• Unified Patent CourtThe Preparatory Committee of the UPC has published a revised timetable for the final stages of preparations for the opening of the Unified Patent Court (UPC).  The revised timetable indicates that the Sunrise Period during which existing European Patents can be opted out of the jurisdiction of the UPC could start in September 2017 and the UPC could start accepting cases in December 2017 when the Unified Patent Court Agreement (UPCA) comes into effect.

    In order for the UPCA to come into effect, it remains for the UK and Germany to ratify the UPCA.  The UK recently announced its intention to proceed with ratification.  Germany was always expected to be the last state to ratify, in order to control the timing of the UPCA coming into effect.  Once the UPCA has come into effect, it will be possible for the EPO to grant Unitary Patents.

    The Preparatory Committee has stressed that the revised timetable is conditional, and there is no guarantee that the timing will not slip further back again.  Patent users should bear in mind that the UPC could be operational by the end of 2017 and so may wish to make preparations to decide which of their granted patents should be opted out of the jurisdiction of the UPC during the Sunrise Period which might start in September 2017.

    This article was reprinted with permission from J A Kemp.

  • By Kevin E. Noonan

    "It was a sight no one could ever forget.  Over the range of hills, as far as eye could see, crept a darkening hem, ever longer and broader, until the shadow spread across the slope from east to west, then downwards, downwards, uncannily swift, and all the green herbiage of that wide vista was being mowed down as if by a giant sickle, leaving only the vast moving shadow, extending, deepening, and moving rapidly nearer."

    Eciton_burchellii_army_antsWhile not one of the "monsters of god" set out in Daniel Quamen's eponymous book, legions of army ants on the move can be terrifying, as illustrated in the quote about from Carl Stephenson's classic 1950's pulp short story, Leiningen versus the Ants.  Recently, the genetic history of these insects has been used for more benign and academic purposes, wherein a team of researchers has used genetic evidence to enlighten our understanding of the geographic development of Central America.

    The study, by Winston et al.[1] and entitled Early and dynamic colionization of Central America drives speciation in Neotropical army ants, assessed genomic DNA differences between nine Eciton species (E. vagans, E. quadriglume, E. rapax, E. dulcium, E. mexicanum, E. lucanoides, E. burchellii, E. drepanophorum and E. hamatum) for sequence diversity over spatial habitats ranging from Brazil to Mexico.  Phylogeny was inferred from 146 specimens comprising 419,804 loci and 6,700,494 nucleotide sites therein.  It was motivated by suggestive evidence that the conventional explanation of how and when the Isthmus of Panama was formed (and the biological consequences thereof) was incomplete.  Until recently, the Isthmus was believed to have formed about 3 million years ago (Ma) and to have resulted in an intermingling of species that had evolved independently in North and South America (called the Great American Biotic Exchange).  However, physical evidence inconsistent with this scenario has been detected, including difference in salinity and benthic carbon between the Pacific Ocean and the Caribbean arising between 4.2 and 4.7 million years ago; Panamanian fluvial deposits in South America that suggest closure of the Isthmus between 13-15 million years ago; and tectonic reconstructions suggesting formation of a volcanic arc about 12 million years ago and development of a series of islands in the area of the Isthmus about 6 million years ago.  There has also been a suggestion that "corridors" arose in the area of the Isthmus surrounding a volcanic area in modern-day Nicaragua and Costa Rica.

    In the face of this uncertainty, the authors chose to make genomic DNA comparisons of Eciton species because these nomadic ants have wingless queens and cannot swim or use foliage or flotsam to bridge water barriers by rafting, indicating that the results of allopatric speciation events could illustrate the history of how the Isthmus arose in the relevant paleogeographic time period.  The paper describes two alternative hypotheses for this speciation:  the Full Closure Colonization (FCC) model, which depends on Eciton colonization after closure of the Isthmus about 3 million years ago; and the Early Dynamic Colonization (EDC) model, which posits episodic, earlier colonization as land bridges, islands, and other land corridors arose (and sometimes retreated) over a much longer time period.  With regard to the EDC model the authors state:

    [D]ispersal into Central America presents both a novel ecological opportunity for colonization and an opportunity for clade diversification across a spaiotemporally complex landscape.  Specifically, rather than a single migration across a suitable corridor into Central America, the complex landscape provided a series of patches of suitable habitat analogous to steppingstones with respect to the eventual colonization of Central America. In this model, we would likely infer in situ divesification/speciation before full formation of the isthmus (c. 3 Ma) as a result of dispersing across a complex geological substrate.

