Another per se rule bites the dust. A reference that discloses a range encompassing a somewhat narrower claimed range may not be sufficient to establish a prima facie case of obviousness

Lee Wright | April 12, 2012

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.

August 23, 2011

Panel:  Lourie, Plager and Dyk.  Opinion by Lourie.  Concurrence-in-part and dissent-in part by Dyk.

Summary:

This article concludes a three-part series regarding this important case from last year.   For part 1, click here.  For part 2, click here.  This final article discusses the following questions:

Question 1:  Does a broad range necessarily render obvious a narrower range falling within that broader range?

Answer 1:  No.

Question 2:  Do all minor chemical differences always lead to a conclusion of obviousness?

Answer 2:  No.

Details:

On May 16, 2008, Genetics sued Novartis in the United States District Court for the District of Delaware to determine priority of invention under 35 U.S.C. § 291.

Genetics alleged that an interference in fact existed between the claims 1, 5, 9 and 10 of the Genetics’ patent (the “’112 patent”) and claims from two Novartis patents (the “’620 patents”).

An interference in fact under § 291 requires that the two patents claim “the same or substantially the same subject matter.”  Slip Track, 304 F.3d at 1263.  “An interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa.” 37 C.F.R. § 41.203(a).  In other words, for two claims to interfere, each claim must anticipate or render obvious the other; failure of either claim to anticipate or render obvious the other defeats the test for interference.

The district court found that no interference in fact existed between the allegedly interfering claims.

Genetics appealed, Genetics asserting, the district court incorrectly applied the two-way test in finding no interference in fact.

Regarding the allegedly interfering claims in the ’112 and ’620 patents of Novartis, Genetics maintains that the amino acid deletion claimed by the ’620 patent is subsumed entirely by the deletion claimed by the ’112 patent; thus, the ’620 patent’s claims would have been prima facie obvious over the allegedly interfering claims of the ’112 patent.

Genetics also contends that the district court erred by failing to find that the ’620 patent’s claims anticipate the ’112 patent’s claims.

Novartis responds that there is no interference in fact between the allegedly interfering claims of the ’112 patent and the ‘620 patents.  Novartis contends that the two-way test is not satisfied because the broader range of deletions permitted by the claims of the ’112 patent does not anticipate or render obvious the narrower range claimed in the Novartis patents.

The claimed truncated Factor VIII proteins in the ’112 and ’620 patents differ in terms of the size of the permitted amino acid deletions, the location of the permitted amino acid deletions, and the degree of allowable amino acid substitutions.  In particular, the deletion in claim 1 of the ’112 patent (and, by extension, claims 5 and 9) ranges in size from 581 to 949 amino acids and is located between amino acids 740 and 1690, whereas the deletion in claims 68, 74, and 83 of the ’620 patent ranges in size from 889 to 909 amino acids and is located between amino acids 740 and 1649.  The ’620 patent’s claims permit substitution of up to 10% of the amino acids, whereas the ’112 patent’s claims do not.  It is undisputed that the ’112 patent permits deletion of amino acids in the 1649-1689 region, whereas the ’620 patent does not.

The majority

In view of the structural differences between the proteins claimed in the ’112 and ’620 patents, the majority held that the district court correctly required as part of the prima facie obviousness inquiry the identification of some reason that would have prompted a researcher to modify the prior art compounds in a particular manner to arrive at the claimed compounds.

The majority cited

Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007); In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc) (“[S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness.” (emphasis added)); In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985) (To establish prima facie obviousness, “there must be adequate support in the prior art for the . . . change in structure.”);  In re Lalu, 747 F.2d 703, 705 (Fed. Cir. 1984) (“In determining whether a case of prima facie obviousness exists, it is necessary to ascertain whether the prior art teachings would appear to be sufficient to one of ordinary skill in the art to suggest making the claimed substitution or other modification.”).  This principle was reaffirmed by the Supreme Court’s opinion in KSR International Co. v. Teleflex Inc., which acknowledged the importance of identifying “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” 550 U.S. 398, 418 (2007).

The majority found that the district court correctly found that Genetics failed to establish any such reason for modifying the group of proteins claimed in the ’112 patent to produce the group claimed in the ’620 patent.

Genetics cited articles that disclosed a number of cleavage cites on the Factor VIII protein.  However, the majority held that “the mere existence of an in vivo cleavage point, without more, would not have provided the requisite ‘reason or motivation,’ to manipulate the claimed proteins of the ’112 patent at that cleavage point to make those claimed in the ’620 patent.”

Genetics asserts that the district court’s conclusion of nonobviousness is contrary to In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).  According to Genetics, Peterson holds that a broad range necessarily renders obvious a narrower range falling within that broader range.  The majority disagreed:  “In Peterson, we stated that ‘[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.’ Id. at 1329 (emphasis added).  The facts here do not present the “typical[]” case contemplated in Peterson, however.”

The majority further distinguishes Peterson, noting:

We noted in Peterson that “we do not have here any assertion that the disclosed range is so broad as to encompass a very large number of possible distinct com-positions,” and that our reasoning did not necessarily extend to “a disclosed range of such breadth.” Id. at 1330 n.1.

