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
This office action is responsive to the amendment filed on 7/14/2025. As directed by the amendment: claims 1 and 4-5 have been amended; no claims have been cancelled; and claims 7-11 have been added. Thus, claims 1-11 are presently pending in this 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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Van Hoven et al. (US 20160367787 A1) in view of Kobayashi (WO 2013008490 A1) further in view of Wijay et al. (US 4921483 A).
Regarding claim 1, Van Hoven discloses a movable catheter (Figs. 1C, 3A-3C and 5B-5C), comprising:
a tube (380, 1000, Figs. 3C and 5B, Paragraph [0035]) comprising a main lumen (1163, Fig. 5C) and a plurality of wire lumens (386, 388, 1162, Figs. 3C and 5C) outside the main lumen, wherein the plurality of wire lumens are spaced apart from each other (Figs. 3C and 5C, Paragraphs [0033] and [0042]) and reach a distal end portion (384, 392, Fig. 3B) of the tube from a proximal end portion (394, Proximal end of 1000, Figs. 3B and 5B-5C) of the tube;
one first wire (90, Fig. 3C) and one second wire (90, 1120, Abstract, Paragraphs [0042] and [0054]), wherein one end portion (Portion of 90 on the left side of 92) of each of the first wire and the second wire is inserted through one of the plurality of wire lumens (386, 1162, Figs. 3B-3C and 5B-5C, Paragraph [0054]), an intermediate part (92) of each of the first wire and the second wire is folded back on the distal end portion of the tube (Figs. 3B-3C), an other end portion (Portion of 90 on the right side of 92) of each of the first wire and the second wire is inserted through another one of the plurality of wire lumens (388, 1162, Figs. 3B-3C and 5B-5C, Paragraph [0054]), and the one end portion and the other end portion of each of the first wire and the second wire are disposed at the proximal end portion of the tube (Figs. 3B-3C and 5B-5C).
Van Hoven further teaches that the pullwires 1120 are folded back in the middle of the wires and by pulling on the proximal end side of the pullwires 1120, the distal end side of the catheter 1000 bends in the pulling direction. One of ordinary skill in the art would recognize that pulling the pullwires 1120 would result in pulling both end portions (the one end portion and the other end portion) of each of the pullwires (Fig. 1C, Paragraphs [0031] and [0036]).
Van Hoven is silent regarding
an operation portion connected to the one end portion and the other end portion of each of the first wire and the second wire disposed at the proximal end portion of the tube, the operation portion configured to simultaneously pull both of the one end portion and the other end portion of each of the first wire and the second wire, and to simultaneously loosen both of the one end portion and the other end portion of each of the first wire and the second wire, the operation portion thereby configured so that, when the operation portion simultaneously pulls both of the one end portion and the other end portion of the first wire, the operation portion simultaneously loosens both of the one end portion and the other end portion of the second wire, and, when the operation portion simultaneously pulls both of the one end portion and the other end portion of the second wire, the operation portion simultaneously loosens both of the one end portion and the other end portion of the first wire; and
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous prior art, Kobayashi teaches a movable catheter (10, 20, Figs. 1-4B), comprising:
one first wire (31, Fig. 2) and one second wire (32); and
an operation portion (22) connected to an end portion of each of the first wire and the second wire (Fig. 2), the operation portion configured to pull the end portion of each of the first wire and the second wire, and to loosen the end portion of each of the first wire and the second wire, the operation portion thereby configured so that, when the operation portion pulls the end portion of the first wire, the operation portion loosens the end portion of the second wire, and, when the operation portion pulls the end portion of the second wire, the operation portion loosens the end portion of the first wire (Figs. 2-4B, Page 51, 2nd paragraph, Page 52, 2nd paragraph, Page 53, 4th paragraph-8th paragraph).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the movable catheter of Van Hoven to incorporate the teachings of Kobayashi to incorporate an operation portion connected to the first wire and the second wire, the operation portion configured to pull the first wire and the second wire, and to loosen the first wire and the second wire, the operation portion thereby configured so that, when the operation portion pulls the first wire, the operation portion loosens the second wire, and, when the operation portion pulls the second wire, the operation portion loosens the first wire in order to perform a swinging operation (deflecting movement operation) of the distal end portion of the catheter tube (Page 52, 2nd paragraph, Kobayashi). In the combination, both end portions of the first wire and the second wire of Van Hoven would be connected to the operation portion of Kobayashi and the operation portion of Kobayashi would be configured to simultaneously pull both end portions of each of the first wire and the second wire, and to simultaneously loosen both end portions of each of the first wire and the second wire and would thereby be configured so that, when the operation portion simultaneously pulls both end portions of the first wire, the operation portion simultaneously loosens both end portions of the second wire, and, when the operation portion simultaneously pulls both end portions of the second wire, the operation portion simultaneously loosens both end portions of the first wire.
