Patent Docs

Webinar on AIA Impact on Section 103 and Non-Obviousness

Strafford will be offering a webinar/teleconference entitled "AIA Impact on Section 103 and Non-Obviousness: Navigating Timing Changes, Post-AIA Treatment of KSR, and Secondary Considerations to Meet Patent Validity Requirements" on June 25, 2013 from 1:00 - 2:30 pm (EDT).  Thomas L. Irving and Erika H. Arner of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel regarding the impact of the Leahy-Smith America Invents Act (AIA) on section 103 and non-obviousness, and offer best practices for meeting the non-obviousness requirement for patent validity.  The panel will review the following questions:

• How has the AIA impacted the determination of obviousness?
• How has the Federal Circuit treated the issues of non-obviousness?
• What practices should counsel employ in order to meet the non-obviousness requirement?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

U.S. Trade Representative Issues 2013 Special 301 Report

By Kevin E. Noonan --

On May 1st, Acting U.S. Trade Representative (USTR) Demetrius Marantis issued the 2013 Special 301 Report.  According to the USTR website, the Report "demonstrates U.S. resolve to take strong action to support critical jobs and exports in IP-intensive industries."  "The actions reflected in this year's report send a message to all trading partners on the Priority Watch List and the Watch List that the United States is prepared to use the Special 301 process to its full effect, both to recognize positive action and, where necessary and appropriate, to identify deterioration of the IPR protection and enforcement systems that play such a vital role in international trade," according to USTR Marantis.  The USTR Report "demonstrates U.S. resolve to take strong action to support critical jobs and exports in IP-intensive industries," according to the website announcement, and "regrets" the inclusion of Ukraine, which "earned the first new Priority Foreign Country designation in 11 years" as the result of its "severely deteriorating climate for IPR protection and market access," and "call[s] upon that government to reverse recent backsliding and swiftly resolve the problems identified" in the Report.  This action follows last year's inclusion of Ukraine on the Priority Watch List "in light of serious and growing concerns relating to counterfeiting and rampant piracy."  On the other hand, the Report hails Canada for making "long-awaited progress on concerns identified in past reports."

The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These watch lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

This Report, on the state of intellectual property rights worldwide, identifies ten countries on a "Priority Watch List" and another 30 countries on the "Watch List," all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the Report lists Algeria, Argentina, Chile, Chine, India, Indonesia, Pakistan, Russia, Thailand, and Venezuela, with Canada and Israel exiting the list compared with last year's Report.  Countries on this list "do not provide an adequate level of IPR protection or enforcement, or market access to persons relying on intellectual property protection."  On the Watch List this year are Barbados, Belarus, Bolivia, Brazil, Bulgaria, Canada, Columbia, Costa Rica, Dominican Republic, Ecuador, Egypt, Finland, Greece, Guatemala, Israel, Italy, Jamaica, Kuwait, Lebanon, Mexico, Paraguay, Peru, Philippines, Romania, Tajikstan, Trinidad and Tobago, Turkey, Turkmenistan, Uzbekistan, and Vietnam; compared to last year, Brunei and Norway have been removed from the list and Canada is on the list this year, with Ukraine having been moved to the Priority Watch List.  The Report lists a "wide range of concerns, including the continued deterioration in IPR protection, enforcement, and market access for persons relying on IPR in Ukraine; the growing problem of misappropriation of trade secrets in China and elsewhere; troubling 'indigenous innovation' policies that may unfairly disadvantage U.S. rights holders in China; the continuing challenges of copyright piracy over the Internet in countries such as Brazil, Italy, and Russia; and other ongoing, systemic IPR enforcement issues presented in many trading partners around the world."  Despite these concerns, the Report evinces a desire to "work[] closely with the governments of [U.S.] trading partners [identified in the Report] to address both emerging and continuing concerns, and to build on the positive results many of these governments have achieved."

The Report notes that public response to a Federal Register Notice used to prepare the Report continued the "enhanced approach to public engagement" instituted last year, with the USTR receiving 41 comments (access to these comments is provided at www.regulations.gov, docket number USTR-2012-0022).  In addition, 13 witnesses provided testimony at a public hearing on February 20, 2013; these witnesses included "representatives of foreign governments, industry, and non-governmental organizations" (available on the USTR website).

The Report notes some "positive developments" in the past year, including copyright amendments in the Bahamas that benefited U.S. copyright holders, and the removal of Brunei from the Watch List due to its "significantly increased its focus on IPR protection and enforcement in recent years, through substantial and meaningful enforcement efforts, including both civil and -- for the first time -- criminal actions."  Also, "Canada enacted the long-awaited Copyright Modernization Act in 2012, which, among other things, is designed to implement Canada's obligations under the WIPO Internet Treaties and address the challenges of copyright piracy in the digital age" which garnered U.S. approval, and Israel "enacted a law improving its procedures for the publication of patent applications."  China was lauded in the Report for the decision by the Supreme People's Court "on the liability of Internet intermediaries ('Rules of Supreme Court on Several Issues Concerning the Application of Law in Adjudication of Civil Disputes Related to Infringement of Right of Communication over Information Networks')."  The Report also extolled Russia for developing an "IPR Action Plan" with the U.S. directed towards "the areas of greatest mutual concern in IPR protection and enforcement," which include enactment of laws for a specialized IPR court and amendments to the Russian criminal code "to revise criminal thresholds for copyright piracy."  Panama, the Philippines, Taiwan and Turkey were also noted for positive measures adopted by their governments in 2012.

Several initiatives were also mentioned.  As in the 2012 Report, these included the Trans-Pacific Partnership Agreement, between the U.S. and Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam, and in addition, Canada, Mexico, and Japan; the Transatlantic Trade and Investment Partnership between the U.S. and the EU; actions by the World Trade Organization in support of IP rights; the Anti-Counterfeiting Trade Agreement (ACTA) between the U.S. and Australia, Canada, Japan, South Korea, Mexico, Morocco, New Zealand, Singapore, with Japan becoming the first signatory to deposit its instrument of acceptance; bilateral and regional initiatives, including free trade agreements and Trade and Investment Framework Agreements; and the USTR Trade Preference Program Reviews such as the Generalized System of Preferences (GSP) program relating to Russia, Lebanon, and Uzbekistan, and regional programs including the Caribbean Basin Economic Recovery Act (CBERA).  Finally, the Representative "looks forward to continuing engagement with trading partners in bilateral, regional, and multilateral fora to improve the global IPR environment"; including the U.S.-EU Summit, and in the Asia Pacific Economic Cooperation (APEC) forum, and the Organization for Economic Cooperation and Development (OECD).

The Report contains a section on "best practices" among U.S. trading partners, including "encourage[ing] trading partners to work with the United States to develop mutually agreed-upon action plans to advance the protection and enforcement of IPR," specifically noting the "action plan" with Russia.  Cooperation between governments is also mentioned, as well as "innovative mechanisms that enable government and private sector rights holders to voluntarily donate or license IPR on mutually-agreed terms and conditions."  These include the use of existing IPR to advance policy goals and innovation, specific examples of which are the Medicines Patent Pool under the auspices of the World Health Organization and the WIPO Re:Search Consortium among the U.S., Brazil and South Africa.

There is a section of the Report again this year regarding "capacity building efforts" that relate to "opportunities for the U.S. Government to work closely with trading partners to address [IPR] concerns."  These efforts are described in the Report as being directed to "building stronger, more streamlined, and more effective systems for the protection and enforcement of IPR," which seems to include an effort to encourage U.S. trading partners to enact criminal penalties for IPR infringement.  The Report documents the efforts of the USPTO's Global Intellectual Property Academy (GIPA) to provide training ("9,217 foreign IP officials from 130 countries through 140 separate programs") as well as programs administered by other U.S. government agencies (including the USPTO's Office of Policy and External Affairs; the International Trade Administration; the Bureau of Customs and Border Protection; the Commercial Law Development Program and programs in law enforcement administered by the Departments of Justice and Homeland Security).

