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 .
This action is in response to Applicant’s election filed on June 1, 2026.
Claims 10-13 are withdrawn.
Claim 19 is added.
Election/Restrictions
Applicants’ election without traverse of claims 1-9 and 14-19 (corresponding to Species I depicted in Figs. 1-2B) in the reply filed on June 1, 2026 is acknowledged. Claims 10 -13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Examiner interprets claim 5 to be directed to a non-elected species because it includes the limitation of “the inner diameter of the extending portion is constant from the base-end to a tip-end of the extending portion”. Examiner interprets the claim to be the inner diameter “increases from the base-end toward the tip-end” which has been elected.
Election was made without traverse in the reply filed on June 1, 2026.
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 1-19 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 1 recites “an insertion hole in which the base-end portion is inserted” renders the claim indefinite because it is unclear whether the insertion hole and the base-end portion are connected. Examiner interprets the insertion hole to be in direct contact with the base-end portion. Claim 1 then recites “a non-inserted tube portion of the catheter tube” rendering the claim unclear because the catheter tube is still inserted into the catheter. Examiner interprets this limitation to mean that the surrounding portion is not in direct contact with the catheter tube. Similarly, examiner interprets the limitation of “apart from the non-inserted tube portion” to mean that the surrounding portion is not in direct contact with the non-inserted tube portion. Moreover, Claim 1 recites “a tip-end side of the catheter” rendering the claim indefinite because it is unclear what the tip-end of the catheter is as there is no defined tip in the claim. Examiner interprets the tip-end side to be the distal most end of the catheter.
Regarding Claim 19, the recited limitation of "the inner space" on lines 9 and 11 lacks antecedent basis. Claim 19 also recites “an outer radius of the catheter tube for an entire of the curved surface” rendering the claim indefinite. Examiner interprets it to mean for an entire surface of the curved surface and recommends amending the claim to make it clear. Additionally, Claim 19 recites “the curved surface smoothly connects the tip-end surface” rendering the claim indefinite. The use of subjective terms such as “smoothly” fails to provide a clear boundary of what the limitation covers. Appropriate action is required.
All remaining claims are rejected by virtue of dependency on the rejected independent claims.
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.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suwito et al. (US 20090192496 A1, herein, Suwito).
Regarding claim 1, Suwito discloses a catheter (Fig.3B) comprising:
a catheter tube (flexured portion 18 – Fig.3B) that includes a base end portion (catheter 14 – Fig.3B); and
a connector (catheter adapter 12 – Fig.3B) that includes:
an insertion hole (see portion between the two lines in annotated Fig.3B) in which the base-end portion (catheter 14 – Fig.3B) is inserted, and
a surrounding portion (see annotated Fig.3B) that has a tubular or annular shape (“catheter adapter is generally cylindrical with an opening”, see para [0014], annotated Fig.3B) and surrounds a part of a non- inserted tube portion of the catheter tube (flexured portion 18 – Fig.3B), wherein
the connector (catheter adapter 12 – Fig.3B) is joined to the base-end portion in the insertion hole (catheter 14 – Fig.3B),
the surrounding portion is (see annotated Fig.3B):
located closer to a tip-end side of the catheter than is the insertion hole (Fig.3B) , and
apart from the non-inserted tube portion (opening 50 – Fig.3B), and
the non-inserted tube portion is out of the insertion hole toward a tip-end side of the catheter (opening 50, see annotated Fig.3B).
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Regarding claim 2, Suwito discloses the catheter (Fig.3B) according to claim 1, wherein
the connector (catheter adapter 12 – Fig.3B) comprises:
a body (body 22 – Fig.1) that includes the insertion hole (see annotated Fig.3B); and
an extending portion (first end 16 – Fig.3B) that extends from the body (body 22 – Fig.1) toward the tip-end side, and
the extending portion constitutes the surrounding portion (see annotated Fig.3B) that has the tubular shape (“catheter adapter is generally cylindrical”, see para [0014], Fig.3B).
Regarding claim 3, Suwito discloses the catheter (Fig.3B) according to claim 2, wherein
the extending portion (first end 16 – Fig.3B) has a tapered inner surface (“the first end 16 is generally tapered”, see para [0039]), and
the tapered inner surface has a diameter that increases toward the tip-end side (“the distance between the root region of the catheter and the catheter adapter tip opening is increased”, see para [0017], Fig.3B).