    The results of genomic DNA comparisons of these ant species provide evidence that the EDC model is far superior to the FCC model and indeed that the FCC model is inconsistent with the speciation events that can be inferred from the genomic DNA comparisons.  Divergence times for three specie coincident across the Nicaraguan-Costa Rican volcanic range (north of the Isthmus) are earlier (E. burchellii, 4.27 Ma; E. vagans, 5.5 Ma; E. mexicanum, 6.61 Ma) than predicted by the FCC model, for example.

    The authors summarize their findings as follows:

    As the early timing (4 –7 Ma) of Central American colonization by Neotropical army ants was robust to multiple calibrations, this provides strong evidence for ephemeral land bridges prior to the full closure of the {Isthmus].  We suggest that these early, inter-continental land connections played an important role in the dispersal of many taxa during the GABI, and likely functioned as a mechanism of speciation through alternating bouts of dispersal and vicariance.  Considering that the majority of lineages in lower Central America exhibit genetic structure in this region—including other Neotropical army ant genera—we predict that support for cryptic diversification and the EDC model will only increase as more research is conducted on weakly dispersing Central American species.  Lastly, our research suggests that the spatial and temporal complexity of the emerging isthmus needs to be seriously evaluated when invoking the commonly used biogeographic phenomenon of sweepstakes dispersal.

    This paper once again illustrates how the ability to elucidate and compare genomic DNA in naturally occurring species can supply important evidence to validate — or rebut — hypotheses regarding subjects as diverse and evolutionary biology and paleogeography, providing a better understanding of the Earth's deep past, the organisms living at those times and how the modern world developed from those beginnings.

    [1] Winston, Kronauer and Moreau, Molec. Ecol., doi: 10.1111/mec.13846 (October 25, 2016)

  • By Michael Borella

    USPTO SealAs discussed in a previous article, the U.S. Patent and Trademark Office recently published new subject matter eligibility examples directed to the abstract idea exception to patentability under 35 U.S.C. § 101.  These "December 2016 examples" each involve a so-called business method.  Business methods have, in general, been looked down upon by the courts and the USPTO for some time, but especially since the Alice Corp. Pty. Ltd. v. CLS Bank Int'l decision.

    That case set forth a two-part test to determine whether claims are directed to patent-eligible subject matter.  One must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further determine 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 generic computer implementation of an otherwise abstract process does not qualify as "significantly more."

    Alice was particularly impactful on business methods, because the Court held that financial and business transactions (the subject matter of many business method claims) are virtually per se abstract.  As a consequence, most eligible business methods have to recite sufficient technical detail (usually computer-related software and hardware) in order to prevail in part two of the inquiry.  In practice, this makes the distinction between business methods claims and software claims fuzzy at best.

    Nonetheless, the USPTO has provided three examples of business methods that can be claimed in a fashion that is eligible.  In last week's article, we discussed the first two (Examples 34 and 35), and here we will cover Example 36.

    Example 36

    Example 36 is a hypothetical invention provided by the USPTO.  Thus, it is not based on the facts of any particular case.  This example is titled "Tracking Inventory," but is much more specific than that.

    The claimed invention is directed to inventory management in a warehouse.  In the prior art, tracking devices, such as RFID tags, may be attached to items stored therein.  Using RFID equipment, one would be able to rapidly locate a particular item.  However, this solution requires the overhead of attaching the RFID tags when storing items, and detaching these tags when removing the items from inventory.  Other prior art methods used cameras to capture images of the items, more specifically, identification codes on the items.  However, using a single camera for this purpose does not provide an accurate 3D location of the item when it is stored.  Of course, items and their locations can be manually logged, but doing so requires even more overhead and is prone to data entry mistakes.  As a result, known inventory management techniques have unacceptably high error rates.

    In order to overcome these deficiencies, the invention uses a high-resolution camera array with overlapping views.  Using this camera array, the contour and shape of stored items, as well as markings on these items can be recorded along with the 3D locations of the items.  Recognition of objects uses a machine-learning-based pattern classifier, such as "a Gaussian mixture model, neural network, Bayes classifier or other known pattern classifier."  According to this hypothetical, "computer vision technology has not been used in the manner disclosed by this inventor prior to the filing of the application."

    The example includes three claims, which we will discuss in turn.  Claim 1 recites:

    1.  A system for managing an inventory record comprising a memory and processor configured to perform the steps of:
        (a) creating an inventory record for an item of inventory comprising acquired images of the item;
        (b) adding classification data relating to the acquired images to the inventory record;
        (c) adding location data relating to each acquired image to the inventory record; and
        (d) updating the inventory record with a physical location of each item of inventory in the warehouse to thereby manage the items of inventory.

    Conducting part one of the Alice analysis, the USPTO characterized the claim as being directed to an abstract idea due to its similarity to other claims deemed abstract.  Particularly, the data collection, recognition, and storage steps are "similar to the data collection and management concepts" found abstract in previous cases.  Additionally, unlike the eligible claims in Enfish, LLC v. Microsoft Corp., the claim's mere invocation of a memory and a processor does not provide a specific improvement to these computer components.

