• By Kevin E. Noonan —

    Federal Circuit SealIn an otherwise unremarkable albeit precedential decision, the Federal Circuit set forth an explication of when the Patent Trial and Appeal Board has, and has not, given the court enough information to determine whether its factual determinations are supported by substantial evidence.  And in its decision handed down today in Icon Health & Fitness, Inc. v. Strava, Inc., Judge O'Malley provided a coda regarding when failure to provide such evidence should result in remand or reversal of the Board's decision.

    The case arose from inter partes reexamination (under the American Inventor Protection Act of 1999, a predecessor to inter partes review under the Leahy–Smith America Invents Act of 2011) of U.S. Patent No. 7,789,800.  The claims are directed to a portable system that permits a user to retrieve one or more exercise programs from a remote server that have motivational content during exercise.  During the reexamination (Control No. 95/002,359), in response to allegations of unpatentability from the third party requestor and determinations by the PTO, a number of claims were found to be obvious.  The PTAB affirmed this decision and patentee Icon Health appealed.

    The Federal Circuit treated the rejected claims in five groups, affirming in part, vacating in part and remanding (which prompted Judge O'Malley to dissent in part).  The Federal Circuit rejected Icon's argument that the Board erred in relying on Strava's expert's opinion that the claims were obvious, for overreaching by opining on questions of law (wherein the opinion "go[es] well beyond supplying opinions regarding factual matters by 'improperly opining as to the legal conclusion of obviousness'").  As an initial matter, the panel opinion considered whether this argument had been waived for (admittedly) not being asserted before the Board.  Citing Automated Merch. Sys., Inc. v. Lee, 782 F.3d 1376, 1379 (Fed. Cir. 2015), the opinion sets forth the considerations courts use for deciding whether waiver applies, including whether (1) "the issue involves a pure question of law and refusal to consider it would result in a miscarriage of justice"; (2) "the proper resolution is beyond any doubt"; (3) "the appellant had no opportunity to raise the objection" below; (4) "the issue presents significant questions of general impact or of great public concern"; or (5) "the interest of substantial justice is at stake," as well as "whether the issue has been fully briefed, a party will be prejudiced by consideration of the issue, or no purpose will be served by remand."  Balancing these factors the Court decided that "[b]ecause the issue has been fully briefed, the record is complete, there will be no prejudice to any party, and no purpose is served by remand," it would consider Icon's arguments even though they had not been advanced before the Board.  On the merits, the Court held that the Board could rely on Strava's expert opinions because "the PTAB is permitted to weigh expert testimony and other record evidence and, in so doing, rely on certain portions of an expert's declaration while disregarding others."  On the ultimate legal question of obviousness, the opinion noted that it has permitted expert testimony to include such statements ("it would have been obvious that") so long as the expert declaration contains statements in support of factual findings (saying an expert's evidence is considered "in the context of the whole declaration").

    For those claims where the panel vacated and remanded, the Court held that either the Examiner or the Board or both failed to set forth the factual bases for deciding that the claims were obvious.  Claims 57-62 and 65 are directed to a cradle having electrical contacts and a computing device to mate with the cradle.  The panel agreed with Icon that the PTAB's decision was not supported by substantial evidence, because neither the Examiner nor the Board made factual findings to support an obviousness determination nor recited an explanation of how the facts supported the ultimate decision that the claims were obvious.  The deficiency was not that the Board relied upon the Examiner's fact-findings but that those findings were based entirely upon attorney argument by Strava.  Because "[a]ttorney argument is not evidence" (other than an admission) it could not support the Board's obviousness determination by substantial evidence.  The panel came to a like result for claims 46 and 74, directed to embodiments comprising a microphone for a user voice-activated controller, as well as claims 98-100, directed to embodiments comprising an accelerometer.

    Icon made similar arguments for Claim 86 (for embodiments where the cradle comprised a wireless interface), but the Court rejected them.  For this claim, the Board incorporated factual findings that the Examiner had actually made, and for which the Court found an adequate evidentiary basis.  Moreover, the Board also explained its decision to the Court's satisfaction on review.  The Court came to a similar conclusion regarding claims 43 and 71, for embodiments comprising a virtual reality display.  Finally, the panel also rejected Icon's allegations that one of the prior art references taught away from the claimed invention, and that the Board had improperly relied upon a written description argument to support rejection of these claims.

