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 .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
1. Claims 1-7 are pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 02/06/2024 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
3. The drawings filed on 07/29/2024 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
4. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
5. Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 indefinite because it recites “wherein the chimeric peptide comprises an orthopoxvirus major histocompatibility complex class 1-like protein (OMCP) peptide linked to an interleukin-2 (IL-2) mutant peptide comprising the amino acid sequence of SEQ ID NO: 5 wherein the OMCP peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 7, SEQ ID NO: 13, and SEQ ID NO: 14, comprising at least one mutation, wherein the at least one mutation is R38A, F42K, or C125S relative to SEQ ID NO: 5, and wherein the population of lymphocytes comprises cytotoxic lymphocytes”. The examiner suggests that is amended to following:
“wherein the chimeric peptide comprises an orthopoxvirus major histocompatibility complex class 1-like protein (OMCP) peptide linked to an interleukin-2 (IL-2) mutant peptide comprising the amino acid sequence of SEQ ID NO: 5, wherein the OMCP peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 7, SEQ ID NO: 13, and SEQ ID NO: 14, wherein the interleukin-2 (IL-2) mutant peptide comprises at least one mutation, wherein the at least one mutation is R38A, F42K, or C125S relative to SEQ ID NO: 5, and wherein the population of lymphocytes comprises cytotoxic lymphocytes”. Claims 2-7 are rejected as dependent claims.
Claim Rejections [Symbol font/0xBE]35 USC § 112 (d)
6. 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.
7. Claims 6-7 are rejected under 35 U.S.C. 112 (d), 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.
Specifically, claims 6-7 recite intended uses for the composition of claim 1, “wherein the composition is for treating a disease or disorder in which it is desirable to increase the number of lymphocytes”, and “wherein the disease or disorder is cancer or a chronic viral infection”. Such an intended use does not materially limit the composition of claim 1.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
8. 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.
9. Claims 1-7 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Margherita Gigante and Elena Ranieri (In Vitro\Ex Vivo Generation of Cytotoxic T Lymphocytes. Chapter 2 in Elena Ranieri (ed.), Methods in Molecular Biology, vol. 1186, pages 13-20, Springer Science Business Media, New York 2014).
Margherita Gigante and Elena Ranieri teach in vitro\ex vivo generation of cytotoxic T lymphocytes and the cytotoxic T lymphocytes (CD8+ T cells) produced by the method (see Fig. 1). Margherita Gigante and Elena Ranieri do not teach the method comprising culturing a population of lymphocytes in the presence of a chimeric peptide. However, the cytotoxic lymphocytes produced by the method of comprising culturing a population of lymphocytes in the presence of a chimeric peptide do not distinguish the cytotoxic lymphocytes in the prior art. Thus, the teaching of Gigante and Elena Ranieri meets the limitations of claims 1-7.
Conclusion
10. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 June 19, 2026
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