• Rule-Based Data Processing Patent Held to Be Directed to Patent-Ineligible Subject Matter

    By Joseph Herndon

    On October 11, 2016, the Federal Circuit issued a precedential opinion in FairWarning IP, LLC v. Iatric Systems, Inc. affirming dismissal of a patent infringement suit brought by FairWarning holding that the asserted patent, U.S. Patent No. 8,578,500, claims patent-ineligible subject matter under 35 U.S.C. § 101.  The Federal Circuit essentially found that the claims were directed to a combination of previously identified abstract-idea categories, and thus, they were found invalid.

    The '500 patent is titled "System and Method of Fraud and Misuse Detection" and discloses ways to detect fraud and misuse by identifying unusual patterns in users' access of sensitive data.  The specification describes systems and methods to detect fraud by an otherwise-authorized user of a patient's protected health information ("PHI").  According to the specification, pre-existing systems were able to record audit log data concerning user access of digitally stored PHI.  The claimed systems and methods record this data, analyze it against a rule, and provide a notification if the analysis detects misuse.  Claim 1 recites:

    1.  A method of detecting improper access of a patient's protected health information (PHI) in a computer environment, the method comprising:
        generating a rule for monitoring audit log data representing at least one of transactions or activities that are executed in the computer environment, which are associated with the patient's PHI, the rule comprising at least one criterion related to accesses in excess of a specific volume, accesses during a pre-determined time interval, accesses by a specific user, that is indicative of improper access of the patient's PHI by an authorized user wherein the improper access is an indication of potential snooping or identity theft of the patient's PHI, the authorized user having a pre-defined role comprising authorized computer access to the patient's PHI;
        applying the rule to the audit log data to determine if an event has occurred, the event occurring if the at least one criterion has been met;
        storing, in a memory, a hit if the event has occurred; and
        providing notification if the event has occurred.

    Step One

    A § 101 challenge has a first step requiring a court to "determine whether the claims at issue are directed to a patent-ineligible concept."  The District Court found that "the '500 patent is directed to or drawn to the concept of analyzing records of human activity to detect suspicious behavior."  The Federal Circuit agreed with the District Court.

    The patented method, as illustrated by claim 1 quoted above, collects information regarding accesses of a patient's personal health information, analyzes the information according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access, and provides notification if it determines that improper access has occurred.

    The Federal Circuit found that the claims are directed to a combination of previously identified abstract-idea categories.  Specifically, the claims here are directed to collecting and analyzing information to detect misuse and notifying a user when misuse is detected.

    Comparing the claims to the recent decision in McRO, Inc. v. Bandai Namco Games America Inc. (Fed. Cir. 2016), which also involved claims reciting rules, the Federal Circuit found distinctions.  In McRO, the Federal Circuit held that, in analyzing step one, the claims were not directed to an abstract idea, but instead were directed to "a specific asserted improvement in computer animation, i.e., the automatic use of rules of a particular type."  The Federal Circuit explained in McRO that the claimed improvement was allowing computers to produce accurate and realistic lip synchronization and facial expressions in animated characters that previously could only be produced by human animators, and the claimed rules in McRO transformed a traditionally subjective process performed by human artists into a mathematically automated process executed on computers.

    The Federal Circuit found that the present claims merely implement an old practice in a new environment.  The claimed rules ask whether accesses of PHI, as reflected in audit log data, are 1) "by a specific user," 2) "during a pre-determined time interval," or 3) "in excess of a specific volume."  These are the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries.

    The Federal Circuit also found that the claims here are not directed to an improvement in the way computers operate, nor does FairWarning contend as much.  While the claimed system and method certainly purport to accelerate the process of analyzing audit log data, the speed increase comes from the capabilities of a general-purpose computer, rather than the patented method itself.

    Thus, because these claims were found to be directed to an abstract idea at step one of the patent-eligibility inquiry, we turn to step two.

    Step Two

    At step two, the court must then examine the elements of the claim to determine whether it contains an inventive concept sufficient to transform the claimed abstract idea into a patent-eligible application.

    The Federal Circuit again agreed with the District Court, which explained that the claims generally require (1) generating a rule related to the number of accesses, the timing of accesses, and the specific users in order to review transactions or activities that are executed in a computer environment; (2) applying the rule; (3) storing the result; and (4) announcing the result.

    The claim limitations, analyzed alone and in combination, were considered to fail to add something more to transform the claimed abstract idea of collecting and analyzing information to detect misuse into a patent-eligible application.

    FairWarning argued some system claims separately, but they were found to fail as well because they simply add the requirement that the system include a "user interface" for selection of a rule, as well as a microprocessor that analyzes audit log data under various rules.

