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 March 16, 2026 has been entered. Applicant’s amendments have overcome the 112(b) rejection previously set-forth in the Non-Final Office Action mailed on 09/18/2025. Currently, claims 1 and 5-6 have been amended, and claims 1, 5-7, 12-15, 17-24, and 30 are pending in the application. Furthermore, Examiner will reference the US Application, instead of the US Patent version of the Daniel reference for ease in citing information using paragraph numbers instead of columns/lines.
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, 5-7, 13-15, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Bee (U.S. Patent No. 7361174 B2), and further in view of Daniel (U.S. Application No. 20160128761 A1).
Regarding independent claim 1, Bee discloses a tissue ablation device (10) (Col. 5, lines 5-9 & Figs. 2-5) comprising:
a sheath (12) for positioning within body tissue, the sheath comprising a distal end (left-most region of the sheath), a proximal end (22a) and a lumen (26) extending therebetween (Col. 5, lines 11-19);
a probe (14) comprising an elongate portion configured to be slidably received in the lumen (Col. 5, lines 16-19), the elongate portion housing a plurality of flat wire electrodes (21a, 21b) (Col. 12, lines 27-28) that are deployable from an aperture along a distal end (16) of the elongate portion (in the embodiment where the probe includes a lumen that extends between the distal end and proximal end 18, wherein the lumen houses the flat wire electrodes, Col. 5, lines 46-59) into a deployed configuration when the distal end of the elongate portion is located at or beyond the distal end of the sheath (Col. 5, lines 60-65 & Figs. 3, 14),
whereby an angle of deployment of the flat wire electrodes from the distal end of the probe is selectable by orientating the probe with respect to the sheath (Col. 7, lines 28-32 & Figs. 4-5),
wherein the probe further comprises a sheath abutting portion (combination of probe proximal end 18, including key element 25 of the index-key 24, and handle 28) configured for receipt at the proximal end of the sheath when the distal end of the elongate portion is located at or beyond the distal end of the sheath (Col. 6, lines 46-65), and the sheath abutting portion and the proximal end of the sheath comprise visual or tactile means for indicating a relative orientation between the sheath abutting portion and the proximal end of the sheath (Col. 5, lines 21-24).
Specifically, a marker (a visual mean) can be placed at the handle or at the proximal end of the probe for indicating the orientation of the probe. Additionally, the sheath abutting portion comprises a visual mean (user is able to visually inspect the orientation of the electrode in order to determine the relative orientation between the sheath abutting portion and the proximal end of the sheath, for example when the electrodes are in a first rotational orientation, the user can infer that the key element 25 of the index-key 24 a fits within the keyway 34a of the indexer 22 a) and a tactile mean (the user is capable of feeling the respective mating between keyways and the index-key as they manually switch between the different positions/orientations of the wire electrodes; this is similar to the method described in paragraph 0090 of the filed Specification of the instant application).
However, Bee does not disclose the elongate portion comprising apertures spaced along a distal end of the elongate portion in order to deploy the electrodes into a substantially planar in-line deployed configuration, nor a joining member for joining the device to a second tissue ablation device.
Daniel, in the same field of endeavor, teaches a tissue ablation device comprising two embodiments for deployment of flat, wire electrodes. The first embodiment comprises one or more spiral electrodes (1904, 1905) in an array protruding from a distal end of a trocar (1902) (pa. 0178 & Fig. 19A) (this embodiment is analogous to the embodiment described in the Bee reference). The second embodiment comprises a trocar (2802) including a distal lumen (2804) and one or more orifices (2806, 2808) spaced along a side of a distal end of the trocar, wherein the electrodes spirals into a substantially circular and planar shape (pa. 0206 & Fig. 28).
Furthermore, Daniel teaches a joining member (2010) for joining/holding the device to a second tissue ablation device in a fixed position (pa. 0103, 0182 & Figs. 20A-20B).
Therefore, it is the Examiner’s position that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongate portion of Bee to be located beyond the distal end of the sheath, as taught by Daniel, as well as to have added the one or more orifices of Daniel to the distal end of the elongate portion of Bee. The Examiner finds that both Bee and Daniel provide for various different arrangements of deploying a plurality of electrodes to circumferential positions relative to the distal end of each sheath, and is further of the position that the probe configurations cited above represent known variants in the art that would both yield predictable results of providing an aperture/lumen for deploying the electrodes so as to treat tissue located circumferentially to the sheath. Lastly, it would have been obvious to add the joining member of Daniel to the device of Bee for the purpose of allowing a user to secure a second ablation device at a fixed position relative to the first ablation device.
Regarding claim 5, Bee/Daniel combination discloses wherein the sheath abutting portion and the proximal end of the sheath comprise surfaces that abut one another in use, the surfaces comprising indicia to visually show the relative orientation between the sheath abutting portion and the proximal end of the sheath (Bee, Col. 5, lines 21-24).
Regarding claim 6, Bee/Daniel combination discloses wherein the sheath abutting portion and the proximal end of the sheath comprise surfaces that abut one another in use, the surfaces comprising complimentary protrusions (24, 25) and recesses (34a-34d) configured to mate when the sheath abutting portion and the proximal end of the sheath are orientated at predefined angles (Bee, Col. 6, lines 46-65).
