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 based on an application filed in Japan on 04/13/2021. It is noted, however, that applicant has not filed a certified copy of the 2021-067432 application as required by 37 CFR 1.55.
The examiner notes an electronic retrieval was attempted via the Electronic Priority Document Exchange on 10/06/2023; however, the attempt failed to return the necessary documents.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 09/18/2023 and 03/24/2025, have been considered by the examiner.
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.
Claims 4 and 5 are 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 4] The claim recites the limitation of “the remaining portion” in the 3rd line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this “remaining portion” is a residual portion of the core layer of the medical tube in the axial direction, a portion of another layer, or a combination of layers. For purposes of examination, it is interpreted that “the remaining portion” refers to a residual structure of the core layer that does not contain the “portion” having the specific configuration.
[Claim 5] The claim is rejected based upon dependency from claim 4.
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 and 4-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kubo et al. (PGPub 2017/0043119).
[Claims 1 and 7] Kubo teaches a catheter (figure 2, item 1a) comprising a medical tube (figure 2, item 15) (paragraph [0025]) comprising:
a tubular core layer (figure 2, items 100/120); and
an outer layer (figure 2, item 130) that is composed of a resin (paragraph [0036]), is arranged at an outer periphery (figure 2) of the core layer (figure 2, items 100/120), and has an outer peripheral surface (figure 2) substantially parallel to an axial direction of the medical tube (figure 2, item 15), wherein
the core layer (figure 2, items 100/120) includes:
a tubular inner core layer (figure 2, item 100) composed of a fluorine-based resin (“polytetrafluoroethylene”) (paragraph [0033]), and
an outer core layer (figure 2, item 120) composed of a resin (see 112b interpretation above) (“polyimide”) (paragraph [0035]) having a Young's modulus higher than a Young's modulus of the fluorine-based (“polytetrafluoroethylene”) resin (polyimide inherently has a higher Young’s modulus than polytetrafluoroethylene), the outer core layer (figure 2, item 120) being arranged at an outer periphery (figure 2) of the inner core layer (figure 2, item 100), and
the core layer (figure 2, items 100/120) has a specific configuration in which crest portions (see annotated figure below) protruding toward a radially outer side of the medical tube (figure 2, item 15) and valley portions (see annotated figure below) protruding toward a radially inner side of the medical tube (figure 2, item 15) are arranged repeatedly in the axial direction of the medical tube (figure 2, item 15).
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[Claims 4 and 5] Kubo teaches the limitations of claim 1, upon which claims 4 and 5 depend. In addition, Kubo discloses the core layer (figure 2, items 100/120) has the specific configuration (see annotated figure below), in a portion in the axial direction of the medical tube (figure 2, item 15), the portion including a distal end of the core layer (figure 2, items 100/120), and does not have the specific configuration in the remaining portion (see annotated figure below) (see 112b interpretation above).
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[Claim 6] Kubo teaches the limitations of claim 1, upon which claim 6 depends. Kubo further discloses the outer core layer (figure 2, item 120) has a thickness less than a thickness of the inner core layer (figure 2, item 100) (figure 2). (The examiner further notes that “a thickness” has not been defined; as such, a relative “thickness” of a structure can be chosen such that it is less than another relative “thickness” of another structure.)
[Claim 8] Kubo teaches the limitations of claim 1, upon which claim 8 depends. Kubo also teaches the crest portions (see annotated figure above) and the valley portions (see annotated figure above) are provided along an entire circumference of the core layer (figure 2, items 100/120) (Kubo teaches the protective layer 120 covers the coil body 110; thus, the crest and valley portions are provided along an entire circumference of the “core layer”) (figure 2; paragraphs [0028], [0029]).
[Claim 9] Kubo teaches the limitations of claim 1, upon which claim 9 depends. In addition, Kubo teaches the crest portions (see annotated figure above) and the valley portions (see annotated figure above) are arranged in an alternating manner in the axial direction of the medical tube (figure 2, item 15) (figure 2; see annotated figure above).
[Claim 10] Kubo teaches the limitations of claim 1, upon which claim 10 depends. Kubo also discloses a first distance (see annotated figure below) between a first crest portion (see annotated figure below) and an adjacent first valley portion (see annotated figure below) is different from a second distance (see annotated figure below) between the first crest portion (see annotated figure below) and an adjacent second valley portion (see annotated figure below) (The examiner further notes that a starting and ending point for the claimed “distance” is not defined).
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[Claim 11] Kubo teaches the limitations of claim 1, upon which claim 11 depends. Kubo further discloses a first distance (see annotated figure below) between a first crest portion (see annotated figure below) and an adjacent first valley portion (see annotated figure below) is the same as a second distance (see annotated figure below) between the first crest portion (see annotated figure below) and an adjacent second valley portion (see annotated figure below) (The examiner further notes that a starting and ending point for the claimed “distance” is not defined).
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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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kubo et al. (PGPub 2017/0043119), in view of Ito et al. (PGPub 2021/0308416).
[Claim 3] Kubo teaches the limitations of claim 1, upon which claim 3 depends. Kubo does not specifically disclose the medical tube has an outer diameter of 5 mm or less.
However, Ito teaches a medical tube (figure 2, item 2) having multiple resin-based layers (figure 3, items 22/23; paragraphs [0029]-[0031]) wherein the outer diameter of the medical tube (figure 2, item 2) is 5 mm or less (paragraph [0042]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the claimed outer diameter range, as taught by Ito, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to disclose or render obvious the structure recited in dependent claim 2.
The closest prior art of record Kubo et al. (PGPub 2017/0043119) and Ito et al. (PGPub 2021/0308416).
The prior art of record fails to teach among all the limitations or render obvious a structure comprising a medical tube comprising:
a tubular core layer; and
an outer layer that is composed of a resin, is arranged at an outer periphery of the core layer, and has an outer peripheral surface substantially parallel to an axial direction of the medical tube, wherein
the core layer includes:
a tubular inner core layer composed of a fluorine-based resin, and
an outer core layer composed of a resin having a Young's modulus higher than a Young's modulus of the fluorine-based resin, the outer core layer being arranged at an outer periphery of the inner core layer, and
the core layer has a specific configuration in which crest portions protruding toward a radially outer side of the medical tube and valley portions protruding toward a radially inner side of the medical tube are arranged repeatedly in the axial direction of the medical tube.
Specifically, regarding dependent claim 2, the prior art to Kubo and Ito, either alone or in combination, fails to disclose or render obvious the specific structural and/or functional features as claimed;
wherein the specific configuration includes an intersecting portion where ridges of two of the crest portions aligned in the axial direction of the medical tube intersect to form a ridge of another of the crest portions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 02/12/2026