DETAILED ACTION
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 .
Response to Amendment
The amendment filed 09/28/2025 has been entered. Claims 1-12 remain pending in the application. Claims 13 & 14 have been entered.
Response to Arguments
Applicant's arguments with respect to claims 1-12 have been considered but are not seen as persuasive, see reasonings below.
Applicant's arguments with respect to claims 13-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Regarding claim 1 & 7, applicant argues Hilleli does not explicitly disclose a pump support. Examiner disagrees, while Hilleli does not explicitly discuss the wall shown in Figure 1 & 2 which is also annotated below, that it is visible that this structure is supporting the pump 56 as well as is mounted on top of the container 72 which contains the cryogen through motor 68 and piston 64. Applicant also argues that pump support does not seal the container which Examiner wants to point out in container 72, it is visible in Figure 1-2 that the pump support seals the container which is connected to piston 64 & motor 68 by not allowing movement from either element. Therefore, Examiner stands by the rejection as taught above and in the Non-Final rejection,
Regarding claims 2-12, Examiner sees claim 1 dependents as being unpatentable over Rubinsky in view of Hilleli as taught by the Non-final action and the reasonings above
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.
Claims 1-12 is rejected under 35 U.S.C 103 as being unpatentable over Rubinsky et al. (EP 0550666) herein referred to as Rubinsky in view of Hilleli et al. (US 20210244457) herein referred to as Hilleli.
Regarding Claim 1, Rubinsky discloses an apparatus (Figure 10), comprising: a single insulated container configured to contain a cryogen (Figure 7B; “DEWAR OR SLUSH CHAMBER”; Claim 15; wherein containers for storing the cryogen are insulated); a first pump and a second pump (Figure 7B; a portion of the pump is disposed within the cryogen; Column 23, lines 12-13; wherein each probe has its own cryogen pump), both disposed in the single insulated container and configured to pump the cryogen from the single insulated container while immersed in the cryogen (Figure 7B; a portion of the pump is disposed within the cryogen; Column 23, lines 12-16; wherein each probe has its own cryogen pump and each pump operates with either continuous or proportional flow of the cryogen to each probe ); and a first probe and a second probe (Column 23, lines 11-13; wherein the system has multiple probes, therefore a first probe and a second probe), having respective first and second proximal ends coupled to receive concurrently the cryogen pumped by the first pump and the second pump (Figure 12; wherein figure 12 is the probe and 306 is the supply tube on the proximal end supplying the cryogen pumped by the pumps through inlet 311; Column 23, lines 12-16; wherein each probe has its own cryogen pump and each pump operates with either continuous or proportional flow of the cryogen to each probe), respectively, and having respective first and second distal ends (Figure 12; wherein end that contains tapered tip 314 is seen as the distal end), which are chilled by the cryogen received through the first and second proximal ends and are configured to be inserted into a body of a living subject (Claim 1; wherein cryogen is supplied to the probes through an open end which is the proximal end and the distal end for freezing living tissue; Column 25 lines 36-38; wherein tips are inserted into a tumor or other organ therefore into a body of a living subject). However, Rubinsky does not explicitly disclose a pump-support, mounted on the container so as to seal the contained cryogen therein, configured to retain the first pump and the second pump immersed in the cryogen; a first motor and a second motor fixed to the pump- support and coupled to drive the first pump and the second pump respectively;
Hilleli discloses an apparatus (Figure 2) comprising a pump-support (See annotated Figure 2 below), mounted on the container so as to seal the contained cryogen therein (See annotated Figure 2 below; support is mounted onto the container therefore holding the pump in place to seal the contained cryogen), configured to retain the pump immersed in the cryogen (See annotated Figure 2 below; support is mounted onto the container therefore holding the pump in place to seal the contained cryogen); a motor fixed to the pump-support and coupled to drive the pump respectively (Figure 2, 68). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified both pumps taught by Rubinsky to contain the structure taught by Hilleli. The motivation being it would be obvious to try different designs and set-ups for pump structure to see which allows for the most efficient design (MPEP 2143 (D)).