    In sum, the Federal Circuit found that the claimed invention is directed to the broad concept of monitoring audit log data, and the claims here do not propose a solution or overcome a problem specifically arising in the realm of computer technology.

    Thus, the claims were found to be patent-ineligible under § 101.

    Procedure

    The District Court granted Iatric's motion and dismissed the case under Rule 12(b)(6) of the Federal Rules of Civil Procedure.  On appeal, FairWarning also argued that "there is an identified claim construction issue" that precludes dismissal under Rule 12(b)(6).  FairWarning argued that, under a correct construction, the District Court would have understood the term audit log data to exist in the computer environment after at least one of the transactions or activities are executed in the computer environment by an authorized user, and the implication of this construction, FairWarning argued, would be that the '500 patent is necessarily rooted in computer technology.

    The Federal Circuit found that simply requiring computer implementation of an otherwise abstract-idea process, as FairWarning would require of the claim, does not make the claims patent eligible, and regardless of the resolution of this construction issue, the '500 patent claims patent-ineligible subject matter.  Thus, any claim construction issue was rendered moot.

    FairWarning IP, LLC v. Iatric Systems, Inc. (Fed. Cir. 2016)
    Panel: Circuit Judges Lourie, Plager, and Stoll
    Opinion by Circuit Judge Stoll

  • By Donald Zuhn

    NVCAEarlier this year, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2016.  The report, which is prepared by the NVCA and PricewaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture capitalists invested $15.3 billion in 961 deals in the second quarter, which constituted a 20% increase in dollars and a 5% decrease in deals as compared with the first quarter of 2016, when nearly $12.7 billion was invested in 1,011 deals (see chart below, which shows total venture funding from the third quarter of 2013 through the second quarter of 2016; data from MoneyTree Reports; click on chart to expand).  The second quarter of 2016 was the tenth consecutive quarter in which more than $10 billion in venture capital was invested.  However, as compared with the second quarter of 2015, invested dollars and deals were down 12% and 22%, respectively, in the second quarter of 2016.

    Venture Funding - Total
    In contrast with the increase in total funding, venture funding in the biotechnology sector decreased from $1.96 billion in the first quarter of 2016 to $1.69 billion in the second quarter of 2016 (see chart below, which shows venture funding for the biotech (blue), medical devices (red), and software (green) sectors since the third quarter of 2013; data from MoneyTree Reports; click on chart to expand).  In addition to experiencing a 14% decrease in dollars, the biotech sector also saw a 19% decrease in deals, with 100 deals in the second quarter of 2016.  Despite the decrease in dollars and deals, the biotechnology sector still received the second largest amount of venture capital for the quarter.

    Venture Funding - Industry
    The software sector once again captured the top spot among the seventeen sectors tracked by the NVCA, collecting $8.74 billion in the second quarter of 2016 (up 70% from the $5.15 billion the industry picked up in the first quarter).  The software sector has now captured the top spot for 27 straight quarters, with the biotech sector finishing second in all but five of those quarters.  The software sector has also received more than $4 billion in funding for the tenth consecutive quarter.

    Medical device and equipment investment increased by 3% with respect to dollars in the second quarter, with $539 million being invested.  Ten of the seventeen sectors tracked by the NVCA remained flat or saw increases in dollars invested in the second quarter of 2016.

    For additional information regarding this and other related topics, please see:

    • "Venture Funding Reaches Highest Level in More Than a Decade," February 25, 2016
    • "Third Quarter Venture Funding Declines 27% from Second Quarter," October 22, 2014
    • "Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second," July 20, 2014
    • "Software Sector Leads First Quarter Venture Funding to Thirteen Year High; Biotech Sector Finishes Second (Again)," April 30, 2014
    • "Biotech Venture Funding Rebounded in 2013 After Strong Fourth Quarter," January 26, 2014
    • "Biotech Venture Funding Sees Second Quarter Rebound," July 22, 2013
    • "Biotech Venture Funding Down 33% in First Quarter," April 30, 2013
    • "Annual Venture Funding Drops for First Time in Three Years," February 4, 2013
    • "Biotech Venture Funding Up 64% in Third Quarter," October 29, 2012
    • "Venture Funding in Life Sciences Sector Drops 9% in Second Quarter," July 22, 2012
    • "Biotech Venture Funding Drops 43% in First Quarter," May 3, 2012
    • "Venture Funding Increased 22% in 2011," February 2, 2012
    • "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
    • "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
    • "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
    • "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

    • "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

    • "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

    • "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

    • "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
    • "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009

    • "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009

    • "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009

  • By Donald Zuhn

    CoverPatent services provider RWS inovia recently released its seventh annual report on global patent and IP trends.  In compiling "The 2016 U.S. Global Patent & IP Trends Indicator," RWS inovia, which produces products for PCT national phase entry and European patent validation, and provides IP translations and search services, surveyed more than 100 companies and universities in May 2016 to identify the trends having the greatest impact on the foreign filing strategies of patentees around the world.

