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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's After-Final submission filed on 07/02/26 (“07/02/26 Amendment") has been entered, and fully considered [by the filing of the 07/20/26 RCE].
Response to Amendment
3. In the 07/02/26 Amendment, claim 1 was amended, and claim 18 was newly added. No claims were cancelled. Accordingly, claims 1-18 are now pending in the application.
4. The 07/02/26 Amendment has overcome the claim rejections under § 103 previously set forth in the Final Office Action mailed 04/06/26 (“04/06/26 Action”).
5. New grounds of rejection under §§ 102 & 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 102
6. 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.
I. REJECTIONS UNDER § 102 BASED ON MULIER
7. Claims 1, 13, 14, & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,876,398 to Mulier et al. (“Mulier”).
8. Regarding claim 1, and with reference to annotated FIG. 2 of Mulier (below), Mulier discloses an ablation instrument (10) for RF-ablation, comprising:
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a flexible hose arrangement (12) [porous segment (12) of catheter body (10) – col. 2, ll. 34-39; FIG. 2] on which a first electrode (21) [elongated coiled electrode (14) – col. 2, ll. 34-39]; FIG. 2] is arranged [FIG. 2],
wherein the first electrode (21) [(14)] comprises multiple adjacent windings (23, 24, 25) [indicated in annotated FIG. 2 above] that wind around a center axis (M) [indicated in annotated FIG. 2 above] at a same radial distance therefrom [clearly shown in FIG. 2] and are arranged following a helical line [e.g., col. 2, line 57 (“helical electrode 14”)], wherein the center axis (M) defines a longitudinal direction (L) [both are indicated in annotated FIG. 2 above; FIG. 2 clearly depicts that coiled electrode (14) includes multiple adjacent windings following a helical line, and which are wound around a center axis that defines a longitudinal direction of the device]
wherein the first electrode (21) [(14)] comprises a terminal winding (25) [indicated in annotated FIG. 2 above] that is connected to an extension (26) that extends away from the first electrode (21) parallel to the longitudinal direction (L) or at an acute angle thereto [the extension comprises a proximal end portion of coiled electrode (14) that clearly extends proximally away from coiled electrode (14) in a direction parallel to the longitudinal direction of the device – see also col. 3, ll. 7-10 (“the proximal end of the coil electrode 14 is coupled to the torque cable by a second crimped ferrule 34. Torque cable 32 serves both to electrical couple electrical connector 22 (FIG. 1) to electrode 14 and to transmit torque along the length of the catheter, allowing screw 18 to be screwed into tissue”)],
wherein a winding section (27) [indicated in annotated FIG. 2 above] is arranged between the terminal winding (25) and the extension (26) [the labelled winding section comprises a section of coiled electrode (14) that extends between the labelled terminal winding and the extension positioned in ferrule (34) – see FIG. 2],
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 (M) and the indicated winding section decreases from the terminal winding proximally toward the extension], and
wherein the first electrode (21) [(14)] is non-expandable in a radial direction relative to the center axis (M) [e.g., col. 3, line 13; FIGS. 1-2].
9. Regarding claim 13, Mulier discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Mulier further discloses wherein the extension (26) is connected to an electrical line (30) [col. 3, ll. 7-10 (“the proximal end of the coil electrode 14 is coupled to the torque cable by a second crimped ferrule 34. Torque cable 32 serves both to electrical couple electrical connector 22 (FIG. 1) to electrode 14 and to transmit torque along the length of the catheter, allowing screw 18 to be screwed into tissue”)],
10. Regarding claim 14, Mulier discloses all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Mulier further discloses wherein the extension (26) and the electrical line (30) are connected to one another by a crimp barrel (29) [broadly, crimped ferrule (34) – col. 3, ll.7-10].
11. Regarding claim 16, Mulier discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Mulier further discloses wherein the winding section [indicated in annotated FIG. 2 above] extends along only a portion of a circumference of the first electrode [clearly shown in FIG. 2].
II. REJECTIONS UNDER § 102 BASED ON GOVARI
12. Claims 1-3, 13, & 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2011/0144639 to Govari (“Govari”) [already of record].
