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 . 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.
Election/Restrictions
Applicant's election with traverse of group I (polypeptides) and SEQ ID 10 in the reply filed on 3 Oct, 2025 is acknowledged. The traversal is on the ground(s) that groups I and IV have unity, and SEQ IDs 10, 14, 16, and 18 are closely related. This is not found persuasive because applicants are arguing partial unity of invention, which is not a concept recognized under US patent law.
Applicants are arguing, in essence, that, if the claims were limited to groups I and IV, and SEQ IDs 10, 14, 16, and 18, then there would be unity of invention and the restriction would not be proper. However, the claims are not limited to those groups and those sequences.
The requirement is still deemed proper and is therefore made FINAL.
Applicants have elected SEQ ID 10. A search was conducted for this invention, and it was determined to be obvious. As a result, claims 1, 5, and 15 were examined and claims 2-4, 6-14, and 16-47 were withdrawn from consideration.
Claims Status
Claims 1-47 are pending.
Claims 2-4, 6-14, and 16-47 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 Oct, 2025.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia et al (US 20140046026 in view of Krupnick et al (US 20190092831) and Guo et al (PNAS (2004) 101(25) p9205-9210).
Applicants are claiming an IL-2 variant with R38A, F42K, L80F, R81D, L85V and I92F mutations compared to the native human sequence.
Garcia et al discuss mutations to skew which receptors IL-2 binds to, to affect activity and side effects (paragraphs 12-14). Specific mutations L80F, R81D, L85V, and I92F are discussed, along with sequences comprising some of these mutations (paragraph 54). Pharmaceutical formulations with an appropriate carrier are discussed (paragraph 110).
The difference between this reference and the examined claims is that this reference does not discuss the R38A and F42K mutations of applicant’s elected species.
Krupnick et al discuss IL-2 variants with an improved side effect profile (p5). Among the mutations discussed are R38A and F42K, along with an optional additional mutation that prevents aggregation (paragraph 60). Pharmaceutical formulations are discussed, with appropriate excipients (paragraph 94).
Guo et al discuss mutations of proteins (title). In general, mutations are additive, although very high mutation levels may interact in more complex ways (p9207, 1st column, 3d paragraph). This reference suggests that, unless too many mutations are added, the effect of adding mutations is predictably additive.
Therefore, it would be obvious to add the mutations of Krupnick et al to the mutations of Garcia et al, to provide for an improved side effect profile as described by Krupnick et al. As Guo et al states that mutations are generally additive, an artisan in this field would attempt this modification with a reasonable expectation of success.
Alternatively, the mutated IL-2 variants claimed by applicants are a combination of known elements (the mutations of Garcia et al and Krupnick et al) yielding expected results (an IL-2 mutant with improved activity and reduced side effects).
Garcia et al and Krupnick et al discuss all the mutations of SEQ ID 10, rendering it, and claims 1 and 5, obvious.
Both Garcia et al and Krupnick et al discuss pharmaceutical formulations with appropriate carriers, rendering obvious claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658