• Strafford #1Strafford will be offering a webinar/teleconference entitled "Demonstrating Patent Eligibility Post-Alice: Impact of McRo and Other Recent Cases — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinion" on December 20, 2016 from 1:00 to 2:30 pm (EST).  Michael L. Kiklis and Stephen G. Kunin of Oblon McClelland Maier & Neustadt will examine recent decisions applying the Supreme Court's decision in Alice Corp. v. CLS Bank on patent eligibility, and discuss the guidance from these opinions and offer best practices for addressing patent eligibility issues.  The webinar will review the following issues:

    • How are the courts applying the framework for patent eligibility created in Alice Corp.?
    • How can patent litigation defendants take advantage of the guidance for Section 101 challenges?
    • What are best practices for patent counsel to demonstrate patent eligibility?

    The registration fee for the webinar is $297.  Those registering by November 25, 2016 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Infringement: Structuring Opinions of Counsel — Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" on December 13, 2016 from 1:00 to 2:30 pm (EST).  Thomas J. Scott, Jr., Senior Vice President and General Counsel, Personalized Media Communications, and April Weisbruch and Eleanor M. Yost of Goodwin Procter will provide patent counsel with an analysis of the evolving role of opinions in the defense of patent infringement claims and the potential use of opinions of counsel, and will also discuss the issue of waiver of the attorney-client privilege and provide best practices for developing opinions of counsel.  The webinar will review the following issues:

    • What is the practical impact of recent Supreme Court and Federal Circuit decisions on utilizing opinions of counsel in defense of willful infringement and induced infringement claims?
    • How does the Supreme Court's new "Totality of the Circumstances" standard impact legal advice on proactive clearance analysis for product planning and strategic portfolio development?
    • Under what circumstances should corporate counsel seek outside opinions of counsel to protect their client from infringement claims?

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

  • By Kevin E. Noonan

    Now that the dramatic change in the political climate that is the election of Donald Trump as President has had time to settle, it may be fruitful to consider whether the election provides opportunities for technology-based industries to convince the President-elect to adopt policies that can work to their advantage.

    Internet AssociationOne group has already taken the initiative:  the Internet Association (a 40-member group that includes Google, Amazon, eBay, Dropbox, Facebook, Groupon, Intuit, Monster, Netflix, Paypal, Reddit, Spotify, Twitter, Yahoo, and Yelp) has written a letter to the President-elect voicing their concerns.  Specifically directed to Internet industries and their concerns, but which also include the benefits to the broader economy from increased connectivity both nationally and globally.  The group lays claim to 6% of the economy, equivalent to $1 trillion in GDP (2014) and $8 trillion exchanged through global e-commerce.  These benefits stem, according to the Association's letter, from "an open architecture that lowers entry barriers, fosters innovation, and empowers choice," representing "the best of American innovation, freedom and ingenuity."

    Following these general comments, the letter appends a list described as a "roadmap" for policies that have fostered (and purportedly will foster) the Internet and "ensure its continued success and ability to create jobs throughout our economy."  These include intermediary liability laws (that limit internet providers' liability for content; copyright exceptions (fair use, compulsory licenses, and exhaustion principles); "data-driven innovation" policies that are concerned with privacy and data security only insofar as internet activities lead to actual harm and not merely supposed harm from data collection per se; and more fluid digital trading policies).

    It is with regard to patents (called patent "reform") that the Association urges policies that may be preferentially beneficial to their industries but not to the biotechnology and pharmaceutical industries.  These include favoring "critical patent subject matter eligibility standards," specifically the test enunciated under Alice v. CLS Bank, on the grounds that the patent system should "focus[] on real advances in technology rather than broad, vague business methods and abstract ideas that fuel patent troll litigation."  "Calls to weaken the Alice decision or Section 101 are misguided and unnecessary as the courts clarify software patentability," which whether true or not give short shrift to the disarray imposed by Supreme Court (Mayo, Myriad) and Federal Circuit (Sequenom, GTG v. Meriel) decisions.  The letter also urges the President-elect to "uphold vigorous post-grant review programs," that provide "small inventors and productive businesses with a meaningful tool to ward off the low quality patents that fuel patent troll litigation."  Again, true or not, this advocacy ignores the deleterious effects of continuous attacks on granted U.S. patents with no hope of repose against serial (if not perpetual) challenge.