    Turning to step two of Alice, the additional elements of "[a] memory for storing data and a processor for processing data are well‐understood, routine, conventional computer components, which in this claim are recited at a high level of generality and perform generic computer functions."  Therefore, when viewed individually, these elements do not lend eligibility.  Furthermore, viewing the elements as a combination only reflects "ordinary usage typically performed by a generic computer, as would be recognized by those of ordinary skill in the field of data processing."  Therefore, claim 1 lacks an inventive concept and is ineligible under § 101.

    The next exemplary claim recites:

    2.  A system for managing an inventory record by tracking the location of items of inventory in a warehouse:
        a high‐resolution video camera array, each video camera positioned at pre‐determined locations with overlapping views, for acquiring at least one high‐resolution image sequence of each item of inventory;
        a memory and processor configured to perform the steps of:
            (a) creating an inventory record for an item of inventory comprising the acquired image sequence of the item from the video camera array;
            (b) adding classification data relating to the acquired image sequence to the inventory record;
            (c) adding location data relating to each acquired image to the inventory record, the location data providing a position of the item of inventory in the image sequence;
            (d) reconstructing the 3‐D coordinates of an item of inventory using the location data from multiple overlapping images and prior knowledge of the location and field of view of the camera(s); and
            (e) automatically updating the inventory record with the 3‐D coordinates of each item of inventory in the warehouse to thereby manage the items of inventory.

    Beginning with part one of Alice, the USPTO concluded that this claim is also directed to an abstract idea, due to four of its steps being analogous to those of claim 1.  Moving on to part two, the USPTO stated that the additional elements of "a high‐resolution video camera array at predetermined positions with overlapping views, memory and processor to (d) reconstruct the 3‐D coordinates of the item of inventory from multiple overlapping images obtained from the camera array and prior knowledge of the location and field of view of the camera(s)" were well-known and conventional.  Since these components perform their typical functions, individually they do not contain an inventive concept.

    But when viewed as an ordered combination, the story is different.  Particularly, the recent Federal Circuit case of BASCOM Global Internet v. AT&T Mobility LLC, stands for the principle that a claim directed to an abstract idea, with additional elements that are individually generic and conventional, can be patent-eligible if the combination of these elements is non-conventional and non‐generic.  In claim 2, "the use of [the] camera array provides the ability to track objects throughout the entire storage space rather than simply the view of a single camera and determine their 3‐D location without any of the manual steps that were required of previous methods."  As noted above, such use is assumed to be non-conventional by the hypothetical.  Moreover, the "claimed solution here is necessarily rooted in computer technology to address a problem specifically arising in the realm of computer vision systems," and the ordered combination of limitations yields a particular, useful application of the abstract idea.  Therefore, the claim satisfies the second part of Alice, and is patent-eligible.

    The final exemplary claim recites:

    3.  A system for managing inventory by tracking the location of items of inventory in a warehouse using image recognition, comprising:
        a high‐resolution video camera array for acquiring at least one high resolution image sequence of each item;
        a memory for storing the acquired image sequences, classification and location data relating to the acquired image sequences, and a recognition model representing contour information and character information of each item; and
        a processor that is configured to manage inventory by performing, for each item, the steps of:
            (a) creating an inventory record for the item comprising the acquired image sequence(s)of the item;
            (b) extracting characteristics from the acquired image sequence(s) of an item to form feature vectors, the characteristics comprising contour information and character information that is stored in the inventory record as classification data relating to the acquired image sequence(s);
            (c) recognizing and tracking the position of item in the image sequence as classification and location data by processing the feature vectors using the stored recognition model and adding the classification and location data to the inventory record;
            (d) determining a physical location of the item in the warehouse using the location data relating to the item in the image sequence(s); and
            (e) automatically updating the inventory record with the physical location of the item.

    Applying step one of Alice, the USPTO concluded that this claim, like claims 1 and 2, is directed to an abstract idea because it entails "data collection and management techniques to practice the concept of inventory management."  With regard to step two, the additional elements of "the camera array, memory and processor limitations do not amount to significantly more for the reasons discussed above for claims 1 and 2."

    Viewing the elements as an ordered combination, however, results in the claim being determined to be eligible.  The USPTO noted that:

    [T]he camera array's acquisition of high resolution image sequences, and the processor's performance of step (b)'s extracting contour and character information from the images to create feature vectors, step (c)'s recognizing and tracking items of inventory using the feature vectors and a recognition model, and step (d)'s determining the physical location of the recognized items using the position of the item in the image sequence(s) is not well‐understood, routine, conventional activity in this field.

