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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the distal tip through a lumen" in line 3. It is unclear to the examiner if the Applicant is referring one of the multi-lumens mentioned in claim 1 or a new one. For examination purpose, the examiner is interpreting it to be one of the multi-lumens.
Claim 9 and 19 recites the limitation "a lumen of proximal shaft" in line 5. It is unclear to the examiner if the Applicant is referring one of the multi-lumens mentioned in claim 1 or a new one. For examination purpose, the examiner is interpreting it to be one of the multi-lumens.
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 1-4 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 2010/0222859) in view of Basu et al.(US 2018/0161093).
Regarding claim 1 and 15, Govari discloses a catheter (fig.1; lasso catheter 14) comprising: a multi-lumen catheter shaft (fig.10, see also [0071]) having a proximal end, a transition region, and a loop extending from a distal end of the transition region to a distal tip (fig.2; loop segment 41), the catheter shaft comprising a first lumen, a second lumen, and a third lumen (fig.10); a location system positioned in the first lumen (position sensor lumen 50), the location system including a distal shaft that extends within the first lumen along at least a portion of the loop (fig.2 and fig.10, see also [0045] and [0071]), an electromagnetic (EM) sensor (fig.2 sensors 31 and 33) attached to an outer surface of the distal shaft at a location along the loop (fig.2 and fig.10, see also [0045] and [0071]), and a pair of electromagnetic (EM) sensor wires extending proximally from the EM sensor to a proximal end of the catheter shaft [0071], the EM sensor and the pair of EM sensor wires positioned along a neutral axis of the catheter shaft within the first lumen (fig.10); and an electrode system (fig.2) including a first plurality of electrodes (fig.2; proximal portion electrodes 35) positioned along an outer surface of the loop (fig.2, see also [0042]), a second plurality of electrodes (distal portion electrodes 35) positioned along the outer surface of the loop (fig.2). Govari teaches that two of the electrodes 35 are selected for performing bi-polar ablation, e.g., radiofrequency ablation in which case a cable 57 may include wires individually leading to the electrodes 35 [0042]. However, Govari does not disclose a first plurality of wires connected to the first plurality of electrodes and extending through the second lumen, and a second plurality of wires connected to the second plurality of electrodes and extending through the third lumen.
Basu teaches catheter body 17 has a central lumen, the intermediate section 19 has multiple lumens 65, 66, 67, 68 and 69 (fig.2B), and the shaft 70 has a central lumen 74 (fig.2B). Basu teaches a first plurality of wires connected to the first plurality of electrodes (fig.2B; see also [0053] and [0073]) and extending through the second lumen, and a second plurality of wires connected to the second plurality of electrodes and extending through the third lumen (fig.2B; see also [0053] and [0073]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Govari with a first plurality of wires connected to the first plurality of electrodes and extending through the second lumen, and a second plurality of wires connected to the second plurality of electrodes and extending through the third lumen as taught by Basu for the purpose of proper isolation.
Regarding claim 2, Govari/ Basu teaches the catheter of claim 1, wherein the location system (fig.10, lumen 50, see also [0045] and [0071]) is electrically isolated from the electrode system (fig.10, see also [0043] of Govari).
Regarding claim 3, Govari/ Basu teaches the catheter of claim 1, wherein the EM sensor is affixed by adhesive to the outer surface of the distal shaft [0046].
Regarding claim 4, Govari/ Basu teaches the catheter of claim 1, wherein the EM sensor wires are free-floating (according to the specification, it is referring not surrounded by heat shrink tube) along an outer surface of the distal shaft (fig.10, see also [0043] of Govari).
Regarding claim 16, Govari/ Basu teaches the catheter of claim15, wherein the EM sensor is positioned on, and the pair of EM sensor wires extend along, a neutral axis of the multi- lumen shaft (fig.10 of Govari).
Regarding claim 17, Govari/ Basu teaches the catheter of claim15, wherein the localization system includes a proximal shaft and a distal shaft located within the first lumen, wherein the proximal shaft extends proximally from a proximal junction defined between the transition region and the loop and the distal shaft extends distally from the proximal junction, wherein the EM sensor is affixed to the distal shaft (fig.2 of Govari).
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Regarding claim 18, Govari/ Basu teaches the catheter of claim 17, wherein the localization system further includes a shape wire extending from transition region to the distal tip, wherein the shape wire extends within a lumen included within the distal shaft and extends along an outer surface of the proximal shaft ([0071] of Govari).
Claims 5-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 2010/0222859) in view of Basu et al.(US 2018/0161093) in further view of Tegg et al. (US 2013/0296781).
