Patent Docs

Webinar on Structuring Opinions of Counsel

Strafford 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.

Does President Trump Provide an Opportunity for Patent-friendly Policies?

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.

One 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.

Biotechnology Innovation Organization's Amicus Brief for In re Aqua Products, Inc.

By Andrew Williams --

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

USPTO Proposes Revisions to Materiality Standard

By Donald Zuhn --

On 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.

USPTO Seeks Comments on New Sequence Standard

By Donald Zuhn --

In 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:  [email protected], 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.

Conference & CLE Calendar

November 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

Webinar on Means-Plus-Function Patent Claims After Williamson

Strafford 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.

FCBA Program on Impact of Administrative Law on PTO Proceedings

The 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.

Webinar on After-Final Practice

Strafford will be offering a webinar/teleconference entitled "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" on November 22, 2016 from 1:00 to 3:00 pm (EST).  Andrew T. Harry and Scott A. McKeown of Oblon McClelland Maier & Neustadt will provide guidance to patent counsel on the various USPTO options for responding after final rejection of a patent application; touch on the basics of each option and focus on strategic considerations and use of the different options; and also provide an update on the ongoing pilot program, review statistics, and discuss their experiences.  The webinar will review the following issues:

• What options are available to patent counsel upon receiving a final rejection to a patent application?
• What factors should patent counsel consider when determining if and which PTO option to use in response to a final rejection?
• How can patent counsel and applicants leverage the PTO options for compact patent prosecution?

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

In re NuVasive, Inc. (Fed. Cir. 2016)

By Andrew Williams --

The Federal Circuit remanded a final written decision of the Patent Trial and Appeal Board ("PTAB" or "Board") because the Board invalidated certain claims in a patent without providing adequate notice or opportunity to the patentee to respond to an assertion about a prior art reference.  Interestingly, in the In re NuVasive, Inc. opinion decided on November 9, 2016, the Federal Circuit reviewed the outcome of two IPR proceedings related to the same patent, U.S. Patent No. 8,187,334, directed to implants for spinal fusion surgery.  In the first proceeding, IPR2013-00507, the original petition had specifically cited to a section of U.S. Patent No. 5,860,973 ("Michelson"), and that section included a description of a prior art structure.  In the other proceeding, IPR2013-00508, there was no such specific citation to the structure, although the Michelson reference was cited.  In both cases, the Board relied on that prior art structure as represented in Figure 18 to invalidate all but one of the challenged claims as obvious.  In reaching its decision for the IPR2013-00508 proceeding, the Federal Circuit concluded that because Figure 18 was not referenced until the petitioner's reply, and because the Board's citation to Figure 18 was material to its invalidation of the claims, NuVasive was entitled to an opportunity to respond to the assertion about this figure.  The same was not true for IPR2013-00507.  The Federal Circuit concluded in that case that because Figure 18 was referenced in the petition, although not with specificity, NuVasive had sufficient notice (although "barely") that it should address the prior art structure found in that figure.  Claims 16 and 17 were the only two claims invalidated in the IPR2013-00508 proceedings that were not also invalidated in the IPR2013-00507 case, so the IPR2013-00508 case was remanded "for further proceedings regarding claims 16 and 17 in accordance with" the opinion.

The technology in the case involved spinal fusion implants designed to be inserted between two vertebrae to replace damaged or diseased discs.  One claimed feature of the patented implants related to its dimensions, specifically a length that is both greater than 40 mm and at least 2.5 times the maximum width. This can be seen in this representative claim (with relevant language highlighted):

1.  A spinal fusion implant of non-bone construction positionable within an interbody space between a first vertebra and a second vertebra, said implant comprising:
    an upper surface including anti-migration elements to contact said first vertebra when said implant is positioned within the interbody space, a lower surface including anti-migration elements to contact said second vertebra when said implant is positioned within the interbody space, a distal wall, a proximal wall, a first sidewall and a second sidewall, said distal wall, proximal wall, first sidewall, and second sidewall comprising a radiolucent material;
    wherein said implant has a longitudinal length greater than 40 mm extending from a proximal end of said proximal wall to a distal end of said distal wall;
    wherein a central region of said implant includes portions of the first and second sidewalls positioned generally centrally between the proximal wall and the distal wall, at least a portion of the central region defining a maximum lateral width of said implant extending from said first sidewall to said second sidewall, wherein said longitudinal length is at least two and half times greater than said maximum lateral width;
    at least a first fusion aperture extending through said upper surface and lower surface and configured to permit bone growth between the first vertebra and the second vertebra when said implant is positioned within the interbody space, said first fusion aperture having: a longitudinal aperture length extending generally parallel to the longitudinal length of said implant, and a lateral aperture width extending between said first sidewall to said second sidewall, wherein the longitudinal aperture length is greater than the lateral aperture width; and at least three radiopaque markers;
    wherein a first of the at least three radiopaque markers is at least partially positioned in said distal wall, a second of said at least three radiopaque markers is at least partially positioned in said proximal wall, and a third of said at least three radiopaque markers is at least partially positioned in said central region.

