DETAILED ACTION
This action is in response to applicant's amendments filed 03/05/26.
The examiner acknowledges the amendments to the claims.
Claims 1-6, 8, 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 .
Response to Arguments
Applicant's arguments filed 03/05/26 have been fully considered but they are not persuasive.
Applicant generally argues that Bowe does not suggest in [0050] shaping the outer catheter (catheter shaft 2) relative to the shape of the acute distal curve 46 (Figure 16) such that the proximal curve 48 (Id.) bend radius and radius of curvature is larger than that of the acute distal curve, and is only generally related to shaping of the outer catheter 2. However, the examiner submits that in [0050] Bowe teaches that the distal tip 2A of the outer catheter 2 (Figure 1) points to the most probable location of the vessel of interest due to the shape of the distal curved section, which includes the proximal curve 48 and acute distal curve 46. Depending on the patient, the acute distal curve may be shaped in a tighter curve to point to the vessel of interest (as seen in Figure 7) relative to the proximal curve. One of ordinary skill in the art would understand that the acute distal curve may optimized to a tighter curve to effectively point to the vessel interest, therein resulting in a larger proximal curve bend radius and radius of curvature relative to the acute distal curve. In other words, one of ordinary skill in the art would acknowledge that the relative bend radius and radius curvature between the acute distal curve and the proximal curve could be optimized in order to facilitate directing and guiding the inner catheter 7 into the vessel of interest from the outer catheter 2.
It is also noted that in [0084] Bowe teaches that the proximal curve 48 may have a bend angle ranging from about 0 degrees to about 100 degrees, while the acute distal curve 46 may have a bend angle ranging from about 0 degrees to about 80 degrees. Therefore, Bowe further teaches that the acute distal curve can have a smaller, tighter range curve that can only go up to 80 degrees while the proximal curve has a larger relative curve that can go up to 100 degrees, which suggests optimizing the proximal curve with a larger bend radius and a larger arc length. It is also noted that even though there is an inner catheter 7, in [0050] Bowe specifically discusses shaping the curve of distal tip 2A of outer catheter 2, and therefore the catheter shaft 2 (as seen in Figure 16) extends as an integral body from a proximal portion to a distal tip 2A (distal end of section 45).
Applicant’s arguments with respect to claim(s) 12 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12, lines 2-4 recite “the catheter shaft has a substantially constant inner diameter in the proximal portion, the inner diameter tapering to a diameter smaller than the substantially constant inner diameter at a portion of the catheter shaft distal to the proximal portion. In [0079]-[0080] of the present application publication, the inner diameter of the catheter is disclosed as generally tapering distally from a proximal portion, but does not necessarily support that the inner diameter is substantially constant in a proximal portion and a portion distal to the proximal portion.
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 12, lines 3-4 recites “the substantially constant inner diameter at a portion of the catheter shaft distal to the proximal portion. There is a lack of antecedent basis for this limitation in the claim (a substantially constant inner diameter at the proximal portion is previously recited in line 2, rather than a substantially constant inner diameter at a portion distal to the proximal portion).
Furthermore, Claim 12, lines 2-4 recite “the catheter shaft has a substantially constant inner diameter in the proximal portion, the inner diameter tapering to a diameter smaller than the substantially constant inner diameter at a portion of the catheter shaft distal to the proximal portion. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, the limitation will be read as the inner diameter is constant within a portion except for the terminal end of said portion.
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, 3, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bowe et al., hereinafter “Bowe” (U.S. Pub. No. 2003/0144657).
Regarding claim 1, Bowe discloses a catheter shaft 2 (Figure 16) comprising a shaft formed from braided material (Figure 15, [0079]; braid 37) encapsulated by a resin jacket (Id., exterior jacket 38 can be made of resin, such as Pebax or other polymers such as nylon [0081]), the catheter shaft extending as an integral body (formed from joined parts) from a proximal portion (near 43 in Figure 15) to a distal tip (free end of section 45), the catheter shaft comprising a distal curved section (pre-formed curve 4; Figure 16) including an acute distal curve 46 proximal of the distal tip ([0084]; curved section 46 can have an acute bend angle ranging from about 0-80 degrees) and a proximal curve (second curve 48; Figure 16) proximal of the distal curve.
However, Bowe does not expressly teach the acute distal curve having a bend radius and an arc length and the proximal curve 48 having a larger bend radius and a larger arc length than the bend radius and the arc length of the acute distal curve 46.
Bowe teaches that the distal curved section (pre-formed curve 4; [0050]) can advantageously be shaped so that when the catheter is advanced, the distal end may point towards a most probable location of the vessel of interest (Id.). Therefore, one of ordinary skill in the art would understand that the bend radius and arc length of the proximal curve may be optimized and modified such that it is larger than a bend radius and arc length of the acute distal curve to effectively conform to a particular patient’s vasculature.
Regarding claim 3, Bowe discloses the resin jacket has a varying durometer along a length thereof ([0081] the resin jacket 38 includes sections of varying stiffness, and therefore varies in durometer, since lower durometer numbers indicate softer, less stiff materials, while higher durometer numbers indicate harder, stiffer materials).
Regarding claim 8, Bowe discloses the distal curved section 4 has a resultant curve angle that directs the distal tip downward and obliquely away from proximal-to-distal direction of a longitudinal axis of the shaft (see downward, oblique direction of section 45 relative to longitudinal axis along straight proximal portion of catheter 2, proximal to third curve 50).
