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
Restriction/Election
1. Applicant's election without traverse of Group III (claims 11-13 and 20) in the reply filed on 02/26/2025 is acknowledged. During a telephone conversation with Lauren N. Winkler on April 4, 2025, a provisional election was made without traverse to prosecute the following species: (i). alpha chain comprising the amino acid sequence of SEQ ID NO: 395; and (ii). beta chain comprising the amino acid sequence of SEQ ID NO: 476. Affirmation of this election must be made by applicant in replying to this Office action.
2. Claims 1-4, 6-9, 11-16, and 19-23 are pending. Claims 11-13 and 20 are currently under consideration. Claims 1-4, 6-9, 14-16, 19, and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed 08/31/2022 on has been considered in part by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Drawings
4. The drawings filed on 04/24/2021 are accepted by the Examiner.
Sequence Compliance
5. This application contains sequence disclosures that are encompassed by the definitions for amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 because not all the amino acid sequences present in the specification (See, e.g., Table 2-7) and drawings (See, e.g., Figs. 13-99) have been identified with a SEQ ID NO.
All the amino acid sequences appearing in the specification and drawings must be identified by a sequence identifier in accordance with 37 C.F.R. 1.821(d). Sequence identifiers for sequence appearing in the drawings may appear in the Brief Description of the Drawings. Applicants must provide appropriate amendments to the specification or drawings inserting the required identifiers. If the amendments are extensive then a substitute specification may be required.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
6. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 11-13 and 20 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 11-13 and 20 are drawn to an isolated TCR or TCR fragment for binding an antigen derived from an Epstein Barr Virus (EBV), the TCR comprising an isolated alpha chain or fragment thereof of claim 1 and an isolated beta chain or fragment thereof claim 6. Claim 1 is drawn to an isolated alpha chain of a T-cell receptor (TCR) or a fragment thereof, comprising at least one complementarity determining region (CDR) amino acid sequence according to any one of SEQ ID NOS: 331-411 and/or Tables 2-7 or an amino acid sequence at least 70% identical thereto, whereas an isolated beta chain of a TCR or a fragment thereof, comprising at least one CDR amino acid sequence according to any one of SEQ ID NOS: 412-492 and/or Tables 2-7 or an amino acid sequence at least 70% identical thereto. Claims 11-13 and 20 do not require that the TCR possess three intact CDRs in the αchain and three intact CDRs in the β chain. Thus, the claims encompass a huge genus of TCRs with a partial structure.
The specification discloses various TCRs (Tables 2-7). Each of them comprises a particular set of six CDRs (Tables 2-7) and a pair of α chain and β chain (see Brief description of the sequences starting on page 8). For example, the elected TCR (Table 7, page 70, Donor J9B, Clone 1) comprises an α chain and a β chain (Fig. 77), and CDR1, CDR2, and CDR3 in the α chain and CDR1, CDR2, and CDR3 in the β chain. It is well established in the art that the formation of an intact antigen binding site of a TCR routinely requires the association of the complete α chain and β chain. Thus, the instant disclosure does not adequately support the huge genus of the claimed TCRs..
Vas-Cath Inc. v Mahurkar, 19 USPQ2d 1111 (Fed. Cir.1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purpose of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention are reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir.1991).
An adequate written description of a chemical invention “requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir.2004); Regents of the Univ. of Cal. V. Eli Lilly & Co., Inc., 119 F.3d 1559, 1556 (Fed. Cir.1997); Fiers v. Revel, 984F.2d 1164, 1171 (Fed. Cir.1993). “A description of what a material does, rather than of what it is, usually does not suffice.” Rochester, 358F.3d at 923; Eli Lilly, 119 F.3d at 1568. In addition, possession of a genus “may be achieved by means of a recitation of a representative number of [compounds]…falling within the scope of the genus.” Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 f. 3d at 927.