13. Regarding claim 1, and with reference to annotated FIG. 4 of Govari (below), Govari discloses an ablation instrument (10) for RF-ablation, comprising:
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a flexible hose arrangement (12) [comprising insertion tube (50) (¶[0028]) and a “tube of smaller diameter” fitted inside tube (50) (¶[0030]); FIGS. 4-5] on which a first electrode (21) is arranged [electrode (60) - ¶[0032]; FIG. 4],
wherein the first electrode (21) [electrode (60)] comprises multiple adjacent windings (23, 24, 25) [indicated in annotated FIG. 4 above] that wind around a center axis (M) [indicated in annotated FIG. 4 above] at a same radial distance therefrom [clearly shown in FIG. 4] and are arranged following a helical line [¶[0032] (“The coil electrode may comprise a wire, which is wound into a helical coil, as shown in the figure, resembling a coil spring”)], wherein the center axis (M) defines a longitudinal direction (L) [the center axis “M” indicated in FIG. 4 above defines a longitudinal axis of the device],
wherein the first electrode (21) [electrode (60)] comprises a terminal winding (25) [indicated in annotated FIG. 4 above] that is connected to an extension (26) that extends away from the first electrode (21) [electrode (60)] parallel to the longitudinal direction (L) or at an acute angle thereto [the extension comprises a portion of wire (62) connected to a proximal end portion of electrode (60), and it clearly extends proximally away from the windings of the electrode in a direction parallel to the longitudinal direction of the device - ¶[0033]; FIG. 4],
wherein a winding section (27) [indicated in annotated FIG. 4 above] is arranged between the terminal winding (25) and the extension (26) [the labelled winding section comprises a section of electrode (60) that extends between the labelled terminal winding and the extension – see FIG. 4], 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. 4 clearly shows, the distance between the center axis (M) and the indicated winding section decreases from the terminal winding proximally toward the extension], and
wherein the first electrode (21) [electrode (60)] is non-expandable in a radial direction relative to the center axis (M) [see ¶[0033] (“Electrode 60 is slid to the desired location on tube 50, and is then glued or otherwise fastened in place”)].
14. Regarding claim 2, Govari discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the flexible hose arrangement (12) comprises at least one inner hose (13) and at least one sheath (14) arranged thereon [as noted above in the rejection of claim 1, the “flexible hose arrangement” of Govari comprises an inner hose (a “tube of smaller diameter” fitted inside tube (50)) and at least one sheath arranged thereon (insertion tube (50)) – see ¶[0030] (“a tube of smaller diameter inside tube 50”)].
15. Regarding claim 3, Govari discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the at least one inner hose (13) [the “tube of smaller diameter” fitted inside tube (50)] has a circular cross-section [clearly shown in FIG. 5].
16. Regarding claim 13, Govari discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the extension (26) is connected to an electrical line (30) [¶[0033]].
17. Regarding claim 16, Govari discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the winding section [indicated in annotated FIG. 4 above] extends along only a portion of a circumference of the first electrode [clearly shown in FIG. 4].
18. Regarding claim 17, Govari discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the first electrode [electrode (60)] is disposed on the inner hose [broadly, electrode (60) is disposed on tube (50) which is disposed on the inner tube (the “tube of smaller diameter” fitted inside tube (50)); note that the claim does not require that the first electrode be disposed “directly” on the inner hose] and is adjacent [interpreted as “lying near, close, or contiguous”] in the longitudinal direction to the at least one sheath [the electrode (60) is both near & close to tube (50) in the longitudinal direction since it is disposed thereon – FIG. 4].
19. Regarding claim 18, Govari discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Govari further discloses wherein the flexible hose arrangement comprises at least one inner hose [as noted above in the rejection of claim 1, the “flexible hose arrangement” of Govari comprises an inner hose (a “tube of smaller diameter” fitted inside tube (50))], wherein the first electrode [electrode (60)] extends about, directly contacts, and is supported by the at least one inner hose [with reference to annotated FIG. 5 of Govari (provided below), electrode (60) extends about (around) both insertion tube (50) and the tube of smaller diameter fitted therein; electrode (60) directly contacts the inner tube at the point “A” (indicated in annotated FIG. 5 below) where it enters the inner tube; and electrode (60) is supported by tube (50) - which is itself is supported by “the tube of smaller diameter” fitted inside tube (50); as such, it is the Examiner’s position that the tube of smaller diameter supports both tube (50) and electrode (60)].
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Claim Rejections - 35 USC § 103
20. 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.
21. 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.
22. Claims 1-9, 13, 14, & 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 5,913,854 to Maguire et al. (“Maguire”) [already of record] in view of Mulier.
