DETAILED ACTION
This action is in response to preliminary amendments received on 8/30/2024. It is acknowledged that all of the originally filed claims 1-21 have been canceled in the response received on 1/21/2021 and new claims 22-41 added. A complete action on the merits of claims 22-41 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.
Claim Objections
Claims 22-41 are objected to because of the following informalities: Claim set dated 1/22/2021 includes claim status indication (canceled) for what appears to be originally filed claims 1-21; however, no originally filed claims 1-21 exist in the application. Furthermore, claims 22-41 include claim status indication of (new), which have been skipped in the following responses such as the latest claim set dated 8/30/2021.
(A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers.
Claims added by a preliminary amendment must have the status identifier (new) instead of (original), even when the preliminary amendment is present on the filing date of the application and such claim is treated as part of the original disclosure. If applicant files a subsequent amendment, applicant must use the status identifier (previously presented) if the claims are not being amended, or (currently amended) if the claims are being amended, in the subsequent amendment. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment.
The status identifier (not entered) is used for claims that were previously proposed in an amendment (e.g., after-final) that was denied entry.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 38 recites the limitation “the first cold energy exchanger” in “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 at a second cold energy exchanger, so as to cause the cold carrier medium before entry into the first cold energy exchanger to be cooled and then transported into the first cold energy exchanger”. There is insufficient antecedent basis for this limitation in the claim. It is noted that since no first cold energy exchanger has been introduced prior to this recitation, it is unclear what first cold energy exchanger is being referred to and therefore, it is unclear how the 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 at a second cold energy exchanger can result in “so as to cause the cold carrier medium before entry into the first cold energy exchanger to be cooled and then transported into the first cold energy exchanger”. Clarification and appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babkin et al. (US Pub. No. 2013/0345688).
Regarding Claim 22, Babkin teaches a cryoablation apparatus (abstract) comprising:
a cryoballoon 102/302/302/502/602 (Figs. 5A-10), provided with a circulating cold carrier medium therein, and adapted for contacting a human tissue and performing cryoablation on the human tissue ([0083]-[0085] and Figs. 5A-10);
a catheter 100/103/300/311/450 (Figs. 3A-10), connected to the cryoballoon, having an inlet end and an outlet end, and adapted for transporting the cold carrier medium into and out of the cryoballoon ([0015]-[0024]);
a storage tank (container 30-Fig. 3A), provided with the cold carrier medium stored therein ([0059]);
a delivery pipeline (input line 38 [0061]), having one end communicated with the storage tank and another end communicated with the inlet end of the catheter (Fig. 3A);
a recovery pipeline (Fig. 3A), having one end communicated with the storage tank and another end communicated with the outlet end of the catheter (“returned liquid refrigerant then passes through a check valve 313 intended to decrease the pressure of the returned refrigerant to slightly above the initial pressure p.sub.0. Finally, the refrigerant re-enters the container 30 through a port or opening 315 completing the flowpath of the liquid refrigerant” [0061]); and
a refrigeration assembly 32, connected in series with the delivery pipeline 38, and adapted for cooling the cold carrier medium in the delivery pipeline ([0061] and Fig. 3A).
Regarding Claim 23, Babkin teaches wherein the refrigeration assembly 32 comprises: a first cold energy exchanger 33, mounted on the delivery pipeline 38 and used for cooling the cold carrier medium flowing through the first cold energy exchanger by heat exchange ([0060]-[0061] and Fig. 3A); and a cold energy generator (“boil-off cryogen 34, 35 provided by transfer line 36 and maintained under a predetermined pressure by check valve 37” [0060], for generating cold energy and providing the cold energy to the first cold energy exchanger 33 ([0058]-[0061]).
Claims 37-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babkin et. Al. (US Pub. No. 2010/0256621); hereon after Babkin’621.
Regarding Claim 37, Babkin-621 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]);
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]).
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]).
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.
Claims 25-26 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Babkin et al. in view of Babkin’621.
Regarding Claim 25, Babkin teaches the invention as applied above, but does not teach wherein 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’621 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).
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’621 teaches in [0061]-[0064].
Regarding Claim 26, Babkin in view of Babkin’621 teaches wherein the refrigeration assembly further comprises a cold storage device (605 when the liquid pump 603 is reversed, Fig. 10 of Babkin), mounted on the recovery pipeline, (configured to be in) communicated with the first cold energy exchanger 32 (via the bypass pipe as disclosed by Babkin’621), and adapted for storing cold energy coming from the first cold energy exchanger ([0095] of Babkin).
Regarding Claims 30, Babkin teaches the invention ad applied above, but does not teach teaches further comprising a rewarming looping path for transporting the cold carrier medium in the storage tank 30 to the inlet end of the catheter of the cryoablation apparatus.
In the same field of invention, Babkin’621 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’621).
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’621 teaches in [0061]-[0064].
Regarding Claim 31, Babkin in view of Babkin’621 teaches wherein the rewarming looping path comprises a rewarming pipe (the pipe connecting the bypass region to the input line 38 in Fig. 8 of Babkin’621), and wherein an inlet end of the rewarming pipe is connected by a second three-way valve (“Bypassing the refrigerator, or switching the flowpaths may be performed using, for example, valves 500, 502. However, other means may be utilized as is known to those of skill in the art” [0063]; therefore although a three-way valve is not specifically shown, since it does teach “other means may be utilized as is known to those of skill in the art” the use of a three-way valve instead of valves 500/502 to thereby control the delivery of fluid either through the bypass line or the refrigerator line would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention as the use of a three-way valve for such cause is a known alternative to the valves discussed) to a side of the delivery pipeline 38 that is located upstream of the first cold energy exchanger (Fig. 8 of Babkin’621).
Regarding Claim 32, Babkin in view of Babkin’621 teaches further comprising 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 after heating the cold carrier medium ([0063]-[0064] and Fig. 8 of Babkin’621).
Regarding Claim 33, Babkin in view of Babkin’621 teaches wherein the rewarming looping path comprises a rewarming pipe with a heating device 504 connected in series, and wherein an inlet end of the rewarming pipe is connected by a second three-way valve (“Bypassing the refrigerator, or switching the flowpaths may be performed using, for example, valves 500, 502. However, other means may be utilized as is known to those of skill in the art” [0063]; therefore although a three-way valve is not specifically shown, since it does teach “other means may be utilized as is known to those of skill in the art” the use of a three-way valve instead of valves 500/502 to thereby control the delivery of fluid either through the bypass line or the refrigerator line would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention as the use of a three-way valve for such cause is a known alternative to the valves discussed) to an upstream side of an inlet to the hot fluid channel (Fig. 8 of Babkin’621).
Allowable Subject Matter
Claims 24, 27-29 and 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.
Regarding Claim 24, Babkin teaches the invention as applied above, but not a bypass pipe communicated with the delivery pipeline (Fig. 8 of Babkin’621); however, neither alone or in combination teach the 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.
Regarding Claim 27, Babkin in view of Babkin’621 teaches the invention as applied above, but neither alone or in combination teach wherein the refrigeration assembly further comprises a heat-insulation device, having a heat-insulation chamber adapted for reducing or eliminating heat conduction to the exterior thereof, 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.
Claims 28-29 are objected due to dependency over claim 27.
Regarding Claim 34, Babkin in view of Babkin’621 teaches the rewarming looping path; 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.
Claims 35-36 are objected due to dependency over claim 34.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794