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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2 September 2025.
With respect to the election of species requirement, the arguments are persuasive, and the requirement is withdrawn. With respect to the restriction requirement, the examiner is not persuaded. In particular, as previously noted, the inventions are separately classified. While there is minimal overlap in the required searches for the two inventions, there is also significant divergence in scope and the content of the prior art. The examiner continues to hold that a significant burden would be present in examining the method as well as the apparatus claims and therefore maintains the restriction requirement, which is hereby made final.
Claim Rejections - 35 USC § 102
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, 3-10 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by.
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).
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.
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.
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). See Response To Arguments below regarding this limitation. 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, 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).
Regarding claims 2, 11 and 21 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). See Response to Arguments below regarding this limitation. 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.
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 argument that Takagi does not teach a catheter “bent on substantially the same plane”, the examiner disagrees. First, the examiner acknowledges that Takagi teaches an out of plane angle alpha or beta, but this falls into the definition of “substantially the same plane”. The examiner notes paragraph [0033] of applicant’s specification as filed on 30 November 2022, which explicitly states “the phrase ‘being curved on substantially the same plane X’ may include not only being curved on the same plane X, but also a case in which a distal portion of the catheter 1 slightly protrudes from the plane X” (emphasis added). As the out of plane portion of Takagi is the distalmost portion thereof, Takagi teaches a catheter which is “bent on substantially the same plane” as the term is defined by the applicant. The examiner therefore holds that this limitation does not patentably distinguish the claimed invention from the teachings of Takagi.
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).
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 claimed invention is unpatentable at this time.
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 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 27 March 2026