Van Hoven in view of Kobayashi are silent regarding
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous art, Wijay teaches
a tip protection member (T) configured to protect a tip of a tube (I) and integrally and unremovably fixed to a distal end portion of the tube (Fig. 2, Col 4, lines 33-36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter of Van Hoven in view of Kobayashi to incorporate the teachings of Wijay to incorporate a tip protection member configured to protect a tip of a tube and integrally and unremovably fixed to a distal end portion of the tube in order to provide a soft atraumatic tip (Col 4, lines 24-25) and minimize damage while advancing the catheter through the body (Col 4, lines 28-32). The modification of Van Hoven in view of Kobayashi further in view of Wijay would teach a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter because the tip T of Wijay would be provided at the distal end portion of the tube of Van Hoven, thus the intermediate parts of the two wires being folded back on the distal end portion of the tube of Van Hoven would not be exposed on the tip of the catheter.
Regarding claim 2, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter according to claim 1, wherein plurality of the wire lumens comprise three or more wire lumens (386, 388, 1162, Figs. 3B and 5C, Van Hoven).
Regarding claim 3, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter according to claim 1, wherein the tube comprises a single-lumen tube (1000, 380, Van Hoven) having the main lumen (Fig. 5C, Van Hoven) and at least one multi-lumen tube (1160, Fig. 5C, Paragraph [0054], Van Hoven) integrally disposed outside the single-lumen tube and comprising a plurality of the wire lumens (1162, Fig. 5C, Van Hoven).
Regarding claim 4, Van Hoven discloses a movable catheter (Figs. 3A-3C and 5B-5C), comprising:
a tube (380, 1000, Figs. 3C and 5B, Paragraph [0035]) comprising a main lumen (1163, Fig. 5C) and a wire lumen (386, 388, 1162, Figs. 3C and 5C) outside the main lumen, wherein the wire lumen reaches a distal end portion (392, Image 1) of the tube from a proximal end portion (394, Proximal end of 1000, Figs. 3B and 5B-5C) of the tube;
two wires (90, 1120, Fig. 3C, Abstract, Paragraphs [0042] and [0054]), wherein one end portion (Portion of 90 on the left side of 92) of each of the wires is inserted through the wire lumen (386, 1162, Figs. 3B-3C and 5B-5C), an intermediate part (Image 1) of each of the wires is folded back on the distal end portion of the tube (Figs. 3B-3C, Image 1), an other end portion (Portion of 90 on the right side of 92) of each of the wires is passed over an outside of the tube (Image 1), and the one end portion and the other end portion of each of the wires are disposed at the proximal end portion of the tube (Figs. 3B-3C and 5B-5C).
Van Hoven further teaches that the pullwires 1120 are folded back in the middle of the wires and by pulling on the proximal end side of the pullwires 1120, the distal end side of the catheter 1000 bends in the pulling direction. One of ordinary skill in the art would recognize that pulling the pullwires 1120 would result in pulling both end portions (the one end portion and the other end portion) of each of the pullwires (Fig. 1C, Paragraphs [0031] and [0036]).