23. Regarding claim 1, and with reference to annotated FIG. 7 of Maguire (below), Maguire teaches an ablation instrument (10) for RF-ablation, comprising:
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a flexible hose arrangement (12) [comprising outer tubular member (38e) and inner tubular member (40e) – col. 5, line 63 – col. 7, line 2; FIGS. 7A, 7C] on which a first electrode (21) [first spiral electrode (44) – col. 2, ll. 63-65 (“FIG. 7 illustrates an alternative tip portion showing two spiral electrodes having circular cross-sectional shapes embedded within an outer tubular member”); & col. 5, line 63 – col. 6, line 16; FIGS. 7A-7C] is arranged [FIG. 7],
wherein the first electrode (21) [first spiral electrode (44)] comprises multiple adjacent windings (23, 24, 25) [indicated in annotated FIG. 7 above] that wind around a center axis (M) [indicated in annotated FIG. 7 above] at a same radial distance therefrom [clearly shown in FIG. 7] and are arranged following a helical line [FIG. 7], wherein the center axis (M) defines a longitudinal direction (L) [FIG. 7 clearly depicts that first spiral electrode (44) includes multiple adjacent windings following a helical line, and which are wound around a center axis that defines a longitudinal direction of the device],
wherein the first electrode (21) [first spiral electrode (44)] comprises a terminal winding (25) [indicated in annotated FIG. 7 above]…, [and]
wherein the first electrode (21) [first spiral electrode (44)] is non-expandable in a radial direction relative to the center axis (M) [col. 5, ll. 63-66].
EXTENSION
Maguire further teaches a winding section (27) [indicated in annotated FIG. 7 above] disposed at the proximal end of the first spiral electrode (44), and wherein a distance (A) between the center axis (M) and the winding section (27) decreases from the terminal winding (25) towards the proximal-most end of the first spiral electrode (44) [as FIG. 7 clearly shows, the distance between the center axis (M) and the indicated winding section decreases from the terminal winding proximally toward the proximal-most end of the first spiral electrode (44)].
Maguire, however, is silent regarding the manner by which the proximal-most end of the first spiral electrode (44) connects to an electrical line/cable to provide power/energy to the first spiral electrode (44).
As such, Maguire does not teach the following emphasized claim limitations:
wherein the first electrode (21) comprises a terminal winding (25) that is connected to an extension (26) that extends away from the first electrode (21) parallel to the longitudinal direction (L) or at an acute angle thereto,
wherein a winding section (27) is arranged between the terminal winding (25) and the extension (26), 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),
Mulier, in a similar field of endeavor, teaches that it was known in the art to provide an electrical connection to a proximal-most end of a helical electrode via an extension that extends away from the first electrode parallel to the longitudinal direction of the device.
More particularly, and with reference to annotated FIG. 2 of Mulier (below), Mulier teaches an ablation instrument (10) for RF-ablation, comprising:
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a flexible hose arrangement (12) [porous segment (12) of catheter body (10) – col. 2, ll. 34-39; FIG. 2] on which a first electrode (21) [elongated coiled electrode (14) – col. 2, ll. 34-39]; FIG. 2] is arranged [FIG. 2], wherein the first electrode (21) [(14)] comprises multiple adjacent windings (23, 24, 25) [indicated in annotated FIG. 2 above] that wind around a center axis (M) [indicated in annotated FIG. 2 above] at a same radial distance therefrom [clearly shown in FIG. 2] and are arranged following a helical line [e.g., col. 2, line 57 (“helical electrode 14”)], wherein the center axis (M) defines a longitudinal direction (L) [both are indicated in annotated FIG. 2 above; FIG. 2 clearly depicts that coiled electrode (14) includes multiple adjacent windings following a helical line, and which are wound around a center axis that defines a longitudinal direction of the device], and wherein the first electrode (21) [(14)] is non-expandable in a radial direction relative to the center axis (M) [e.g., col. 3, line 13; FIGS. 1-2].
