Patent Law Weblog

recent posts

about

  • The Chamberlain Group, Inc. v. Techtronic Industries Co. (Fed. Cir. 2019)

    By Michael Borella —

    Federal Circuit SealAnother week and another technology patent falls to a patentable subject matter challenge under Alice Corp. v. CLS Bank Int'l.  In this case, the patentee may have effectively shot itself in the foot with its own statements made in the specification.  But the Federal Circuit also provides its clearest explanation yet (but one that is still not clear enough) of how it expects the second part of the Alice analysis to be carried out.

    Chamberlain sued Techtronic Industries (TTI) and several other parties in the Northern District of Illinois, contending infringement of U.S. Patent No. 7,224,275.  TTI moved the District Court for judgment as a matter of law that the '275 patent was invalid under 35 U.S.C. § 101.  The District Court denied the motion and TTI appealed.

    Claim 1 of the '275 patent was deemed representative by the parties.  It recites:

    1.  A movable barrier operator comprising:
        a controller having a plurality of potential operational status conditions defined, at least in part, by a plurality of operating states;
        a movable barrier interface that is operably coupled to the controller;
        a wireless status condition data transmitter that is operably coupled to the controller, wherein the wireless status condition data transmitter transmits a status condition signal that:
            corresponds to a present operational status condition defined, at least in part, by at least two operating states from the plurality of operating states; and
            comprises an identifier that is at least relatively unique to the movable barrier operator, such that the status condition signal substantially uniquely identifies the movable barrier operator.

    Notably, the claim does not cover an entire garage door opening apparatus, such as a track, pulley, cable, or belt.  It effectively involves only a controller (e.g., a microprocessor), the movable barrier interface (e.g., a motor), and a wireless transmitter.

    The Alice test is used to determine whether claims are eligible for patenting under § 101.  One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

    The District Court found that the claimed invention was "not directed to the transmission of data, but to garage door openers that wirelessly transmit status information."  Ultimately, the District Court found that "the asserted claims are directed to a particular improvement over prior art which uses a particular manner of sending and experiencing data," which it deemed patent-eligible in light of [the Federal Circuit's] decision in Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc.

    On Appeal, the Federal Circuit applied the Alice test.  The Court quickly concluded that claim 1 was directed to abstract idea of "wirelessly communicating status information about a system."  Driving this outcome was the specification, and in particular the fact that the "only described difference between the prior art movable barrier operator systems and the claimed movable barrier operator system is that the status information about the system is communicated wirelessly, in order to overcome certain undesirable disadvantages of systems using physical signal paths."  The Court noted that the identified abstract idea was similar to those found ineligible in various other Federal Circuit cases, such as Amdocs (Israel) Ltd. v. Openet Telecom, Inc.; Affinity Labs of Tex., LLC v. DIRECTV, LLC; and Affinity Labs of Texas, LLC v. Amazon.com Inc.  The Court also seemed put off by the claim's breadth, as it wrote that it is "not limited to a specific implementation of a technological improvement to communication systems . . . [r]ather . . . a system that wirelessly communicates status information."  The Court further found that the wireless communication is not a technological improvement.  Notably, "that the claimed invention transmits data wirelessly and therefore does not rely on a wired path is not itself a technological improvement, but rather simply a feature of wireless communication, which the specification explains was already a basic, conventional form of communication."

    Chamberlain argued that the claims involved a non-abstract and "novel combination of its prior art movable barrier operator with a transmitter that is wireless."  But the Court found this argument to be based on a field of use limitation and therefore still abstract under Alice.  Additionally, Chamberlain attempted to establish that the physical aspects of the claimed invention were enough to avoid the abstract idea classification.  But, using reasoning that should surprise no one at this point, the Court stated that this was not the case when using "off-the-shelf technology for its intended purpose."

    The Court then applied the second part of the Alice test.  It observed that "[t]he specification describes each individual element of the asserted claims—including the controller, the interface, and the wireless data transmitter—as 'well understood in the art.'"  Chamberlain argued that "the ordered combination of . . . elements provides the inventive concept because there is no evidence in the record that a new type of movable barrier operator that includes an integrated controller and a wireless transmitter to transmit a status signal was well-understood, routine and conventional to a skilled artisan."  In response, the Federal Circuit explained that:

    The appropriate question is not whether the entire claim as a whole was well-understood, routine and conventional to a skilled artisan (i.e., whether it lacks novelty), but rather, there are two distinct questions: (1) whether each of the elements in the claimed product (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field, and (2) whether all of the steps as an ordered combination add nothing to the laws of nature that is not already present when the steps are considered separately.

    The Court never explained what exactly it means for all steps of an ordered combination to add nothing over the steps considered separately.

    In any event, the Court went on to state that "the specification makes clear that transmitting information wirelessly was conventional at the time the patent was filed and could be performed with off-the-shelf technology [and] wireless transmission is the only aspect of the claims that [Chamberlain] points to as allegedly inventive over the prior art."  Further, "[w]ireless communication cannot be an inventive concept here, because it is the abstract idea that the claims are directed to."  As the Court found no inventive concept, the claim failed the Alice test.

    Accordingly, the Federal Circuit reversed the District Court and held the asserted claims invalid under § 101.

    This case is another example of judicial-exception-creep, in line with that of ChargePoint, Inc. v. SemaConnect, Inc.  Similar to that decision, an invention that adds particular communication abilities to a physical device is rendered an "abstract idea" because the Court found that the only innovative part of what is claimed was the (allegedly abstract) communication itself.  Of course, the specification served to quickly sink the claim by admitting that all claimed elements were known in some fashion or another (even if the combination was not), but under the current patent-eligibility regime even a more carefully-worded application would have likely led to the same outcome.