    The demographics of the Trump campaign may provide an opportunity for other voices, specifically biotech and pharma company voices, to be heard.  At least publicly, the high-tech community in general and Silicon Valley companies specifically were not particular supporters of Mr. Trump's campaign.  In addition, the pharmaceutical industry is traditionally a section of the business community favored by Republican administrations.  Thus, Republican control of Congress and a Trump administration may result in a government more likely to understand the realities of drug and diagnostic method development and the importance of patents in fostering innovation in that sector.  The circumstances suggest that it may be wise for leaders in these industries, and their trade and professional groups, to begin to consider how best to bring their concerns to Congress and most particularly to the President-elect, while he is deciding what policies to pursue in the first two years of his administration (before the midterm elections may change the Congressional calculus).  Mr. Trump campaigned on the theme that he understood business as a successful businessman and thus he may be receptive to such proposals.  And perhaps the best approach might be to take advantage of his belief that the policies of the current administration, both domestic and abroad, have led to a lack of competitiveness with our trading partners and competitors.  A later post will explore the differences in patent-eligibility (and thus patenting) and natural products and diagnostic methods in other countries, but getting Mr. Trump's attention to these issues may be as simple as letting him know that "China is winning" in light of some of the very policies (such as subject matter eligibility) touted by the Internet Association in their letter.

  • By Andrew Williams

    Biotechnology Innovation Organization (BIO)On Friday, December 9, 2016, the Federal Circuit will hear oral arguments en banc in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR proceedings.  Specifically, the Court will be considering the following questions:

    (a) When the patent owner moves to amend its claims under 35 U.S.C. § 316(d), may the PTO require the patent owner to bear the burden of persuasion, or a burden of production, regarding patentability of the amended claims as a condition of allowing them?  Which burdens are permitted under 35 U.S.C. § 316(e)?

    (b) When the petitioner does not challenge the patentability of a proposed amended claim, or the Board thinks the challenge is inadequate, may the Board sua sponte raise patentability challenges to such a claim?  If so, where would the burden of persuasion, or a burden of production, lie?

    The briefing of the parties, Appellant (Aqua Products, Inc.) and Intervenor (the Director of the United States Patent and Trademark Office), was completed this past week.  Amicus Curiae briefs were submitted by the Intellectual Property Owners Association; the Case Western Reserve University School of Law Intellectual Property Venture Clinic and The Ohio Venture Association; the Houston Intellectual Property Law Association; the American Intellectual Property Law Association; the Pharmaceutical Research and Manufacturers of America; the Biotechnology Innovation Organization (BIO); Askeladden, L.L.C.; the Internet Association, and the Computer & Communications Industry Association, Dell, Garmin, Intel, Red Hat, Samsung, SAP America, SAS Institute, the Software & Information Industry Association, Symmetry, and Vizio.  In this post, we will review the amicus brief filed by BIO in support of Aqua Products.

    With regard to the first question, BIO asserted that the PTO is not permitted to require a patentee to bear the burden of proving the patentability of a proposed substitute claim.  Whereas the PTO can require the patentee to come forward with information related to determining whether the amendment enlarges the scope of the claims, introduces new matter, and is responsive to an instituted ground of purported invalidity, it may not require the patentee to bear the burden of proving patentability of the proposed claims.  After the patentee has produced such evidence, it is the petitioner that must establish the unpatentability of the substitute claims.  According to BIO, there should be no affirmative duty on the patentee to prove the patentability of a substitute claim.