    The 2016 report notes that 68% of survey respondents are from the U.S. and 32% are from Europe.  In addition, the report provides the following industry breakdown for survey respondents:  mechanical/engineering (16.8%), university/association/non-profit (15.9%), pharmaceuticals or biotech industries (14.0%), electrical/electronics (10.3%), IT/software/media (8.4%), and chemicals/materials (6.5%) (the remaining 28% of respondents were classified as "other," which encompasses manufacturing, telecommunications, teaching/research, consulting, pest control, and mining).  With regard to the size of respondents, the report notes that 37.4% of respondents had one to 100 employees, 19.6% had 101 to 1,000 employees, 32.7% had 1,001 to 10,000 employees, and 10.3% had more than 10,000 employees.  The report also indicates that 37.4% of survey respondents had no in-house patent attorneys or agents, 48.6% had one to four attorneys or agents, 6.5% had five to nine attorneys or agents, 5.6% had ten to 24 attorneys or agents, and 1.9% had 25 or more attorneys or agents.

    The 2016 report indicates that for U.S. applicants, fallout from the Alice Corp. v. CLS Bank ruling was the dominating issue in 2015, and for European applicants, the unitary patent was the main topic of concern.  With respect to filing expectations, 79.2% of respondents said they filed as many patent applications as they expected to file in 2015, 8.3% filed more than they expected, and 12.5% filed less than they expected.  The 2016 report indicates that 36.5% of survey respondents filed between four and nineteen patent families in 2015, 24% filed 1-3 patent families, 12.5% filed 20-49 patent families, 10.4% filed either no patent families or more than 100 patent families, and 6.3% filed 50-99 patent families.  The report noted that respondents have been filing fewer patent families as compared to three years ago.

    In addition, respondents filed 34.3% of their patent families internationally in 2015, down from 49% in 2014 and 52% in 2013.  The report notes that 66.7% of those international filings were made using the PCT, 2.6% were made using the Paris Convention, and 30.6% were made using a combination of the PCT and Paris Convention.  For respondents using the PCT to file internationally, 64% respondents had used the USPTO as the International Searching Authority, 56% had used the EPO, 31% had used the Korean IP Office (KIPO), and 8% had used the Australian Patent Office.  With regard to the countries in which respondents regularly filed, the top twelve jurisdictions were:

    1. United States
    2. Europe
    3. China
    4. Japan
    5. Canada
    6. India
    7. Australia
    8. South Korea
    9. Brazil
    10. Russia
    11. Singapore
    12. South Africa

    With respect to IP budgets, 41.4% of survey respondents experienced IP budget cuts in 2015 (of which 12.1% of respondents were experiencing budget cuts for the first time in recent years).  For respondents who had reduced foreign patenting costs in 2015, cost savings were achieved by filing in fewer countries (41.0%), bringing steps in-house (23.7%), negotiating with U.S. or European counsel (19.8%), consolidating foreign counsel (18.4%), negotiating with foreign counsel (17.1%), using non-law firm providers (14.5%), reducing costs on patent translations (11.8%), and consolidating local counsel (9.2%).  For survey respondents who brought steps in-house, those steps included annuities (29.0%), drafting specifications (17.1%), foreign patent filing (17.1%), patent translations (11.8%), U.S. or European prosecution (9.2%), filing U.S. or European patent applications (7.9%), and foreign patent prosecution (6.6%).

  • By Donald Zuhn –-

    USPTO SealIn a Patent Alert e-mail distributed last month, the U.S. Patent and Trademark Office announced the release of an enhanced version of its Patent Assignment Search System.  The Office noted that the new system provides an improved layout, labeling, and tooltips, allowing users to perform a "Quick Look-Up" search to display desired assignment data directly.  The new layout (see screenshot below) also includes "Search" and "Advanced Search" tabs.  Users will be able to export data to CSV, PDF, and XML files, and view attached patent assignment documents for all electronically available documents from mid-1998 to the present.  In addition, users will be able to access the legacy Assignments on the Web (AOTW) system.  Finally, an API (application programming interface) will be available for external applications to retrieve and read assignments data.  A full list of new features and enhancements can be found here.

