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 .
Election/Restrictions
2. Applicant’s election without traverse of Group II (claims 16-19) in the reply filed on September 3, 2025 is acknowledged. However, claim 19 has been amended to depend from independent claim 1. Hence, it is not examined with the elected Group.
3. Claims 1-22 are pending.
Claims 1-15 and 19-22, drawn to non-elected inventions are withdrawn from examination.
Claims 15 and 19 have been amended.
Claims 16-18 are examined on merits.
Claim Objections
4. Claim 16 is objected to because of the following informality: CD8+ and CD4+ and is cited in step b), lines 6 and 7. The pluses should be cited as a superscript, CD8+ and CD4+.
Correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 16-18 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.
a. Claim 16 reads on treating cancer with the administration of a lympho-depleting chemotherapy and a lymphocyte cell composition wherein, the composition is obtained by several processes including an optional step. The step is “…optionally vaccinated against a viral antigen and/or a tumor neoantigen present in the subject”, see step b), lines 4 and 5. However, this step is not required or mandatory, hence the last wherein clause in claim 16 reading on “…an expanded population of CD4+ T cells specific to the viral and/or tumor neoantigen…” is incongruent. Accordingly, the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 102
7. 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.
8. Claim(s) 16-18 is/are rejected 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). Fuchs discloses treating cancer with “adminstration 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.
9. Claim(s) 16-18 is/are rejected 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). Gumrucko 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
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, Monday through Friday and occasionally Saturday evenings.
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.
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.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
26 September 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643