DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 8 and 9 are cancelled. A complete action on the merits of pending claims 1-7 and 10-20 appears herein.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schmidt (US 2002/0095202 A1) in view of Stewart (US 2002/0111618 A1).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7, 10-11, 13-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2002/0095202 A1) in view of Stewart (US 2002/0111618 A1).
Regarding claim 1, Schmidt teaches a medical device (Fig. 1) comprising:
an elongate body having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion; (Fig. 1, Char. 4: tube)
an electrode located on the distal portion; (Fig. 1: The distal most coiled electrode (10)) and
a conductor (Fig. 1, Char. 6: wire leads) extending from the electrode to the proximal portion, wherein the electrode and the conductor are formed of a single piece of continuous material; (Fig. 1 and Par. [0036]: Wire leads (6) each have terminal ends (2) and coiled electrodes (10))
wherein the electrode includes a plurality of undulations. (Merriam-webster.com defines undulation as “a wavy appearance, outline, or form;” Fig. 1-3: Coiled electrodes (10) have a wavy outline)
Schmidt further teaches the electrode catheter is flexible. (Par. [0013])
Schmidt, as applied to claim 1 above, is silent regarding the plurality of undulations being arranged parallel to a longitudinal axis of the elongate body.
Stewart, in a similar field of endeavor, teaches a cardiac catheter flexible enough such that the distal end can be bent to be at least perpendicular with the proximal end of said catheter where the “wavey” portions as seen in Fig. 2A are seen as parallel to a longitudinal axis of the elongated body as they extend along the body. (Fig. 2A)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schmidt, as applied to claim 1 above, to incorporate the teachings of Stewart, and configure the catheter of Schmidt to be flexible enough, such that the distal end of tube (4) of Schmidt can be bent at least perpendicularly to the proximal end of tube (4). Doing so would allow for the catheter to be easily navigated through the vessels used in the introduction/retraction path to/from the target site, as well as allow for the distal tip to be easily maneuvered into any position relative to a target tissue with minimal movement of the proximal end of the catheter.
In this combination, when the distal end of tube (4) is disposed perpendicularly to the proximal end of tube (4), the undulations of the coiled electrodes (10) would be disposed parallel to a longitudinal axis of the proximal end of tube (4).
Regarding claim 20, the method steps for making the device would be intuitive to the structure provided in Schmidt, as applied to claim 1 above, given that the method steps of claim 20, as best understood by examiner, appear to make the device of claim 1.
Regarding claim 2, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches the medical device is a dilator, guidewire, catheter, or perforation device. (Schmidt: Par. [0036]: Fig. 1 depicts an electrode catheter)
Regarding claim 3, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches a first surface electrode positioned proximal of the electrode. (Schmidt: Fig. 1: The second distal most coiled electrode (10))
Regarding claim 4, the combination of Schmidt/Stewart, as applied to claim 3 above, teaches a second surface electrode positioned proximal of the first surface electrode. (Schmidt: Fig. 1: The third distal most coiled electrode (10))
Regarding claim 5, the combination of Schmidt/Stewart, as applied to claim 4 above, teaches the electrode, the first surface electrode, and the second surface electrode have a same diameter. (Absent a statement otherwise, one of ordinary skill in the art would expect all coiled electrodes (10) of Schmidt to have the same diameter)
Regarding claim 7, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches the electrode comprises a plurality of loops positioned along a longitudinal axis of the elongate body. (Schmidt: Fig. 1: each of the coiled electrodes (10) comprise three loops)
Regarding claim 10, the combination of Schmidt/Stewart, as applied to claim 7 above, teaches the plurality of loops are joined by a conductive material. (Schmidt: Fig. 10, and Par. [0049]: Cross-bar (56) is formed by welds or a fusing of the coils (54))
Regarding claim 11, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches the conductor extends within the lumen to the proximal end. (Schmidt: Fig. 1)
Regarding claim 13, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches the conductor extends along a surface of the elongate body. (Schmidt: Fig. 1: wire leads (6) extend along an inner surface of tube (4))
Regarding claim 14, the combination of Schmidt/Stewart, as applied to claim 1 above, teaches the distal portion includes a taper. (Schmidt: Fig. 1: tip member (12) comprises a tapered end)
Regarding claim 15, Schmidt teaches
an elongate body (Fig. 1, Char. 4: tube) having a proximal portion (Fig. 1, the proximal half of tube (4)) and a tapered distal end; (Fig. 1, the distal half of tube (4))
a coiled electrode located on the tapered distal end; (Fig. 1: The distal most coiled electrode (10)) and
a conductor (Fig. 1, Char. 6: wire leads) extending from the coiled electrode to the proximal portion, wherein the coiled electrode and the conductor are formed of a single piece of continuous material; (Fig. 1 and Par. [0036]: Wire leads (6) each have terminal ends (2) and coiled electrodes (10))
wherein the coiled electrode includes a plurality of undulations. (Merriam-webster.com defines undulation as “a wavy appearance, outline, or form;” Fig. 1-3: Coiled electrodes (10) have a wavy outline)
Schmidt, as applied to claim 15 above, is silent regarding the plurality of undulations being arranged parallel to a longitudinal axis of the elongate body.
