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 7/9/25 are acknowledged. Claims 1, 10, 36, 49, 53, 78 have been amended. Claims 2-9, 11-34, 37-48, 50-52, 54-57, 59-71, 73-77, 79-81, 84-89, 91-98, 100, and 102-110 have been canceled. Clams 111-115 have been added. Claims 1, 10, 35, 36, 49, 53, 58, 72, 78, 82-83, 90, 99, 101 and 111-115 are pending.
Claims 35, 82, 83, 90, 99 and 101 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/10/25.
Claims 1, 10, 36, 49, 53, 58, 72, 78, and 111-115 are under examination.
Withdrawn Rejections
The rejection of claims 1-4, 10, 16, 36, 49, 53, 58, 72, and 78 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto.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 16, 36, 49, and 53 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or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendment thereto. See paragraph 9, page 13 of the previous Office action.
The rejection of claim 1, 2, 4, and 16 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Viney et al. (US Patent Application Publication 2018/0340014 A1, published November 29, 2018), is withdrawn in light of Applicant’s amendment thereto. See paragraph 15, page 14 of the previous Office action.
The rejection of claims 1-4, 10, 16, 36, 49, 72, and 78 and 16 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Bernett et al. (US Patent Application Publication 2019/0241638 A1, published August 8, 2019), is withdrawn in light of Applicant’s amendment thereto. See paragraph 16, page 15 of the previous Office action.
The rejection of claims 1-2, 16, 36, 49, 58, 72, and 78 is/are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Butz et al. (WO 2016/164937 A2, published October 13, 2016), is withdrawn in light of Applicant’s amendment thereto. See paragraph 17, page 16 of the previous Office action.
New Rejection 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.
Claim 49 is 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.
Claim 49 recites “…a, or a polypeptide”. This limitation renders the claim indefinite because it is unclear if Applicant intends for another alternative to be present after the indefinite article “a”. Dependent claims 53, 58, and 72 do not cure the deficiencies of claims 49, and thus, are included in the rejection. Clarification and/or correction is required.
Claim 72 is indefinite because it states that the modified IL-2 is conjugated to a protein; however, claim 49 from which the claim depends limits the fusion partner to a water-soluble polymer, a lipid, or a polypeptide. Clarification and/or correction is required.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 72 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Although claim 72 depends from a preceding claim, the claim does not further limit the claim from which it depends. Claim 72 depends from claim 49 which limits the fusion partner to a water-soluble polymer, a lipid, or a polypeptide. The recitation of a protein is broader in scope that the alternatives listed in claim 49. Thus, claim 72 is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 36, 78, and 111-115 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wittrup et al. (WO 2005007121 A1, published January 27, 2005).
The claims are drawn to a modified interleukin 2 (IL-2) polypeptide, which comprises an amino acid sequence set forth in SEQ ID NO:1 or SEQ ID NO:2 and a substitution with cysteine at a position Y31.
Wittrup et al. teach a mutant interleukin-2 (IL-2) polypeptide comprising an amino acid sequence of SEQ ID NO:2 and comprising a Y31C mutation (See claim 11 and page 3). Wittrup et al. teach that the mutant IL-2 can be fused to a heterologous polypeptide (See page 5). Wittrup et al. teach that the heterologous polypeptide can be joined at the N-terminus, C-terminus, or both (See page 5). Wittrup et al. teach the heterologous polypeptide is an antibody or an antigen binding fragment thereof (See page 5). Wittrup et al. teach a pharmaceutical composition comprising the mutant IL-2 and a pharmaceutically acceptable carrier (See pages 26-27). Wittrup et al. teach that the reference IL-2 sequence may have a deletion of one or more amino acid residues, for example at position 1, which is interpreted as an N-terminal deletion (See page 15). Thus, Wittrup et al. anticipate the claims.
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.
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/SANDRA CARTER/ Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
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