DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 16, 2026 has been entered.
3. Claims 1-22 are pending.
Claims 1-15 and 19-22, drawn to non-elected inventions are withdrawn from examination.
Claim 16 has been amended.
Claims 16-18 are examined on merits.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 102
4. The rejection of claim(s) 16-18 under 35 U.S.C. 102(a)(2) as being anticipated by Gumrucku et al., WO 2020/252441 A2 (effective filing day 14 June 2019) is withdrawn in light of the amendment to claims 16, see Amendments to the Claims and Remarks, page 8, both submitted September 16, 2026.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 102
5. 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)(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.
6. The rejection of claim(s) 16-18 under 35 U.S.C. 102(a)(1) as being anticipated by Fuchs et al., WO 2013/169386 A1 (published 14 November 2013/ IDS reference 1 submitted December 3, 2024) is maintained.
Applicant initially sets forth the criteria for a proper anticipation rejection, see Remarks submitted September 16, 2026, paragraph (para.) bridging pages 6 and 7.
Applicant argues with the amendment to claim 16 “Fuchs does not disclose the presently claimed method…”, see page 7.
Contrary to Applicant’s assertions, Fuchs discloses “(i) the donor comprises at least one human leukocyte antigen (HLA) Class II allele mismatch relative to the subject in the donor versus the subject direction and the HLA Class II allele mismatch” and “the donor comprises at least one human leukocyte antigen (HLA) Class II allele mismatch relative to the recipient in the donor versus the recipient direction (an HLA Class II allele mismatch in the donor versus recipient direction, i.e., "graft-versus-host direction) and the HLA Class II allele mismatch”, see sections 0009, 0010-0015, 0017, 0018 0024, 0031, 0038, 0039, 0045, 0046, 0050-0052 and 0056. Accordingly, the rejection is maintained.
Fuchs discloses treating cancer with “administration is first the allogenic lymphocyte composition and then administration of a chemotherapeutic agent to the subject. For example, the chemotherapeutic agent is selected from the group consisting of dasatinib,”, as well as “…5 -fluorouracil, taxotere, clodronate, and gemcitabine…, see page 16, section 0044; and sections 0054, 0055 bridging pages 22 and 23. Some of these said agents are able to deplete or inhibit myeloid-derived suppressor cells.
“[V]ariations of the chemotherapy regimen that is given prior to infusion of allogeneic lymphocytes (may include cyclophosphamide, 5-fluorouracil, gemcitabine, dasatinib, combinations thereof; 2) variations in the source of donor lymphocytes (may be from related or unrelated donors, may include defined mismatches at HLA Class I or Class II genetic loci; 3) variations in the types of cells selected for infusion, such as depletion of CD4+CD25+ regulatory T cells, depletion of CD8+ T cells.”,see page 3, section 0008.
“A method of making an allogenic lymphocytic composition comprising: providing a peripheral blood cell composition from a human donor allogenic to the recipient, the peripheral blood cell composition comprising CD4+ T-cells, CD8+ T-cells, and natural killer cells, wherein (i) the donor comprises at least one human leukocyte antigen (HLA) Class II allele mismatch relative to the recipient in the donor versus the recipient direction and the HLA Class II allele mismatch is at a gene selected from the group consisting of HLA-DRB1, HLA-DQB1, and HLA -DPB1, and (ii) the recipient does not have detectable antibodies reactive against human leukocyte antigens of the donor; and making the allogenic lymphocyte composition from the peripheral blood cell composition by reducing the number of CD8+ T-cells in the peripheral blood cell composition by at least one order of magnitude, wherein (a) the number of CD4+ T-cells in the allogenic lymphocyte composition differs from the number of CD4+ T-cells in the peripheral blood cell composition by less than about 50%,”, see page 3 section 0009.
“[T]he method further comprises administering a successive lymphoreductive non-lymphoablative treatment to the subject to induce transient lymphopenia in the subject; and subsequently administering to the subject a successive allogenic lymphocyte composition derived from an additional peripheral blood cell composition of an additional human, allogenic donor, the successive allogenic lymphocyte composition comprising a number of CD4+ T-cells and a number of natural killer cells from the additional peripheral blood cell composition of the additional donor, wherein (i) the additional donor comprises at least one human leukocyte antigen (HLA) Class II allele mismatch relative to the subject in the additional donor versus the subject direction and the HLA Class II allele mismatch is at a gene selected from the group consisting of HLA-DRB1, HLA-DQB1, and HLA-DPB1,”, section 0012 on page 5.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
30 September 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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