CTNF 19/172,151 CTNF 96175 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. Information Disclosure Statement The information disclosure statements (IDS) submitted on 5/7/2025 and 5/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. 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. 08-34 AIA Claim (s) 1-2, 6-9, 11-13, 15-18 and 20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim (s) 1-10 of U.S. Patent No. 12,280,223 to Massimini . Although the claims at issue are not identical, they are not patentably distinct from each other because : Regarding claim 1, Massimini claims: A method for generating pressure waves to induce fractures at a treatment site within or adjacent a vessel wall (see Claim 1, Col. 38, Lines 41-43), the method comprising steps of: advancing a catheter to the treatment site, the catheter including an elongate shaft and a balloon coupled to the elongate shaft, the balloon having a balloon wall (see Claim 1, Col. 38, Lines 44-47), the balloon being configured to be filled with a balloon fluid (see Claim 1, Col. 38, Lines 50-51); disposing a first light guide along the elongate shaft so that a distal portion of the first light guide is positioned within the balloon fluid, the first light guide being in optical communication with a light source and the balloon fluid (see Claim 1, Col. 38, Lines 48-53); positioning a first focusing element at the distal portion of the first light guide, the first focusing element being in optical communication with the light source (see Claim 1, Col. 38, Lines 54-56); activating the light source to provide light (see Claim 1, Col. 38, Lines 56-59); directing the light from the light source through the first light guide (see Claim 1, Col. 38, Lines 55-60); and further directing the light from the light source with the first focusing element to be focused at a first location at a first distance away from the distal portion of the first light guide so that plasma formation in the balloon fluid is initiated away from the distal portion of the first light guide and so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site (see Claim 1, Col. 38, Lines 54-64). Regarding claim 2, Massimini claims the invention of claim 1, Massimini further claims positioning a second focusing element at the distal portion of the first light guide, the second focusing element being in optical communication with the light source; and further directing the light from the light source with the second focusing element to be focused at a second location at a second distance away from the distal portion of the first light guide so that plasma formation in the balloon fluid is initiated away from the distal portion of the first light guide and so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site (see Claim 2). Regarding claim 6, Massimini claims the invention of claim 1, Massimini further claims wherein the step of disposing includes the distal portion of the first light guide including a distal tip of the first light guide; and wherein the step of positioning includes the first focusing element being located at the distal tip of the first light guide (see Claim 4). Regarding claim 7, Massimini claims the invention of claim 6, Massimini further claims wherein the step of disposing includes the first light guide having a longitudinal axis; and wherein the step of further directing the light from the light source with the first focusing element includes the first location being spaced away from the distal tip of the first light guide and being centered on the longitudinal axis of the first light guide (see Claim 5). Regarding claim 8, Massimini claims the invention of claim 6, Massimini further claims wherein the step of further directing the light from the light source with the first focusing element includes the first distance being at least 1 pm and at most 5 mm away from the distal tip of the first light guide (see Claim 6). Regarding claim 9, Massimini claims the invention of claim 1, Massimini further claims wherein the step of positioning the first focusing element includes the first focusing element including one of a convex lens, a convex mirror, and a gradient-index (GRIN) lens (see Claim 3). Regarding claim 11, Massimini claims the invention of claim 1, Massimini further claims wherein the step of disposing includes the first light guide having a longitudinal axis; and further comprising steps of positioning a first diverting feature at the distal portion of the first light guide, the first diverting feature being in optical communication with the first focusing element; and directing light from within the first light guide with the first diverting feature toward the first focusing element and toward the balloon wall, the first location being spaced away from the longitudinal axis of the first light guide (see Claim 9). Regarding claim 12, Massimini claims the invention of claim 11, Massimini further claims wherein the step of directing light from within the first light guide with the first diverting feature includes the first diverting feature being a fiber diffuser (see Claim 10). Regarding claim 13, Massimini claims the invention of claim 11, Massimini further claims steps of positioning a second focusing element at the distal portion of the first light guide, the second focusing element being in optical communication with the light source; and further directing the light from the light source with the second focusing element to be focused at a second location at a second distance away from the distal portion of the first light guide so that plasma formation in the balloon fluid is initiated away from the distal portion of the first light guide and so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site (see Claim 2). Regarding claim 15, Massimini claims the invention of claim 1, Massimini further claims coupling a second light guide to the elongate shaft so that a distal portion of the second light guide is positioned within the balloon fluid, the second light guide being in optical communication with the light source and the balloon fluid; positioning a second focusing element at the distal portion of the second light guide, the second focusing element being in optical communication with the light source; directing the light from the light source through the second light guide; and further directing the light from the light source with the second focusing element to be focused at a second location at a second distance away from the distal portion of the second light guide so that plasma formation in the balloon fluid is initiated away from the distal portion of the second light guide and so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site (see Claim 7). Regarding claim 16, Massimini claims the invention of claim 15, Massimini further claims wherein the step of disposing includes the first light guide having a longitudinal axis; and wherein the step of further directing the light from the light source with the first focusing element includes the first location being spaced away from the distal tip of the first light guide and being centered on the longitudinal axis of the first light guide (see Claim 5). Regarding claim 17, Massimini claims the