A significant part of the Report focuses on "trends" in counterfeiting and copyright piracy, as it has in other years.  This area "continue[s] on a global scale," according to the Report, "involving the mass production and far-reaching sales of a vast array of fake goods, including counterfeit semiconductors, medicines, health care products, food and beverages, automobile parts, such as air bags, aircraft parts, apparel and footwear, toothpaste, shampoos, razors, electronics, batteries, chemicals, sporting goods, motion pictures, and music."  The Report recites a "[s]ustained growth in piracy of copyrighted products in virtually all formats," which "offer enormous profits and little risk."  Online sales of counterfeit goods "will soon surpass the volume of such goods sold" in physical markets, which raise "difficulties" for IPR enforcement.  Also noted is an increase in legitimate businesses, such as courier services, enlisted to deliver infringing goods, as well as the practice of producing the goods and the counterfeit labels separately, specifically citing Canada and Vietnam for such practices.  There is also the emergence of "Media Box piracy," defined as a situation "whereby 'boxes,' often with capability to play high definition content, are loaded with large quantities of pirated works.  These boxes may be sold with preloaded content, but can later have new content uploaded for a relatively low fee.  Boxes may be purchased online, with the user's chosen content, and delivered via postal service, or may have online capabilities allowing consumers to download infringing content from the Internet or through downloadable apps.  This problem has been reported in China, Indonesia, Malaysia, Taiwan, Thailand, and Vietnam."

The Report calls for "[s]tronger and more effective criminal and border enforcement" to reverse these trends.  Another "growing" problem is counterfeit pharmaceuticals, either final drug product or active pharmaceutical ingredients (API); Brazil, China, India, Indonesia, Lebanon, Peru, and Russia are cited as countries where the former type of counterfeiting is a problem and China is cited as being a "major source" of counterfeit APIs.

Another section of the Report is concerned with digital piracy, particularly over the Internet, which is "a significant concern in many U.S. trading partners."  The "increased availability of broadband Internet connections around the world . . . has [] made the Internet an extremely efficient vehicle for disseminating copyright-infringing products, replacing legitimate markets for rights holders," according to the Report.  Piracy is a "significant" concern, with "[u]nauthorized retransmission of live sports telecasts over the Internet" being singled out as "a growing problem."  New technologies, including media boxes as discussed above, are also recognized to be a problem, with "U.S. copyright industries also report[ing] growing problems with piracy using mobile telephones, tablets, flash drives, and other mobile technologies."  Further mentioned are the "emergence of private servers, which permit "cloud-based entertainment software" to have access to such unauthorized servers "to play copyrighted video games that are made available through hacked software and/or circumvention of the rights holders' technological protection measures."  In this regard, the Report specifically calls out SlySoft, "a company headquartered and operating in Antigua, which developed and sells a program called 'Any DVD HD' enabling the user to defeat the encryption technology embedded in Blu-ray Discs that prevents unauthorized reproduction and distribution," operating despite an Antiguan law prohibiting "manufacture or import for sale or rental any such circumvention device."  Despite cooperation between the Antiguan government and a "consortium of electronic manufacturers, software companies, and motion picture studios that developed these technological protection measures," progress on changing Antiguan law is deemed "slow" in the Report.

The Report asserts that the U.S. "will work with its trading partners to combat these growing problems," and urges U.S. trading partners to "adequately implement the WIPO Internet Treaties."  The Report specifically recites a list of trading partners that includes Argentina, Belarus, Brazil, Chile, China, Colombia, India, Indonesia, Italy, Mexico, Philippines, Romania, Russia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, and Vietnam in this regard, and Switzerland is "strongly encourage[d] . . . to combat online piracy vigorously."

Trade secrets and forced technology transfer are identified as problems in "a wide variety of industry sectors" that include "information and communication technologies, services, biopharmaceuticals, manufacturing, and environmental technologies."  The threat of trade secret misappropriation is "increasing," particular with regard to electronic espionage.  Particularly noted in the Report in this regard is China, with trade secret theft involving "departing employees, failed joint ventures, cyber intrusion and hacking, and misuse of information submitted to government entities for purposes of complying with regulatory obligations," with remedies in China being "difficult to obtain."  "Chinese actors are the world's most active and persistent perpetrators of economic espionage," according to the U.S. National Counterintelligence Executive, with recent evidence indicating that "actors affiliated with the Chinese military and Chinese Government have systematically infiltrated the computer systems of over one hundred U.S. companies and stolen hundreds of terabytes of data, including all forms of trade secrets, such as proprietary technology, manufacturing processes, and confidential business information."

The Report cited a publication by the U.S. Intellectual Property Enforcement Coordinator on February 20, 2013 of "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," which "highlights U.S. efforts to combat the theft of trade secrets that could be used by foreign governments or companies to gain an unfair economic advantage by harming U.S. innovation and creativity."  These include:

• "Focusing diplomatic efforts to protect trade secrets overseas;
• Promoting voluntary best practices by private industry to protect trade secrets, including information security, physical security, and human resources policies;
• Enhancing domestic law enforcement operations, especially through the activities of the Department of Justice, Federal Bureau of Investigations, Department of Defense, and the National IPR Coordination Center;
• Improving domestic legislation to protect against trade secret theft, [and]
• Conducting public awareness campaigns and stakeholder outreach to encourage all stakeholders to be aware of the dangers of trade secret theft."

The Report also notes that "threat of trade secret theft is not the only way that foreign actors may seek to undermine U.S. commercial advantages," and urges U.S. trading partners to "eject trade-distortive policies," which include:

• Requiring the transfer of technology as a condition for allowing access to a market, or for allowing a company to continue to do business in the market;
• Directing state-owned enterprises in innovative sectors to seek non-commercial terms from their foreign business partners, including with respect to the acquisition and licensing of IPR;
• Failing to effectively enforce IPR, including patents, trademarks, trade secrets, and copyrights, thereby allowing firms to gain competitive advantages from their misappropriation or infringement of another's IPR;
• Failing to take meaningful measures to prevent or deter cyber intrusions;
• Requiring use of, or providing preferences to, products or services in which IPR is either developed or owned locally, including with respect to government procurement;
• Manipulating the standards development process to create unfair advantages for domestic firms, including with respect to the terms on which IPR is licensed;
• Requiring unnecessary disclosure of confidential business information for regulatory approval, or failing to protect such information.

As it has for the past few years, the Report contains a section on "Intellectual Property and Health Policy," again specifically mentioning the 2001 Doha Declaration on the TRIPS Agreement.  The Report states that the Declaration "recognized the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria, and other epidemics," and that the U.S. "respects a trading partner's right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines."  Accordingly, the Report states that the U.S. "respects our trading partners' rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement, and encourages its trading partners to consider ways to address their public health challenges while maintaining intellectual property systems that promote investment, research, and innovation."  The U.S. "strongly supports" the WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.  The Report, in a section relating to "pharmaceutical and medical device innovation" cites "the policies of several developed trading partners, including Finland, Germany, Greece, Hungary, Italy, Korea, New Zealand, Poland, Portugal, Romania, Spain, Turkey, and Taiwan, on issues related to innovation in the pharmaceutical sector and other aspects of health care goods and services."  The U.S. is "seeking to establish or continue dialogues with relevant trading partners to address these and other sectoral concerns, and encourage a common understanding on questions related to innovation in the pharmaceutical and medical device sectors," specifically regarding China in this regard.

The Report contains in a final section a review of U.S. activities in the WTO to resolve disputes with countries such as China and the EU over trade issues.

Section II of Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.

As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  The Report seems to revert to earlier attempts, generally no more than partially successful, by the U.S. and other Western governments to implement international trade treaties designed to increase IP rights protection.  It remains to be seen if that approach is continued in next year's Report, or if U.S. trade policy will continue to swing through the pendulum of the carrot or the stick regarding international intellectual property rights enforcement.

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

• "U.S. Trade Representative Issues 2012 Special 301 Report," May 1, 2012
• "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 4, 2011
• "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 19, 2010
• "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
• "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008

Patent Profile: Mayo Foundation Receives Patent for Methods of Selecting Medications

By Josh Bosman --

In March, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,401,801, entitled "Methods for Selecting Medications."  The '801 patent, which is assigned to the Mayo Foundation for Medical Education and Research, contains claims that share some similarities with the claims in U.S. Patent No. 6,680,302, which was licensed to Prometheus Laboratories, Inc., and which was at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc.

