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
The instant application, filed on 11/14/2024, claims foreign priority to KR 10-2020-0050313 filed on 04/24/2020 and KR 10-2021-0052174, filed 04/22/2021. Claims 1-11 of the instant application are directed to subject matter that was introduced for the first time in the instant application, filed on 11/14/2024. The earlier foreign priority documents fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for a “a balloon catheter” as recited by claims 1-11. Accordingly, claims 1-11 are not entitled to the benefit of the prior foreign priority documents because the foreign priority documents do not disclose a “balloon catheter” and Figures 25-40, and thus is considered to be unsupported within the disclosures listed above. The earliest disclosure for the subject matter of claims 1-11 and thus the effective filing date for the subject matter of claims 1-11 is 11/14/2024.
Drawings
The drawings were received on 05/19/2026. These drawings are acceptable.
Response to Amendment
In response to the amendment filed on 05/19/2026, No Claims have been cancelled, and Claims 1-11 are pending.
The substitute specification filed 05/19/2026 has been entered.
In response to the claim amendments filed 05/19/2026, the previous 112b rejections of Claims 5-7 and 10-11 have been obviated.
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 05/19/2026, with respect to the rejection(s) of claim(s) 1 under Yoshino (US PGPub 2021/0052914) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoshino (US PGPub 2021/0052914) in view of Kinoshita (US PGPub 2008/0253114). Kinoshita teaches wherein the balloon is mounted to an interior surface of the guide shaft (see rejection below).
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.
Claim(s) 1, 4, 6, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) in view of Kinoshita (US PGPub 2012/0253114).
Regarding Claim 1, Yoshino teaches a balloon catheter (20 and 10) comprising:
an external catheter (20/21; Figure 1; Paragraph 0041);
a balloon (22) connected to one side (the distal side) of the external catheter (20/21) and capable of being inflated or contracted and inserted into a target site (2; Figures 2B-2C) of a living body (Paragraph 0072-0073; Figures 2B-2C) ;
an internal catheter (10/11; Figure 1 and Figure 2E) having one side (a distal side; 12; Figure 1 and Figure 2E) inserted into the balloon (22) and the other side (13; Figure 1) penetrating into an inside of the external catheter (20/21) (Paragraph 0074) and capable of moving in a first direction inserted into the balloon (22; Figure 2E; Paragraph 0074) or a second direction discharged from the balloon (as shown in Figures 2D and 2E, the probe/internal catheter is placed within the external catheter (30) and thus since there is no structure preventing the internal catheter from being withdrawn from the balloon, it’s the Examiner’s position that the internal catheter can be withdrawn from the balloon since they are independently actuatable structures); and
a driving part (13; Figure 1; handle portion of internal catheter 10) configured to move and discharge the internal catheter (10) inserted into the inside of the balloon (22) in the second direction in a state that the balloon (22) is inflated and fixed to the target site of the living body (as shown in Figures 2D and 2E; Paragraph 0073-0074).
wherein the external catheter (20) comprises a guide part (21; shaft) configured to guide a movement of the internal catheter (10/11; Paragraph 0044), and wherein the balloon (22) is connected to one side (distal side) of the guide part (21), and wherein the internal catheter (11) is configured to be removed from the interior of the balloon (22) in the state that the balloon (22) is inflated and fixed to the target site of the living body 2D-2E; It’s the examiner’s position that the internal catheter can be removed from the interior of the balloon during inflation since the internal catheter (10) is a separate device that is inserted after the balloon is inflated and is capable to being withdrawn while the balloon is inflated, even though this limitation is not specifically disclosed in the drawings, the device of Yoshino is configured to allow the internal catheter (11) to be withdrawn from the balloon (22) while the balloon (22) is inflated).
Yoshino fails to disclose:
wherein the guide part is configured not to extend across an interior of the balloon in the state that the balloon is inflated and fixed to the target site of the living body.
