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 Election/Restrictions Claim 17-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 November 2025. 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) 1-7, 9-11 and 14-16 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kreidler (US 2004/0220610) . Regarding claim 1, Kreidler discloses a n introducer sheath (Fig. 24, 300) for insertion into the body of a patient through an access site of the body (¶[0168], where it is a deployment system with for implanting and delivery) , the introducer sheath comprising: a longitudinal sheath member (Fig. 24, 500) for insertion into the access site to carry out intravascular work (¶[0168], where the delivery system 500 is designed for atrial work, Note: this a functional limitation) ; and a radiopaque marker element (Fig. 28, 586) arranged over the outer surface of the longitudinal sheath member (Fig. 28, where 586 is on an external surface at end of the device) , in which introducer sheath the radiopaque marker element is moveable along at least part of the longitudinal length of the longitudinal sheath member from a first position ( at which the radiopaque marker element is not in contact with the access site (¶[0198], where the movable core 312 can be in a retracted or advanced state using the slider assembly 400) , to a second position, at which the radiopaque marker element abuts the access site such that insertion of the radiopaque marker element into the access site is prevented (¶[0198], where the movable core 312 can be in a retracted or advanced state using the slider assembly 400) . Regarding claim 2, Kreidler discloses t he introducer sheath of c laim 1, wherein the longitudinal sheath member (500) further comprises a second radiopaque marker (Fig. 29A, 590) element fixedly disposed at a distal section thereof (¶[0196], where the marker is fixedly attached at a tip) . Regarding claim 3, Kreidler discloses t he introducer sheath of c laim 2, wherein the second radiopaque marker (590) element is disposed at a distal end of the longitudinal sheath member (Fig. 29A, where the marker 590 is at a distal tip of 504) . Regarding claim 4, Kreidler discloses t he introducer sheath of claim 1, further comprising a biasing element (Fig. 28, 568) configured to bias the radiopaque marker element to the second position (¶[0178], [0198]) . Regarding claim 5, Kreidler discloses the introducer sheath of claim 4, wherein the biasing element is configured such that, in the relaxed state of the biasing element, the radiopaque marker element is aligned with a distal end of the longitudinal sheath member (¶[0198], where the retracted state of the device would keep the distal end of the marker element at least at the distal end of 500) . Regarding claim 6, Kreidler discloses the introducer sheath of claim 4, wherein the biasing element is a spring (¶[0178], where 568 has a spring coil section) . Regarding claim 7, Kreidler discloses the introducer sheath of claim 6, further comprising a sheath hub (Fig. 24, 538) disposed at a proximal end of the longitudinal sheath member (Fig. 24, where 538 is at a proximal end and the distal end is located at 312) , and wherein the spring is disposed between the sheath hub and the radiopaque marker element (Fig. 28, 568, Fig. 24, 538, where the biasing element 5 68 is located distal to 538 and proximal to marker 586) . Regarding claim 9, Kreidler discloses the introducer sheath of claim 1, wherein the radiopaque marker (58 6 ) element comprises a first radiopaque part (¶[0181], where 568 is radiopaque) and a second non-radiopaque part (¶[0181], where 584 is joined with 5 86 and is not radiopaque) . Regarding claim 10, Kreidler discloses the introducer sheath of claim 9, wherein the first radiopaque part is disposed at a distal section of the radiopaque marker element (Fig. 29, where 58 6 is located at the distal end) . Regarding claim 11, Kreidler discloses the introducer sheath of claim 1, wherein the radiopaque marker (586) element consists of a radiopaque material (¶[0181], [0198], where the marker 586 is radiopaque and is necessarily made form a radiopaque material in order to be seen under fluouroscopy) . Regarding claim 14, Kreidler discloses the introducer sheath of claim 1, wherein the radiopaque marker element is configured to encompass the access site (¶[0198], where the radiopaque marker is designed to be inserted to the access site and is for use with the access site) . Regarding claim 15, Kreidler discloses the introducer sheath of claim 1, wherein the radiopaque marker element touches the outer surface of the longitudinal sheath member (Fig. 24, 28, where 586 touches at least a portion of the external surface and is not located interior to body of the device) . Regarding claim 16, Kreidler discloses the introducer sheath of claim 1, wherein the radiopaque marker element is moveable along the longitudinal length of the longitudinal sheath member by sliding the radiopaque marker element relative to the longitudinal sheath member (¶[0198], where the marker is movable along the longitudinal axis) . 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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kreidler (US 2004/0220610) in view of Sela et al. (US 2011/0152721). Regarding claim 8, Kreidler discloses the introducer sheath of claim 6, however, Kreidler does not specifically teach wherein the spring is made from Nitinol. Sela teaches a medical device with a core wire, sensor and a coupler. The device of Sela includes a Nitinol spring (Fig. 1A, 118). The use of Nitinol to make a spring for a device such as this is known in the art. Kreidler does teach that parts of the device can be made from nitinol and does not restrict the specifics of the spring coils in the device to a specific material. There is no evidence of record that establishes that changing the spring material would result in a difference in function of the Kreidler device. Further, a person having ordinary skill in the art, being faced with modifying the spring coil of Kreidler , would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed material . Lastly, applicant has not disclosed that the claimed material solves any stated problem, indicating that the material “may” be Nitinol , therefore there appears to be no criticality placed on the material as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spring coil material be Nitinol as an obvious matter of design choice within the skill of the art. Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler (US 2004/0220610). Regarding claim 12, Kreidler discloses the introducer sheath of claim 1, however, Kreidler does not specifically teach wherein the radiopaque marker element is tapered along a longitudinal length thereof parallel to the longitudinal axis of the longitudinal sheath member. There is no evidence of record that establishes that changing the shape of the radiopaque marker would result in a difference in function of the Kreidler device. Further, a person having ordinary skill in the art, being faced with modifying the marker of Kreidler , would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape . Lastly, applicant has not disclosed that the claimed shape solves any stated problem, indicating that the shape “may” be tapered , therefore there appears to be no criticality placed on shape as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the to have the shape of the marker be tapered as an obvious matter of design choice within the skill of the art. Regarding claim 13, Kreidler discloses the introducer sheath of claim 1, however, Kreidler does not specifically teach wherein a distal section of the radiopaque marker element is wider than a proximal section thereof. There is no evidence of record that establishes that changing the shape of the radiopaque marker would result in a difference in function of the Kreidler device. Further, a person having ordinary skill in the art, being faced with modifying the marker of Kreidler , would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape . Lastly, applicant has not disclosed that the claimed shape solves any stated problem, indicating that the shape “may” be tapered , therefore there appears to be no criticality placed on shape as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the to have the shape of the marker be tapered as an obvious matter of design choice within the skill of the art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT HADEN M RITCHIE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1699 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8am-5:30pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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. /HADEN MATTHEW RITCHIE/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783