The prior art Michelson reference described several spinal fusion implants, some of which were long and wide, but one of which was long and narrow.  The following four picture from that patent show two different implants and their respective insertion into the vertebrae:

Both petitions cited to other references as the primary reference for an obviousness assertion, but also cited to Michelson as teaching implants with elongated shapes with "dimensions that are longer than wide."  However, only in the IPR2013-00507 petition did Medtronic (the petitioner) cite to column 10, line 6 through column 11, line 15 for this proposition.  Nevertheless, this section described five different figures (16-20), and Figure 18 itself was never specifically identified.

Medtronic only specifically identified Figure 18 in both proceedings after NuVasive filed its Patent Owner Response, in which it argued that "no single reference taught an implant that was both longer than 40 mm and had a length at least 2.5 times its width."  Medtronic pointed out in its Reply that Figure 18 disclosed exactly such an implant.  NuVasive requested leave to file a motion to strike or in the alternative, the opportunity to file a surreply, but the Board denied all such attempts.  Instead, the Board assured NuVasive it understood its position and would take it into account when making the final determination.  Nevertheless, the PTAB ultimately held all but one challenged claim obvious, relying heavily on Figure 18.  NuVasive appealed, and Medtronic cross-appealed on claim 18 but ultimately withdrew from the case.

The Federal Circuit pointed out that the APA imposes particular requirements on the Patent Office, including timely informing patent owners of the matters of fact and law asserted against the patent and providing all parties the opportunity to respond after notice is provided.  In this case, the Court found the assertions regarding Figure 18 to be material, differentiating this case from Genzyme Therapeutic Prods. Ltd. v. Biomarin Pharm. Inc., in which the Court found that newly cited references were provided to establish the state of the art.  The Federal Circuit concluded that NuVasive was entitled to an opportunity to respond to the facts about Figure 18, even though Michelson was cited in both petitions ("And under the APA's fact-specific standard, common sense, and this court's precedent, that entitlement was not lessened in this case by virtue of the opportunity NuVasive had to respond to other factual assertions about Michelson.").  In other words, even though NuVasive had to respond to other assertions regarding Michelson, the new assertions regarding Figure 18 were sufficiently distinct to assure NuVasive an opportunity to respond to them.

However, for the IPR2013-00507, the Court found that NuVasive had had that opportunity from the outset of the case, because Medtronic had cited to the section of the specification that happened to include a description of Figure 18.  This was sufficient, according to the Court, to put NuVasive on notice that it should address the dimensions of the implant in its Patent Owner Response.  What is unclear, however, is what is the maximum amount of text that needs to be referenced to still create such an obligation for a Patent Owner?  The clear takeaway for petitioners, however, is that to the extent possible with word-count constraints, make as many ancillary citations to as much cited art as possible in the hopes of creating such an obligation.

One final observation that was not adequately explained by the Court is that NuVasive cited to Michelson Figures 16, 19, and 20 in its Patent Owner Response to demonstrate that the art used long-and-wide implants.  The patent owner explained that these configurations were desirable because they maximized the surface area of contact with the vertebrae.  Nevertheless, it is difficult to explain why NuVasive wasn't already on notice that it should explain why Figure 18 had similar dimensions as the claim invention, especially considering this figure was found in the midst of the other cited figures.  In fact, the Board had concluded that this citation to the other figures by NuVasive was sufficient to allow Medtronic to raise Figure 18 in its reply.  ("[A] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response.")  It is unclear, therefore, why NuVasive was not under an obligation at that point to differentiate the dimensions of Figure 18 from the claimed invention.  Going forward, it would probably behoove a Patent Owner to do so.  But, until the law changes, this In re NuVasive case should sufficiently support any requirement that the Patent Owner be provided with the opportunity to respond in such situations.

