Opinion ID: 2760666
Heading Depth: 2
Heading Rank: 2

Heading: Enablement of the Promega patents

Text: The district court construed the asserted claims in the Promega patents with the “open loci set” limitation broadly, finding that the language of the claims “makes it clear that they are not limited to the recited loci because they all use the word ‘comprising’ when listing the loci.” Promega I, slip op. at 21. Thus, the district court conclud- Invents Act, Pub. L. No. 112-29, took effect on September 16, 2012. Because the applications resulting in the patents at issue in this case were filed before that date, we will refer to the pre-AIA version of § 112. 14 PROMEGA CORP v. LIFE TECHNOLOGIES CORP. ed that “all of the asserted [open loci set] claims allow for unrecited loci.” Id. For example, claim 23 of the ’598 patent recites an STR loci combination that comprises three specific loci. Under the district court’s construction, claim 23 encompasses not only the 3-plex co-amplification recited in the claims, but it also encompasses any other larger, more complex multiplex reaction, so long as it includes the three recited loci. Based on this construction—which is not disputed on appeal—LifeTech moved for summary judgment of invalidity of the asserted claims of the Promega patents for lack of enablement under § 112, ¶ 1. The district court denied LifeTech’s motion, concluding that the asserted claims need not enable “unrecited elements.” Promega I, slip op. at 21, 28. The enablement requirement is set forth in 35 U.S.C. § 112, ¶ 1: The specification shall contain a written description of the invention, and the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. The enablement requirement ensures that “the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.” Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed. Cir. 1999). The scope of the claims must be “less than or equal to the scope of enablement.” Id. at 1196. Here, we disagree with Promega’s characterization that unrecited STR loci combinations in the “open loci set” limitation of the asserted claims are merely “unrecited elements”; under the undisputed claim construction, they are part of the claim scope. In this field of technology, PROMEGA CORP v. LIFE TECH 15 introducing even a single STR locus to an existing loci multiplex significantly alters the chemistry of, and has an unpredictable effect on, whether the resulting multiplex will successfully co-amplify. There is no genuine dispute that identifying STR loci multiplexes that will successfully co-amplify is a complex and unpredictable challenge, and as a result, undue experimentation may be required to identify a successfully co-amplifying multiplex that adds even a single new locus to an existing loci combination. To illustrate, Promega repeatedly argued to the United States Patent and Trademark Office (Patent Office) during prosecution that its then-pending claims were patentable because the prior art did not disclose “methods for selecting, coamplifying, and evaluating the specific sets of short tandem repeat loci” recited in the claims. J.A. 1012 (emphasis added). 7 According to Promega, this lack of disclosure was critical, as the state of the art in this technology area “d[id] not disclose or suggest that any arbitrary combination of loci can be co-amplified without undue experimentation.” J.A. 1225. Promega also stated that “multiplex amplification” of specific STR loci combinations disclosed in the prior art “cannot be extended to predict the success of multiplexing unrelated combinations of loci.” Id. at 1224. Promega explained that this was because the prior art “clearly indicate[d] that each individual [STR] locus responds differently when subjected to the PCR using locus-specific primers.” Id. at 1226. As a result, Promega stated that the prior art could not “provide any direction as to which of many possible [STR loci combination] choices is likely to be successful.” Id. 7 LifeTech collected over seventy similar representations to the Patent Office made by Promega during prosecution of the Promega patents. J.A. 1223–31. 16 PROMEGA CORP v. LIFE TECHNOLOGIES CORP. More specifically, Promega represented to the Patent Office that the addition of even a single locus to an existing loci combination rendered that new loci combination patentable. See, e.g., J.A. 1226 (arguing a claim was patentable because “[o]ne of those four loci [disclosed in the prior art] is not included in the list of loci of claim 1 [of the ’660 patent].”). For example, Promega argued that a claim reciting a 3-plex loci combination was patentable over prior art that disclosed only two of the three loci. J.A. 1230 (“No more than two of the STR loci disclosed in the [prior art reference] are included in any of the sets of at least three loci listed in step (b) of claim 21 [of the ’598 and ’235 patents] as amended.”); see also J.A. 1227 (“[The prior art reference] fails to disclose the suitability of more than two of the loci listed in claim 1 [of the ’660 patent].”). Thus, Promega