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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP 2022-141908, filed on 09/07/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/31/2023, 02/08/2024, 03/26/2024, 07/08/2024, and 09/20/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mihara (JP 2021087574 A).
Regarding claim 1, Mihara discloses a catheter (catheter 10) comprising:
a first tube including a first lumen (first inner tube 40 has first lumen 42), and
a second tube including a second lumen (second inner tube 50 has second lumen 52),
wherein 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).
Regarding claim 3, Mihara discloses an outer periphery of the catheter is elliptical in a transverse section (Fig. 3, "The outer tube 30 has an elliptical shape in a cross section cut in a plane orthogonal to the length direction of the catheter 10.").
Regarding claim 5, Mihara discloses the catheter according to claim 1 (catheter 10), wherein
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).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mihara as applied to claim 1 above, and further in view of Nakayama et al. (United States Patent Application Publication No. US 2017/0368303 A1; herein, Nakayama).
Regarding claim 2, Mihara discloses the catheter according to claim 1 (catheter 10), further comprising a connection layer (outer tube 30) covering at least a portion of outer peripheral surfaces of the first tube and the second tube (Fig. 2, outer peripheral faces 41, 51) to connect the first tube and the second tube (Figs. 2 and 3). Mihara also discloses the material of the inner layer is preferably “…a resin having excellent slipperiness. Such resins are derived from fluororesins such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer) or FEP (tetrafluoroethylene-hexafluoropropylene copolymer) and polyethylene.” and the material of the outer layer is preferably “…a polyamide-based resin. Examples of the polyamide resin include polyamides and polyamide elastomers.”.
Mihara does not disclose the connection layer having a melting point lower than a melting point of each of the inner layer and the outer layer. However, Nakayama teaches in paragraph [0034] an outer layer formed of a resin material such as “…polyamide, polyamide elastomer, polyester, polyurethane…For example, in the outer layer 19, polyamide is used.”. It is well known in the art there are a variety of polyamides, each with a different melting point. Given that Mihara provides a selection of materials for both the inner and outer layers, it would have been obvious to one of ordinary skill in the art to choose one of the outer layer materials as taught by Nakayama that has a lower melting point than the aforementioned Mihara 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 material of the outer tube of Mihara to be a material with a lower melting point than that of the inner and outer layers of the first tube as taught by Nakayama in order to allow the first tube to maintain its original shape while the outer tube can be formed around it, providing additional strength.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mihara as applied to claim 1 above, and further in view of Howat et al. (United States Patent Application Publication No. US 2010/0057051 A1; herein, Howat).
Regarding claim 4, 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 adhesive layer disclosed by Mihara to be a coil as taught by Howat in order to provide the catheter with enhanced kink resistance through a range of bending angles.
Conclusion
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783