DETAILED ACTION
This action is in response to amendments received on 07/15/2026. Claims 1-8 and 10-14 were previously rejected and claims 9 and 15 withdrawn from consideration. Claims 1-8 and 10-13 have been amended. A complete action on the merits of claims 1-8 and 10-14 follows below.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Claims 9 and 15 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
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.
Claims 1-8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Werneth (US Pub. No. 2022/0183752).
Regarding Claim 1, Werneth teaches a radiofrequency medical device (catheter 1), comprising:
an elongate body 13/20 having a proximal portion, a distal portion (in one embodiment distal end 17 is interpreted to be the distal end, in a second interpretation distal end 21 is interpreted to be the distal portion), and an outer diameter (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67);
a tip electrode 128/23 located on the distal portion, wherein the tip electrode includes an outer surface having a diameter larger than the outer diameter of the distal portion (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67) and wherein the tip electrode is configured to deliver RF energy sufficient to puncture tissue (“elongate shaft 13 further comprises a shaft ablation assembly 20 and a distal ablation assembly 21 configured to deliver energy, such as RF and/or Irreversible Electroporation energy, to tissue 41. The shaft ablation assembly 20 is proximal to the distal end of the distal portion 19, and includes at least one shaft ablation element 22, or shaft electrode 127, fixedly or removable attached to the shaft 13 and configured to deliver ablation energy to tissue. The distal ablation assembly 21 is at the distal end of the distal portion 19 and includes at least one tip ablation element 23, or electrode tip 128, configured to deliver ablation energy to tissue” [0021], “tip ablation elements 23, located at the distal end of the shaft (tip electrodes 128)” [0371], “the ablation catheters of the present invention may be used to treat one or more medical conditions by delivering ablation energy to tissue. Conditions include an arrhythmia of the heart, cancer, and other conditions in which removing or denaturing tissue improves the patient's health” [0026]; therefore, Examiner takes the position that the generator is configured to deliver high power such as radiofrequency (RF) to ablate tissue and thus is configured to destroy/denature the tissue wall or weaken it to the point that it is configured to puncture tissue);
a plurality of ablation electrodes 114/127/132/22 disposed along the distal portion 17/21 (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67), the plurality of ablation electrodes configured to delivery ablation energy ([0017], [0020]-[0026], [0201], [0232] and [0371]);
a handle 103 coupled to the proximal portion of the elongate body (Figs. 1, 3, 16-17, 46, 52, 62a-62c); and
a steering mechanism operably associated with the handle (a combination of steering device 144, mandrel 26 and one or more steering wire 25 is here interpreted to be a steering mechanism since the steering device 144 is rotatable with respect to the handle to rotate said elongate shaft 13 “said steering device 144 is drivable in rotation with respect to said handle 103 so that a rotation of said steering device 144 with respect to said handle causes a rotation of said elongate shaft 13” [0163], steering wires are configured to deflect the distal end of the catheter in one or more directions “one or more steering wires 25 configured to deflect the distal portion 17 in the one or more deflection directions” [0022] and the shape setting mandrel 26 is configured to enhance deflection and maintain the tip in a certain deflection configuration “the shape setting mandrel 26 configured to perform or enhance the deflection (steering and shape) of the distal portion 17, such as to maintain deflections in a single plane” [0022] such that the catheter is allowed to be steered and positioned at the target area, all of which are operably associated with the handle by the teachings of [0046]-[0047], [0052]-[0053], [0151]-[0152], “steering device 144 is connected to said handle 103” [0162], “said steering device 144 comprises a through hole 145” [0164], “said shape setting mandrel 26 passes through said through hole 145” [0165], “Lever (single)—connected to the two pull wires for tip deflection” [0364] (positioned on the handle [0362]) and [0371]), the steering mechanism being configured to deflect the distal portion of the elongate body ([0022], [0114]-[0122], [0150]-[0166] and “carrier assembly may be attached to a control shaft that is coaxially disposed and slidingly received within the lumen of the shaft. The carrier assembly is deployable by activating one or more controls on a handle 103 of the catheter 1, such as to engage one or more ablation elements against cardiac tissue, typically atrial wall tissue or other endocardial tissue. The shaft may include deflection means, such as means operably connected to a control on a handle of the catheter or through a center lumen where different shape mandrels 26 can be placed to change the catheter distal section shape. The deflection means may deflect the distal portion of the shaft in one or more directions, such as deflections with two symmetric geometries, two asymmetric geometries, or combinations of these. Asymmetries may be caused by different radius of curvature, different length of curvature, differences in planarity, other different 2-D shapes, other different 3-D shapes, and the like” [0371] and Figs. 14-16 and 46).