    The invention here (as in ChargePoint) might have been more rationally invalidated on grounds of obviousness, though its 2003 priority date was well before wireless transceivers were being added to all kinds of conventional devices.  Nonetheless, § 101 is once again the wrong tool for applying the prior art motivated invalidation.  There are other parts of the statute to serve that function.

    The Chamberlain Group, Inc. v. Techtronic Industries Co. (Fed. Cir. 2019)
    Panel: Circuit Judges Lourie, O'Malley, and Chen
    Opinion by Circuit Judge Chen

  • University of California/Berkeley Granted Yet Another CRISPR Patent

    By Kevin E. Noonan —

    University of California-BerkleyOn Tuesday, the U.S. Patent and Trademark Office granted U.S. Patent No. 10,385,360 to the University of California/Berkeley, directed to an aspect of its CRISPR technology (where CRISPR is an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats).  The independent claims of the '360 patent read as follows:

    1.  A nucleic acid molecule encoding a single molecule DNA-targeting RNA, wherein the single molecule DNA-targeting RNA comprises: (a) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a target sequence in a target DNA molecule, and (b) a protein-binding segment comprising two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides, wherein the DNA-targeting segment is positioned 5' of both of said two complementary stretches of nucleotides, and wherein the single molecule DNA-targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule.

    4.  A composition comprising: (1) a single molecule DNA-targeting RNA, or a nucleic acid encoding said single molecule DNA-targeting RNA, wherein the single molecule DNA-targeting RNA comprises: (a) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a target sequence in a target DNA molecule, and (b) a protein-binding segment comprising two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides, wherein the DNA-targeting segment is positioned 5' of both of said two complementary stretches of nucleotides, and wherein the single molecule DNA-targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule; and (2) one or more of: (i) a nuclease inhibitor, (ii) a buffering agent, and (iii) a pharmaceutically-acceptable, non-toxic carrier or diluent.

    The priority relationship of the '360 patent to the rest of the Berkeley portfolio is set forth on the face of the patent:

    This application is a continuation of U.S. patent application Ser. No. 15/435,233 filed Feb. 16, 2017 (U.S. Patent No. 10,407,697, issue date Sep. 10, 2019), which is a continuation of U.S. patent application Ser. No. 15/138,604 filed Apr. 26, 2016 (U.S. Patent No. 10,113,167, issued Oct. 30, 2018), which is a continuation of U.S. patent application Ser. No. 14/685,502 filed Apr. 13, 2015 (U.S. Patent No. 10,000,772, issued Jun. 19, 2018), Ser. No. 14/685,504 filed Apr. 13, 2015 (U.S. Patent No. 10,301,651, issued May 28, 2019), Ser. No. 14/685,513 filed Apr. 13, 2015 (abandoned), Ser. No. 14/685,514 filed Apr. 13, 2015 (abandoned), Ser. No. 14/685,516 filed Apr. 13, 2015 (abandoned), and Ser. No. 14/942,782 filed Nov. 16, 2015 (U.S. Patent No. 10,227,611, issued Mar. 12, 2019), each of which is a continuation of U.S. patent application Ser. No. 13/842,859 filed Mar. 15, 2013 (U.S. Patent No. 10,266,850, issued Apr. 23, 2019), which claims the benefit of U.S. Provisional Patent Application Nos. 61/652,086 filed May 25, 2012, 61/716,256 filed Oct. 19, 2012, 61/757,640 filed Jan. 28, 2013, and 61/765,576, filed Feb. 15, 2013, each of which applications is incorporated herein by reference in its entirety.

    None of these patents are involved in the recently declared interference, nor are they the subject of the Board's order to inform the Board and Senior Party, the Broad Institute, should they be allowed.  The claims correspond to an RNA component of a CRISPR-Cas9 complex for performing "gene editing" rather than the more comprehensive claims reciting the entire system.

    The prosecution history shows no rejection on either the written description nor enablement provisions of 35 U.S.C. § 112(a), which is curious in view of the breadth of the claims (which can be read as comprising "a DNA-targeting segment comprising any nucleotide sequence that is complementary to any target sequence in a target DNA molecule").  In view of the recent penchant for the Federal Circuit to be concerned about claim breadth (see "Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. (Fed. Cir. 2019)" and "Amgen Inc. v. Sanofi (Fed. Cir. 2017)").  These circumstances — at least in theory — leave these claims vulnerable to invalidation should Berkeley attempt to enforce them against a putative infringer (perhaps, for example, anyone licensing the Broad patents) or more immediately a post-grant review challenge before the Patent Trial and Appeal Board.

    The "Reasons for Allowance" of these claims is instructive regarding at least how the USPTO is thinking about CRISPR:

    The instant claims recite "a single molecule DNA-targeting RNA" comprising "a DNA targeting segment" and "a protein-binding segment," wherein the protein-binding segment comprises "two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides" and wherein the "single molecule DNA targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule".