    Accordingly, the claim recites features that improve over the inaccurate solutions of the past.  Notably, this claim recites detail about how feature vectors are extracted from images, and then later used find the items.  As a result, the claim is patent eligible.

    Analysis

    Not unlike Example 35, which we discussed in the previous post, the eligible claims for Example 36 recite technical detail that goes beyond the high-level steps that are used in generic solutions to the problem.  Chiefly, claim 2 recites how specific features of the camera array are used to carry out these steps, and claim 3 provides steps that are specific to a particular way of processing, storing, and retrieving representations of the images and the items' locations.  On the other hand, claim 1 is ineligible because it recites a high-level process that could be carried out by generic hardware in virtually any fashion.

    Rather than rejecting claim 1 as being indefinite or obvious, the USPTO is signaling that it will continue to use § 101 as a hammer to knock down overly-broad claims.  Nonetheless, these examples provide illustrations of what type of technical detail and how much of it is needed to meet the requirements of the statute and Alice.

  • CalendarJanuary 25, 2017 – "Functional Patent Claims After Williamson: Understanding the Benefits and Risks for Your University's Patent Portfolio" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    January 26, 2017 – "Leveraging Latest Patent Decisions, Navigating New Complexities, Cases to Watch in 2017 — Key Lessons on Patent Eligibility, Deference on Appeal, Venue, Estoppel, Continuation Patent Applications, and More" (Strafford) – 1:00 to 2:30 pm (EST)

    January 31, 2017 – "Patent Mistakes in the Administrative State" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 12:00 to 1:30 pm, Chicago, IL

    January 31, 2017 – "Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation — Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues" (Strafford) – 1:00 to 2:30 pm (EST)

    February 1, 2017 – "Patent Litigation 2017: The Courts and Patent Trial and Appeal Board" (Federal Circuit Bar Association) – 10:00 am to 5:00 pm (PT), Santa Clara, CA

    February 22, 2017 – "Patent-Eligibility Update: Abstract Ideas in the Federal Circuit and USPTO" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

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

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

  • The Chisum Patent Academy will be offering the next session of its Advanced Patent Law Seminar on March 9-10, 2017 in Cincinnati, OH.  The seminar is co-taught by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Janice Mueller, who was a tenured full Professor at the University of Pittsburgh School of Law from 2004-2011.  The registration fee for the seminar is $1,500; a maximum of ten registrations will be accepted for the seminar.  Those interested in registering for either seminar can do so here.  Additional information regarding the seminar can be obtained here or by e-mailing info@chisum.com.

    Chisum Patent Academy

  • JMLSThe John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be hosting Saurabh Vishnubhakat, Associate Professor of Law, Texas A&M University School of Law, who will be presenting on "Patent Mistakes in the Administrative State" from 12:00 to 1:30 pm on January 31, 2017 at the John Marshall Law School in Chicago, IL.  Professor Vishnubhakat will discuss how to differentiate among the various types of mistakes that arise in the patent system and will share empirical insights about how the means for correcting those mistakes is changing.  He will draw in particular on his own ongoing research into patent examination and both judicial and administrative review of patent validity.

    The registration fee for the lecture is $30.  Those interested in registering for the conference can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation — Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues" on January 31, 2017 from 1:00 to 2:30 pm (EST).  Thomas L. Irving and Amanda K. Murphy, Ph.D., of Finnegan Henderson Farabow Garrett & Dunner, and Margaret J. Sampson of Baker Botts will provide guidance to patent counsel on understanding the types of activity that may lead to a finding of inequitable conduct and practical tactics to reduce the risk of a finding of inequitable content in litigation, and also examine arguments that have worked to avoid a finding of inequitable conduct and those that haven't.  The webinar will review the following issues:

    • What are the most common assertions defendants make when raising the inequitable conduct defense?
    • What are best practices prosecutors and litigators should employ when pursuing and defending inequitable conduct allegations?
    • What guidance do post-Therasense decisions and the USPTO proposed rules provide on how inequitable conduct will be treated?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a program entitled "Patent Litigation 2017: The Courts and Patent Trial and Appeal Board" on February 1, 2017 from 10:00 am to 5:00 pm (PT) at the Santa Clara University School of Law in Santa Clara, CA.  The program will include presentations on the following topics:

    • Patent Policy in the New Administration
    • Practice Before the Board
    • Lunch Q&A with Circuit Judge Jimmie V. Reyna of the U.S. Court of Appeals for the Federal Circuit
    • Trial Court Practice
    • Appellate Practice

    Those interested in registering for the program, can do so here.  Additional information regarding the program can be found here.

