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 .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 03/06/2026.
Response to Amendment
The examiner acknowledges that no amendments have been made to the claims, with claims 1-6 and 16 canceled in prosecution. Claims 7-15 are currently pending in the present application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 7-8, 13, 15 is/are rejected under 35 U.S.C. 103 as being anticipated by Masuda (US Patent No 20180360333) herein known as Masuda R1 in view of Masuda (US Patent No 20170281270) herein known as Masuda R2.
Regarding claim 7, Masuda R1 teaches an electrode catheter comprising: a catheter shaft (catheter shaft 10, [0061]); a connector connected to a proximal end side of the catheter shaft (see electrical connection 41 found on the proximal side of the catheter shaft, [0062], see also fig 1); an electrode mounted on a distal end side of the catheter shaft (see ring electrodes 201 to 210 which are found mounted on the distal end part 101, [0061]); and a lead wire connected to an inner peripheral surface of the electrode at a distal end (see the respective leads 301 to 310 going through the catheter shaft 10 and coupled to the respective ring electrodes on an inner peripheral, [0061]), extending through an interior of the catheter shaft, and connected to the connector at a proximal end (wherein the connector 41 and catheter shaft 10 incorporate the plurality of leads 301 to 310, [0062]), the catheter shaft having a coupled structure formed by alternately coupling a plurality of non-metal tubes (wherein the outer tubing 13 of the catheter shaft 10 is formed of a braided resin material, [0061]) and a metal ring for electrode formation by bringing respective end surfaces into contact each with each other (and see wherein the metal ring shaped electrodes 201-210 are formed in correspondence with the surface of the multiple sections of outer tubing 13 of the catheter 10, thereby resulting in a plurality of non-metal tubes [0061], see also the figure 2 visualizing the end surfaces contacting each other).
Masuda R1 does not explicitly teach wherein the plurality of non-metal tubes are separated from each other and one of the plurality of non-metal tubes is disposed between and coupled with adjacent two of the plurality of metal rings.
However, the analogous electrode catheter device which is taught by Masuda R2 does disclose the plurality of non-metal tubes are separated from each other (see in which the plurality of divided tube members 620-625 of the prior art of Masuda R2 are divided tube members and may be individually coupled to the catheter device structure, [0043], see also fig 5) and one of the plurality of non-metal tubes is disposed between and coupled with adjacent two of the plurality of metal rings (see from Masuda R2 fig 5, in which the nonmetal tube members 620-625 are separate but yet adjacent and coupled to the respective metal ring electrode members 111-115 along the catheter shaft).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode catheter device of Masuda R1 with that of the individual and separated non-metal and metal ring layers of the catheter which is taught by Masuda R2 in order to help insulate the metal ring electrodes from each other and allow for increased flexibility when operating the electrode catheter for treatment, as disclosed by Masuda R2, [0060].
Regarding claim 8, Masuda R1 teaches the electrode catheter according to claim 7, wherein at least a portion of an outer peripheral surface of the coupled structure is coated with a coating layer (wherein the outer tubing 13 of the catheter shaft 10 is coated with a resin material, [0061]), and the coating layer includes an exposure window configured to expose at least a portion of an outer peripheral surface of the metal ring (see in which side holes 15 are seen as the exposure windows as they extend throughout the outer tubing layer 13 in correspondence to expose the ring electrodes 201 – 210 which would be covered by the resin coating layer effectively creating the windows, [0061]).
Regarding claim 13, Masuda R1 teaches the electrode catheter according to claim 8, wherein a plurality of the exposure windows is formed in the circumferential direction of the metal ring (Masuda R1 teaches that there is a side hole 15 corresponding to each ring-shaped electrode and therefore by definition contains a plurality of exposure windows to correspond to each ring electrode, [0061]).
Regarding claim 15, Masuda R1 teaches the electrode catheter according to claim 7, wherein a ratio of a length of the metal ring in an axial direction to a length of each of the plurality of the non-metal tubes in an axial direction is from 0.25 to 0.42 (see wherein the axial length of the ring shaped electrodes is 0.5 to 10mm, [0101], and the space in between electrodes or the resin tubing space is between 1 to 10mm, [0102], that therefore results in a ratio between the metal ring portions and non-metal tubing ranging between 0.05 to 1, therefore covering the range ratio as claimed).
Claim(s) 9-12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda (US Patent No 20180360333) in view of Masuda (US Patent No 20170281270) herein known as Masuda R2 further in view of Kenji (Japanese Patent No 2012034852A).
