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 Amendments filed on March 17, 2026 have been entered. Applicant’s amendments have overcome the abstract objection previously set-forth in the Non-Final Office Action mailed on 12/17/2025. Currently, claims 9-10, 12-13, 15, 17, 21-27, and 30-31 have been amended, and claims 1-10, 12-13, 15, 17-31 are pending in the application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9, 12-13, 18, 20-21, 23-24, 27, 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (W.O. Application No. 2020065587 A2).
Regarding independent claims 9 and 21, Olson discloses a surgical method and system (100) (pa. 0029 & Figs. 1-2), comprising:
delivering energy to a tissue at a surgical site with an electrode array (204) of a surgical device (114) (pa. 0041, 0046);
receiving, by a controller (142) that is operatively coupled to the surgical device, information indicative of a contact quality of the electrode array with the tissue (pa. 0046-0047), wherein the contact quality is determined across at least three sets of electrodes of the electrode array (pa. 0066, 0082); and
automatically controlling, by the controller, a pressure applied by at least one electrode of the electrode array on the tissue based on the contact quality of the electrode array with the tissue (pa. 0081) and at least one tissue property (an electrophysiological signal) (pa. 0015, 0047), wherein the contact quality is based on a determination that contact resistance between at least two sets of electrodes of the electrode array differs from contact resistance between at least one other set of electrodes of the electrode array (pa. 0066, 0081-0082).
Regarding claims 12 and 23, Olson discloses comprising the controller increasing or decreasing controlling the pressure applied by the at least one electrode to readjust contact between the electrode array and the tissue in response to non-uniform contact quality (pa. 0081).
Regarding claims 13 and 24, Olson discloses the controller controlling the pressure of the at least one electrode by adjusting a fill volume of a balloon (200) of the surgical device (pa. 0008, 0081).
Examiner highlights that since the balloon includes a lumen that extends along a catheter shaft to transport a fluid to inflate or deflate the balloon, and since the controller is capable of adjusting the pressure of the balloon based on quality contact, then it is inherent that the controller is capable of directly adjusting the fill volume of the balloon.
Regarding claims 18 and 27, Olson discloses providing fluid from the surgical device to the surgical site (pa. 0031), specifically, catheter (114) is connected to a fluid source (118) for delivering a biocompatible irrigation fluid such as saline through a pump (120), wherein the pump includes a variable volume syringe pump (pa. 0041), and
based on controlling the expulsion of the fluid, adjusting an electrical level or an ionic level.
Examiner notes that by introducing the irrigation fluid to the tissue, it inherently changes both its electrical properties (conductivity/impedance) and its ionic composition. Saline solution is an electrolyte containing sodium and chloride ions that, when introduced into the extracellular space, enhances the tissue's ability to conduct electricity. Furthermore, the influx of ions reduces the electrical resistance (impedance) of the tissue-electrode interface, allowing higher RF current to flow into the tissue.
Regarding claims 20 and 29, Olson discloses wherein a surgical hub (i.e., combination of display 140, ECU/controller 142, processor 164, memory 162, and input device 160) includes the controller (pa. 0032, 0038).
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 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 9 and 21 above, and further in view of Salahieh (W.O. Application No. 2011143468 A2).
Regarding claims 10 and 22, Olson discloses the controller controlling the pressure of the at least one electrode based on the tissue property (pa. 0015, 0047, 0081).
However, Olson does not explicitly disclose that the tissue property includes at least one of an impedance, a collagen composition, or a moisture level.
Salahieh, in the same field of endeavor, teaches the contact quality of the electrode with the tissue can be assessed through impedance measurements (00237-00238), which would allow for proper determination of not only electrode-tissue contact but amount of force in which they are in contact (pa. 00237), and therefore allow the user to adjust/control the dept of energy penetration to avoid thrombus formation and inadvertent charring of the tissue (pa. 00234).
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 incorporated the closed-loop method of adjusting the expandable member based on impedance measurements of tissue, as taught by Salahieh, into the controller of Olson in order to help avoid thrombus formation and inadvertent charring of the tissue (Salahieh, pa. 00234).
Claims 19, 28, 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 9 and 21 above, and further in view of Caplan (E.P. Application No. 3714826 A1).
Regarding claims 19 and 28, Olson discloses the catheter can include a temperature sensor (pa. 0041).
However, Olson does not disclose the controller adjusting a variable parameter of a control algorithm of the surgical device and executing the control algorithm including the adjusted variable parameter, thereby affecting the energy delivery from the electrode to the tissue.
Caplan, in the same field of endeavor, teaches the controller (360) adjusting a variable parameter (e.g., temperature of energy delivery) of a control algorithm (based on processed temperature sensor signals) of the surgical device and executing the control algorithm including the adjusted variable parameter, thereby affecting the energy delivery from the electrode to the tissue (pa. 0124).
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 included the control algorithm of the controller of Caplan to the controller of Olson for the purpose of further adjusting the delivery of energy to the tissue based on additional sensed data, such as temperature for example, in order to prevent/avoid undesirable treatment outcomes.
Regarding claims 30 and 31, Olson discloses the controller being configured to control the pressure of the at least one electrode.
However, Olson does not disclose adjusting position of the at least one electrode by moving the surgical device rotationally or translationally.
Caplan, in the same field of endeavor, teaches the controller being configured to control the pressure of the at least one electrode by adjusting position of the at least one electrode by moving the surgical device rotationally or translationally via a motion transfer assembly (335) (pa. 0141).