  • By Michael Borella

    USPTO SealAbout a week before the holidays, the U.S. Patent and Trademark Office quietly published a trio of new subject matter eligibility examples directed to the abstract idea exception to patentability.  These are the latest in a series of examples provided by the USPTO to its examining corps, the series including previous examples published in December 2014, January 2015, and July 2015 (other USPTO publications include example claims directed to the law of nature and natural phenomenon exceptions).  While the focus of this guidance is to educate examiners about how to determine whether pending claims are valid under 35 U.S.C. § 101, practitioners and patentees will find the examples to be helpful when considering how to draft and amend claims.

    Notable about the new examples (which we will call "the December 2016 examples" for sake of differentiation), is that all three are so-called business methods.  In the January 2015 and July 2015 sets, the example claims focused on computer hardware and software — this is the USPTO's first detailed characterization of business method claims.  The line between software and business methods is blurry at best (many business methods are intended to be computer-implemented).  But, as we will see, the December 2016 examples do little to sharpen any such distinction.

    In recent years, business methods have become the red-headed step child of patent law.  In the 1994 State Street Bank & Trust v. Signature Financial Group case, the Federal Circuit held that business methods are patent-eligible so long as they produce a "useful, concrete and tangible result."  This test was overturned in Bilski v. Kappos, where the Supreme Court found a disembodied business method claim to be too abstract for eligibility.  Post-Bilski, however, all one had to do was add hardware components to a claim in order to meet the requirements of § 101.  Given the aforementioned overlap between software and business methods, doing so was not particular burdensome in most cases.

    But in 2014, the Supreme Court opined once again regarding a business method's validity under § 101, this time clarifying that merely adding computer elements to an otherwise abstract claim was just "draftsman's art."  This case, of course, was Alice Corp. Pty. Ltd. v. CLS Bank Int'l, which set forth a two-part test to determine whether claims are directed to patent-eligible subject matter.  One must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further determine 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 generic computer implementation of an otherwise abstract process does not qualify as "significantly more."

    It is well-established that Alice had a deleterious impact on a large number of patents and applications, with the district courts finding claims challenged under § 101 to be invalid at a rather astounding rate of 75% immediately after the decision came down (more recently this rate has dropped below 55%).  While several art units in the USPTO issued significantly more § 101 rejections post-Alice, none was impacted more than the technical center 3600 which examines most business method patent applications.  Therein, these applications have been subject to a rejection rate of over 85%.

    As a consequence, there has been a significant amount of consternation and wringing of hands amongst patentees and attorneys over how to claim inventions that might incorporate financial and/or administrative subject matter.  Now that the USPTO has spoken on the issue, some extent of clarity has been added to the mix.  Still, it is likely that this aspect of the eligibility debate will remain open for some time to come.

    Example 34

    Example 34, the first of the December 2016 examples, is directed to the fact pattern of the BASCOM Global Internet v. AT&T Mobility LLC case, and the USPTO closely follows the reasoning of the Federal Circuit therein.  In short, BASCOM stands for the principle that a claim directed to an abstract idea, with addition elements that are individually generic and conventional, can be patent-eligible if the combination of these elements is nonnconventional and non‐generic.  Since we have covered the BASCOM decision in detail, we will not repeat the analysis here.

    Example 35

    Example 35 is a hypothetical invention provided by the USPTO.  Thus, it is not based on the facts of any particular case.  This example is titled "Verifying A Bank Customer's Identity To Permit An ATM Transaction," but is better summarized as "two-factor authentication for ATM transactions."

    As background, it is assumed that basic ATM transactions are well-known.  According to the example:

    To conduct a transaction, a customer typically inserts a bank card into the appropriate slot in the ATM and inputs a personal identification number (PIN) that verifies that the user is an authorized user for the bank account associated with the bank card.  The account data is read from the card using the reader in the ATM and the PIN associated with the card.  The network communicator transmits the read data and PIN to a remote computer at the financial institution, which then transmits instructions back to the ATM regarding authorization to carry out the requested transaction.

    These transactions, however, are subject to at least two types of fraud.  An unauthorized person could gain access to a user's card and PIN, and fraudulently use these to obtain funds from the user's account.  Also, a false card reader can be affixed to the ATM, allowing unauthorized persons to acquire information about the card and PIN.

    The hypothetical invention purports to solve both of these problems by requiring two-factor authentication for all ATM transactions.  In order to use an ATM, the user must be issued a smart card and download an application to their wireless communication device (e.g., smartphone).  When the ATM reads the user's card (which may be accomplished by the card reader or wirelessly via RFID), the ATM generates a random code and displays it to the user on a screen of the ATM.  The user must then enter this code into the application.  Then, the wireless communication device transmits a secure acknowledgment of the code to the ATM or a related system for verification.  In some embodiments, the ATM transmits the code to the wireless communication device (e.g., by way of Bluetooth).  Responsively, the application displays a representation of the code on the screen of the wireless communication device, which can be scanned by the ATM to verify the code.  In either case, when the code is validated within a pre-defined period of time from its generation, the ATM unlocks its keypad so that the user can enter his or her PIN.

