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February 24, 2010

Fragments

Andrew Chapman and David King had a patent idea "directed to divalent antibody fragments comprising two antibody heavy chains and at least one polymer molecule attached to the heavy chains in a site-specific manner on each chain... Chapman's invention involves joining together two fragments with an interchain bridge containing a polymer, thus achieving a circulating half-life that is intermediate between that of an individual fragment and a whole antibody."

In Re Andrew P. Chapman and David J. King (CAFC 2009-1270) precedential

6,025,158 ("Gonzalez") "describes linking antibody fragments to a polymer to increase an antibody's circulating half-life for therapeutic purposes." Gonzalez was the singular basis for rejection of Chapman under 35 U.S.C. § 102(e) and 35 U.S.C. § 103(a). The patent board upheld the examiner's rejections.

Chapman appealed to the CAFC. "Both parties agree that the sole question on appeal is the accuracy of the Board's description of Gonzalez, the primary reference."

The CAFC standard of review -

The Patent and Trademark Office ("PTO") is governed by the Administrative Procedure Act ("APA"), and PTO decisions are reviewed under the APA standard. Dickinson v. Zurko, 527 U.S. 150, 152 (1999). Thus, we review Board's legal conclusions without deference, and review its findings of fact to determine if they are supported by substantial evidence. See Hitzeman v. Rutter, 243 F.3d 1345, 1353-54 (Fed. Cir. 2001); see also 5 U.S.C. § 706(2).

The short form of obviousness, sans KSR, was cited in this case -

Whether an invention would have been obvious is a legal question based on underlying findings of fact, including (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness. In re Gartside, 203 F.3d 1305, 1319 (Fed. Cir. 2000) (citing, ultimately, Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)).

Chapman argued that Gonzalez taught away from his claimed invention.

Chapman's argument for reversal also rests on his claim that Gonzalez "teaches away" from Chapman's claimed invention as a matter of law. A finding that a reference teaches away can preclude a finding that the reference renders a claim obvious. See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326 (Fed. Cir. 2009) ("An inference of nonobviousness is especially strong where the prior art's teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements."). Whether or not a reference teaches away from a claimed invention is a question of fact. See In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995).

Chapman argues that Gonzalez teaches away from Chapman's claimed invention because Gonzalez teaches the existence of multiple locations on an antibody fragment to which a polymer molecule, or multiple polymer molecules, can be attached.

The CAFC found that Chapman's 'teaching away' argument an exaggeration at best, because, along with other techniques, Gonzalez disclosed the same mechanism as Chapman was claiming.

Gonzalez specifically discloses a preference for the hinge cysteine as an attachment point for a polymer. See, e.g., Gonzalez, col.19 ll.56-65, col.19 ll.40-46, cols.102-123. Moreover, Gonzalez offers this teaching to solve the very problem that Chapman was trying to solve here--increasing the circulating half-life of the antibody fragment. Id. col.15 ll.15-24. Therefore, Gonzalez does not teach away from using the hinge cysteine as an attachment for a polymer. Further, Chapman argues that while Gonzalez teaches attaching a polymer to a F(ab')2 fragment, Gonzalez does not teach using the polymer as a bridge. While it may be correct that Gonzalez does not explicitly teach using the polymer as a bridge between the two fragments, Gonzalez does not teach away from doing so.

The fine print went to the extent of damage caused by three errors in finding of fact by the Board, which the government admitted as errors on appeal, but which they argued as harmless. The onus is on the appellant to show otherwise.

Alternatively, Chapman argues that three of the Board's factual findings concerning the scope and content of Gonzalez are not supported by substantial evidence and that a reversal is required. As discussed below, the government agrees that the Board's opinion includes three erroneous statements, but the government urges that the three errors in the Board's opinion are harmless. The judicial review provision of the APA includes a harmless error rule. See 5 U.S.C. § 706 ("[D]ue account shall be taken of the rule of prejudicial error"). We have noted that "the harmless error rule applies to appeals from the Board just as it does in cases originating from district courts." In re Watts, 354 F.3d 1362, 1369 (Fed. Cir. 2004) (citing In re McDaniel, 293 F.3d 1379, 1385-86 (Fed. Cir. 2002); Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997)). We have said that

to prevail the appellant must not only show the existence of error, but also show that the error was in fact harmful because it affected the decision below. See Munoz v. Strahm Farms, Inc., 69 F.3d 501, 504 (Fed. Cir. 1995) ("The correction of an error must yield a different result in order for that error to have been harmful and thus prejudice a substantial right of a party."); see also Palmer v. Hoffman, 318 U.S. 109, 116 (1943) ("He who seeks to have a judgment set aside because of an erroneous ruling carries the burden of showing that prejudice resulted.").

Id. The Supreme Court has recently reaffirmed that "review of ordinary administrative proceedings" is like "review of civil cases in this respect. Consequently, it is clear that the burden of showing that the error is harmful normally falls upon the party attacking the agency's determination." Shinseki v. Sanders, 129 S. Ct. 1696, 1706 (2009) (citations omitted). In the light of this standard, we proceed to consider the three errors, and whether they were harmless.

Two of the three errors were found pertinent to rejection.

Because we cannot say with confidence that the Board would have reached the same conclusion in the absence of these errors, we are persuaded they are indeed harmful. See Kotteakos v. United States, 328 U.S. 750, 765 (1946) ("[I]f one cannot say, with fair assurance, . . . that the judgment was not substantially swayed by the error, it is impossible to conclude that substantial rights were not affected." This is not a situation where "an agency's path, though convoluted, can be discerned." In re Huston, 308 F.3d 1267, 1281 (Fed. Cir. 2002) (quotation and citation omitted).

Chapman had argued for a clean reversal, but the remand was far from victory for Chapman.

On remand, the Board need only revisit its conclusion of obviousness in light of a corrected understanding of Gonzalez. The Board is in no way precluded from, and indeed may be correct in, finding the claims to be obvious, particularly in the light of Gonzalez's disclosure of joining two antibody fragments together with a polymer to make a dumbbell-shaped structure.

This case appears a close call on the merits, which makes examiner carelessness and PTO overstepping all the more egregious in being a waste of resources, as a little more care would have produced a lot more clarity.

Posted by Patent Hawk at February 24, 2010 6:34 PM | Prior Art

Comments

What is refreshing and important in the Federal Circuit’s opinion is that mischaracterizations of references relied upon by the patent examiner (or the BPAI) for obviousness rulings are not to be simply glossed over as “harmless error.” Put differently, the Chapman decision gives patent applicant’s a viable legal basis to hold a patent examiner’s (as well as the BPAI’s) “feet to the fire” to challenge an obviousness (or anticipation) rejection based on one or more mischaracterizations of a reference.

Posted by: EG at February 25, 2010 11:08 AM