Regarding Claim 2, Rubinsky in view of Hilleli discloses the apparatus according to claim 1. Hilleli also discloses wherein the pump is respectively selected from a group comprising a bellows pump and a piston pump (Claim 12 & 13). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump taught by Rubinsky for the pump taught by Hilleli. The motivation being a simple substitution of one known pump, the pump taught by Rubinsky for another pump, the pump taught by Hilleli to obtain predictable results of supplying a cryogen to a probe (MPEP 2143 (B)).
Regarding claim 3, Rubinsky discloses the apparatus according to claim 1, wherein the first pump and the second pump are not connected (Column 23, lines 13-16; wherein the pump controls the amount and rate being supplied to each probe therefore, if each pump has its own probe as taught in claim 1, they are independent of each other therefore not connected).
Regarding claim 4, Rubinsky discloses the apparatus according to claim 1, wherein the cryogen pumped by the first pump is at a first rate of flow (Column 23, lines 13-16; wherein the pump controls the amount and flow rate being supplied to each probe), and wherein the cryogen pumped by the second pump is at a second rate of flow (Column 23, lines 13-16; wherein the pump controls the amount and flow rate being supplied to each probe), and wherein the first and second rates of flow are independent of each other (Column 23, lines 13-16; each pump has its own probe as taught in claim 1, they are independent of each other therefore not connected since the pump controls the amount and flow rate being supplied to each probe).
Regarding claim 5, Rubinsky discloses the apparatus according to claim 4, wherein the first distal end comprises a first temperature sensor and the second distal end comprises a second temperature sensor (Figure 12, 326; Column 28 lines 15-18), and wherein the first rate of flow is in response to a first temperature measured by the first temperature sensor and the second rate of flow is in response to a second temperature measured by the second temperature sensor (Column 13; lines 24-27; wherein temperature readings by a thermocouple on the tip of a probe is for measuring and controlling probe tip temperatures; Column 11, lines 32-57; wherein temperature of the probe affects the flow rate therefore by controlling the temperature based on the measured temperature by the thermocouple which is a temperature sensor will change the flow rate).
Regarding claim 6, Rubinsky discloses the apparatus according to claim 1, and comprising a processor configured to operate the first pump and the second pump (Figure 10, 222).
Regarding claim 7, Rubinsky discloses a method (Column 19, lines 4-31), comprising: providing a single insulated container configured to contain a cryogen (Figure 7B; “DEWAR OR SLUSH CHAMBER”; Claim 15; wherein containers for storing the cryogen are insulated); disposing a first pump and a second pump in the single insulated container (Figure 7B; a portion of the pump is disposed within the cryogen; Column 23, lines 12-16; wherein each probe has its own cryogen pump and each pump operates with either continuous or proportional flow of the cryogen to each probe), and configuring the pumps to pump the cryogen from single insulated container while immersed in the cryogen (Column 23, lines 13-16; wherein the pump controls the amount and flow rate being supplied to each probe); and coupling a First probe and a second probe respectively to the first pump and the second pump (Column 23, lines 12-16; wherein each probe has its own cryogen pump and each pump operates with either continuous or proportional flow of the cryogen to each probe), wherein the first probe and the second probe have respective first and second proximal ends coupled to receive concurrently the cryogen pumped by the first pump and the second pump (Figure 12; wherein figure 12 is the probe and 306 is the supply tube on the proximal end supplying the cryogen pumped by the pumps through inlet 311; Column 23, lines 12-16; wherein each probe has its own cryogen pump and each pump operates with either continuous or proportional flow of the cryogen to each probe), respectively have respective first and second distal ends (Figure 12; wherein end that contains tapered tip 314 is seen as the distal end), which are chilled by the cryogen received through the first and second proximal ends and are configured to be inserted into a body of a living subject (Claim 1; wherein cryogen is supplied to the probes through an open end which is the proximal end and the distal end for freezing living tissue; Column 25 lines 36-38; wherein tips are inserted into a tumor or other organ therefore into a body of a living subject). Regarding Claim 8, Rubinsky discloses the method according to claim 7. However, Rubinsky does not explicitly disclose wherein the first pump and the second pump are respectively selected from a group comprising a bellows pump, a plunger pump and a piston pump.
Hilleli discloses an apparatus for supplying a cryogen wherein the pump is respectively selected from a group comprising a bellows pump and a piston pump (Claim 12 & 13). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump taught by Rubinsky for the pump taught by Hilleli. The motivation being a simple substitution of one known pump, the pump taught by Rubinsky for another pump, the pump taught by Hilleli to obtain predictable results of supplying a cryogen to a probe (MPEP 2143 (B)).
