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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 June 2026 has been entered.
Claim Rejections - 35 USC § 103
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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2011/0071503 to Takagi et al. (Takagi hereinafter) in view of WO 2008012914 to Shimizu et al. (Shimizu).
Regarding claim 1, Takagi teaches a catheter (10, see Fig. 1) comprising a tubular body (14) including a lumen (41, see Fig. 3), a shaped portion (18) at a distal end that is bent in a same plane (A, see Fig. 2), including a proximal bent portion (20) defining a first angle (see paragraph 59), a distal bent portion (22) defining a second angle (see paragraph 61) distal of the proximal bent portion and bent to the same side (i.e. clockwise in Fig. 1), an intermediate linear portion (21) between the proximal and distal bent portions, and a distal linear portion (23) disposed distal of the distal bent portion. Takagi further teaches that a first minimum radius of curvature is 15-25mm (paragraph 59), and a second radius of curvature is 5-10mm (paragraph 61). Takagi thus teaches that the first radius is between 3 and 5 times the second, which overlaps and therefore anticipates the claimed range (see MPEP 2131.03). Finally, Takagi teaches that the catheter is substantially bent in a same plane (A, of Fig. 2). Takagi does not teach a lubricating coating from a distal opening of the catheter along an axial direction. Shimizu teaches such a coating (see paragraph 29, “hydrophilic coating”) which makes easier an introduction operation of the catheter. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a lubricating coat as taught by Shimizu on the catheter of Takagi in order to make introduction operations easier. Thus modified, the claimed invention differs from the catheter of Takagi only in the recitation of particular relative dimensions of lubricating coating. Accordingly, it would have been obvious as of the effective filing date of the application to arrive at the claimed dimensions as the difference from the prior art is at most a recitation of relative dimensions (see MPEP 2144.04 IV A). Regarding the length of coating, the examiner notes that Shimizu teaches coating up to the second curve (11, see paragraph 29). In an analogous position, the distal tip (23) and bent portion (22) would be coated in Takagi. Since these elements are part of the shaped portion (18), the shaped portion is considered to have the coating.
Regarding claims 2 and 11 simultaneously, Takagi teaches the parent claims from which these claims depend. Takagi does not teach the specific dimensions of these claims, though the examiner notes that the claimed values fall into the general ranges taught by Takagi (as discussed in paragraphs 59-62). Additionally, Takagi teaches that the particular geometry involved is result effective in preventing damage to the patient (paragraphs 119-120). Accordingly, it would have been obvious at the time the invention was filed to optimize within the range taught by Takagi to arrive at the claimed dimensions as the routine optimization of a known result effective variable (in this case, the relevant geometry, see MPEP 2144.05). Additionally or alternatively, the claimed invention differs from the catheter of Takagi only in the recitation of particular relative dimensions. Accordingly, it would have been obvious as of the effective filing date of the application to arrive at the claimed dimensions as the difference from the prior art is at most a recitation of relative dimensions (see MPEP 2144.04 IV A).
Regarding claim 3, Takagi teaches a guiding or guide wire (48) support catheter (see e.g. paragraph 68).
Regarding claim 4, Takagi teaches that the proximal bent portion (20), the intermediate linear portion (21), the distal bent portion (22) and the distal linear portion each extend distally from the previous element.
Regarding claim 5, Takagi teaches axes passing longitudinally through the main body and the proximal and distal linear portions, and that the angle formed by the main body and the intermediate linear portion is the angle spanned by the proximal bent portion such that straightening or folding over the proximal bent portion will align the intermediate portion with the main body.
Regarding claim 6, Takagi teaches that the proximal bent portion may have a radius of curvature of 15-25mm and an angle of 70-90 degrees (paragraph 59). Since these ranges respectively overlap and touch the claimed ranges, Takagi anticipates claim 6 (see again MPEP 2131.03).
Regarding claim 7, Takagi teaches axes passing longitudinally through the main body and the proximal and distal linear portions, and that the angle formed by the intermediate and the distal linear portion is the angle spanned by the distal bent portion such that straightening or folding over the distal bent portion will align the intermediate portion with the distal linear portion.
