CTNF 19/000,061 CTNF 94257 DETAILED ACTION This action is pursuant to the claims filed on 12/23/2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 05/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 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. 07-34-01 Claim 9 is 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. Claim 9 recites the limitation "the first catheter position" and “the second catheter position”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if these recited positions are to be interpreted as the real respective positions of the first and second catheter elements, the generated respective first position of the first catheter element and second position of the second catheter element, or a first and second position of one of the catheter elements. Claim Rejections - 35 USC § 102 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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Cohen (U.S. PGPub No. 2018/0042683) . Regarding claim 1, Cohen teaches A system for use with an electrophysiological procedure, the system comprising: a catheter assembly including a plurality of coaxially disposed catheter elements (Fig 1A probe 20 and sheath 21 are coaxial elements) , the plurality of catheter elements including a first catheter element and a second catheter element (probe 20 and sheath 21) , the first catheter element forming an elongated lumen defining a longitudinal axis and the second catheter element disposed within the lumen ([0041] sheath has lumen to contain probe 20) , the first and second catheter elements movable with respect to each other along the longitudinal axis ([0041]) , wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal ([0049] sheath 21 has tracking system) and the second catheter element includes a second tracking sensor configured to generate a second electrical signal ([0042] probe 20 comprises tracking system) ; and a controller (Fig 1A processor 46 and operating console 48) configured to: generate a first position of the first catheter element based on the first electrical signal and generate a second position of the second catheter element based on the second electrical signal ([0044] and Fig 1a, tracking modules 52/54 track probe 20 and sheath 21 as disclosed above) ; in response to a detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element ([0041] probe 20 moves longitudinally with respect to the sheath 21; [0060-0065] discussing slide variable for when the probe 20 moves longitudinally out of sheath 21) : apply a historical correction to the first and second positions based on a previously determined first and second position vector to obtain an initially corrected first and second positions ([0077-0079] and Fig 5b, cost function is used to find best position between measured points M and calculated locations E) ; apply a longitudinal adjustment to the initially corrected first and second positions based on a constraint applied to the detected longitudinal movement ([0079]) ; and generate an anatomical map of an organ of the electrophysiological procedure with a visualization of the catheter assembly including the longitudinal adjustment ([0056] and Fig 7 step 306 described in [0097]). Regarding claim 2, Cohen further teaches wherein the controller is configured to update the previously determined first and second position vector in response to the detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element ([0060-0066] and Fig 2, slide variable is determined to detect longitudinal movement and calculate and display said movement when it is present) . Regarding claim 3, Cohen further teaches wherein the updated previously determined first and second position vector is based on a plurality of previously determined first and second position vectors (Fig 2, 5A-B, 7, multiple iterations would necessarily mean updated previously determined positions are based on a plurality of previously determined positions). Regarding claim 4, Cohen further teaches wherein the update to the previously determined first and second position vector is based on a parameter of the electrophysiological procedure ([0056] position of catheter is displayed in relation to a 3D map 60 of the heart (i.e., the corrected positions are based on a parameter of the electrophysiological procedure)) . Regarding claim 5, Cohen further teaches wherein the update to the previously determined first and second position vector is based on a time period of the electrophysiological procedure ([0111] and Fig 8, updates to previously determined first and second position vector are intrinsically based on a time period of the heart procedure (i.e., movement and subsequent location of the sheath and probe within heart is based on a period of time during the procedure, which is iteratively corrected in the modeling and display)). Regarding claim 6, Cohen further teaches wherein the update to the previously determined first and second position vector is based on an anatomical location of the electrophysiological procedure ([0056] position of catheter is displayed in relation to a 3D map 60 of the heart (i.e., the corrected positions are based on an anatomical location of the electrophysiological procedure)). Regarding claim 7, Cohen further teaches wherein the update to the previously determined first and second position vector is based on a plurality of parameters of the electrophysiological procedure (updated position vectors are based on both anatomical location and time period of the electrophysiological procedure as stated in claims 5-6 above). Regarding claim 8, Cohen further teaches wherein the controller is configured to laterally align the first position with the second position based on a lateral displacement and a rotational displacement determined from the first position and the second position ([0078-0085] controller calculates for lateral and rotational displacement from first and second positions such that the new first and second positions are laterally aligned with each other with respect to previous positions; Display of Fig 4A-B shows lateral alignment of first and second position). Regarding claim 9, Cohen further teaches wherein the first catheter position includes a first location in space and a first tangent, and the second catheter position includes a second location in space and a second tangent (see Figs 4A-B each catheter element position is in a location in space with respective tangents) , and wherein the first location and the first tangent are laterally aligned with the second location and the second tangent based on a lateral departure and a rotational deflection determined from the first tangent and the second tangent (Fig 4A-B, modified Fig 4A below shows first tangent of the sheath and second tangent of the probe that are laterally aligned based on a lateral departure and rotational deflection of probe curve 160A and sheath curve 162A) . PNG media_image1.png 402 376 media_image1.png Greyscale Regarding claim 10, Cohen further teaches wherein the controller is configured to track the first catheter element via impedance tracking ([0049] sheath can be tracked via impedance sensing) and to track the second catheter element via magnetic tracking ([0042] probe has magnetic tracking) . Regarding claim 11, Cohen further teaches wherein the controller is configured to laterally align the second position to the first position ([0078-0085] controller calculates for lateral and rotational displacement from first and second positions such that the new first and second positions are laterally aligned with each other with respect to previous positions; Display of Fig 4A-B shows lateral alignment of first and second position). Regarding claim 12, Cohen further teaches wherein the controller is configured to apply the longitudinal adjustment to the second position with respect to the first position ([0060-0066] slide variable accounts for applying longitudinal adjustment to second position (probe 20) with respect to first position (sheath 21)) . Regarding claims 13-14, Cohen further teaches wherein the detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element is based on an independent parameter that detects the relationship between the sheath and electrodes on the catheter ([0065] slide variable is based on distance between probe and sheath distal ends); wherein the independent parameter includes sheath detection mechanism ([0065] measuring a distance between the sheath and probe distal ends requires a sheath detection mechanism; see also sheath position and orientation values 152 of Fig 3) . Regarding claim 15, Cohen further teaches wherein the first catheter element includes a catheter sheath (sheath 21). Regarding claim 16, Cohen further teaches wherein the second catheter element includes an ablation catheter (probe 20 is configured for ablation as disclosed in [0041]). Regarding claim 17, Cohen teaches A system for use with an electrophysiological procedure, the system comprising: a catheter assembly including a plurality of coaxially disposed catheter elements (Fig 1A probe 20 and sheath 21 are coaxial elements) , the plurality of catheter elements including a first catheter element and a second catheter element (probe 20 and sheath 21) , the first catheter element forming an elongated lumen defining a longitudinal axis and the second catheter element disposed within the lumen ([0041] sheath has lumen to contain probe 20) , the first and second catheter elements movable with respect to each other along the longitudinal axis ([0041]) , wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal ([0049] sheath 21 has tracking system) and the second catheter element includes a second tracking sensor configured to generate a second electrical signal ([0042] probe 20 comprises tracking system) ; and a controller (Fig 1A processor 46 and operating console 48) configured to: generate a first position of the first catheter element based on the first electrical signal and generate a second position of the second catheter element based on the second electrical signal ([0044] and Fig 1a, tracking modules 52/54 track probe 20 and sheath 21 as disclosed above) ; in response to a detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element based on a sheath detection ([0041] probe 20 moves longitudinally with respect to the sheath 21; [0060-0065] discussing slide variable for when the probe 20 moves longitudinally out of sheath 21 based on a sheath detection) : apply a historical correction to the first and second positions based on a previously determined first and second position vector to obtain an initially corrected first and second positions ([0077-0079] and Fig 5b, cost function is used to find best position between measured points M and calculated locations E) ; apply a longitudinal adjustment to the initially