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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, in line 8, “longitudinal portion” should be replaced with --- portion ---.
Appropriate correction is required.
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, 6-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhadkevich (US Pub No. 2019/0167271) in view of Goyal et al. (US Pub No. 2022/0338929). Note that the provisional application No. 63/179924 of Goyal et al., filed on April 26, 2021, supports the below relied upon teachings of Goyal et al., wherein the specification of the provisional application is a copy of the PG-Pub specification).
With regards to claim 1, Zhadkevich discloses a catheter comprising:
a catheter shaft (104) having at least one curve (i.e. “curvature Gamma” which is located distal to the distal occluding balloon (42) and/or “curvature Alpha” which is a curvature between the proximal (38) and distal (42) occluding balloons) near a distal end of the catheter shaft (paragraph [0070], referring to the occluding catheter (37) having a shaft (104) and a proximal occluding balloon (38) and a distal occluding balloon (42); paragraph [0262], referring to the shaft having an “Alpha” curvature between the proximal and distal occluding ballons and a distal curvature “Gamma”; Figures 2, 5B); and
an inflatable balloon (i.e. 42; “distal occluding balloon”) coupled to or formed on an exterior surface of a distal region of the catheter shaft (paragraphs [0070], [0262], referring to the distal occluding balloon (42); Figures 2, 5B);
wherein the at least one curve comprises a distal curve (i.e. “Gamma” curvature) and a proximal curve (i.e. “Alpha” curvature), and the inflatable balloon (42) is between the distal curve and the proximal curve (paragraph [0262], referring to the shaft having an “Alpha” curvature between the proximal and distal occluding ballons and a distal curvature “Gamma”; Figures 2, 5B, in particular see Figure 5B, wherein the balloon (42) is between the distal curve (Gamma) and the proximal curve (Alpha)),
wherein the distal curve configures the distal end of the catheter to point outwardly away from a longitudinal axis of a portion of the catheter shaft, the longitudinal portion of the catheter shaft located proximal to the proximal curve (paragraph [0079], referring to “In addition the distal tip of the catheter located at the distal balloon 42 may have an angle Gamma (γ) ranging between 120 and 230 degrees in relation to the long axis of the catheter shaft that would increase the range of catheter deflection and provide more versatility during the catheter torqueing and further manipulation with, or without using a guidewire 142 in order to get an access to the ostia of the Left carotid and Left subclavian arteries.”, and thus if the angle Gamma was adjusted to, for example 185-230 degrees, in relation to the long axis of the catheter shaft, the curve of the distal tip would point outwardly away from a longitudinal axis of a portion of the catheter shaft located proximal to the proximal curve (further see the below annotated Figure 5B); paragraph [0083], referring to variables “such as the desired angles and curvatures of the catheter may vary depending on the patient’s anatomy…thus promoting further catheter flexion, extension, lateral bending and/or combination of thereof…” and therefore the catheter has flexibility such that the longitudinal axis of the portion of the catheter is capable of assuming various shapes in various directions, including a shape/direction such that the distal end of the catheter points outwardly away from a longitudinal axis of a portion of the catheter shaft located proximal to the proximal curve; Figures 1-5).
Annotated Figure 5B:
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However, Zhadkevich does not specifically disclose that the curvature profile of the catheter shaft near the distal end thereof is a curvature profile of a Simmons catheter.
Goyal et al. disclose an endovascular catheter comprising a hooked catheter referred to as a Simmons (SIM) DC 20a which is characterized by a soft distal tip that is pre-formed into the shape of a hook (Abstract; paragraphs [0003]-[0006], [0151], [0153]; Figure 5). Accessing vessels from the right radial artery (RRA) will often require navigation through branch points where the branch points are more acute and where a high proportion of the overall route consists of unsupported vessel zones, wherein for these procedures, the use of diagnostic catheters that have a “hooked” catheter tip as the means of initially placing endovascular equipment (EE) into a desired artery are required (paragraph [0151]; Figure 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the distal end of the catheter of Zhadkevich with a distal end having a curvature profile of the catheter shaft near the distal end thereof being a curvature profile of a Simmons catheter, as taught by Goyal et al., as the substitution of one known distal end of a catheter for another yields predictable results (i.e. accessing desired vessels) to one of ordinary skill in the art and further the hooked profile of the Simmons catheter allows effective access through more acute branch points and unsupported vessel zones (paragraph [0151]). One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable. Further, note that the above modification of Zhadkevich to have the distal end of the catheter assume a curvature profile of a Simmons catheter as claimed would result in the distal end of the catheter to point outwardly away from the longitudinal axis of the portion of the catheter shaft as claimed.
With regards to claim 6, Zhadkevich discloses that a distal end of the inflatable balloon is about 100 mm or less from the distal end of the diagnostic catheter shaft, and wherein the distal end of the inflatable balloon is about 2 mm or more from the distal end of the catheter shaft (paragraphs [0159]-[0160], referring to the catheter tip length being 5 mm, range of 0-25mm/0-10 mm, and further the distal portion of the catheter being 40mm-60mm, and thus it would be clear that the distal end of the inflatable balloon would be about 100 mm or less and 2 mm or more from the distal end of the catheter shaft; Figure 5B).
