Prosecution Insights
Last updated: April 19, 2026
Application No. 18/357,976

METHODS OF CELL THERAPIES

Non-Final OA §101§102§103§112§DP
Filed
Jul 24, 2023
Examiner
SMITH, ADAM MICHAEL
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Trustees of Columbia University in the City of New York
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds
3y 2m
To Grant

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
15 currently pending
Career history
15
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
37.5%
-2.5% vs TC avg
§102
25.0%
-15.0% vs TC avg
§112
21.4%
-18.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 0 resolved cases

Office Action

§101 §102 §103 §112 §DP
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claim Rejections - 35 USC § 112 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 69-71, 75-78, 80, 83 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 69-71, 75-78, 80, 83, the phrase "about" renders the claims indefinite because it refers to an undefined range that is not known/used in the art, and it not objectively defined in the specification. This renders the metes and bounds of the claims unclear. (MPEP 2173.02. See Packard, 751 F.3d at 1311, 110 USPQ2d at 1787). 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. Claim 72 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 72 depends from claim 66. Claim 66 claims a method comprising administering to a subject a population of hematopoietic cells, wherein the subject has undergone a heart transplant. Claim 72 clams the method of claim 66, wherein administering said population of hematopoietic cells does not result in a Grade II graft-versus-host disease within a month, within a year, or within three years after said organ transplant. This limitation does not provide patentable weight. The intended result of performing a method does not impose any structural or operational requirements on the steps. (see MPEP 2111.04). 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 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. 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 – (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. Claims 66, 68-74, 76-82, 84-85 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2021236711A1, effective filing date 05/21/2020. WO2021236711A1 discloses, “To avoid graft rejection, transplantation of organs may be accompanied by transfer of donor derived CD3+ cells and CD34+ cells.” (paragraph 0027). They disclose, “administering cellular compositions including CD3+ and CD34+ cells and a calcineurin inhibitor to a recipient of an organ transplant.” (paragraph 0057) and “Methods of the present invention may be used in conjunction with transplantation of any solid or non-solid organ. For example…heart…” (paragraph 0058). Thus, they have detailed a method of administrating hematopoietic cells to a heart transplant recipient (claim 66), and specifically CD34+/CD3+ cells (claim 76). This anticipates claim 66 and claim 76. The disclosure also includes, “ the organ may be bone marrow, peripheral blood, and lymphoid tissue.” (paragraph 0058). This anticipates claim 79 which claims an organ that comprises a population of hematopoietic stem cells or hematopoietic progenitor stem cells. They go on to disclose, “The CD3+ and CD34+ cells may be obtained from one or more apheresis products, which may be from a donor before or after they have already donated an organ.” (paragraph 0018). This anticipates claim 68 and claim 81 because the hematopoietic cells would by definition be HLA matched to the organ donor in this situation. Furthermore, “the cellular product may contain at least 1 x 10^4 CD34+ cells per kg of recipient weight” (paragraph 0036) and, “the cellular product may contain at least 1 x 10^4 CD3+ cells per kg of recipient weight” (paragraph 0036). These disclosures anticipate claim 69 (at least about 1 x 10^4 CD34+ cells), claim 77 (at least about 1 x 106 CD34+ cells), as well as claim 70 and 80 (comprises no more than about 1 x 104/kg CD3+ cells) because the amount of CD3+ cells can be 1 x 10^4 according to the disclosure. The disclosure further outlines, “…the cellular product may be provided…one…week after the organ transplant.” (paragraph 0058). This anticipates claim 71 and 78 because it means that the hematopoietic cells will be administered at least about a day after the organ transplant (claim 71) and prior to 30 days after organ transplant (claim 78). Furthermore, they disclose, “…the effective amount of the calcineurin inhibitor {an immunosuppressant} is administered about 1 month…prior to administration of the CD3+ and CD34+ cells.” (paragraph 0015). This anticipates claim 73 which says the immunosuppression regime be administered to the subject prior to the receipt of hematopoietic cells. They also disclose, “…the recipient is exposed to drugs, antibodies, irradiation, or some combination thereof at a dose that is too low to eradicate all the bone marrow cells. Typically, the conditioning regimen includes treatment with anti-thymocyte globulin (ATG), total lymphoid irradiation, and corticosteroids…” (paragraph 0059). This anticipates claim 74 and claim 82 which both say the immune suppression regime comprises administering anti-thymocyte globulin (ATG). They also disclose, “Any known calcineurin inhibitors may be used in the present invention. For example, cyclosporine A, tacrolimus or sirolimus can be administered to improve survival, tolerance, and/or function of the CD3+ cells.” (paragraph 0011). This anticipates claim 84 and 85 which outline administering tacrolimus to the subject (claim 84) and administering one or more mTOR inhibitors (sirolimus) to the subject (claim 85). Claim Rejections - 35 USC § 103 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. 