    With regard to the second question, BIO asserted that the PTAB's role as impartial adjudicator would be threatened if it were to begin inquiring about the "adequacy" of any petitioner opposition to substitute claims.  Nevertheless, in cases where the petitioner does not oppose the substitute claims, the Board is still required to ensure that the substitute claims meet the requirements of 35 U.S.C. § 316(d) and related regulations.  However, this inquiry should be limited to determining whether the proposed substitute claims is broader in scope than the originals, whether they present new matter, whether they do not respond to a ground of unpatentability, and whether written description support is lacking in the originally filed disclosure and priority documents.  If the claims fail any of these inquiries, the PTAB should have the authority to deny the motion.  Finally, with regard to the second element of the Court's question, BIO asserted that if the claims met the above detailed requirements, the narrowed claims should be presumptively patentable.  Therefore, if there is no challenge from the petitioner, the Board's role should not extend beyond making these determinations.

    The BIO amicus brief supported its argument by citing to the legislative history.  In fact, BIO pointed out that the ability to amend claims was included in the statute with little debate or controversy, which suggests that the ability of the patent owner to amend its claims was "a common and otherwise unremarkable procedure that would unfold as a matter of course if not of right."  Moreover, BIO pointed the Patent Office's own rulemaking to implement the new AIA post-grant proceedings, in which it used the ability to amend claims as a justification for the use of the broadest reasonable interpretation standard for claim construction.

    BIO continued to argue in its amicus brief that the burden allocation utilized by the Patent Office is inconsistent with the statute.  35 U.S.C. § 316(d) allows a patentee to propose substitute claims that do not enlarge the scope and that do not introduce new matter.  BIO pointed out that the next subsection, 316(e), specifies that a proposition of unpatentability in an instituted IPR must be proved by the petitioner.  Of course, this subsection establishes the evidentiary standard for IPR proceedings as a whole, but it does not specifically establish a different standard for claim amendments.  In fact, BIO points out that under the PTO's interpretation of this subsection, the burden will fall on the petitioner for only some propositions of unpatentability, but not for others.

    BIO concluded its amicus brief by asserting that the facilitation of more amendments would advance the intended policy outcomes of the AIA.  The goal of the AIA was to improve patent quality.  However, the binary outcome of IPR proceedings (claims survive or are struck down) has frustrated this objective.  In fact, BIO has pointed out that several proposals have been proposed to address improvements in the amendment process.  Nevertheless, for the time being, BIO urged the Federal Circuit to provide guidance to establish an IPR amendment process that fulfills the intended objectives:  "a facile and robust means to improve patent quality, while maintaining the integrity of the post-grant system."

    Patent Docs will continue to monitor this case.

    For additional information regarding this topic, please see:

    • "In re Aqua Products, Inc. — CAFC Grants Rehearing En Banc to Consider PTAB Motions to Amend," August 15, 2016

  • By Donald Zuhn

    USPTO SealOn October 28, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (81 Fed. Reg. 9451), proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings.  The Office previously issued a notice of proposed rulemaking regarding the same rules in July 2011 following the Federal Circuit's decision in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc), but indicated in the latest notice that given the passage of time since the comment period closed on the prior notice, the Office felt it was appropriate to seek additional comments from stakeholders before issuing a final rulemaking.

    In its latest notice, the Office points out that the Therasense decision does not require the Office to harmonize its materiality standard underlying the duty of disclosure with the Federal Circuit's but-for materiality standard underlying the inequitable conduct doctrine.  However, the Office asserts that "[a] unitary materiality standard is simpler for the patent system as a whole."  The Office also believes that by adopting the Therasense but-for standard for materiality in the proposed rules changes, "the frequency with which charges of inequitable conduct are raised against applicants and practitioners for failing to disclosure material information to the Office will be reduced."  The Office further believes that adopting the but-for materiality standard will "reduce the incentive to submit marginally relevant information in information disclosure statements (IDSs)."

