CTNF 18/267,636 CTNF 83296 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on 6/15/23 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner. Claim Objections 07-29-01 AIA Claim 11 is objected to because of the following informalities: “decreases” “decreasing” in lines 2 and 3, typographical error . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. Claims 8, 11, 15, 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The use of “and/or” makes the claims indefinite as the bound of the claim is undefined. Claims 9-11 are further rejected based on dependency. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21 AIA Claim s 1-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Takagi et al. (US 2010/0030165) (“Takagi”). Takagi discloses a medical catheter (and method for fabricating a medical catheter) comprising: (claims 1, 13, 2, 14) A medical catheter (Fig. 4) [0050-53], comprising a catheter body, wherein the catheter body comprising a proximal section and a distal section sequentially arranged along an axis, wherein the proximal section has a stiffness that is greater than a stiffness of the distal section, wherein the distal section comprises a transition section and a flexible section sequentially arranged from a proximal end to a distal end thereof, wherein the flexible section has a stiffness that is smaller than a stiffness of the transition section, wherein the stiffness of the transition section gradually decreases from a proximal end to a distal end thereof, and wherein a ratio of an axial length of the flexible section to an axial length of the transition section is 0.05-0.4. [0087, 0069, 0080, 0129] the lengths of the flexible sections are not particularly limited. Because there is no limit on the lengths of the flexible sections, the ratios of these sections to each other can be varied to fall within the scope of the claim ratios, 0.05-0.4 or 0.1-0.25. Such a modification to change the lengths of the segments in proportion to one another would have been considered a design consideration to a person having ordinary skill in the art before the effective filing date of the claimed invention; this type of modification fails to patentably distinguish over Takagi. Claims 3,4: the catheter body further comprises a tip section located distally with respect to the distal section, wherein the tip section has a stiffness that is smaller than the stiffness of the proximal section, and wherein the tip section has an axial length ranging from 0.2 cm to 6 cm. The tip section comprises at least one radiopaque marker, and wherein the radiopaque marker is any one of a radiopaque ring, a radiopaque band, a radiopaque spring and a radiopaque dot, or a combination thereof. [0067,0069,0064] Claims 5,15: As above with the ratios of lengths of the catheter sections, Takagi does not directly disclose the ratios of a two-point bending flexural strength of the flexible section to a two-point bending flexural strength of the proximal section is 0.005-0.7, and/or wherein the two-point bending flexural strength of the flexible section ranges from 0.01 N to 1.0 N. (claim 15) a two-point bending flexural strength of the flexible section and a two-point bending flexural strength of the proximal section satisfy F2/F1 Є[ 0.005, 0.7] and/or F2Є[0.01 N 1.0N],where F2 represents the two-point bending flexural strength of the flexible section, measured in N; and F1 represents the two-point bending flexural strength of the proximal section, measured in N. Takagi does disclose flexural strengths without the specifics of the claimed limitations [0080, 0014,0031, 0053-0054]. Such a modification to change the flexural strengths of the segments in proportion to one another would have been considered a design consideration to a person having ordinary skill in the art before the effective filing date of the claimed invention; this type of modification fails to patentably distinguish over Takagi. [0080] Claims 6, 7, 16, 17: Again, because there is no limit on the lengths of the flexible sections, the lengths of the sections can range from the lengths claimed. Such a modification to change the lengths of the segments in proportion to one another would have been considered a design consideration to a person having ordinary skill in the art before the effective filing date of the claimed invention; this type of modification fails to patentably distinguish over Takagi. Further, Takagi does disclose the overall length of the catheter to be 100cm (1000mm) in one example [0134]. Claims 8, 18: the catheter of Takagi further discloses: a radially outer layer 2, a radially intermediate layer 76 and a radially inner layer 6, wherein each of the outer layer and the inner layer is made of a polymeric material, and wherein the intermediate layer is a braided structure and/or a spiral structure. [0119-0120, 0088, 0133] Claim 9: a braid density of a distal end of the intermediate layer is lower or higher than a braid density of a proximal end of the intermediate layer, or wherein in case of the intermediate layer being a spiral structure, the intermediate layer has a spiral density gradually decreasing from a proximal end to a distal end thereof. [0053] Fig. 4 Claim 10: the intermediate layer is spirally wound from a single-stranded wire, or wherein the intermediate layer is braided and/or spirally wound from a multi-stranded wire. [0058] Claim 11: a stiffness of the polymeric material of the outer layer gradually decreases from a proximal end to a distal end thereof, and/or wherein the outer layer has a wall thickness gradually decreasing from the proximal end to the distal end thereof and has a constant inner diameter. [0062] Claim 12: the medical catheter has an inner diameter ranging from 0.40 mm to 2.24 mm and an outer diameter ranging from 0.42 mm to 2.8 mm. [0027,0061] Again, because there is no limit on the diameters of the catheters, the diameters can range from the diameters as claimed. Such a modification to change the diameters in proportion to one another would have been considered a design consideration to a person having ordinary skill in the art before the effective filing date of the claimed invention; this type of modification fails to patentably distinguish over Takagi. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST. 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, Kevin Sirmons can be reached at 571-272-4965. 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. /DEANNA K HALL/Primary Examiner, Art Unit 3783 Application/Control Number: 18/267,636 Page 2 Art Unit: 3783 Application/Control Number: 18/267,636 Page 3 Art Unit: 3783 Application/Control Number: 18/267,636 Page 4 Art Unit: 3783 Application/Control Number: 18/267,636 Page 5 Art Unit: 3783 Application/Control Number: 18/267,636 Page 6 Art Unit: 3783 Application/Control Number: 18/267,636 Page 7 Art Unit: 3783 Application/Control Number: 18/267,636 Page 8 Art Unit: 3783