DETAILED 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 .
The amendments and remarks filed 5/5/26 is acknowledged. Claims 53, 54, 56, 58, 62, 63, 67, 68 have been amended. Claims 1-52 and 57 have been canceled. Claims 53-56 and 58-72 are pending.
Claims 60-61, 66, and 71-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/30/25. 4. Claims 53-59, 62-65, and 67-70 are under examination as they read on the elected species.
Claims 53-56, 59, 62-65, and 67-70 are under examination as they read on the elected species.
Withdrawn Objections/Rejections
The objection to the specification for informalities is withdrawn in light of Applicant’s amendment thereto. See paragraph 5, page 2 of the previous Office action.
The rejection of claims 53-59, 62-65, and 67-70 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto. See paragraph 7, page 3 of the previous Office action.
The rejection of claims 53-59, 62-65, and 67-70 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or a joint inventor (or for applications subject to pre- AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s amendment thereto. See paragraph 9, page 12 of the previous Office action.
The rejection of claims 53-55 and 59 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bernett et al. (WO 2018071919A1, published April 19, 2018), is withdrawn in light of Applicant’ amendment thereto. See paragraph 12, page 13 of the previous Office action.
The rejection of claims 53-57 and 59 under 35 U.S.C. 102(a)(2) as being anticipated by Bernett et al. (US Patent Application Publication 2020/0140512 A1, published May 7, 2020), is withdrawn in light of Applicant’s amendment thereto. See paragraph 13, page 14 of the previous Office action.
New Rejections Necessitated by Applicant’s Amendment
Claim Rejections - 35 USC § 112
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.
Claims 53-56, 59, 62-65, and 67-70 are 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.
Amended claims 53, 62, and 67 recite wherein the IL-15 variant polypeptide consists of the amino acid sequence of SEQ ID NO: 2 comprising amino acid residues position V63 and I68 substituted with another amino acid, and wherein the IL-15 variant polypeptide is selected from the group of polypeptides having the amino acid sequence set forth in SEQ ID NOS: 79-81.
This limitation is indefinite because the claim recites two sequence options for the IL-15 variant polypeptide. The first wherein clause states that the variant IL-15 polypeptide consist of the sequence of SEQ ID NO: 2 comprising substitutions at residues V63 and I68 substituted with another amino acid, but the second wherein clause recites another set of sequence options for the variant IL-15 polypeptide. It is unclear which sequence is required for the variant IL-15 polypeptide. Thus, the claim scope is ambiguous and one of skill in the art would not be apprised of the metes and bounds of the claim. It is suggested that Applicant amend the claim to recite “wherein the IL-15 variant polypeptide is selected from the group of polypeptides having the amino acid sequence set forth in SEQ ID NOS: 79-81” to overcome the rejection. The dependent claims do not cure the deficiencies of the claims and thus, are included in the rejection.
Claims 54, 63, and 68 recite “a IL-15Rα domain that is an IL-15RαSushi domain which comprises an amino acid sequence set forth in SEQ ID NO: 5”. This limitation is indefinite because it is unclear if Applicant intends for the claim to encompass the full-length polypeptide sequence set forth in SEQ ID NO: 5, of if Applicant intends for the claims to encompass fragments of SEQ ID NO: 5. The use of the terms “a” and “the” to refer to sequences identified by SEQ ID NOs result in claims having different scopes. The use of the term “a” encompasses amino acid sequences that comprise the full-length sequence or any portion of the sequence. Thus, a claim reciting “a peptide of SEQ ID NO:X” is anticipated by any peptide or larger polypeptide sequence. The use of the term “the” encompasses only amino acid sequences that comprise the full-length of SEQ ID NO:X, with or without additional amino acids at either or both ends. Thus, a claim reciting “the peptide of SEQ ID NO:X” is anticipated by the sequence of amino acids as specified by SEQ ID NO:X, with or without additional amino acids at either or both ends. Because of the indefinite claim language, the scope of the claim is ambiguous, and one of skill in the art would not be apprised of the metes and bounds of the claims. Clarification and/or correction is required.
Claim Status
No claims are allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa L. Ford can be reached at (571)272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervi.sory Patent Examiner, Art Unit 1674
