United States: Federal Circuit Review - Issue 37

Specific Claim Limitation That Uses "Comprising" in an Unpredictable Art May Not Be Enabled; and "Active Inducement" Under § 271(f)(1) Does Not Require a Third Party.

Promega Corp. v. Life Techs. Corp., No. 2013-1011, -1029, -1376, 2014 U.S. App. LEXIS 23482 (Fed. Cir. Dec. 15, 2014) (Chen, J.) (Prost, C.J., dissenting).  Click Here for a copy of the opinion.

Promega sued Life Technologies on five patents related to a forensic DNA identification technique known as "short tandem repeat"(STR) profiling.  

Promega alleged direct infringement in the US, and also alleged indirect infringement under § 271(f)(1), because Life Technologies shipped one component of the accused STR kits (a polymerase used for the amplification reactions) from the US to the UK, where the kit was then assembled and sold worldwide.  Life Technologies argued that these shipments did not infringe under this statute, because it shipped a single component to itself and not to someone else.  Additionally, it said that the exported polymerase was not "all or a substantial portion of the components of a patented invention" as the statute requires.

STR profiling counts the number of times a particular DNA sequence is repeated at selected genome locations called STR loci.  This count can vary among individuals, creating distinct patterns called "alleles," or markers, of a particular locus.  A particular set of alleles at multiple loci within an individual's DNA can be used to create a DNA "fingerprint" unique to that individual.  From a DNA sample, multiple copies of the DNA at each STR locus in a set of multiple loci are made, in a process called "amplification."  Promega's patents relate to a co-amplification method that uses primer pairs to copy DNA at multiple STR loci simultaneously and (importantly) without overlap or interference between the primer pairs for different targeted loci.   

More specifically, some of the patent claims recited a kit for analyzing STR repeats in STR loci from a DNA sample comprising a container containing primers for each locus in a set of STR loci which can be co-amplified, comprising three specified STR loci (HUMCSF1PO, HUMTPOX, and HUMTH01). The district court concluded that Promega's second use of the word "comprising" in the "a set of . . . loci" limitation covered not only the three loci recited in the claim, but also any other loci combination containing those three recited loci.  

On summary judgment, the district court rejected Life Technologies' invalidity argument that the "open ended" claims were not enabled, because according to the defendant, the "comprising" language is open to every possible loci – a scope which the specification and the state of the art did not support.  According to the district court, "the asserted [open loci set] claims allow for unrecited loci" and such claims need not enable "unrecited elements."  The court granted summary judgment of infringement to Promega and held a trial on damages, but on JMOL it vacated the jury's finding of willful infringement and its damages award.  Both parties appealed.

The Federal Circuit reversed the district court's denial of summary judgment on invalidity, finding that the open-ended claim language rendered the affected claims invalid for lack of enablement.  The Court disagreed that these STR loci combinations are merely "unrecited elements." They are part of the claim scope under the undisputed claim construction.  This claim scope was not enabled because identifying such loci was "a complex and unpredictable challenge" and amounted to undue experimentation.  When arguing for patentability, Promega urged that STR loci combinations in the prior art "cannot be extended to predict the success of multiplexing unrelated combinations of loci" and could not "provide any direction as to which of many possible [STR loci combination] choices is likely to be successful."  In these circumstances, Promega's open-ended claims were too broad.  

Under MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012), the Court found that instead of tying the key claim limitation to what the specification enabled, the patentee sought to extend its scope in order to cover later invented devices."  Under  Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013), the Court found "undue experimentation" because 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.  In particular, the relevant usage of "comprising" was not in the preamble, it was within the claim limitation that lists combinations of 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.' [citation omitted] 2007).  Promega's claims differ from customary 'open ended' 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 indisputably advances in this unpredictable art." (emphasis added).

On infringement, the Federal Circuit reversed the district court's JMOL, finding that Life Technologies was liable under § 271(f)(1).  The Court held that no third party is required to "actively induce" an infringing combination outside the United States.  Here, "induce" in the statute simply means "to cause," and in this case, to cause the infringing combination.  The court reasoned that the statute could have required involving another party simply by requiring the "active inducement of another," but this language is absent and cannot be imposed.  Infringement could not be avoided by exporting components of a claimed combination for assembly overseas by shipping components to oneself instead of to some other party.