argued that “the disclosure of some of the individual loci in the various [recited] sets of loci coamplified” was insufficient to render a claim unpatentable. See id. Promega pressed the same position when defending the validity of the Promega patents in this action. In particular, Promega argued that the loci multiplexes recited in its claims were new inventions even though they “comprised” prior art loci combinations that are subsets of its claimed STR loci. Promega justified its position by repeatedly describing the identification of new successfully co-amplifying STR loci combinations as “unpredictable.” E.g., Cross Appellant’s Br. 8; 25, 61–62. In addition, Promega’s expert opined that at the time of filing the parent application to the ’598 patent, “any new STR multiplex . . . was inventive, even where one added a single new locus to a pre-existing multiplex (e.g. adding a new locus to a multiplex of two loci to make a triplex; adding a new locus to a multiplex of three loci to make a quadruplex, etc.).” J.A. 715. Thus, Promega explained that without a preexisting publication or teaching, a skilled artisan “could not predict with any certainty . . . PROMEGA CORP v. LIFE TECH 17 whether a given set of loci would co-amplify successfully together.” J.A. 1358. Promega urged that “[t]he lack of these novel and unobvious locus combinations in the prior art, together with the unpredictable nature of this art, is fatal to [LifeTech’s] obviousness arguments.” Id. at 1360. But when describing the scope of its claims for purposes of infringement, Promega sings a different tune. Despite the overwhelming evidence that the addition of a single locus to an existing loci combination can fundamentally transform the character of the resulting multiplex reaction, Promega argues that LifeTech’s STR kits infringe its claims because any and all co-amplifying loci combinations that include the STR loci recited in the claims are encompassed by the claims. Promega has chosen broad claim language “at the peril of losing any claim that cannot be enabled across its full scope of coverage.” MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012). Our previous decisions in MagSil and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013), are instructive. In MagSil, a patentee asserted infringement of a claim directed to a device used in computer hard drive disks that required a “change in resistance by at least 10%” between two electrodes on the device. 687 F.3d at 1379–80. The specification disclosed information sufficient to enable a skilled artisan to achieve a change in resistance of 11.8%, and at the time of the invention, those in the field aspired to achieve changes in resistance of around 24%. Id. at 1381, 1383. Instead of tying the key claim limitation to what the specification enabled, the patentee sought to extend its scope in order to cover laterinvented devices that achieved greater than 600% changes in resistance. Id. at 1383. To do so, the patentee contended that its claims encompassed the entire range of changes in resistance from 10% up to infinity because it had used standard “open claim” language that “d[id] not exclude additional, unrecited elements.” Id. We rejected 18 PROMEGA CORP v. LIFE TECHNOLOGIES CORP. the patentee’s argument because the specification of the patent “d[id] not contain sufficient disclosure to present even a remote possibility that an ordinarily skilled artisan could have achieved the modern dimensions of this art.” Id. at 1382. We determined that “the specification enabled a marginal advance over the prior art,” but did not support the infinite range of resistive changes encompassed by this claim limitation. Id. Although the Promega patents recite specific sets of STR loci instead of an open-ended range as in MagSil, the claims at issue here are similar in that they cover the successful co-amplification of a virtually unlimited number of STR loci combinations (so long as they include the recited loci) through recitation of the “open loci set” limitation. And as in MagSil, we need not delineate the precise boundary at which Promega’s claims are no longer enabled. It is sufficient to conclude, based on Promega’s own statements, that the teachings of Promega’s patents would not have enabled a skilled artisan at the time of filing to identify significantly more complicated sets of STR loci combinations that would successfully coamplify—such as those found in LifeTech’s STR kits— without undue experimentation. Thus, like the patentee in MagSil, Promega’s “difficulty in enabling the asserted claims is a problem of its own making.” 687 F.3d at 1384. In Wyeth, the patentee asserted infringement of claims covering a broad class of drug compounds with certain structures and properties. 