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 .
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 11/20/2025 are acknowledged.
Applicants are reminded that the original election of species were SEQ ID NO:22 for an IL-2 variant, N26Q and N29S for the first type of mutation, F42A and Y45A for second type of mutation, and N88R for the third type of mutation. See applicants response dated 06/07/2024.
However, the above originally elected species do not read amended claims. Accordingly, the previous 103 rejection is withdrawn and a new grounds of rejection, necessitated by applicant’s current amendments to the claims, is made in this office action. The new 103 rejection is based on the different interpretation of the previously applied reference, which provides an explanation of the rejection. See the rejection below.
Response to Arguments
Applicants main argument is that presently claimed IL-2 variants comprises mutation combinations exemplified by IL-2-22 and IL-2-24 and the improved properties of these variants are fully demonstrated in the specification of the present application. Further argue that neither Wittrop nor Souza provide any teaching or suggestions that claimed mutations would increase the stability of IL-2 compared with wild type IL-2.
Claims are examined in light of IL-2 variant, i.e., IL-2-24, represented by (ii) in the claims. Shown data is limited to IL-2-22 and no data is shown for the IL-2-24.
Wittrop teaches possible mutations on IL-2 at 26, 29 and 88 positions, and these mutations are expected to change the property, such as mutations improve potency. Wittrop silent on stability of the mutations, which does not mean that mutations of Wittrop are not stable. The purpose of mutations for a given protein is to improve its stability and/or activity. However, advantages of mutations are well known in the art. Applicants claimed mutation is ‘art recognized mutation for IL-2’, as evidenced from the cited art. So, the combination should result in increase in the stability of the peptide.
Claiming a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference.”
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).” (MPEP 2112 V) (MPEP 2100-48).
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 6-7, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wittrup (US 2005/0142106 A1) in view of Souza (WO 85/00817) and Viney (US 2018/0340014 A1).
Claims require recited either (i) or (ii). In this office action, the rejection is based on (ii).
For claim 1:
Wittrup teaches possible mutations in IL-2 at various positions to improve its activity, and some mutations, which are related to instant claims, are at 26, 29 and 88 [see 0006, claims 1, 5 and 9]. Wittrup further teaches N29S [see 0054 and claim 11].
The difference is that Wittrup is silent on applicants N26Q and N88R.
It appears that art recognized possible mutations at various positions in IL-2. For example, Souza teaches N26Q [see claim 33]. Viney teaches N88R and also teach N29S [see claim 1 and 27].
Therefore, it is obvious to incorporate art recognized mutations in the teachings of Wittrup and arrive at applicants IL-2 with a reasonable expectation of success in light of guidelines provided in the cited art.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
For claim 6:
The recited property is expected from the teachings of prior art, since combination reads the applicants IL-2 polypeptide, absent evidence to the contrary.
For claim 7:
Viney teaches C125A in addition to N88R and N29S [see claim 1 and 27].
For claim 9:
It appears that SEQ ID NO: 34 does not have applicants claimed mutations. The SEQ ID NO:41 is obvious over the cited art, as explained under For claim 1 above.
For claim 10:
Cited art does not teach the conjugated form of IL-2 with PEG etc., and so in the teachings of cited art the IL-2 is interpreted as monomeric form.
For claim 12:
Cited art teaches mutant IL-2 for treating cancer etc., by administering mutant IL-2 composition, and so, it is interpreted as a pharmaceutical composition.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual mutations in IL-2 are known and also recognized in the art, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL, because applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
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 SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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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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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658