Regarding claim 17, Bowe discloses a hub 43 adjacent to the proximal portion (Figure 15).
Claims 2, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of Okamura et al., hereinafter “Okamura” (U.S. Pub. No. 2022/0203070).
Regarding claim 2, Bowe discloses the claimed invention, as discussed above, except for the catheter comprising a 3-5 French (Fr) catheter, although acknowledges that small diameter catheters are required for certain areas of vasculature ([0002]).
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 Bowe 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, Bowe discloses 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 the catheter of Bowe with a hydrophilic coating as claimed, as taught by Okamura, in order to facilitate insertion into the vasculature (Id.).
Regarding claim 20, Bowe discloses 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. Bowe discloses inside the catheter (outer catheter 2) may be an inner catheter 7 (Figure 14). Okamura further teaches in [0097] that an inner catheter may instead be a dilator receivable within the catheter shaft 2. It would have been obvious to one of ordinary skill before the effective filing date to modify Bowe 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 4, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657).
Regarding claim 4, Bowe discloses the claimed invention, as discussed above, except does not expressly teach that the resin jacket has a lower durometer along the distal curved section 4 and a higher durometer proximal of the distal curved section, although Bowe generally teaches that the resin jacket 38 includes sections of varying stiffness, including a more proximal portion having a greater durometer than a distal portion ([0081]). Therefore, a skilled artisan would have found it obvious to have the resin jacket have a lower durometer (more flexible) distal curved section and a higher durometer (less flexible, stiffer) proximal of the distal curved section to facilitate steering at the proximal portion and to facilitate advancement, tracking, and bending of the distal tip through tortuous vasculature.
Regarding claims 10-11, Bowe as modified teaches the distal curved section 4 (Figure 16 of Bowe) further includes a second-proximal curve 50 (Figure 16) proximal of the proximal curve 48, wherein the second-proximal curve is spaced from the proximal curve by a straight section 49 (Id., [0084]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of Calhoun et al., hereinafter “Calhoun” (U.S. Patent No. 10,668,258).
Regarding claim 5, Bowe discloses the claimed invention, as discussed above, including the distal tip is rounded, thick, blunt, and/or soft (see blunt distal tip at end of section 45 in Figure 16 and soft distal tip 39 in Figure 15, [0080]). However, Bowe does not disclose that the distal tip is rounded, thick, blunt, and/or soft due at least in part to the resin jacket 38, although teaches that the resin jacket may be formed of different durometer materials ([0081]).
In the same field of art, namely catheters, Calhoun teaches in Figure 21C, col. 32, lines 23-24 catheter having a distal tip 613b being soft due at least in part to a jacket 619b.
It would have been obvious to one of ordinary skill before the effective filing date to modify Bowe such that the distal tip being soft is due at least in part to the resin jacket, as taught by Calhoun, since it has been held to be within the general skill of a worker in the art to select a known material (in the form a jacket) on the basis of its suitability for the intended use (to form an atraumatic, soft distal tip).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of Webler et al., hereinafter “Webler” (U.S. Pub. No. 2007/0167822).
Regarding claim 6, Bowe discloses the claimed invention, as discussed above, except for wherein a portion of the resin jacket including or adjacent to the distal tip is echogenic.
In [0070], [0072]-[0073] Webler teaches a catheter including a jacket having a portion including or adjacent to a distal tip being echogenic.
It would have been obvious to one of ordinary skill before the effective filing date to modify the resin jacket to be echogenic as claimed, as taught by Webler, to facilitate visualization of a leading end of the device during advancement when utilizing ultrasonic imaging.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of Shwab (U.S. Pat. No. 5,069,673).
Regarding claim 12, Bowe discloses the claimed invention, as discussed above, except for wherein the catheter shaft has a substantially constant inner diameter in the proximal portion, the inner diameter tapering to a diameter smaller than the substantially constant inner diameter at a portion of the catheter shaft distal to the proximal portion.
Shwab teaches a catheter shaft (Figure 2) that has a substantially constant inner diameter in a proximal portion 22, the inner diameter tapering to a diameter smaller than the substantially constant inner diameter at a portion 26 of the catheter shaft distal to the proximal portion.
It would have been obvious to one of ordinary skill before the effective filing date to vary the inner diameter to a smaller tapered diameter towards the distal end, as taught by Shwab, since the smaller diameter results in a thickened wall that provides increase resistance to unplanned collapsing or buckling of that section of the catheter (Shwab; col. 3, lines 57-62).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of Castaneda et al., hereinafter “Castaneda” (U.S. Patent No. 5,279,596).
Regarding claim 13, Bowe discloses 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).
Claims 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of McFerran et al., hereinafter “McFerran” (U.S. Pub. No. 2006/0089618).
Regarding claims 15-16, and 19, Bowe discloses the claimed invention, as discussed above, except for further comprising a radiopaque marker band adjacent to the distal tip, or wherein a portion of the resin jacket including or adjacent to the distal tip comprises a radiopaque material additive that acts as a radiopaque marker, or
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. In [0031] McFerran further teaches that a radiopaque material additive that acts as a radiopaque marker may be added to the catheter tip.
It would have been obvious to one of ordinary skill before the effective filing date to modify Bowe 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bowe (U.S. Pub. No. 2003/0144657) in view of McMillan (U.S. Pub. No. 2008/0140023).
Regarding claim 18, Bowe discloses 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.).
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 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