    Judge O'Malley dissented in part based on the panel's decision to remand for further considerations.  In her view (shared with Judge Newman, in In re Van Os, 844 F.3d 1359, 1362 (Fed. Cir. 2017)), the PTO (and PTAB) bear the burden of establishing unpatentability during examination (and reexamination).  Failing to do so should not result in remand (essentially, giving the Office another bite at the invalidity apple), but in the Court reversing the Board and affirming the validity of claims 46, 57-62, 65, 74 and 98-100.  These differing approaches can be understood based on whether inter partes reexamination is considered to involve the patentee and the Board (with the third party requestor providing counterpoint to the Board's deliberations) or whether the public interest should be the principal factor in the outcome.  Insofar as reexaminations and post-grant reviews generally are thought to be best used to ensure valid patents are granted by the PTO, procedural issues like those that concern Judges O'Malley and Newman are trumped by the importance of "getting it right."  Thus, the Board should be permitted on remand to properly consider the evidence and come to the "correct" conclusion.  This seems to be the view held by the Patent Office and the majority of the Federal Circuit.  It is also likely shared by the Supreme Court in light of that Court's concerns with patenting improperly preventing the free use of technology and falling outside the bounds of limited "monopoly" just sufficient to promote progress according to the Founders' intent.

    Icon Health & Fitness, Inc. v. Strava, Inc. (Fed. Cir. 2017)
    Panel: Circuit Judges O'Malley, Reyna, and Wallach
    Opinion by Circuit Judge Wallach; concurring-in-part and dissenting-in-part opinion by Circuit Judge O'Malley

  • By James Cherry* & Adam Denley** —

    Australian FlagThe scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims.  Second medical use inventions can be claimed in an ever increasing number of claim formats depending on the jurisdiction.  While such inventions in Europe are now claimed in purpose-limited-product format, or so called 'EPC2000' format, and in the U.S. are pursued in method of medical treatment format, the humble Swiss-style claim has been again shown to be of immense value in Australia even though methods of treatment claims are also an allowable format.  So much so, that an injunction against a competitor was granted solely on the basis of infringement of Swiss-style claims.

    How did this occur?

    The basic legal test is that the exclusive patent rights conferred on a patentee in Australia includes the right to offer an invention for sale.  Should a patentee have a product or composition of matter claim then an offer by a third party of a product which falls within the scope of that granted claim will, or course, be an infringement.  However, it is less clear what conduct infringes a patent for a second, or subsequent, medical use invention.

    In the recent pregabalin court case1 it was held that for method of medical treatment claims, an offer to sell a product referred to in those method claims cannot be an infringement as infringement requires the actual method of treatment to be performed.  Australia does have statutory contributory infringement provisions which are enlivened where the supply of a product occurs and the use of that product by a person would be an infringement.  However, these contributory infringement provisions were found not to apply where a third party merely offers to supply a product, but does not in fact supply that product.

    This then leaves the often forgotten Swiss-style claim which arose in Europe to circumvent the exclusion of methods of medical treatment as patentable subject matter.  This claim format, "Use of substance X in the manufacture of a medicament for the treatment of condition Y", is often overshadowed by method of treatment format as it avoids claiming the medical treatment in a rather unusual way by claiming the manufacture but obtaining novelty and inventiveness from the condition to be treated.  The injunction granted in the pregabalin case was on the basis that it was an infringement of a Swiss-style claim to offer to supply a pharmaceutical product that results from the use of a method of manufacture the subject of the granted Swiss-style claims.  This clearly highlighted a benefit of the granted Swiss-style claims that was not afforded by the granted method of medical treatment claims.

    Australian courts have confirmed that Swiss-style claims have different scope than method of medical treatment claims (see our previous article here), and this pregabalin decision shows that the scope for enforcement of Swiss-style claims is also different and perhaps broader.

    1 Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94.

    * Mr. Cherry is a Principal with and the Managing Director of FPA Patent Attorneys.
    ** Dr. Denley is an Associate Principal with FPA Patent Attorneys.

    This article was reprinted with permission from FPA Patent Attorneys.

