Interference No. 103,854
specification helps to resolve the issue of what the inventors intended by the meaning of the
phrase “encapsulated in a liposome.”
In turning to the prosecution history, however, we find what appears to be the origin of
the problematic claim language. Claims 4 and 26 of the original Wallach specification were
directed to a multimer comprising a liposome. The examiner rejected these claims as being
indefinite under 35 U.S.C. § 112, second paragraph. Paper No. 9, p. 5. In so doing, the
examiner stated that she “interpreted these claims to mean the encapsulation of TNF-R
multimers in liposomes for examining purposes” [emphasis added]. Id. In addition, the
examiner rejected the claims over two references, one of which (Allen, U.S. Patent
4,837,028, issued Jun. 6, 1989) was said to describe the encapsulation of a pharmaceutical
agent within a liposome in order to preserve its half-life in the blood stream and to reduce
any toxic side effects [emphases added]. Id., p. 7. The examiner concluded that “it would
have been obvious to one of ordinary skill in the art that TNF-BP multimers could be placed
within liposomes to increase their half-life and reduce their possible side effects because the
primary references teach that TNF-BPs bind TNF to prevent its activity while the remaining
references teaches [sic, teach] the use of liposomes to administer agents such as TNF to
retain activity, increase half life, and reduce side effects” [emphasis added]. Id. In response
to these rejections, Wallach did not object to the examiner’s statements. Rather, they
amended the claims to include the phrase “encapsulated in a liposome.”11 Paper Nos. 10
and 13.
Thus, from the prosecution history, we find that the phrase “encapsulated in a
liposome” was used by the examiner in concordance with the ordinary and accustomed
11 Wallach deleted claim 26 by amendment in Paper No. 13, p. 2. The
numbering of claim 4 was changed to claim 7 when the Wallach application issued as a
patent.
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