DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s Amendment filed March 20, 2026 (hereinafter “03/20/26 Amendment") has been entered, and fully considered.
3. In the 03/20/26 Amendment, the Specification was amended to change recitations of “coating” (14) to instead recite “sheath” (14), which Applicant attributes to “an erroneous translation of the German word ‘Mantel’, which was incorrectly translated as ‘coating’” [03/20/26 Amendment, pg. 9]. Examiner acknowledges that the amendments are supported by the EP priority document, and the context of the term’s use in the Specification, as well as by the drawings.
4. In the 03/20/26 Amendment, claims 1, 2, & 15 were amended, and claims 16 & 17 were newly added. No claims were cancelled. Therefore, claims 1-17 are now pending in the application.
5. The 03/20/26 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the Non-Final Office Action mailed 11/03/25 (“11/03/25 Action”).
6. New rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 103
7. 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.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
9. Claims 1-13, 16, & 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,972,026 to Laufer et al. (“Laufer”) in view of U.S. Patent Application Publication No. 2007/0156130 to Thistle et al. ("Thistle").
10. Regarding claim 1, and with reference to annotated FIG. 2 of Laufer below, Laufer teaches an ablation instrument (10) for RF-ablation, comprising:
a flexible hose arrangement (12) [as broadly as claimed, the “arrangement” comprises catheter sheath (250) and elongated rod (230) - col. 5, line 57 - col. 6, line 2; see also col. 4, ll. 3-4 (“It is understood that the term "rod" also encompasses tubes which have hollow channels”); and col. 9, ll. 33-36 (“The elongated rod and outer catheter of the device are made of a flexible material so that it can be maneuvered through a bronchoscope”)] on which a first electrode (21) is arranged [electrode coil (220) - col. 5, line 57 - col. 6, line 2; electrode coil (220) is attached to (on) catheter sheath (250) at end coupler (235) of sheath (250), and is also disposed on/around rod (230)],
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ANNOTATED FIG. 2 OF LAUFER
wherein the first electrode (21) [coil (220)] comprises multiple adjacent windings (23, 24, 25) that wind around a center axis (M)… and are arranged following a helical line, wherein the center axis (M) defines a longitudinal direction (L) [FIG. 2 clearly depicts that coil electrode (220) includes multiple adjacent windings following a helical line, and which are wound around a center axis that defines a longitudinal direction of rod (230)],
wherein the first electrode (21) [coil (220)] comprises a terminal winding (25) [indicated in annotated FIG. 2 of Laufer above] that is connected to an extension (26) [indicated in annotated FIG. 2 of Laufer above] that extends away from the first electrode (21) [coil (220)] parallel to the longitudinal direction (L) or at an acute angle thereto [the “extension” labelled above in annotated FIG. 2 comprises a portion of electrode coil (220) that clearly extends away from coil (220) in a direction parallel to the longitudinal direction of rod (230)],
wherein a winding section (27) [indicated in annotated FIG. 2 of Laufer above] is arranged between the terminal winding (25) and the extension (26) [the labelled winding section comprises a section of electrode coil (220) that extends between the labelled terminal winding and the labelled extension in annotated FIG. 2 above], and
wherein a distance (A) between the center axis (M) and the winding section (27) decreases from the terminal winding (25) towards the extension (26) [as FIG. 2 clearly shows, the distance between the center axis and the winding section decreases from the terminal winding proximally toward the extension - see also col. 6, ll. 5-7].
MULTIPLE ADJACENT WINDINGS
Laufer contemplates different, expandable electrode coil configurations, including coils having a barrel configuration [see FIG. 2 (addressed above)], coils having a cone-shaped contour [see FIG. 3], and multiple single loop coils (each with one winding) having the same diameter [see FIG. 4].
While the relied-upon embodiment of Laufer [FIG. 2] teaches a coil electrode having multiple adjacent windings (as established above), the adjacent windings have different diameters from one another (i.e., different radial distances from the center axis). As such, Laufer does not teach the following emphasized claim limitation:
wherein the first electrode (21) comprises multiple adjacent windings (23, 24, 25) that wind around a center axis (M) at a same radial distance therefrom.
