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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 40, 42-55, 58 and species: isolated IL-2 variant polypeptide, a method of treating cancer, L19Q, R38A, T41G, F44G, E62E, P65R, E68E, Y107G, Q126K, SEQ ID NO: 112, an antibody as the heterologous protein which targets a tumor associated antigen, a PD-1 antagonistic antibody, SEQ ID NOs: 141, 175, and 179 in the reply filed 02/28/2025 is acknowledged.
Claims 47-54, 56-57, and 59 are withdrawn from consideration pursuant to 37 CFR1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 02/28/2025.
Claims 40, 46, 55, 58, and new claims 60-61 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to claim 42 due to minor informalities are hereby withdrawn in view of the cancellation of the claim.
Objections to claim 46 due to minor informalities are hereby withdrawn in view of amendments to the claims to correct their grammar.
Withdrawn Rejections
Rejections of claims 40, 42-46, 55, and 58 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of amendments to the claims.
Rejections of claims 40, 42-46, 55, and 58 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for IL-2 polypeptide variants in SEQ ID NOs: 44-51, 64-66, and 110-120, does not reasonably provide enablement for all IL-2 polypeptide variants with the claimed amino acid substitutions, are hereby withdrawn in view of amendments to the claims.
New Rejections Necessitated by 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 40, 55, and 58 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.
Instant claims 40, 55, and 58 recite a sequence, SEQ ID NO: 3, for the isolated IL-2 variant polypeptide, and also recite amino acid residue substitutions. The instant claims list out two options of potential substitutions: L19H, P65R, S125I or L19Q, P65R, S125I. It is unclear which of these groups of substitutions are represented by SEQ ID NO: 3, or if all possible combinations of substitutions are encompassed by SEQ ID NO: 3.
Conclusion
Claims 46 and 60-61 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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