The claimed methods of the '801 patent include obtaining a biological sample from a patient and determining the patient's genotype for a panel of genes.  Then, based on the genotype for the panel of genes, a clinician would select a psychotropic medication for the patient, which according to the patent, provides a safe method to avoid potentially dangerous side effects.  The genes of interest in the '801 patent include at least three cytochrome P450 genes and a serotonin transporter gene.  These genes are known to be important for drug metabolism and neurotransmission, respectively, and when examined individually or collectively, may be correlated to a patient's sensitivity or resistance to a given medication.

A specific example of a gene of interest in the patent is the P450 CYP2D6, a gene with many known alleles corresponding to increased or decreased drug metabolizing activity.  For example, the CYP2D6*4 allele results in a truncated version of the gene's protein that does not have catalytic activity.  Therefore, a patient with the CYP2D6*4 allele would be determined to be a poor metabolizer and assigned to an appropriate medication profile that provides medications that are acceptable for use or medications to be used with caution under close monitoring.  By determining a patient's genotype for the panel of genes claimed, a practitioner can use the methods of the invention to anticipate side effects to a medication and allow a clinician to avoid a number of medications a patient may not tolerate.

The two independent method claims recite a long list of genes and alleles to be examined in step (1) and an even longer list of medications to select from based on the patient's genotype in step (3).  Abridged versions of claims 1 and 2 recite (with emphasis added):

1.  A method of administering an antidepressant medication to a patient in need thereof comprising:
    (1)  determining the patient[']s genotype for a panel of genes comprising the following: . . .
    (2)  assigning a metabolic phenotype to the patient based on the genotype of the cytochrome P450 genes in (1), wherein the metabolic phenotype is selected from poor (P), intermediate (I), and extensive (E), and said phenotype is assigned based upon the number of functional alleles for each cytochrome P450 gene as follows: P=no fully functional alleles and either one or no partially functional alleles, I=either one fully functional allele and a non-functional allele or two partially functional alleles, and E=either one fully functional allele and one partially functional allele or two fully functional alleles; and
    (3)  administering to the patient an antidepressant medication selected from the group consisting of: . . . .

2.  A method of administering an antidepressant medication to a patient in need thereof comprising:
    (1)  determining the patients genotype for following panel of genes: . . .
    (2)  assigning a metabolic phenotype to the patient based on the genotype of the cytochrome P450 genes in (1), wherein the metabolic phenotype is selected from poor (P), intermediate (I), and extensive (E), and said phenotype is assigned based upon the number of functional alleles for each cytochrome P450 gene as follows: P=either two partially functional alleles or two increased functional alleles, I=either one fully functional allele and a partially functional allele or one fully functional allele and an increased functional allele, and E=either one partially functional allele and one increased functional allele or two fully functional alleles; and
    (3)  administering to the patient an antidepressant medication selected from the group consisting of: . . . .

As at least two dozen alleles are to be tested for a given patient, and the list of potential medications to be administered in claim 2 is three pages long.  The '801 patent also includes claims directed to methods that "further compris[e] receiving, in a computer system, the patients genotype for the panel of genes, said computer system comprising a database, wherein said database comprises a plurality of antidepressant medication profiles," and "[a] non-transitory computer readable medium containing executable instructions that when executed cause a processor to perform operations comprising: (a) receiving a patient's genotype for a panel of genes . . . (b) assigning a metabolic phenotype to the patient based on the genotype of the cytochrome P450 genes in (1) . . .  and (c) outputting a list of medications suitable for administering to the patient . . . ."

USPTO News Briefs

By Donald Zuhn --

USPTO Modifies After Final Consideration Pilot Program

Earlier this month, the U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 29117) regarding modifications to the After Final Consideration Pilot Program (AFCP).  The AFCP, which was implemented in April 2012, provides examiners with a limited amount of non-production time -- three hours for utility and reissue applications -- to consider responses filed following a final rejection (see "USPTO to Assess After Final Consideration Pilot Program").  When the program was originally implemented, the Office indicated that when an examiner determines that "the nature and extent of the amendments or arguments presented in the response can be fully considered within the limited amount of time authorized by the [AFCP]," the examiner should consider the after final response, and when the examiner determines otherwise, the examiner "should treat the response according to current practice, without non-production time authorized."

In implementing the original AFCP, the Office described six "limited situations [in which] further amendments or arguments may be considered" under the AFCP:

1.  The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action.
2.  The amendment places the application in condition for allowance by rewriting objected-to claims in independent form.
3.  The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search.
4.  The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims.
5.  The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search.
6.  The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]

The Office's notice regarding the modified program, otherwise known as the After Final Consideration Pilot Program 2.0 (AFCP 2.0), indicates that there are three main differences between the original AFCP and the AFCP 2.0:  (1) an applicant must file a request to participate in the AFCP 2.0; (2) a response after final rejection under the AFCP 2.0 must include an amendment to at least one independent claim; and (3) when a response does not result in a determination that all pending claims are in condition for allowance, the examiner will request an interview with the applicant to discuss the response.  The notice also specifies that the requirements for participating in the AFCP 2.0 are:

(1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
(2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
(3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the notice, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
(4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
(5) the required papers must be filed via the EFS-Web.

The AFCP 2.0 took effect on May 19, 2013, and the pilot program will run until September 30, 2013.  The Office notes that the AFCP 2.0 is intended "to reduce pendency by reducing the number of Requests for Continued Examination (RCE) and encouraging increased collaboration between the applicant and the examiner to effectively advance the prosecution of the application."

USPTO Announces Patent for Humanity Winners

Last month, the U.S. Department of Commerce announced the winner of the USPTO Patents for Humanity pilot program.  The Patents for Humanity pilot program, which was launched in February 2012, is a competition recognizing patent owners and licensees who address global challenges in health and standards of living.  The competition was divided into four categories:  medical technology (with separate subcategories for medicines & vaccines and diagnostics & devices), food and nutrition, clean technology, and information technology.  Winners received accelerated processing of select matters at the USPTO in addition to recognition for their work.  The 2012 winners were as follows:

Medical – Medicines & Vaccines
• Gilead Sciences, for making HIV drugs available to the world's poor using a network of generics manufacturers in Asia and Africa.
• University of California, Berkeley, for developing research and license agreements to provide a lower-cost, more reliable way to produce anti-malarial compounds.

Medical – Diagnostics & Devices
• SIGN Fracture Care International, for distributing low-cost fracture implants to speed healing in developing world hospitals.
• Becton Dickinson (BD), for creating a fast, accurate TB diagnosis machine and placing 300 systems in 22 High Burden Countries.

Food & Nutrition
• DuPont Pioneer, for developing an improved strain of sorghum fortified with more protein and vitamins for use in sub-Saharan Africa.
• Intermark Partners Strategic Management LLP, for extracting edible protein and vitamins from waste rice bran in Latin America.

Clean Tech
• Procter & Gamble, for distributing a small chemical packet which removes impurities and contaminants from drinking water and has purified nearly 5 billion liters worldwide.
• Nokero, for delivering solar light bulbs and phone chargers for off-grid villages through local entrepreneurs.

Information Tech
• Sproxil, Inc, for deploying a system to identify counterfeit drugs with an ordinary cell phone in sub-Saharan Africa.
• Microsoft Corporation, for providing machine learning tools that allow health researchers to better analyze large data sets.