    The closest prior art is Siksnys (US 9,637,739) and Siksnys (WO 2013/141680) each of which claim priority to US 61/625,420 (filed April 17, 2012) and US 61/613,373 (filed March 20, 2012), which are both prior to the instant effective filing date of May 25, 2012.  These priority documents describe a method of assembling a CRISPR-Cas9 DNA cleavage complex by combining Cas9, crRNA, tracrRNA, and RNase III (see Example 2) or just Cas9, crRNA, and tracrRNA (see Example 3).  Siksnys further discloses the criticality of the tracrRNA molecule to the assembly of a functional Cas9-crRNA DNA cleavage complex (see Figure 16).  These disclosures are supported by US 61/613,373 filed March 20, 2012.  In addition, Deltcheva (Deltcheva et al. (2011) Nature, 471:602-607 and supplementary data published online March 30, 2011) is a relevant prior art.  Deltcheva teaches that "tracrRNA is required for crRNA maturation in S. pyogenes" (see Figure 1).  Deltcheva further illustrates that "Co-processing of tracrRNA and pre-crRNA requires both endogenous RNase III and Csnl in vivo" (see Figure 2), wherein Csnl is a synonym for Cas9. Deltcheva illustrates that this crRNA maturation occurs via hybridization between the crRNA and the tracrRNA to form a dsRNA duplex (see Figure 1).  These disclosures indicate that the prior art recognized both the dsRNA duplex formation between crRNA and tracrRNA and further recognized the criticality of the tracrRNA to the maturation of the crRNA and to the assembly of the Cas9-crRNA cleavage complex.

    However, the prior art did not sufficiently describe or recognize the presence of the tracrRNA molecule in the Cas9-crRNA DNA cleavage complex itself.  This is supported by Siksnys' characterization of the DNA cleavage complex as a "Cas9-crRNA complex" (see Figure 15), which refers only to two components, and the characterization of a "ternary complex" (see description of Figure 14), which refers to the Cas9-crRNA in a complex with the target dsDNA (see Figure 14), for example.  Because the prior art as a whole did not sufficiently describe or recognize the presence of the tracrRNA molecule in the Cas9-crRNA DNA cleavage complex, one of ordinary skill in the art would not have had sufficient motivation to "covalently link" the crRNA and the tracrRNA molecule together with "intervening nucleotides" to form a "single molecule" DNA-targeting RNA as required by the instant claims.  The claims recite eligible subject matter at least because naturally occurring crRNAs and tracrRNAs that hybridize to form a dsRNA duplex capable of forming a complex with a Cas9 protein are not "covalently linked to one another with intervening nucleotides" to form a "single-molecule" DNA-targeting RNA as required by the instant claims.  Accordingly, this structural feature renders the claimed subject matter markedly different from its naturally occurring counterpart.

    This allowance is consistent with the PTAB's judgment of no interference-in-fact in Interference No. 106,048, affirmed by the Federal Circuit, stating "Broad has provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC's claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment.  Specifically, the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRI SPR-Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment.  This evidence shows that the parties' claims do not interfere." (see Interference No. 106,048, "Decision on Motions" mailed February 15, 2017, page 2).  The PTAB's judgment involved and was applicable to all claims of US Patent 8,906,616.

    Accordingly, because the claims of US 8,906,616 have been deemed to be "limited to . . . a eukaryotic environment", and because the instant claims are not limited to a eukaryotic environment, the instant claims do not interfere with the claims of US Patent 8,906,616 or any other claim deemed to be "limited to . . . a  eukaryotic environment."

  • Conference & CLE Calendar

    CalendarAugust 29, 2019 – "How Late Is Too Late? Setting the Timeline for Patent Protection" (Fitch Even) – 12:00 to 1:00 pm (EDT)

    September 9, 2019 – "The Evolving Patent Eligibility of Life Sciences Method Claims" (Practising Law Institute) – 11:00 am to noon (EDT)

    September 17, 2019 – "Best Practices for Patenting Chemical and Material Compositions" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 17, 2019 – "A Primer on the Laws of Cannabis, Marijuana and CBD" (Loeb & Loeb LLP) – 1:00 to 2:00 pm (ET)

    October 3-4, 2019 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago IL

  • Webcast on Patent Eligibility of Life Sciences Method Claims

    PLI #1Practising Law Institute (PLI) will be offering a one-hour webcast on "The Evolving Patent Eligibility of Life Sciences Method Claims" on September 9, 2019 beginning at 11:00 am (EDT).  Patent Docs author Donald L. Zuhn, Jr. of McDonnell Boehnen Hulbert & Berghoff LLP will moderate a panel consisting of Brian A. Cocca of Regeneron Pharmaceuticals, Inc.; June E. Cohan of the Office of Patent Legal Administration at the U.S. Patent and Trademark Office; and Sarah E. Fendrick of McDonnell Boehnen Hulbert & Berghoff LLP.  The panel will discuss:

    • Recent Federal Circuit decisions regarding the patent eligibility of diagnostic method claims and method of treatment claims;
    • What can be distilled from these decisions to better draft patent eligible life sciences method claims;
    • How these decisions are impacting the examination of life sciences method claims at the USPTO;
    • And what may lay ahead in view of the petition for certiorari in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • MBHB Webinar on Patenting Chemical and Material Compositions

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Best Practices for Patenting Chemical and Material Compositions" on September 17, 2019 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorneys Steven Sarussi and James Suggs will provide strategies and practice tips for dealing with the uncertainty of the ever-changing patent law landscape, in the U.S. and abroad, with respect to chemical patent applications, at the time of drafting and during prosecution, with a focus on being prepared to overcome rejections during prosecution, and to provide broad but defensible coverage. Topics will include:

    • Future-proofing your chemical and compositional patent applications for worldwide prosecution
    • Functional claiming in the chemical space
    • Combination inventions and how to claim them
    • Strategies for overcoming rejections — even unreasonable ones
    • Providing claims in prosecution that are defensible in later 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.

