Appeal 2006-1953
Application 10/195,347
teaches that the plug/insert should consist substantially of certain
bioabsorbable polymers that are not naturally occurring ECM under the
Specification’s definition. However, Schwartz also teaches that, “in a
preferred embodiment, the insert 16 can contain within the matrix ‘repair
factors’ such as growth factors and/or attachment factors and/or cell factors”
(Schwartz, col. 11, ll. 9-12).
“The repair factors may be chemically combined with the basic
implant composition (e.g., during polymerization thereof)” (id. at col. 11, ll.
23-25). Schwartz teaches that
[a]s the cell factors, the insert may also include . . . cartilage
progenitor cells. . . . Other cell types, such as mesenchymal
stem cells, tissue (e.g., small intestine submucosa),
chondrocytes, . . . and genetically engineered cells may also be
a part of or added to the insert material. Indeed, bio-absorbable
or essentially bio-absorbable pieces of ex vivo cartilage may be
employed in the insert.
(Schwartz, col. 11, ll. 29-41 (emphasis added).) The resulting composition
is shaped, preferably into a hexagon (id. at col. 9, l. 8) and dried (id. at col.
10, ll. 52-57 (insert “typically has the felt-like feel of a non-woven fabric”)).
Thus, Schwartz teaches a preferred embodiment in which cell factors,
including chondrocytes and/or small intestine submucosa, are combined with
the basic implant composition during its polymerization, formed into a
plug/insert, and combined with an anchor to form a cartilage repair device.
The resulting device comprises a plug/insert made of a shaped mixture of
basic implant composition and small intestine submucosa, and therefore
“compris[es] a shaped and dried naturally occurring extracellular matrix,” as
recited in claim 1.
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