  • CalendarFebruary 28, 2017 – "Trends in Paragraph IV Challenges: What Lies Ahead in 2017 and Beyond" (The Knowledge Group) – 12:00 to 2:00 pm (EST)

    March 1, 2017 – "Ex Parte Schulhauser and Claim Drafting for Computer-Implemented Inventions" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    March 2, 2017 – "From Chevron to Cuozzo Round II: A Closer Look at Administrative Law Issues in PTO Proceedings" (Federal Circuit Bar Association) – 1:00 pm to 2:00 pm (EST)

    March 2, 2017 – "Responding to Patent Demand Letters: Leveraging State Laws on Bad Faith Assertion of Patents — Determining What to Include or Exclude in Response, Minimizing Risk of Litigation" (Strafford) – 1:00 to 2:30 pm (EST)

    March 2, 2017 – "Induced Infringement of Method Claims in Light of Suprema v. ITC" (The Knowledge Group) – 12:00 to 1:00 pm (EST)

    March 8, 2017 – "How to Structure PTAB Proceedings and Appeals before the Federal Circuit" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:00 pm (ET)

    March 9, 2017 – "How to Use Broadest Reasonable Interpretation to Your Advantage in Patent Prosecution — Establishing Scope of Claims, Avoiding Sect. 112(f), Preserving Enforceability" (Strafford) – 1:00 to 2:30 pm (EST)

    March 9-10, 2017 - Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH.

    March 14, 2017 – "Post-Grant Review at the PTAB: What Petitioners and Patent Owners are Doing and What Lies Ahead?" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    ***Patent Docs is a media partner of this conference or CLE

  • MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Post-Grant Review at the PTAB: What Petitioners and Patent Owners are Doing and What Lies Ahead?" on March 14, 2017 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorney and Patent Docs author Andrew Williams, Ph.D. and MBHB attorney James L. Lovsin will discuss the following topics:

    • An overview of PGR-proceeding mechanics, and how they differ from IPRs;
    • A review of the PGR petitions filed to date, identifying any potential trends;
    • An analysis of strategies used by PGR petitioners, and used by patent owners seeking to avoid institution, including how petitioners and patent owners are addressing asserted prior art that is not a patent or published application; and
    • A discussion of how we think the PGR estoppel provision might be applied from a review of Federal Circuit and district court cases applying the comparable provision for IPR proceedings.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Ex Parte Schulhauser and Claim Drafting for Computer-Implemented Inventions" on March 1, 2017 from 2:00 to 3:00 pm (ET).  Christopher Francis of Bejin Bieneman, Scott McKeown of Oblon, and Eric Raciti of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will discuss follow-on decisions citing Schulhauser to provide insight into the varied types of method-claim limitations that have not been given patentable weight, including how to avoid emerging trigger words such as, "carrying out a step upon a threshold being exceeded," "upon," "whether," or "when," and will also discuss how these decisions extend Schulhauser's holding to system, machine, and apparatus claims without means-plus-function limitations, and will give other relevant practice tips.

    The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "From Chevron to Cuozzo Round II: A Closer Look at Administrative Law Issues in PTO Proceedings" on March 2, 2017 from 1:00 pm to 2:00 pm (EST).  Andrew M. Mason of Klarquist Sparkman, LLP will moderate a panel consisting of Russell E. Cass of Sidley Austin LLP; Melissa N. Patterson, Attorney, Appellate Staff, Civil Division, U.S. Department of Justice; Molly Silfen, Office of the Solicitor, U.S. Patent and Trademark Office; and Lucas C. Townsend of Gibson, Dunn & Crutcher LLP.  The panel will take a deeper dive into some of the specific cases and administrative law issues that arise in PTO proceedings, including the reviewability of PTAB institution decisions, PTO rulemaking, claim amendments in PTAB proceedings, and the requirement for due process / fair notice in PTO proceedings.

    The registration fee for the webcast is $125 (non-member private practitioner), $50 (non-member government/academic/retired), or free (FCBA member).  Those interested in registering for the webcast, can do so here.

  • The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Induced Infringement of Method Claims in Light of Suprema v. ITC" on March 2, 2017 from 12:00 to 1:00 pm (EST).  Jonathan H. Spadt of RatnerPrestia and Louis L. Campbell of Winston & Strawn LLP will provide attendees with an in-depth analysis of the fundamentals as well as recent developments in the induced infringement of method claims resulting from the Suprema v. ITC case.  The panel will cover the following topics:

    • Induced Infringement: A Legal Perspective
    • Section 337 of the Tariff Act — An Overview
    • Identifying a Section 337 Violation
    • Recent Court Decisions
    • Decisions Prior to Suprema
    •
    Practical Effects and Implications of Suprema

    The registration fee for the webcast is $299 (regular rate) or $199 (government/nonprofit rate).  Those interested in registering for the webinar can do so here.

