Appeal No. 2004-2221 Page 2
Application No. 09/731,412
water into the matrix and the release of the therapeutic or prophylactic agent
from the matrix, wherein the drug is released over shorter periods of time as
compared to release from matrices not incorporating the hydrophobic or
amphiphilic compound,
the matrix being formed by a method comprising emulsifying a polymer
solution, the therapeutic or prophylactic agent, hydrophobic or amphiphilic
compound, and pore forming agent, then removing solvent and pore forming
agent to produce a matrix.
The examiner relies upon the following reference:
Gombotz et al. (Gombotz) 5,942,253 Aug. 24, 1999
Claims 20-24 and 27-32 stand rejected under 35 U.S.C. § 102(e) as being
anticipated by Gombotz. After careful review of the record and consideration of
the issue before us, we reverse.
DISCUSSION
According to the rejection,
Gombotz [ ] teach[es] injection or transmucosal delivery of
microparticles comprising polylactic acid or a biadhesive polymer
(abstract).
Cellulose is disclosed (column 5 line 21) 0.1%-10% active is
specified (column 9 lines 18-19). 4:1 lipid to active is disclosed
(column 10 line 7). Phospholipids are specified (column 10 line 8).
Pore formers are disclosed (column 9 lines 51-55).
Paper No. 9, pages 2-3.
The examiner does not mention a hydrophobic or amphiphilic compound
in the rejection, but in the Examiner’s Answer, the examiner states that Gombotz
teaches the use of hydrophobic compounds as stabilizers for the active GM-CSF
(the therapeutic or prophylactic agent). See Examiner’s Answer, page 4.
Appellants argue that Gombotz does not teach the removal of the pore
forming agent from the matrix. See Appeal Brief, pages 6-7. While appellants
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