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 .
Response to Amendment
The amendment filed on 06/02/2026 has been entered. Claim 1 has been amended. Claims 4 and 5 are in the original/previously presented form. Claims 2 and 3 are cancelled. Thus, claims 1, 4, and 5 remain pending in the 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Mihara (JP 2021087574 A), and further in view of Yamashita (WO 2017/149974 A1) and Howat et al. (United States Patent Application Publication No. US 2010/0057051 A1; herein, Howat).
Regarding claim 1, Mihara discloses a catheter (catheter 10) comprising: a first tube including a first lumen (FIG. 4, first inner tube 40 has first lumen 42), and a second tube including a second lumen (FIG. 4, second inner tube 50 has second lumen 52), the first tube includes an inner layer that is an innermost layer of the first tube (FIG. 4, first inner layer 44), an outer layer surrounding the inner layer (FIG. 4, first outer layer 46), and a reinforcing layer sandwiched between the inner layer and the outer layer (FIG. 4, first adhesive layer 45).
Mihara does not disclose a connection layer connecting the first tube and the second tube, and covering at least a portion of outer peripheral surfaces of the first tube and the second tube, wherein: in a cross section of the catheter, the first tube and the second tube are exposed to outside of the connection layer at both ends in a direction along which the first tube and the second tube are aligned side by side, and an outer periphery of the catheter has an elliptical shape formed by an outer periphery of the connection layer in combination with exposed portions of the outer peripheral surfaces of the first tube and the second tube, and the connection layer has a melting point lower than a melting point of each of the inner layer and the outer layer.
However, Yamashita teaches a connection layer (FIG. 4E, connecting wall) connecting the first tube and the second tube (FIG. 4E, “a connecting wall 23 formed between the first shaft portion 21 and the second shaft portion 22”), and covering at least a portion of outer peripheral surfaces of the first tube and the second tube (FIG. 4E, “The connecting wall 23 is formed to the near side of the front end of the first shaft portion 21 and the second shaft portion 22”), wherein: in a cross section of the catheter, the first tube and the second tube are exposed to outside of the connection layer at both ends in a direction along which the first tube and the second tube are aligned side by side (FIG. 4E), and an outer periphery of the catheter has an elliptical shape formed by an outer periphery of the connection layer in combination with exposed portions of the outer peripheral surfaces of the first tube and the second tube (FIG. 4E, “the outer wall surface 232…is configured with a curved shape”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Mihara to include a connection layer covering portions of the outer peripheral surfaces of the first and second tubes as taught by Yamashita in order to connect “the centers of the first [tube] and the second [tube]”. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Mihara to have the first and second tubes exposed from the connection layer and the connection layer in an elliptical shape as taught by Yamashita in order to integrate the first tube and the second tube “with each other while preventing the cross-sectional shape of the distal end of the [catheter] from being as large as possible”.
Mihara in view of Yamashita still does not disclose the connection layer has a melting point lower than a melting point of each of the inner layer and the outer layer.
However, Howat teaches the connection layer has a melting point lower than a melting point of each of the inner layer and the outer layer (FIG. 3, [0023], [0024], [0026], Liner 31 comprises a fluoropolymer, such as PTFE or FEP. Outer jacket 44 can comprise of a polyether block amide, nylon, or polyurethane. It is commonly understood in the art that a fluoropolymer, such as those listed above have higher melting points than those of the polymeric materials listed. In the case of Howat, one having ordinary skill in the art could create a device having the inside tube being made of a fluoropolymer with a melting point higher than the covering tube being made of one of the listed polymeric materials.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection layer taught by Yamashita of the modified catheter disclosed by Mihara to specify the connection layer has a melting point lower than the inner and outer layers as taught by Howat in order to enhance formation of a secure bond between the connection layer and the inner and outer layers ([0024]) without disrupting the structural integrity of the first tube ([0023]).
Regarding claim 4, in the modified catheter of Mihara, Mihara does not disclose the reinforcing layer is a coil. However, Howat teaches the reinforcing layer is a coil (FIG. 3, [0022], coil 40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcing layer disclosed by modified Mihara to be a coil as taught by Howat in order to reinforce the first tube and provide the catheter with enhanced kink resistance through a range of bending angles ([0006], [0008]).
Regarding claim 5, in the modified catheter of Mihara, Mihara discloses the reinforcing layer is a first reinforcing layer (FIG. 4, first adhesive layer 45), the inner layer is a first inner layer (FIG. 4, first inner layer 44), the outer layer is a first outer layer (FIG. 4, first outer layer 46), and the second tube (second inner tube 50) includes a second inner layer that is an innermost layer of the second tube (FIG. 4, second inner layer 54), a second outer layer surrounding the second inner layer (FIG. 4, second outer layer 56), and a second reinforcing layer sandwiched between the second inner layer and the second outer layer (FIG. 4, second adhesive layer 55).
Response to Arguments
Applicant’s arguments, found on pages 4-9 of Applicant’s Remarks filed 06/02/2026, with respect to claims 1 and 2 have been considered but are moot because the arguments do not apply in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kato (WO 2020255737 A1) is considered relevant prior art with regards to a catheter having two tubular members surrounded by a resin columnar body.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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