Thistle, in a similar field of endeavor, relates to RF electrosurgical probes for the treatment of tissue [¶[0001]]. More particularly, Thistle teaches a tissue ablation probe (12) comprising, inter alia, a coiled ablation electrode (22) that is radially expandable relative to shaft (20) between a collapsed geometry [FIG. 2] and an expandable geometry [FIG. 3 (provided below)] [see ¶[0025] for ablating tissue [note also the embodiment of FIG. 6 which includes three coiled ablation electrodes (¶[0032])].
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FIG. 3 of THISTLE
As seen in FIG. 3, coiled ablation electrode (22) includes multiple adjacent windings wound around a central, longitudinal axis of shaft (20) at a same radial distance therefrom. Further, in the expanded geometry of FIG. 3, the windings of electrode (22) have a larger diameter than the diameter of the shaft (20), meaning that a distance between the central, longitudinal axis of shaft (20) and a winding section arranged between a proximal-most winding of coil (22) and the point where coil (22) extends from shaft (20) will decrease toward the extension point.
Given (as noted above) that Laufer already contemplates different, expandable electrode coil configurations, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Laufer to utilize a commonly-known, art-recognized expandable coil configuration for electrode coil (220) known to be useful for ablating tissue, including, e.g., a coil having multiple adjacent windings that wind around a center axis at a same radial distance therefrom, as taught by Thistle, to provide the predictable result of allowing for the application of ablative energy to tissue.
11. Regarding claim 2, the combination of Laufer and Thistle teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the flexible hose arrangement (12) comprises at least one inner hose (13) [as noted above in the rejection of claim 1, the “arrangement” includes elongated rod (230); elongated rod comprises “an inner hose” - col. 5, line 57 - col. 6, line 2; see also col. 4, ll. 3-4 (“It is understood that the term "rod" also encompasses tubes which have hollow channels”); and col. 9, ll. 33-36 (“The elongated rod and outer catheter of the device are made of a flexible material…”)] and at least one sheath (14) [as noted above in the rejection of claim 1, the “arrangement” also includes catheter sheath (250) - col. 5, line 64; FIG. 2] arranged thereon [sheath (250) includes end coupler (235) (see col. 5, line 64) that is arranged on elongated rod (230), as clearly seen in FIG. 2].
12. Regarding claim 3, the combination of Laufer and Thistle teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the at least one inner hose (13) [rod (230)] has a circular cross-section [rod (230) is a “tube” having a circular cross-section - col. 4, ll. 3-4 (“It is understood that the term "rod" also encompasses tubes which have hollow channels”); FIG. 2].
13. Regarding claim 4, the combination of Laufer and Thistle teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the at least one inner hose (13) comprises a depression (28) oriented radially inwardly [inner hose (230) comprises a coupler (270) attached thereto which includes a depression (bottom opening that receives coil end) oriented radially inwardly - FIG. 2; col. 6, ll. 18-22].
14. Regarding claim 5, the combination of Laufer and Thistle teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the depression (28) is at least partly arranged below the first electrode (21) [as broadly as claimed, the bottom depression/opening of coupler (270) is arranged below the upper portions of the windings of the electrode coil - FIG. 2].
15. Regarding claim 6, the combination of Laufer and Thistle teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches at least one additional electrode (22) [electrode coil (210) - col. 5, line 57 - col. 6, line 2; FIG. 2] that is spaced apart from the first electrode (21) [electrode coil (220)] in the longitudinal direction (L) [as clearly shown in FIG. 2, the additional electrode coil (201) is spaced distally from the first electrode coil (220) in the distal direction along the longitudinal direction (L) defined by the center axis].
