Appeal No. 2005-1442 Page 3
Application No. 09/734,786
Discussion
1. Claim construction
Claims 1 and 11 are representative of the claims on appeal and read as follows:
1. A method to introduce a nucleic acid molecule into a mammalian subject
which method comprises
transplanting into the dermis of said subject at least one hair follicle that
has been modified ex vivo to contain said nucleic acid molecule.
11. A method to introduce a nucleic acid molecule into a mammalian subject
which method comprises transplanting into the corresponding tissue of said mammal a
histocultured intact tissue that has been modified ex vivo to contain said nucleic acid
molecule;
wherein said histoculture has been treated with collagenase prior to
modifying said tissue with the nucleic acid.
Thus, claim 1 is directed to a method of introducing a nucleic acid into a mammal
by modifying a hair follicle ex vivo to contain the nucleic acid and transplanting the hair
follicle to the mammal. Claim 1 does not explicitly require that the nucleic acid be
expressed or provide any particular benefit to the mammal.
Claim 11 is similar to claim 1 but encompasses treating tissues other than hair
follicles; in addition, claim 11 requires that the tissue be treated with collagenase before
being modified with the nucleic acid.
2. Enablement
The examiner rejected claims 1-8, 11, 13-15, 17, and 19, all of the claims
remaining, under 35 U.S.C. § 112, first paragraph, on the basis that the specification
does not enable those skilled in the art to practice the claimed method without undue
experimentation. The examiner considered the factors set out in In re Wands, 858 F.2d
731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), and concluded that
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