The Broader Meanings of the CLS Bank Decision

By Kevin E. Noonan --

"The name of the game is the claim." -- Judge Giles Sutherland Rich

Much has and will continue to be written about the Federal Circuit's en banc decision in CLS Bank Int'l v. Alice Corp. last week, and most of the commentary has and will be critical of the path the court took in arriving at its per curiam decision affirming the District Court's determination that the system, method, and computer-readable media claims fall within a judicially created exception to the broad scope of patent-eligible subject matter under Section 101.  The decision establishes without doubt that Section 101 jurisprudence has been broken by the Supreme Court's return to its subjective, non-statutory approach exemplified in Benson v. Gottschalk and Parker v. Flook, first in Bilski v. Kappos and then in full flower in Mayo v. Prometheus.  These decisions swing the pendulum from Congressional determinations of patent-eligibility to the Court's "we know it when we see it" standard that is not only directly contrary to the Congressional mandate that created the Federal Circuit but also contrary to the Constitutional basis for the Court's review of actions by Congress regarding patents.  Specifically, no one with any knowledge of patent law can seriously argue that the Court's recent forays in finding exceptions to patent eligibility in any way "promote[s] the Progress . . . of the useful Arts."

But the decision also illustrates another fracture among the Federal Circuit judges that cannot be laid at the Supreme Court's doorstep and that in its own way is just as contrary to the statutory scheme and to almost two centuries of U.S. patent law.  That is the practice of not limiting the inquiry to the language of the claims, but to disregard or ignore express claim language in an effort to ascertain "what the inventor has invented."  While this tendency has many antecedents -- including the Supreme Court's Section 101 meanderings but also in the Federal Circuit's application of the written description requirement and the rubric that the claims should be interpreted in view of the specification -- it has surfaced frankly in other Federal Circuit decisions, most notably in Retractable Techs., Inc. v. Becton, Dickinson & Co., and in the opinions expressed concurrent with the Court's decision not to rehear the case en banc.

In the Retractable Technologies case, Retractable Technologies sued Becton Dickinson for infringing claims of U.S. Patent Nos. 5,632,733; 6,090,077; and 7,351,224.  These patent claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury.  The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments.  The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

The Federal Circuit reversed, in a decision by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader.  The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure.  The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece body construction.  Specifically, the majority based its decision on the specification, which described the claimed invention as comprising a one-piece body.  In addition, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies.  Moreover, there was no disclosure of a multiple piece syringe body in specification.  In reversing the District Court's construction, the majority said:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.

(citations omitted, emphasis added)

Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more" (emphasis added).  Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

These disagreements regarding both the proper claim construction here and the proper method for performing claim construction generally also arose in the Federal Circuit's decision not to grant en banc review.  Two dissents were filed in the Court's decision not to hear the claim construction decision en banc:  one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterized claim construction as "the single most important event in the course of a patent litigation."  However, the Federal Circuit's rules for making claim construction determinations remain "ill-defined and inconsistently applied," even by the Court in her view.  While citing commentators to support this conclusion, this dissent focused on the question at issue in Retractable Technologies and, according to Judge Moore, a question that arose generally from a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  Her dissent contended that this was the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

Judge Moore relied principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude."  She discounted the concerns voiced by the Retractable Technologies majority, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question would be one of validity rather than claim construction, she stated, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, her dissent relied on the mantra that the "plain meaning" of the clams controls (and the dissent voiced surprise that this question was not resolved in Phillips).  Judge Moore stated her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002)(emphasis added).  Any deviation from this procedure should be applied narrowly, in her opinion, and specifically, her dissent opined that the choice of an overbroad term may affect validity but should not be considered for claim construction.  Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent contrasted the majority decision in Phillips with the panel decision here:  in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied.  And the evidence, according to this dissent, failed to support a claim limited to single-body embodiments.

Judge Moore identified the problem with the panel decision with particularity:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

(emphasis in original)

While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, her dissent stated simply that the Court "does not rewrite claims"; Retractable Technologies was not a case, Judge Moore contended, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification."  Rather, that case was illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation."  That was enough to convince Judge Moore and Chief Judge Rader that claim construction required reconsideration by the court en banc.  Judge Moore also wrote that the Retractable Technologies case had a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction would permit or require deference to a district court's factual determinations under Markman v.Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

When considered in this light, some of the sentiments expressed by Judge Lourie's "concurring" opinion in CLS Bank Int'l can be appreciated as more than just acquiescence to a perceived Supreme Court mandate to reign in a "patent-happy" USPTO.  Examples of the propensity to focus on what was "invented," rather than what is claimed, include the "description" of the invention as:

[A] computerized trading platform used for conducting financial transactions in which a third party settles obligations between a first and a second party so as to eliminate "counterparty" or "settlement" risk . . . .  Settlement risk refers to the risk to each party in an exchange that only one of the two parties will actually pay its obligation, leaving the paying party without its principal or the benefit of the counterparty's performance.  Alice's patents address that risk by relying on a trusted third party to ensure the exchange of either both parties' obligations or neither obligation.

As well as the opinion's discussion of the relevant Supreme Court rubrics:

Where bona fide § 101 concerns arise, however, it is important at the outset to identify and define whatever fundamental concept appears wrapped up in the claim so that the subsequent analytical steps can proceed on a consistent footing.  . . .  In short, one cannot meaningfully evaluate whether a claim preempts an abstract idea until the idea supposedly at risk of preemption has been unambiguously identified.

With the pertinent abstract idea identified, the balance of the claim can be evaluated to determine whether it contains additional substantive limitations that narrow, confine, or otherwise tie down the claim so that, in practical terms, it does not cover the full abstract idea itself.

Even computer-readable medium claims cannot stand under this analysis ("under § 101 we must look past drafting formalities and let the true substance of the claim guide our analysis").

This approach, which Judge Lourie terms the "inventive concept" approach, may be consistent with recent musings by the Supreme Court on the philosophical bases for patent eligibility, but it is in stark contrast with what Judge Moore in Retractable Technologies recognized was a "bedrock principle," i.e., first interpreting the claims consistent with the specification and prosecution history, because only then can the particular questions mandated by the Supreme Court -- whether the claims implicate a law of nature, natural phenomenon or abstract idea, whether the claims completely preempt any implicated law of nature, natural phenomenon or abstract idea, or whether the claims "merely embody, use, reflect, rest upon, or apply those fundamental tools" be answered.

The application of these principles is not lost on the dissenting members of the Court, including Chief Judge Rader who writes directly to this point in his "additional observations" as well as in his concurring-in-part, dissenting-in-part opinion where he was joined by Judges Linn, Moore, and O'Malley.  The Chief Judge, as a former Congressional staffer to Senator Orin Hatch, has written before about the importance of courts relying on the language of the statute in rendering their opinions (such as in Merck v. Integra and the Hatch-Waxman Act) and he does so again here, explicating the legislative history and interdependence of Sections 101, 102, and 103 of the 1952 Patent Act (in the process emphasizing that Congress had relegated the "inventiveness" question, fruit of prior Supreme Court decisions, to Section 103; indeed, even the Court itself has recognized that Congress was "merely" codifying this requirement, as noted, inter alia, in Graham v. John Deere).  In doing so, he rebuts Judge Lourie's concurring opinion but also the "less than pellucidly clear" language in Bilski and the outright inapt language in Mayo, which most clearly introduces these concepts back into the Section 101 analysis contrary to Congressional intent.  Indeed, Chief Judge Rader recognizes the danger in the application of judicial subjectivity in Judge Lourie's (and the Mayo) approach:

Any claim can be stripped down, simplified, generalized, or paraphrased to remove all of its concrete limitations, until at its core, something that could be characterized as an abstract idea is revealed . . . .  A court cannot go hunting for abstractions by ignoring the concrete, palpable, tangible limitations of the invention the patentee actually claims.

The Chief Judge states his case succinctly in his "Additional Reflections" to the court's en banc decision:

When all else fails, consult the statute!

And for evidence that all else has failed, I need only recite Bilski v. Kappos, 130 S. Ct. 3218 (2010), Mayo Collaborative Servs. Inc. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), Ass'n for Molecular Pathology v. U.S. Patent & Trademark Off., 689 F.3d 1303 (Fed. Cir. 2012), cert granted in part, 133 S. Ct. 694 (2012), MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250 (Fed. Cir. 2012), Dealertrack, Inc. v. Huber, 674 F.3d 1315 (Fed. Cir. 2012), and Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), and this list can and will go on and grow.

And the remedy is the same:  consult the statute!

