Interference Nos. 103,882, 103,933, and 104,228 Consolidated Judgment
Gregory v. Tsui et al. Page 4
10. Gregory urges that Tsui failed to provide a written description of the manner and
process of making the subject matter of the counts.3
11. Gregory acknowledges that it is sufficient, for the purposes of interference priority
benefit, to have disclosed and enabled a single embodiment within the scope of the count (e.g.,
882 Paper No. 1274 at 13-14).
12. Gregory's argument with regard to the 882 count is that Tsui's 609 application
does not disclose the manner of making of any "DNA" within the scope of the count.
13. The 882 count is directed to a nucleic acid encoding the CFTR protein.
14. Gregory's argument with regard to the 933 count is that Tsui's 609 application
does not disclose the manner of making the "DNA component" of the scope of the count.
15. The 933 count is directed to a recombinant vector for a target cell where the
vector contains regulatory DNA operably linked to CFTR DNA such that the target cell will
express CFTR protein.
16. Gregory's argument with regard to the 228 count is that Tsui's 609 application
does not disclose the manner of making the "DNA" for encoding the protein of the count.
17. The 228 count is directed to the CFTR protein.
3 The parties debated whether 35 U.S.C. 112[1] requires a written description of how to make the subject
matter at issue. While we agree with Gregory that the statute literally requires "a written description...of the manner and
process of making" the contested subject matter, that fact is not dispositive since the statute further states that the
description need only be "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make and use the same...." See Northern Telecom, Inc. v.
Datapoint Corp., 908 F.2d 931, 941, 15 USPQ2d 1321, 1329 (Fed. Cir. 1990) (explaining that the focus is on whether,
starting with the disclosure, one skilled in the art could have made invention without resort to undue experimentation).
As the Northern Telecom opinion noted, the disclosure need not be "a production specification." Id.
4 Gregory Preliminary Motion 1 (To Deny Benefit).
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