Regarding Claim 2, Werneth teaches wherein the elongate body includes a lumen 118 extending from the proximal portion to the distal portion ([0110], [0114]-[0115], [0121], [0371] and Figs. 24, 28, 52-53, 67).
Regarding Claim 3, Werneth teaches wherein the plurality of ablation electrodes 114/127 are configured to deliver bipolar RF energy ([0035], [0091], [0189], [0219] and Fig. 55).
Regarding Claim 4, Werneth teaches wherein the plurality of ablation electrodes 114/127/132/22 are positioned proximal of the tip electrode 128/116/105/23 (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67).
Regarding Claim 5, Werneth teaches wherein the plurality of ablation electrodes are individually actuatable to change the size of a tumor ablation boundary (“In one aspect, if two electrodes are used, it is contemplated that the distal electrode would be one and each of the body electrodes would be selected based on the length requirements of the ablation” [0378] and “In one aspect, this array could be a plurality or series of monopolar and/or bipolar probes arranged in various shapes, configurations, or combinations in order to allow for the ablation of multiple shapes and sizes of target regions of tissue. Various array patterns can reduce the need to reposition the electrode array during treatment by allowing multiple selectively activatable electrode patterns 112” [0379]).
Regarding Claim 6, Werneth teaches wherein the steering mechanism includes a rotatable knob (“said steering device 144 is drivable in rotation with respect to said handle 103 so that a rotation of said steering device 144 with respect to said handle causes a rotation of said elongate shaft 13” [0163] and Fig. 52 shows a rotation knob on the handle).
Regarding Claim 7, Werneth teaches wherein the steering mechanism includes a pull wire 25 or a push rod 26 ([0022], [0114]-[0115], [0121], [0150]-[0158], [0164], [0252], [0371] and Figs. 24, 28, 52-53, 67).
Regarding Claim 8, Werneth teaches wherein the pull wire 25 or push rod 26 is attached to the elongate body offset from a longitudinal axis of the elongate body (mandrel 26 in Fig. 53 or at least one of the steering wires 25 in Figs. 24 and 67).
Regarding Claim 10, Werneth teaches wherein the handle 103 is removably attached to the elongate body (since the handle is a separate element and thus can be taken apart, given the broadest reasonable interpretation, it is interpreted to be removably attached to the catheter).
Regarding Claim 11, Werneth teaches further comprising: a connector (8 or 9 or 10) configured to removably engage an RF generator ([0038]-[0039], [0376], [0381]-[0382] and Figs. 62a-62c).
Regarding Claim 12, Werneth teaches wherein the elongate body 13 has a variable stiffness between the proximal portion and the distal portion (“elongate shaft 13 may include difference is the stiffness of the shaft along its length” [0022], also see [0083] and [0143]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth as applied above, in view of Roman (US Pub. No. 2010/0057072).