Regarding claim 5 and 7-8, Govari/Basu teaches the catheter of claim 4, further comprising: a shape wire (fig.10, see also [0071] of Govari) affixed to the distal tip and extending proximally from the distal tip through a lumen included within the distal shaft ([0071] of Govari); a first heat shrink tube located in the intermediate loop section that secures the EM sensor wires to the outer surface of the distal shaft in at least the intermediate loop section of the loop and shrink tube located in the proximal loop section that surrounds the distal shaft, wherein the EM sensor wires extends between the first heat shrink tube and the second heat shrink tube. However, Govari/Basu does not teach an activation wire affixed to the distal tip and extending proximally from the distal tip through the lumen included within the distal shaft. Tegg teaches a catheter can comprise a deflectable catheter shaft section comprising an elongated body extending along a longitudinal axis and a plurality of lumens extending along the longitudinal axis of the elongated body [0059]. Tegg teaches a first heat shrink tube located in the intermediate loop section that secures the EM sensor wires to the outer surface of the distal shaft in at least the intermediate loop section of the loop and shrink tube located in the proximal loop section that surrounds the distal shaft, wherein the EM sensor wires extends between the first heat shrink tube and the second heat shrink tube [0018]. Tegg further teaches the step of placing a heat shrink tube over the one or more polymeric tubes such that both ends of the heat shrink tube are covering the mandrel alignment tools 120 at both ends of the tooling 138. The exemplary method comprises the eleventh step of pre-shrinking the heat shrink tube. The step of pre-shrinking the heat shrink tube can be accomplished with a heat gun or other heat source [0081]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Govari/Basu with heating process that provides heat shrink to provide the desired structure to the one and more tubes as taught by Tegg for the purpose of achieving the desired structure of the catheter.
Regarding claim 6, Govari/Basu/Tegg teaches the catheter of claim 5, wherein the loop includes a proximal loop section extending distally from the transition region, an intermediate loop section extending distally from the proximal loop section, and a distal loop section extending distally from the intermediate loop section, wherein the EM sensor is located in the distal loop section and wherein the EM sensor wires are free-floating along an outer surface of the distal shaft (fig.2). Tegg further teaches an activation wire (fig.2B; planarity wire 34) affixed to the distal tip and extending proximally from the distal tip through the lumen included within the distal shaft ([0059]-[0060]).
Regarding claim 9, Govari/Basu/Tegg teaches the catheter of claim 8, further comprising: a proximal junction located between the loop and the transition region, wherein the distal shaft extends distally from the proximal junction and a proximal shaft extends proximally from the proximal junction (see annotated figure below), wherein the activation wire is located within a lumen of the proximal shaft and wherein the shape wire is located external to the proximal shaft (fig.2B of Tegg).
Regarding claim 10, Govari/Basu/Tegg teaches the catheter of claim 9, wherein a distal end of the proximal shaft abuts a proximal end of the distal shaft at the proximal junction (see annotated figure above).
Regarding claim 11-14, Govari/Basu does not teach further including a third heat shrink tube surrounding the EM sensor wires and extending proximally from the proximal junction, wherein the third heat shrink tube extends along an outer surface of the second heat shrink tube; further including a fourth heat shrink tube surrounding the proximal shaft and the shape wire in at least a portion of the transition region; wherein a fifth heat shrink tube surrounds the first plurality of wires located within the second lumen and a sixth heat shrink tube surrounds the second plurality of wires located within the third lumen and wherein the second and third lumens of the multi-lumen shaft are approximately equal in size and wherein the first lumen is larger than the second lumen and the third lumen.
Tegg teaches the step of place heat shrink tube over one or more polymeric tube [0081].Tegg further teaches heat shrink tubing is known by those of ordinary skill in the art. The exemplary method comprises the eleventh step of pre-shrinking the heat shrink tube. The step of pre-shrinking the heat shrink tube can be accomplished with a heat gun or other heat source [0081]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Govari/Basu with heating process that provides heat shrink to provide the desired structure to the one and more tubes as taught by Tegg for the purpose of achieving the desired structure of the catheter.
Regarding claim 19, Govari/ Basu/Tegg teaches the catheter of claim 18, wherein the localization system further includes an activation wire for modifying a geometry of the loop, the activation wire extending from the proximal catheter end to the distal tip, wherein the activation wire extends within a lumen of the proximal shaft and within the lumen of the distal shaft ([0059]-[0060] of Tegg).
Regarding claim 20, Govari/Basu/Tegg teaches the catheter of claim 15, the loop comprising a proximal loop section, an intermediate loop section, and a distal loop section, wherein the EM sensor is positioned in the distal loop section (fig.2 of Govari), wherein EM sensor wires surrounded by a first heat shrink tube in the transition region, secured between a second heat shrink tube and a distal shaft in the proximal and intermediate loop sections, and are free floating in the distal loop section ([0081] of Tegg).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-2721213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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