And more specifically (and invoking Giles Sutherland Rich, the only patent jurist the Supreme Court deigns to consider worthy of its recognition), the Chief Judge writes:

And what about "exceptions" like natural laws and natural phenomena?  Of course, these are universal constants created, if at all, only by God, Vishnu, or Allah.  But, for perspective, even gravity is not a natural law in Einsteinian theory, but a symptom of a curved universe.  Einstein posited the speed of light as the only true natural constant.  Thus, in context, equating the personalized medicinal effect of a human-created pharmaceutical in patients of different metabolic rates and genetic makeups with the speed of light (or even gravity) is only possible in a netherworld of undefined judicial insights.  Moreover, to inject the patentability test of "inventiveness" into the separate statutory concept of subject matter eligibility makes this doctrine again "the plaything of the judges who, as they became initiated into its mysteries, delighted to devise and expound their own ideas of what it meant; some very lovely prose resulting."  Giles S. Rich, Principles of Patentability, 28 Geo. Wash. L. Rev. 393, 404 (1960).

Among other things, Judge Rich was remarkably prescient.

Paul Scofield, as Sir Thomas More, recites a speech in A Man for All Seasons that is apropos to Judge Rader's point.  Speaking about God and the devil, the dialog reads as follows:

Alice More:  Arrest him!

More:  Why, what has he done?

Margaret More:  He's bad!

More:  There is no law against that.

William Roper (at right):  There is!  God's law!

More:  Then God can arrest him.

Alice:  While you talk, he's gone!

More:  And go he should, if he was the Devil himself, until he broke the law!

Roper:  So now you'd give the Devil benefit of law!

More:  Yes.  What would you do?  Cut a great road through the law to get after the Devil?

Roper:  I'd cut down every law in England to do that!

Moore:  And when the last law was down, and the Devil turned round on you -- where would you hide, Roper, the laws all being flat?  (He leaves him)  This country's planted thick with laws from coast to coast -- man's laws, not God's -- and if you cut them down -- and you're just the man to do it -- d'you really think you could stand upright in the winds that would blow then?

The Supreme Court, in its recent focus on patent eligibility, is like Roper, believing that the importance of getting the amount of patent eligibility "just right" is important enough to ignore the law (at least that portion of the law that mandates that claims are what sets forth the metes and bounds of an invention), at all costs.  Judge Rader and those members of the Federal Circuit who recognize the folly in this endeavor have, at least, this reliance on the law to guide them, when other members of the Federal Circuit seem to have lost their way in the fog of recent Supreme Court jurisprudence.

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Fresenius Kabi USA LLC v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-00925; filed May 23, 2013 in the District Court of Delaware

• Plaintiff:  Fresenius Kabi USA LLC
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Infringement of U.S. Patent Nos. 5,714,520 ("Propofol Compostion [sic] Containing Edetate," issued February 3, 1998), 5,731,355 ("Pharmaceutical Compositions of Propofol and Edetate," issued March 24, 1998), 5,731,356 ("Pharmaceutical Compositions of Propofol and Edetate," issued March 24, 1998) and 5,908,869 ("Propofol Composition Containing Edetate," issued June 1, 1999) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the complaint here.

Purdue Pharma L.P. et al. v. PAR Pharmaceutical, Inc.
1:13-cv-03374; filed May 17, 2013 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Grunenthal GmbH
• Defendant:  PAR Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 8,337,888 ("Pharmaceutical Formulation Containing Gelling Agent," issued December 25, 2012) and 8,309,060 ("Abuse-Proofed Dosage Form," issued November 13, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals, LLC
1:13-cv-03372; filed May 17, 2013 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals LLC
• Defendant:  Amneal Pharmaceuticals, LLC

Infringement of U.S. Patent No. 8,337,888 ("Pharmaceutical Formulation Containing Gelling Agent," issued December 25, 2012) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Conference & CLE Calendar

May 29, 2013 - AIA and Patent Due Diligence Understanding the AIA Impact and Best Practices for the Due Diligence Process (Strafford) - 1:00 - 2:30 pm (ET)

May 30, 2013 - Harmonization of USPTO Ethical Standards in the Post-AIA Era (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 - 11:15 am (CT)

May 30, 2013 - CLS Opinions: What to Do Now (Intellectual Property Owners Association) - 2:00 - 3:00 pm (ET)

June 5-7, 2013 - Advanced Forum on Biosimilars (American Conference Institute) - New York, NY

June 9-11, 2013 - IP Business Congress (Intellectual Asset Management) - Boston, MA

June 11, 2013 - Preventing Chinese Trade Secret Theft: The Obama Administration's Strategy on Mitigating the Theft of U.S. Trade Secrets (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

June 12, 2013 - Post-Grant Patent Proceedings Before the PTAB (Strafford) - 1:00 - 2:30 pm (EDT)

June 12-14, 2013 - Fundamentals of Patent Prosecution 2013: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

July 15-16, 2013 - Global Patenting Strategy and Practice (American Conference Institute) - New York, NY

July 15-19, 2013 - Patent Law Summer Intensive (Benjamin N. Cardozo School of Law) - New York, NY

June 25-26, 2013 - Maximising Pharma Patents (C5 (UK)) - London, England

July 10-12, 2013 - Fundamentals of Patent Prosecution 2013: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

July 31 to August 2, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 5-7, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

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

IPO Webinar on CLS Bank Int'l v. Alice Corp.

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "CLS Opinions: What to Do Now" on May 30, 2013 beginning at 2:00 pm (ET).  A panel consisting of Michael Chernoff, Director of Legal Services, Patent Operations for Accenture; Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy at the U.S. Patent and Trademark Office; and J. Michael Jakes of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will provide their thoughts on the following topics:

• Bolstering the specification of a patent to follow the line of reasoning in RCT and Ultramercial;
• Including as much detail as possible on how the computer implements the idea, even though that's not a guarantee the claims will be found eligible;
• Focusing on Judge Lourie's rejection of the idea that subject matter eligibility is a threshold question that a judge must always consider first, and his emphasis that all issued patents are presumed to be valid; and
• Whether the Federal Circuit's rulings in prior software patent cases, such as Cybersource and Dealertrack, are precedential.

The registration fee for the webinar is $120 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

ACI Global Patenting Strategy and Practice Conference

American Conference Institute (ACI) will be holding its Advanced Summit on Global Patenting Strategy and Practice on July 15-16, 2013 in New York, NY.  ACI faculty will help attendees:

• Develop a global patenting strategy to protect the commercial embodiment of your product in critically important markets around the world;
• Determine the impact of patent harmonization efforts on your ability to protect your IP in foreign jurisdictions;
• Review and understand the standards for patentability, filing requirements, claim construction, and obviousness or inventive step in major markets like the EU, China, Japan, Korea, and more;
• Contrast the opposition procedures utilized in the U.S. post-America Invents Act, at the EPO, in China, and elsewhere;
• Utilize the ITC as a forum for litigating international patent disputes; and
• Craft effective strategies for protecting trade secrets in numerous countries, whether they have robust IP protections in place or not.

In particular, ACI's faculty will offer presentations on the following topics:

• Understanding the Importance of Developing a Global Strategy for Your Patent Portfolio  -- to be presented in part by Patent Docs author Dr. Kevin Noonan
• An Alignment of Interests: Determining the Impact of Patent Harmonization Efforts on IP Protection
• Devising Effective Strategies for Working with Inventors in Foreign Jurisdictions
• A Review of Guidelines for Patentability and Novelty in Different Patent Office
• Comparing Claim Drafting and Construction Standards in Important Jurisdictions
• Exploring Obviousness and Inventive Step Concepts Around the World
• Analyzing Written Description and Specification Requirements Across Different Patent Regimes
• Comparing and Contrasting Opposition Proceedings in the US and EU
• Navigating the "Ins" and "Outs" of Opposition Practice Across the World
• Using the International Trade Commission (ITC) as a Venue for Global Patent Conflicts
• Crafting Effective Strategies for Protecting Trade Secrets in Multiple Jurisdictions
• Addressing the Challenges Presented by Compulsory Licensing Provisions Abroad

Two post-conference workshops will be held on July 17, 2013.  The first, entitled "Mastering the Foreign Patent Law and Regulatory Requirements for Life Sciences Companies in a Global Context," will be offered from 9:00 am to 12:00 pm.  The second, entitled "The Interactive Working Group Session: Negotiating the Obstacles and Challenges Associated with Patenting a Product in Numerous Jurisdictions," will be offered from 1:30 pm to 4:30 pm.

