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 .
Applicant’s amendments and comments, received December 19, 2025, have been fully considered by the examiner. The following is a complete response to the December 19, 2025 communication.
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 1-4, 9, 50, 70 and 125 are rejected under 35 U.S.C. 103 as being unpatentable over Jun (2009/0287206) in view of the teaching of Fung et al (6,120,476).
Regarding claim 1, Jun provides a probe for forming a lesion comprising an elongate member comprising a distal tip (10) and a proximal end (50), the elongate member defining a lumen (Figure 4) wherein a cooling fluid circulates through the lumen with a portion of the fluid ejected from an orifice (22 – Figure 4). The probe includes at least one active portion located at the distal tip (10) for the delivery of energy. Jun further discloses a temperature sensor (40) but fails to expressly disclose the temperature sensor is located within the distal tip.
Fung et al disclose another device comprising a tip electrode to deliver RF energy to tissue as well s a means to provide a cooling fluid. Fung et al provide a temperature sensor (41,45 – Figure 3) which is secured within the tip electrode (Figure 3) to more accurately measure the temperature of the tip electrode.
To have provided the Jun device with a temperature sensor located within the active tip to more accurately measure the temperature of the active tip would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Fung et al fairly teach it is known to provide a temperature sensor in an active tip electrode.
Regarding claim 2, the elongate member is at least partially composed of a conductive material (i.e. 20 is metal for conducting energy). Regarding claim 3, the probe further comprises a layer of insulation (24) covering the conductive material with the active portion being exposed (Figure 4). Regarding claim 4, the examiner maintains that would necessarily be a wire connected to the electrodes of Jun to provide RF energy, and Fung et al specifically show a wire (40) connected to the electrode(s) for the delivery of RF energy. Regarding claim 9, the distal tip comprises a protrusion (i.e. pointed tip) and Fung et al provide the teaching of providing the temperature sensor within the tip. Regarding claim 50, the probe includes an inlet lumen and an outlet lumen (Figure 4 of Jun).
Regarding claim 70, Jun in view of Fung et al provides a probe as discussed with respect to claim 1 above in a system including a cooling pump to deliver the cooling fluid (61 – Figure 2) and a generator (63- Figure 2) for delivery of energy to the probe.
Regarding claim 125, Jun provides a plurality of orifices at the distal tip (Figure 4, for example).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Jun (‘206) in view of Fung et al (‘476) and further in view of the teaching of Brannan et al (2014/0276200).
Jun fails to disclose a pneumatic resistor comprising a tube positioned within the lumen of the elongate member as claimed.
Brannan et al disclose another device for delivery of energy to tissue as well as means to deliver a cooling fluid to maintain a desired tissue temperature. The cooling fluid is delivered through a lumen in the probe, and Brannan et al specifically teach that the lumen may have a pneumatic resistor (e.g. flow restriction device) to control the delivery of the fluid. See, for example, paragraph [0065].
To have provided the Jun device, as modified by the teaching of Fung et al, with a flow restriction device or baffle (i.e. pneumatic resistor) located within the fluid delivery tube to control the fluid flow as desired within the probe would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Brannan et al fairly teach it is known to use such a flow restrictor to control fluid flow in a similar device.
Claims 51 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Jun (‘206) in view of the teaching of Fung et al (‘476) and further in view of the teachings of Lorentzen (5,951,546) and Lakshmanan et al (10,493,172).
Jun fails to specifically disclose imaging of the probe, or the use of a contrast agent to assist in imaging of the probe.
The examiner maintains that it is generally well known to provide ultrasound imaging when inserting a probe into tissue to ensure the probe is inserted into a desired tissue region. Lorentzen discloses a similar RF probe device that includes means to circulate a cooling fluid, and specifically teach that it is general known to provide ultrasound imaging of the probe during insertion (col. 1, lines 20-35, for example). Lakshmanan et al further provide the teaching that it is generally known to provide contrast agents during ultrasound imaging, and specifically teach that it is known to use bubbles in the fluid as a contrast agent to enhance ultrasound imaging (para. [0065], for example).
To have provided the Jun system, as modified by the teaching of Fung et al, with a contrast agent including bubbles to allow for ultrasound imaging during insertion of the probe into tissue would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Lorentzen teaches it is fairly known to use ultrasound imaging to guide such a probe into tissue, and further since Lakshmanan et al teach of the known use of contrast agents including bubbles to enhance ultrasound imaging.
Allowable Subject Matter
Claims 85 and 118-124 are allowed. The prior art fails to disclose the specific method steps of providing the claimed probe, circulating a fluid through the probe, and determining a power profile of the device, comparing the power profile to a predetermined power profile and controlling the flow of fluid based on the comparison of the power profiles as claimed.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 9, 42, 50-52, 70 and 125 have been considered but are moot because the new ground of rejection provides a new reference to specifically teach the use of a temperature sensor located within a tip of an energy delivery device that employs a cooling fluid. Regarding claim 42, the examiner maintains the Brannan et al device specifically discloses the use of baffles and other flow restriction devices (i.e. pneumatic resistors) in the supply tube to control the flow of the fluid, and providing such a flow restrictor in the lumen of the elongate member of Jun would obviously include placing the flow restrictor adjacent the orifices which emit the fluid to tissue. Applicant has not substantively argued the rejection of the remaining dependent claims, and the examiner maintains these rejections remain tenable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/February 24, 2026