IPR claim construction of “effective amount” based on prosecution history and obviousness conclusions affirmed; no abuse of discretion in Board’s denial to amend after modifying institution decision

Genentech, Inc. v. Andrei Iancu (USPTO)

Docket No. 2019-1263, -1265, -1267, -1270
IPRs 2017-00731, -01121, -02063, -00737, -01122, -01960
March 26, 2020

Brief Summary: Board’s claim construction (e.g., “effective amount”), obviousness conclusion and denial of amendment after modifying its institution decision under SAS affirmed.

Summary: Genentech (GT) appealed Board IPR final written decisions (FWDs) finding the challenged claims of US 7,846,441 and 7,892,549 relating to methods for treating cancers that overexpress the ErbB2 receptor with an antibody “which binds to epitope 4D5” unpatentable for obviousness, and the Board’s denial of GT’s motion to amend in the -00731 IPR. In reaching its obviousness decisions, “the Board construed the claim terms ‘an amount effective to extend the time to disease progression in the human patient’ and ‘an effective amount’ to be in comparison to no treatment.” The FC panel reviewed the Board’s claim construction de novo as it is “based solely on intrinsic evidence”, and explained that “[t]he prosecution history ‘is often of critical significance in determining the means of the clams’” ((Teva, US 2015; Vitronics, FC 1996; Springs Window, FC 2003 (FC 2003)). During prosecution, in response to an indefiniteness rejection as to the “extend the time” limitation, GT stated that “the combination…is administered in an amount effective to extend the time to disease progression relative to an untreated patient” which “[t]he Board determined…was an express choice, which defined the claim term and led to the issuance of the ‘441 patent.” While GT argued that the Board erred by relying “on its exchange by using it ‘to override the meaning evident from the specification”, the FC panel found that “[t]he specification does not…define the disputed terms” and that GT had “expressly rejected” another comparator (“taxoid alone”) provided by the examiner (“Genentech provided an unequivocal, direct response to the examiner’s inquiry….”; “applies equally to the same claim term that appears in the ‘549 patent, which shares a specification and is in the same family.”) The FC panel therefore concluded that the “extend the time” and “an effective amount” limitations were correctly construed by the Board.

The Board also found GT did not have “a statutory right to amend” under section 316(d)(1) or 316(d)(2) after modifying its decision to include institution on Ground 1 based on the SAS decision (US 2018), and found GT “failed to establish good cause”. The Board also held that, alternatively, “Petitioner’s request for adverse judgment as to Ground 1 under [section] 37 CFR 42.73(b) mooted the issue.” The FC panel found that the Board’s conclusions were not an abuse of discretion “of its own procedural rules”.

This entry was posted in Claim Construction, Inter Parties Review (IPR), IPR, Obviousness, Prosecution History Estoppel. Bookmark the permalink.

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