CTNF 18/028,050 CTNF 80605 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 08-25-01 AIA Applicant’s election without traverse of Group I, claims 1, 2, 5-7, 9-14 and 17 in the reply filed on 2/23/2026 is acknowledged. 08-06 AIA Claim s 22-24, 27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 2/23/2026 . Claim Rejections - 35 USC § 112 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites that the donor of the hematopoietic stem cell product is deceased. However, the status of the donor being alive or deceased does not limit the infused donor cells and merely states the status of the donor . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102/103 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. 07-07-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. 07-20-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. 07-27-aia AIA Claim(s) 1, 2, 5 and 9-11 is/are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Spinner et al. (2019, Blood Advances, Vol. 3(16), pgs. 2454-2464) . Regarding claims 1 and 10, Spinner et al. teach a method of achieving immune tolerance (total lymphoid irradiation and antithymocyte globulin (TLI-ATG) in a recipient comprising: conditioning the subject with a plurality of total lymphoid irradiation doses, Infusing the recipient with donor, in vitro engineered, hematopoietic stem cell product to achieve high level mixed-chimerism with the donor hematopoietic cells (see Abstract and pg. 2455 col. 1 last parag. bridge col. 2 parag. 3). Regarding svldTBI in claims 1 and 11, while Spinner does not explicitly teach performing this step, Spinner teaches that there several efforts are underway to improve upon their TLI-ATG conditioning by augmenting donor chimerism to reduce relapse rates via a single very low dose of TBI at 80 cGy as the final dose (pg. 2462 col. 1 last parag.). Thus it would have been obvious to include a step of svldTBI as Spinner teaches that this may improve TLI-ATG conditioning. Regarding claim 2, Spinner teaches that donor comprises 1 or more MHC-mismatches (15%) relative to the recipient (see Abstract). Regarding claim 5, Spinner does not teach if the donors are alive or deceased, however the limitation that the donor is dead is given no patentable weight since the donated cells would have no structural or functional changes that would distinguish them (based upon the status of the donor) from the cells donated in Spinner. Regarding claim 9, Spinner teaches that the plurality of TLI doses was a total of 8 Gy and delivered in fractionated doses of 0.8 Gy (pg. 2455 col. 2 parag. 2). Thus the teachings of Spinner anticipate or render claims 1, 2, 5 and 9-11 obvious . 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. 07-21-aia AIA Claim (s) 1, 6, 7, 12-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spinner et al. (2019, Blood Advances, Vol. 3(16), pgs. 2454-2464) in view of Strober et al. (US 2020/0254015 A1, published 8/13/2020) . Regarding claim 1, Spinner et al. teach a method of achieving immune tolerance (total lymphoid irradiation and antithymocyte globulin (TLI-ATG) in a recipient comprising: conditioning the subject with a plurality of total lymphoid irradiation doses, Infusing the recipient with donor, in vitro engineered, hematopoietic stem cell product to achieve high level mixed-chimerism with the donor hematopoietic cells (see Abstract and pg. 2455 col. 1 last parag. bridge col. 2 parag. 3). Regarding svldTBI in claims 1 and 11, while Spinner does not explicitly teach performing this step, Spinner teaches that there several efforts are underway to improve upon their TLI-ATG conditioning by augmenting donor chimerism to reduce relapse rates via a single very low dose of TBI at 80 cGy as the final dose (pg. 2462 col. 1 last parag.). Regarding claim 14, Spinner teaches that CD8+ T cells can be administered to convert patients with mixed chimerism to full donor chimerism (pg. 2462 col. 1 last parag. bridge col. 2 parag. 1). Regarding claim 17, while Spinner does not teach administered T reg cells, it would have been obvious to do so since Spinner teaches that T reg cells protect against graft versus host disease (pg. 2455 col. 1 parag. 2). Spinner does not teach: Transplanting a solid organ, That the patient has an autoimmune disease, Administering CD34+ and CD3+ cells. Regarding claim 6, Strober et al. teach for a method for the combined transplantation of a solid organ and hematopoietic cells to an HLA mismatched recipient, where tolerance to the graft is established through development of a stable mixed chimera (parag. 8). Regarding claim 7, Strober teaches that the recipient can have an autoimmune disease (parag. 3). Regarding claims 12 and 13, Strober teaches that ≥ 10 x 10 6 /Kg CD34+ and CD3+ cells are administered to the subject (parag. 75). Thus, at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Spinner regarding a method of achieving immune tolerance in a subject with the teachings of Strober regarding administering hematopoietic cells and a solid organ in a subject to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make such a combination since Strober teaches that solid organs can be transplanted along with hematopoietic cells such as CD34 and CD3. There would have been a reasonable expectation of success that CD34 and CD3 cells along with a solid organ could be transplanted into the subjects of Spinner since Strober teaches demonstrates as such. Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6. 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, Peter Paras can be reached at 571-272-4517. 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. /DAVID A MONTANARI/Examiner, Art Unit 1632 Application/Control Number: 18/028,050 Page 2 Art Unit: 1632 Application/Control Number: 18/028,050 Page 3 Art Unit: 1632 Application/Control Number: 18/028,050 Page 4 Art Unit: 1632 Application/Control Number: 18/028,050 Page 5 Art Unit: 1632 Application/Control Number: 18/028,050 Page 6 Art Unit: 1632 Application/Control Number: 18/028,050 Page 7 Art Unit: 1632 Application/Control Number: 18/028,050 Page 8 Art Unit: 1632
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