Interference No. 104,696 Paper 65
Khavari v. Tang Page 3
irritant", while Tang claim 167 requires no comparable limitations. According to Khavari
(Paper 24 at 7), its claim I defines, at most, a species of the Tang claim 167.
[7] Mammals are vertebrates [ 1002 at fl.
[8] Hair is characteristic of mammalian skin, although not all mammalian skin has hair [ 1002
at 2].
[9] Khavari's disclosure states [2001 at 4:17-20):
Preferably ...the skin to which the polynucleotide is applied is intact and is not
pretreated to remove hair.
[10] Khavari submitted portions of Tang's disclosure [2002]:
[10.1] The first page provides part of a protocol involving shaving and chemically depilating
mice. The protocol also includes the use of adenovirus as a vector.
[10.2] The second page describes evidence that "shaving appeared as an essential component for
NIVS [non-invasive vaccination onto the skin] presumably due to the mechanical
removal of cornified epithelium along the shaving path." The example involved
"adenovirus-mediated NIVS".
[10.3] The third page provides an example involving pre-shaved mice. Again an adenovirus
vector [AdCMV] is used.
[111 It is not clear whether any of these examples involve a "immunogen-encoding
polynucleotide ...not contained within a viral particle" as required in Khavari claim 1.
[121 Tang's involved claims 148 and 149 state:
148. A method of non-invasively inducing a systemic immune response,
comprising topically administering, a plasmid DNA and liposome complex vector
that encodes a gene of interest and expresses a protein encoded by the gene of
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