U.S. Pat. No. 9,492,559 B2
March 13, 2019
Brief summary: Board FWD found that the challenged claims relating to Pfizer’s Prevnar(TM) 13 vaccine were shown by a preponderance of the evidence to be unpatentable for obviousness.
Summary: The Board issued a final written decision (FWD) finding the claims unpatentable for obviousness (§ 103(a)). The challenged claims are directed to “immunogenic composition[s] comprising a Streptococcus pneumoniae serotype 22F glycoconjugate…of between 1000 kDa and 12,500 kDa…and a carrier protein” at a ratio of “between 0.2 and 2”, with “a S. pneumoniae serotype 15B glycoconjugate and a S. pneumoniae serotype 33F glycoconjugate”, or a ratio of “mM acetate per mM isolated polysaccharide is at least 0.6.” MSD challenged the claims on three obviousness grounds based on “Merck 2011” (a PCT application), “GSK 2008” (a GSK PCT), “PVP 2013” (a Japan Natl. Inst. Infect. Dis. website publication), and/or Hsieh 2000 (a journal publication). The Board explained that under the broadest reasonable interpretation approach (since this IPR was filed before Nov. 13, 2018; “ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure”), the term “immunogenic” requires “that functional antibody be elicited against each immunogen contained in the composition”. The Board first found MSD had shown by a preponderance of the evidence that certain claims were “obvious over Merck 2011 (a 15-valent S. pneuomoniae vaccine including 22F conjugated to a carrier protein), GSK 2008 (13-valent conjugate vaccine including “S. pneuomoniae saccharide conjugate of 22F”), and overlapping ratios in other references (based on expert testimony, e.g., “the knowledge of the ordinary artisan”). The Board disagreed with Pfizer’s optimization arguments since, e.g., “Merck 20011 specifically provides methods to constrain polysaccharide sizes within a particular size range” and “GSK 2008 demonstrates that the artisan preferred a range of conjugated polysaccharide sizes overlapping that recited by the ‘559 claims” and “disclosed methods to optimize the size” (e.g., “supporting the reasonable position of Dr. Paradiso that the ordinary artisan would ‘probably have a good idea on how to vary these parameters’”; “routine optimization would have been obvious…conjugate size is a results effective variable” (In re Applied Mat., FC 2012; In re Aller, CCPA 1955; In re Peterson, FC 2003 (“overlapping ranges”)). The Board also found that while the ratio described in Merck 2008 “does not necessarily equate” to that of the claims, it also concluded that Merck’s “teaching nevertheless suggests that the ratio…represents an optimizable variable” and “the final conjugated composition of serotype 22F in Merck 2011 would have been expected to render claim 1 obvious” (Ineos, FC 2015 (“range is anticipated…if the reference discloses a point within the range”); similar finding as to GSK 2008 (In re Susi, CCPA 1971 (“preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments”); In re Fulton (FC 2004) (“mere disclosure of more than one alternative does not constitute a teaching away” absent some criticism or discouragement)). The Board also found a reasonable expectation of success (e.g., “no evidence showing that any serotype 22F glycoconjugate fails to result in an immunogenic response”). The Board similarly found that obviousness by a preponderance of the evidence in view of Merck 2011, GSK 2008, and PVP 2013, as well as in view of Merck 2011, GSK 2008, “and the knowledge of the ordinary artisan with purification and conjugation techniques of Hsieh 2000” was shown for similar reasons.
The Board also denied Pfizer’s motion to amend contingent on a finding of unpatentability of certain claims. The Board explained that it “must assess the patentability of the proposed substitute claims ‘without placing the burden of persuasion on the patent owner’” (Aqua Prods., FC 2017 (en banc)), but also that the “proposed substitute claims, however, must still meet the statutory requirements of 35 U.S.C. § 316(d) and the procedural requirements of 37 C.F.R. § 42.21 as a threshold matter” (USPTO Guidance (Nov. 2017) (must show a reasonable number of claims, not seeking to enlarge claim scope or introduce new matter, responsive to a ground of unpatentability, and written description support)). Pfizer’s proposed new claim 46 required, e.g., “the composition” to “exhibit more than a 2-log increase above baseline in serum IgG levels” in rabbits “following administration…of an initial dose and a booster dose.” The Board found no broadening or indefiniteness, and written description support but denied the motion after finidng the proposed substitute claims “would have been obvious over the combination of Merck 2011, GSK 2008, Hausdorff, and the knowledge of the skilled artisan” (and PVP 2013 for proposed new claim 47) (reasonable expectation of success since, e.g., “Patent Owner does not identify a statement in Merck 2011 that immune interference occurred in PCV-15”, and not a “general approach” or “general guidance” case (Pfizer, FC 2007)).
The Board also denied Pfizer’s motion to exclude two exhibits since one (Skinner 2011) was “submitted as rebuttal evidence regarding the knowledge of an ordinary artisan regarding immune interference” (“simply as evidence of what it described” and “not hearsay” (EMC, PTAB, May 15, 2014) and the other (Hausdorff) was relevant (OddzOn, FC 1997 (“there is a ‘low threshold for relevancy’”)).