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 September 2nd 2025 has been entered. Claims 1-2, 4-5, and 7-18 are pending in the application. Applicant’s amendments to the Specification and Claims has overcome each and every objection previously set forth in the Non-Final Office Action mailed April 3rd 2025.
Claim Objections
Applicant is advised that should claim 4 be found allowable, claims 8 and 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, and should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 4 and 8-9 include identical limitations and are all dependent on claim 1. Claim 11 and 13 include identical limitations and are both dependent on claim 1.
Claim 18 is objected to because of the following informalities: “the inner diameter” should be corrected to “the inner diameter of the hollow part” for clarity. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6, 10-11, 13, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McClure (US 5507732 A).
Regarding claim 1, McClure discloses a catheter (abstract) comprising a hollow tube-shaped strain relief including a hollow part penetrating through in an axial direction (the strain relief 25, retainer cap 20, and distal seal 65, which are all being interpreted as part of the claimed strain relief, are hollow along their axial direction through lumens 120, 125, and 130, Col 3 lines 59-65 & Fig. 2), and a catheter body having a base end part inserted into the hollow part (catheter shaft 70 passing through all lumens, Col 3 lines 60-65 & Fig. 1 and 2; the catheter shaft 70 having a distal end), wherein the strain relief includes an outer-diameter gradually-decreasing part in which an outer diameter thereof gradually decreases toward a tip end (the outer diameter of strain relief 25 and part of cap 20 decreases gradually toward the tip, see Fig. 1 and annotated Fig. 2 below in which the outer-diameter gradually-decreasing part is annotated as “ODGDP”), wherein a gradual decrease rate of the outer diameter in the outer-diameter gradually-decreasing part increases toward the tip end (the initial rate at which the diameter decreases is smaller than the rate at which the diameter decreases further down the strain relief 25 towards the tip, see Fig. 1 and 2), and an inner diameter of the hollow part gradually decreases from a base end to the tip end entirely in the axial direction (the section of strain relief lumen 130 closest to the distal end having an inner diameter that gradually decreases from the distal end to the tip end of strain relief 25; the section annotated as “INNER” in annotated Fig. 2 below; the decrease occurring entirely in the axial direction).
Regarding claim 2, McClure discloses all the limitations of claim 1. McClure further discloses the catheter wherein the outer-diameter gradually-decreasing part includes a first outer-diameter gradually-decreasing part on a base end side (the outer diameter of strain relief 25 closest to the distal end is being interpreted as the first outer-diameter gradually-decreasing part on a base end side, see Fig. 1 and 2; annotated as “1st” in Fig. 2 below), and a second outer-diameter gradually-decreasing part on a tip end side (the outer diameter of strain relief 25 between the section closest to the distal end and the tip of strain relief 25, see Fig. 1 and 2; annotated as “2nd” in Fig. 2 below), the first outer-diameter gradually-decreasing part having an outer diameter that changes at a first gradual decrease rate and the second outer-diameter gradually-decreasing part having an outer diameter that changes at a second gradual decrease rate larger than the first gradual decrease rate (the two sections of strain relief 25 have different rates at which the outer diameter decreases; the section annotated “1st” having a smaller rate of diameter decrease compared to the rate of diameter decrease of the section annotated “2nd” further down strain relief 25, see annotated Fig. 2 below).
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Regarding claims 5, 10-11, and 13, McClure discloses all the limitations of claims 1-2. McClure further discloses the catheter including a handle that supports the base end part of the catheter body inserted into the strain relief (manifold 15, which supports seal 65, supports the distal portion of the catheter shaft 70, see abstract and Fig. 1; the part of catheter shaft 70 inserted into seal 65 is being interpreted as the claimed base end part of the catheter body), wherein the strain relief has a housed part on a base end side and an exposed part on a tip end side, the housed part being housed in the handle and the exposed part being exposed from the handle (the distal seal 65 is housed in manifold 15 and strain relief 25 is exposed on the tip end side, see abstract and Fig. 1; the distal seal 65, cap 20, and strain relief 25 all being interpreted as the claimed strain relief), and a gradual decrease rate of the outer diameter in the exposed part is larger than a gradual decrease rate of an inner diameter in the exposed part (the section annotated “2nd” of strain relief 25, in annotated Fig. 2 above, having a rate of diameter decrease greater than the rate of diameter decrease of the inner diameter of lumen 130, annotated as “INNER” in Fig. 2 above).