Regarding claim 7, Bee/Daniel combination discloses wherein the predefined angles are about 0, 90, 180 and 270 (Bee, see Fig. 5).
Regarding claim 13, Bee discloses the plurality of flat wire electrodes in the probe are configured to assume selectable deployed configurations (Col. 5, line 67 – Col. 6, lines 1-9).
However, Bee does not disclose the device is selectable from a plurality of available probes, nor the plurality of electrodes being a flat wire electrode.
Daniel, in the same field of endeavor, teaches the use of any number of single-trocar ablation devices simultaneously in any number of configurations to form a variety of additional ablation systems for target tissue volumes of different sizes and/or shapes. (pa. 0211, 0221, 0228).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have added additional probes/electrodes to the ablation system of Bee in order to allow the user to easily make replacement of parts during or after a procedure for cleaning.
Regarding claim 14, Bee/Daniel combination discloses further comprising a deployment actuator (handle 28) which is operable to deploy the electrode from the distal end of the probe (Bee, Col. 5, lines 62-65).
Regarding claim 15, Bee/Daniel combination discloses wherein the deployment actuator is operable to advance and retract the electrode between the deployed configuration and a retracted configuration (Bee, Col. 5, lines 16- 19 and 63-67).
Regarding claim 30, Bee discloses the invention substantially as claimed in claim 1 and discussed above.
However, Bee does not disclose wherein the joining member is configured to define a variable spacing between the joined tissue ablation devices.
Daniel, in the same field of endeavor, teaches the joining member is configured to hold and secure each of the ablation devices in a fixed position relative to every other ablation device being used (pa. 0103), wherein the electrode spacing is defined by the width of joining member (pa. 0186).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bee and Daniel, as applied to claim 1 above, and further in view of Moss (U.S. Application No. 20110202053 A1).
Regarding claim 12, Bee/Daniel combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they does not disclose the plurality of electrodes are each independently deployable through a respective orifice at the end of or along a side of the elongate portion at the distal end of the probe.
Moss, in the same field of endeavor, teaches an energy delivery device (1) comprising a plurality of electrodes elements (7,9,11,13,15,17) (pa. 0024 & Fig. 1) that are each independently deployable through a respective orifice (distal holes of guide sleeve 22) at the end of or along a side of an elongate portion at a distal end of a probe (5) via a deployment mechanism (inside handle 23) configured to independently control the extent (length) of the deployment of each electrode from the probe using electrode slide tabs (26) (pa. 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the deployment mechanism, including the slide tabs, taught by Moss to the handle of Bee in order to allow the user to have better control of the independent deployment of each flat wire electrode during a procedure.
Response to Arguments
Applicant’s arguments, filed 09/09/2026, with respect to the 103 rejection of claim 1 under Bee in view of Daniel have been fully considered and are partially persuasive.
With regards to independent claim 1, Applicant argues that the Bee reference does not teach, "a plurality of flat wire electrodes that are deployable from apertures spaced along a distal end of the elongate portion into a substantially planar in-line deployed configuration when the distal end of the elongate portion is located at or beyond the distal end of the sheath". Specifically, Applicant contends that while the shaft 14 of Bee can be advanced to the distal end of the cannula 12 or slightly beyond the end, the shaft cannot be advanced beyond the end of the cannula, and if apertures were included spaced along the distal end of the shaft, they would never exit the end of the cannula and any electrode associated with those apertures would not be deployed. Examiner agrees that the prior art combination of Bee and Daniel was at most silent with respect to how the combination resulted in the probe and the electrodes extending distally from the sheath. Therefore, Examiner has submitted an updated version of the rejection above to more fully set-forth how the combination of references addresses all the limitations set-forth in independent claim 1.
Furthermore, for the sake of completeness, with regards to the independent claim 1, Applicant further argues that the Bee reference teaches an ablation device configured to treat tumors, which comprises delicate electrodes only intended to be deployed in a very limited area around the distal end 16 of the device, and therefore cannot be combined with the Daniel reference. However, Examiner disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one of ordinary skill in the art to have added the one or more orifices taught by the Daniel to the distal end of the elongate portion of Bee since both probe configurations for deploying the electrodes out of the distal end are known variants in the art and they both would have yielded the same predictable results of providing an aperture/lumen for deploying a plurality of electrodes. Furthermore, the ablation device of Daniel is also configured to treat tumors (pa. 0163). Therefore, the rejection is maintained.
Lastly, with regards to the independent claim 1, Applicant argues that one of ordinary skill in the art would not have been motivated to add the joining member of Daniel to the device of Bee for the purpose put forth by the Examiner, that being to allow a user to secure a second ablation device at a fixed position relative to the first ablation device because doing so would be contrary to the teachings of Bee, namely that the distal end 16 be positioned with the tumor. However, Examiner disagrees.
As established above, both the Bee and the Daniel references teach ablation devices configured to be inserted into a patient in order to treat tumors. Therefore, the Daniel's reference, which teaches the joining member, contemplates an embodiment utilizing this new structural feature in order to join a second ablation device which would be useful to a surgeon for treating different conditions, such as tumors. Therefore, for all the reasonings set-forth above, the rejection is maintained.
With regards to dependent claim 12, Applicant further contends that the Moss reference does not cure any of the deficiencies described in the filed Remarks section. However, as explained above, Moss does not need to teach any of the claim language of the independent claim 1.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