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Van Hoven is silent regarding
an operation portion connected to the one end portion and the other end portion of each of the two wires disposed at the proximal end portion of the tube, the operation portion configured to simultaneously pull both of the one end portion and the other end portion of each of the two wires, and to simultaneously loosen both of the one end portion and the other end portion of each of the two wires, the operation portion thereby configured so that, when the operation portion simultaneously pulls both of the one end portion and the other end portion of one of the wires, the operation portion simultaneously loosens both of the one end portion and the other end portion of other one of the wires, and, when the operation portion simultaneously pulls both of the one end portion and the other end portion of the other one of the wires, the operation portion simultaneously loosens both of the one end portion and the other end portion of the one of the wires; and
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous art, Kobayashi teaches a movable catheter (10, 20, Figs. 1-4B), comprising:
two wires (31, 32, Fig. 2); and
an operation portion (22) connected to an end portion of each of the two wires (Fig. 2), the operation portion configured to pull the end portion of each of the two wires, and to loosen the end portion of each of the two wires, the operation portion thereby configured so that, when the operation portion pulls the end portion of one of the wires, the operation portion loosens the end portion of the other one of the wires, and, when the operation portion pulls the end portion of the other one of the wires, the operation portion loosens the end portion of the one of the wires (Figs. 2-4B, Page 51, 2nd paragraph, Page 52, 2nd paragraph, Page 53, 4th paragraph-8th paragraph).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the movable catheter of Van Hoven to incorporate the teachings of Kobayashi to incorporate an operation portion connected to the two wires, the operation portion configured to pull the two wires, and to loosen the two wires, the operation portion thereby configured so that, when the operation portion pulls one of the wires, the operation portion loosens the other one of the wires, and, when the operation portion pulls the other one of the wires, the operation portion loosens the one of the wires in order to perform a swinging operation (deflecting movement operation) of the distal end portion of the catheter tube (Page 52, 2nd paragraph, Kobayashi). In the combination, both end portions of each of the two wires of Van Hoven would be connected to the operation portion of Kobayashi and the operation portion of Kobayashi would be configured to simultaneously pull both end portions of each of the two wires, and to simultaneously loosen both end portions of each of the two wires and would thereby be configured so that, when the operation portion simultaneously pulls both end portions of the one of the wires, the operation portion simultaneously loosens both end portions of the other one of the wires, and, when the operation portion simultaneously pulls both end portions of the other one of the wires, the operation portion simultaneously loosens both end portions of the one of the wires.
Van Hoven in view of Kobayashi are silent regarding
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous art, Wijay teaches
a tip protection member (T) configured to protect a tip of a tube (I) and integrally and unremovably fixed to a distal end portion of the tube (Fig. 2, Col 4, lines 33-36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter of Van Hoven in view of Kobayashi to incorporate the teachings of Wijay to incorporate a tip protection member configured to protect a tip of a tube and integrally and unremovably fixed to a distal end portion of the tube in order to provide a soft atraumatic tip (Col 4, lines 24-25) and minimize damage while advancing the catheter through the body (Col 4, lines 28-32). The modification of Van Hoven in view of Kobayashi further in view of Wijay would teach a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter because the tip T of Wijay would be provided at the distal end portion of the tube of Van Hoven, thus the intermediate parts of the two wires being folded back on the distal end portion of the tube of Van Hoven would not be exposed on the tip of the catheter.