  • Software Patent Directed to Pairing Activity Trackers to a Device Considered Patent-Eligible

    By Joseph Herndon —

    District Court for the Northern District of CaliforniaIn the U.S. District Court for the Northern District of California (San Jose Division), Fitbit, Inc., sued Aliphcom (d/b/a Jawbone) for infringement of U.S. Patent Nos. 9,026,053; 9,106,307; and 9,048,923.  Jawbone filed a motion for judgment on the pleadings that the patents are invalid for failure to claim patent-eligible subject matter under 35 U.S.C. § 101.  The Court denied the motion and found that the patents recite eligible subject matter because the claim limitations, when considered as an ordered combination, supply an inventive concept that transforms the abstract idea into patent eligible subject matter.

    The patents relate to a specific approach to pairing a wireless device, such as a wearable activity tracker, to a "client" and/or "server."  All of the asserted patents share the same specification, and all of the asserted claims recite a method or system for pairing that involves three discrete entities:  a portable monitoring device, a "client," and a "server."  Pairing begins when a user enters account login information (e.g., creates an account or logs into an existing account) in the client.  Next, the client sends a signal to the server to indicate that the pairing process has been triggered, and the server sends back a user interface or user data for use in the pairing process.  The client then wirelessly detects nearby monitoring device(s), requests response(s) from these device(s), and then sends those response(s) to the server.  The server then sends back the list of responsive device(s) that are eligible for pairing (because, for example, they are not already paired with another user account, they are compatible with the user's account, etc.).  The client then sends the eligible device(s) a request to pair.  These device(s) then cue the user, who "taps" the particular device they wish to pair.  The "tapped" device identifies itself to the client, and the client and server complete the pairing process.

    The asserted independent claims generally follow this process.  For example, claim 1 of the '053 patent recites:

    1.  A wireless communication method comprising:
        a first portable biometric device and a second device communicating wirelessly to initiate a pairing process between the first portable biometric device and the second device, wherein the first portable biometric device comprises, at least one sensor, and wireless communication circuitry in a unit suitable to be worn by a moving human device user, wherein initiating the pairing process comprises,
        the second device receiving user login information to log the user into a user account;
        the second device sending a signal to a server that indicates the start of the pairing process;
        the server sending a user interface for pairing to the second device;
        the second device wirelessly detecting the first biometric device, and requesting a response from the first biometric device;
        the second device receiving a response from the first biometric device, including a device identification;
        in response to the second device forwarding the received response to the server, the server sending a list of detected devices eligible for pairing to the second device; and
        when the first biometric device is on the list of detected devices, the second device sending a command to the first biometric device to enter pairing mode;
        the first portable biometric device generating a cue to the first portable biometric device user requesting the first portable biometric device user to validate the pairing between the first portable biometric device and the second device;
        the first portable biometric device receiving input from the user indicating the user's agreement to validate the pairing request, wherein input comprises tapping only the first portable biometric device one or more times anywhere on its exterior;
        the first portable biometric device detecting the tapping using a motion sensor;
        the first portable biometric device responding to the user input by remotely signaling the second device to complete the pairing process;
        the second device and the first portable biometric device remotely communicating to complete the pairing process, wherein the first portable biometric device and a second device are remote from each other throughout the pairing process, after which the first portable biometric device and the second device are able to recognize each other; and
        the first portable biometric device and the second device automatically communicating to wirelessly exchange data subsequent to pairing when the first portable biometric device and the second device are within wireless communication range;
        wherein data comprises sensor data collected and stored by the first portable biometric device.

    The Court followed the two-step process to determine whether the claims satisfied section 101.  First, the court must determine whether the claims at issue are directed to a patent-ineligible concept.  Second, if the claims are directed to patent-ineligible subject matter, the Court must consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application.

    Step One

    The Court noted that, to date, the Federal Circuit has provided two examples of software claims that are not directed to an abstract idea.  First, in Enfish, the Federal Circuit determined that claims directed to a specific type of self-referential table for a computer database were not abstract because they focused on the specific asserted improvement in computer capabilities (i.e., the self-referential table for a computer database) instead of a process that qualifies as an abstract idea for which computers are invoked merely as a tool.  Second, in McRO, Inc. v. Bandai Namco Games Am. Inc., the Federal Circuit found that patents that automated part of a preexisting method for 3-D facial expression animation were not abstract because they focused on a specific asserted improvement in computer animation, i.e., the automatic use of rules of a particular type.