    Assignment Search Screenshot

  • CalendarOctober 11, 2016 - Patents Ombudsman Program and Pro Se Assistance Program (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    October 12, 2016 – "Addressing §101 Patent Eligibility Rejections: Getting Off the Hook" (The Knowledge Group) – 10:00 am to 12:00 pm (EST)

    October 13, 2016 – "Leveraging USPTO Examiner Count System: Efficiently Prosecuting Patents, Lowering Prosecution Costs" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 19, 2016 – "To Patent or Not to Patent: When to Keep Your IP a Trade Secret" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

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

  • USPTO SealThe U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on October 11, 2016.  Anthony Knight, Director of Stakeholder outreach and Patents Ombudsman Program, and Mindy Bickel, Associate Commissioner for Innovation Development, will detail the Patents Ombudsman Program and Pro Se Assistance Program, and the services they provide.  Through a discussion of frequent issues facing patent prosecutors today, the speakers will help circumvent some more common problems and get feedback on other assistance they might be able to provide.

    Instructions for viewing the webinar can be found here.

    Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.

  • The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Addressing §101 Patent Eligibility Rejections: Getting Off the Hook" on October 12, 2016 from 10:00 am to 12:00 pm (EST).  Seth M. Cannon of Carter, DeLuca, Farrell & Schmidt, LLP and Viresh R. Patel of Jones Robb PLLC will help attendees understand many of the important issues and insights with regard to recent court decisions on patent eligibility, as well as the impact of the Alice decision, and also present key findings and best practices in addressing §101 patent eligibility rejections issued by the USPTO.  The webinar will cover the following topics:

    • Subject Matter Eligibility Under §101: An Overview
    • Identifying Patent-Eligible Inventions
    • Best Practices for Drafting Patent Applications in View of Alice
    A Review of Subject Matter Eligibility Rejections Issued by the USPTO
    • Best Practices for Addressing Subject Matter Eligibility Rejections
    • Identifying and Traversing Common Rationale Relied Upon in Rejections
    • Analogizing and Distinguishing Relevant Court Decisions and Examples Provided in the § 101 Guidelines
    • Claim Amendment Strategies for Addressing Subject Matter Eligibility Rejections
    • Procedural Tips for Traversing Subject Matter Eligibility Rejections
    • Utilizing Examiner Interviews to Address § 101 Rejections

    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.

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

    Many research efforts into the microbiome have focused primarily on the human microbiome, i.e., microorganisms within and on the body, and how changes in these microbial communities correlate with changes in health and disease.  Less attention, however, has been paid to the microbial communities external to humans and how changes in these communities can affect health.  These communities have a broad range, from the microbiome of indoor spaces, also called the microbiology of the built environment (MoBE), to microbial communities found outdoors.  Microbial communities that give certain foods, such as San Francisco sour dough bread, various wines, beers, and even cheeses, characteristic qualities like taste and texture are also examples of external microbiomes.  As with the human microbiome, scientists do not yet fully understand how changes in external or indoor microbiomes could alter human health, but we see plentiful possibilities for further research and intellectual property protection of subsequent innovation, especially with regards to the MoBE.  This article concludes with a sampling of some of the patenting activity in this area.

    Efforts to Understand the Environmental and Built Microbiomes

    Initial research efforts into external microbiomes centered mostly around environmental microbial communities.  The Earth Microbiome Project (EMP) is a large-scale research endeavor that has attempted to categorize and classify microbial communities in different biomes across the globe in an effort to elucidate the "Earth's microbiome" using a variety of metagenomic and metatranscriptomic approaches.  These approaches focus on large-scale and often high-throughput data collection and analyses.  Projects such as the EMP emphasize that the composition of complex environmental microbial communities that surround us are largely unknown to researchers.

    Although projects such as the EMP look at environmental microbial communities, they leave out an important aspect of human life—the indoor microbiome, or the microbiology of the built environment (MoBE).  Various research efforts are currently being undertaken to foster growth in this area.  The National Academies of Science and Engineering have begun a consensus study to understand issues related to the MoBE including its formation and effects on human health.  The end goal of the study is to gather enough information to apply the findings to novel building materials and architectural approaches.  Although a report is expected in 2017, efforts to understand the indoor microbiome are still in their infancy.  As this field expands, so will, we believe, opportunities for patentable innovation related to it.

