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 Arguments
Applicant’s arguments filed on 05/05/2025 have been fully considered but are moot in view of a new grounds of rejection. Nevertheless, to advance prosecution, Examiner addresses the following argument:
Applicant argues that Reid does not disclose adjusting coolant flow rates to change a direction of heat dissipation of an ablation device.
While Examiner acknowledges that Reid does not disclose changing a direction of heat dissipation, Examiner asserts that Reid is not being relied upon to teach this limitation. As discussed below (see Claim Rejection 35 USC § 103), Reid discloses an analogous ablation device that adjusts an inflow rate of coolant or a type of coolant to control heat dissipation from the ablation device. Reid provides motivation for one of ordinary skill in the art to modify the ablation setting disclosed by Ladtkow to be either an inflow rate of coolant or coolant type. Therefore, it is not Reid alone that teaches adjusting coolant flow rates to change a direction of heat dissipation, but the proposed combination of Ladtkow in view of Reid (and Morneau).
Claim Rejections - 35 USC § 103
Claims 1, 3-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ladtkow et al. (US 2014/0046316), in view of Morneau et al. (US 2020/0155217), in view of Reid JR (US 2013/0178841).
In re claim 1, Ladtkow discloses a system (FIG. 1; abstract), comprising:
an ablation device (12), comprising:
a housing (23) with a proximal end (20) and a distal end (22), the housing partitioned into a plurality of sections (FIG. 3B);
a cable (Fig. 3B: 36) disposed at least partially within the housing [0099],
the cable configured to generate ablation energy dissipated from the distal end of the housing to ablate anatomical tissue [0090];
at least one inflow channel (Fig. 3B: 19c’ from 19a’/19c’, 19c’) disposed at least partially within a first section of the housing (circular region occupied by 19a’/19c’), the at least one inflow channel fluidically connectable to a coolant reservoir (32) to dispense a coolant into the distal end of the housing [0091]; and
a plurality of outflow channels (Fig. 3B: 19a’) disposed at least partially within the housing (Fig. 3B) and that enable removal of the coolant from the distal end of the housing [0092, 0093],
wherein the plurality of outflow channels are positioned in different sections of the plurality of sections of the housing than the first section (Fig. 3B; [0098]; Examiner notes that under the broadest reasonable interpretation a “section” is being interpreted as a designated area or region);
a processor [0108] and
a memory [0108] storing data thereon that, when executed by the processor, enable the processor to:
determine a desired orientation of the heat dissipation of the ablation device relative to the anatomical tissue ([0135, 0136]; [0144]);
adjust an ablation setting ([0108]: “microwave energy output”) associated with the ablation device; and
cause the laser fiber to generate the ablation energy [0108].
Ladtkow does not disclose:
a -laser fiber disposed at least partially within the housing.
wherein the plurality of outflow channels are positioned in different sections of the plurality of sections of the housing than the first section to enable control of a direction of heat dissipation associated with the ablation energy
the ablation setting being adjusted to change the direction of the heat dissipation to achieve the desired orientation of the heat dissipation;
the ablation setting being at least one of
an inflow rate of the coolant through the at least one inflow channel and
an outflow rate of the coolant through at least one outflow channel of the plurality of outflow channels.
Morneau discloses an analogous ablation device for ablating a tissue of a patient (abstract). Examples of ablative energy delivered by the ablation device include but are not limited to microwave energy and laser energy (using one or more optical fibers) [0158].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ablation device taught by Ladtkow to have a laser fiber, as taught by Morneau. One would have been motivated to make this modification because both microwave energy and laser energy are known ablation-based energy sources. Moreover, one of ordinary skill in the art would have the ability to select the type of ablation-based energy source that would best meet their needs. Accordingly, such a modification would yield “a laser fiber disclosed at least partially within the housing”, and wherein “the laser fiber is configured to generate ablation energy…”.
Regarding the ablation setting being “at least one of an inflow rate of the coolant through the at least one inflow channel and an outflow rate of the coolant through at least one outflow channel of the plurality of outflow channels”.
Reid JR discloses an analogous ablation device (FIG. 8A) that directs coolant (Fig. 1: 36) throughout the device (FIG. 2B: movement of coolant indicated by black arrows) to reduce (or eliminate) the amount of energy radiating from the ablation device (abstract). As discussed in Reid JR, the ablation device achieves such an effect by enabling an operator to adjust both a flow rate of the coolant and a type of coolant [0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the proposed combination to have the ablation setting comprise an inflow rate of the coolant, or a type of coolant, as taught by Reid JR. One would have been motivated to make this modification because both are known ways to control the amount of heat that radiates from an ablation device. Accordingly, such a modification would yield the proposed combination adjusting “the inflow rate of coolant through the at least one inflow channel”.
Regarding the outflow channels being positioned in a plurality of different sections other than the first section “to enable control of a direction of heat dissipation associated with the ablation energy” and the inflow rate being adjusted “to change the direction of heat dissipation to achieve the desired orientation of the heart dissipation”, Examiner asserts that the proposed modification (see paragraph 12) yields the limitations described above because of the inflow/outflow channel asymmetry disclosed by Ladtkow (see FIG. 3B). For example, looking at FIG. 3B of Ladtkow one of ordinary skill in the art can appreciate that 1) increasing the inflow rate of coolant through the at least one inflow channel (19’c) would change the direction of heat dissipation and 2) controlling a direction of heat dissipation is made possible by the outflow channels (19a’ top right and 19a’ bottom) being positioned in a plurality of different sections other than the first section which contains the inflow channel.
In re claim 3, the proposed combination yields (all mapping directed to Ladtkow) wherein the plurality of outflow channels comprise three outflow channels (Fig. 3B: 19a’, 19a’, and 19a’ from 19a’/19c’; [0097]).
