovery pipeline to form a precooling looping path connecting a storage tank and a first cold energy exchanger in series, wherein the bypass pipe is communicated with the delivery pipeline via a first three-way valve as claimed.
In the same field of cryoablation art, Vancelette teaches a bypass pipe that is communicated with a delivery pipeline (at least one of 224a-h) and a recovery pipeline to allow the delivery pipeline and the recovery pipeline to form a precooling looping path connecting a storage tank and a first cold energy exchanger in series via a first three-way valve 202/302 (“After primary refrigerant 124 is divided into refrigerant lines 224a-h, a probe control valve 202 is inserted into each line. The probe control valve 202 is a three way valve, preferably a three way solenoid valve, for selectively directing gas away from cryostat 210. Gas directed away from cryostat 210 is directed ultimately back to gas mix compressor 203. Valves 202 can each selectively allow all gas to pass through into the probes, reroute all gas back to the compressor 203, or allow a predetermined amount of gas to both the probes and the compressor 203. Return flow to compressor 203 of refrigerant lines 224a-h first passes through restrictor 204 in each respective line for mass flow balancing of the entire system 200” [0026] and Fig. 3, also see [0027]-[0030] and [0032]-[0033] and Fig. 4).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to include such a bypass system in the invention of Babkin in order to allow for better temperature control of the probe in view of the teachings of Vancelette.
Regarding Claim 38, Babkin teaches wherein, in the recovering step, the cold carrier medium after cold energy exchange with the target tissue is transported out of the human body, and residual cold energy in the cold carrier medium transported out of the human body is utilized to carry out cold energy exchange with the cold carrier medium flowing out of the storage tank 30 at a second cold energy exchanger 32, so as to cause the cold carrier medium before entry into the first cold energy exchanger 33 to be cooled and then transported into the first cold energy exchanger (“the refrigerant re-enters the container 30 through a port or opening 315 completing the flowpath of the liquid refrigerant. The system provides continuous flow of a refrigerant, and the path A-B-C-D-A*-A” [0048], also note that as soon as the fluid enters refrigerator 32 it starts cooling down before entering loop 33).
Regarding Claim 39, Babkin teaches wherein a part of cold energy is stored in the precooling stage, and then transferred to the cold carrier medium recovered from a catheter, so as to be exchanged to the cold carrier medium flowing out of the storage tank at a second cold energy exchanger 32 (Fig. 8 and [0047]-[0048]).
Regarding Claim 40, Babkin teaches wherein, in the rewarming step, the cold carrier medium is circulated through a heating device 504 for being warmed, and then the cold carrier medium after being warmed is transported to the target tissue of the human body, so as to warm the cooled target tissue by heat exchange between the cold carrier medium and the target tissue ([0061]-[0064]).
Regarding Claim 41, Babkin teaches wherein, in the rewarming step, uncooled cold carrier medium is transported to the human body, so as to warm the target tissue by heat exchange between the uncooled cold carrier medium and the target tissue (fluid flowing through valve 500 and heating unit 504 and bypassing the refrigerator as seen in Fig. 8 and discussed in [0061]-[0064]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22 and 25-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,303,180. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a refrigeration systems comprising a storage tank, provided with the cold carrier medium stored therein; a delivery pipeline, having one end communicated with the storage tank and another end communicated with the inlet end of a catheter; a recovery pipeline, having one end communicated with the storage tank and another end communicated with the outlet end of the catheter; a refrigeration assembly, connected in series with the delivery pipeline, and adapted for cooling the cold carrier medium in the delivery pipeline; a first cold energy exchanger, mounted on the delivery pipeline and used for cooling the cold carrier medium flowing through the first cold energy exchanger by heat exchange; a cold energy generator, for generating cold energy and providing the cold energy to the first cold energy exchanger; and a bypass pipe communicated with the delivery pipeline and the recovery pipeline to allow the delivery pipeline and the recovery pipeline to form a precooling looping path connecting the storage tank and the first cold energy exchanger in series, wherein the bypass pipe is communicated with the delivery pipeline via a first three-way valve.
Allowable Subject Matter
Claims 34-36 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 and by receiving an acceptable Terminal Disclaimer.
Regarding Claim 34, Walton in view of Baust, Vancelette and Babkin teaches the invention as applied above; however, neither alone or in combination teach wherein the rewarming looping path also comprises a rewarming backflow pipeline for connecting the outlet end of the catheter of the cryoablation apparatus to the storage tank as claimed.
Claims 35 and 36 depend on claim 34.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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