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 incorporated the motion transfer assembly taught by Caplan to the surgical device of Olson for the purpose of allowing the user further control of the position of the surgical device in order to enhance electrode contact with the tissue.
Claims 15, 17, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 9 and 21 above, and further in view of Christopher (U.S. Application No. 20200305972 A1).
Regarding claims 15 and 25, Olson discloses providing fluid from the surgical device to the surgical site (pa. 0031), specifically, catheter (114) is connected to a fluid source (118) for delivering a biocompatible irrigation fluid such as saline through a pump (120), wherein the pump includes a variable volume syringe pump (pa. 0041).
However, Olson does not explicitly disclose controlling expulsion of fluid from the surgical device to the surgical site based on the at least one tissue property, wherein the tissue property includes at least one of an impedance, a collagen composition, or a moisture level.
Christopher, in the same field of endeavor, teaches a system (10) comprising an injectate delivery device (100) comprising functional elements (109) such as impedance sensors positioned on an expandable assembly (130) (pa. 0202), and an assembly for delivering one or more fluids to the tissue (pa. 0087 & Fig. 1), wherein the system further comprises a controller (210) and one or more fluid transfer mechanisms (e.g. mechanisms to transfer fluid in and/or out of device 100) (pa. 0097). The controller comprises fluid control components (e.g. valves and/or pumps) configured to initiate, regulate, modify, stop and/or otherwise control the fluid transfer mechanisms. Furthermore, the impedance sensor is configured to provide information to the controller in order to initiate/stop, regulate, or modify the delivery to fluid to the tissue based on the sensor readings (pa. 0202).
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 included the impedance sensor taught by Christopher on the expandable member/balloon of Olson, as well as modified the functionality of the controller of Olson to include the functionality of the controller of Christopher to allow for the sensed impedance information to control the variable pump of Olson for the purpose of providing additional control of the ablation procedure and avoid unwanted treatment outcomes.
Regarding claims 17 and 26, Olson discloses providing fluid from the surgical device to the surgical site (pa. 0031), specifically, catheter (114) is connected to a fluid source (118) for delivering a biocompatible irrigation fluid such as saline through a pump (120), wherein the pump includes a variable volume syringe pump (pa. 0041). Furthermore, the controller is capable of measuring the quality contact of the electrode with the tissue (pa. 0046-0047).
However, Olson does not disclose the controller controlling the expulsion of fluid from the surgical device to the surgical site based on the contact quality of the electrode array with the tissue.
Christopher, in the same field of endeavor, teaches wherein a system comprises functional elements (109), which can comprise pressure sensors positioned on an expandable assembly (130) (pa. 0202), and an assembly for delivering one or more fluids to the tissue (pa. 0087 & Fig. 1), wherein the system further comprises a controller (210) and one or more fluid transfer mechanisms (e.g. mechanisms to transfer fluid in and/or out of device 100) (pa. 0097). The controller comprises fluid control components (e.g. valves and/or pumps) configured to initiate, regulate, modify, stop and/or otherwise control the fluid transfer mechanisms. Furthermore, the pressure sensor is configured to provide information to the controller in order to initiate/stop, regulate, or modify the delivery to fluid to the tissue based on the sensor readings (pa. 0202).
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 functionality of the controller of Olson to include the functionality of the controller of Christopher to allow for the sensed contact quality information to control the variable pump of Olson for the purpose of providing additional control of the ablation procedure and avoid unwanted treatment outcomes.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-10, 12-13, 15, 17, 18-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 9 of U.S. Application No. 17/494,385 in view of Olson (W.O. Application No. 2020065587 A2).
Regarding instant claims 9 and 21, it is the Examiner’s position that copending independent claim 1 is narrower in some aspects given that the copending claim recites a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 1. These narrower aspects include the claimed electrode array and controller. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claims 9 and 21 and the copending claim 1 exists in that the copending claim 1 fails to provide “wherein the contact quality is based on a determination that contact resistance between at least two sets of electrodes of the electrode array differs from contact resistance between at least one other set of electrodes of the electrode array.” Olson, however, provides for a similar surgical method as that of the copending claim and specifically contemplates measuring the contact quality based on a determination that contact resistance between at least two sets of electrodes of the electrode array differs from contact resistance between at least one other set of electrodes of the electrode array (pa. 0066, 0081-0082). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have modified the functionality of the controller of the copending application with the functionality of the controller of Olson in order to provide for a combined controller functionality that is able to detect contact quality is based contact resistance between multiple sets of electrodes.
With respect to dependent claims 10, 12-13, 15, 17, 18-20, 22-29 see copending application claims 2, 5-6, 9, 19-20.
Response to Arguments
Applicant' s arguments, see pages 9-12 of the Remarks filed 03/17/26, with respect to the rejection of claims 9 and 21 under 35 U.S.C. 103 as unpatentable over Caplan in view of Salahieh has been fully considered and is persuasive. Specifically, Applicant’s amendments to further require the controller to measure the contact quality based on a determination that contact resistance between at least two sets of electrodes of the electrode array differs from contact resistance between at least one other set of electrodes of the electrode array is defined over Caplan and Salahieh given that they do not contemplate this claimed feature. Therefore, the prior rejection based on Caplan in view of Salahieh has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 9, 12-13, 18, 20-21, 23-24, 27, 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (W.O. Application No. 2020065587 A2).
It is the Examiner’s position that the newly filed rejections based on the Olson reference is tenable for at least the reasoning set forth in the action above.
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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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