  • Webinar on Cannabis, Marijuana, and CBD Law

    Loeb & LoebLoeb & Loeb LLP will be offering a webinar entitled "A Primer on the Laws of Cannabis, Marijuana and CBD" on September 17, 2019 from 1:00 to 2:00 pm (ET).  Monique Bhargava, Brian Heidelberger, Caroline Hudson, and David Levine of Loeb & Loeb LLP will discuss:

    • The locations (across the United States) where cannabis and marijuana are legal
    • The advertising and marketing laws as applied to:
        – Food, drugs and cosmetics
        – Influencers
        – Events
    • The most recent trademark and IP issues in relation to the cannabis and marijuana industry
    • The latest on M&A and other corporate-related matters in the industry

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)

    By Donald Zuhn —

    Federal Circuit SealEarlier this month, in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting a motion for judgment as a matter of law filed by Appellee Genetic Veterinary Sciences, Inc., d/b/a Paw Prints Genetics ("PPG"), and as a result, found that the asserted claims of U.S. Patent Nos. 9,157,114 were patent ineligible under 35 U.S.C. § 101.  The Federal Circuit also affirmed the District Court's denial of a motion to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction filed by Appellants LABOKLIN GmbH & Co. KG ("LABOKLIN") and the University of Bern ("the University").

    The '114 patent, which is owned by the University, relates to in vitro methods for genotyping Labrador Retrievers, in order to discover whether a dog might be a genetic carrier of Hereditary Nasal Parakeratosis ("HNPK"), a disease that causes crusts and fissures to appear on a dog's nose.  A professor at the University discovered that the presence of HNPK in Labrador Retrievers resulted from a point mutation in the gene SUV39H2.  Claims 1-3 of the '114 patent recite:

    1.  An in vitro method for genotyping a Labrador Retriever comprising:
    a) obtaining a biological sample from the Labrador Retriever;
    b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and
    c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

    2.  The method according to claim 1, wherein the genotyping is achieved by PCR, real-time PCR, melting point analysis of double-stranded DNA, mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension.

    3.  The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each comprising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein:
    a) said first primer hybridizes to a first DNA strand of the SUV39H2 gene;
    b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H2 gene; and
    c) the 3' ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

    The University, which is an instrumentality of the Swiss Confederation having a place of business in Bern, Switzerland, granted an exclusive license for the '114 patent to LABOKLIN, which is a German company with its principal place of business Bad Kissingen, Germany.  LABOKLIN entered into two sublicenses of the '114 patent in the United States.  PPG offers laboratory services for testing for genetic variations and mutations known to cause certain diseases in dogs, including a test for detecting the presence of a mutation in the SUV39H2 gene.

    In January 2017, after obtaining the consent of the University, LABOKLIN sent a cease-and-desist letter to PPG asserting that PPG had infringed the '114 patent.  PPG responded by filing suit against LABOKLIN and the University and seeking a declaratory judgment that the asserted claims of the '114 patent are patent ineligible under § 101.  LABOKLIN and the University moved to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction.  The District Court, however, issued an Order finding jurisdiction established over both LABOKLIN and the University.  The dispute proceeded to trial on PPG's invalidity defense, and following the close of both parties' evidence, but before the case was submitted to the jury, the District Court granted PPG's motion for judgment as a matter of law and found the asserted claims patent-ineligible under § 101.

    On appeal, LABOKLIN and the University argued that the District Court lacked personal jurisdiction over LABOKLIN because LABOKLIN lacked sufficient contacts with the forum, and lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity.  With respect to Appellants' argument that the District Court lacked personal jurisdiction over LABOKLIN, the Federal Circuit disagreed with Appellants' assertion that a cease-and-desist letter along with licensing activity in the forum was not enough to confer jurisdiction.  The Federal Circuit stated that "[a]s the District Court aptly pointed out, here, 'LABO[KLIN] is not merely a remote patentee assisting a U.S. company with enforcement, but instead, it is the U.S. enforcer.'"  The Federal Circuit therefore determined that the facts of the case established that LABOKLIN's activities satisfy the minimum contacts requirement without offense to due process, and thus, personal jurisdiction over LABOKLIN in the District Court was reasonable and fair.

    Turning to Appellants' argument that the District Court lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity, the Federal Circuit began by noting that under the Foreign Sovereign Immunities Act ("FSIA"), "a foreign state is presumptively immune from the jurisdiction of United States courts; unless a specified exception applies, a federal court lacks subject-matter jurisdiction over a claim against a foreign state," and that under 28 U.S.C. § 1605(a)(2), if a foreign state engages in "commercial activity . . . in the United States," an exception to sovereign immunity applies.  Citing Intel Corp. v. Commonwealth Sci. & Indus. Research Org., 455 F.3d 1364, 1370 (Fed. Cir. 2006), the Court further noted that a defendant's "acts of (1) obtaining a United States patent and then (2) enforcing its patent so it could reap the profits thereof—whether by threatening litigation or by proffering licenses to putative infringers—certainly" are commercial activity.