    According the example, this invention involves the following improvements:

    Applicant's method allows the ATM to receive user card data in a more secure and efficient manner.  Customer card data entry begins before PIN entry and verification, so if the ATM user is not the authorized customer and does not have the appropriate verification software on their mobile device, the transaction is concluded before entry of the PIN.  This method prevents skimming and other techniques to fraudulently obtain a customer's PIN and even theft of the card since the downloaded software can authenticate the user and likewise authenticate the ATM before the PIN is produced.

    The example includes three claims, which we will discuss in turn.  Claim 1 recites:

    1.  A method of conducting a secure automated teller transaction with a financial institution by authenticating a customer's identity, comprising the steps of:
        obtaining customer‐specific information from a bank card,
        comparing, by a processor, the obtained customer‐specific information with customer information from the financial institution to verify the customer's identity, and
        determining whether the transaction should proceed when a match from the comparison verifies the authenticity of the customer's identity.

    Conducting part one of the Alice analysis, the USPTO characterized the claim as being directed to the abstract idea of "fraud prevention by verifying the authenticity of the customer's identity prior to proceeding with a banking transaction" which is a conventional, long-standing business practice.  Thus, the claim is analogous to those found to be abstract in Alice, Bilski v. Kappos, CyberSource Corp. v. Retail Decisions, Inc., and other cases.

    Moving to part two, the USPTO found that the claim recites the additional limitations of "obtaining customer‐specific information from a bank card" and "a processor comparing data."  The former, however, is a conventional action of an ATM and "is recited at a high level of generality such that it amounts to insignificant pre‐solution activity," while the latter "does not represent any computer function beyond what processors typically perform."  Therefore, taken individually, these additional elements do not confer patent-eligibility.  Further, even when viewed as an ordered combination, this combination of elements is "no more than the sum of their parts, and provides nothing more than mere automation of verification steps that were in years past performed mentally by tellers when engaging with a bank customer."  Since, "mere automation of an economic business practice does not provide significantly more," the USPTO concluded that this claim fails to meet the requirements of § 101.

    The next example claim recites:

    2.  A method of conducting a secure automated teller transaction with a financial institution by authenticating a customer's identity, comprising the steps of:
        obtaining customer‐specific information from a bank card,
        comparing, by a processor, the obtained customer‐specific information with customer information from the financial institution to verify the customer's identity, by
        generating a random code and transmitting it to a mobile communication device that is registered to the customer associated with the bank card,
        reading, by the automated teller machine, an image from the customer's mobile communication device that is generated in response to receipt of the random code, wherein the image includes encrypted code data,
        decrypting the code data from the read image, and
        analyzing the decrypted code data from the read image and the generated code to determine if the decrypted code data from the read image matches the generated code data, and
        determining whether the transaction should proceed when a match from the analysis verifies the authenticity of the customer's identity.

    Beginning with part one of Alice, the USPTO concluded that this claim also recites an abstract method of fraud prevention by identity verification — a fundamental business transaction.  Moving quickly to part two, the USPTO viewed the generating, reading, decrypting, and analyzing sub-steps individually as additional limitations.  According to the USPTO, "obtaining information from a bank card and the comparing data do not provide significantly more" for similar reasons as the additional elements of claim 1.  Further, the "the processor and the mobile communication device are recited at a high level of generality and perform programmed functions that represent conventional and generic operations for these devices, including reading data, generating random codes, and analyzing data."  Thus, individually, these elements do not provide an inventive concept.

    But, when viewed in combination, the elements of the claim provide for "a nonconventional and non‐generic way to ensure that the customer's identity is verified in a secure manner that is more than the conventional verification process employed by an ATM alone."  Particularly, these steps represent "a sequence of events that address unique problems associated with bank cards and ATMs (e.g., the use of stolen or 'skimmed' bank cards and/or customer information to perform unauthorized transactions)."  As such, the claim is a practical application of an abstract idea to solve a specific problem through nonconventional technical means, and is patent-eligible.

    The final example claim recites:

    3.  A method of conducting a secure automated teller transaction with a financial institution by authenticating a customer's identity, comprising the steps of:
        obtaining customer‐specific information from a bank card,
        comparing, by a processor, the obtained customer‐specific information with customer information from the financial institution to verify the customer's identity, by
        generating a random code and visibly displaying it on a customer interface of the automated teller machine,
        obtaining, by the automated teller machine, a customer confirmation code from the customer's mobile communication device that is generated in response to the random code, and
        determining whether the customer confirmation code matches the random code, and
        automatically sending a control signal to an input for the automated teller machine to provide access to a keypad when a match from the analysis verifies the authenticity of the customer's identity, and to deny access to a keypad so that the transaction is terminated when the comparison results in no match.

