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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1, 4-9, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
4. It is noted that claims 21-28 have been newly added.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 4-5, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Baust U.S. 2012/0059364 (herein referred to as “Baust”) and in view of Pourfard U.S. 2025/0072950 (herein referred to as “Pourfard”).
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, wherein the heater is selectively energized to heat a targeted portion of the liquid 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”).
Baust fails to teach the heater is to be entirely submerged within the volume of liquid cryogen and adjacent to a liquid level of the liquid cryogen, such that the targeted portion of liquid cryogen is adjacent to the liquid level of the liquid cryogen.
Pourfard teaches a cryoablation system of analogous art (Fig. 3, ref num 600), wherein the system comprises a Dewar (Fig. 3, ref num 604; para 0058, “main reservoir 604”) and a heater (Fig. 3, ref num 606). The heater is entirely submerged within a volume of liquid cryogen within the Dewar (Fig. 3, ref num 606 is submerged within volume; para The primary heat exchanger 606 is shown submerged in the coolant in the main reservoir 604”; para 0079, “first heat exchanger 606 is shown submerged within the LN2 of the main reservoir 604”; para 0106 describes the coolant as liquid nitrogen). This controls the level of liquid nitrogen within the Dewar (para 0004). 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 entirely submerged within the liquid cryogen in order to better control the level of liquid nitrogen in the Dewar.
While Baust as modified fails to teach the heater selectively heats the portion of liquid cryogen adjacent to the liquid level of the liquid cryogen, Baust does teach that the heater changes the temperature of the immediate area of cryogen when energized (para 0058, “when the heater is activated, it boils the nitrogen within the immediate area”). This would indicate that if the targeted cryogen was adjacent to the liquid level of cryogen, then it would be heated as desired. Therefore, Baust teaches selectively heating targeted areas of the cryogen.
While Baust as modified fails to explicitly teach that the heater is adjacent to a liquid level of the liquid cryogen, rearrangement of this part would require routine skill in the art. Therefore, one of ordinary skill in the art would be able to place the heater adjacent to the liquid level of the liquid cryogen, as this achieves the same desired effect of heating the desired liquid cryogen.
8. Regarding Claim 4, Baust teaches the heater is configured to convert liquid nitrogen to cryogen vapor (para 0057-0059).
9. 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).
10. 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.
11. Regarding Claim 14, Baust teaches the cryogen is Nitrogen (para 0057-0058).
12. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Baust and Pourfard, and further in view of DeLonzer U.S. 2007/0244474 (herein referred to as “DeLonzer”).
13. 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.
14. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baust and Pourfard, and further in view of Levin U.S. 2013/0103020 (herein referred to as “Levin”).
15. 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.
16. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Baust and Pourfard, and further in view of Duong U.S. 2014/0276706 (herein referred to as “Duong”).
17. 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 as well as one heater of the plurality of heaters is configured to be entirely submerged within the volume of liquid cryogen and adjacent to a liquid level of the liquid cryogen and is selectively energized to heat the targeted portion of the liquid cryogen.
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.
Pourfard teaches a cryoablation system of analogous art (Fig. 3, ref num 600), wherein the system comprises a Dewar (Fig. 3, ref num 604; para 0058, “main reservoir 604”) and a heater (Fig. 3, ref num 606). The heater is entirely submerged within a volume of liquid cryogen within the Dewar (Fig. 3, ref num 606 is submerged within volume; para The primary heat exchanger 606 is shown submerged in the coolant in the main reservoir 604”; para 0079, “first heat exchanger 606 is shown submerged within the LN2 of the main reservoir 604”; para 0106 describes the coolant as liquid nitrogen). This controls the level of liquid nitrogen within the Dewar (para 0004). 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 entirely submerged within the liquid cryogen in order to better control the level of liquid nitrogen in the Dewar.
While Baust as modified fails to teach the heater selectively heats the portion of liquid cryogen adjacent to the liquid level of the liquid cryogen, Baust does teach that the heater changes the temperature of the immediate area of cryogen when energized (para 0058, “when the heater is activated, it boils the nitrogen within the immediate area”). This would indicate that if the targeted cryogen was adjacent to the liquid level of cryogen, then it would be heated as desired. Therefore, Baust teaches selectively heating targeted areas of the cryogen.
While Baust as modified fails to explicitly teach that the heater is adjacent to a liquid level of the liquid cryogen, rearrangement of this part would require routine skill in the art. Therefore, one of ordinary skill in the art would be able to place the heater adjacent to the liquid level of the liquid cryogen, as this achieves the same desired effect of heating the desired liquid cryogen.
Allowable Subject Matter
18. Claims 22-28 allowed.
19. Claims 11-13 and 21 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.
20. 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. The prior art of record also fails to specifically teach that in a plurality of heaters, the one heater that is selectively energized changes as the volume of liquid cryogen in the Dewar changes.
Conclusion
21. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
22. 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
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