    In response to Appellants' argument that the University was presumptively immune from the jurisdiction of U.S. courts under the FSIA because the District Court erred in finding that the commercial activity exception under the FSIA applied to the University's immunity, the Federal Circuit explained that "[t]he University cannot claim immunity in the District Court because it obtained a U.S. patent and then participated in licensing and enforcing the '114 patent, which constitutes 'commercial activity' under the FSIA."  The Court also explained that "it matters not to [the Court's] analysis that it was LABOKLIN that physically wrote and sent the cease-and-desist letter to PPG, because the University conceded that it still retained substantial rights in the patent, such that the University, as the sole 'patentee,' ultimately controlled enforcement of the '114 patent."  The Federal Circuit therefore determined that the commercial activity exception to sovereign immunity applied such that the District Court properly exercised subject-matter jurisdiction over the University pursuant to § 1605(a).

    On the issue of patent eligibility, LABOKLIN and the University argued on appeal that the asserted claims are directed to a patent-eligible application of the discovery of the underlying natural phenomenon because the asserted claims claim a man-made laboratory procedure.  The Federal Circuit, however, disagreed with Appellants' argument.

    The Federal Circuit began its patent eligibility analysis by briefly reviewing four of its previous decisions:  Ariosa Diagnostics, Inc. v. Sequenom, Inc.; In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation; Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International Ltd.; and Natural Alternatives International, Inc. v. Creative Compounds, LLC.  The Court then declared that "[h]ere, the Asserted Claims are not directed to a new and useful method for discovery because they begin and end with the point discovery of the HNPK mutation in the SUV39H2 gene," adding that:

    [C]laim 1 simply states that the search for the mutation involves the laboratory examination of Labrador Retriever DNA, which resulted in the revelation of the mutation.  The mutation location itself and the fact that it is inherited through male and female dog carriers mating are both natural phenomena.

    Noting that "the plain language of claim 1 demonstrates that it is directed to nothing more than 'observing or identifying' the natural phenomenon of a mutation in the SUV39H2 gene," the Court determined that "the Asserted Claims are directed to natural phenomenon at Alice step one."

    The Federal Circuit also disagreed with Appellants' argument that the claimed methods apply a new discovery of the SUV39H2 gene and develop novel genotyping methods for Labrador Retrievers, finding instead that "[n]othing in claim 1's language suggests the invention of a new method for genotyping."  In affirming the District Court's finding of patent ineligibility, the Federal Circuit determined that "the Asserted Claims provide no tangible result save the observation and detection of a mutation in a dog's DNA."  So, while such discovery constituted "a positive and valuable contribution," the Federal Circuit found that "these claims fall short of statutory patentable subject matter."

    Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)
    Panel: Circuit Judges Wallach, Hughes, and Stoll
    Opinion by Circuit Judge Wallach

  • Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2019)

    By Kevin E. Noonan —

    Federal Circuit SealLast week, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) finding claims of U.S. Patent No. 7,064,197 to be invalid for anticipation or obviousness, in Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2019).  Because Enzo raised the issue du jour, that subjecting a patent granted prior to enactment of the Leahy-Smith America Invents Act (AIA) to inter partes review (IPR) was unconstitutional, the U.S. government joined the appeal to defend the constitutionality of PTAB proceedings under these circumstances.

    Representative claims of the '197 patent read as follows:

    1.  A non-porous solid support comprising one or more amine(s), hydroxyl(s) or epoxide(s) thereon, wherein at least one single-stranded nucleic acid is fixed or immobilized in hybridizable form to said non-porous solid support via said one or more amine(s), hydroxyl(s) or epoxide(s).

    17.  An array comprising various single-stranded nucleic acids fixed or immobilized in hybridizable form to a non-porous solid support.

    (wherein italicized terms were important to the PTAB decision).

    The Board held in a Final Written Decision that all the claims in IPR were invalid for being anticipated by a prior art reference to Fish or obvious by the combination of Fish and secondary references, or a reference to van Prooijen-Knegt ("VPK") with (obviousness) or without (anticipation) reliance on secondary references.  The basis for these determinations based on the VPK reference relied, inter alia, on the Board finding that the '197 patent was not entitled to its earliest priority date for failure of the priority application to satisfy the written description requirement for the "non-porous solid support" limitation recited in challenged claims.  Enzo appealed.

    The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges O'Malley and Chen.  The panel characterized the teaching of the Fish reference as "a microradioimmunoassay for detecting antibodies that bind to double-stranded DNA ('dsDNA') . . . us[ing] poly-L-lysine ('PLL') 'to facilitate the binding of pure dsDNA to plastic surfaces' [and that] single-stranded DNA ('ssDNA') [was used] in the form of a mixture of synthetic polymers deoxyadenosine ('poly-dA') and deoxycytidine ('poly-dC') or 'denatured calf thymus DNA.'"  According to the opinion, all challenged claims required single-stranded DNA to be "capable of binding through Watson-Crick base pairing" (italics in opinion), using a construction the parties agreed upon.  This construction was the basis for the Board to decide that the Fish reference anticipated all of the '197 challenged claims, despite Enzo's argument that Fish did not show hybridization (the Board saying that the Fish disclosure just needed to be capable of hybridization according to the claim language).  Enzo's expert countered (unpersuasively) that there were interactions that could arise using the methods disclosed in Fish that would preclude hybridization, and without the reference disclosing actual hybridization it was incorrect to presume that hybridization could occur (as required in Enzo's claims).  Becton's expert disagreed, basing his testimony on the presumed interaction between the phosphate backbone of the DNA and the positively charged polylysine coating, which would presumably leave the bases available for hybridization.

