DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
1. Formal Matters
A. Claims 54-56 and 58-74 are pending and are the subject of this Office Action.
B. All objections and rejections identified in the Office Action dated 7/11/25 have been withdrawn. However, a new rejection appears below.
2. Nonstatutory Double Patenting
Claims 54-56 and 58-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,827,699 in view of Qiu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to methods of using the antibody with an Fc region identical to those produced in the patent. It is noted that the instant application is not a DIV of ‘699 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
More specifically, the instant claims are drawn to methods of treatment by removing excess antigen in the blood using an antibody identical to that of the patent. The patent claims do not recite such a treatment. However, Qiu teach that FcRn antigen binding is pH dependent (pH 6.9 vs pH 7.4 as instantly claimed). Qiu teach that this differential binding can be used to extend the life of the circulating antibody (fragments). The introduction states -
In this study, we seek to explore whether it is possible to generate small affinity antibody fragments, i.e., single chain variable fragment (scFv Abs), that can interact directly with human FcRn in a pH-dependent way. The scFvfragments should have higher binding affinity at pH6.0 towards FcRn than those of hIgG or SA,but almost no binding at pH7.4”
Indicating –
they may have excellent recycling properties and could be used as a long circulation carrier for therapeutical proteins and peptides
Though Qiu does not teach the antigen has two or more physiological states associated with a condition, it still would have been obvious to have used the method of the patent in view of the teachings of Qiu to remove any desired antigen in order to reduce its physiological effects.
3. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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