Regarding claim 8, Takagi teaches that the second minimum curvature radius is 5-10mm and spans an angle of 60-65 degrees (paragraph 61). Since these ranges fall within the claimed ranges, Takagi anticipates claim 7 (see again MPEP 2131.03).
Regarding claim 9, Takagi teaches that the first minimum radius may be 25mm and the second minimum radius may be 5mm, such that the first is 5 times the second.
Regarding claim 10, Takagi teaches a catheter (10, see Fig. 1) comprising a tubular body (14) including a lumen (41, see Fig. 3), a shaped portion (18) at a distal end that is bent in a same plane (A, see Fig. 2), including a proximal bent portion (20) defining a first angle (see paragraph 59), a distal bent portion (22) defining a second angle (see paragraph 61) distal of the proximal bent portion and bent to the same side (i.e. clockwise in Fig. 1), an intermediate linear portion (21) between the proximal and distal bent portions, and a distal linear portion (23) disposed distal of the distal bent portion. Takagi further teaches that a first minimum radius of curvature is 15-25mm (paragraph 59), and a second radius of curvature is 5-10mm (paragraph 61). Takagi thus teaches that the first radius is between 3 and 5 times the second, which overlaps and therefore anticipates the claimed range (see MPEP 2131.03). Similarly, Takagi teaches that the proximal bent portion may have a radius of curvature of 15-25mm and an angle of 70-90 degrees (paragraph 59) and that the second minimum curvature radius is 5-10mm and spans an angle of 60-65 degrees (paragraph 61). These teachings anticipate those of claim 10 by the same analysis as above. Finally, Takagi teaches that the catheter is substantially bent in a same plane (A, of Fig. 2). Takagi does not teach a lubricating coating from a distal opening of the catheter along an axial direction. Shimizu teaches such a coating (see paragraph 29, “hydrophilic coating”) which makes easier an introduction operation of the catheter. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a lubricating coat as taught by Shimizu on the catheter of Takagi in order to make introduction operations easier. Thus modified, the claimed invention differs from the catheter of Takagi only in the recitation of particular relative dimensions of lubricating coating. Accordingly, it would have been obvious as of the effective filing date of the application to arrive at the claimed dimensions as the difference from the prior art is at most a recitation of relative dimensions (see MPEP 2144.04 IV A).
Regarding claim 12, Takagi teaches that the proximal bent portion (20), the intermediate linear portion (21), the distal bent portion (22) and the distal linear portion each extend distally from the previous element.
Regarding claim 13, Takagi teaches axes passing longitudinally through the main body and the proximal and distal linear portions, and that the angle formed by the main body and the intermediate linear portion is the angle spanned by the proximal bent portion such that straightening or folding over the proximal bent portion will align the intermediate portion with the main body.
Regarding claim 14, Takagi teaches axes passing longitudinally through the main body and the proximal and distal linear portions, and that the angle formed by the intermediate and the distal linear portion is the angle spanned by the distal bent portion such that straightening or folding over the distal bent portion will align the intermediate portion with the distal linear portion.
Allowable Subject Matter
Claim 21 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: the limitations of a coating extending at least 400mm from the tip of a catheter having the structure of claim 1 as in claim 21 is not shown in or fairly suggested by the prior art of record in combination with the remaining limitations of claim 21.
Response to Arguments
Applicant’s arguments, see page 11, filed 19 December 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102(a)(1) 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 Shimizu as discussed above.
With respect to the limitation of the lubricious coating, this limitation is taught by Shimizu as discussed above. Regarding the length, the examiner notes that Shimizu teaches that only the tip (i.e. beyond curve 11) is coated (paragraph 29). The equivalent element in Takagi would be L2, which is disclosed as having a length of 5-50 mm (paragraph 62). Claim 1 requires only that the shaped portion is coated with the coating – therefore as long as any part of it is coated, it is partially coated and this is sufficient to meet the limitations of the claim.
With respect to the length dimensions of the catheter in new claim 21, the examiner notes paragraphs 57-60 of Takagi as teaching a similar length catheter. Additionally, as discussed above with respect to claims 2, 11, and 21, the mere recitation of relative lengths of the catheter does not patentably distinguish the claimed invention.
In view of the above, the examiner holds that the rejected claims are unpatentable at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 15 July 2026
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