CTNF 19/256,095 CTNF 77702 DETAILED ACTION 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. Election/Restrictions 08-08 AIA Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-8 , drawn to a marker , classified in A61M 25/0108 . II. Claim s 9-20 , drawn to a catheter , classified in A61M 16/04 . 08-15 Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the marker device of group 1 can be used with different medical imaging devices where the marker is not required to work in conjunction with a catheter. The subcombination has separate utility such as imaging devices that are used in non-invasive procedures. The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. 08-23 AIA During a telephone conversation with David Burse on 05/08/26 a provisional election was made with traverse to prosecute the invention of group I regarding the marker, including claim s 1-8 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 9-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). Information Disclosure Statement 06-49-07 AIA The information disclosure statement filed 06/30/25 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Claim Rejections - 35 USC § 102 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, and 3-8 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Baron et al. (US 2022/0273323 A1) . With respect to claim 1, Baron discloses a marker device, comprising (see structure #900 in Figure 9 attached herein): a ring structure having a distal end, a proximal end, and a body extending between the distal end and the proximal end (see ring structure #940 having a distal end A, a proximal end C, and a body extending between the distal end and the proximal end B labeled by the examiner herein), wherein the ring structure is made from a radiopaque material (see paragraphs 0163-0164); wherein the distal end of the ring structure comprises protruding elements disposed circumferentially around an axis of the ring structure (see distal end A having curvilinear shape including peaks as and valleys where Figure 9 show a peak A considered as the claimed protruding element); and wherein the proximal end of the ring structure is configured to couple with, or extends from, a PNG media_image1.png 205 440 media_image1.png Greyscale tubular structure, wherein the proximal end of the ring structure is distal to the tubular structure (see Figure 9 showing the element #940 couple to a cylindrical portion #930 and also see Figure 11A zooming out the device by showing the portion #1160 extends to connect to a tubular sleeve #1140); wherein each of the protruding elements has a length and a width (see Figure 9 showing distal end A having curvilinear shape including peaks as and valleys considered as the claimed protruding elements, hence the elements shape having a length and a width), wherein the length is measured parallel to a longitudinal axis of the marker device and is shorter than PNG media_image2.png 137 87 media_image2.png Greyscale the width (see Figure showing length L is shorter than width W as labeled by the examiner herein), and wherein the distal end of the ring structure has a sinusoidal profile extending circumferentially around the longitudinal axis of the marker device (see distal end A having curvilinear shape including peaks as and valleys where said configuration is a sinusoidal profile and it extends circumferentially around the longitudinal axis of the marker device as seen in said Figure 9). With respect to claim 3, Baron discloses the protruding elements comprise respective curvilinear tip surfaces (see distal end A having curvilinear shape including peaks as and valleys where Figure 9 show a peak A considered as the claimed protruding element where A is pointing to the tip of the curve). With respect to claim 4, Baron discloses the distal end of the ring structure further comprises curvilinear trough surfaces, and wherein each of the curvilinear trough surfaces is disposed between two adjacent ones of the curvilinear tip surfaces (see distal end A having curvilinear shape including peaks as and valleys in a consecutive manner where Figure 9 show a peak A where A is pointing to the tip of the curve of multiple peaks and wherein each peak is adjacent to each other). With respect to claim 5, Baron discloses the curvilinear tip surfaces and the curvilinear trough surfaces together form a sinusoidal profile extending circumferentially around the longitudinal axis of the marker device (see distal end A having curvilinear shape including peaks as and valleys in a consecutive manner where Figure 9 show a peak A where A is pointing to the tip of the curve of multiple peaks and wherein each peak is adjacent to each other extending circumferentially). With respect to claim 6, Baron discloses a ratio calculated by dividing the length by a total longitudinal length of the ring structure is at least 0.5 (see paragraph 0144). With respect to claim 7, Baron discloses the ring structure has a plurality of holes disposed circumferentially at the body of the ring structure (see paragraphs 0006-0008, and 0138 disclosing the tip further as an open cells or apertures configuration forming the tip as shown in Figure 21A). With respect to claim 8, Baron discloses at least one of the holes has an elongated configuration extending at least partially around the longitudinal axis of the marker device (see paragraphs 0006-0008, and 0138 disclosing the tip further as an open cells or apertures configuration forming the tip as shown in Figure 21A where said openings are depicted as elongated) . 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 2 is rejected under 35 U.S.C. 103 as being unpatentable over Baron et al. (US 2022/0273323 A1) in view of Barker et al. (US 2008/0200943 A1) . With respect to claim 2, Baron discloses the claimed invention as stated above except for specifying the proximal end of the ring structure comprises tabs disposed circumferentially around the longitudinal axis of the marker device, and wherein the tabs are configured to be welded to, or extend from the tubular structure. However, Barker discloses the proximal end of the ring structure comprises tabs disposed circumferentially around the longitudinal axis of the marker device, and wherein the tabs are configured to be welded to, or extend from the tubular structure (see Figure 4A showing tabs #416 as described in paragraph 0077 where the tabs can be welded). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the proximal end of the ring structure comprises tabs disposed circumferentially around the longitudinal axis of the marker device, and wherein the tabs are configured to be welded to, or extend from the tubular structure as taught by Barker in combination with Baron for the purpose of affixing or securing the tip to the tube using a known processes as welding as disclosed by Baron (see paragraph 0164 discussing the radiopaque material may be attached to the device by any suitable method, for example, by mechanical attachment; e.g., embedded in a portion of the catheter, circumferential circumscription, or the like; adhesive bonding, weld ing, soldering, combinations thereof or the like) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses markers . Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-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, Raymond Keith can be reached at 571-270-1790. 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. /DIXOMARA VARGAS/Primary Examiner, Art Unit 3798 Application/Control Number: 19/256,095 Page 2 Art Unit: 3798 Application/Control Number: 19/256,095 Page 3 Art Unit: 3798 Application/Control Number: 19/256,095 Page 4 Art Unit: 3798 Application/Control Number: 19/256,095 Page 5 Art Unit: 3798 Application/Control Number: 19/256,095 Page 6 Art Unit: 3798 Application/Control Number: 19/256,095 Page 7 Art Unit: 3798 Application/Control Number: 19/256,095 Page 8 Art Unit: 3798 Application/Control Number: 19/256,095 Page 9 Art Unit: 3798
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