    In the notice, the Office proposes changes to the rules of practice to harmonize the materiality standard for the duty of disclosure before the Office with the but-for materiality standard for establishing inequitable conduct before the courts in light of the Federal Circuit's decision in Therasense.  The Office is also proposing changes to the rules of practice to explicitly reference "affirmative egregious misconduct" as set forth in Therasense.  In particular, the Office proposes the following changes to 37 C.F.R. § 1.56(a) and (b) (wherein text to be deleted is indicated by strikethrough and text to be added is indicated by underlining):

    1.56 Duty to disclose information material to patentability.
        
        
    (a) A patent by its very nature is affected with a public interest.  The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability.  Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability under the but-for materiality standard as defined in paragraph (b) of this section.  The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned.  Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application.  There is no duty to submit information which is not material to the patentability of any existing claim.  The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d)(b) through (d) and 1.98.  However, no patent will be granted on an application in connection with which affirmative egregious misconduct was engaged in, fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.  The Office encourages applicants to carefully examine:
            (1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
            (2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.
        (b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
            (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
            (2) It refutes, or is inconsistent with, a position the applicant takes in:
                (i) Opposing an argument of unpatentability relied on by the Office, or
                (ii) Asserting an argument of patentability.
    A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.
        (b) Information is but-for material to patentability if the Office would not allow a claim if the Office were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction consistent with the specification.

    Similar changes are being proposed to 37 C.F.R. § 1.555(a) and (b).

    In response to its July 2011 notice, the Office received 24 comments.  As indicated in the latest notice, several of these comments motivated the Office to make further changes to the proposed rules.  In particular, the Office notes that to avoid potential confusion, the language regarding affirmative egregious misconduct was moved from the definition of the materiality standard for disclosure of information as previously proposed, to 37 C.F.R. § 1.56(a) and 37 C.F.R. § 1.555(a).  In addition, the explicit reference to the Therasense decision was removed from the previously proposed rules.  The Office further modified the previously proposed rules to state that a claim is given its broadest reasonable construction "consistent with the specification."  Finally, the Office is no longer requiring applicants to explain or clarify the relationship of the prior art to the claimed invention as proposed in the prior notice of proposed rulemaking.

    In addressing the comments to the prior notice, the Office also notes that "[t]he duty does not pertain to information that is only material to claims that have been cancelled or withdrawn."  With regard to the language regarding cumulative information set forth in existing 37 C.F.R. §§ 1.56 and 1.555 (which has been removed from the proposed changes to the rules in the latest notice), the Office contends that "[i]nformation that is merely cumulative to information already on the record would not be material under the but-for standard," and therefore the Office "is not requesting that applicants submit cumulative information."

    The Office did not, however, change the rules such that the duty of disclosure would end upon payment of the issue fee rather than the patent grant as proposed in several comments.  Nor did the Office change the rules to abrogate the duty of disclosure as also proposed in several comments.

    Written comments regarding the notice of proposed rulemaking can be sent by e-mail to:  AC58.comments@uspto.gov; by regular mail addressed to:  Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Matthew Sked, Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  Written comments must be submitted by December 27, 2016 to be considered.

  • By Donald Zuhn

    USPTO SealIn a notice published last month in the Federal Register (81 Fed. Reg. 74775), the U.S. Patent and Trademark Office has requested comments from the public on WIPO Standard ST.26, a new standard for the presentation of nucleotide and/or amino acid sequences in patent applications.  The new standard was adopted by the Committee on WIPO Standards (CWS) in March and would replace the old WIPO Standard ST.25, which was originally adopted by the USPTO in July of 1998.

    WIPO Standard ST.26 arose out of an effort that began in October 2010, when the CWS established a task force, with the European Patent Organisation as the lead, to draft a revised standard for filing nucleotide and/or amino acid sequence listings in XML format.  The new standard is composed of six documents: the main body of the standard, a first annex setting forth the controlled vocabulary for use with the sequence part of the standard, a second annex setting forth the Document Type Definition (DTD) for the standard, a third annex containing a sequence listing specimen, a fourth annex setting forth the character subset from the Unicode Basic Latin Code Table, and a fifth annex setting forth additional data exchange requirements for patent offices.  A proposed sixth annex would provide a guidance document for applicants and national and regional patent offices.  The USPTO has made all of the documents available here.

