DETAILED ACTION
This action is in response to applicant's amendments filed 06/24/26.
The examiner acknowledges the amendments to the claims.
Claims 1-6, 10-20 are pending in this application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/13/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 10-20 have been considered but are moot because of the new grounds of rejection set forth 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.
Claims 1, 5-6, 10, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al., hereinafter “Shah” (U.S. Pub. No. 2004/0073158) in view of Elia et al., hereinafter “Elia” (U.S. Pub. No. 2019/0038868).
Regarding claim 1, Shah discloses a catheter 100 (Figure 10; [0044]), comprising:
a catheter shaft extending as an integral body from a proximal portion (including portion of 54 in Figure 10) to a distal tip (including 101), the catheter shaft being formed with a distal curved section 101 including a distal curve 111C proximal of the distal tip and a proximal curve 111B proximal of the distal curve, wherein the distal curved section has a resultant curve angle 111 that directs the distal tip downward and obliquely away from a longitudinal axis of the shaft (see distal end 103 extending downwards and slanting away from a longitudinal axis aligned with proximal portion [of 54]).
However, Shah does not expressly teach the catheter shaft formed from braided material encapsulated by a resin jacket.
In another embodiment of Shah (Figure 4, [0031]), a catheter shaft is formed from braided material 34 which is encapsulated by a resin jacket 16 (sheath 16 can be made of a polymeric material; [0023]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the catheter shaft with a braided material encapsulated by a resin jacket to incorporate a reinforcing material that may promote visibility and a jacket that promotes maneuverability (Shah; [0023], [0031]).
Furthermore, Shah does not expressly teach the distal curve being acute (the drawings are not to scale; [0005]), or the distal curve having a bend radius and an arc length and the proximal curve having a larger bend radius and a larger arc length than the bend radius and the arc length of the distal curve. However, in annotated Figure 10 of Shah below, the shape of the distal tip extending downward and obliquely suggests the distal curve forms an acute angle between a longitudinal axis extending proximally from the distal tip and a longitudinal axis extending through a portion of catheter proximal to the distal curve. Also, the distal curve 111C shown in Figure 10 is tighter and shorter than proximal curve 111B, therefore suggesting that the proximal curve has a larger bend radius and a larger arc length than a bend radius and an arc length of the acute distal curve.
PNG
media_image1.png
570
449
media_image1.png
Greyscale
Furthermore, Elia teaches a catheter 600 (Figure 11B; [0076]) having a distal curve 602 and a proximal curve 601, wherein the proximal curve has a larger bend radius than the bend radius of the distal curve (Id.) allowing a deformation and greater flexibility which allows for easier insertion of a distal tip of the catheter in hard-to-access organs ([0019]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah such that the distal curve is acute and the proximal curve having a larger bend radius and a larger arc length than a bend radius and arc length of the acute distal curve, in order to facilitate directing and inserting the distal tip of the catheter within hard-to-reach areas for a particular patient’s anatomy (Id.).
Regarding claim 5, Shah as modified teaches the distal tip is rounded, thick, blunt (see blunt end 103 in Figure 10 of Shah), and/or soft ([0023]; due to silicone material), due at least in part to the resin jacket (Id.).
Regarding claim 6, Shah as modified teaches a portion of the resin jacket including or adjacent to the distal tip is echogenic (Shah, [0034], [0044]; echogenic material can be incorporated in polymeric sheath).
Regarding claim 10, Shah as modified teaches the distal curved section further includes a second-proximal curve 111A proximal of the proximal curve 111B (Shah, Figure 10).
Regarding claim 16, Shah as modified teaches a portion of the resin jacket including or adjacent to the distal tip comprises a radiopaque material additive that acts as a radiopaque marker (Shah, [0034], [0044]; radiopaque material can be incorporated in polymeric sheath).
Regarding claim 17, Shah as modified teaches the claimed device, as discussed above, except for the catheter further comprising a hub adjacent to the proximal portion.
However, in another embodiment of Shah shown in Figure 6A, catheter 50 comprises a hub 56 ([0033]) adjacent to a proximal portion (of 54). It would have been obvious to one of ordinary skill before the effective filing date to modify the catheter 100 with a hub, in order to facilitate introduction of elements and materials through the catheter (Id.).
Claims 2, 14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Pub. No. 2004/0073158) in view of Elia (U.S. Pub. No. 2019/0038868), as applied to claim 1 above, and further in view of Okamura et al., hereinafter “Okamura” (U.S. Pub. No. 2022/0203070).
Regarding claim 2, Shah as modified teaches the claimed invention, as discussed above, except for the catheter comprising a 3-5 French (Fr) catheter.
Okamura teaches a catheter having a distal curved section (Figure 1), wherein the catheter comprises a 3-5 French (Fr) catheter ([0050]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the catheter size of Shah as modified such that it is a 3-5 French (Fr) catheter, as taught by Okamura, when used in applications with small diameter vasculature.
Regarding claim 14, Shah as modified teaches the claimed invention, as discussed above, except for further comprising (i) a hydrophilic coating on the resin jacket, or (ii) a lubricious additive in the resin jacket.
Okamura further teaches a hydrophilic/lubricious coating on the resin jacket ([0080]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah as modified with a hydrophilic coating as claimed, as taught by Okamura, in order to facilitate insertion into the vasculature (Id.).
Regarding claim 20, Shah as modified teaches the claimed invention, as discussed above, including the catheter of claim 1, wherein the catheter may be capable of delivery or recapture, except for a dilator receivable within the catheter shaft.
Okamura further teaches in [0097] that an inner catheter may be a dilator receivable within a catheter shaft 2.
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah as modified with a dilator as claimed, as taught by Okamura, depending on the application of the catheter where widening of vessels is needed in the vasculature.