    Jawbone argued that the asserted claims are directed to the abstract ideas of identifying and validating an electronic device through minimal user interaction, and as such, they focus on a fundamental building block of today's internet-based society — wirelessly connecting two computerized devices to enable the exchange of data.

    The Court found that Jawbone's characterization of the claims sweeps too broad, and the "character as a whole" of the claims is not directed to device pairing generally, but a specific flavor of portable device pairing, which is aware of user account information, relies on a "server" to regulate the list of eligible devices, and uses "tapping" as the means of user validation.  The Court highlighted the claims' use of (1) a server to identify eligible devices and (2) tapping to indicate user validation, which specifically improves portable monitoring device technology, as this overcomes the problem that portable monitoring devices are small and often do not have keyboards or buttons that could be used in a pairing process.

    While device pairing, in its most basic form, constitutes an abstract idea according to the Court, the claims are more specific.  The claim features of a server and tapping confine the asserted claims to less than device pairing generally, and appear to provide an improvement to device pairing solutions that lack these steps.  But the Court found that the claims present a close call about how to characterize what the claims are directed to, and in such cases, an analysis of whether there are arguably concrete improvements in the recited computer technology could take place under step two.  Thus, the Court declined to decide whether the claims' particular variant of portable device pairing is an abstract idea, and assessed whether, even if it is, the concrete improvements they recite are inventive concepts under step two.

    Step Two

    In assessing step two, courts must consider the elements of each claim both individually and as an ordered combination and assess whether there are any additional features in the claims that constitute an inventive concept.

    The Court found that none of the claim elements, assessed individually, provide an inventive concept.  The Court also found that the claims' relation to wearable activity tracker technology, in and of itself, does not make them patent-eligible.

    But the Court found that the ordered combination of claim elements, interpreted in the light most favorable to Fitbit, contains inventive concepts.  First, the addition of tapping as the form of validation is an inventive concept.  As the background section of the patents highlights, one problem that confronted the process of pairing small, portable devices was that they were purposefully designed to eliminate keyboards and multiple buttons in order to satisfy other design criteria.  Tapping overcame this problem in an inventive way because it took advantage of the inherent, technical capabilities of the portable monitoring device — its ability to detect motion with a motion sensor — to provide a manner of validating the device that was different from traditional forms of input (i.e., buttons and keyboards).

    Jawbone nevertheless contended that tapping cannot supply an inventive concept because it was known in the art.  The Court noted that this argument conflates patent eligibility with novelty, which are inquiries that, although they might sometimes overlap, are separate.  Thus, even if tapping was a known form of validation, this does not necessarily prevent it from having a transformative effect on an abstract idea and bringing it within the realm of patentable subject matter.  Adding in tapping to a portable device pairing process — even if tapping was a known form of validation — transforms a more abstract device pairing process into something specific:  a pairing process narrowly tailored to a certain class of devices, which enables them to be paired even though they lack buttons or keyboards.  In this sense, the Court determined that it "improves an existing technological process" by expanding the scope of devices that can be paired.

    The Court found that the use of a server as a part of the claimed pairing process also supplies an inventive concept.  As the name suggests, the concept of pairing traditionally involves two devices:  the device that gets paired and the device it is paired with.  By injecting a third device — a server — into this process, the asserted claims shift this paradigm so that all of the information needed for pairing does not have to be provided through the two devices.  Instead, the server can also regulate and facilitate this process.  Thus, the server limitation also helps transform a more abstract device pairing process into "something more" because it narrows it to a specific, discrete implementation of this idea that specifically addresses needs in the particular field of portable device monitors.

    In sum, both the use of tapping and the use of a server, when considered along with the rest of the claims as an ordered combination, supply an inventive concept that transforms the asserted claims into patent eligible subject matter under step two.  As a result, the Court concluded that the asserted claims are patent eligible under 35 U.S.C. § 101 because they contain an inventive concept sufficient to transform these claims into patentable subject matter.

    Order Denying Defendants' Motion for Judgment on the Pleadings by District Judge Edward J. Davila

  • By Donald Zuhn —

    Supreme Court Building #1Earlier today, in Life Technologies Corp. v. Promega Corp., the Supreme Court reversed a determination by the Federal Circuit that there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States, holding instead "that a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f)(1)."