invention of claim 16, Massimini further claims wherein the step of coupling includes the second light guide having a longitudinal axis; and wherein the step of further directing the light from the light source with the second focusing element includes the second location being spaced away from the distal portion of the second light guide and being centered on the longitudinal axis of the second light guide (see Claim 7). Regarding claim 18, Massimini claims the invention of claim 15, Massimini further claims wherein the step of disposing includes the first light guide having a longitudinal axis; and further comprising steps of positioning a first diverting feature at the distal portion of the first light guide, the first diverting feature being in optical communication with the first focusing element; and directing light from within the first light guide with the first diverting feature toward the first focusing element and toward the balloon wall, the first location being spaced away from the longitudinal axis of the first light guide (see Claim 9). Regarding claim 20, Massimini claims the invention of claim 1, Massimini further claims wherein the step of disposing includes the first light guide being an optical fiber; and wherein the step of activating includes the light source being a laser (see Claim 8) . Allowable Subject Matter Claims 1-2, 6-9, 11-13, 15-18 and 20 are conditionally in condition for allowance pending a resolution to the above non-statutory double patenting rejection over U.S. Patent No. 12, 280,223. The cited claims contain all of the allowable limitations present in the reference patent and are thus allowable for the same reasons. For clarity, in regards to claim 1, the closest prior art of record, namely Hastings (US 2011/0257641 A1) (previously of record as the closest prior art of record for U.S. Patent 12, 280, 223) discloses: A method for generating pressure waves to induce fractures at a treatment site within or adjacent a vessel wall (see Figs. 14 and 19; see also Para. [0066] and [0108]), the method comprising steps of: advancing a catheter (central shaft 88 and balloon 64, together making up a “catheter” as shown in Fig. 14) to the treatment site (see Fig. 14), the catheter including an elongate shaft (central shaft 88, see Fig. 14) and a balloon coupled to the elongate shaft (balloon 64, see Fig. 14), the balloon having a balloon wall (see Fig. 14), the balloon being configured to be filled with a balloon fluid (see Para. [0023], [0110] and [0154]-[0155]); disposing a first light guide (optical fiber 92, see Figs. 14 and 19; see also Para. [0023]) along the elongate shaft (see Fig. 14) so that a distal portion of the first light guide is positioned within the balloon fluid (see Para. [0023], [0110] and [0154]-[0155]), the first light guide being in optical communication with a light source and the balloon fluid (see Para. [0012] and [0022]); positioning a first focusing element (collimating lens 102, see Fig. 19) at the distal portion of the first light guide (see Fig. 19 and Para. [0171]), the first focusing element being in optical communication with the light source (see Para. [0012] and [0022]); activating the light source to provide light (see Para. [0012], [0022], [0151] and [0154]-[0155]); directing the light from the light source through the first light guide (see Para. [0012], [0022], [0151], [0154]-[0155] and [0170]-[0171]); and further directing the light from the light source with the first focusing element to be focused at a first location at a first distance away from the distal portion of the first light guide (see Figs. 14 and 19; see also Para. [0019]-[0023], [0151], [0154]-[0155], [0170]-[0171] and [0211]-[0212]) so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site (see Para. [0023]). However, while Hastings discloses wherein a laser light beam is directed to a target site to break up an occlusion via bursting cavitation bubbles (see Para. [0023]), Hastings does not expressly disclose wherein plasma formation occurs in the balloon fluid and is initiated away from the distal portion of the first light guide and so that rapid bubble formation occurs, thereby imparting pressure waves upon the treatment site. A secondary reference, namely Dodick (WO 9524867 A1) (previously of record as the closest prior art of record for U.S. Patent 12, 280, 223) teaches wherein pulsing a laser at 20 ns width and 15mJ of energy with 10 pulses per second through a saline solution causes plasma bubble formation which causes shockwave to travel through said saline to strike and fracture a lesion in contact with a balloon (see Dodick Abstract). However, it would not have been obvious to one of ordinary skill in the art to have modified the laser of Hastings to be pulsed in this manner as Hastings is directed towards directing energy directly into tissue to cause plasma formation to occur in said tissue in order to generate shockwaves and rupture a lesion (see Para. [0066] in addition to Para. [0020], [0023], [0065]-[0067] and [0212]-[0215]). To have modified the laser energy and frequency to generate plasma bubbles in balloon fluid, as opposed to the tissue directly, would have both yielded unpredictable results to one of ordinary skill in the art in addition to potentially taking away the primary way in which the device of Hastings functions as detailed in Para. [0189]. Such a modification would have required excessive experimentation to ensure that the substitution of focus from the tissue to balloon fluid would not result in loss-of-function in generating plasma formation within tissue as the primary function of the device of Hastings. 12-151-08 AIA 07-43 12-51-08 Claim s 3-5, 10, 14 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 07-43-03 AIA As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Conclusion 07-96 The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2021/0108303 A1 to Schultheis, US 12274485 B2 to Schultheis, US 2003/0136756 A1 to LeClair, US 2024/0108404 A1 to Weiss, US 2012/0221013 A1 to Hawkins, US 2023/0405268 A1 to Beach and US 2025/0275782 A1 to Hasenberg all disclose balloon catheters comprising an electrical element configured to generate shockwave to break up a target occlusion with a target vessel. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F. 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, Darwin Erezo can be reached at 5712724695. 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. /M.B.H./Examiner, Art Unit 3771 /DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771 Application/Control Number: 19/172,151 Page 2 Art Unit: 3771 Application/Control Number: 19/172,151 Page 3 Art Unit: 3771 Application/Control Number: 19/172,151 Page 4 Art Unit: 3771 Application/Control Number: 19/172,151 Page 5 Art Unit: 3771 Application/Control Number: 19/172,151 Page 6 Art Unit: 3771 Application/Control Number: 19/172,151 Page 7 Art Unit: 3771 Application/Control Number: 19/172,151 Page 8 Art Unit: 3771 Application/Control Number: 19/172,151 Page 9 Art Unit: 3771 Application/Control Number: 19/172,151 Page 10 Art Unit: 3771 Application/Control Number: 19/172,151 Page 11 Art Unit: 3771
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