corrected first and second positions based on a constraint applied to the detected longitudinal movement ([0079]) ; and generate an anatomical map of an organ of the electrophysiological procedure with a visualization of the catheter assembly including the longitudinal adjustment ([0056] and Fig 7 step 306 described in [0097]). Regarding claim 18, Cohen teaches wherein the controller is configured to update the previously determined first and second position vector in response to the detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element ([0060-0066] and Fig 2, slide variable is determined to detect longitudinal movement and calculate and display said movement when it is present) ; and wherein the updated previously determined first and second position vector is based on a plurality of previously determined first and second position vectors (Fig 2, 5A-B, 7, multiple iterations would necessarily mean updated previously determined positions are based on a plurality of previously determined positions). Regarding claim 19, Cohen teaches A system for use with an electrophysiological procedure, the system comprising: a catheter assembly including a plurality of coaxially disposed catheter elements (Fig 1A probe 20 and sheath 21 are coaxial elements) , the plurality of catheter elements including a first catheter element and a second catheter element (probe 20 and sheath 21) , the first catheter element forming an elongated lumen defining a longitudinal axis and the second catheter element disposed within the lumen ([0041] sheath has lumen to contain probe 20) , the first and second catheter elements movable with respect to each other along the longitudinal axis ([0041]) , wherein the first catheter element includes a first tracking sensor configured to generate a first electrical signal ([0049] sheath 21 has tracking system) and the second catheter element includes a second tracking sensor configured to generate a second electrical signal ([0042] probe 20 comprises tracking system) ; and a controller (Fig 1A processor 46 and operating console 48) configured to: track the first catheter element via impedance tracking ([0049] sheath can be tracked via impedance sensing) and to track the second catheter element via magnetic tracking ([0042] probe has magnetic tracking); generate a first position of the first catheter element based on the first electrical signal and generate a second position of the second catheter element based on the second electrical signal ([0044] and Fig 1a, tracking modules 52/54 track probe 20 and sheath 21 as disclosed above) ; in response to a detected longitudinal movement of the second catheter element along the longitudinal axis with respect to the first catheter element based on a sheath detection ([0041] probe 20 moves longitudinally with respect to the sheath 21; [0060-0065] discussing slide variable for when the probe 20 moves longitudinally out of sheath 21 based on a sheath detection) : apply a historical correction to the first and second positions based on a previously determined first and second position vector to obtain an initially corrected first and second positions ([0077-0079] and Fig 5b, cost function is used to find best position between measured points M and calculated locations E) ; apply a longitudinal adjustment to the initially corrected first and second positions based on a constraint applied to the detected longitudinal movement ([0079]) ; and generate an anatomical map of an organ of the electrophysiological procedure with a visualization of the catheter assembly including the longitudinal adjustment ([0056] and Fig 7 step 306 described in [0097]). Regarding claim 20, Cohen further teaches wherein the controller is configured to apply the longitudinal adjustment to the second position with respect to the first position ([0060-0066] slide variable accounts for applying longitudinal adjustment to second position (probe 20) with respect to first position (sheath 21)) . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto- processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-35 AIA Claim s 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of copending Application No. 18/512,811 (reference application) in view of Cohen . Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate and/or make obvious the instant claims in view of Cohen . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 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, Joseph Stoklosa can be reached at (571) 272-1213. 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. /ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794 Application/Control Number: 19/000,061 Page 2 Art Unit: 3794 Application/Control Number: 19/000,061 Page 3 Art Unit: 3794 Application/Control Number: 19/000,061 Page 4 Art Unit: 3794 Application/Control Number: 19/000,061 Page 5 Art Unit: 3794 Application/Control Number: 19/000,061 Page 6 Art Unit: 3794 Application/Control Number: 19/000,061 Page 7 Art Unit: 3794 Application/Control Number: 19/000,061 Page 8 Art Unit: 3794 Application/Control Number: 19/000,061 Page 9 Art Unit: 3794 Application/Control Number: 19/000,061 Page 10 Art Unit: 3794 Application/Control Number: 19/000,061 Page 11 Art Unit: 3794 Application/Control Number: 19/000,061 Page 12 Art Unit: 3794 Application/Control Number: 19/000,061 Page 13 Art Unit: 3794
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