In re claim 4, the proposed combination yields (all mapping directed to Ladtkow unless indicated otherwise) wherein the data when processes by the processor, further enable the processor to adjust [0108] at least one of a temperature of the coolant, and a type of coolant to achieve the desired orientation of the heat dissipation (see proposed modification above (In re claim 1) where ablation setting is modified to be flow rate or coolant type).
In re claim 5, the proposed combination yields (all mapping directed to Reid JR) wherein the data, when processed by the processor, further enable the processor to: a first coolant type ([0040]: “shielding fluid”) to a second coolant type ([0040]: “cooling solution”).
In re claim 6, the proposed combination yields (all mapping directed to Ladtkow),
wherein the plurality of outflow channels comprises a first outflow channel (19’a bottom) and a second outflow channel (19a’ from 19a’/19c’),
wherein the first outflow channel has a first outflow rate (inherent), and
wherein the second outflow channel has a second outflow rate (inherent) different than the first outflow rate (FIG. 3B; Examiner notes it is apparent that the first outflow channel and the second outflow channel will have different flow rates given that the outflow channels differ in both size and shape).
In re claim 7, the proposed combination yields (all mapping directed to Ladtkow) wherein the processor causes the ablation energy to be generated at a first power ([0136]: power of “microwave energy” transmitted) at a first time [0136] and at a second power ([0137]: power of “additional application of energy”) *greater than the first power at a second time later than the first time ([0137]: “following treatment of the target”).
*Regarding the limitation “greater than the first power”, as discussed in Ladtkow following treatment a combination of imaging modalities and temperature sensing techniques can be used to determine whether or not additional application of energy is necessary [0137]. Examiner notes that Ladtkow further discloses using information collected via temperature sensing techniques to automatically adjust the microwave energy output by the laser device [0108]. Examiner asserts that adjusting the microwave energy would involve either increasing or decreasing the energy delivered to a target tissue. Therefore, the proposed combination yields generating ablation energy at “a second power greater than the first power”.
In re claim 8, the proposed combination yields (all mapping directed to Ladtkow), wherein the data when processed by the further enable the processor to:
receive, when the ablation energy is generated at the first power, anatomical tissue temperature information associated with a temperature of the anatomical tissue ([0137]: “temperature sensing techniques”; [0139]); and
further adjust, based on the anatomical tissue temperature information and a surgical plan ([0137]: “confirming ablation zones”), at least one of the inflow rate of the coolant through the at least one inflow channel (see above modification, In re claim 1) and the outflow rate of the coolant through the at least one outflow channel of the plurality of outflow channels.
In re claim 9, the proposed combination yields (all mapping directed to Ladtkow)
wherein the plurality of sections further comprises a second section (region occupied by 19a’ on top right), and
wherein the at least one outflow channel of the plurality of outflow channels is disposed in the second section (apparent, see FIG. 3B).
In re claim 10, the proposed combination yields (all mapping directed to Ladtkow)
wherein the plurality of sections further comprises a second section (region occupied by 19a’ on top right) and a third section (region occupied by 19a’ on bottom)
wherein the laser fiber is disposed in the first section (FIG. 3B),
wherein a first outflow channel of the plurality of outflow channels is disposed in the second section (apparent, see FIG. 3B), and
wherein a second outflow channel of the plurality of outflow channels is disposed in the third section (apparent, see FIG. 3B).
In re claim 11, the proposed combination yields (all mapping directed to Ladtkow),
wherein the plurality of sections further comprises a second section (region occupied by 19a’ on top right), a third section (region occupied by 19a’ on bottom), and a fourth section (region occupied by 19c’ on top left),
wherein the laser fiber is disposed in the first section (FIG. 3B)
wherein a first outflow channel of the plurality of outflow channels is disposed in the second section (FIG. 3B),
wherein a second outflow channel of the plurality of outflow channels is disposed in the third section (FIG. 3B), and
wherein an inflow channel is disposed in the fourth section (FIG. 3B).
The proposed combination does not yield:
wherein a third outflow channel of the plurality of outflow channels is disposed in the fourth section.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the inflow channel disposed in the fourth section with a third outflow channel. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her grasp. If this leads to anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed third outflow channel is not disclosed as being crucial or unexpected. Further a person of ordinary skill in the art would consider a third outflow channel being disposed in the fourth section, since there are a finite number of channel types (i.e., inflow or outflow) that could be disposed in the fourth section.
In re claim 20, see above (In re claim 1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ladtkow et al. (US 2014/0046316), in view of Morneau et al. (US 2020/0155217), in view of Reid JR (US 2013/0178841), in view of Brennan et al. (US 11,369,434).
In re claim 2, the proposed combination yields (all mapping directed to Ladtkow)
wherein the at least one inflow channel comprises two inflow channels (19c’ from 19a’/19c’ and 19c’)
The proposed combination does not yield:
wherein the laser fiber and the two inflow channels are positioned within the first section.
Brennan discloses an analogous ablation device (abstract, Fig. 4: 200) with a first inflow channel (227 on bottom), a second inflow channel (227 on top), a first outflow channel (229 on bottom), a second outflow channel (229 on top), a housing (214), and an ablation cable (220). As shown in FIG. 4, the first and second inflow channels are positioned around the ablation cable in a first section (open space occupied by internal components) of the housing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to position the second inflow channel in the first section, as taught by Brennan. One would have been motivated to make this modification both because it is known and because doing so would ensure that the laser fiber is cooled sufficiently. Accordingly, such a modification would yield “wherein the laser fiber and the two inflow channels are positioned within the first section”.
Conclusion
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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