Kinoshita teaches a balloon catheter (Figure 2) comprising
An external catheter (12; Figure 2; Paragraph 0052 and 0057)
A balloon (13) attached to one side of the external catheter and configured to be inflated (Paragraph 0057)
An internal catheter (11) which is inserted into the balloon (13; Figure 2; Paragraph 0057)
Wherein the external catheter (12) has a guide part (the part of shaft from 121o to the distal end which is attached to balloon 13) to guide the movement of the internal catheter (11),
wherein the guide part (distal end of shaft 12) is configured not to extend across an interior of the balloon (13) in the state that the balloon is inflated and fixed to the target site of the living body (guide part does not extend into the interior of the balloon since the balloon is attached to the interior of the guide part in Figure 2; Paragraph 0059).
It would have been obvious to one of ordinary skill in the art to modify the balloon catheter of Yoshino such that the balloon was attached to the internal lumen of the external catheter, as taught by Kinoshita, for the advantage of ensuring that no material is leaked from the junction between the balloon and the external catheter (Paragraph 0059; Kinoshita).
Regarding Claim 4, the combination of references disclosed above teaches the balloon catheter of claim 1, wherein Yoshino teaches further comprising: a stopper (27a) configured to limit a movement range of the internal catheter (10/11) in the second direction (Paragraph 0051 discloses that probe insertion section 27a (Figure 1, 2D, 2E) has a sealing cock that functions to hold an arrangement position of the internal catheter 10/11 while in lumen 24 of the external catheter).
Regarding Claim 6, the combination of references disclosed above teaches the balloon catheter of claim 1, wherein Yoshino teaches further comprising: a stopper (27a) configured to limit a movement range of the internal catheter (10/11) in the first direction and a movement range of the second direction (Paragraph 0051 discloses that probe insertion section 27a (Figure 1, 2D, 2E) has a sealing cock that functions to hold an arrangement position of the internal catheter 10/11 while in lumen 24 of the external catheter).
Regarding Claim 8, the combination of references disclosed above teaches the balloon catheter of claim 1, wherein Yoshino teaches the driving part (13) comprises: an actuator (handle portion of probe/internal catheter 10) configured to move the internal catheter (10) in the second direction (the actuator is whatever structure the user grasps to move the probe slidable within the outer catheter (20/21)).
Regarding Claim 10, the combination of references disclosed above teaches the balloon catheter of claim 1, wherein Yoshino teaches further comprising: a stopper (27a) detachably fixed to the internal catheter (10/11) and configured to limit a movement range of the internal catheter (10/11) in the first direction (Paragraph 0051 discloses that probe insertion section 27a (Figure 1, 2D, 2E) has a sealing cock that functions to hold an arrangement position of the internal catheter 10/11 while in lumen 24 of the external catheter).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) and Kinoshita (US PGPub 2012/0253114) as applied to claim 1 above, and further in view of Foley (US Patent 5,078,131)
Regarding Claim 2, the combination of references disclosed above teaches the balloon catheter of claim 1, wherein Yoshino teaches a coupling part (27a) coupled to the outer circumference of the internal catheter (10/11; Figure 2E, Paragraph 0051), and a guide part (21; Figures 2B-2E), wherein the balloon (22) is connected to the guide part (21; Figures 2B-2E) but fails to disclose wherein the external catheter comprises:
a stretchable part coupled to the coupling part and capable of being stretched; and
Foley teaches a catheter system for insertion into the body (abstract) comprising an external catheter (10, 18, 26, and 28; Figure 1) and an internal catheter (30 and 32; Figures 1-2), wherein the external catheter comprises a coupling part (28) coupled to an outer circumference of the internal catheter (30), a stretchable part (26) coupled to the coupling part (28) and capable of being stretched (see Figures 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the external catheter of Yoshino to include a stretchable part, as taught by Foley, for the advantage of limiting and predetermined the maximum movement of the internal catheter relative to the external catheter.
Regarding Claim 3, the combination of references disclosed above teaches the balloon catheter of claim 2, wherein Foley teaches the stretchable part (26) has a bellows shape (Figure 2; Foley).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) and Kinoshita (US PGPub 2012/0253114) as applied to claim 4 and 6 above, and further in view of Kasper (US Patent 4,148,319).
Regarding Claim 5, the combination of references disclosed above teaches the balloon catheter of claim 4, but fails to disclose wherein the first stopper comprises:
a hook groove formed in the external catheter; and
a hook formed in the internal catheter and hooked to the hook groove when the internal catheter moves in the second direction.