    The Federal Circuit had earlier determined in Promega Corp. v. Life Technologies Corp. that substantial evidence supported a jury's finding that Life Technologies infringed U.S. Patent No. RE37,984 ("the Tautz patent") under 35 U.S.C. § 271(f)(1), and therefore had reversed the District Court's grant of judgment as a matter of law (JMOL) of noninfringement.  The Tautz patent, which is owned by Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. and exclusively licensed to Promega, claims a kit for testing at least one STR locus that contains: (1) a mixture of primers; (2) a polymerizing enzyme such as Taq polymerase; (3) nucleotides for forming replicated strands of DNA; (4) a buffer solution for the amplification; and (5) control DNA.  Life Technologies manufactures genetic testing kits that provide components for carrying out a multiplex amplification of STR loci from DNA samples, wherein the kits contain (1) a primer mix; (2) Taq polymerase; (3) PCR reaction mix including nucleotides; (4) a buffer solution; and (5) control DNA.

    In 2010, Promega sued Life Technologies for infringement of the Tautz patent (as well as four other patents owned by Promega), alleging that Life Technologies had sold kits that were not covered by the license agreement between the parties (the license agreement limited Life Technologies' use of the patents-in-suit to activities related to legal proceedings, i.e., live forensic investigations conducted by police officers).  The parties moved for summary judgment on infringement and invalidity, with the District Court determining that Life Technologies' sales outside the license agreement's field of use were infringing.  Following trial, the jury returned a verdict of willful infringement.  Life Technologies then moved for JMOL and the District Court granted the motion, finding that Promega had failed to present sufficient evidence to sustain a jury verdict under § 271(f)(1), and vacated the finding of infringement.

    On appeal, the Federal Circuit reversed the District Court's grant of JMOL of noninfringement.  The panel was divided as to the finding of infringement under § 271(f)(1), but the divide centered on another aspect of the statute.  With regard to the issue of whether infringement under § 271(f)(1) requires that at least two components be supplied from the U.S., the Federal Circuit held "that there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States," and "based on the facts of this particular case . . . conclude[d] that substantial evidence supports the jury's verdict that LifeTech is liable for infringement under § 271(f)(1) for shipping the Taq polymerase component of its accused genetic testing kits to its United Kingdom facility."

    The Supreme Court granted certiorari to determine whether a party that supplies a single component of a multicomponent invention for manufacture abroad can be held liable for infringement under § 271(f)(1).  As the Court pointed out in its opinion, Life Technologies manufactured all but one component of its kits in the United Kingdom — manufacturing Taq polymerase in the United States and then shipping the Taq polymerase to its United Kingdom facility to be combined with the other four components of the kit.

    The Court began by noting that § 271(f)(1) reads as follows (with emphasis added):

    Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

    According to the Court, "[t]he threshold determination to be made is whether §271(f)(2)'s requirement of 'a substantial portion' of the components of a patented invention refers to a quantitative or qualitative measurement."  Life Technologies argued that § 271(f)(1) establishes a quantitative threshold, and Promega countered that a "substantial portion" of the components includes a single component if that component is sufficiently important to the invention.

    In answering the threshold inquiry, the Court noted that the Patent Act does not define the term "substantial," and that the ordinary meaning of the term was of "little help," since "[a]ll agree the term is ambiguous and, taken in isolation, might refer to an important portion or to a large portion."  However, when the Court looked at the context in which the term appears in the statute, that context pointed to a quantitative meaning.  In particular, the Court indicated that the terms "all" and "portion" in the statute convey a quantitative meaning.  The Court also noted that "there is nothing in the neighboring text to ground a qualitative interpretation."

    The Court declined Promega's invitation to adopt a "case-specific approach" in which the factfinder would have to decipher whether the components at issue are a "substantial portion" under either a qualitative or quantitative test, stating that "[h]aving determined the phrase 'substantial portion' is ambiguous, our task is to resolve that ambiguity, not to compound it by tasking juries across the Nation with interpreting the meaning of the statute on an ad hoc basis."  Moreover, the Court noted that:

    [C]onsidering the qualitative importance of a component . . . might just as easily complicate the factfinder's review.  Surely a great many components of an invention (if not every component) are important.  Few inventions, including the one at issue here, would function at all without any one of their components.  Indeed, Promega has not identified any component covered by the Tautz patent that would not satisfy Promega's "importance" litmus test.  How are courts—or, for that matter, market participants attempting to avoid liability—to determine the relative importance of the components of an invention?  Neither Promega nor the Federal Circuit offers an easy way to make this decision.