    Applying step one of Alice, the USPTO concluded that this claim, like claims 1 and 2, is directed to the abstract idea of "a method of fraud prevention by identity verification before proceeding with a banking transaction."  Regarding step two, the USPTO observed that the generating, obtaining, and determining sub-steps, when considered individually, are generic or conventional steps recited at a high level of generality.  Accordingly, from this perspective, they do not lend eligibility to the claim.

    Nonetheless, when considered in combination, these elements "operate[] in a non‐conventional and non‐generic way to ensure that the customer's identity is verified in a secure manner that is more than the conventional verification process employed by an ATM alone."  Like the Office's position regarding claim 2, this combination goes beyond the conventional sequence of events in an ATM transaction, and therefore entails an inventive concept.

    Analysis

    The inclusion of BASCOM in these examples as a "business method" is curious, though telling.  While the claims in BASCOM are arguably technical rather than business-oriented, the USPTO relied heavily on the reasoning of that case to justify its positions on the claims of Example 35.

    But more substantively, the USPTO is making it clear that in order for a claim related to a financial or business transaction to be eligible, that claim should recite technical content in detail and not just at a high level.  The claim should include more than just a recitation that a transaction occurs, but the steps used to enable that transaction.  Further, the claimed invention should enable capabilities that were not enabled or not possible with known, conventional transactions.  In other words, when a claim uses technological steps to provide a nonconventional and desirable result, the claim will be viewed more favorably in the § 101 determination.  In contrast, claim 1 is ineligible because it recites the transaction without specifying exactly how it takes place, while the steps and the combination thereof were arguably known and conventional.

    Of course, this begs the question of whether pure business methods that recite new and/or improved non-technical procedures are eligible post-Alice.  The USPTO does not provide answer here, perhaps because the Federal Circuit has yet to find such a claim valid.

  • By Kevin E. Noonan

    FDAOn Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA).  This Guidance, entitled Considerations in Demonstrating Interchangeability with a Reference Product, Is long-awaited and addresses a important aspect of the biosimilar drug regime.  Interchangeability, which is the standard for conventional, small molecule generic drugs, is challenging for biologic drugs because of their size and complexity, and because the biosimilarity standard encompasses molecules that are not atom-for-atom identical to the reference biologic drug product.  Accordingly, the ease with which conventional generic drugs are substituted for brand name versions is not appropriate for biosimilar drugs, and the statute sets out standards for interchangeability status (Section 351(k)(4) of the PHS Act), wherein FDA must find that:

    (A) the biological product—
        (i) is biosimilar to the reference product; and
        (ii) can be expected to produce the same clinical result as the reference product in any given patient; and
    (B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

    Interchangeability is important for a variety of reasons, particularly with regard to biosimilar drug acceptance and the ability for the interchangeable biosimilar to be substituted for a reference biologic drug product without intervention or approval of a health care provider.  Accordingly, such drugs are rewarded with additional layers of exclusivity (indeed, the only exclusivity for biosimilar drugs contained in the statute, as set forth in the PHSA under Section 351(k)(6)), wherein FDA shall not grant interchangeability status for any second biosimilar drug until the later of:

    (A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product; [or]
    (B) 18 months after –
        (i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or
        (ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or
    (C)(i) 42 months after approval of the first inter- changeable biosimilar biological product if the applicant that submitted such application has been sued under sub- section (l)(6) and such litigation is still ongoing within such 42-month period; or
        (ii) 18 months after approval of the first interchange- able biosimilar biological product if the applicant that sub- mitted such application has not been sued under subsection (l)(6).

    The Guidance provides FDA's first attempt to operationalize the statutory requirements and give the biopharmaceutical industry guidance on what the agency will require to grant interchangeability status to a biosimilar drug.