With regard to the above-emphasized claim limitations absent from Maguire, Mulier teaches:
wherein the first electrode (21) [(14)] comprises a terminal winding (25) [indicated in annotated FIG. 2 above] that is connected to an extension (26) that extends away from the first electrode (21) parallel to the longitudinal direction (L) or at an acute angle thereto [the extension comprises a proximal end portion of coiled electrode (14) that clearly extends proximally away from coiled electrode (14) in a direction parallel to the longitudinal direction of the device – see also col. 3, ll. 7-10 (“the proximal end of the coil electrode 14 is coupled to the torque cable by a second crimped ferrule 34. Torque cable 32 serves both to electrical couple electrical connector 22 (FIG. 1) to electrode 14 and to transmit torque along the length of the catheter, allowing screw 18 to be screwed into tissue”)],
wherein a winding section (27) [indicated in annotated FIG. 2 above] is arranged between the terminal winding (25) and the extension (26) [the labelled winding section comprises a section of coiled electrode (14) that extends between the labelled terminal winding and the extension positioned in ferrule (34) – see FIG. 2], 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 (M) and the indicated winding section decreases from the terminal winding proximally toward the extension].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Maguire to implement a known, art-recognized configuration for connecting the winding section of the first spiral electrode (44) to an electrical line/cable), such as an extension, to provide power/energy to the first spiral electrode (44), or more particularly, wherein the first electrode (21) comprises a terminal winding (25) that is connected to an extension (26) that extends away from the first electrode (21) parallel to the longitudinal direction (L) or at an acute angle thereto, wherein a winding section (27) is arranged between the terminal winding (25) and the extension (26), 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), all as taught by Mulier, since such a particular known connection configuration was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Mulier, and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Maguire), and the results (connecting
an electrical line/cable to a spiral electrode) 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).
24. Regarding claim 2, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the flexible hose arrangement (12) comprises at least one inner hose (13) and at least one sheath (14) arranged thereon [as noted above in the rejection of claim 1, the “flexible hose arrangement” of Maguire comprises inner tubular member (40e) with outer tubular member (38e) arranged thereon - col. 5, line 63 – col. 7, line 2; FIGS. 7A, 7C].
25. Regarding claim 3, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the at least one inner hose (13) [inner tubular member (40e)] has a circular cross-section [clearly shown in, e.g., FIG. 7B]
26. Regarding claim 4, the combination of Maguire and Mulier teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the at least one inner hose (13) [inner tubular member (40e)] comprises a depression (28) oriented radially inwardly [broadly, the depression that accommodates the bottom of electrode (44) as shown/labelled in annotated FIG. 7C provided below].
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27. Regarding claim 5, the combination of Maguire and Mulier teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the depression (28) is at least partly arranged below the first electrode (21) [clearly shown in FIG. 7C].
28. Regarding claim 6, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches at least one additional electrode (22) that is spaced apart from the first electrode (21) in the longitudinal direction (L) [as clearly shown in the second annotated version of FIG. 7 of Maguire (provided below), a second spiral electrode (44) is provided – col. 2, ll. 63-65 (“FIG. 7 illustrates an alternative tip portion showing two spiral electrodes having circular cross-sectional shapes embedded within an outer tubular member”); & col. 5, line 63 – col. 6, line 16; FIGS. 7A-7C].
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29. Regarding claim 7, the combination of Maguire and Mulier teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the at least one additional electrode (22) [second spiral electrode (44)] comprises multiple windings [indicated in the second annotated FIG. 7 above] that wind around a second center axis [same axis “M” labelled above] and are arranged following a second helical line [FIG. 7], wherein the second center axis defines a second longitudinal direction [FIG. 7 clearly depicts that second spiral electrode (44) likewise includes multiple windings following a helical line, and which are wound around a second center axis that defines a longitudinal direction], [and]
wherein the at least one additional electrode (22) [second spiral electrode (44)] comprises a second terminal winding [indicated in the second annotated FIG. 7 above]…,
SECOND EXTENSION
Maguire further teaches a second winding section (27) [indicated in the second annotated FIG. 7 above] disposed at the proximal end of the second spiral electrode (44), and wherein a second distance between the second center axis and the second winding section decreases from the proximal-most end of the second spiral electrode (44) [as the second annotated FIG. 7 clearly shows, the distance between the center axis (M) and the indicated second winding section decreases from the second terminal winding proximally toward the proximal-most end of the second spiral electrode (44)].
Maguire, however, is silent regarding the manner by which the proximal-most end of the second spiral electrode (44) connects to an electrical line/cable to provide power/energy to the second spiral electrode (44).
As such, Maguire does not teach the following emphasized claim limitations:
wherein the at least one additional electrode (22) comprises a second terminal winding that is connected to a second extension that extends away from the at least one additional electrode (22) parallel to the second longitudinal direction or at a second acute angle thereto,
wherein a second winding section is arranged between the second terminal winding and the second extension, 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 noted above in the rejection of claim 1, Mulier teaches that it was known in the art to provide an electrical connection to a proximal-most end of a helical electrode via an extension that extends away from the electrode parallel to the longitudinal direction of the device.