Regarding Claim 8, Rubinsky discloses the method according to claim 7. However, Rubinsky does not explicitly disclose wherein the first pump and the second pump are respectively selected from a group comprising a bellows pump, a plunger pump and a piston pump.
Hilleli discloses an apparatus for supplying a cryogen wherein the pump is respectively selected from a group comprising a bellows pump and a piston pump (Claim 12 & 13). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump taught by Rubinsky for the pump taught by Hilleli. The motivation being a simple substitution of one known pump, the pump taught by Rubinsky for another pump, the pump taught by Hilleli to obtain predictable results of supplying a cryogen to a probe (MPEP 2143 (B)).
Regarding claim 9, Rubinsky discloses the method according to claim 7, wherein the first pump and the second pump are not connected (Column 23, lines 13-16; wherein the pump controls the amount and rate being supplied to each probe therefore, if each pump has its own probe as taught in claim 1, they are independent of each other therefore not connected).
Regarding claim 10, Rubinsky discloses the method according to claim 7, wherein the cryogen pumped by the first pump is at a first rate of flow (Column 23, lines 13-16; wherein the pump controls the amount and flow rate being supplied to each probe), and wherein the cryogen pumped by the second pump is at a second rate of flow (Column 23, lines 13-16; wherein the pump controls the amount and flow rate being supplied to each probe), and wherein the first and second rates of flow are independent of each other (Column 23, lines 13-16; each pump has its own probe as taught in claim 1, they are independent of each other therefore not connected since the pump controls the amount and flow rate being supplied to each probe).
Regarding claim 11, Rubinsky discloses the method according to claim 10, wherein the first distal end comprises a first temperature sensor and the second distal end comprises a second temperature sensor (Figure 12, 326; Column 28 lines 15-18), and wherein the first rate of flow is in response to a first temperature measured by the first temperature sensor and the second rate of flow is in response to a second temperature measured by the second temperature sensor (Column 13; lines 24-27; wherein temperature readings by a thermocouple on the tip of a probe is for measuring and controlling probe tip temperatures; Column 11, lines 32-57; wherein temperature of the probe affects the flow rate therefore by controlling the temperature based on the measured temperature by the thermocouple which is a temperature sensor will change the flow rate).
Regarding claim 12, Rubinsky discloses the method according to claim 7, and comprising operating the first pump and the second pump by a single processor (Figure 10, 222).
Claim 13-14 is rejected under 35 U.S.C 103 as being unpatentable over Rubinsky and Hilleli in view of Danley et al. (US 8418480) herein referred to as Danley.
Regarding Claim 13, Rubinsky in view of Hilleli discloses the apparatus according to claim 1. However, Rubinsky in view of Hilleli does not explicitly disclose comprising a cover, positioned between the container and the pump-support, whereon the pump-support is mounted, the cover being configured to seal the container.
Danely discloses an apparatus (Figure 1) comprising a cover (Figure 3, 208), positioned between the container and the pump-support (See annotated Figure 1 below), whereon the pump-support is mounted (Figure 3, 207), the cover being configured to seal the container (Column 6 lines 53-55). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump support taught by Rubinsky in view of Hilleli to include the structure taught by Danley. The motivation being to allow for movement of the motor freely in an up-and-down motion with respect to cover (Danley, Column 6, Lines 55-57).
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Regarding Claim 14, Rubinsky in view of Hilleli discloses the method according to claim 7. However, Rubinsky in view of Hilleli does not explicitly disclose positioning a cover between the container and the pump-support; mounting the pump-support on the cover; and sealing the container with the cover.
Danely discloses an method (Column 6, lines 43-62) comprising positioning a cover between the container and the pump-support; (See annotated Figure 1 below), mounting the pump-support on the cover (Column 6 lines 53-55), and sealing the container with the cover.
(Column 6 lines 53-55). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump support taught by Rubinsky in view of Hilleli to include the structure taught by Danley. The motivation being to allow for movement of the motor freely in an up-and-down motion with respect to cover (Danley, Column 6, Lines 55-57).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794