Regarding claim 17, McClure discloses all the limitations of claim 1. McClure further discloses the catheter wherein the strain relief includes an outer diameter unchanged part, of which an outer diameter is uniform, provided on a base end side of the strain relief (the two opposing flat sides 80 of cap 20 having a uniform diameter, this being interpreted as the outer diameter unchanged part, Col 5 lines 14-19 & seen in Figs. 2 and 4-5; annotated as “ODUP” in annotated Fig. 2 above), wherein the outer-diameter gradually-decreasing part is disposed on a tip side of the strain relief with respect to the outer diameter unchanged part (the outer diameter of strain relief 25 and part of cap 20 decreases gradually toward the tip, see Fig. 1 and 2; the sections of strain relief 25 and cap 20 with decreasing diameters located on a tip side with respect to flat sides 80, see Figs. 1-2 and 4 and annotated Fig. 2 above), wherein the outer-diameter gradually-decreasing part continues from a connection point between the outer-diameter gradually-decreasing part and the outer diameter unchanged part to a tip end of the strain relief (the “ODGDP” continues from a point, annotated above as “CONNECTION POINT” in Fig. 2 above, between the “ODGDP” and the “ODUP” to a tip end of the strain relief 25, see Fig. 1 and annotated Fig. 2 above), and wherein the outer diameter unchanged part and the outer-diameter gradually-decreasing part are formed of a single member (strain relief 25 and cap 20 are being interpreted as forming a single member as they are assembled together to form a singular product, Col 5 lines 45-47 and Col 3 lines 55-60 & Fig. 1).
Regarding claim 18, McClure discloses all the limitations of claim 1. McClure further discloses the catheter wherein a gradual decrease rate of the inner diameter is uniform entirely in the axial direction (a gradual decrease rate of the inner diameter, annotated as “INNER” in annotated Fig. 2 above, is uniform entirely in the axial direction).
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.
Claim(s) 4, 7-9, 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over McClure (US 5507732 A), in view of Kawaguchi (JP 2017051211 A).
Regarding claims 4 and 7-9, McClure discloses all the limitations of claims 1-2. However, McClure fails to explicitly disclose the catheter wherein an outer diameter of the catheter body is equal to or less than 1.0 millimeter. However, Kawaguchi the catheter wherein an outer diameter of the catheter body is equal to or less than 1.0 millimeter (the outer diameter of shaft 20 is 0.3 mm to 3 mm, [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of McClure with Kawaguchi to include an outer diameter of the catheter body equal to or less than 1.0 millimeter since such a modification would allow the catheter to be inserted into a living body lumen such as a blood vessel ([0017] of Kawaguchi).
Regarding claims 12 and 14-16, McClure, as modified by Kawaguchi, discloses all the limitations of claims 4 and 7-9. McClure further discloses the catheter including a handle that supports the base end part of the catheter body inserted into the strain relief (manifold 15, which supports seal 65, supports the distal portion of the catheter shaft 70, see abstract and Fig. 1; the part of catheter shaft 70 inserted into seal 65 is being interpreted as the claimed base end part of the catheter body), wherein the strain relief has a housed part on a base end side and an exposed part on a tip end side, the housed part being housed in the handle and the exposed part being exposed from the handle (the distal seal 65 is housed in manifold 15 and strain relief 25 is exposed on the tip side, see abstract and Fig. 1; the distal seal 65, cap 20, and strain relief 25 all being interpreted as the claimed strain relief), and a gradual decrease rate of the outer diameter in the exposed part is larger than a gradual decrease rate of an inner diameter in the exposed part (the section noted “2nd” of strain relief 25, in annotated Fig. 2 above, having a rate of diameter decrease greater than the rate of diameter decrease of the inner diameter of lumen 130, annotated as “INNER” in Fig. 2 above).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 response to Applicant’s arguments that the inner section does not extend until the tip end, the Examiner finds that the claim language, as instantly presented, does not require this limitation. The limitation of “an inner diameter of the hollow part gradually decreases from a base end to the tip end entirely in the axial direction” limits the direction in which the inner diameter of the hollow part gradually decreases being axially in a direction towards the tip from the base. The inner diameter of the section annotated as “INNER” in McClure does gradually decrease from a base end to the tip end, the decrease occurring entirely in the axial direction. The Examiner suggest amending claim 1 to include definite boundaries for the extension of the inner diameter being claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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