Finally, the Federal Circuit held that exporting only a single component  from the U.S. may be sufficient to violate  § 271(f)(1).  Life Technologies pointed to the plural term "components" in the statute, but the Court noted that the key requirement was to supply "all or substantial portion" of the components from the United States.  A single component may suffice, and did suffice here, because the polymerase manufactured in the U.S. and shipped abroad was an essential component, without which the products in question could not function.

The Federal Circuit remanded the case to the district court to determine damages owing to Promega under the remaining claims that did not use the open-ended term "comprising."  Chief Judge Prost filed a dissent to argue that "actively induce" should require a third party.

Goods and Services Not Generally Recognized as Having a Common Source of Origin Requires "Something More" Than a Showing That They Are "Used Together" to Establish Relatedness.

In re St. Helena Hospital, No. 2014-1009, 2014 U.S. App. LEXIS 23564 (Fed. Cir. Dec. 16, 2014) (Linn, J.).   Click Here for a copy of the opinion.

St. Helena Hospital applied to the PTO to register "TAKETEN," a service mark associated with its 10-day residential health improvement program. St. Helena identified the service as "[h]ealth care services, namely, evaluating weight and lifestyle health and implementing weight and lifestyle health improvement plans in a hospital-based residential program." The examiner rejected St. Helena's application, citing likelihood of confusion with the registered mark "TAKE 10!," which was registered for goods, specifically "printed manuals, posters, stickers, activity cards and educational worksheets dealing with physical activity and physical fitness" and "pre-recorded videocassettes featuring physical activity and physical fitness promotion programs." The TTAB affirmed, finding that such goods and services are sufficiently related to cause confusion because they are complementary; they can be used together.  

Likelihood of confusion involves a balancing of the relevant Dupont factors (Application of E.I. DuPont

DeNemours & Co., 476 F.2d 1357, 1361 (C.C.P.A. 1973)), which, in this case, include: (1) the similarity or dissimilarity of the marks in terms of appearance, sound, meaning, and commercial impression; (2) the similarity or dissimilarity and nature of the goods and services; and (3) the similarity or dissimilarity of established, likely-to-continue channels of trade; and (4) the degree of consumer care. 

With respect to the first Dupont factor, the Federal Circuit rejected St. Helena's argument and agreed with the Board that "TAKETEN" and "TAKE 10!" are similar "in appearance, sound, meaning, and commercial impression." For the second factor, the Court considered whether "the consuming public may perceive [the respective goods and services of the parties] as related enough to cause confusion about the source or origin of the goods and services." The PTO has the burden of providing sufficient evidence to establish relatedness between the registered goods and St. Helena's services.  Here, because the relatedness between the registered goods and St. Helena's services was obscure, the court required that the PTO show "something more" than "the mere fact that the goods and services can be 'used together.'" Because the PTO failed to show "something more," it had not satisfied its burden of establishing relatedness.

For the third factor, the Court agreed with the PTO that St. Helena's services and the registered goods are not necessarily in different channels of trade, because the registered goods are not limited by distribution to educators.  However, the court disagreed with PTO that the channels of trade are necessarily similar, just because the registered goods and St. Helena's services are promoted through websites. The Court held that "[a]dvertising on the Internet is ubiquitous and 'proves little, if anything, about the likelihood that consumers will confuse similar marks used on such goods or services.'"  Consequently, "Both sides' evidence regarding the channels of trade is lacking."

For the fourth factor, the Board conceded that customers of St. Helena's services "will exercise a high degree of care," but it found "no basis to conclude that the consumers would exercise that level of care in analyzing printed materials received while participating in the services." The Federal Circuit found no evidence to support the Board's finding.   

Balancing these Dupont factors, the Federal Circuit concluded that the PTO's refusal to register "TAKETEN" based on the registered mark "TAKE 10!" was unsubstantiated.  The similarities between the respective marks themselves were outweighed by the other factors.  The court therefore reverse and remanded.

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