    Having determined that the term "substantial portion" refers to a quantitative measurement, the Court next turned to the question of whether, as a matter of law, a single component can ever constitute a "substantial portion" so as to trigger liability under § 271(f)(1).  In answering that question in the negative, the Court noted that § 271(f)(1) consistently refers to "components" in the plural, stating that "[t]ext specifying a substantial portion of 'components,' plural, indicates that multiple components constitute the substantial portion."  The Court therefore held that "one component does not constitute 'all or a substantial portion' of a multicomponent invention under §271(f)(1)," adding that to resolve the question presented, the Court did not need to define how close to "all" of the components "a substantial portion" must be.

    Having found that the phrase "substantial portion" in § 271(f)(1) has a quantitative, not a qualitative, meaning, and further, that § 271(f)(1) does not cover the supply of a single component of a multicomponent invention, the Court reversed the judgment of the Federal Circuit and remanded the case since only a single component of the patented invention at issue was supplied from the United States.

    Life Technologies Corp. v. Promega Corp. (2017)
    Opinion of the Court by Justice Sotomayor, joined by Justices Kennedy, Ginsburg, Breyer, and Kagan; joined as to all but Part II-C by Justices Thomas and Alito;
    Opinion concurring in part and concurring in the judgment by Justice Alito, joined by Justice Thomas;
    Chief Justice Roberts took no part in the decision of the case.

  • By Nicholas Vincent* and Anthony D. Sabatelli** —

    Research into the human microbiome has resulted in such unprecedented amounts of data that challenges related to both interpretation and management have emerged.  Somewhat paradoxically, current statistical methods have made it such that it is more difficult and less likely to identify statistically significant results from large data sets.  We see much potential for the expansion of intellectual property protection in the area of big data related to the microbiome, not only as a result of recent research advances and the desire to better and more efficiently handle big data, but also because of several recent Federal Circuit decisions in intellectual property law that provide some promising guidance for protecting software and computing information that may be required for managing and interpreting microbiome-related data.  Moreover, the United States Patent and Trademark Office (USPTO) has provided examples for crafting potentially patent eligible claims in this space, a promising step forward in what has become a difficult area for IP protection.

    The Human Microbiome Project and the Introduction of Big Data

    When the Human Microbiome Project (MHP) began in 2008, researchers had hoped to describe and characterize the microbial communities living in association with humans.  In particular, the MHP aimed to describe the microorganism population of five areas of the human body:  the mouth, skin, vagina, gut, and nose/lung.  Understanding the normal composition of these communities would, researchers hoped, help to shed light on how various external influences (disease, diet, medication, etc.) might affect the composition.  However, taking this further to find causative relationships between the microbiome and disease where only correlations have been shown has remained a rather difficult task.  In particular, the HMP resulted in large, and at times unwieldy, sets of data.  Although these data sets contained a plethora of information, they were difficult to comb through and understand to their fullest extent.

    Since the beginnings of the MHP, microbiome related research has ballooned, with scientists regularly seeking to make connections between an individual's microbiome and the likelihood of developing a certain disease or condition, such as, for example, obesity, or even exhibiting certain psychological conditions.  As research in the area expands, many researchers continue to call for better ways to manage and curate the resulting large datasets that have resulted from these investigations.  Additionally, it is apparent to many in the field that there are shortcomings in data interpretation that have prevented an understanding of causative relationships between microbial communities rather than only correlative ones.

    As the costs related to sequencing technologies have decreased dramatically, it has become increasingly more possible to produce large-scale datasets that are the product of sequencing microbial communities.  Sequencing communities to understand their composition has eliminated the historical concern of in vivo culture conditions, particularly because so many microorganisms are 'unculturable' under current lab conditions, thereby excluding them from analyses of microbial community compositions.

    Handling Big Data and Associated Challenges

    Large datasets often seem like a veritable treasure trove of information for researchers, but challenges abound with regards to interpretation.  It is possible to think of these datasets as large tangled networks that require appropriate methods, treatment, and attention to reveal their hidden secrets.  As mentioned above, a somewhat paradoxical situation arises with large datasets:  the larger the dataset, the more difficult it is to extract statistically significant information.  This is due to multiple hypothesis corrections, and it may only be solved through the development of novel statistical methods for analysis and interpretation.  As such, novel statistical methods and computing analysis approaches are needed to better deal with these large datasets.  This, in turn, requires an intellectual property landscape amenable to protecting innovations in this space.

