IN RE MARTIN GLEAVE (Fed. Cir. March 26, 2009)
Claims at Issue:
1. A bispecific antisense oligodeoxynucleotide, wherein substantially all of the oligodeoxynucleotide is complementary to a portion of a gene encoding human IGFBP-2 and substantially all of the oligodeoxynucleotide is also complementary to a gene encoding human IGFBP-5, and wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5.
4. The antisense oligodeoxynucleotide according to claim 1, wherein the oligodeoxynucleotide consists essentially of a series of bases as set forth in any of Seq. ID. Nos. 3 through 7. [Those sequences range from eighteen to twenty-two DNA bases in length and SEQ ID NO: 5 is a 20mer.]
The claims were rejected as anticipated by Wraight.
"In Wraight, the applicants listed every fifteen-base-long sense oligodeoxynucleotide in the IGFBP-2 gene. The list includes more than 1400 sequences. Wraight also disclosed the general concepts that antisense oligonucleotides are preferably between fifteen and twenty-five bases in length, and that some antisense oligonucleotides may be bispecific (i.e., capable of inhibiting “an IGFBP such as IGFBP-2 and/or IGFBP-3”). Finally, Wraight states that “[a]ntisense oligonucleotides to IGFBP-2 may be selected from molecules capable of interacting with one or more” of the sense oligonucleotides described in the long list. "
The court explained what constitutes a proper 102(b) rejection
A reference is anticipatory under § 102(b) when it satisfies particular requirements. First, the reference must disclose each and every element of the claimed invention, whether it does so explicitly or inherently. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375 (Fed. Cir. 2006). While those elements must be “arranged or
combined in the same way as in the claim,” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008), the reference need not satisfy an ipsissimis , 545 F.3d 1312, 1314 (Fed. Cir. 2008); , 339 F.3d 1373, 1380–81 (Fed. Cir. 2003); verbis test, In re Bond, 910 F.2d 831, 832–33 (Fed. Cir. 1990). Second, the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” Impax Labs., Inc. v. Aventis Pharms. Inc.see In re LeGrice, 301 F.2d 929, 940–44 (CCPA 1962). As long as the reference discloses all of the claim limitations and enables the “subject matter that falls within the scope of the claims at issue,” the reference anticipates—no “actual creation or reduction to practice” is required. Schering Corp. v. Geneva Pharms., Inc.see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985).
Gleave (the appellant) argued that
“Wraight does not describe any particular individual antisense species,” because Wraight merely gives the public “ink, formed into strings of letters, without inventive thought and without placing the public in possession of anything new. There is no guidance to make particular selections, and no understanding of which of the targets would be useful, and what the properties of the related antisense would be.”
The Federal Circuit, however, stated that the enablement requirement of 102 is not how to use for a composition, just how to make.
The court explained that any confusion about utility or use comes from case law related to method claims. The court explained to enable a method you have to be able to use it not make it."A thorough reading of our case law, however, makes clear that a reference need disclose no independent use or utility to anticipate a claim under § 102. E.g., Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005)"
"Gleave’s claims are to compositions of matter—oligonucleotides—and therefore a reference satisfies the enablement requirement of § 102(b) by showing that one of skill in the art would know how to make the relevant sequences disclosed in Wraight. "…"Thus, the fact that Wraight provides “no understanding of which of the targets would be useful” is of no import, because Gleave admits that it is well within the skill of an ordinary person in the art to make any oligodeoxynucleotide sequence. See Appellant’s Br. 10. As such, Wraight is an enabling disclosure sufficient to anticipate Gleave’s invention under § 102(b). "
Applicant also argued that the prior art did not teach any oligo with antisense activity. The appellant's lawyer even admitted this even with the following phrase "sufficient length to act as an antisense inhibitor " in the claim. Therefore, they viewed the antisense inhibitor limitation as an intended use and not relevant for 102 analysis. "Certainly where the claims themselves do not require a particular activity, we have no call to require something more from the anticipating reference. "
Gleave argued that a long list should not be anticipatory and should be treated more like a generic statement. Court explained that lists and generic terms have always been treated differently except when a genus can anticipate a species when:
compounds that falls within the genus is so limited that a person of ordinary skill in the art can “at once envisage each member of this limited class.” Eli
Lilly, 471 F.3d at 1376. In that limited circumstance, a reference describing the genus anticipates every species within the genus. See Perricone, 432 F.3d at 1377.
The court explained this argument regarding the two types of claims fails for two reasons:
First, Wraight expressly lists every possible fifteen-base-long oligodeoxynucleotide sequence in IGFBP-2, and under our precedent, this list anticipates Gleave’s claims. Second, even if we were to accept Gleave’s invitation to treat Wraight as equivalent to the statement that one “could make antisense that targets IGFBP-2,”4 which we decline to do, a person of ordinary skill in the art equipped with an IGFBP sequence is admittedly capable of envisioning how to make any antisense sequence. Thus, even
if we were to adopt Gleave’s policy position, Gleave’s claims would not be entitled to a patent over Wraight.
The explained that at most Gleave has invented a method of use not a claim for the composition itself.
What wasn't explained is why the claims to the specific sequences were anticipated since only 15mers were disclosed in Wraight and those in claim 4 were from 18-22 and the elected species was a 20mer. The only explanation that I can think of is that Wraigh said an antisense oligo that is from 15-25 can be made and therefore all oligos 18-22 could be at once envisaged? Thoughts?
The full opinion can be found here.
Posts