Kasper teaches a urinary retention catheter (abstract) comprising an external catheter (18; Figure 8) comprising a balloon (36) on a distal end, and a movable inner catheter (stylet, not labeled but has elements 102, 104, 106 and 106 in Figure 8; Column 13, Lines 27-55), wherein the balloon catheter comprises a stopper (102/104) configured to limit the movement of the stylet/inner catheter in a second direction (proximally relative to the balloon 36), wherein the first stopper comprises:
a hook groove (94) formed in the external catheter (18); and
a hook (102/104) formed in the internal catheter (stylet) and hooked to the hook groove when the internal catheter (stylet) moves in the second direction (proximally; Column 13, Lines 27-55).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the stopper mechanism taught by Yoshino with the stopper mechanism as taught by Kasper since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the stopper mechanism taught by Kasper would be sufficient to prevent unwanted proximal movement of the internal catheter relative to the external catheter.
Regarding Claim 7, the combination of references disclosed above teaches the balloon catheter of claim 6, but fails wherein the second stopper comprises:
two catch protrusions spaced apart with a spacing and connected along a movement direction of the internal catheter to the outer circumference of the external catheter; and
a moving protrusion connected to the outer circumference of the internal catheter and is arranged between the two catch protrusions.
Kasper teaches a urinary retention catheter (abstract) comprising an external catheter (18; Figure 8) comprising a balloon (36) on a distal end, and a movable inner catheter (stylet, not labeled but has elements 102, 104, 106 and 106 in Figure 8; Column 13, Lines 27-55), wherein the balloon catheter comprises a stopper (102/104) configured to limit the movement of the stylet/inner catheter in a second direction (proximally relative to the balloon 36), wherein the first stopper comprises:
two catch protrusions (22 and 94; as seen in Figure 8) spaced apart with a spacing and connected along a movement direction of the internal catheter (stylet) to the outer circumference of the external catheter (18; as seen in Figure 8); and
a moving protrusion (106/108) connected to the outer circumference of the internal catheter (stylet; Figure 8) and is arranged between the two catch protrusions (22 and 94).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the stopper mechanism taught by Yoshino with the stopper mechanism as taught by Kasper since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the stopper mechanism taught by Kasper would be sufficient to prevent unwanted proximal movement of the internal catheter relative to the external catheter.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) and Kinoshita (US PGPub 2012/0253114) as applied to claim 1 above, and further in view of Shturman (US Patent 5,331,947)
Regarding Claim 9, Yoshino teaches the balloon catheter of claim 1, but fails to disclose wherein the driving part comprises: a fluid supply part configured to inject fluid into the balloon so that the internal catheter moves in the second direction by the fluid injected into the balloon.
Yoshino teaches wherein the handle (25) of the external catheter has a fluid supply part (27b; Figure 1) but fails to disclose that the handle of the external catheter is capable of moving the internal catheter and thus fails to disclose the claimed subject matter outlined above.
Shturman teaches an inflatable sheath (30) which housing an inner ultrasound catheter (20) which has a fluid supply port (80), the fluid supply part (80) configured to inject fluid into the balloon (30) so that the internal catheter (20) moves in the second direction by the fluid injected into the balloon (Column 2, Lines 55-65; Shturman).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the driving part of Yoshino, to include the teachings of Shturman such that the internal catheter can be moved only when the balloon is expanded by the fluid, as taught by Shturman, for the advantage of preventing inadvertent sliding of the external catheter relative to the internal catheter during deployment when the balloon is not expanded.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) and Kinoshita (US PGPub 2012/0253114) as applied to claim 10 above, and further in view of Bell (US Patent 5,465,731).
Regarding Claim 11, the combination of references disclosed above teaches the balloon catheter of claim 10, but fails to disclose wherein the stopper has a U-shape.
Bell teaches a medical device which for insertion into the body (Figure 2) in which an outer catheter (180; Figure 2) houses a slidably disposed inner catheter (190; Figure 2), wherein a locking tab/stopper (105; Figure 2) comprises a U shape, and is for the purpose of locking the inner catheter (190) from sliding relative to the outer catheter (180; Column 6, Lines 6-16).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the stopper mechanism taught by Yoshino with the stopper mechanism as taught by Bell since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the stopper mechanism taught by Bell would be sufficient to prevent unwanted proximal movement of the internal catheter relative to the external catheter.
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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