    Implications of an Altered Microbiome

    It is largely unclear how an altered external or built microbiome will affect human health.  Several initial investigations have sought to understand the role potential pathogens play as part of the indoor microbiome.  Handorean, et al. determined that aerosolized particles from soiled linens in healthcare settings could contribute to pathogen exposure.  Additionally Rhoads, et al. noted that temperature setting is critical in control of pathogens such as Legionella pneumophila in water heaters and water taps.  Both of these findings suggest that environmental changes and the introduction of pathogens into external or indoor microbiomes can easily lead to potential exposure, suggesting the need for novel filtration and sterilization techniques and approaches.

    Many researchers are also beginning to explore whether exposure to an altered indoor microbiome in infancy or childhood could lead to the development of adverse health outcomes like asthma and allergies.  Several studies have further investigated the connection between an altered indoor environment and immunological development in children.  Avershina, et al. found that high vacuum cleaning frequency is associated with an altered gut microbiome during pregnancy and for 2-year old children.  In even younger subjects, Shin et al. found that operating room microbes may seed C-section-born children with microbes, and therefore the indoor microbiome of the birth room can play an especially important role in immune development and health in a subset of newborn children.  Furthermore, King, et al. determined that shotgun sequencing could reveal normal hospital microbiomes and detect any fluctuations in microbial community composition, including the emergence of opportunistic pathogens.  Research into MoBEs has not been restricted to hospitals: Hewitt, et al. found that bacterial diversity in offices varies from city to city.

    Although research efforts have begun to elucidate the external and indoor microbiomes, many questions remain.  In September 2016, Adams, et al. proposed ten questions regarding indoor microbiomes and data collection related to them, not only in an effort to advance the field, but also in an effort to standardize its methods, approaches, and interpretations.  In short, much research is needed, but as we learn more, we see the opportunity emerging for novel patents.

    Intellectual Property and Patent Considerations of External and Built Microbiomes

    Although initial patent applications have been filed that are relevant to monitoring, sampling, and detecting external microbial communities, we expect the space to expand rapidly as more basic research is completed.  In 2012, patent application WO2012116289A2 (for this and all other mentioned patent applications, see Appendix A) was filed describing microbial population changes in response to radiation, and using those changes as identifiers of the type of radiation that has occurred.

    In 2015, patent application WO2015103165A1 was filed by Biota Technology, Inc. describing novel and unique methods, systems, and processes for monitoring, analyzing, and controlling the microbial presence in industrial activities.  The company also filed patent application WO2015103332A2 describing novel and unique methods for characterizing the microbiome associated with hydrocarbon processes, including production and exploration.

    Recently, Trans-Vac Systems LLC filed patent application US20160041074A1, which recognizes how humans alter the built microbiome both in living areas and medical settings, and proposes novel air monitoring and filtration system inventions to remove potential pathogens from MoBEs.

    Closing

    As research efforts rapidly expand, we expect growth in the need for patents to protect novel advancements related to the built environment.  As we understand more with regards to how the indoor environment affects human health, we expect an increased need to patent novel inventions related to sterilization and filtration techniques and apparatuses.  Further, as we learn how building materials and approaches can affect the indoor microbiome, we expect an increased need for patents ranging from actual building material products to architectural approaches.  Additionally, previous patent applications (WO2015103165A1 and WO2015103332A2, for example) have highlighted the potential of microbiome-related intellectual property advances in the fields of fuel and energy exploration.

    Table

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

    For additional information regarding this topic, please see:

    • "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

  • Just When You Thought the Federal Circuit Was Softening Restrictions on Software Patents, the Tide Turns Again

    By Joseph Herndon

    Federal Circuit SealIntellectual Ventures I LLC ("IV") sued Symantec Corp. and Trend Micro (defendants) for infringement of various claims of three U.S. Patents (Nos. 6,460,050; 6,073,142; and 5,987,610).  The District Court held the asserted claims of the '050 patent and the '142 patent to be ineligible under § 101, and the asserted claim of the '610 patent to be eligible.  The Federal Circuit affirmed as to the ineligibility of the asserted claims of the '050 patent and '142 patent, but reversed as to the asserted claim of the '610 patent, resulting in finding all asserted claims ineligible under § 101.

    Some reasoning applied during the two-step analysis, and in particular when finding that the patents are "directed to abstract ideas," is not clearly provided by the Federal Circuit.  The analysis for each of the three patents is summarized below.  This decision just muddies the waters following other recent patent-owner friendly decisions in which the Federal Circuit seemed to be creating more ways for software patents to survive.

    The decision further includes quite an interesting concurrence in which First Amendment rights were discussed as being implicated with Software patents??  Further comments will be provided on the concurrence alone.