    Intellectual Property and Big Data

    The legal landscape with respect to intellectual property protection surrounding software is rapidly evolving.  Many have interpreted the Supreme Court decision in Alice Corp. v. CLS Bank International to suggest that software and algorithm-based innovations are not patent eligible under 35 U.S.C. § 101.  This has resulted in countless challenges for those seeking to patent advancements in software and computing.  There have, however, been several important decisions issued by the United States Court of Appeals for the Federal Circuit that have provided some hope for the patent eligibility of software-related innovations.  First, there is the Enfish decision, which focused on improvements in the prior art instead of the abstract nature of the software-related claims.  The claims were ruled patent eligible under 35 U.S.C. § 101.  Second is the BASCOM decision, which stated that a District Court decision holding a computer network filtering system as patent ineligible had incorrectly applied the framework for patent subject matter eligibility put forth in the Alice decision, and that the filtering system was, in fact, patent eligible.  Third is the McRO decision, which stated that lip synchronization software claims were directed towards an improvement in already existent technology and were not merely directed towards an abstract idea.  Similar to the Enfish decision, the McRO decision focused on an improvement in the prior art instead of the abstract nature of the software-related claims.

    In addition to these promising decisions regarding patent eligibility of software-related claims, the United States Patent and Trademark Office (USPTO) has issued a memo on Recent Subject Matter Eligibility Decisions to provide guidance in drafting claims that may have been rendered patent ineligible under the Alice framework.  Moreover, the USPTO has signaled it will continue to provide guidance in the future and has continued to emphasize the importance of its subject matter eligibility court case guidance chart, which provides claims drafters guidance on which cases should be cited as precedential and which should not.

    Conclusion and Outlook: Advancing Big Data from the Microbiome in the Current Legal Landscape

    We see a promising movement towards patents incorporating advancements pertaining to computing and including large data sets and sequencing.  In several granted patents (see Table 1), we have also begun to note research that relies on and is indicative of advancements related to big data and sequencing.  Although the patents in Table 1 do not include big data claims, the claims that are presented have often resulted from and rely on these kinds of advancements.  As patents related to software and computing become more accessible, we expect a corresponding expansion in patent applications relying on big data.

    Taken together, we believe that the Federal Circuit's and USPTO's actions suggest a more navigable landscape for patent-eligible claims related to software and computing — an area from which microbiome research could greatly benefit and progress.  In the developing legal landscape, we believe that microbiome researchers will be better armed to develop novel innovations that tackle the complexities of big data.  The focus will have to be on advancements over prior art instead of the abstract nature of the computing advances.  These advances will not only help to interpret the data that are already available, but will also help researchers to ask more probing questions.  Currently, many investigations have revealed strong correlations between changes in the microbiome and disease.  Further advancements in the management of big data will hopefully bring microbiome research into a new era — one that addresses causative relationships that have, thus far, remained largely elusive.

    Table 1

    * Nicholas Vincent is a Technology Specialist at Dilworth IP
    ** Dr. Sabatelli is a Partner with Dilworth IP

    Note — the authors of the above post will be offering a free webinar on February 22, 2017 at 2:00 pm (EST).  The webinar, entitled "Patenting the Microbiome: Trends, Challenges, and Insights," will offer an overview of the microbiome, specifically, the IP challenges that it presents, and recommendations for a robust path forward.  Those interested in registering for the webinar, can do so here.

    For additional information regarding this topic, please see:

    • " The Emergent Microbiome: A Revolution for the Life Sciences — Part IX, The Microbiome and Immunotherapy II," December 6, 2016
    • "The Emergent Microbiome: A Revolution for the Life Sciences — Part VIII, The Microbiome and Immunotherapy I," October 31, 2016
    • "The Emergent Microbiome: A Revolution for the Life Sciences — Part VII, The Microbiology of the Built Environment," October 5, 2016
    • "The Emergent Microbiome: A Revolution for the Life Sciences – Part V, Patents Relating to Obesity and Metabolic Disorders," February 28, 2016
    • "The Emergent Microbiome: A Revolution for the Life Sciences – Part IV, Obesity and other Metabolic Disorders," February 18, 2016
    • "Jackson Laboratory Hosts Microbiome Symposium Related to Cancer and Immunology," January 19, 2016
    • "The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Psychobiotics," October 13, 2015
    • "The Emergent Microbiome: A Revolution for the Life Sciences – Part II, 2015 Patent Trends," August 11, 2015
    • "The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders," August 10, 2015