Office Action 2: Notice of Allowance (2025-01-15)

CLAIMS:
Amendments to the Claims:

1\. (previously presented) A monoclonal antibody or antigen-binding fragment thereof that specifically binds to the TRBV-9 family beta-chain region of the human T cell receptor, comprising a heavy chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 16 and a light chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 18.

2\. (previously presented) The monoclonal antibody according to Claim 1, which includes a heavy chain having the amino acid sequence of SEQ ID No:
20 and a light chain having the amino acid sequence of SEQ ID No: 22.

3\. (previously presented) The monoclonal antibody according to Claim 2, which is a full-length IgG antibody.

4\. (previously presented) A nucleic acid that encodes a monoclonal antibody or antigen-binding fragment thereof according to Claim 1, wherein the antibody or antigen binding fragment thereof specifically binds to the TRBV9 family beta-chain region of the human T receptor.

5\. (original) An expression vector containing a nucleic acid according to Claim 4.

6\. (previously presented) A method of obtaining a host cell for producing an antibody or antigen-binding fragment thereof that specifically binds to the TRBV-9 family beta-chain region of the human T cell receptor, comprising a heavy chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 16 and a light chain variable domain, the amino acid sequence of

which is shown in SEQ ID No: 18 comprising co-transformation of a cell with a vector according to Claim 5.

7\. (previously presented) A host cell for obtaining an antibody or antigen- binding fragment thereof that specifically binds to the TRBV-9 family beta- chain region of the human T cell receptor, comprising a heavy chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 16 and a light chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 18 comprising a nucleic acid according to Claim 4.

8\. (previously presented) A method of obtaining an antibody or antigen- binding fragment thereof according to Claim 1, comprising culturing a host cell for obtaining a monoclonal antibody or antigen-binding fragment thereof that specifically bind to the TRBV-9 family beta-chain region of the human T cell receptor, comprising a heavy chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 16 and a light chain variable domain, the amino acid sequence of which is shown in SEQ ID No: 18 in a culture medium under conditions ensuring the production of said antibody, followed by isolation and purification of the obtained antibody.

9\. (previously presented) A pharmaceutical composition comprising an antibody or antigen-binding fragment thereof according to Claim 1 in combination with one or more pharmaceutically acceptable excipients.

10\. (currently amended) The pharmaceutical composition of Claim 19, wherein said disease or disorder is ankylosing spondylitis, celiac disease, T cell leukemia, orT cell lymphoma.

11\. (previously presented) A pharmaceutical composition comprising an antibody or antigen-binding fragment thereof according to Claim 1 and at least in a therapeutically effective amount one other therapeutically active compound.

12\. (currently amended) The pharmaceutical composition of Claim 20, wherein said disease or disorder is ankylosing spondylitis, celiac disease, T cell leukemia, orT cell lymphoma.

13\. (previously presented) The pharmaceutical composition according to Claim 12, wherein the other therapeutically active compound is selected from a small molecule, antibody or steroid hormones.

14\. (previously presented) A method for inhibiting the biological activity of the T cell receptor, the beta-chain of which belongs to the TRBV9 family, in a subject in need of such inhibition, comprising administering to the subject an effective amount of an antibody or antigen-binding fragment thereof according to Claim 1.

15\. (previously presented) A method for treating a disease or disorder mediated by the human T cell receptor bearing the TRBV9 family beta-chain, comprising administering to a subject in need of such treatment an antibody or antigen-binding fragment thereof according to Claim 1 in a therapeutically effective amount.

16\. (previously presented) The method for treating a disease or disorder according to Claim 15, wherein the disease or disorder is selected from the

group: ankylosing spondylitis, celiac disease, T cell leukemia, T cell lymphoma.

17- 18. (cancelled)

19\. (currently amended) The pharmaceutical composition according to Claim 9, wherein the composition is for treating a disease or disorder mediated by the TRBV9 family beta-chain region of the human T receptor.

20\. (currently amended) The pharmaceutical composition according to Claim 11, wherein the composition is for treating a disease or disorder mediated by the human T cell receptor bearing the TRBV9 family beta-chain.

21\. (previously presented) A method for treating a disease or disorder mediated by the human T cell receptor bearing the TRBV9 family beta-chain, comprising administering to a subject in need of such treatment a pharmaceutical composition according to Claim 9 in a therapeutically effective amount.

22\. (currently amended) The method for treating a disease or disorder according to Claim 21, wherein the disease or disorder is ankylosing spondylitis, celiac disease, T cell leukemia,or T cell lymphoma.