    The '050 Patent

    The '050 patent is entitled "Distributed Content Identification System."  The patent application was filed on December 22, 1999, and the '050 patent issued on October 1, 2002.  The patent is directed to methods of screening emails and other data files for unwanted content.  Independent claim 9 is representative and recites:

    9.  A method for identifying characteristics of data files, comprising:
        receiving, on a processing system, file content identifiers for data files from a plurality of file content identifier generator agents, each agent provided on a source system and creating file content IDs using a mathematical algorithm, via a network;
        determining, on the processing system, whether each received content identifier matches a characteristic of other identifiers; and
        outputting, to at least one of the source systems responsive to a request from said source system, an indication of the characteristic of the data file based on said step of determining.

    According to IV, this method of filtering emails is used to address the problems of spam e-mail and the use of e-mail to deliver computer viruses.  The Federal Circuit, however, agreed with the District Court that receiving e-mail (and other data file) identifiers, characterizing e-mail based on the identifiers, and communicating the characterization — in other words, filtering files/e-mail — is an abstract idea.

    The Federal Circuit equated the claimed features to a practice for people receiving paper mail to look at an envelope and discard certain letters, without opening them, from sources from which they did not wish to receive mail based on characteristics of the mail.  Supposedly, the list of relevant characteristics could be kept in a person's head.

    The Federal Circuit also found that claim 9 of the '050 patent resembled claims that have been held directed to an abstract idea.  Recently, in BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, a claim to a "content filtering system for filtering content retrieved from an Internet computer network" was found to be directed to an abstract idea (although later saved in step two from ineligibility).

    The Federal Circuit proceeded to Mayo/Alice step two to determine whether the claims contain an "inventive concept" that renders them patent-eligible.  IV argued that the proffered prior art did not anticipate or render obvious the asserted claims of the '050 patent.  The Federal Circuit noted that while the claims may not have been anticipated or obvious because the prior art did not disclose all features, that does not suggest that the idea of "determining" and "outputting" is not abstract, much less that its implementation is not routine and conventional.

    To be clear, the Federal Circuit stated that the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter, despite the fact that the second step is considered a search for an "inventive concept".  A bit confusing indeed.

    The Federal Circuit found that the steps of the asserted claims of the '050 patent do not "improve the functioning of the computer itself," and are also distinguishable from those in BASCOM, which allegedly improved an existing technological process by describing "how [a] particular arrangement of elements is a technical improvement over prior art ways of filtering [Internet] content."  The Federal Circuit found that there is not, in the '050 patent, any "specific or limiting recitation of . . . improved computer technology," as the asserted claims describe only generic computer elements.

    Finally, the Federal Circuit found that the asserted claims do not contain any limitations that address IV's purported technological improvements of requiring automatic updates to the antivirus or antispam software or the ability to deal with a large volume of such software.  The Federal Circuit summarized that when a claim directed to an abstract idea contains no restriction on how the result is accomplished and the mechanism is not described, then the claim is not patent-eligible.  Thus, the asserted claims of the '050 patent were found to be not patent-eligible under § 101.

    The '142 Patent

    The '142 patent is entitled "Automated Post Office Based Rule Analysis of E-Mail Messages and Other Data Objects for Controlled Distribution in Network Environments."  The patent application was filed on June 23, 1997, and the '142 patent issued on June 6, 2000.  The patent is directed to methods of routing e-mail messages based on specified criteria (i.e., rules).  Claim 1 is representative and recites:

    1.  A post office for receiving and redistributing email messages on a computer network, the post office comprising:
        a receipt mechanism that receives an e-mail message from a sender, the e-mail message having at least one specified recipient;
        a database of business rules, each business rule specifying an action for controlling the delivery of an e-mail message as a function of an attribute of the e-mail message;
        a rule engine coupled to receive an e-mail message from the receipt mechanism and coupled to the database to selectively apply the business rules to the e-mail message to determine from selected ones of the business rules a set of actions to be applied to the e-mail message; and
        a distribution mechanism coupled to receive the set of actions from the rule engine and apply at least one action thereof to the e-mail message to control delivery of the e-mail message and which in response to the rule engine applying an action of deferring delivery of the e-mail message, the distribution engine automatically combines the email message with a new distribution list specifying at least one destination post office for receiving the e-mail message for review by an administrator associated with the destination post office, and a rule history specifying the business rules that were determined to be applicable to the e-mail message by at least one rule engine, and automatically delivers the e-mail message to a first destination post office on the distribution list instead of a specified recipient of the e-mail message.