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. 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. 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. Claim 75 and claim 83 are rejected under 35 U.S.C. 103 as being unpatentable over PG PUB WO2021236711A1, effective filing date 05/21/2020. PG PUB WO2021236711A1 discloses, “To avoid graft rejection, transplantation of organs may be accompanied by transfer of donor derived CD3+ cells and CD34+ cells.” (paragraph 0027). They disclose, “administering cellular compositions including CD3+ and CD34+ cells and a calcineurin inhibitor to a recipient of an organ transplant.” (paragraph 0057), and “Methods of the present invention may be used in conjunction with transplantation of any solid or non-solid organ. For example…heart…” (paragraph 0058). Thus, they have detailed a method of administrating hematopoietic cells, specifically CD34+/CD3+ cells, to a heart transplant recipient. However, they do not provide definitive guidance on when to provide the immunosuppressive regime or for how long. They also do not detail the use of corticosteroids in their primary method. However, PG PUB WO2021236711A1 does disclose additional guidance including, “…the cellular product may be provided…one…weeks after the organ transplant.” (paragraph 0058). Furthermore, they disclose, “The effective amount of the calcineurin inhibitor may also be administered about 1 month…after administration of the CD3+ and CD34+ cells.” (paragraph 0015). They also disclose that “…in addition to the administration of calcineurin inhibitors, the recipient's immune system may be conditioned in conjunction with providing the cellular product. For example…the conditioning regimen includes treatment with anti-thymocyte globulin (ATG), total lymphoid irradiation, and corticosteroids …” (paragraph 0059). Finally, they disclose, “…the regimen comprising as effective amount of the calcineurin inhibitor (an immunosuppressant) may be administered for about 3 days…” (paragraph 0015). These disclosures, when taken together, provide an explicit teaching/suggestion to provide CD3+/CD34+ cells one week after transplant, and then administer corticosteroids 1 month after the administration of the cellular transplant. Therefore, corticosteroids are administered to the subject one or more days after the organ transplant, which renders claim 83 obvious. It also provides an explicit teaching/motivation to only continue the immunosuppressive regime for 3 days. Thus claim 75 is rendered obvious because the aforementioned scenario results in the discontinuation of the immunosuppression regime 33 days after the administration of hematopoietic cells. Claim 75 says that the immunosuppression regime is ceased about 1 to 100 days after administering the hematopoietic cells. Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim 76 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 46 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 77 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 47 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 78 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 48 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 79 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 51 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 80 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 52 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 81 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 53 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 82 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 54 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 83 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 55 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 84 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 56 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 85 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 58 of copending Application No. 18456422 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. 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. Claim 66 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 46 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are claims to a method of establishing a mixed chimerism and administering hematopoietic cells to a subject to prevent rejection of an organ transplant. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 68 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 53 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of administering a mixed chimerism of hematopoietic cells to a subject to prevent rejection of an organ transplant wherein the hematopoietic cells are HLA matched to the organ transplant. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 69 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of administering a mixed chimerism of hematopoietic cells to a subject to prevent rejection of an organ transplant wherein the amount of CD34+ cells administered is/can be 1*10^6 cells per kilogram of said subject. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 70 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of administering a mixed chimerism of hematopoietic cells to a subject to prevent rejection of an organ transplant wherein the population of CD34+ cells contain no more than about 1*10^4 CD3+ cells per kilogram of said subject. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 71 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of administering a mixed chimerism of hematopoietic cells to a subject to prevent rejection of an organ transplant wherein the population of hematopoietic cells are administered at least 1 day after the organ transplant. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 72 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 57 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of establishing a mixed chimerism of T-cells and administering them to a patient who has undergone an organ transplant so as to prevent grade II graft vs host disease. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 73 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 55 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of administering an immunosuppressant regime (corticosteroids are an immunosuppressant) and both claims include the possibility of administering the regime on the day of the organ transplant. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 74 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 54 of copending Application No. 18456422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of establishing a mixed chimerism of T-cells and administering them to a patient who has undergone an organ transplant and further administering anti-thymocyte globulin to them. Both claims include the possibility that ATG can be administered prior to hematopoietic cell transplant. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim 71 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject that has undergone an organ transplant. Both claims include the possibility that cells can be administered 10 days after transplant. Claim 76 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant. Claim 77 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering at least 1*10^6 CD34+ cells per kilogram to a subject who has undergone an organ transplant. Claim 79 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant wherein the organ comprises a population of hematopoietic stem cells or hematopoietic progenitor stem cells. Claim 81 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant wherein the CD34+ cells are HLA matched to said organ transplant. Claim 82 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant and further administering rabbit anti-thymocyte globulin (ATG) to the subject. Both claims include the possibility that the ATG treatment could be administered at least 1 day after organ transplant. Claim 83 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant and further administering corticosteroids to the subject on the day of the transplant. Both claims include the possibility that the corticosteroid treatment could be administered at least 1 day after organ transplant. Claim 84 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant and furthermore administering tacrolimus to the subject. Both claims include the possibility that the tacrolimus treatment could be administered at least 1 day after organ transplant. Claim 85 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of US Patent No. US11786558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are a method of establishing a mixed chimerism and administering CD34+ cells to a subject who has undergone an organ transplant and furthermore administering one or more mTOR inhibitors to the subject. Allowable Subject Matter Claim 67 is 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. The closest prior found was WO2021236711A1, effective filing date 05/21/2020. WO2021236711A discloses the combination of solid organ transplant (specifically heart transplant) with hematopoietic cell transplant to help prevent rejection of the transplanted organ. “To avoid graft rejection, transplantation of organs may be accompanied by transfer of donor derived CD3+ cells and CD34+ cells.” (paragraph 0027). They disclose, “administering cellular compositions including CD3+ and CD34+ cells and a calcineurin inhibitor to a recipient of an organ transplant.” (paragraph 0057) and “Methods of the present invention may be used in conjunction with transplantation of any solid or non-solid organ. For example…heart…” (paragraph 0058). However, WO2021236711A does suggest or mention the idea of combing two different solid organ transplants with a hematopoietic cell transplant. The examiner was unable to locate any source (patent or non-patent literature) published prior to the effective filing date of the application (1/25/2021) that details a case of two solid organ transplants combined with a hematopoietic cell transplant. The examiner was also unable to locate any source (patent or non-patent literature) published prior to the effective filing date of the application that suggests or mentions the idea of two solid organ transplants combined with a hematopoietic cell transplant. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-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, Tracy Vivlemore can be reached at (571) 272-2914. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-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, Tracy Vivlemore can be reached at (571) 272-2914. 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. /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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Prosecution Timeline

Jul 24, 2023
Application Filed
Dec 08, 2025
Non-Final Rejection — §101, §102, §103 (current)

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1-2
Expected OA Rounds
Grant Probability
3y 2m
Median Time to Grant
Low
PTA Risk
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