DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Election/Restrictions
3. Applicant’s election without traverse of Group I, Claims 1-14 drawn to a cryoablation apparatus, in the reply filed on 12/04/2025 is acknowledged.
4. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1-5 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baust U.S. 2012/0059364 (herein referred to as “Baust”).
7. Regarding Claim 1, Baust teaches a cryoablation apparatus (Fig. 1, ref num 30) comprising:
a. a Dewar (Fig. 1, ref num 6) configured to retain a volume of cryogen (para 0057, “The dewar 6 stores liquid cryogen”); and
b. a heater assembly positioned in the Dewar (Fig. 1, ref num 44), the heater assembly comprising at least one heater configured to heat a targeted portion of the cryogen as the volume of the cryogen in the Dewar changes (para 0058, “an immersion heater 44 housed in the internal open chamber 42 heats the cryogen to create a desired pressure…when the heater is activated, it boils the nitrogen within the immediate area… liquid nitrogen is converted to supercritical nitrogen (SCN) within the pressurization apparatus. The SCN is then directed to the heat exchanger for subcooling and tuned to the liquid phase to attain an excess temperature”).
8. Regarding Claim 2, Baust teaches the target portion of the cryogen comprises a portion of the cryogen at or near a liquid level of the cryogen (para 0057, “dewar 6 is filled with liquid nitrogen… to a maximum level 13”).
9. Regarding Claim 3, Baust teaches the targeted portion of the cryogen comprises a portion within a predetermined distance from the liquid level of the cryogen (para 0058-0059, 0067, 0072).
10. Regarding Claim 4, Baust teaches the heater is configured to convert liquid nitrogen to cryogen vapor (para 0057-0059).
11. Regarding Claim 5, Baust teaches the heater assembly is coupled to a transfer conduit inside the Dewar (Fig. 1, ref num 44 is coupled to ref num 40 and 1).
12. Regarding Claim 14, Baust teaches the cryogen is Nitrogen (para 0057-0058).
Claim Rejections - 35 USC § 103
13. 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.
14. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Baust and in view of DeLonzer U.S. 2007/0244474 (herein referred to as “DeLonzer”).
15. Regarding Claim 6, Baust fails to teach the heater assembly is coupled to a wall of the Dewar.
DeLonzer teaches a cryoablation apparatus of analogous art (Fig. 7) wherein the apparatus comprises a Dewar (Fig. 7, ref num 3) and a heater assembly positioned in the Dewar (Fig. 7, ref num 7), such that the heater assembly is coupled to a wall of the Dewar (para 0031, “heater 7… may be disposed on the inside wall of the dewar”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the heater assembly coupled to a wall of the Dewar, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
16. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baust and in view of Levin U.S. 2013/0103020 (herein referred to as “Levin”).
17. Regarding Claim 7, Baust fails to teach the heater assembly is coupled to a support bar in the Dewar.
Levin teaches a cryoablation apparatus of analogous art (Fig. 2a), wherein the apparatus comprises a Dewar (Fig. 2a, ref num 10) and a heater assembly positioned in the Dewar (Fig. 2a, ref num 241). The heater assembly is coupled to a support bar in the Dewar (Fig. 2a, ref num 271 is coupled to shaft, ref num 271). This achieves the desired operation pressure within the Dewar (para 0070, “An electrical heater 271 is placed on the lower section of the feeding conduit 262; this allows achieving operation pressure in the internal space of the Dewar flask 101”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baust to have the heater assembly coupled to a support bar in the Dewar in order achieve the desired pressure within the Dewar.
18. Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Baust and in view of Duong U.S. 2014/0276706 (herein referred to as “Duong”).
19. Regarding Claim 8, while Baust fails to explicitly teach the heater assembly comprises a plurality of heaters, another embodiment of Baust teaches a plurality of heaters (Fig. 4, ref num 44; para 0074, “the chambers 40, each comprising an individual immersion heater 44”). The plurality of heaters enhances the heater assembly (para 0073). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first embodiment of Baust to include a plurality of heaters in order to enhance the heater assembly.
Baust fails to teach that each of the plurality of heaters are positioned at different height levels to a base of the Dewar.
Duong teaches a cryoablation apparatus of analogous art (Figs. 1, 4, and 7), wherein the apparatus comprises a heater assembly with a plurality of heaters (Fig. 7, ref num 154 having heaters, ref nums 168, 172), such that the heaters are each positioned at a different height relative to a base of a Dewar (Fig. 7, ref num 170 = Dewar; ref num 168 is higher compared to the bottom of ref num 170; para 0080, “the heat exchanger 168 is positioned at the neck of a Dewar 170”). This ensures that the cryogen is a gas as it exits the Dewar, above the liquid level of cryogen (Fig. 7, ref num 176 is above ‘liquid level’; para 0080). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baust to have the plurality of heaters at different heights relative to the base of the Dewar in order to continue the heating process above the liquid level of the cryogen.
20. Regarding Claim 10, Baust fails to teach the at least one heater is positioned at a top of the Dewar.
Duong teaches a cryoablation apparatus of analogous art (Figs. 1, 4, and 7), wherein the apparatus comprises a heater assembly (Fig. 7, ref num 154 having heaters, ref nums 168, 172), such that the heater is positioned at a top of the Dewar (Fig. 7, ref num 170 = Dewar; ref num 168 is higher compared to the bottom of ref num 170; para 0080, “the heat exchanger 168 is positioned at the neck of a Dewar 170”). This ensures that the cryogen is a gas as it exits the Dewar, above the liquid level of cryogen (Fig. 7, ref num 176 is above ‘liquid level’; para 0080). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baust to have the heater positioned at a top of the Dewar in order to continue the heating process above the liquid level of the cryogen.
21. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Baust.
Regarding Claim 9, Baust teaches the heater is positioned inside an insulated enclosure in the Dewar (para 0057, “vacuum insulating dewar 6”; Fig. 1, ref num 44 is inside the insulated enclosure).
While Baust fails to explicitly teach the heater assembly comprises a plurality of heaters, another embodiment of Baust teaches a plurality of heaters (Fig. 4, ref num 44; para 0074, “the chambers 40, each comprising an individual immersion heater 44”). The plurality of heaters enhances the heater assembly (para 0073). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first embodiment of Baust to include a plurality of heaters in order to enhance the heater assembly.
Allowable Subject Matter
22. Claims 11-13 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.
23. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to specifically teach the heater being configured to move in the Dewar, further that it is slidably positioned on a shaft in the Dewar and configured to slide along the shaft as a liquid level of the cryogen in the Dewar changes, such that the heater comprises a float having a predetermined buoyancy that is configured to maintain the at least one heater at a predetermined position relative to the liquid level of the cryogen in the Dewar.
Conclusion
24. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794