(c) Antiviral Activity Was Confirmed For The 2'-Modified 16 Nucleosides Of The Storer Claims And Structurally Similar 17 Compounds 18 19 Studies involving no more than routine experimentation have confirmed the antiviral
20 activity against HCV of (i) multiple compounds within the Storer Claims, and (ii) compounds
structurally similar to the compounds of the Storer claims. (Ex 1011 21 , ¶¶82-94.) For example,
22 PSI-6130, a compound within the Storer Claims, exhibits anti-HCV activity in the HCV replicon
system, and its 5´-triphosphate exhibits anti-HCV activity in an in vitro 23 assay for HCV
polymerase activity. (Ex 1107, at 155, Fig. 1, and 156, ¶ bridging left and right cols.; Ex 1108 24 ;
Ex 1110, at 80, ¶ bridging left and right cols., at 82, right col., 2nd ¶ and Table 1; Ex 1109 25 , at col.
18
60:56 to col. 61:32, Tables 1, 2, and 3; Ex 1011 1 , ¶¶82-85.) R7128, another compound within the
Storer claims, exhibits anti-HCV activity in humans. (Ex 1107, at ¶ bridging 156 and 157; Ex 2
1108; Ex 1011 3 , ¶¶86-87.) And PSI-7409, yet another compound within the Storer Claims,
exhibits anti-HCV activity. (Ex 1111 4 , at 3190, Fig. 1 and col. 2, 2nd full ¶; 3191, Fig. 2; and
Abstr.; Ex 1011 5 , ¶¶88-89.) (d) One Skilled In The Art As Of June 28, 2002 Would Have 6 Known How-To-Use The 2'-Modified Nucleosides Of The 7 Storer Claims In The Claimed Methods 8 9 Further, the ’350 and ’907 apps. describe how-to-use 2'-F-2'-Me ribonucleosides within
10 the Storer Claims for treating an HCV infection in a host infected with HCV, including the
11 administration of an effective amount of the compounds, or their pharmaceutically acceptable
salts. (Ex 1003, at 8:23-28; Ex 1002, at 12:21-26; Ex 1011 12 , ¶31.) The applications also describe
13 pharmaceutical compositions comprising such compounds, how to administer them for treating
a patient infected with a Flaviviridae 14 virus and appropriate routes of administration, dosages
and dosage forms. (Ex 1003, at 111:9 to 113:30; Ex 1002, at 117:3 to 119:28; Ex 1011 15 , ¶31.) D. The ’907 App. Discloses Formulae That Satisfy The Written Description 16 Requirement For The Claims Of The Storer Patent 17 18 The written description requirement is satisfied where an application describes the
19 invention in sufficient detail so that those skilled in the art would have recognized that the
inventor possessed the invention at the time of filing. See, e.g., Vas-Cath, Inc. v. Mahurkar 20 ,
21 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). Description of a genus can constitute the disclosure of
22 a species within it where one skilled in the art would have been able to “at once envisage” the
species. Petering, 301 F.2d 676, 682 (CCPA 1962); Schaumann 23 , 572 F.2d 312, 316-17 (CCPA
24 1978). One may look to the preferred embodiments to assist in determining which compounds
can be at once envisaged. Id 25 .
20 activity against HCV of (i) multiple compounds within the Storer Claims, and (ii) compounds
structurally similar to the compounds of the Storer claims. (Ex 1011 21 , ¶¶82-94.) For example,
22 PSI-6130, a compound within the Storer Claims, exhibits anti-HCV activity in the HCV replicon
system, and its 5´-triphosphate exhibits anti-HCV activity in an in vitro 23 assay for HCV
polymerase activity. (Ex 1107, at 155, Fig. 1, and 156, ¶ bridging left and right cols.; Ex 1108 24 ;
Ex 1110, at 80, ¶ bridging left and right cols., at 82, right col., 2nd ¶ and Table 1; Ex 1109 25 , at col.
18
60:56 to col. 61:32, Tables 1, 2, and 3; Ex 1011 1 , ¶¶82-85.) R7128, another compound within the
Storer claims, exhibits anti-HCV activity in humans. (Ex 1107, at ¶ bridging 156 and 157; Ex 2
1108; Ex 1011 3 , ¶¶86-87.) And PSI-7409, yet another compound within the Storer Claims,
exhibits anti-HCV activity. (Ex 1111 4 , at 3190, Fig. 1 and col. 2, 2nd full ¶; 3191, Fig. 2; and
Abstr.; Ex 1011 5 , ¶¶88-89.) (d) One Skilled In The Art As Of June 28, 2002 Would Have 6 Known How-To-Use The 2'-Modified Nucleosides Of The 7 Storer Claims In The Claimed Methods 8 9 Further, the ’350 and ’907 apps. describe how-to-use 2'-F-2'-Me ribonucleosides within
10 the Storer Claims for treating an HCV infection in a host infected with HCV, including the
11 administration of an effective amount of the compounds, or their pharmaceutically acceptable
salts. (Ex 1003, at 8:23-28; Ex 1002, at 12:21-26; Ex 1011 12 , ¶31.) The applications also describe
13 pharmaceutical compositions comprising such compounds, how to administer them for treating
a patient infected with a Flaviviridae 14 virus and appropriate routes of administration, dosages
and dosage forms. (Ex 1003, at 111:9 to 113:30; Ex 1002, at 117:3 to 119:28; Ex 1011 15 , ¶31.) D. The ’907 App. Discloses Formulae That Satisfy The Written Description 16 Requirement For The Claims Of The Storer Patent 17 18 The written description requirement is satisfied where an application describes the
19 invention in sufficient detail so that those skilled in the art would have recognized that the
inventor possessed the invention at the time of filing. See, e.g., Vas-Cath, Inc. v. Mahurkar 20 ,
21 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). Description of a genus can constitute the disclosure of
22 a species within it where one skilled in the art would have been able to “at once envisage” the
species. Petering, 301 F.2d 676, 682 (CCPA 1962); Schaumann 23 , 572 F.2d 312, 316-17 (CCPA
24 1978). One may look to the preferred embodiments to assist in determining which compounds
can be at once envisaged. Id 25 .