    The Federal Circuit agreed with the Board that the evidence supported their conclusion, characterizing the capacity to hybridize as an inherent property and citing Eli Lilly & Co. v. Barr Labs., Inc. for the proposition that "[a] reference includes an inherent characteristic if that characteristic is the 'natural result' flowing from the reference's explicitly explicated limitations."  251 F.3d 955, 970 (Fed. Cir. 2001) (quoting Cont'l Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)).  The panel held that the evidence from the experts, as well as the inherent property of single-stranded DNA to hybridize under appropriate conditions, supported the Board's decision that Fish anticipated the challenged claims.  The panel also rejected Enzo's allegation that Fish did not disclose an "array" of single-stranded DNA molecules, saying that the Board's determination to the contrary was supported by substantial evidence.

    Turning to the Board's decision that certain of the challenged claims were rendered obvious by Fish in view of secondary references, the panel agreed that the additional limitations recited in these claims ("wherein said nucleic acid comprises a nucleic acid sequence complementary to a nucleic acid sequence of interest sought to be identified, quantified or sequenced," or, "wherein said nucleic acid is RNA," or, "wherein said nucleic acids comprise a gene sequence or pathogen sequence") resulted in claims obvious in view of the Fish teachings.  With regard to the Board's obviousness determination based on the combination of Fish with other references, the Court affirmed the Board's decision that there was substantial evidence that the skilled worker would have had a motivation to combine the references and a reasonable expectation of success.  These references bolstered the teachings in Fish to include covalent linkage between the non-porous support (motivated by greater stability) and to substitute the polyvinyl tray supports disclosed in Fish with properly treated glass supports.  The substantial evidence provided by the cited references was supported, according to the panel, by the testimony of Becton's expert witness.

    Finally, the panel dealt summarily with Enzo's argument that subjecting patents granted prior to enactment of the AIA to the IPR provisions of the AIA was unconstitutional:

    We recently addressed this issue in Celgene Corp. v. Peter, No. 18-1167, 2019 WL 3418549, at *12–16 (Fed. Cir. July 30, 2019), which is now precedent that governs this case.  Celgene held that "retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment."  Accordingly, we hold that the retroactive application of IPR proceedings to the '197 patent, which issued before the enactment of the AIA, is not an unconstitutional taking under the Fifth Amendment.

    The Supreme Court invited patentees to explore the extent to which IPRs could constitute a Taking under the Fifth Amendment, in its Oil States Energy Services, LLC. v. Greene's Energy Group, LLC decision ("our decision should not be misconstrued as suggesting that patents are not property for purposes of the Due Process Clause or the Takings Clause").  Several patentees having taken the Court up on its invitation, it seems the time is ripe for Supreme Court review of the Federal Circuit's determination that IPRs do not raise constitutional takings issues.

    Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2019)
    Nonprecedential disposition
    Panel: Circuit Judges Lourie, O'Malley, and Chen
    Opinion by Circuit Judge Lourie

  • Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)

    By Kevin E. Noonan —

    Federal Circuit SealLast week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written description requirement in Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.

    ANDA litigation arose over Nalproprion Pharma's Contrave® extended-release tablets of the combination of naltrexone hydrochloride and buproprion hydrochloride, for treatment of obesity, and Orange Book-listed U.S. Patent Nos. 7,375,111; 7,462,626; and 8,916,195.  The following claims were at issue in this litigation:

    Claim 11 of the '195 patent:

    A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is ad- ministered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution pro- file in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
        a) between 39% and 70% of naltrexone re- leased in one hour;
        b) between 62% and 90% of naltrexone re- leased in two hours; and
        c) at least 99% in 8 hours;
        wherein about 16 mg of said sustained re- lease formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.

    Claim 1 of the '195 patent:

    A composition for affecting weight loss comprising:
        (a) a sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof in an amount effective to in- duce weight loss in an individual; and
        (b) a sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof in an amount effective to enhance the weight loss effect of the bupropion or salt thereof;
    wherein said composition is in a single oral dosage form fixed combination.

    Claims 26 and 31 of the '626 patent:

    A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone, wherein naltrexone and buproprion are administered together.

    A method of treating overweight or obesity, comprising administering a weight loss effective amount of a first and second compound to an individual who has been diagnosed as suffering from overweight or obesity in order to treat said overweight or obesity, wherein said first compound is bupropion, or a pharmaceutically acceptable salt thereof, and said second compound is naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the weight loss activity of said first and second compounds is enhanced compared to the administration of the same amount of either compound alone, wherein at least one of sad drugs are in a sustained release formulation and are administered in a single oral dosage form.

    (where the italicized portions of these claims were recited in independent and/or dependent claims related to asserted claims 26 and 31).

    The District Court found that defendant Actavis had not established that claim 11 of the '195 patent was invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) with regard to the claim limitation reciting USP dissolution methods ("USP1" versus "USP2").  The claims expressly recited the USP 2 Paddle Method, but Actavis argued that the specification disclosed only the UPS 1 Basket Method.  The District Court based its decision on the skilled worker not having a doubt that the inventors had possession of the invention based on the nature of the dissolution method disclosed in the specification.  The Court held that disclosure of a "substantially equivalent method" was sufficient to satisfy the requirement.

    The District Court also rejected Actavis' arguments that claims 26 and 31 of the '626 patent and claim 1 of the '195 patent were obvious, on the grounds that "it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss," holding that this argument amounted to "a classic case of hindsight bias."