Stewart, in a similar field of endeavor, teaches a cardiac catheter flexible enough such that the distal end can be bent to be at least perpendicular with the proximal end of said catheter. (Fig. 2A)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schmidt, as applied to claim 1 above, to incorporate the teachings of Stewart, and configure the catheter of Schmidt to be flexible enough, such that the distal end of tube (4) of Schmidt can be bent at least perpendicularly to the proximal end of tube (4). Doing so would allow for the catheter to be easily navigated through the vessels used in the introduction/retraction path to/from the target site, as well as allow for the distal tip to be easily maneuvered into any position relative to a target tissue with minimal movement of the proximal end of the catheter.
In this combination, when the distal end of tube (4) is disposed perpendicularly to the proximal end of tube (4), the undulations of the coiled electrodes (10) would be disposed parallel to a longitudinal axis of the proximal end of tube (4).
Regarding claim 16, the combination of Schmidt/Stewart, as applied to claim 15 above, teaches a first surface electrode positioned proximal of the coiled electrode. (Schmidt: Fig. 1: The second distal most coiled electrode (10))
Regarding claim 17, the combination of Schmidt/Stewart, as applied to claim 16 above, teaches a second surface electrode positioned proximal of the first surface electrode. (Schmidt: Fig. 1: The third distal most coiled electrode (10))
Regarding claim 19, the combination of Schmidt/Stewart, as applied to claim 15 above, teaches the coiled electrode comprises a plurality of loops positioned along a longitudinal axis of the elongate body. (Schmidt: Fig. 1: each of the coiled electrodes (10) comprise three loops)
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2002/0095202 A1) in view of Stewart (US 2002/0111618 A1), as applied to claims 4 and 17 respectively above, and further in view of Chen (US 2015/0196357 A1).
Regarding claims 6 and 18, the combination of Schmidt/Stewart, as applied to claims 4 and 17 respectively above, is silent regarding the first surface electrode and the second surface electrode have different lengths.
Chen, in a similar field of endeavor, teaches an electrode group comprising electrodes of varying sizes/lengths. (Claim 1)
Absent a statement of criticality and unexpected results, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Schmidt/Stewart, as applied to claims 4 and 17 respectively above, such that the coiled electrodes (10) of Schmidt have varying lengths. Such a modification would have involved a mere change in the size of a component, and would allow for an increased number of different ablation patterns and lesion sizes to be created. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2002/0095202 A1), in view of Stewart (US 2002/0111618 A1), as applied to claim 1 above, and further in view of Anderson (US 2014/0214059 A1).
Regarding claim 12, the combination of Schmidt/Stewart, as applied to claim 1 above, is silent regarding the conductor is encapsulated in a wall of the elongate body.
Anderson, in a similar field of endeavor, teaches encapsulating an electrical conductor within a wall of an elongate body. (Par. [0039])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Schmidt/Stewart, as applied to claim 1 above, to incorporate the teachings of Anderson, and configure the wire leads (6) of Schmidt to be encapsulated within the walls of tube (4) of Schmidt. Doing so would be a simple substitution of one wire containment configuration for another for the predictable result of containing/protecting wires (6), and would help to anchor wires (6) in place.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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