23\. (previously presented) A method for treating a disease or disorder mediated by the human T cell receptor bearing the TRBV9 family beta-chain, comprising administering to a subject in need of such treatment a

Amdt. dated November 26, 2024 Reply to Office Action of August 27, 2024 pharmaceutical composition according to Claim 12 in a therapeutically effective amount.

24\. (currently amended) The method for treating a disease or disorder according to Claim 23, wherein the disease or disorder is ankylosing spondylitis, celiac disease, T cell leukemia, or T cell lymphoma.

OFFICE ACTION:
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 .
Claim Status
Applicant’s 26 November 2024 amendment is acknowledged. Claims 17 and 18 have been cancelled without prejudice or disclaimer. Claims 10, 12, 19, 20, 22, and 24 have been amended. Claims 1-16 and 19-24 are pending and under examination on the merit.
Rejections and Objections Withdrawn
Objections to the abstract and drawings are withdrawn with amendment to the specification by applicant.
Objections to claims 10, 12, 22, and 24 are withdrawn with amendment to the specification by applicant.
Rejection of claims 10, 12, 19 and 20 under 35 U.S.C. 112(a) for scope of enablement is withdrawn with amendment to claims by applicant. The claims now only discuss the treatment, not prevention, of a disease or disorder mediate by TRBV9-bearing T lymphocytes. As such, the enablement rejection is withdrawn.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claims 1-16 and 19-24 are allowed. Toyabe and colleagues (Clin Exp Immunol, 2003, 135(1):92-97), closest prior art, disclose a TRBV9-binding antibody/antigen-binding fragment (Fab) as well as a nucleic acid encoding the aforementioned protein. Furthermore, this group describes an expression vector, a host cell for producing the Ab/Fab after incorporation of the nucleic acid-containing vector, a method for obtaining said host cell and finally, a method for producing an antibody or an antigen-binding fragment thereof. The authors report that the disclosed antibody/antigen-binding fragment is able to bind to TRBV9 expressed on PBMCs of EBV-infected individuals.
However, the heavy chain variable and light chain variable sequences of the TRBV9-binding antibody of Toyabe is distinct from the instant claimed TRBV-9 antibody comprising a heavy chain variable and light chain variable sequences of SEQ ID NOs:16 and 18, respectively.  Further, it is not obvious to modify the antibody of Toyabe to arrive at the instant claimed antibody.  As such the aforementioned claims and their dependent claims that require the instant claimed TRBV-9 antibody comprising the amino acid sequences of SEQ ID NOs:16 and 18 are also free of prior art.
For these reasons, claims 1-16 and 19-24 are allowed.
CONCLUSION
Any comments considered necessary by applicant must be submitted no later than the
payment of the issue fee and, to avoid processing delays, should preferably accompany the issue
fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for
Allowance”.

APPLICANT REBUTTAL: REMARKS
Status of the Claims:
The present application contains twenty-two pending claims. Claims 1- 4, 6-9, 11, 13-16, 21 and 23 are as previously presented. Claims 10, 12, 19, 20, 22 and 24 have been amended strictly to advance prosecution. Claims 17 and 18 are cancelled without prejudice or disclaimer. Claim 5 remains as originally filed. The Applicant respectfully submits that no new matter has been added to the application by the present amendment and that full support for the claim amendments exists in the application as originally filed. No new matter has been added.
Abstract:
The Abstract has been amended to remove implied phrases and legal phraseology.
Drawings:
The description relating to Figure 3 has been amended to clarify that the measurement is of a percentage of dead cells. With respect to Figure 2, the two panels have been labelled Figure 2A and Figure 2B, as suggested by the Office. The attached replacement sheet of drawings includes these changes to Fig. 2, where the two panels are now labelled Figure 2A and Figure 2B respectfully. This sheet, which includes Figs. 2A and 2B, replaces the original sheet including Fig. 2. An annotated sheet showing the changes is also provided. The changes to the drawings are supported by the originally filed application. No new matter has been added.
Claim Objections:
Claims 10, 12, 22 and 24 have been amended to include the conjunction "or" at the end of the list. Removal of the objection is respectfully requested.
35 U.S.C. 112
The Office has rejected claims 10, 12, 19 and 20 under 35 U.S.C. 112, due to the term- "prevention of a condition." Strictly to advance prosecution, claims 22 and 24 have been amended to remove the word "prevention". Withdrawal of the rejection under 35 U.S.C. 112 is respectfully requested.
CONCLUSION