    The Federal Circuit reversed the District Court regarding its obviousness decision in an opinion by Judge Lourie, joined by Chief Judge Prost and Judge Wallach, and affirmed the District Court on its written description determination over Chief Judge Prost's dissent.  The majority's written description decision was based in part on the "peculiarity" of the structure of claim 11, which is directed to a method for treating obesity using specific amounts of the two drugs and reciting the method for determining the dissolution profile of what the majority termed "resultant in vitro parameters," which were not the "operative steps to treat overweight or obesity."  The majority found no clear error in the District Court's holding that "irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it."  The majority noted that this determination by the District Court was supported by more credible testimony from Nalproprion Pharma's expert and "untrustworthy, self-serving statements by Actavis's expert."  The majority stated that it refused to disturb the District Court's weighing of witness credibility in the performance of its "fact-finding function."  The majority further recognized (in the face of the Chief Judge's dissent) that "[w]hile as a general matter written description may not be satisfied by so-called equivalent disclosure," under these facts the District Court had not clearly erred.

    Turning to the District Court's non-obvious determination for claims 26 and 31 of the '626 patent and claim 11 of the '195, patent, the panel unanimously held these determinations to be error as a matter of law.  The opinion sets forth the teachings of the asserted references, characterizing them as disclosing the use of an opioid antagonist like naltrexone and "withdrawal attenuating agents," including buproprion for minimizing weight gain, inter alia, during smoking cessation, and bupropion or naltrexone alone in weight loss regimes.  The Federal Circuit disagreed with the District Court's conclusion of non-obviousness, stating that:

    The prior art here discloses the claimed components of the composition claims and the steps of the method claims including the use claimed by the method.  . . .  The references teach that bupropion causes weight loss.  . . .  Likewise, the record indicates that naltrexone can cause weight loss.  . . .  Given that both drugs had shown weight loss effects, we conclude that a person of ordinary skill would have been motivated to combine them.  In fact, such persons did so.

    The panel rejected as unpersuasive Nalproprion Pharma's argument that the FDA would not and had not approved buproprion for weight loss, saying that this was not dispositive for the question of whether the skilled worker would have had a motivation to combine the asserted references.  Further, the opinion states:

    The inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss.  Contrary to Nalpropion Pharma's view, persons of skill did combine the two drugs even without understanding bupropion's mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant.  . . .  ("The precise mechanism for bupropion SR that is responsible for effects on weight loss is unknown.")  . . .  Thus, we conclude that skilled artisans would have been motivated to combine the two drugs for weight loss with a reasonable expectation of success [citations to the record omitted].

    The Court found "every limitation of the claims at issue" was found in the asserted art, and rejected Nalproprion Pharma's purported evidence for secondary considerations (failure of others, unexpected results) to rebut their finding that these claims were obvious.  According to the Court, "the inventors only combined two drugs known to affect weight loss.  Both drugs were known to affect weight loss, and combining them for this known purpose as claimed in the patents yields no unpredictable result."  The Federal Circuit thus found claim 11 of the '195 patent and claims 26 and 31 of the '626 patent to be invalid for obviousness.

    The Chief Judge's dissent on the written description question was based on the majority's reliance on "substantially equivalent disclosure" to support claim language not having clear and explicit support in the specification.  The Chief Judge characterizes the majority's decision as "add[ing] what appears to me to be a new rule to this court's long-standing written description jurisprudence."  She sets forth three reasons for her disagreement with the majority:

    First, the USP 2 clause is limiting.  Second, the majority's "substantially equivalent" rule is inconsistent with this court's precedent.  Third, the district court clearly erred in finding that the '195 patent's written description includes a disclosure "substantially equivalent" to USP 2.

    Important to the Chief Judge's reasoning, inter alia, were arguments from the prosecution history where the patentee appeared to rely on the dissolution profile (and the manner of determining it) to distinguish the claims from the prior art.  The Chief also disagreed with the District Court's (and the majority's) disregard for defendant's expert testimony and found his assertion that the USP1 an USP2 methods would not have produced the same dissolution profile results to have been relevant to the written description issue before each court.

    Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)
    Panel: Chief Judge Prost and Circuit Judges Lourie and Wallach
    Opinion by Circuit Judge Lourie; dissenting in part opinion by Chief Judge Prost

  • Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. (Fed. Cir. 2019)

    By Donald Zuhn —

    Federal Circuit SealLast month, in Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., the Federal Circuit affirmed a decision by the U.S. District Court for the District of Delaware finding the asserted claims of U.S. Patent Nos. 6,992,180 and 8,097,405 invalid for lack of enablement.  Enzo had asserted the '180 patent in three separate suits against (1) Roche Molecular Systems, Inc.; Roche Diagnostics Corp.; Roche Diagnostics Operations, Inc.; and Roche Nimblegen, Inc. ("Roche"); (2) Becton, Dickinson and Co.; Becton Dickinson Diagnostics Inc.; and GeneOhm Sciences, Inc. ("BD"); and (3) Abbott Laboratories and Abbott Molecular, Inc. ("Abbott").  In a fourth suit, Enzo asserted the '405 patent against Abbott.