Regarding claim 9, the previous combination teaches the electrode catheter according to claim 8.
The prior combination does not teach wherein a length of the exposure window in an axial direction connecting a proximal end and a distal end of the catheter shaft is longer than a width of the metal ring in a circumferential direction.
However, the analogous electrode catheter device taught by Kenji does disclose wherein a length of the exposure window in an axial direction connecting a proximal end and a distal end of the catheter shaft is longer than a width of the metal ring in a circumferential direction (see Kenji, [0064] – [0065], in which the axial length of the exposure window 321 may be anything from 0.2 to 2mm, and the circumferential width of the metal ring can be any length from 0.3 to 4mm. Therefore, the exposure window of Kenji is capable of being longer in the axial direction then the width of the metal ring in the circumferential direction).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode catheter device taught by Masuda R1 and Masuda R2 to contain the specific catheter exposure window structure taught by Kenji as it allows for the interior metal electrode ring to form an electrode area ideal for energy control and delivery on the catheter, as taught by Kenji, [0029].
Regarding claim 10, the previous combination of Masuda R1 and Masuda R2 teaches the electrode catheter according to claim 9.
The prior combination does not teach wherein the exposure window has an elliptical shape.
However, see for example the analogous electrode catheter device taught by Kenji which discloses an analogous window opening 321 which is formed on the outer periphery of the electrode tubing and is able to take on any preferred shape including elliptical, [0068]. See also Kenji, figure 5, for visuals on the shaped window opening 321.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode catheter device taught by Masuda R1 and R2 to contain the specific catheter exposure window structure taught by Kenji as it is a simple design choice for the window shape for one skilled in the art and allows for the interior metal electrode ring to form an electrode area ideal for energy delivery on the catheter, as taught by Kenji, [0029].
Regarding claim 11, the combination teaches the electrode catheter according to claim 8, wherein a ratio of the length of the exposure window in the axial direction to a length of the metal ring in the axial direction is from 0.35 to 0.65 (from Kenji, [0067], the ratio width of the opening window 321 to the metal ring width in the axial direction is 0.1 to 0.9, therefore enclosing the range as claimed).
Regarding claim 12, the combination teaches the electrode catheter according to claim 8, wherein a ratio of a width of the exposure window in a circumferential direction to a circumferential length of the catheter shaft is from 0.13 to 0.52 (see Kenji, [0068], in which it is described that the opening window would cover half of the circumferential length of the metal ring part 41. That therefore leads to an exposure ratio of 0.5 in the circumferential direction of the catheter and therefore falls within the claimed range as taught).
Regarding claim 14, the combination teaches the electrode catheter according to claim 7, wherein the catheter shaft includes a metal tube on a proximal end side of the coupled structure, and a slit having a spiral shape is formed in at least a distal end portion of the metal tube (see from Kenji in which the electrode catheter part is formed from a double tube structure, in which the second coil or spiral tube 74 found at the distal end portion of the catheter device is formed of a metal material, [0052], see also figure 3 depicting the metal spiral tube 74 extending from the proximal end side to the distal end side).
Response to Arguments
Applicant’s arguments with respect to the amended claim(s) 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In specific regards to the argued limitation of the independent claim 7, the examiner agrees with applicant that the prior art of record of Masuda R1 does not explicitly teach the limitation of having the non-metal and metal ring components being separate-able on the catheter end such that the metal and non-metal components are coupled adjacently. However, after further search and consideration, necessitated by the request for continued examination, it has been found that the new prior art of record of Masuda R2 does disclose the plurality of non-metal tubes are separated from each other (see in which the plurality of divided tube members 620-625 of the prior art of Masuda R2 are divided tube members and may be individually coupled to the catheter device structure, [0043], see also fig 5) and one of the plurality of non-metal tubes is disposed between and coupled with adjacent two of the plurality of metal rings (see from Masuda R2 fig 5, in which the nonmetal tube members 620-625 are separate but yet adjacent and coupled to the respective metal ring electrode members 111-115 along the catheter shaft). Therefore, as the new prior art of record of Masuda R2 does teach the deficiencies of Masuda R1, claims 7 and all dependents are now rejected under the new prior art of record rejection of Masuda R1 in view of Masuda R2 set forth in the present office action.
As no further arguments or remarks have been made regarding any other dependent claims, they too remain rejected under the present prior art of record rejection set forth in this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794