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 .
Response to Amendment and Arguments
2. 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Claims 1-15 and 19-22, drawn to non-elected inventions are withdrawn from examination.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.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Objections
Claim Objections
4. Claim 16 is no longer objected to because the pluses should be cited as a superscript, CD8+ and CD4+, see Amendments to the Claims submitted March 31, 2026, page 4.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The rejection of claims 16-18 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment to claim 16, see Amendments to the Claims submitted March 31, 2026, page 4.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 102
6. 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.
(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.
7. 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 March 31, 2026, page 7, 3rd paragraph (para.).
Applicant argues “…claim 16 has been amended to recite that the
donor is vaccinated against a viral antigen and/or a tumor neoantigen present in the subject and that the donor is either partially HLA-mismatched or HLA-haploidentical.
Fuchs does not teach methods of treating cancer using a lymphocyte composition in which lymphocytes are obtained from a donor that is vaccinated against a tumor-specific antigen and is partially HLA-mismatched or HLA-haploidentical to the recipient, the CD8+ T cells are depleted, and that tumor vaccine-primed CD4+ T cells are cultured ex vivo of the vaccinated donor with tumor-specific antigen peptides.”, see Remarks, page 7, last two paragraphs (paras.).
In conclusion, Applicant avers the prior art “…does not disclose or suggest each and every element of the…claimed invention…”, see page 8, 1st para. of the Remarks.
Contrary to Applicant’s assertions, Fuchs discloses “[d]onors may be immunized to defined antigens prior to lymphocyte infusions or may be polarized with cytokines ex vivo to enrich for Type I (IFN-gamma producing) or Type 17 (IL-17-producing) T cells”, wherein the defined antigens may be a viral antigen or an antigen from a range of cancers and tumor types, see page 3, section 0008; page 7, section 0017; page 12, sections 0032 and 0033; page 18, section 0049; and section 0053 spanning pages 20-22. Furthermore, the “ideal donor” is then completely mismatched at HLA Class II alleles (in particular, HLA-DRB1, HLA-DQB1, and HLA-DPB1)”, as well as may be partially HLA-mismatched (haploidentical), see page 13, section 0037; page 18, section 0048; page 33, section 0080; and claim 24 bridging pages 41 and 42. Fuchs also discloses “ex vivo expansion of CD4+ T-cells may be performed, in such embodiments the number of CD4+ T-cells can greatly exceed the original number.”, see page 11, section 0029. 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.
8. 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 maintained.
Applicant initial sets forth the criteria for a proper anticipation rejection, see Remarks submitted March 31, 2026, page 7, 3rd paragraph (para.).
Applicant argues “…claim 16 has been amended to recite that the
donor is vaccinated against a viral antigen and/or a tumor neoantigen present in the subject and that the donor is either partially HLA-mismatched or HLA-haploidentical.
Gumrucku does not teach methods of treating cancer using a lymphocyte composition in which lymphocytes are obtained from a donor that is vaccinated against a tumor-specific antigen and is partially HLA-mismatched or HLA-haploidentical to the recipient, the CD8+ T cells are
depleted, and that tumor vaccine-primed CD4+ T cells are cultured ex vivo of the vaccinated donor with tumor-specific antigen peptides.”, see page 8, 3rd and 4th paragraphs (paras.).
In conclusion, Applicant avers the prior art “…does not disclose or suggest each and every element of the…claimed invention…”, see page 8, last para. of the Remarks.
Contrary to Applicant’s assertions the donor has been immunized with one or more biological modifiers, see page 35, section 0169; and page 36, section 0170. It’s within the Examiner’s purview a biological modifier may be any agent capable of triggering and/or modulating an immune response. Therefore, the antigen disclosed in section 0095, page 17 is regarded as a biological modifier.
“The source of the donor lymphocytic cells, including sources such as peripheral blood mononuclear cells, as used herein are required to be allogeneic to the recipient patient for isolation of the desired lymphocytic cells including: NK cells, gdT cells, iNKT cells, and CD3 T cells for use in the anti-cancer, anti viral, and/or anti-bacterial immunotherapy methods according to the present invention. Thus, the donor inhibitory ligand mismatches with the patient (e.g. host) HLA.”, see page 20, section 0108.
Accordingly, the rejection is maintained.
Gumrucku discloses administering a lympho-suppressive agent or chemotherapeutic agent and a lymphocyte cell composition to treat cancer, see abstract; page 3, sections 0019, 0020 and 0022; section 0169 bridging pages 35 and 36. The lympho-depleting chemotherapy is cyclophosphamide or fludarabine, thereby facilitating all outcomes set forth in claims 16 and 17, see page 15, sections 0085 and 0086; and page 31.
The lymphocyte cell composition contains peripheral blood mononuclear cells lymphodepleted of particular T cells subsets, thereby lymphodepleting the subject’s own immune cells to create room or space for the new immune cells, see section 0155 bridging pages 30 and 31. CD8 T cells can be specifically depleted, see page 49, section 0208.
The wherein clauses do not recite any active method steps, but simply state the intended results after the administration of the lympho-depleting chemotherapy and lymphocyte cell composition.
Conclusion
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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.
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, 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
June 2, 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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