With regards to claim 7, Zhadkevich discloses that a length of the balloon along a direction of the catheter shaft ranges from about 5 mm to about 20 mm (paragraphs [0159]-[0160], referring to the distal balloon average length being 15 mm, range 5-52mm/5-25 mm).
With regards to claim 8, Zhadkevich discloses that the catheter further comprises an inflation lumen (132) having an inflation opening (60) inside the balloon (42) and an inflation port (130, 138) at a proximal end of the catheter shaft, wherein the inflation lumen and the inflation port inflates or deflates the balloon by passing an inflation fluid (i.e. “injection of gas or fluid”) across the inflation opening (paragraphs [0084]-[0087], referring to the inflation of the distal occluding balloon using inflation ports (130/138), wherein the common inflation port (130) and inflation channel (132) have distal openings (60) at a distal balloon (42)).
With regards to claim 10, Zhadkevich discloses that the catheter is a diagnostic angiography catheter (paragraphs [0062], [0084], [0161], [0166], referring to the catheter being used/studied under angiography, and therefore is considered to be an “angiography” catheter).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhadkevich in view of Goyal et al. as applied to claim 1 above, and further in view of Sina (US Pub No. 2015/0051632).
With regards to claims 2-3, as discussed above, the above combined references meet the limitations of claim 1. However, they do not specifically disclose that an outer diameter of the catheter shaft ranges from about 1.2 mm to about 2.5 mm and an inner diameter of a catheter lumen inside the catheter shaft ranges from about 0.1 mm to about 2mm.
Sina discloses a catheter for angioplasty including an outer shaft (102) and an inner shaft (104) disposed within the outer shaft (102), wherein the outer shaft (102) has an outer diameter of 1.45 mm and a wall thickness of 0.10 mm, wherein, as would be understood by those skilled in the art, other sizes may be utilized for the outer shaft (102) and inner shaft (Abstract; paragraph [0026], note that with a wall thickness of 0.10 mm, the inner diameter of the outer shaft would be 1.35 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the outer diameter of the catheter shaft and the inner diameter of the catheter lumen inside the catheter shaft of the above combined references with an outer diameter that ranges from about 1.2 mm to about 2.5 mm and an inner diameter that ranges from about 0.1 mm to about 2mm, as taught by Sina, as the substitution of one known cardiovascular catheter size (i.e. inner and outer diameter) for another yields predictable results (i.e. ability to fit within arteries, etc.) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhadkevich in view of Goyal et al. as applied to claim 1 above, and further in view of Crittenden et al. (US Patent No. 5,102,390).
With regards to claim 9, as discussed above, the above combined references meet the limitations of claim 1. However, Zhadkevich does not specifically disclose that the catheter further comprises a radiopaque marker at or near the distal end of the catheter shaft.
Crittenden et al. disclose a balloon angioplasty system, wherein at least one radiopaque marker is mounted on each of a probe and a catheter to enable fluoroscopic determination of the relative positions of the catheter and a probe and further radiopaque markers may be mounted to indicate the proximal and distal regions of the balloon (Abstract; column 7, lines 31-35, referring to the leader segment (48) including a radiopaque coil spring (50) which is attached to the distal end of the core wire (44); column 8, lines 42-44, referring to the radiopaque marker band (72) which is made of platinum; column 11, lines 11-49, referring to the pair of marker bands (74,76) which are located adjacent to the proximal and distal ends; claims 5-7).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the catheter of the above combined references further comprise a radiopaque marker at or near the distal end of the catheter shaft, as taught by Crittenden et al., in order to enable fluoroscopic determination of the relative positions of the catheter and a probe and further indicate the proximal and distal regions of the balloon, thereby aiding in accurately guiding the catheter and ballon to a desired position (Abstract; column 11, lines 11-49; claims 5-7).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 6-10 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. Goyal et al. has been introduced to teach a curvature profile of the catheter shaft near the distal end thereof being a curvature profile of a Simmons catheter.
With regards to Zhadkevich, Applicant points to paragraph [0079] of Zhadkevich which sets forth that “the distal part of the catheter aiming at the central axis of the proximal balloon and/or segment 44 of the shaft..”, which Applicant claims is the opposite of the distal end of the catheter aiming away from the main longitudinal axis of the shaft.
However, Examiner notes that the above cited paragraph [0079] further sets forth “In addition the distal tip of the catheter located at the distal balloon 42 may have an angle Gamma (γ) ranging between 120 and 230 degrees in relation to the long axis of the catheter shaft that would increase the range of catheter deflection and provide more versatility during the catheter torqueing and further manipulation with, or without using a guidewire 142 in order to get an access to the ostia of the Left carotid and Left subclavian arteries”. Thus, if the angle Gamma was adjusted to, for example 185-230 degrees, in relation to the long axis of the catheter shaft, the curve of the distal tip would point outwardly away from a longitudinal axis of a portion of the catheter shaft located proximal to the proximal curve. See the below annotated Figure 5B:
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The claims therefore remain rejected.
Conclusion
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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