Regarding claim 5, Van Hoven discloses a movable catheter (Figs. 3A-3C and 5B-5C), comprising:
a tube (380, 1000, Figs. 3C and 5B, Paragraph [0035]) comprising a main lumen (386, 1162, Figs. 3C and 5C) and a wire lumen (388, 1162, Figs. 3C and 5C) outside the main lumen, wherein the wire lumen reaches a distal end portion (384, 392, Fig. 3B) of the tube from a proximal end portion (394, Proximal end of 1000, Figs. 3B and 5B-5C) of the tube;
two wires (90, 1120, Fig. 3C, Abstract, Paragraphs [0042] and [0054]), wherein one end portion (Portion of 90 on the left side of 92) of each of the wires is inserted through the wire lumen (Fig. 3C), an intermediate part (92) of each of the wires is folded back on the distal end portion of the tube (Figs. 3B-3C), an other end portion of each of the wires is inserted through the main lumen (Figs. 3B-3C), and the one end portion and the other end portion of each of the wires are disposed at the proximal end portion of the tube (Figs. 3B-3C and 5B-5C).
Van Hoven further teaches that the pullwires 1120 are folded back in the middle of the wires and by pulling on the proximal end side of the pullwires 1120, the distal end side of the catheter 1000 bends in the pulling direction. One of ordinary skill in the art would recognize that pulling the pullwires 1120 would result in pulling both end portions (the one end portion and the other end portion) of each of the pullwires (Fig. 1C, Paragraphs [0031] and [0036]).
Van Hoven is silent regarding
an operation portion connected to the one end portion and the other end portion of each of the two wires disposed at the proximal end portion of the tube, the operation portion configured to simultaneously pull both of the one end portion and the other end portion of each of the two wires, and to simultaneously loosen both of the one end portion and the other end portion of each of the two wires, the operation portion thereby configured so that, when the operation portion simultaneously pulls both of the one end portion and the other end portion of one of the wires, the operation portion simultaneously loosens both of the one end portion and the other end portion of other one of the wires, and, when the operation portion simultaneously pulls both of the one end portion and the other end portion of the other one of the wires, the operation portion simultaneously loosens both of the one end portion and the other end portion of the one of the wires; and
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous art, Kobayashi teaches a movable catheter (10, 20, Figs. 1-4B), comprising:
two wires (31, 32, Fig. 2); and
an operation portion (22) connected to an end portion of each of the wires (Fig. 2), the operation portion configured to pull the end portion of each of two wires, and to loosen the end portion of each of the two wires, the operation portion thereby configured so that, when the operation portion pulls the end portion of one of the wires, the operation portion loosens the end portion of the other one of the wires, and, when the operation portion pulls the end portion of the other one of the wires, the operation portion loosens the end portion of the one of the wires (Figs. 2-4B, Page 51, 2nd paragraph, Page 52, 2nd paragraph, Page 53, 4th paragraph).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the movable catheter of Van Hoven to incorporate the teachings of Kobayashi to incorporate an operation portion connected to the two wires, the operation portion configured to pull the two wires, and to loosen the two wires, the operation portion thereby configured so that, when the operation portion pulls one of the wires, the operation portion loosens the other one of the wires, and, when the operation portion pulls the other one of the wires, the operation portion loosens the one of the wires in order to perform a swinging operation (deflecting movement operation) of the distal end portion of the catheter tube (Page 52, 2nd paragraph, Kobayashi). In the combination, both end portions of each of the two wires of Van Hoven would be connected to the operation portion of Kobayashi and the operation portion of Kobayashi would be configured to simultaneously pull both end portions of each of the two wires, and to simultaneously loosen both end portions of each of the two wires and would thereby be configured so that, when the operation portion simultaneously pulls both end portions of the one of the wires, the operation portion simultaneously loosens both end portions of the other one of the wires, and, when the operation portion simultaneously pulls both end portions of the other one of the wires, the operation portion simultaneously loosens both end portions of the one of the wires.
Van Hoven in view of Kobayashi are silent regarding
a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter.
