Appeal No. 2001-1499 Page 16
Application No. 08/957,654
Since the proteinases inhibited in the in vitro experiment were the same
proteinases that would be affected in vivo, I find that Rao’s results would have
provided a reasonable expectation that alpha-1-antitrypsin at 150-600 µg/ml
would be effective for treating chronic wounds in vivo. See In re O’Farrell, 853
F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (“Obviousness does
not require absolute predictability of success. . . . For obviousness under § 103,
all that is required is a reasonable expectation of success.”).
To the extent that the amount of alpha-1-antitrypsin used by Rao might
have needed optimization when used therapeutically, it is well-established that it
is “ordinarily within the skill of the art” to optimize a variable that is recognized to
affect results. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA
1980). The instant specification does not assert that the amount of alpha-1-
antitrypsin used is critical, nor do Appellants argue that their method of using
alpha-1-antitrypsin provided unexpectedly superior results.
The examiner also rejected claims 5 and 9 as obvious over Gillis, Rao,
and Clark, and she rejected claim 6 as obvious over Gillis, Rao, and Glover. I
would affirm these rejections as well.
Claims 5 and 9 are directed to the method and composition of claims 1
and 7, respectively, and add the limitation that the alpha-1-antitrypsin used is “a
product of transgenic technology.” Clark teaches transgenic production of alpha-
1-antitrypsin. See page 2, line 29, to page 3, line 1. Clark also teaches that the
disclosed method provides desired proteins at high yield and low cost, and free
of infectious agents. Page 2, lines 1-5. I agree with the examiner that Clark’s
Page: Previous 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next
Last modified: November 3, 2007