CTNF 19/202,992 CTNF 82797 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. Drawings 06-37 AIA The drawings were received on 5/8/2025 . These drawings are accepted for examination . 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 22-44 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. Regarding claims 22, 31, and 37, each claim is recited as depending from canceled claim 1. Applicant indicated in the interview of 6/2/2026, that the claims were all meant to depend from instant claim 18, and indication as to that will be provided via formal amendment to the instant action. Regarding claims 28, the claim is currently recited as depending from claim 5, which is currently canceled. Claims 29-30 depend from claim 28, and all 3 claims are unclear as to which claim they depend from. The limitations have been considered on their own with respect to the double patenting rejection, below, but have not been considered with respect to prior art, as it is unclear exactly which claim they are intended to depend from. Applicant is required to provide an updated claim set which properly addresses the dependency of these claims. Regarding claim 22 specifically, it is unclear what about the base (aside from threading) allows for unform compression of the rounded of a turret. It is believed any threading at the base which can receive the rounded end of a turret will allow for this configuration, though it is believed that the locking collar with threading of claim 23 allows for the uniform compression in conjunction with the socket, not the socket alone (see claim 24). If this is not the case, Applicant should address why this assertion is incorrect in their remarks, otherwise it is believed this recitation will require further 112(b) rejections. 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 AIA Claim(s) 18-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Karmarkar et al (US 2009/0118610) . Regarding claims 18-20, Karamarkar et al discloses and teaches a guide for an MR targeting of an are with a trajectory guide capable of ‘use for targeting’ of an area of a subject that includes a contrast agent (0072, 0086, 0092-0093) and is capable of being inserted into an adjustable support (Fig 10-14, 0175-0177, and 0164-0177 for locking/adjustment). Karamarkar et al discloses multiple instances of the guides which include contrast on a guide which is insertable into a turret (Abs, Fig 10-14, 0147-0151) . 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. 07-20-02-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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karmarkar et al (US 2009/0118610) in view of Solar (US 2004/0167391). Regarding claim 21, Karmarkar et la disclose and teach the use of MR contrast agents, but fail to specify Gadolinium as the contrast agent (0072, 0093). Attention is briefly directed to the teachings of Solar et al which expressly teach the use of MR imaging with contrast agents in a lumen/tool portion with Gadolinium as such a contrast fluid (0102). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized a Gadolinium-based contrast such as taught by Solar et al with the system and methods of Karmarkar et al to provide enhancement during MR imaging (0102, Solar) . 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 18-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-25 of U.S. Patent No. 10,426,374, claims 1-16 of U.S. Patent No. 10,426,375, claims 1-25 of U.S. Patent No. 11,298,043, or claims 1-13 of U.S. Patent No. 12,318,183 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed elements are disclosed in the ‘374, ‘375, ‘043, and ‘183 patents as follows: *Examiner note: Dependencies from canceled claim 1, are considered to be from independent claim 18 for the purpose of analysis. 19/202992 Prior patents: ‘374, ‘375, ‘043, ‘183 18 . A device comprising: a solid support containing a plurality of magnetic resonance imaging (MRI) visible trajectory guides capable of use for targeting of a desired area of a subject, wherein the guides contain a contrast agent, and wherein the solid support is dimensioned for insertion into an adjustable support. Claims 1, 19: ‘374 Claim 10: ‘183 19 . The device of claim 18, wherein the adjustable support is an adjustable turret, the adjustable turret being affixable to the desired area of the subject thereby allowing visualization of each MRI-visible trajectory guide using an MRI imager. Claims 1, 10-14, 19-21, 23: ‘374 Claims 1-2, 5-11, 16: ‘375 Claims 1, 10-16, 21-22: ‘043 Claims 1-5: ‘183 20 . The device of claim 18, wherein each of the plurality of MRI-visible trajectory guides is inseparable from one end of a flat surface of the solid support. Claims 1-6, 10, 15-16, 19: ‘374 Claims 1, 6-10: ‘183 21 . The device of claim 18, wherein the contrast agent comprises gadolinium. Claim 9: ‘374 22 . An adjustable targeting system, the system comprising: an adjustable turret comprising a distal end, a rounded end and at least one channel running from the distal end to the rounded end, the device of claim 1 inserted in the adjustable turret; and a base comprising a surface having exterior threading and defining a socket, the socket being configured to receive the rounded end of the adjustable turret, wherein the base allows for essentially uniform compression on the rounded end of the adjustable turret. Claims 1, 10, 15, 19-25: ‘374 Claims 1, 8, 11-16: ‘375 Claims 1, 2,5-8, 13-25: ‘043 Claims 1, 6, 10-13: ‘183 23 . The adjustable targeting system of claim 22, further comprising a locking collar comprising threading on an internal surface compatible with the external threading of the base. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 24 . The adjustable targeting system of claim 23, wherein turning the locking collar a first direction compresses the rounded end to lock the adjustable turret in a desired trajectory and turning the locking collar a second direction decompresses the rounded end to allow for retargeting of a trajectory of the adjustable turret, and wherein turning the locking collar the first direction compresses the rounded end between the base and the locking collar to lock the adjustable turret in a desired trajectory. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 25 . The adjustable targeting system of claim 23, wherein the adjustable targeting system is configured such that when affixed to the desired area of the subject the base and the locking collar are ex vivo. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 26 . The adjustable targeting system of claim 22, wherein the adjustable targeting system is configured such that when affixed to a tissue surface of the subject the adjustable turret is ex vivo. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 27 . The adjustable targeting system of claim 23, wherein the locking collar comprises a knurled external surface to facilitate grip on the locking collar and to facilitate turning the locking collar. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 28 . An adjustable targeted delivery system, the system comprising: the adjustable targeting system according to claim 5 ; and a delivery device or electrode dimensioned for insertion into one of the at least one channel of the adjustable turret. Claims 21-22: ‘374, Claims 6, 7, 25: ‘043, Claims 12-13: ‘183 29 . The adjustable targeted delivery system of claim 28, wherein the delivery device or electrode comprises a depth stop positioned at a point along a length of the delivery device or electrode to prevent inserting the delivery device into one of the at least one channel past said point. Claims 21-22: ‘374, Claims 6, 7, 25: ‘043, Claims 12-13: ‘183 30 . The adjustable targeted delivery system of claim 28, wherein the electrode is dimensioned for insertion into one of the at least one channel of the adjustable turret. Claims 21-22: ‘374, Claims 6, 7, 25: ‘043, Claims 12-13: ‘183 31 . A method of magnetic resonance imaging (MRI)-assisted targeting of a desired area of a subject, the method comprising: affixing a base comprising a surface having exterior threading and defining a socket on the desired area of the subject; inserting an adjustable turret comprising at least one channel and a rounded end into the base, wherein the socket is dimensioned to receive the rounded end and allow the adjustable turret to undergo an adjustment comprising an angle adjustment and a roll adjustment; positioning the device of claim 1 within the adjustable turret; visualizing one of the at least one MRI-visible trajectory guides using an MRI imager; determining the trajectory of one of the at least one MRI-visible trajectory guides based on the visualizing; and adjusting the adjustable turret based on the determined trajectory of one of the at least one MRI-visible trajectory guides to target the desired area of the subject. Claims 10-16: ‘374 Claim 1: ‘375 Claims 1-25: ‘043 Claims 1-7: ‘183 32 . The method according to claim 31, wherein the adjustable turret is positioned ex vivo. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 33 . The method according to claim 31, wherein the base is positioned ex vivo. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 34 . The method according to claim 31, wherein the method further comprises locking the adjustable turret in place following the adjusting. Claims 11-17: ‘374, Claims 5-7: ‘375, Claims 10-12: ‘043, Claims 2-8: ‘183 35 . The method according to claim 34, wherein the locking comprises tightening a locking collar to compress the adjustable turret between the locking collar and the base. Claims 11-17: ‘374, Claims 5-7: ‘375, Claims 10-12: ‘043, Claims 2-8: ‘183 36 . The method according to claim 31, wherein the at least one channel of the adjustable turret is a plurality of channels. Claim 6: ‘183, Claims 1, 10, 15, 19-21: ‘374, Claims 11-16: ‘375, Claims 16-22: ‘043 37 . A method of magnetic resonance imaging (MRI)-assisted delivery of an agent or an electrical current to a desired area of a subject, the method comprising: affixing a base comprising a surface having exterior threading and defining a socket on the desired area of the subject; positioning an adjustable turret comprising a rounded end into the base, wherein the socket is dimensioned to receive the rounded end and allow the adjustable turret to undergo an adjustment comprising an angle adjustment and a roll adjustment; inserting the device of claim 1 into the adjustable turret; visualizing the at least one MRI-visible trajectory guides using an MRI imager; determining the trajectory of one of the at least one MRI-visible trajectory guides based on the visualizing; and adjusting the adjustable turret based on the determined trajectory of one of the at least one MRI-visible trajectory guide to target the desired area of the subject; and delivering the agent or the electrical current to the desired area of the subject using the determined trajectory of one of the at least one MRI-visible trajectory guide. Claim 1, ‘043: ‘375, Claims 10-16: ‘374, Claims 1, 6, 22-25: ‘043 Claims 1, 3-7: ‘183 38 . The method according to claim 37, wherein the method comprises MRI-assisted delivery of the agent and the delivering comprises inserting a delivery device containing an agent into the at least one channel of the adjustable turret. Claims 21-22: ‘374, Claims 6, 7, 25: ‘043, Claims 12-13: ‘183 39 . The method according to claim 38, wherein the delivery device comprises a needle or cannula. Claim 3: ‘043 40 . The method according to claim 38, wherein the agent is a gene therapy vector. Claim 4: ‘043 41 . The method according to claim 37, wherein the method comprises MRI-assisted delivery of the electrical current and the delivering comprises inserting an electrode into the at least one channel of the adjustable channel. Claims 1, 6, 22-25: ‘043 42 . The method according to claim 37, wherein the base comprises a flange and the affixing comprises mounting a fastener through the flange to affix the base to the desired surface of the subject. Claim 9: ‘043, Claims 1, 9: ‘183, Claims 10, 18: ‘374, Claim 4: ‘375 43 . The method according to claim 37, wherein the method further comprises locking the adjustable turret in place following the adjusting. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 44 . The method according to claim 43, wherein the locking comprises tightening a locking collar to compress the adjustable turret between the locking collar and the base. Claims 11-16: ‘374, Claims 6,7: ‘375, Claims 11-12: ‘043, Claims 2-8: ‘183 Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30. 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, Keith Raymond 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. /JOEL LAMPRECHT/Primary Examiner, Art Unit 3798 Application/Control Number: 19/202,992 Page 2 Art Unit: 3798 Application/Control Number: 19/202,992 Page 3 Art Unit: 3798 Application/Control Number: 19/202,992 Page 4 Art Unit: 3798 Application/Control Number: 19/202,992 Page 5 Art Unit: 3798 Application/Control Number: 19/202,992 Page 6 Art Unit: 3798 Application/Control Number: 19/202,992 Page 7 Art Unit: 3798 Application/Control Number: 19/202,992 Page 8 Art Unit: 3798 Application/Control Number: 19/202,992 Page 9 Art Unit: 3798 Application/Control Number: 19/202,992 Page 10 Art Unit: 3798 Application/Control Number: 19/202,992 Page 11 Art Unit: 3798
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