16. Regarding claim 7, the combination of Laufer and Thistle teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
With reference to the second annotated FIG. 2 of Laufer (provided below), Laufer further teaches:
wherein the at least one additional electrode (22) [electrode coil (210)] comprises multiple windings that wind around a second center axis and are arranged following a second helical line, wherein the second center axis defines a second longitudinal direction [FIG. 2 clearly depicts that second electrode coil (210) likewise includes multiple windings following a helical line, and which are wound around a second center axis that defines a longitudinal direction of rod (230), i.e., the center axis of the portion of rod (230) extending distally from coupler (270)],
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SECOND ANNOTATED FIG. 2 OF LAUFER
wherein the at least one additional electrode (22) [second electrode coil (210)] comprises a second terminal winding [indicated in second annotated FIG. 2 of Laufer above] that is connected to a second extension [indicated in second annotated FIG. 2 of Laufer above] that extends away from the at least one additional electrode (22) [coil (210)] parallel to the second longitudinal direction or at a second acute angle thereto [the “2nd extension” labelled above in second annotated FIG. 2 comprises a portion of electrode coil (210) that clearly extends away from coil (210) in a direction parallel to the second longitudinal direction of rod (230)],
wherein a second winding section [indicated in second annotated FIG. 2 of Laufer above] is arranged between the second terminal winding and the second extension [the labelled 2nd winding section comprises a section of electrode coil (210) that extends between the labelled 2nd terminal winding and the labelled 2nd extension in annotated FIG. 2 above], and
wherein a second distance between the second center axis and the second winding section decreases from the second terminal winding towards the second extension [as FIG. 2 clearly shows, the distance between the second center axis and the second winding section (i.e., the radius of coil (210)) decreases from the 2nd terminal winding proximally toward the 2nd extension - see also col. 6, ll. 5-7 (“In this state, each coil has a "barrel" configuration so that the diameter of the outer contour formed by each coil is largest at its center and smallest at its two ends”)].
17. Regarding claim 8, the combination of Laufer and Thistle teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein an insulator (31) [rotatable coupler (270) - col. 5, line 65 - col. 6, line 2; see also col. 7, ll. 38-48 (“The above embodiments illustrate systems that employ bipolar electrodes. In each system, the electrodes emit RF energy with one conductive element acting as the active electrode and the other acting as the return electrode, or vice versa. One electrode would be connected to the positive electrode of the generator and the other would be connected to the negative electrode. An insulator is located between the conductive elements. In general, when operating in the bipolar mode, electrodes that have different polarities are electrically insulated from each other”); FIG. 2] is arranged between the first electrode (21) [(220)] and the at least one additional electrode (22) [(210)] [clearly shown in FIG. 2].
18. Regarding claim 9, the combination of Laufer and Thistle teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the insulator (31) [(270)] comprises at least one face (32, 33) following the helical line [a proximal face of coupler (270) follows the helical line of first electrode coil (220) in that both are aligned with one another along the longitudinal direction of the center axis; see FIG. 2].
19. Regarding claim 10, the combination of Laufer and Thistle teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the insulator (31) [(270)] is configured in a hollow cylindrical manner [FIG. 2 shows rod (230) extending through coupler (270)] and comprises a cavity (34) for location of the extension (26) therein [as broadly as claimed, and as shown in FIG. 2, coupler (270) includes two cavities, each of which is capable of performing the function of housing an end (extension) of a coil electrode therein].
20. Regarding claim 11, the combination of Laufer and Thistle teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the insulator (31) comprises at least one adhesive reservoir [as broadly as claimed, coupler (270) includes two cavities (the proximal and distal face of coupler (270) each include a cavity for receiving a coil end), each of which is capable of holding adhesive (FIG. 2); note also claim 12 (below) which defines the adhesive reservoir as a “cavity”].
21. Regarding claim 12, the combination of Laufer and Thistle teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the at least one adhesive reservoir is formed by a cavity (34, 35) on at least one face of the insulator (31) [the proximal and distal face of coupler (270) each include a cavity (for receiving a coil end) capable of holding adhesive (FIG. 2)].
22. Regarding claim 13, the combination of Laufer and Thistle teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the extension (26) is connected to an electrical line (30) [by line (215) - see col. 6, ll. 37-40 (“Each coil in the embodiment shown in FIG. 2 is connected to an appropriate source of energy. For example, coils 210 and 220 can be connected by lines 215 and 225 to a radio frequency generator 130 as shown in FIG. 1A”)]
23. Regarding claim 16, the combination of Laufer and Thistle teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 16 further recites the limitation “wherein the winding section extends along only a portion of a circumference of the first electrode.”
Laufer was modified above (in the rejection of claim 1) to utilize the expandable coil configuration of Thistle. As previously explained in the rejection of claim 1, in the expanded geometry of FIG. 3 of Thistle, the windings of electrode (22) have a larger diameter than the diameter of the shaft (20), meaning that a distance between the central, longitudinal axis of shaft (20) and a winding section arranged between a proximal-most winding of coil (22) and the point where coil (22) extends from shaft (20) will decrease toward the extension point. As such, the winding section will not extend along a full circumference of the electrode.
