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 Election/Restriction Requirement
Applicant’s election without traverse of Group I (encompassing claims 1-11), in the reply filed on 12/15/2025 is acknowledged.
Applicant's election with traverse of Species II in the reply filed on 12/15/2025 is acknowledged. The traversal is on the grounds that 1) Examiner failed to establish a series search burden and 2) there would be no serious search burden for searching the three identified species. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on 10/27/2025 the species are independent and distinct due to their mutually exclusive characteristics. In addition, these species are not obvious variants of each other based on the current record. For these reasons, the Election of Species requirement is maintained.
Claim Rejections - 35 USC § 112
Claims 1-11 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1,
The limitation “wherein the at least one inflow channel and the plurality of outflow channels are positionable in different sections of the housing”, raises a clarity concern. Specifically, the phrase “positionable” implies that the at least one inflow channel and the plurality of outflow channels could be moved or adjusted in real time if desired. This is inconsistent with Applicant’s specification which shows multiple ablation device configurations (instant specification: FIG. 1C-1D) that each have differently positioned inflow/outflow channels. For examination purposes, the limitation “wherein the at least one inflow channel and the plurality of outflow channels are positionable in different sections of the housing” will be interpreted as requiring the at least one inflow channel and the plurality of outflow channels to be positioned in different sections of the housing. In other words, “wherein the at least one inflow channel and the plurality of outflow channels are positioned in different sections of the housing”.
The limitation “determine a desired orientation of the ablation device relative to the anatomic tissue; adjust an ablation setting associated with the ablation device to achieve the desired orientation” raises a clarity concern. Specifically, it is unclear how adjusting an ablation setting (i.e., coolant temperature, coolant inflow rate, coolant outflow rate, or coolant type) would change the “orientation” of the ablation device relative to the tissue. Examiner asserts that such adjustments would not change device orientation (i.e., determined angle (instant specification [0114]) but instead would change how the heat dissipates from the ablation probe. Examiner notes that as best understood, based on Applicant’s specification, the processor determines an orientation of the ablation device ([0113]; [0114]: “orientation of the probe relative to the anatomical tissue may comprise an angle…”) and then adjusts an ablation setting (coolant temperature, flow rates, etc.) to achieve a desired direction/orientation of heat dissipation [0121, 0122]. Therefore, for examination purposes the limitation “determine a desired orientation of the ablation device relative to the anatomic tissue; adjust an ablation setting associated with the ablation device to achieve the desired orientation” will be interpreted as “determine a desired orientation of the ablation device relative to the anatomic tissue; adjust an ablation setting associated with the ablation device to achieve a desired heat profile”.
Examiner notes that dependent claims 2-11 inherit the same deficiencies.
In re claim 9, it is unclear how the limitations “wherein the different sections comprise a first section and a second section, wherein the at least one inflow channel is disposed in the first section, and
wherein at least one outflow channel of the plurality of outflow channels is disposed in the second section.” further limit claim 1. Specifically, Examiner notes that the term “section” is broad and can be interpreted as essentially any designated area or region. Therefore, in the instant case, the area that each outflow/inflow channel occupies would be considered a “section”. In other words, the mere existence of a separate inflow channel and separate outflow channel implies that they are each disposed in “a section” of the housing.
In re claim 10, see above (In re claim 9).
In re claim 11, see above (In re claim 9).
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, 2, 3, 6, 7, 8, 9, 10, and 11 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 re claim 1, Ladtkow discloses a system (FIG. 1; abstract), comprising:
an ablation device (12), comprising:
a housing (23) extending from a proximal end (20) to a distal end (22);
a cable (Fig. 3B: 36) disposed at least partially within the housing [0099],
wherein the cable is 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’) disposed at least partially within the housing, 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’) each 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 at least one inflow channel and the plurality of outflow channels are positionable in different sections of the housing (Fig. 3B; Regarding the limitation “positionable” see above section Claim Rejections 112 (In re claim 1 (i))) to control a heat profile associated with the ablation energy ([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 ablation device relative to the anatomical tissue ([0135, 0136]; [0144]);
adjust an ablation setting ([0108]: “microwave energy output”) associated with the ablation device to achieve the desired orientation ([0108]; Regarding the limitations “the desired orientation” see above section Claim Rejections 112 (In re claim 1 (ii)); Examiner notes that an ablation setting is adjusted to achieve a known “tissue temperature”); 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.
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.
In re claim 2, the proposed combination yields (all mapping directed to Ladtkow) wherein the at least one inflow channel comprises two inflow channels (Fig. 3B: 19c’ and 19c’ from 19a’/19c’ ).
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’).
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
adjust, based on the anatomical tissue temperature information and a surgical plan ([0137]: “confirming ablation zones”), the ablation setting associated with the ablation device [0137, 0108].
In re claim 9, the proposed combination yields
wherein the different sections comprise a first section and a second section (inherent),
wherein the at least one inflow channel is disposed in the first section (inherent), and
wherein at least one outflow channel of the plurality of outflow channels is disposed in the second section (inherent).
In re claim 10, the proposed combination yields
wherein the different sections comprise a first section and a second section, and a third section (inherent),
wherein the laser fiber and the at least one inflow channel is disposed in the first section (inherent),
wherein a first outflow channel of the plurality of outflow channels is disposed in the second section (inherent), and
wherein a second outflow channel of the plurality of outflow channels is disposed in the third section (inherent).
In re claim 11, the proposed combination yields
wherein the different sections comprise a first section, a second section, a third section, and a fourth section (inherent),
wherein the laser fiber and the at least one inflow channel is disposed in the first section (inherent),
wherein a first outflow channel of the plurality of outflow channels is disposed in the second section (inherent),
wherein a second outflow channel of the plurality of outflow channels is disposed in the third section (inherent), and
wherein a third outflow channel of the plurality of outflow channels is disposed in the fourth section (inherent).
Regarding the inherency of claims 9-11, Examiner notes that as discussed above (see section Claim Rejections 112(b) In re claim 9) the term “section” is broad and essentially refers to any designated area or region. Examiner asserts that one could imagine several different types of “sections” Ladtkow could be divided into that would satisfy the limitations of claims 9-11. Some examples of potential sections to illustrate this assertion are shown in Examiner FIGS. 1-2 below.
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Claims 4 and 5 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 4, the proposed combination does not yield, wherein the ablation setting comprises a temperature of the coolant, an inflow rate of the coolant, an outflow rate of the coolant, a type of coolant, or a combination thereof.
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.
In re claim 5, the proposed combination yields (all mapping directed to Reid Jr), further enable the processor to: change the type of coolant from a first coolant type ([0040]: “shielding fluid”) to a second coolant type ([0040]: “cooling solution”).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gallardo et al. (US 10,743,932) discloses an ablation catheter (abstract, FIG. 1) with multiple cooling fluid delivery channels (FIG. 4A: 43, 47).
Kulstad et al. (US 2021/0145534) discloses an analogous ablation device with the ability to keep tissue surrounding an ablation site at a target temperature (abstract). The target temperature is maintained by adjusting a coolant temperature and a coolant flow rate (abstract).
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