In this case the majority noted, in contrast, about 68,000 protein variants are encompassed by the claims of the ’112 patent.

In dismissing the case law regarding homologs, analogs, and isomers referenced by the dissent, which typically differ, at most, by only a few atoms, the majority noted that here the claimed truncated proteins vary enormously in structure.  The majority also noted that “even in cases involving such ostensibly minor chemical differences, prima facie obviousness is by no means inevitable.  See, e.g., Grabiak, 769 F.2d at 730 (reversing the PTO’s finding of prima facie obviousness even though the prior art compound differed from the claimed compound ‘only by the presence . . . of a sulfur atom instead of a particular oxygen atom’).”

The majority concluded that “[o]n the facts of this case, the nontrivial differences in the proteins at issue compel the requirement of identifying a reason for the chemical modification.”

The majority distinguished Peterson in that Peterson noted that “‘we do not have here any assertion that the disclosed range is so broad as to encompass a very large number of possible distinct compositions,’ and that our reasoning did not necessarily extend to ‘a disclosed range of such breadth.’ Id. at 1330 n.1.”  Rather, the majority found here that about 68,000 protein variants are encompassed by the claims of the ’112 patent.

The majority further emphasizes in Peterson the court’s holding was based on the recognition that “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” 315 F.3d at 1330.  However, here the majority holds that “the only evidence of motivation in the present record is that of researchers to make smaller, truncated proteins to solve the cloning difficulties associated with the large size of Factor VIII.  That motivation would not have supplied researchers with a reason to make the group of proteins claimed in the ’620 patent encompassing larger truncated proteins than those claimed in the ’112 patent.  Simply put, the typical desire of scientists to find an optimum value within a narrow disclosed range, id., does not apply to the facts of this case.”

The Dissent

The dissent argued “we should look to whether there was enough structural similarity between the patents-in-suit to make to the inventors at the time of the invention.”  And that:

Our precedent has established that “[s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds.” In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995). Moreover, such structural similarity (i.e., an established structural relationship between a prior art compound and the claimed compound) can give rise to a case of prima facie obviousness. Id. Thus, “a known compound may suggest its [homologs,] analogs, or isomers” because such compounds “often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” Id. In In re Jones, 958 F.2d 347, 349 (Fed. Cir. 1992), we acknowledged that “particular types or categories of structural similarity[,] without more[,] have, in past cases, given rise to prima facie obviousness.” (citing In re Dillon, 919 F.2d 688, 692–94 (Fed. Cir. 1990) (tri-orthoesters and tetra-orthoesters), cert. denied, 500 U.S. 904 (1991)); In re May, 574 F.2d 1082 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341 (CCPA 1970) (acid and ethyl ester)).1 In this case, the truncated Factor VIII proteins of the ’112 patent and the truncated Factor VIII proteins of the Novartis patents are not merely homologs, analogs, or isomers—they are all variants of the exact same protein, exhibiting the exact same procoagulant functions.

The similarities in structure and function would provide the requisite motivation to modify the proteins of the ’112 patent to obtain the proteins of the Novartis proteins. See In re Dillon, 919 F.2d 688, 696 (“[T]he fact that the claimed and the prior art compounds possessed the same activity were added factors in the establishment of a prima facie case.”).

Second, under our prior authority, a prima facie case of obviousness can also exist if the range of an earlier patent incorporates the range of later patents. That is the case here where it is clear that the range of retentions in the ’112 patent fall within the range of retentions of the Novartis patents, as discussed above. Our case law has held that “[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003). “[E]ven a slight overlap in range establishes a prima facie case of obviousness.” Id. at 1329; see also In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (finding prima facie obviousness where range of prior art reference (100–600 Angstroms) overlapped the claimed range (50–100 Angstroms)); In re Woodruff, 919 F.2d 1575, 1578 (CCPA 1990) (holding a claimed invention obvious because claimed range (“more than 5% to about 25%” carbon monoxide) abutted range of prior art (“about 1–5%” carbon monoxide)); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (finding prima facie obviousness where the claimed range of the prior art reference (0.020–0.035% carbon) overlapped the claimed range (0.030–0.070% carbon)). Significantly, when “the claimed ranges are completely encompassed by the prior art, the conclusion [of obviousness] is even more compelling than in cases of mere overlap.” Peterson, 315 F.3d at 1330.  Here, as in Peterson, the range of retentions or deletions in the Novartis patents overlap significantly with the range of the ’112 patent, and are, in my view, prima facie obvious.

The dissent concludes “as the court in Peterson made clear, it is the facts of a particular case that will render it ‘typical’ or not. 315 F.3d at 1329. An expansive range of variants should not per se defeat a prima facie case of obviousness.”

Comments/Tips:

The court has again held against a per se rule of obviousness.

USPTO Examiners frequently cite Peterson for the proposition that “a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).  And “[i]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”  See MPEP 2144.05 Obviouness of Ranges.

In view of the instant opinion, such per se rules of obvious should no longer exist.

Full Opinion

Patent At Issue

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