Regarding claim 4, Suwito discloses the catheter (Fig.3B) according to claim 3, wherein the tapered inner surface joins an inner wall of the insertion hole (first end 16 to catheter 14, see annotated Fig.3B).
Regarding claim 5, Suwito discloses the catheter (Fig.3B) according to claim 2, wherein
an inner diameter of the extending portion (first end 16 – Fig.3B) at a base-end of the extending portion is greater than a diameter of the insertion hole (Fig.3B), and
the inner diameter of the extending portion is constant from the base-end to a tip-end of the extending portion, or increases from the base-end toward the tip-end (first end 16 to catheter 14, see annotated Fig.3B).
Regarding claim 6, Suwito discloses the catheter (Fig.3B) according to claim 1, wherein an inner surface of a tip-end section of the surrounding portion (opening 50 of surrounding portion, see annotated Fig.3B) is curved such that an inner diameter of the surrounding portion increases toward a tip-end of the surrounding portion (under broadest reasonable interpretation, the examiner interprets the opening 50 and the increasing space surrounding the catheter tube as an increase in diameter, see surrounding portion from the left hand side to the right in annotated Fig.3B).
Regarding claim 7, Suwito discloses the catheter (Fig.3B) according to claim 2, wherein an inner surface of a tip-end section of the surrounding portion (opening 50 of surrounding portion, see annotated Fig.3B) is curved such that an inner diameter of the surrounding portion increases toward a tip-end of the surrounding portion (under broadest reasonable interpretation, the examiner interprets the opening 50 and the increasing space surrounding the catheter tube as an increase in diameter, see surrounding portion from the left hand side to the right in annotated Fig.3B).
Regarding claim 8, Suwito discloses the catheter (Fig.3B) according to claim 3, wherein an inner surface of a tip-end section of the surrounding portion (opening 50 of surrounding portion, see annotated Fig.3B) is curved such that an inner diameter of the surrounding portion increases toward a tip-end of the surrounding portion (under broadest reasonable interpretation, the examiner interprets the opening 50 and the increasing space surrounding the catheter tube as an increase in diameter, see surrounding portion from the left hand side to the right in annotated Fig.3B).
Regarding claim 9, Suwito discloses the catheter (Fig.3B) according to claim 4, wherein an inner surface of a tip-end section of the surrounding portion (opening 50 of surrounding portion, see annotated Fig.3B) is curved such that an inner diameter of the surrounding portion increases toward a tip-end of the surrounding portion (under broadest reasonable interpretation, the examiner interprets the opening 50 and the increasing space surrounding the catheter tube as an increase in diameter, see surrounding portion from the left hand side to the right in annotated Fig.3B).
Regarding claim 14, Suwito discloses the catheter (Fig.3B) according to claim 1, wherein
the connector (catheter adapter 12 – Fig.3B) comprises:
a body (body 22 – Fig.1) that includes the insertion hole (see portion between the two lines in annotated Fig.3B), and
the body and the surrounding portion are integrally formed in a single piece (“the catheter tube is attached to a first end of a catheter adapter such that the catheter tube and the catheter adapter comprise a single unit”, see para [0014], Fig.3B).
Regarding claim 15, Suwito discloses the catheter (Fig.3B) according to claim 1, wherein
the connector (catheter adapter 12 – Fig.3B) has a light transmitting property (under broadest reasonable interpretation, the examiner interprets light transmitting property as the ability to allow light to pass through, hence, a translucent thermoplastic material may be light transmitting (“the catheter adapter may include a variety of materials including polypropylene, polyvinyl chloride, and/or polyethylene”, see para [0014])),
the catheter tube has a light absorbing property (the examiner interprets light absorbing property as the ability of materials to capture or absorb light, hence, synthetic polymers are capable of absorbing light (“the catheter tube may include a variety of materials including silicone, IntiSilf silicone, polyurethane, and polyethylene”, see para [0012])), and
the connector is welded to the base-end portion (“the catheter tube may be attached to the catheter adapter using a variety of methods including heated tool, hot gas, vibration, spin, ultrasonic... infrared, laser welding...”, see para [0014]).