Due to the breadth of the genus of the TCRs and lack of the definitive structural features of the genus, one skilled in the art would not recognize from the disclosure that Applicant was in possession of the genus of TCRs
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
8. 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.
9. Claim 11 is 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 11 recites “an isolated TCR or TCR fragment for binding an antigen derived from an Epstein Barr Virus (EBV), the TCR comprising: (i) an isolated alpha chain or fragment thereof according to Claim 1; and/or (ii) an isolated beta chain or fragment thereof according to Claim 6.” The use of “and/or” between (i) and (ii) renders the claim ambiguous because, for example, an isolated alpha chain or fragment thereof alone cannot be “an isolated TCR or TCR fragment” that binds an antigen derived from an Epstein Barr Virus (EBV).
It is noted that claim 1, from which claim 11 depends, is indefinite because it refers to table.
Claim Rejections under 35 USC § 112 (d)
10. 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.
11. Claim 12 is 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, claim 12 recites “wherein the antigen is derived from latent membrane protein 1 (LMP-1) and/or latent membrane protein 2 (LMP-2)”. However, the TCR with elected alpha chain and beta chain of claim 11 do not possess such property.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
12. 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.
13. Claims 11, 13, and 20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2018/129270 A1 (12 July 2018).
WO 2018/129270 A1 teaches a T-cell receptor (TCR; Abstract), wherein the TCR comprises a β chain of SEQ ID NO: 35 or SEQ ID NO: 37 (claim 12). The β chain sequence comprises the sequences MNHEY and SVGAGI, which corresponds the CDR1 and CDR2 sequences in Table 7 of the present application. WO 2018/129270A1 teaches the use of a spacer region between the α chain and the β chain (page 21, paragraph [0087]). The TCR binds an antigen derived from an Epstein Barr Virus (EBV) (claims 14-15). WO 2018/129270 A1 teaches a composition comprising a nucleic acid encoding the TCR (claims 5-6). Thus, the teachings of WO 2018/129270 A1 meet the limitations of claims 11, 13, and 20.
14. Claims 11 and 20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2015/160928 A2 (22 October, 2015).
WO2015/160928A2 teaches a T-cell receptor (TCR) that binds to phosphopeptide-HLA-A2 complex and a composition comprising the TCR (Abstract; pages 29-30; claims 19-25). The TCR comprises an amino acid sequence of SEQ ID NO: 36 in the alpha chain, which comprises the CDR2 sequence IRSNERE (page 11, line 17; claim 4 on page 82). The CDR2 sequence IRSNER taught by WO2015/160928A2 corresponds to the CDR2 sequence IRSNER as defined in Table 7 of the present application. Since the TCR taught by WO2015/160928A2 possesses the structural features of claim 11, the binding property recited in the preamble of claim 11 is inherent to the TCR taught by WO2015/160928A2 Thus, the teachings of WO 2015/160928 A2 meets the limitations of claims 11 and 20.
15. Claim 11 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Leb et al. (Journal of Allergy and Clinical Immunology 121:64-71, 2008).
Leb et al. teach a human T-cell receptor (TCR) specific for Art v 1 (Abstract). Leb et al. teach a TCR α-chain sequence comprising the sequences TSINN and IRSNER (page 66, Figure 1). The sequence TSINN corresponds to the CDR1 sequence TSINN as defined in Table 7 of the present application, whereas the sequence IRSNER corresponds to the CDR2 sequence IRSNER as defined in Table 7 of the present application. Leb et al. teach a composition comprising a nucleic acid encoding the TCR (page 65, the 3rd paragraph of left column; the 2nd paragraph of right column). Thus, the teaching of Leb et al. meets the limitations of claim 11.
Claim Objections
16. Claims 11 and 20 are objected to because of the following informalities: (i). Claims 11 and 20 depend from non-elected claim 1; (ii). Claims 11 and 20 recite non-elected subject matter. Appropriate correction is required.
Conclusions
17. 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 1646 April 9, 2025