Again, and with reference to the rejection of claim 1 (which is incorporated herein), Mulier teaches wherein an electrode (14) comprises a terminal winding that is connected to an extension that extends away from the first electrode parallel to the longitudinal direction (L) [the extension comprises a proximal end portion of coiled electrode (14) that clearly extends proximally away from coiled electrode (14) in a direction parallel to the longitudinal direction of the device – see also col. 3, ll. 7-10 (“the proximal end of the coil electrode 14 is coupled to the torque cable by a second crimped ferrule 34. Torque cable 32 serves both to electrical couple electrical connector 22 (FIG. 1) to electrode 14 and to transmit torque along the length of the catheter, allowing screw 18 to be screwed into tissue”)],
wherein a winding section is arranged between the terminal winding and the extension [the winding section comprises a section of coiled electrode (14) that extends between the terminal winding and the extension positioned in ferrule (34) – see FIG. 2], and
wherein a distance between the center axis and the winding section decreases from the terminal winding towards the extension [as FIG. 2 clearly shows, the distance between the center axis (M) and the indicated winding section decreases from the terminal winding proximally toward the extension].
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 Maguire and Mulier to likewise implement the same known, art-recognized configuration for connecting the winding section of the second spiral electrode (44) to an electrical line/cable, such as an extension, to provide power/energy to the second spiral electrode (44), or more particularly, wherein the at least one additional electrode (22) comprises a second terminal winding that is connected to a second extension that extends away from the at least one additional electrode (22) parallel to the second longitudinal direction or at a second acute angle thereto, wherein a second winding section is arranged between the second terminal winding and the second extension, 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, all as taught by Mulier, since such a particular known connection configuration was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Mulier, and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Maguire/Mulier), and the results (connecting an electrical line/cable to a spiral electrode) 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).
30. Regarding claim 8, the combination of Maguire and Mulier teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein an insulator (31) is arranged between the first electrode (21) and the at least one additional electrode (22) [with reference to the annotated excerpt of FIG. 7A of Maguire (provided below), a thicker portion (in the radial dimension) of outer tubular member (38e) is disposed between first spiral electrode (44) and second spiral electrode (44); outer tubular member (38e) is made of an insulative material – e.g., col. 5, line 63 – col. 6, line 24].
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31. Regarding claim 9, the combination of Maguire and Mulier teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the insulator (31) comprises at least one face (32, 33) following the helical line [as broadly as claimed, the proximal, vertical face of the indicated insulator follows the helical line of first spiral electrode (44)].
32. Regarding claim 13, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire was modified above (in the rejection of claim 1) to include the extension of Mulier. Mulier further teaches wherein the extension (26) is connected to an electrical line (30) [col. 3, ll. 7-12].
33. Regarding claim 14, the combination of Maguire and Mulier teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Maguire was modified above (in the rejection of claim 1) to include the extension of Mulier. Mulier further teaches wherein the extension (26) and the electrical line (30) are connected to one another by a crimp barrel (29) [col. 3, ll. 7-12].
34. Regarding claim 16, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the winding section extends along only a portion of a circumference of the first electrode [clearly shown in FIG. 7].
35. Regarding claim 17, the combination of Maguire and Mulier teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the first electrode [first spiral electrode (44)] is disposed on the inner hose [inner tubular member (40e)] [FIGS. 7A, 7C] and is adjacent in the longitudinal direction to the at least one sheath [outer tubular member (38e)] [clearly shown in FIG. 7A where, e.g., a section of outer tubular member (38a) is disposed between (and separates) electrode sections (44)].
36. Regarding claim 18, the combination of Maguire and Mulier teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the flexible hose arrangement comprises at least one inner hose [as noted above in the rejection of claim 1, the “flexible hose arrangement” of Maguire comprises an inner hose (inner tubular member (40e)) with outer tubular member (38e) arranged thereon - col. 5, line 63 – col. 7, line 2; FIGS. 7A, 7C], wherein the first electrode [first spiral electrode (44)] extends about [FIGS. 7, 7A], directly contacts [FIG. 7C], and is supported by [FIG. 7A] the at least one inner hose [(40e)].
37. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maguire and Mulier, as applied to claim 8 above, and further in view of U.S. 5,972,026 to Laufer et al. (“Laufer”) [already of record].