    The '180 patent relates to non-radioactive labeling of polynucleotides where the label is attached at the phosphate position of a nucleotide.  Representative claim 1 of the '180 patent recites:

    1.  An oligo- or polynucleotide which is complementary to a nucleic acid of interest or a portion thereof, said oligo- or polynucleotide comprising at least one modified nucleotide or modified nucleotide analog having the formula

    Sig-PM-SM-BASE

    wherein PM is a phosphate moiety, SM is a furanosyl moiety and BASE is a base moiety comprising a pyrimidine, a pyrimidine analog, a purine, a purine analog, a deazapurine or a deazapurine analog wherein said analog can be attached to or coupled to or incorporated into DNA or RNA wherein said analog does not substantially interfere with double helix formation or nucleic acid hybridization, said PM being attached to SM, said BASE being attached to SM, and said Sig being covalently attached to PM directly or through a non-nucleotidyl chemical linkage, and wherein said Sig comprises a non-polypeptide, non-nucleotidyl, non-radioactive label moiety which can be directly or indirectly detected when attached to PM or when said modified nucleotide is incorporated into said oligo- or polynucleotide or when said oligo- or polynucleotide is hybridized to said complementary nucleic acid of interest or a portion thereof, and wherein Sig comprises biotin, iminobiotin, an electron dense component, a magnetic component, a metal-containing component, a fluorescent component, a chemiluminescent component, a chromogenic component, a hapten or a combination of any of the foregoing.

    (emphasis in opinion).

    The '405 patent is directed to in situ hybridization using a probe non-radioactively labeled at any non-Ward position to identify chromosomes, and liquid phase hybridization using a non-radioactively labeled probe to hybridize and detect a target sequence in a liquid medium.

    The opinion notes that the asserted patents are based on work done by Dr. David Ward and others at Yale University, who developed a non-radioactive probe by attaching a label to a polynucleotide via a chemical linker at a base position of a nucleotide.  Dr. Ward had demonstrated that attaching labels at certain positions of the nucleotide ("Ward positions") would not disrupt the polynucleotide's ability to hybridize and be detected upon hybridization.  Enzo licensed the patent portfolio encompassing Dr. Ward's discovery and filed an application directed to non-radioactive labeling at additional positions on a nucleotide.

    In characterizing the claims of the '180 patent, the opinion indicates that:

    The claims are not directed to any specific polynucleotide, nor do they focus on the chemistry or linker used to attach a label, the number of labels to attach to a polynucleotide, or where within the polynucleotide to attach those labels.  Instead, the claims encompass all polynucleotides with labels attached to a phosphate, as long as the polynucleotide remains hybridizable and detectable upon hybridization.

    With respect to the '405 patent, the opinion indicates that "[t]hese claims cover using probes labeled non-radioactively at any position on the nucleotide, including the three Ward positions."

    In the suits against Roche and BD, the District Court granted summary judgment in favor of the Defendants, finding the asserted claims of the '180 patent invalid for lack of enablement.  With respect to the '405 patent, the District Court granted summary judgment in favor of Abbott, finding the asserted claims of that patent invalid for lack of enablement.  Enzo appealed those judgments, and the Federal Circuit consolidated the appeals.

    The panel begins its analysis by noting that "the issue in this appeal is not simply whether the specification enables labeling; the question is whether it enables creation of a labeled probe that is both hybridizable and detectable upon hybridization."  And in affirming the District Court's determinations that the asserted claims of the '180 and '405 patents are invalid for lack of enablement, the Federal Circuit concludes that "even if we assume that the specification teaches one of skill in the art how to create the broad range of labeled polynucleotides covered by the claims, . . . the specification still fails to teach one of skill in the art which combinations will produce a polynucleotide that is hybridizable and detectable upon hybridization, as required by the claim language."

    Citing the Court's decision in Wyeth v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013), the opinion notes that "[t]he facts in this appeal largely mirror those in Wyeth," explaining that "[a]s in Wyeth, the asserted claims here require not just a particular structure, but a particular functionality (i.e., the labeled polynucleotides must be hybridizable and detectable upon hybridization)."  And the Court concludes that in the instant case "the specification fails to teach one of skill in the art whether the many embodiments of the broad claims would exhibit that required functionality."

    Finding that "[t]he scope of the claims is quite broad," the Court determined that claim 1 of the '180 patent "places almost no limitations on the structure of the claimed polynucleotide, other than the fact that the label is attached to the phosphate portion of the nucleotide," and "does not restrict the chemistry used to attach the label, the chemical linker used, the number of labels within a probe, or the location of the labels on the probe (i.e., whether they are terminal or internal)."  And according to the opinion, "[t]he specification's guidance as to how such variables would or would not impact the functionality of the claimed probes is sparse."  The panel concludes that:

    Given the unpredictability of the art at the time and the serious doubts held by those of skill in the art regarding whether labels could be attached to non-Ward positions without disrupting hybridization, merely stating that a labeled polynucleotide will work as a probe is not sufficient to enable one of skill in the art to know that it would indeed function as a probe—i.e., be hybridizable and detectable upon hybridization.

    The opinion also notes that Enzo's expert had explained that one of skill in the art "would need to actually make the compound and test it in a hybridization experiment" in order to be comfortable that an oligonucleotide or polynucleotide encompassed by the asserted claims would work as a probe.

    With respect to the '405 patent, the opinion indicates that the asserted claims of that patent are broader than the asserted claims of the ʼ180 patent, explaining that "rather than covering only phosphate-labeled polynucleotides, they also cover labeling at other locations on a nucleotide."  The opinion concludes that "[b]ecause the specification does not enable the narrower scope of polynucleotides claimed in the '180 patent, it also cannot enable the broader scope of polynucleotides claimed in the ʼ405 patent."  The Federal Circuit therefore affirmed the District Court's grant of summary judgment that the asserted claims of the '180 and '405 patents are invalid for lack of enablement.

    Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. (Fed. Cir. 2019)
    Panel: Chief Judge Prost and Circuit Judges Reyna and Wallach
    Opinion by Chief Judge Prost