24. Regarding claim 17, the combination of Laufer and Thistle teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches wherein the first electrode is disposed on the inner hose and is adjacent in the longitudinal direction to the at least one sheath [as clearly seen in FIG.2 of Laufer, electrode coil (220) is disposed on/around rod (230), and is adjacent in the longitudinal direction (along the center axis that defines the longitudinal direction) to catheter sheath (250), i.e., electrode (220) and sheath (250) are arranged side-by-die in the longitudinal direction].
25. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Laufer and Thistle, as applied to claim 13 above, and further in view of U.S. Patent Application Publication No. 2005/0055020 to Skarda ("Skarda").
26. Regarding claim 14, the combination of Laufer and Thistle teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
The combination of Laufer and Thistle does not, however, teach:
wherein the extension (26) and the electrical line (30) are connected to one another by a crimp barrel (29).
Skarda, in a similar field of endeavor, teaches that it was known to connect an electrical conductor to a helical ablation electrode in a variety of different manners, including, e.g., mechanical crimping [see Skarda, ¶[0017] (“Furthermore, a pair of wires from insulated electrical wires 9 (FIGS. 2A and 3B) are coupled to ablation electrode 120, via mechanical crimping or staking or welding or any other means known to those skilled in the art, either passing from their respective lumen into lumen 20 or passing outside shaft 5 from their respective lumen, in order to power ablation electrode 120”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Laufer and Thistle such that the extension and the electrical line be connected to one another using a known, art-recognized method such as mechanical crimping, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Skaarda), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Laufer and Thistle, and the results (securing the electrical conductor to the end of the electrode coil) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
27. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Laufer and Thistle, as applied to claim 2 above, and further in view of U.S. Patent Application Publication No. 2022/0061915 to Kim et al. ("Kim").
28. Regarding claim 15, the combination of Laufer and Thistle teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Laufer further teaches that the at least one inner hose (13) [(230)] surrounds a lumen (17) [i.e., the inner lumen of rod (230) - see col. 4, ll. 3-4 (“It is understood that the term "rod" also encompasses tubes which have hollow channels”); FIG. 2].
The combination of Laufer and Thistle does not, however, teach the following emphasized limitation:
wherein the at least one inner hose (13) surrounds a lumen (17) inside of which a supply hose (20) is arranged having at least one exit opening (38) to supply a cooling fluid inside the lumen to cool the first electrode without contacting the first electrode.
However, the use of a coolant supply hose (lumen) to circulate coolant through the interior of a catheter portion upon which electrodes are disposed, without contacting the electrodes, was well known in the art before the effective filing date of the claimed invention.
As one example, Kim, in a similar field of endeavor, teaches an RF ablation catheter (100) having a distal part [intra-septal part (120)] with one or more electrodes (124) formed on an outer surface thereof for transmitting RF energy [¶’s [0060], [0062], [0068]; FIG. 4].
Kim additionally teaches that that the distal part [intra-septal part (120)] includes a coolant lumen (140) with an opening to inject a coolant into an interior of part (120) on which the electrodes (124) are disposed, and then exits through a coolant outlet lumen (150) so that the coolant can flow backwards through the coolant outlet lumen (150) to be discharged [e.g., ¶’s [0085], [0086], [0088], & [0093]-[0096]; FIG. 4]. As shown in FIG. 4, the coolant circulates within the interior of distal part (120), and does not contact the electrodes (124).
Kim teaches that the benefits of cooling the interior in such a manner include lowering the temperature of the electrode (of the distal part) to prevent carbonization around the electrode, and to facilitate RF transmission, and widen a range of cauterization [e.g., ¶[0013]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Laufer and Thistle such that the inner hose (230) of Laufer include a supply hose arranged having at least one exit opening to supply a cooling fluid inside the lumen to cool the first electrode without contacting the first electrode, as taught by Kim, since such a modification would provide the benefit/advantage of lowering the temperature of the coil electrode of Laufer/Thistle to prevent carbonization around the electrode, and to facilitate RF transmission, and widen a range of cauterization, as explicitly taught by Kim.
Response to Arguments
29. As noted above, the 03/20/26 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the 11/03/25 Action.
30. Applicant's arguments concerning the prior rejections under § 102 have been fully considered and are persuasive (in view of the current Amendment). Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection under § 103 based on the combination of Laufer and Thistle are set forth in detail above, necessitated by Applicant’s Amendment.
Conclusion
31. 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 extension fee 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 date of this final action.
32. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794