The agenda for the Global Patenting Strategy and Practice conference can be found here, and additional information about the post-conference workshops can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,295 (conference and both workshops).  Those registering by June 21, 2013 will receive a $200 discount.  Patent Docs readers who reference the discount code "PD200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Global Patenting Strategy and Practice conference.

Webinar on Post-Grant Proceedings

Strafford will be offering a webinar/teleconference entitled "Post-Grant Patent Proceedings Before the PTAB" on June 12, 2013 from 1:00 - 2:30 pm (EDT).  Scott A. McKeown and Greg H. Gardella of Oblon Spivak McClelland Maier & Neustadt will discuss the new post-grant patent practice and offer best practices for counsel to either patentees or third parties in inter partes review, post-grant review, and covered business method challenges.  The panel will review the following questions:

• How has post-grant practice been transformed since the America Invents Act?
• What are the best practices for the new post-grant review and inter partes review?
• What are the strategic approaches for counsel dealing with covered business method patent challenges?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

Webinar on Trade Secret Theft

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Preventing Chinese Trade Secret Theft: The Obama Administration's Strategy on Mitigating the Theft of U.S. Trade Secrets" on June 11, 2013 from 10:00 am to 11:15 am (CT).  MBHB attorney Joshua Rich will cover recent developments in the attempt to mitigate theft of U.S. trade secrets.  Topics to be covered include:

• An overview of the "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets"
• Recent Obama Administration steps to implement the Administration strategy
• Industry and public suggestions for the improvement of Federal trade secret law
• Pending Congressional measures for the prevention of trade secret misappropriation

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

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)

By Kevin E. Noonan --

Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the basis for deciding priority and defining the scope of prior art to a claimed invention.  Nevertheless, the provisions of the 1952 Act remain in force for any application filed prior to March 16, 2013, and the Federal Circuit's recent decision in Dey, L.P. v. Sunovion Pharmaceuticals, Inc., illustrates that there remain issues in the "old" law that will continue to be explicated and addressed.

The issue in the Dey case is the patentability bar under 35 U.S.C. § 102(b) that arises from "public use" of an invention more than one year prior to an applicant's filing date.  The circumstances surrounding the assertion of invalidity under this provision of the statute were somewhat unusual, as recognized by the Court:  typically it is the accused infringer who asserts a patentee's own prior public use as invalidating, but here defendant Sunovion asserted its own prior clinical trial as a public use of Dey's claimed invention.  Specifically, both Sunovion and Dey developed pharmaceutical formulations of a known drug, formoterol, as a nebulized formulation for treating chronic obstructive pulmonary disorders (COPS) such as emphysema.  Both companies owned patents on their formulations:  No. 6,040,344 to Sunovion (filed in 1998 and issued in March 2000); and Nos. 7,348,362; 7,462,645; 7,465,756; 7,473,710; and 7,541,385 to Dey (all claiming priority to July 10, 2003).  Sunovion was the first to market in 2007 with its Brovana product, after what the Court terms a "long" path to obtaining regulatory approval.  Sunovion's clinical trials began in 1998, and of interest in the decision is a particular Phase III clinical trial, Study 50, that began in February 2002, wherein one of the formulations tested was identical to the Brovana formulation.

Just prior to launch, Dey sued Sunovion for infringement of its patents, and Sunovion filed a motion for summary judgment of invalidity for prior public use under § 102(b), based on its own clinical trials.  Under Sunovion's legal theory, the Phase III clinical trial identified as Study 50 included a formulation (given to 124 clinical trial participants) that was within the scope of Dey's patent claims and the conditions of the clinical trial constituted a prior public use that occurred more than one year before Dey's earliest filing date of July 10, 2003.  The conditions Sunovion cited in support of the prior art status of its clinical trial were:

• Patients were told that they were being given a formulation of formoterol
• Patients enrolled in the trial were told they could (and indeed should) inform their personal physicians about the trial
• Patients enrolled in the study were under no conditions of confidentiality
• At least some of the vials ("a fraction of one percent") of the formulated drug were unaccounted for during and after the clinical trial

The District Court granted summary judgment against Dey, finding that Sunovion had established by clear and convincing evidence that the asserted claims of Dey's patents in suit were invalid as being anticipated under the "public use" prong of § 102(b).

The Federal Circuit reversed, in an opinion by Judge Bryson, joined by Judge O'Malley over a dissent by Judge Newman.  The panel noted that the purpose of the bar was to "discourage[e] the removal, from the public domain, of inventions that the public reasonably has come to believe are freely available," citing Tone Bros., Inc. v. Sysco Corp., 28 F.3d 1192, 1198 (Fed. Cir. 1994).  The test for deciding whether a prior use was a "public use" under the statute has two elements:  "'whether the purported use:  (1) was accessible to the public; or (2) was commercially exploited,'" citing Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).  Factual issues to be considered when determining whether a prior use constitutes a "public use" include "'the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use'" according to the opinion, citing Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371, 1379 (Fed. Cir. 2004).  In the absence of commercial exploitation a confidentiality agreement could "negate" the status of a prior use as a public use.  Invitrogen at 1382.

The status of a prior use as a public use is not dependent on the public use being an applicant's use; activities of third parties (such as Sunovion here) can constitute an invalidating prior public use.  Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1334 (Fed. Cir. 2005).  But such a third party use must be a public not a private use (i.e., the fact that there was a prior use by another does not by itself constitute a public use) according to the Court, citing Woodland Trust v. Flower- tree Nursery, Inc., 148 F.3d 1368, 1371 (Fed. Cir. 1998), and W.L. Gore & Assocs. v. Gar- lock, Inc., 721 F.2d 1540, 1549-50 (Fed. Cir. 1983).  The opinion notes that, as with all question under § 102 this is a question of fact depending on the circumstances, such as a situation where there is no confidentiality agreement:  there, "the skill and knowledge of those observing an invention can shed light on the degree to which it was kept confidential" and even "limited disclosure" may suffice if it is to "those who are skilled enough to know, understand, and 'easily demonstrate the invention to others,'" citing Netscape Commc'ns Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed. Cir. 2002).

The Federal Circuit reversed the District Court's summary judgment because it found disputed issues of material fact that made summary judgment inappropriate.  However the majority opinion went on to set forth the considerations important for making the determination and the places where in the majority's opinion the District Court went astray.  The majority identified two issues important to the District Court's decision that warranted comment.  The first was the lower court's determination that the use of the particular "infringing" formulation during the clinical trial was "open and free," a determination with which the Court disagreed.  The basis for this disagreement revolved around the incapacity of the clinical trial participants to "reverse engineer" the formoterol formulation even knowing the identity of the drug.  In addition, the panel majority disagreed that the study participants were provided with a "personal supply" of the formulations that they could use "however they saw fit" and that provided them with an "unfettered use of the composition for weeks at a time."  The panel agreed with Dey that the use by the study participants was anything but "unfettered," citing the restrictions contained in agreements between the clinical trial administrators and participants, including requirements that the participants be the only individuals taking the medication and that they keep "accurate usage logs"; the Court also noted that despite the extremely low level of the formulation that was unaccounted for the participants and administrators in the trials were required to return all unused portions of the drug and to account for all administered and inventory supplies of the formulated drug.  Specifically the opinion states:

The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public.

The majority also disagreed that the details of the clinical trial were not required to be kept confidential by trial participants.  The issue for the Court was what information was kept confidential and here the panel noted that "the particulars of its invention -- embodied in the formulation and stability characteristics of Batch 3501A -- were kept sufficiently confidential to avoid a finding of 'public use.'"  Also important for the panel's decision were the confidentiality obligations imposed on the clinical investigators (clearly more knowledgeable than the patients), who were required to sign confidentiality agreements.  The panel majority found that the individuals most likely to have sufficient disclosure for the clinical trial to be a public use were under an obligation not to disclose (thereby negating the clinical trial as a public use as to those individuals), and that the individuals (the patients) not under  any confidentiality obligations had insufficient information to constitute prior disclosure of the invention.

