Trilateral Project 24.1-Biotechnology 207

The USPTO is quite flexible and no general rule exists.

Consequently, the answer depends on facts in each case and on significance of the modification to both the claimed subject matter and the described subject matter. The description of the claimed compound in the original disclosure must be adequate to identify and distinguish the claimed subject matter without complete reliance on the sequence itself for these purposes.

Yes. For example, addition of a DNA sequence during prosecution is not new matter if the DNA had been deposited earlier. Assuming that a proper descriptive fingerprint exists for the deposit, the change should not be new matter because it is simply adding an inherent aspect of an already known invention. See Kennecott Corp. V. Kyocera Intl., 835 F.2d 1419, 1422, 5 USPQ2d 1194, 1197 (Fed. Cir. 1987) (holding that addition of an inherent quality was not new matter); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (holding that a structural formula may be corrected without raising a new matter rejection).