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 .
Response to Amendment
Applicant’s amendment filed 05/20/2026 is acknowledged. Claims 1, 3, 5-7, and 13 are amended. Claims 8, 11-12, 15-17, and 21-23 are cancelled. Claims 1-7, 9-10, and 13-14 are under examination.
Objections Withdrawn
The objection to claim 1 for minor informalities reciting the acronyms "GVHD" and "GVL" without first writing out the terms is withdrawn in response to Applicant’s amendment correcting the informality by reciting "graft-versus-host disease (GVHD)" and "graft-versus-leukemia (GVL)."
Rejections Withdrawn
Any previous rejections of claims 8, 11-12, 15-17, and 21-23 are hereby withdrawn in response to Applicant’s cancelation of the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Maintained
Claim Rejections - 35 USC § 112(a) – Written Description
The rejection of claims 1-7, 9-10, and 13-14 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 maintained for reasons of record and the following.
Response to Arguments
Applicant argues at pages 4-6 of the Remarks filed 05/20/2026 that the amendment to claim 1 narrows the genus of anti-IL-2 antibodies to those having a specific structure-function relationship, namely, antibodies that "form[] a complex with IL-2 that enhances IL-2 binding to IL-2Ra and blocks IL-2 binding to IL-2RB" and where that complex "prevents GVHD while preserving GVL activity" in a subject receiving an HCT, citing the specification for support of this limitation (para[0042]). Applicant argues that the specification discloses possession of anti-IL-2-JES6 that forms an IL-2C that enhances IL-2 interaction with IL-2Rα and augments IL-2Rαhi Foxp3⁺Treg expansion, while blocking IL-2 interaction with IL-2Rβ on conventional T cells and this satisfies the structure-function relationship regarding the antibodies encompassed by the amended claims, specifically anti-IL-2 antibodies that augment IL-2 binding to IL-2Rα and block IL-2 binding to IL-2RB have tolerogenic effects and can prevent GVHD while preserving GVL activity. Applicant argues that the claims are directed to a method of preventing GVHD while preserving GVL, not to the antibodies themselves and an ordinary artisan would understand that all antibodies capable of forming a complex with IL-2 that enhances IL-2 binding to IL-2Rα and blocks IL-2 binding to IL-2RB prevent GVHD while preserving GVL activity in a subject receiving an HCT.
This has been fully considered, but is not found to be persuasive. The amendment to claim 1 merely recites the function of anti-IL-2-JES6 and provides no clarity to the structure of the antibodies encompassed by the genus. The amendment only narrows the claim to the function, not the structure, of what the antibody does. The specification only teaches that anti-IL-2-JES6 forms an IL-2C that enhances IL-2 interaction with IL-2Rα and augments IL-2Rαhi Foxp3⁺Treg expansion, which is merely the function of the antibody and does not provide the required structure that must be conserved within the anti-IL-2 antibody to maintain this function. As evidenced by the specification and the teachings of Spangler et al., 2015, not all anti-IL2 antibodies have the claimed activity, such as the S4B6 antibody which blocks IL-2Rα binding to IL-2 in the IL-2C (Spangler, Graphical Abstract). As such, neither the amendment nor the specification provides evidence of possession of a representative number of anti-IL-2 antibodies that share the requisite structure to perform the requisite function. Furthermore, the applicant shows no evidence of possession of any human antibodies. The specification provides no evidence of possession of the genus, and the amended claim provides no more information on the requisite structure of the antibodies encompassed by the method than the original claim. As such, the applicant only provides evidence of possession of a method of using the anti-IL-2-JES6 antibody.
Claim Rejections - 35 USC § 112(a) – Enablement
The rejection of claims 1-7, 9-10, and 13-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is maintained for reasons of record and the following.
Response to Arguments
Applicant argues that upon amendment one skilled in the art would understand from the specification that all antibodies capable of forming a complex with IL-2 that enhances IL-2 binding to IL-2Ra and blocks IL-2 binding to IL-2RB prevents GVHD while preserving GVL activity in a subject receiving an HCT and thus undertaking to find or make all such antibodies is not necessary to enable the claims.
This has been fully considered, but is not found to be persuasive. As outlined above, the amendment merely recites the function of anti-IL-2-JES6 and provides no clarity to the structure that all antibodies encompassed by the genus must possess. As evidenced by the specification and the teachings of Spangler et al., 2015, not all anti-IL2 antibodies have the claimed activity, such as the S4B6 antibody which blocks IL-2Rα binding to IL-2 in the IL-2C (Spangler, Graphical Abstract). Given that not all anti-IL2 antibodies have the claimed activity, it would require undo experimentation to make and screen for all anti-IL2 antibodies that have the claimed activity.
Claim Rejections - 35 USC § 102
The rejection of claims 1-4, 7, 9-10, 13-14 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Zeng et al., 2018 (WO2018156955) is maintained for reasons of record and the following.
Response to Arguments
Applicant argues that Zeng does not teach that the anti-IL-2-JES6 antibody forms a complex with IL-2 that enhances IL-2 binding to IL-2Ralpha and blocks IL-2 binding to IL-2Rbeta and therefore does not anticipate the instant claims.
This has been fully considered, but is not found to be persuasive. As evidenced by the teachings of Spangler et al., 2015, the anti-IL-2 antibody, anti-IL-2-JES6, forms a complex with IL-2 that enhances IL-2 binding to IL-2Ralpha and blocks IL-2 binding to IL-2Rbeta (Spangler, Highlights, Graphical Abstract, & Summary). The amended claims simply recite the inherent characteristics of anti-IL-2-JES6. Zeng already teaches the use of the same disclosed anti-IL-2 antibody, anti-IL-2-JES6 antibody, in the claimed method and the amendment merely recites inherent characteristics already present in this antibody, as evidenced by Spangler. Reciting an inherent characteristic of the antibody that was not disclosed by Zeng does not change that Zeng already teaches the same method of using the same antibody.
Claim Rejections - 35 USC § 103
The rejection of claims 1-7, 9-10, and 13-14 under 35 U.S.C. 103 as being unpatentable over Zeng et al., 2018 (WO2018156955) and Fleury et al., 2010 (CN201080007046) is maintained for reasons of record and the following.
Response to Arguments
Applicant argues that Fleury is cited solely for disclosing the existence of recombinant and/or human antibodies and does not disclose any type of anti-IL-2 antibody, much less those recited in the claims. Applicant argues that Fleury does not cure the deficiencies of Zeng.
This has been fully considered, but is not found to be persuasive. In response to applicant's arguments against Fleury individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Since Fleury teaches that antibodies can be human and/or recombinant, it would be obvious to an ordinary artisan that an anti-IL-2 antibody could be human and/or recombinant. It is the combination of Zeng and Fleury that makes it obvious that an anti-IL-2 antibody could be human and/or recombinant.
Conclusion
No claims are allowed. 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.
Advisory Information
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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