    The '142 patent's abstract describes the invention as "[a] system, method and various software products . . . for automatic deferral and review of e-mail messages and other data objects in a networked computer system, by applying business rules to the messages as they are processed by post offices."  Claim 1 also describes the patented system as a "post office" — albeit an electronic one.

    The District Court held that "the asserted claims of the '142 patent are directed to human-practicable concepts, which could be implemented in, for example, a brick-and-mortar post office."  The Federal Circuit agreed, and this allegedly demonstrated that the concept is well-known and abstract.

    Turning to step two, the specification states that the claims can "operate[] on a conventional communications network" and the patent discloses only generic computers performing generic functions.  The Federal Circuit found that this confirms that the implementation of the abstract idea is routine and conventional, and does not "improve the functioning of the computer itself."  Thus, the asserted claims of the '142 patent were found to be not patent-eligible under § 101.

    The '610 Patent

    The '610 patent is entitled "Computer Virus Screening Methods and Systems."  The patent application was filed on February 12, 1998, and the patent issued on November 16, 1999.  The patent is directed to using computer virus screening in the telephone network.  Claim 7 is the only asserted claim of the '610 patent, and claim 7 depends from claim 1, which provides:

    1.  A virus screening method comprising the steps of:
        routing a call between a calling party and a called party of a telephone network;
        receiving, within the telephone network, computer data from a first party selected from the group consisting of the calling party and the called party;
        detecting, within the telephone network, a virus in the computer data; and
        in response to detecting the virus, inhibiting communication of at least a portion of the computer data from the telephone network to a second party selected from the group consisting of the calling party and the called party.

    7.  The virus screening method of claim 1 further comprising the step of determining that virus screening is to be applied to the call based upon at least one of an identification code of the calling party and an identification code of the called party.

    The District Court held claim 7 of the '610 patent to be patent-eligible, but the Federal Circuit reversed this decision.

    The Federal Circuit found that the idea of virus screening was well known when the '610 patent was filed, and thus, was a long prevalent practice in the field of computers, and, as the patent admits, performed by many computer users.  The specification recites conventional "virus screening software," and the Federal Circuit noted that by itself, virus screening is well-known and constitutes an abstract idea.

    At step two of Mayo/Alice, the Federal Circuit found that there is no other aspect of the claim that is anything but conventional.  Just as performance of an abstract idea on the Internet is abstract, so too the performance of an abstract concept in the environment of the telephone network is abstract.

    The Federal Circuit further found that the asserted claim does not improve or change the way a computer functions.  IV argued that the claims of the '610 Patent include meaningful limitations that narrow the claimed invention to a specific way of screening for computer viruses within the telephone network . . . and does not preempt all virus detection.  The Federal Circuit basically ignored this argument and stated that while preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.

    In summary, the Federal Circuit compared the claims to Enfish and DDR Holdings, and stated that unlike the claims at issue in Enfish (which involved a "specific type of data structure designed to improve the way a computer stores and retrieves data in memory") claim 7 of the '610 patent does not improve or change the way a computer functions.  Nor does claim 7 overcome a problem unique to the Internet as was the case in DDR Holdings.

    Judge Stoll provided a dissent with respect to the '610 patent.  Judge Stoll noted that the '610 patent confirms that the claimed invention "advantageously screen[s] computer data for viruses within a telephone network before communicating the computer data to an end user," and this was a fundamental architectural shift from prior-art virus screening, which occurred locally on an end user's computer rather than centrally as in the invention.  Such a shift improved the overall security of telecommunication networks by thwarting the ability of viruses to reach and exploit end users.

    Although Judge Stoll agrees that the patent is directed to the abstract idea of "virus screening," Judge Stoll found that claim 7 is eligible as an ordered combination under step two.  While the network components and virus screening software recited by the claim may themselves be conventional, claim 7's inventive concept is moving virus screening software from its typical location on end users' computers and deploying it instead "within the telephone network" itself.  Thus, the invention harnesses network architecture and exploits it by utilizing a non-conventional and non-generic arrangement of virus screening components, which improves overall network security and usability.  As to this arrangement being non-conventional and non-generic, the District Court had before it IV's expert testimony that the invention provided a novel solution to the protection gap problem and greatly reduced the likelihood of an end user receiving a virus when it held claim 7 eligible.

    Judge Stoll analogized the claims in the BASCOM case to the present claims.  In BASCOM, the claims were directed to filtering content on the Internet, i.e., not on a user's local computer, and the present invention advantageously screens computer data for viruses within a telephone network before communicating the computer data to an end user.  Judge Stoll found no meaningful difference between BASCOM and this case in terms of eligibility because claim 7 also purports to improve the functioning of the computer itself, or, at the very least, the functioning of the network.