In analogous art, Wijay teaches
a tip protection member (T) configured to protect a tip of a tube (I) and integrally and unremovably fixed to a distal end portion of the tube (Fig. 2, Col 4, lines 33-36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter of Van Hoven in view of Kobayashi to incorporate the teachings of Wijay to incorporate a tip protection member configured to protect a tip of a tube and integrally and unremovably fixed to a distal end portion of the tube in order to provide a soft atraumatic tip (Col 4, lines 24-25) and minimize damage while advancing the catheter through the body (Col 4, lines 28-32). The modification of Van Hoven in view of Kobayashi further in view of Wijay would teach a tip protection member configured to protect a tip of the catheter and integrally and unremovably fixed to the distal end portion of the tube so that the intermediate parts of the two wires, the intermediate parts being folded back on the distal end portion of the tube, are not exposed on the tip of the catheter because the tip T of Wijay would be provided at the distal end portion of the tube of Van Hoven, thus the intermediate parts of the two wires being folded back on the distal end portion of the tube of Van Hoven would not be exposed on the tip of the catheter.
Regarding claim 6, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, wherein:
the plurality of wire lumens comprise four wire lumens (386, 388, 1162, Figs. 3B and 5C, Van Hoven),
the operation portion comprises two grip sections (221, Kobayashi),
when one of the grip sections is operated, both ends of the first wire are pulled at the same time, and a tip of the tube is deflected in a specific direction (Van Hoven teaches that when the wire is pulled, a tip of the tube is deflected in a specific direction, as shown in Fig. 1C and in the combination, when one of the grip sections, as taught by Kobayashi, is operated, both ends of one wire are pulled at the same time, and a tip of the tube is deflected in a specific direction, as taught by Van Hoven), and
when the other grip section is operated, both ends of the second wire are pulled at the same time, and the tip of the tube is deflected in a direction opposite to the specific direction (Van Hoven teaches that when another wire is pulled, the tip of the tube is deflected in an opposite direction, as shown in Fig. 1C and in the combination, when the other grip section, as taught by Kobayashi, is operated, both ends of the other wire are pulled at the same time, and the tip of the tube is deflected in the direction opposite to the specific direction, as taught by Van Hoven).
Regarding claim 7, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, wherein the tip protection member is fixed to the distal end portion of the tube (Col 4, lines 33-36 and Col 5, line 64, Wijay) such that the tip protection member remains attached while the distal end portion is deflected by the wires (The modification of Van Hoven in view of Kobayashi further in view of Wijay would teach the tip protection member remaining attached while the distal end portion is deflected by the wires because Wijay teaches that the tip T is affixed to the distal end of the tube by known methods in the art, thus while the distal end portion of Van Hoven is deflected by the wires, the tip protection member of Wijay would remained attached).
Regarding claim 8, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, wherein the tip protection member is heat-fused to the distal end portion of the tube so as to form a unitary structure (Fig. 2, Col 4, lines 33-36, Wijay).
Regarding claim 9, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, but Van Hoven in view of Kobayashi are silent regarding wherein the tip protection member includes a lumen substantially equal in diameter to the main lumen of the tube, such that the main lumen extends continuously through the tip protection member.
Wijay teaches the tip protection member includes a lumen (14) substantially equal in diameter to a main lumen (12) of the tube (Fig. 2), such that the main lumen extends continuously through the tip protection member (Fig. 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tip protection member of Wijay to incorporate the teachings of Wijay to incorporate a lumen substantially equal in diameter to the main lumen of the tube, such that the main lumen extends continuously through the tip protection member in order to allow a device to pass through the aligned lumens (Abstract).
Regarding claim 10, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, wherein the tip protection member covers the folded-back intermediate portions of the wires at the distal end portion of the tube (The modification of Van Hoven in view of Kobayashi further in view of Wijay would teach wherein the tip protection member covers the folded-back intermediate portions of the wires at the distal end portion of the tube because the tip T of Wijay would be affixed to the distal end portion of Van Hoven, therefore covering the folded-back intermediate portions of the wires at the distal end portion).
Regarding claim 11, Van Hoven in view of Kobayashi further in view of Wijay disclose the movable catheter of claim 1, wherein the tip protection member has a substantially hemispherical distal end surface (Fig. 2, Wijay).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 4-5 have been considered but are moot because the new ground of rejection does not rely on Cerier (US 2004010245 A1) being applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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