38. Regarding claims 10-12, the combination of Maguire and Mulier teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
The combination of Maguire and Mulier does not, however, teach:
[claim 10] wherein the insulator (31) is configured in a hollow cylindrical manner and comprises a cavity (34) for location of the extension (26) therein;
[claim 11] wherein the insulator (31) comprises at least one adhesive reservoir; &
[claim 12] wherein the at least one adhesive reservoir is formed by a cavity (34, 35) on at least one face of the insulator (31).
Laufer, in a similar field of endeavor, teaches a device comprising, inter alia, a catheter sheath (250) and an electrode coil (220) [see 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)].
With reference to the annotated excerpt of FIG. 2 of Laufer (provided below), Laufer teaches that it was known to interface a proximal-most end of an electrode coil to an electrical line (215) [col. 6, ll. 37-40] via an extension (labelled in FIG. 2 below) that is received in a cavity of an insulator [broadly, coupler (235)].
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More particularly, Laufer teaches:
wherein the insulator (31) [(235)] is configured in a hollow cylindrical manner [FIG. 2] and comprises a cavity (34) for location of the extension (26) therein [broadly, coupler (235) includes a cavity for receiving the extension (proximal coil end) therein for connection to electrical line (215)];
wherein the insulator (31) [(235)] comprises at least one adhesive reservoir [as broadly as claimed, coupler (235) includes a cavity which is capable of holding adhesive (FIG. 2)]; &
wherein the at least one adhesive reservoir is formed by a cavity (34, 35) on at least one face of the insulator (31) [the distal face of coupler (235) includes a cavity (for receiving a coil end) capable of holding adhesive (FIG. 2)].
Still further, Laufer teaches that it was known to separate/isolate a distal end of a first coil electrode from a proximal end of a second coil electrode via an insulator [coupler (270)] having cavities therein for receipt of the respective coils ends [see the second annotated excerpt of FIG. 2 of Laufer below].
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Annotated Excerpt of FIG. 2 of Laufer
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 Maguire and Mulier such that the insulator of Maguire [as labelled in the annotated excerpt of FIG. 7A of Maguire provided above in the rejection of claim 8] be modified to include cavities for receiving the respective ends of the electrodes, or more particularly, wherein the insulator (31) is configured in a hollow cylindrical manner and comprises a cavity (34) for location of the extension (26) therein, wherein the insulator (31) comprises at least one adhesive reservoir, & wherein the at least one adhesive reservoir is formed by a cavity (34, 35) on at least one face of the insulator (31), since such a technique for securing and separating respective ends of adjacent electrode coils was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Laufer, and one of ordinary skill in the art would have been capable of applying this known arrangement to the known device (of Maguire/Mulier), and the results (separating/securing the ends of the adjacent electrodes) 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).
39. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maguire and Mulier, as applied to claim 2 above, and further in view of U.S. 2022/0061915 to Kim et al. ("Kim") [already of record].
40. Regarding claim 15, the combination of Maguire and Mulier teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Maguire further teaches wherein the at least one inner hose (13) [inner tubular member (40e)] surrounds a lumen (17) [FIG. 7A] inside of which… [is provided] a cooling fluid [cooling fluid (32) – col. 6, ll. 9-12] inside the lumen to cool the first electrode [first spiral electrode (44)] without contacting the first electrode [see col. 1, ll. 57-59 (“Second, the inner surface can be covered by a material which prevents direct contact by the cooling fluid with a bare inner surface of the linear electrode”)].
The combination of Maguire and Mulier does not, however, teach how the cooling fluid is introduced into the lumen, and therefore does not explicitly 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 Maguire and Mulier such that Maguire 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 particular fluid introduction arrangement was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Kim, and one of ordinary skill in the art would have been capable of applying this known arrangement to the known device (of Maguire/Mulier), and the results (introduction of coolant into an interior lumen of an ablation device) 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).
Response to Arguments
41. As noted above, the 07/02/26 Amendment has overcome the claim rejections under § 103 previously set forth in the 04/06/26 Action.
42. New grounds of rejection under §§ 102 & 103 are set forth herein, necessitated by Applicant’s Amendment.
Citation of Pertinent Prior Art
43. While U.S. 2005/0055020 to Skarda (“Skarda”) [of record] is considered cumulative to the teachings of Mulier and Govari, it is noted that Skarda also reads on independent claim 1, as broadly as currently claimed [see Skarda at, e.g., ¶’s [0017] - [0019]; claims 1, 14, & 29; and FIG. 3B (reproduced below)].
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Conclusion
44. 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, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. 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/Primary Examiner, Art Unit 3794
Prosecution Insights