The panel majority noted that the circumstances surrounding the clinical trial were common and that prior precedent "routinely rejected the argument that such an arrangement necessarily strips the trial of confidentiality protection or renders it accessible to the public," citing Bayer Schering Pharma AG v. Barr Labs., Inc., No. 05- CV-2308 (PGS), 2008 WL 628592, at *11-12, *38-42 (D.N.J. Mar. 3, 2008); Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., 364 F. Supp. 2d 820, 873-75, 912-13 (S.D. Ind. 2005), aff'd, 471 F.3d 1369, 1380-81 (Fed. Cir. 2006); Janssen Pharmaceutica N.V. v. Eon Labs Mfg., Inc., 374 F. Supp. 2d 263, 276 (E.D.N.Y. 2004), aff'd, 134 F. App'x 425, 430-31 (Fed. Cir. 2005); and In re Omeprazole Patent Litig., 490 F. Supp. 2d 381, 508 (S.D.N.Y. 2007), aff'd on other grounds, 536 F.3d 1361 (Fed. Cir. 2008).  Circumstances in common in such cases and the case at bar noted by the Court is that study participants were informed as to the identity of the administered drug, that such patients were entrusted to administer doses themselves not under the control or supervision of a study administrator or doctor and that these prior participants were permitted to discuss the trial with their personal physicians.

Finally, the panel majority identified several other "misconceptions" underlying the District Court's decision.  These included that lack of any confidentiality obligations to Dey by Sunovion's clinical trial participants, which the panel recognized would require any third party prior use (even a secret use) to be a patent-invalidating public use.  And the panel rejected Sunovion's attempt, in their view, to stretch precedent related to "experimental use," such as New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1299 (Fed. Cir. 2002), and City of Elizabeth v. American Nicholson Pavement Co., 97 U.S. 126, 136 (1877), to apply in this situation.  In those cases the invention was "public" but was not appreciated by the public under circumstances where the use was necessary to demonstrate reduction to practice of the invention ("During experimentation, the public might have knowledge of an invention (because they see it), but may not be using the invention within the meaning of the statute (because the inventor is experimenting)").  Accordingly, the Court remanded the case to the District Court for reconsideration on the merits.

Judge Newman's dissent was not based on her disagreement with the outcome but rather because she would prefer the Court remand with instructions to deny the motion on the grounds that the Sunovion clinical trials did not constitute a "public use."  "No sound reason appears for remanding for findings or trial, when the matter is readily resolved on undisputed facts.  Nor is there any reason for casting judicial doubt on the standard confidentiality procedures of clinical trials, at this late date of decades of established practice," in Judge Newman's view.

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Newman, Bryson, and O'Malley
Opinion by Circuit Judge Bryson; dissenting opinion by Circuit Judge Newman

Supreme Court Grants Certiorari in Medtronic v. Boston Scientific

By Andrew Williams --

On May 20, 2013, the Supreme Court granted certiorari in the Medtronic Inc. v. Boston Scientific Corp. case (Supreme Court docket number 12-1128).  The sole issue on appeal is encapsulated by the question presented:

QUESTION PRESENTED:

In Medlmmune, Inc. v. Genentech, Inc., 549 U.S. 118, 137 (2007), this Court ruled that a patent licensee that believes that its products do not infringe the patent and accordingly are not subject to royalty payments is "not required . . . to break or terminate its . . . license agreement before seeking a declaratory judgment in federal court that the underlying patent is . . . not infringed."

The question presented is whether, in such a declaratory judgment action brought by a licensee under Medlmmune, the licensee has the burden to prove that its products do not infringe the patent, or whether (as is the case in all other patent litigation, including other declaratory judgment actions), the patentee must prove infringement.

As suggested, this wrinkle is the inevitable consequence of the Court's previous MedImmune decision, which allowed a patent licensee to challenge the validity (and non-infringement) of a patent in a DJ action without repudiating the license.  In such a case, however, the patent holder could not have brought its own patent infringement action (because of the license agreement), and more importantly, the patent holder could not bring an infringement counterclaim.  The Supreme Court did not address in MedImmune whether the patent holder would still have the burden of proving infringement in such a case where the licensee was seeking to disturb the status quo ante.  This issue was answered in the negative by the Federal Circuit in Medtronic Inc. v. Boston Scientific Corp., 695 F.3d 1266 (Fed. Cir. 2012), as we reported at the time.  In its petition for cert., Medtronic equated this with a "presumption of infringement," and noted that proving the negative can be "a formidable task."  In any event, it can be assumed that the Supreme Court took up this case because it disagreed with the Federal Circuit's decision, and therefore the burden will likely shift back to the patentee to prove infringement in the MedImmune context.  Nevertheless, it may be useful to look at the factual differences between the MedImmune and Medtronic cases, and identify what to do if faced with a similar situation in the interim.

One of the most significant differences between these two cases is that, despite the lengths that Justice Scalia takes to categorize the suit in MedImmune as one for a determination of non-infringement, that earlier case was really a case about validity.  MedImmune had entered into a license agreement with Genentech for rights to an existing patent related to the production of chimeric antibodies, and for the future rights to a then-pending patent application related to the coexpression of immunoglobulin chains in a host cell.  That pending application issued as the "Cabilly II" patent, and Genentech informed MedImmune that its manufacture of Synagis, a drug used to prevent respiratory tract disease in infants and young children, was covered by this patent.  MedImmune's precise position on whether the Cabilly II patent covered the manufacture of Synagis is unclear from the description in the Court's opinion.  However, it appears that MedImmune believed that it did not "infringe any valid claim," and did not believe that there would be no infringement regardless of the validity of the claims.

The situation in the current Medtronic case is distinct.  Medtronic had entered into a license agreement in 1991 with the predecessor-in-interest of the patents-in-suit, which covered cardiac resynchronization therapy ("CRT") devices.  However, the products that were the subject of this case were not marketed until 2004, and therefore (obviously) they were not specifically identified in the license.  Nevertheless, the license contained a provision by which the licensor could identify new Medtronic products that it believed were covered by its patents.  If Medtronic believed that any newly identified products were not covered by the agreement, they had the option to initiate a declaratory judgment action to challenge the non-infringement and/or validity of the asserted patents.  In other words, this agreement had a MedImmune provision more than 15 years before the Supreme Court decided the case.  So, at its heart, the present case is a non-infringement case (non-infringement of the licensed patents), not necessarily a validity case (even though there were validity counts in the lower court).

So, why does this matter?  Well, it might not.  But, a review of the reasoning used by the Supreme Court in MedImmune shows that the logic begins to unravel if it is applied to every factual situation.  In MedImmune, the Court gave the impression that it is axiomatic that a licensee can bring a declaratory judgment action without repudiating the contract, but in so doing, it needed to overcome many logical hurdles to reach that conclusion.  This is because the existence of a license should remove any case-or-controversy as required by Article III.  Nevertheless, as the Court put it:  "[t]he rule that a plaintiff must destroy a large building, bet the farm, or (as here) risk treble damages and the loss of 80 percent of its business, before seeking a declaration of its actively contested legal rights finds no support in Article III."  MedImmune Inc., 549 U.S. at 134.  Is this always the case, though?  It would not appear to be in situations where the patent and the licensed product or method existed when the license agreement was reached.  In such a case, if the licensee had a reasonable belief that the patent was invalid (or not infringed), such as an opinion of counsel, then it should not be at risk of treble damages.  Instead, after MedImmune, such a licensee can negotiate the best terms possible, and still be able to subsequently attack the patents while hiding behind the license as a shield.  The MedImmune logic, therefore, only appears to be applicable to after-arising patents or products/methods.