    The Guidance is expressly focused on therapeutic protein products with regard to the evidence necessary to establish interchangeability with a reference biologic drug product that is a therapeutic protein.  As with almost all other FDA Guidances on biosimilars, this one recites that interchangeability determinations shall be made after consideration of the totality of the evidence that a biosimilar dug satisfies the statutory requirements.  Thus, the first requirement is that a biosimilar applicant show that its drug is biosimilar to the reference biologic drug product, and envisions that first licensure will be on biosimilarity grounds.  With regard to the requirement that a purportedly interchangeable biosimilar drug would be "expected to produce the same clinical result as the reference product in all of the reference product's licensed conditions of use," the Guidance sets forth a nonlimiting set of data and information:

    • The identification and analysis of the critical quality attributes
    • The identification of analytical differences between the reference product and the proposed interchangeable product, and, in addition, an analysis of the potential clinical impact of the differences
    • An analysis of mechanism(s) of action in each condition of use for which the reference product is licensed, which may include the following:
        -  The target receptor(s) for each relevant activity/function of the product
        -  The binding, dose/concentration response, and pattern of molecular signaling upon engagement of target receptor(s)
        -  The relationship between product structure and target/receptor interactions
        - The location and expression of target receptor(s)
    • The pharmacokinetics and biodistribution of the product in different patient populations The immunogenicity risk of the product in different patient populations
    • Differences in expected toxicities in each condition of use and patient population (including whether the expected toxicities are related to the pharmacological activity of the product or to off-target activities)
    • Any other factor that may affect the safety or efficacy of the product in each condition of use and patient population for which the reference product is licensed

    If there are differences between the reference biologic drug product and the biosimilar with respect to any of these factors, the Guidance asserts that the biosimilar applicant must supply a scientific justification as to why those differences don't preclude a determination of interchangeability.  However, the Guidance does not envision that satisfying this standard will necessarily require additional clinical studies.  Also, an applicant can (but FDA recommends that she does not) seek approval for less than all the indications approved for the reference biologic drug product (and in this regard the Guidance envisions that an applicant may "extrapolate" the data and information supporting interchangeability for one indication to support interchangeability for additional indications).

    As for the other statutory requirement, that "for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch," the Guidance expects a biosimilar applicant will need to do one or more "switching studies" (the general requirements being set forth with some specificity in the Guidance) that will be used to assess the risk to safety or efficacy of alternating between the reference biologic drug product and the biosimilar.

    The Guidance provides "an overview of important scientific considerations in demonstrating interchangeability with a reference product," including:

    • Data and information needed to support a demonstration of interchangeability
    • Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
    • Recommendations regarding the use of a U.S.-licensed reference product in a switching study or studies
    • Considerations for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.

    And the Guidance then sets forth more detailed explication of these considerations, including product-dependent factors that could influence the data needed to show interchangeability (again urging a "stepwise" approach to establishing interchangeability as FDA has urged for establishing biosimilarity) and showing a high degree of biosimilarity (with reference to biosimilarity Guidances regarding so-called "fingerprint identity" measures of biosimilarity).  The information and data should be aimed at reducing the amount of residual uncertainty, which is expected to depend on the structural and functional complexity of the biosimilar drug.  Particularly called out in this regard is the risk of product-specific immunogenicity, which may be more relevant to some biosimilar drugs than others depending on the nature of the reference biologic drug product.

    The Guidance also envisions that interchangeability may require biosimilar product postmarketing data, and that such data would not obviate the need for other, interchangeability-related data (e.g., from switching studies, particularly with regard to comparison of pharmacokinetic or pharmacodynamics parameters).

    The Guidance provides detailed discussion of the characteristics of switching studies expected to be required to satisfy interchangeability requirements, for those drugs expected to be administered to a patient more than once (presumably this category encompasses many of not most biologic drugs).  These studies will depend on how the drug will be used in practice, according to the Guidance, and the Guidance sets out considerations regarding study endpoints, design and analysis, sample size and number of switches, sampling for PK, PD and immunogenicity, study population, and study analysis, as well as conditions of use and routes of administration.

    There is also a section regarding the conditions under which data can be extrapolated (e.g., from one condition of use to another for which the reference biologic drug product is licensed), supported by scientific justification based on mechanism of action, immunogenicity risk, expected toxicities, or "[a]ny other factor that may affect the safety or efficacy of the product in each condition of use and patient population for which the reference product is licensed."

    Unlike the Guidances concerning the grounds for establishing biosimilarity, which permit comparative data with a non-U.S. licensed reference biologic drug products to be submitted, the Guidance states that switching studies must be performed using a U.S. licensed reference biologic drug product.  This is because in these studies the reference biologic drug product is not used just as a control but is also part of the study, administered in both the switching arm and the non-switching arm.  This limitation appears to be based on concerns regarding unpredictable differences in immunogenicity or PK profiles, as well as the existence of several ex-U.S. versions of biosimilar drugs having slight but perhaps clinically relevant differences when used in a switching study that could negatively impact the reliability of study results.

    The Guidance ends with a detailed description of presentation designs for the data and information supporting an interchangeability determination (referencing Section VII of FDA's earlier Guidance entitled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product) and a section on postmarketing safety monitoring.  The Guidance also contains an Appendix related to Comparative Use Human Factor Studies.

    And like all such Guidances, it contains an express disclaimer:

    This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.