Appeal 2007-1152
Application 10/660,924
Atkinson recognizes that NOD mice – despite species differences – have
value in predicting outcome in human disease.
Appellant provided two declarations by Dr. David Scharp
(“Declaration of David Scharp, M.D.”, dated Nov. 25, 2003, and “Second
Declaration of David Scharp, M.D. under 37 C.F.R. § 1.132”, dated Apr. 28,
2005) showing that NOD mice who received the treatment described in the
Specification were prevented from becoming diabetic (Supp. Appeal Br. 5-6;
Declaration of David Scharp, M.D., ¶ 5-8). For example, Scharp showed
that 3 out 10 mice who received the tolerizing dose of encapsulated islet
cells, prior to the onset of diabetes, remained diabetes-free after eight weeks
(Declaration of David Scharp, M.D., ¶ 10). Atkinson states that NOD mouse
are the favored model for Type I diabetes (Atkinson, at 601, col. 1), and as
discussed above, considered them an important tool for understanding and
developing treatments for diabetes (Atkinson, at 604, col. 1).2 Thus, we find
the post-filing evidence in the Scharp Declarations sufficient “to prove that
the disclosure was in fact enabling when filed.” In re Brana, 51 F.3d 1560,
1576, fn.19, 34 USPQ2d 1436, fn.19 (Fed. Cir. 1995).
The Examiner’s position appears to be that because mouse models
don’t always work,3 they cannot be relied upon to enable a specification –
2 Dr. Scharp makes similar comments about the value of NOD mice,
including their proven value in developing markers for predicting human
patients who will develop clinical Type I diabetes (Second Declaration of
David Scharp, M.D. under 37 C.F.R. § 1.132, ¶ 2).
3 “Mestas . . . teach that there exist significant differences between mice and
humans in immune system development . . . [quoting Mestas:] [‘]As
therapies for human diseases become ever more sophisticated and
specifically targeted[,] it becomes increasing important to understand the
potential limitations of extrapolating data from mice to humans. The
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