    The Office is requesting comments from the public regarding any of the new standard's documents, and in particular, is seeking comments on the comprehensiveness and clarity of WIPO Standard ST.26 and the proposed guidance document annex, as well as comments regarding the proposed authoring/validation tool for creation of a sequence listing in XML.  The Office's notice indicates that the "[a]vailability of an authoring tool in advance of the WIPO Standard ST.26 effective date is key to a successful transition from WIPO Standard ST.25," noting that direct conversion from one standard to the other is not possible due to numerous differences between the two standards.  The notice also points out that a sequence listing generated in the WIPO Standard ST.26 XML format is not as easily readable as a sequence listing generated in its ST.25 counterpart, which will make the authoring tool even more important to the success of transitioning from the old standard to the new standard.

    Comments on WIPO Standard ST.26 can be submitted by e-mail to:  seq_listing_xml@uspto.gov, or by regular mail to:  Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Susan C. Wolski, Office of International Patent Legal Administration, Office of the Deputy Commissioner for International Patent Cooperation.  Comments must be received by the Office by December 27, 2016 to be considered.

  • CalendarNovember 15, 2016 – "Covered Business Method (CBM) Patent Review: Another Way to Kill Software Patents?" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    November 15, 2016 – "That's a Fact! The Role of Factual Disputes in PTAB Institution Decisions in the Life Sciences" (Federal Circuit Bar Association) – 1:00 to 2:00 pm (ET)

    November 22, 2016 – "After-Final Practice: Navigating Expanding PTO Options to Compact Patent Prosecution — Utilizing Post-Prosecution Pilot Program (P3), After-Final Consideration Pilot 2.0, Pre-Appeal Conference and More" (Strafford) – 1:00 to 3:00 pm (EST)

    December 6, 2016 – "From Chevron to Cuozzo: Practical Impacts of Administrative Law on PTO Proceedings" (Federal Circuit Bar Association) – Boston, MA

    December 8, 2016 – "Means-Plus-Function Patent Claims After Williamson: Navigating the New Standard — Assessing Impact on Prosecution, Litigation and IPRs" (Strafford) – 1:00 to 2:30 pm (EST)

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Means-Plus-Function Patent Claims After Williamson: Navigating the New Standard — Assessing Impact on Prosecution, Litigation and IPRs" on December 8, 2016 from 1:00 to 2:30 pm (EST).  Thomas L. Irving and Amanda K. Murphy, Ph.D. of Finnegan Henderson Farabow Garrett & Dunner, and Wanli Tang, Ph.D. of Jones Day will provide patent counsel with a review of how means-plus-function and/or functional claims are used after the Williamson decision as well as the benefits and risks involved with using means-plus-function and/or functional claims in view of both litigation in the district courts and IPRs before the PTAB. The panel will also offer their experiences and best practices for overcoming the challenges of means-plus-function claims and leveraging Section 112(f) and functional claims for maximum patent protection.  The webinar will review the following issues:

    • What impact will the Williamson decision have on functional claim interpretation?
    • What are the benefits and limitation of using means-plus-function patent claims?
    • What practices can counsel employ to leverage §112(f) to increase the likelihood of surviving IPRs?

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

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a program entitled "From Chevron to Cuozzo: Practical Impacts of Administrative Law on PTO Proceedings" on December 6, 2016 from 1:00 to 2:00 pm (ET) at the Northeastern University School of Law in Boston, MA.  Andrew M. Mason of Klarquist Sparkman LLP will moderate a panel consisting of Lucas C. Townsend of Gibson, Dunn & Crutcher and Philip Warrick, Office of the Solicitor, U.S. Patent and Trademark Office.  The panel will focus on the practical consequences of the requirements of the Administrative Procedure Act ("APA") and administrative law, generally, in PTO proceedings, including examination, reexamination, appeals, and PTAB trials such as inter partes review.  The panel will also provide an overview of the APA-PTO intersection, discuss how leading administrative law decisions affect PTO proceedings, and cover strategic considerations relating to APA challenges.

    Additional information regarding the program can be found here.