    Judge Stoll further noted that the claims at issue do not simply invoke the Internet as a means to an end, but they improve the security and functioning of the Internet itself.

    In response, Judge Dyk disagreed and found this case to be unlike BASCOM, where the technology overcame existing problems with other Internet filtering systems, and because the record does not indicate that claim 7 recites any improvement to conventional virus screening software, it is conventional.

    This decision, overall, provides more confusion than guidance as to how to determine eligibility of software patent claims.  With respect to the '610 patent, the two judges each have differing views for whether the claims are like or unlike those in BASCOM, and basically, depending on how the claims are "characterized", the outcome of the case is controlled.  This is troubling because the claims should not be characterized at all, and should stand on their own.  In terms of determining what is conventional, it seems that the Court can characterize the claims in a way to achieve a desired outcome.  More standard rules need to be applied and followed.

    Intellectual Ventures I LLC v. Symantec Corp. (Fed. Cir. 2016)
    Panel: Circuit Judges Dyk, Mayer, and Stoll
    Opinion by Circuit Judge Dyk; concurring opinion by Circuit Judge Mayer; opinion dissenting-in-part by Circuit Judge Stoll

  • By Kevin E. Noonan

    Supreme Court Building #1The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval activities are properly within the scope of the Hatch-Waxman "safe harbor" (as set forth in 35 U.S.C. § 271(e)(1)).  This was the question presented to the Court:

    Whether the safe harbor protects a generic drug manufacturer's bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be submitted to the FDA upon request.

    The case below, styled Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. involved a District Court's determination that U.S. Patent No. 7,575,886 was not infringed by Teva nor by Amphastar and additional defendants in companion cases decided together.  The claims at issue were directed to enoxaparin, an anticoagulant drug marketed since 1993 under the brand name Lovenox®.  Momenta marketed the first generic version of the drug and sought to block additional generic entrants by asserting the '866 patent, which claimed methods for ensuring that each batch of the drug met quality standards.  The District Court held that co-defendant Amphastar's activities alleged by Momenta to infringe the '886 patent fell within the scope of the § 271(e)(1) safe harbor as being "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . ." under the statute.

    The Federal Circuit vacated the District Court's grant of summary judgment in Amphastar's favor, in an opinion by Judge Wallach joined by Judge Moore and by Judge Dyk, who also dissented in part on other aspects of the decision.  The majority relied on its interpretation of the "purpose" of the statute from the legislative history:

    [Section 271(e)(1)] provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent . . . .  This section does not permit the commercial sale of a patented drug by the party using the drug to develop such information . . . .  The information which can be developed under this provision is the type which is required to obtain approval of the drug. . . .  The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement [emphasis in opinion].

    The opinion noted that while the contours of the safe harbor have been deemed broad (citing, inter alia, Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005), Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011), and AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997)), the safe harbor is not without boundaries.  These exceptions include research tools not subject to FDA approval (Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–66 (Fed. Cir. 2008)) and information "routinely reported" to the FDA post-approval (citing Classen).  Earlier, the Federal Circuit had affirmed denial of Momenta's motion for preliminary injunction on the grounds that the movant was unlikely to prevail, but in light of a fuller record than had been available at the preliminary injunction stage, the Court was convinced that the FDA submissions relied upon by Amphastar were sufficiently "routine" that they fell outside the scope of the § 271(e)(1) safe harbor.  The opinion contrasted the routine nature of the submissions made based on the use of Momenta's method with "non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications ('INDs'), new drug applications ('NDAs'), supplemental NDAs, or other post-approval research results."  Because Amphastar's submissions using Momenta's patented technology were routine, they were not "reasonably related to the development and submission of information" as required by the statute to qualify for the safe harbor, and the District Court's decision to the contrary was clearly erroneous in the Federal Circuit's opinion.  This decision was based in part on the panel's apprehension that deciding in Amphastar's favor would "result in manifest injustice" because it would be the first case to have § 271(e)(1) encompass "activities related to ongoing commercial manufacture and sale."  The majority's conclusion was supported by the Federal government as amicus, wherein "the government argued that the routine use of a patented testing process in the commercial manufacture of a drug is not 'reasonably related to the development and submission of information to [the] FDA' and thus not shielded from liability by § 271(e)(1).'"

    Denial of certiorari does not connote agreement by the Court, of course, but until the Court decides to address this issue the question of what activities are not within the safe harbor remains unclear, particularly with regard to ones such as safety testing that are performed post-approval (see "Supreme Court Denies Certiorari in Momenta Case").