Broadening amendments in conjunction with narrowing amendments do not preclude the presumption that prosecution history estoppel applies. Here, for example, broadening a use requirement for a particular transfer member element did not preclude the presumption that prosecution history estoppel applies based on a concurrent narrowing amendment that the transfer member include a particular type of seal.
Background / Facts: The patent being asserted here is directed to a device for introducing or withdrawing a sample from a container holding a fluid without contaminating the fluid. In particular, the claims recite a “removable, replaceable transfer member” to maintain a closed system. During prosecution, claim 1 was amended to add the requirement that the transfer member’s seal have “a first end comprised of a bellows-shaped part sealingly attached to said holder, and a second end comprising a self-sealing membrane portion interiorly formed at an end of said bellows part.” The applicant stated that the purpose of the amendment was to make claim 1 “allowable and distinguishable over the cited references.” Claim 1 was also amended, however, to remove the requirement that the transfer member be removable for replacement “after use.”
Issue(s): Whether the broadening amendment to the transfer member precludes a presumption that prosecution history estoppel applies to the narrowing amendment of the same element.
Holding(s): No. “Although the applicant eliminated the ‘after use’ language, the applicant nonetheless added the requirement that the seal have a first and second end with distinct elements. This narrows the seal limitation, which in turn narrows the transfer member limitation. And the applicant even stated in its reasons for amendment that ‘none of the references show or disclose a seal formed like the present one.’ [] Thus, these amendments were added to overcome a previous rejection. And to the extent this statement is ambiguous, we note that the Supreme Court has stated ‘[w]here no explanation is established … the court should presume that the patent applicant had a substantial reason related to patentability for including the limiting element added by amendment.’”