Claims 3-4, 15, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Pub. No. 2004/0073158) in view of Elia (U.S. Pub. No. 2019/0038868), as applied to claim 1 above, and further in view of McFerran et al., hereinafter “McFerran” (U.S. Pub. No. 2006/0089618).
Regarding claims 3-4, Shah as modified teaches the claimed invention, as discussed above, except does not expressly teach the resin jacket has a varying durometer along a length thereof, or wherein the resin jacket has a lower durometer along the distal curved section and a higher durometer proximal of the distal curved section, although in [0036] Shah teaches the distal tip of the catheter being relatively soft and having a stiffness less than that of a proximal portion.
In [0005], [0021], [0022], McFerran teaches a catheter having a resin jacket (polymeric outer layer), wherein the resin jacket has a varying durometer along a length thereof, and wherein the resin jacket has a lower durometer along a distal section and a higher durometer proximal of the distal section.
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah as modified with a varying durometer as claimed, as taught by McFerran, in order to facilitate tracking of the catheter through vasculature (McFerran; see abstract).
Regarding claims 15 and 19, Shah as modified teaches the claimed invention, as discussed above, except a radiopaque marker band adjacent to the distal tip and a marker on the proximal portion thereof.
In Figure 2 and [0029]-[0030] McFerran teaches a catheter with a radiopaque marker band 70 adjacent to a distal tip, and a marker 72 on a proximal portion thereof.
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah as modified with the above radiopaque features as claimed, as taught by McFerran, to impart radiopacity to different elements of the catheter shaft, therein facilitating radiographic visualization during fluoroscopic imaging (Id.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Pub. No. 2004/0073158) in view of Elia (U.S. Pub. No. 2019/0038868), as applied to claim 1 above, and further in view of Berenstein et al., hereinafter “Berenstein” (U.S. Patent No. 5,895,378).
Regarding claim 12, Shah as modified teaches the claimed device, as discussed above, except for the catheter shaft has a constant inner diameter in the proximal portion, the inner diameter tapering along the length of the catheter shaft to a diameter at the distal tip of the catheter shaft smaller than the constant inner diameter. Shah does teach in Figure 6B, [0037] catheter 50 having a catheter shaft with an inner diameter in a proximal portion tapering along the length to a smaller diameter at the tip of the catheter shaft.
In Figure 1, Berenstein teaches a catheter shaft having a substantially constant inner diameter in a proximal portion 110 (col. 4, lines 29-33), the inner diameter tapering along the length of the catheter shaft (along 115) to a diameter at a distal tip 111/112 of the catheter shaft smaller than the constant inner diameter.
Although Berenstein teaches a “substantially constant” rather than “constant” inner diameter in the proximal portion, one of ordinary skill in the art would understand that substantially constant dimensions allow for variations or manufacturing tolerances. Furthermore, a skilled artisan would be motivated to have the inner diameter of the proximal portion of Shah as modified to be constant to increase the uniformity of the catheter thereby keeping the diameter away from a range of error and ensuring quality of the device.
It would have been obvious to one of ordinary skill before the effective filing date to modify Shah as modified such that the inner diameter in the proximal portion is constant, the inner diameter tapering along the length of the catheter shaft to a diameter at the distal tip of the catheter shaft smaller than the constant inner diameter, as taught by Berenstein, since a skilled artisan would understand that the varying diameters results in varying flexibilities (Berenstein; see abstract), with a thinner more flexible tip and a larger more rigid proximal portion, which facilitates tracking through vasculature.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Pub. No. 2004/0073158) in view of Elia (U.S. Pub. No. 2019/0038868), as applied to claim 1 above, and further in view of Castaneda et al., hereinafter “Castaneda” (U.S. Patent No. 5,279,596).
Regarding claim 13, Shah as modified teaches the claimed invention, as discussed above, except for the catheter shaft further comprises a coil section distal of the braided material at the distal tip.
In Figures 3-4 Castaneda teaches a catheter shaft comprising a coil section 28 (col. 3, lines 30-36) distal of a braided material (braided layer 18 within proximal portion 14; col. 3, line 13).
It would have been obvious to one of ordinary skill before the effective filing date to modify the catheter shaft with a coil section distal to the braided material as claimed, as taught by Castaneda, since the coil section would facilitate twisting while providing an underlying strength and stability to the distal tip (col. 3, line 55 to col. 4, line 10 of Castaneda).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. Pub. No. 2004/0073158) in view of Elia (U.S. Pub. No. 2019/0038868), as applied to claim 17 above, and further in view of McMillan (U.S. Pub. No. 2008/0140023).
Regarding claim 18, Shah as modified teaches the claimed invention, as discussed above, except for the hub comprises a visual indicator aligned with a direction of the distal curve.
In Figure 10 and [0015] McMillan teaches a hub 18 including a visual indicator 31 aligned with a direction with a direction of a curve at the distal end.
It would have been obvious to one of ordinary skill before the effective filing date to modify the hub in Bowe as claimed, as taught by McMillan, in order to provide the surgeon with a direct visual indication of the orientation of the curve at the distal end (Id.).
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a catheter including, inter alia, a catheter shaft having a distal curved section including an acute distal curve proximal of a distal tip and a proximal curve proximal of the distal curve, the distal curved section has a resultant curve angle that directs the distal tip downward and obliquely away from a longitudinal axis of the shaft, the distal curved section further includes a second-proximal curve proximal of the proximal curve, wherein the second-proximal curve is spaced from the proximal curve by a straight section. In Figure 10 of Shah (U.S. Pub. No. 2004/0073158; discussed above), the second-proximal curve 111A is adjacent to and not spaced from the proximal curve 111B by a straight section.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. 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, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DIANE D YABUT/Primary Examiner, Art Unit 3771
Prosecution Insights