720 F.3d at 1384–85. Although the specification disclosed only one species of the compound having these particular characteristics, the patentee nevertheless contended that its claims encompassed tens of thousands of other species within the genus that were not disclosed by the patent. Id. at 1382, 1384– 85. The undisputed evidence, however, was that a skilled artisan could not determine whether a particular compound would exhibit the claimed properties without PROMEGA CORP v. LIFE TECH 19 synthesizing and screening that compound, a “laborious” and “iterative” testing process. Id. at 1385. Even if this testing process for any one compound would have been routine to a skilled artisan, we determined that practicing the full scope of the claims required “more than routine experimentation” because the specification disclosed “only a starting point for further iterative research in an unpredictable and poorly understood field.” Id. at 1385–86. In particular, we noted that the specification was “silent” as to how to modify the disclosed compound “in a way that would preserve the recited utility.” Id. at 1385. Further, even the patentee conceded that because of the unpredictable nature of the art, practicing the full scope of the claims would require testing each of the tens of thousands of potential species within the claimed genus. Id. As a result, we concluded that undue experimentation would have been required in order to practice the full scope of the claims and thus the claims were invalid for lack of enablement. Id. at 1386. While the claims of the Promega patents are not di- rected to a genus of compounds as in Wyeth, the claims at issue here similarly cover potentially thousands of undisclosed embodiments in an unpredictable field. And similar to Wyeth, the specification of the Promega patents provides only a starting point—specific STR loci combinations that successfully co-amplify—with no disclosure that would have allowed a skilled artisan, absent laborious testing, to add new loci to these recited STR loci combinations that would still successfully co-amplify. Undue experimentation is a matter of degree, and even “a considerable amount of experimentation is permissible,” so long as it is “merely routine” or the specification “provides a reasonable amount of guidance” regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360–61 (Fed. Cir. 1998) (internal quotation omitted). But permissible routine experimentation “is not without bounds.” Wyeth, 720 F.3d at 1386 (citation 20 PROMEGA CORP v. LIFE TECHNOLOGIES CORP. omitted). As the extensive evidence here demonstrates, undue experimentation would have been required in order to enable the full scope of coverage sought by Promega— the successful co-amplification of potentially thousands of unrecited STR loci combinations. Promega argues that its “open loci set” limitations “permit” its claims to encompass a potentially limitless number of primers and multiplex reactions that are not enabled by the specification. Cross Appellant’s Br. 55. Promega then seeks to shift the focus away from the particular facts of this case by contending that nearly every claim using the transitional phrase “comprising” would be invalidated if we were to reject its position and agree with LifeTech. These fears are unfounded. It is true that when used in the preamble of a claim, the term “comprising” permits the inclusion of other steps, elements, or materials in addition to the elements or components specified in the claims. See In re Baxter, 656 F.2d 679, 686 (CCPA 1981). As we stated in Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1371 (Fed. Cir. 2005), open claims “embrace technology that may add features to devices otherwise within the claim definition” (emphasis added). But the relevant usage of “comprising” here is not the one recited in the preamble. Rather, it is within the specific claim limitation that lists combinations of successfully co-amplifying STR loci, combinations whose identification and discovery Promega itself asserts is a complex and unpredictable endeavor. While the term “comprising” in a claim preamble may create a presumption that a list of claim elements is nonexclusive, it “does not reach into each [limitation] to render every word and phrase therein open-ended.” See Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007). Promega’s claims differ from customary “openended” claims in that Promega’s usage of “comprising” in its “open loci set” limitation, as construed, expands the claims at a key limitation in order to cover what are PROMEGA CORP v. LIFE TECH 21 indisputably advances in this unpredictable art. Under the circumstances here, the numerous embodiments covered by Promega’s claims cannot be merely regarded as “unrecited elements” in a standard “open-ended” claim. Since the Promega patents do not enable a skilled artisan to practice the full breadth of this claim scope without undue experimentation, the challenged claims of the Promega patents are invalid for lack of enablement. Accordingly, we reverse the district court’s denial of LifeTech’s motion for summary judgment of invalidity of the four Promega patents for lack of enablement under § 112, ¶ 1 and vacate the district court’s grant of Promega’s motion for summary judgment of infringement for the Promega patents. 8