Appeal No. 1997-2356
Application 08/109,798
soluble extenders or carriers which may include tricarboxylic and dicarboxylic acids (e.g.
citric acid and tartaric acid) and inorganic salts, such as sodium or potassium phosphate.
The water content of the lyophilized composition is preferred to be less than 1% but may
be as high as 5%. Answer, page 5. The pH of the growth factor formulations described by
Finkenaur may be between 5 and 8. Finkenaur, page 5, lines 5-6. In one particular
growth factor formulation, sodium chloride is used as a tonicity agent. Finkenaur, example
1, page 6. Thus Finkenaur provides general evidence of a formulation comprising nerve
growth factor, biologically acceptable salts, buffers providing the claimed pH range and
water. The specific examples of Finkenaur, however, appear to be directed to EGF
formulations.
The examiner relies on Pignatti for establishing an acceptable pH range for NGF of
4.0 to 10. Pignatti, Table I, page 157, Figure 1. More particularly, Pignatti discloses NGF
is biologically active and does not aggregate in a pH range of 4.0 to 7.6, which overlaps
the claimed pH range of 4.5 to 6.0. Pignatti, Table I, page 157, Figure 1.
Wang is relied on by the examiner primarily for establishing that serum albumin is a
known stabilizer for enzymes. Answer, page 7. Diem is indicated by the examiner
to establish the concentration of NaCl in normal saline of 0.85%. Diem additionally
discloses that sodium citrate/HCl has buffering capacity in the range of 1.2 to 5.0 and that
4
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007