Regarding Claim 13, Werneth teaches a system for performing a medical procedure, comprising: an elongate body 13/20 having a proximal portion, a distal portion 17/21, and an outer diameter (Figs. 25-27, 41 and 44);
a tip electrode 128/116/105/23 located on the distal portion, wherein the tip electrode includes an outer surface having a diameter larger than the outer diameter of the distal portion (Figs. 25-28, 38, 40-41, 44, 47a-47c, 48-49, 52 and 67) and wherein the tip electrode is configured to deliver RF energy sufficient to puncture tissue (“elongate shaft 13 further comprises a shaft ablation assembly 20 and a distal ablation assembly 21 configured to deliver energy, such as RF and/or Irreversible Electroporation energy, to tissue 41. The shaft ablation assembly 20 is proximal to the distal end of the distal portion 19, and includes at least one shaft ablation element 22, or shaft electrode 127, fixedly or removable attached to the shaft 13 and configured to deliver ablation energy to tissue. The distal ablation assembly 21 is at the distal end of the distal portion 19 and includes at least one tip ablation element 23, or electrode tip 128, configured to deliver ablation energy to tissue” [0021], “tip ablation elements 23, located at the distal end of the shaft (tip electrodes 128)” [0371], “the ablation catheters of the present invention may be used to treat one or more medical conditions by delivering ablation energy to tissue. Conditions include an arrhythmia of the heart, cancer, and other conditions in which removing or denaturing tissue improves the patient's health” [0026]; therefore, Examiner takes the position that the generator is configured to deliver high power such as radiofrequency (RF) to ablate tissue and thus is configured to destroy/denature the tissue wall or weaken it to the point that it is configured to puncture tissue);
a handle 103 (Figs. 1, 3, 16-17, 41, 46, 52, 62a-62c);
a steering mechanism associated with the handle (a combination of steering device 144, mandrel 26 and one or more steering wire 25 is here interpreted to be a steering mechanism since the steering device 144 is rotatable with respect to the handle to rotate said elongate shaft 13 “said steering device 144 is drivable in rotation with respect to said handle 103 so that a rotation of said steering device 144 with respect to said handle causes a rotation of said elongate shaft 13” [0163], steering wires are configured to deflect the distal end of the catheter in one or more directions “one or more steering wires 25 configured to deflect the distal portion 17 in the one or more deflection directions” [0022] and the shape setting mandrel 26 is configured to enhance deflection and maintain the tip in a certain deflection configuration “the shape setting mandrel 26 configured to perform or enhance the deflection (steering and shape) of the distal portion 17, such as to maintain deflections in a single plane” [0022] such that the catheter is allowed to be steered and positioned at the target area, all of which are operably associated with the handle by the teachings of [0046]-[0047], [0052]-[0053], [0151]-[0152], “steering device 144 is connected to said handle 103” [0162], “said steering device 144 comprises a through hole 145” [0164], “said shape setting mandrel 26 passes through said through hole 145” [0165], “Lever (single)—connected to the two pull wires for tip deflection” [0364] (positioned on the handle [0362]) and [0371] and Figs. 14-16 and 46),
and a connector (8 or 9 or 10) configured for electrically connecting with a radiofrequency generator ([0038]-[0039], [0376], [0381]-[0382] and Figs. 62a-62c);
although Werneth teaches an element of the steering mechanism (steering device 144) includes a rotatable knob, the knob is used to rotate the catheter with respect to the handle and not being configured to deflect the distal portion of the elongate body. It is noted that Werneth teaches “The shaft may include deflection means, such as means operably connected to a control on a handle of the catheter or through a center lumen where different shape mandrels 26 can be placed to change the catheter distal section shape” in [0371]; however, the control is not shown to know if it is a rotatable knob or not.
In the same field of invention, Roman teaches “Knob 151 is configured, when rotated, to cause distal portion DP to deflect in one or more directions, such as to curve in one direction when rotated clockwise, and another direction when rotated counter-clockwise. In one embodiment, described in detail herebelow, knob 151 is attached to two steering wires which are captured in the distal portion DP and cause bi-directional steering such as symmetric or asymmetric steering. In alternative embodiments, 1, 3, 4 or more steering wires may be incorporated, such as steering wires separated by 120.degree. or 90.degree., causing deflection in a single plane, or three or more planes. Each deflection may have a simple geometry such as a single plane, fixed radius curve, or more complex geometries” [0072].