Regarding claim 16, Suwito discloses the catheter (Fig.3B) according to claim 2, wherein
the connector (catheter adapter 12 – Fig.3B) has a light transmitting property (under broadest reasonable interpretation, the examiner interprets light transmitting property as the ability to allow light to pass through, hence, a translucent thermoplastic material may be light transmitting (“the catheter adapter may include a variety of materials including polypropylene, polyvinyl chloride, and/or polyethylene”, see para [0014])),
the catheter tube has a light absorbing property (the examiner interprets light absorbing property as the ability of materials to capture or absorb light, hence, synthetic polymers are capable of absorbing light (“the catheter tube may include a variety of materials including silicone, IntiSilf silicone, polyurethane, and polyethylene”, see para [0012])), and
the connector is welded to the base-end portion (“the catheter tube may be attached to the catheter adapter using a variety of methods including heated tool, hot gas, vibration, spin, ultrasonic... infrared, laser welding...”, see para [0014]).
Regarding claim 17, Suwito discloses the catheter (Fig.3B) according to claim 3, wherein
the connector (catheter adapter 12 – Fig.3B) has a light transmitting property (under broadest reasonable interpretation, the examiner interprets light transmitting property as the ability to allow light to pass through, hence, a translucent thermoplastic material may be light transmitting (“the catheter adapter may include a variety of materials including polypropylene, polyvinyl chloride, and/or polyethylene”, see para [0014])),
the catheter tube has a light absorbing property (the examiner interprets light absorbing property as the ability of materials to capture or absorb light, hence, synthetic polymers are capable of absorbing light (“the catheter tube may include a variety of materials including silicone, IntiSilf silicone, polyurethane, and polyethylene”, see para [0012])), and
the connector is welded to the base-end portion (“the catheter tube may be attached to the catheter adapter using a variety of methods including heated tool, hot gas, vibration, spin, ultrasonic... infrared, laser welding...”, see para [0014]).
Regarding claim 18, Suwito discloses the catheter (Fig.3B) according to claim 4, wherein
the connector (catheter adapter 12 – Fig.3B) has a light transmitting property (under broadest reasonable interpretation, the examiner interprets light transmitting property as the ability to allow light to pass through, hence, a translucent thermoplastic material may be light transmitting (“the catheter adapter may include a variety of materials including polypropylene, polyvinyl chloride, and/or polyethylene”, see para [0014])),
the catheter tube has a light absorbing property (the examiner interprets light absorbing property as the ability of materials to capture or absorb light, hence, synthetic polymers are capable of absorbing light (“the catheter tube may include a variety of materials including silicone, IntiSilf silicone, polyurethane, and polyethylene”, see para [0012])), and
the connector is welded to the base-end portion (“the catheter tube may be attached to the catheter adapter using a variety of methods including heated tool, hot gas, vibration, spin, ultrasonic... infrared, laser welding...”, see para [0014]).
Regarding claim 19, Suwito discloses the catheter (Fig.3B) according to claim 1, wherein
the surrounding portion (see annotated Fig.3B) includes:
an inner surface (opening 50 – Fig.3B) that defines an internal space of the surrounding portion; and
a tip-end surface that is included in an outer surface of a tip-end section of the surrounding portion and extends in a radial direction of the surrounding portion (“the chamfered and/or rounded opening may also provide a bending surface to support the flexured portion of the catheter such that the flexured portion of the catheter may bend along the contour of the bending surface”, see para [0017], Fig3B),
the inner surface (opening 50 – Fig.3B) includes:
a tapered surface that is tapered toward the tip-end side such that a diameter of the inner space increases toward the tip-end side (“the first end 16 is generally tapered”, see para [0039], Fig3B); and
a curved surface (opening 50 – Fig.3B) that is continued from the tapered surface and curved toward the tip end surface such that the diameter of the inner space further increases toward the tip-end side (examiner interprets the opening 50 and the increase in space surrounding the catheter tube as an increase in diameter, see surrounding portion from the left hand side to the right in annotated Fig.3B),
the curved surface has a radius of curvature greater than an outer radius of the catheter tube for an entire of the curved surface (“flexured portion 18 is supported by the rounded opening 50 in maintaining the necessary degree of curve for the catheter 14 so as to avoid an occlusion and maintain the optimal degree of insertion”, see para [0048], Fig.3B), and
the curved surface smoothly connects the tip-end surface to the tapered surface (opening 50 – Fig.3B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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