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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The claims are drawn to a balloon catheter and not the device for generating a magnetic field
The abstract of the disclosure is objected to because it is directed to subject matter disclosed however not being claimed. The claims in this application are drawn to the balloon catheter which can be used during radiation therapy (Paragraph 00386 and 0387 of instant specification PGPub 2025/0065086 in Paragraph 0386-0387). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim 5-7 and 10-11 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 5 recites the limitation "the first stopper" in Line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that “a first stopper” is introduced in Claim 4 and Claim 5 appears to further limit the subject matter of Claim 4 and thus the Examiner will interpret Claim 5 to depend on Claim 4 (not Claim 1 as currently presented).
Regarding Claims 6, the limitation “a second stopper” renders the claim indefinite because the term “second” implies there is a first stopper, however Claim 6 depends on Claim 1, which does not recite a first stopper (the first stopper is recited in Claim 4). It appears from the specification and as best understood by the Examiner that this is a second embodiment of a stopper, and not a second stopper in use with a first stopper (see Paragraph 0372 of instant specification PGPub). For purposes of examination, the Examiner will interpret the second stopper to be a stopper according to a second embodiment, and thus Claim 6 will only require one stopper.
Claim 7 recites the limitation "the second stopper" in Line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that “a second stopper” is introduced in Claim 6 and Claim 7 appears to further limit the subject matter of Claim 6 and thus the Examiner will interpret Claim 7 to depend on Claim 6 (not Claim 1 as currently presented). Furthermore, Claim 7 is also rejected for incorporating the same errors of Claim 6 outlined above and thus the second stopper will be interpreted to be a second embodiment of a stopper, as best understood by the Examiner.
Regarding Claims 10, the limitation “a third stopper” renders the claim indefinite because the term “second” implies there is a first and second stopper, however Claim 10 depends on Claim 1, which does not recite a first or second stopper (the first stopper is recited in Claim 4 and the second stopper is recited in Claim 6). It appears from the specification and as best understood by the Examiner that this is a third embodiment of a stopper, and not a third stopper in use with a first and second stopper (see Paragraph 0380 of instant specification PGPub). For purposes of examination, the Examiner will interpret the third stopper to be a stopper according to a third embodiment, and thus Claim 10 will only require one stopper.
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.
Claim(s) 1, 4, 6, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshino (US PGPub 2021/0052914).
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).
Regarding Claim 4, Yoshino teaches the balloon catheter of claim 1, further comprising: a first 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, Yoshino teaches the balloon catheter of claim 1, further comprising: a second 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, Yoshino teaches the balloon catheter of claim 1, wherein 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, Yoshino teaches the balloon catheter of claim 1, further comprising: a third 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 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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) as applied to claim 1 above, and further in view of Foley (US Patent 5,078,131)
Regarding Claim 2, Yoshino 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
a guide part coupled to the stretchable part and configured to guide a movement of the internal catheter.
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), and a guide part (10) coupled to the stretchable part (26) and configured to guide a movement of the internal catheter (32).
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) 5and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshino (US PGPub 2021/0052914) as applied to claim 1 above, and further in view of Kasper (US Patent 4,148,319).
Regarding Claim 5, Yoshino teaches the balloon catheter of claim 1, 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, Yoshino teaches the balloon catheter of claim 1, 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) 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) as applied to claim 10 above, and further in view of Bell (US Patent 5,465,731).
Regarding Claim 11, Yoshino teaches the balloon catheter of claim 10, but fails to disclose wherein the third 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
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.
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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