Since Werneth already teaches “The shaft may include deflection means, such as means operably connected to a control on a handle of the catheter or through a center lumen where different shape mandrels 26 can be placed to change the catheter distal section shape” in [0371], it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a similar rotatable control means as disclosed by Roman in the invention of Werneth in order to allow easy deflection of the distal tip by rotating the control knob.
Regarding Claim 14, Werneth teaches further comprising: a radiofrequency generator ([0003], [0198], [0372]-[0373] and [0387]-[0390]).
Response to Arguments
Applicant's arguments filed 07/15/2026 have been fully considered but they are not persuasive.
With regards to the 102 rejection over Werneth, Applicant argues that “Werneth attributes distal deflection to other structures and modes of operation, including steering wires 25, a handle lever connected to the steering wires, and insertion or removal of shape-setting mandrel 26. Although Werneth generally refers elsewhere to deflection means operably connected to a handle control, the rejection identifies steering device 144, not such other means or control, as the claimed steering mechanism and does not identify any disclosure that steering device 144 actuates steering wires 25 or shape-setting mandrel 26, or that operation of steering device 144 otherwise causes deflection of distal portion 17. The rejection therefore combines the handle association of steering device 144 with the deflection attributed to different components, without identifying the claimed operative relationship in the arrangement relied upon for anticipation. Accordingly, the cited portions of Werneth do not disclose the steering mechanism in the arrangement required by claim 1, namely, a steering mechanism operably associated with the handle and configured to deflect the distal portion of the elongate body. At most, the cited portions disclose steering device 144 associated with handle 103 for rotating elongate shaft 13 and separate structures for deflecting or shaping distal portion 17”.
As evidenced by the rejection of independent claims 7 and 8 and the paragraphs cited in the rejection of claim 1, Examiner had previously interpreted the combination of steering device 144, one or more steering wires 25 and different shape mandrels 26 to be the steering mechanism as the combination of these elements provide for steering of the distal tip of the catheter to the target area. Examiner has better explained the previous position as stated above, which clarifies that the combination of the elements 114, 25 and 26 are being interpreted to be the steering mechanism, since claim 1 only requires the steering mechanism to provide for the deflection of the tip without excluding steering and/or rotation of the tip as well.
With regards to claim 13, the scope of the invention has now changed to require a rotatable knob to control the deflection of the tip. Due to the change of the scope a new reference has been relied on to teach that limitation.
Furthermore, Applicant states “Independent claims 1 and 13 have also been amended to expressly recite that the tip electrode is configured to deliver RF energy sufficient to puncture tissue. The present application describes the tip electrode as "adapted to deliver sufficient RF energy to puncture the tumor" and describes the distal portion as being "sufficiently stiff to enable the tip electrode to puncture the tumor." See paras. [0005] and [0049]. Werneth does not disclose this limitation. To the contrary, Werneth expressly teaches that its electrode tip 128 "has an external surface shaped to be atraumatic and resiliently biased in rounded configuration." See Werneth at [0173]. An atraumatic, rounded tip electrode is the antithesis of a tip electrode configured to deliver RF energy sufficient to puncture tissue. Accordingly, Werneth fails to disclose the tip electrode limitation of amended claims 1 and 13”.
Examiner respectfully disagrees with this assumption and maintains that the tip electrode 128 configured to deliver RF energy to ablate tissue and thereby, Examiner takes the position that the generator is configured to deliver high power such as radiofrequency (RF) to ablate tissue and thus is configured to destroy/denature the tissue wall or weaken it to the point that it is configured to puncture tissue. It is noted that an atraumatic ablation electrode configured to deliver high power energy (such as RF energy) to tissue is configured to puncture tissue, even if it is specifically designed to minimize that risk. It is also noted that the distal tip electrode of the current invention is also rounded and the puncturing of the tissue is provided by the delivery of the RF energy. Therefore, applicant’s arguments are not found persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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