In fact, the MedImmune case had the ideal fact situation for the logic presented.  MedImmune needed the license to the first patent to practice its method of manufacture without fear of suit.  Therefore, it could not repudiate the agreement, even though it believed that the claims of the issued Cabilly II were invalid (and, unfortunately, the Court's opinion in silent as to why the Cabilly II application was included in the first place).  This is the classic "bet-the-farm" situation.  This is not necessarily the case for the Medtronic fact scenario, which encompasses after-arising products that were not part of the agreement.  Specifically in that case, it was the license provision dealing with new products that required Medtronic to bring its declaratory judgment action.  However, in these cases, it all comes down to license drafting -- what mechanism does the agreement use to incorporate products or methods that do not exist at the time of execution?  Correspondingly, the response to the question presented of whether the licensor patent holder or the licensee should have the burden of proving infringement/non-infringement should also depend on the particular facts.

But, in the end, this distinction will likely not matter, because the MedImmune decision was decided as a non-infringement case (over the protests of Justice Thomas in dissent).  It is possible that Justice Scalia took such pains to describe the case as such, because a DJ case directed solely to validity of patents would have looked a lot more like an advisory opinion, and therefore satisfaction of Article III's case-or-controversy requirement would have been more suspect.  It can therefore be presumed that a majority of the Court will still not view these cases as factually distinct.  And, given that cert. was granted, it is likely that the Medtronic burden-of-proof issue will swing back to the patentee.

What actions should a licensor patent holder take if now faced with a MedImmune-style DJ action?  It would clearly seem advisable to put on the best infringement case possible, in case the burden of proof does shift back.  Otherwise, it would seem critical to treat all of these issues upfront when entering into a license agreement.  Careful attention should go into any provision that would determine how any new patent or product/method would get incorporated into the agreement, if such a provision is even included at all.  It is not inconceivable that that parties would need to renegotiate for any subsequent activity that might be incorporated to the agreement.

Patent Docs will continue to monitor this case and provide any updates as warranted.

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Opinions by Judge Moore, Judge Newman, and Judges Linn and O'Malley

By Michael Borella --

A previous post presented the background of this case, as well as Judge Lourie's plurality concurrence, and a second post addressed Chief Judge Rader's concurrence-in-part and dissent-in-part.  As noted in those posts, Alice's claimed inventions involved the reduction of settlement risk using a third-party intermediary.  This post continues the story of Alice by discussing the dissenting-in-part opinion by Circuit Judge Moore, the concurring-in-part and dissenting-in-part opinion by Circuit Judge Newman, and the dissenting opinion by Circuit Judges Linn and O'Malley.

Judge Moore's dissent-in-part

Judge Moore begins her opinion, which was joined by Judges Rader, Linn, and O'Malley, with a warning:  "if all of these claims, including the system claims, are not patent-eligible, this case is the death of  hundreds of thousands of patents, including all business method, financial system, and software patents as well as many computer implemented and telecommunications patents."  She noted that 320,799 patents were granted over a 13 year period in the USPTO's "Electrical Computers, Digital Processing Systems, Information Security, Error/Fault Handling" technology area, and that all of these patents were potentially at risk under Judge Lourie's opinion.

Like Judge Rader, Judge Moore stated that claims must be considered as a whole, and under that standard, Alice's system claims would be patent-eligible.  She noted that Prometheus explicitly indicated that interpreting the judicial exceptions to subject matter patentability too broadly would "eviscerate patent law" because at some level all inventions are based on abstract ideas, laws of nature, and/or natural phenomena.

Judge Moore also argued against the conflation of § 101, § 102, and § 103.  She noted that Judge Lourie's "inventive concept" analysis introduced a time-dependency into the § 101 inquiry that was more appropriate for the inquiries of the other sections.  To illustrate this point, she provided examples:

Even though the concept of addition is an abstract idea, the first calculator that could perform addition was a patent-eligible machine under § 101.  If someone subsequently discovered that, by rewiring the calculator, it could perform addition and subtraction (both abstract mathematical concepts), the improved calculator would similarly be patent-eligible.  The act of modifying the circuitry of a known device such that it is configured to apply an abstract idea does not transform it into an abstract idea.

Accordingly, largely based on the same general reasoning as Judge Rader, Judge Moore would have found Alice's system claims patent-eligible.

Judge Newman's concurrence-in-part and dissent-in-part

Judge Newman begins by noting that this case has provided three incompatible standards for § 101 analysis, opening the door for "opportunistic litigation, whose result will depend on the random selection of the panel."  She plainly stated that the Federal Circuit has failed to clarify the interpretation of § 101.

Judge Newman's position, like that of four of her colleagues, is that the § 101, § 102, and § 103 inquiries are separate.  She writes "it is not necessary, or appropriate, to decide whether subject matter is patentable in order to decide whether it is eligible to be considered for patentability."  She propounded a simplification of the § 101 inquiry by suggesting that "when the subject matter is within the statutory classes in section 101, eligibility is established."  Invoking the oft-quoted phrase that patent law embraces "anything under the sun that is made by man," she would push off all considerations of claim breadth to the other sections of the statute.

Ultimately, Judge Newman positioned her separate opinion as call for the Federal Circuit to affirm three basic principles of patentable subject matter.

1)  "The court should hold that section 101 is an inclusive statement of patent-eligible subject matter."  Judge Newman advocated eliminating claims that are abstract or that pre-empt abstract ideas or the other judicial exceptions using "laws of novelty, utility, prior art, obviousness, description, enablement, and specificity."

2)  "The court should hold that the form of the claim does not determine section 101 eligibility."  Whether the invention is claimed as a method, CRM, or system, and whether it is implemented with hardware or software, would not be relevant to the § 101 inquiry for Judge Newman.  Like Judge Lourie, she would attempt to decrease the impact of the so-called "clever draftsman."

3)  "The court should confirm that experimental use of patented information is not barred."  Perhaps most important of the three, Judge Newman believes that the popular media has misconstrued the debate on patentable subject matter to mean that a patented invention cannot further be studied.  In particular, she would have the Court hold that experiments that improve or build upon patented subject matter, compare it with alternatives, seek to understand its mechanisms, and to find new applications should be considered non-infringing activities.

Judge Linn's and Judge O'Malley's dissent

In stark contrast to their colleagues, Judges Linn and O'Malley would reverse the District Court ruling and find all claims patent-eligible for procedural reasons.

Since the summary judgment motions were filed prior to claim construction, the District Court gave the claims, for purposes of considering these motions, an interpretation defined by Alice.  Thus, Judges Linn and O'Malley afforded that the District Court was "required to read into the claims whatever limitations Alice asserted a skilled artisan would assume they possessed."  And, as noted above, the parties stipulated at trial that all claims required a computer and a memory to be performed.

Consequently, Judges Linn and O'Malley faulted Judges Rader and Moore of improperly construing the method claims more broadly than the system claims, and also reproached Judge Lourie for importing the breadth of the method claims into the system and CRM claims.  Judges Linn and O'Malley would have all claims rise or fall together.

With respect to the patent-eligibility of the system claims, the judges reiterated the position of Judge Rader.  However, they would also apply the same analysis to the method and CRM claims, and find those claims meeting the § 101 requirements as well.

Judges Linn and O'Malley concluded with a discussion of software patents at large.  Rather than use § 101 to mitigate a supposed "proliferation and aggressive enforcement of low quality software patents" concerning the various amici curiae, they would push this issue back to Congress for legislative action.  They suggested that Congress could limit the term of software patents, or limit their scope by requiring functional claiming.

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc)
Opinion for the court per curiam; concurring opinion by Circuit Judge Lourie, joined by Circuit Judges Dyk, Prost, Reyna, and Wallach; concurring-in-part and dissenting-in-part opinion by Chief Judge Rader, joined by Circuit Judge Moore, and by Circuit Judges Linn and O'Malley as to all but part VI of that opinion; dissenting-in-part opinion by Circuit Judge Moore, joined by Chief Judge Rader and Circuit Judges Linn and O'Malley; concurring-in-part and dissenting-in-part opinion by Circuit Judge Newman; dissenting opinion by Circuit Judges Linn and O'Malley; additional reflections by Chief Judge Rader.