Appeal No. 2006-1879 Page 4
Application No. 10/010,114
lipophilic long chain alkyl group, a fusogenic peptide, cholic acid, a cholesteryl group, or
a derivative) attached to a nitrogen of the polyamine component via specified linkages.
2. Enablement
The examiner rejected claims 1, 2, 5-9, and 17-52 under 35 U.S.C. § 112, first
paragraph, for nonenablement. The examiner focused on the aspect of the claimed
method that involves transferring a nucleic acid encoding a therapeutic protein into
cells.1 The examiner concluded that the specification is enabling for a method of
transferring a nucleic acid encoding a therapeutic protein into cells in vitro but is not
enabling for the same method carried out in vivo. See the Examiner’s Answer, page 3.
The examiner reasoned that “[t]he in vivo aspect of claims 1, 2, 5-9 and 17-52 is
interpreted as gene therapy as the specification does not disclose a use for delivering a
therapeutic protein other than for therapeutic purposes.” Id. The examiner noted that
the instant application has an effective filing date of September 28, 1994,2 and cited
several references as evidence that undue experimentation would have been required
to successfully carry out gene therapy as of that date. Id., pages 4-6.
The examiner noted that the specification does not “disclose any particular DNA
sequences that can be administered by applicant’s claimed methods” to treat any
specific disease. Id., page 6. The examiner summarized the most relevant working
examples:
1 The examiner restricted the claims based on the type of protein encoded by the transferred nucleic acid.
See the restriction requirement mailed August 13, 2003. Appellant elected the claims directed to a
method of transferring a nucleic acid encoding a therapeutic agent. See the paper filed September 11,
2003. The examiner has stated that “[b]ased on this election . . . claims 1, 2[,] 4-9, [and] 17-52, are
interpreted as methods of delivering a therapeutic agent using applicant’s novel multifunctional molecular
complex.” Examiner’s Answer, pages 7-8.
2 The instant application claims benefit under 35 U.S.C. § 120 of the filing date of application serial
number 08/314,060, filed September 28, 1994.
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