In re NuVasive, Inc. (Fed. Cir. 2016)
Panel: Circuit Judges Moore, Wallach, and Taranto
Opinion by Circuit Judge Taranto

Early Reaction to Presidential Election Results

By Donald Zuhn –-

Earlier today, in a result that stunned at least 47.7% of the American electorate and many observers abroad, a contentious Presidential election finally came to a conclusion, with Republican candidate Donald J. Trump defeating the Democratic challenger, Hillary Clinton.  As of late Wednesday evening, The New York Times reports that Mr. Trump has secured 279 electoral votes to Secretary Clinton's 228 votes -- even though Secretary Clinton currently holds a 230,053 edge in the popular vote, with Secretary Clinton securing 59,923,027 votes (47.7%) to Mr. Trump's 59,692,974 votes (47.5%).

With Mr. Trump now set to be sworn in as the 45th President of the United States in January, supporters of both candidates have begun to wonder how a Trump Presidency might impact their lives.  And readers of this space have likely focused on the possible impact of a Trump Administration on patents and innovation, as well as on the hi-tech and life sciences sectors.

With respect to patents, the Intellectual Property Owners Association reported that while Mr. Trump had been mostly silent on intellectual property law and policy on the campaign trail, the 2016 Republican Party Platform includes a section on "Intellectual Property Rights" that states:

Private property includes not only physical property such as lands and homes, but also intellectual property like books and patents.  Article 1, section 8 of the Constitution gives Congress the power to safeguard intellectual property rights for "Authors and Inventors."  By protecting the proprietary rights of creators and innovators, the Constitution promotes the general welfare by providing incentives for investment in all sorts of technology and artistic works.  Intellectual property is a driving force in today's global economy of constant innovation.  It is the wellspring of American economic growth and job creation.  With the rise of the digital economy, it has become even more critical that we protect intellectual property rights and preserve freedom of contract rather than create regulatory barriers to creativity, growth, and innovation.

Protecting intellectual property is also a national security issue.  We must guard against counterfeit parts that can compromise the reliability of our weapons systems and the safety of military personnel.  Today, the worst offenses against intellectual property rights come from abroad, especially in China.  We call for strong action by Congress and a new Republican president to enforce intellectual property laws against all infringers, whether foreign or domestic.

Earlier today, FierceBiotech reported on the immediate impact of the election on the biopharma industry, noting that the Nasdaq Biotechnology Index and S&P Biotech were up 6% and 9%, respectively, this morning.  FierceBiotech also reported that European biopharma stocks had also surged by the morning after the election.  According to the industry publication, many investors may be betting that Mr. Trump, and the Republican party, will not push as hard on the issue of drug pricing as Secretary Clinton would have had she won.  The publication suggested that "Clinton has remained a concern for biopharma, given that she openly 'declared war' on pharma pricing last year and has, along with Democrat (and failed presidential hopeful) Sen. Bernie Sanders, shaken stocks with their tweets denouncing 'price gouging' from the industry."

Nature News reported that Mr. Trump's election win had stunned U.S. researchers.  In a separate report, Nature News collected social media reaction to Mr. Trump's victory, noting that the election results had generated "shock, disbelief and fear of funding cuts" among U.S. researchers.  The publication is also tracking the impact of Mr. Trump's election on science in the U.S. and beyond, asking researchers to complete a short online poll.

Scientific American received responses from the Trump campaign regarding Mr. Trump's position on several science issues, and published those responses in a report earlier today.  On innovation, the Trump campaign stated that:

[T]he federal government should encourage innovation in the areas of space exploration and investment in research and development across the broad landscape of academia.  Though there are increasing demands to curtail spending and to balance the federal budget, we must make the commitment to invest in science, engineering, healthcare and other areas that will make the lives of Americans better, safer and more prosperous.

And on the importance of long-term investment in research, the campaign indicated that:

[W]e must have programs such as a viable space program and institutional research that serve as incubators to innovation and the advancement of science and engineering in a number of fields.  We should also bring together stakeholders and examine what the priorities ought to be for the nation.  Conservation of resources and finding ways to feed the world beg our strong commitment as do dedicated investment in making the world a healthier place.

Location-Based Online Gaming Patents Found to be Directed to Patentable Subject Matter

By Joseph Herndon --

Plaintiff CG Technology Development, LLC sued Defendants Bwin.Party Digital Entertainment, PLC in the U.S. District Court for the District of Nevada for infringement of various patents via operation of various online casino games.  Bwin filed a motion to dismiss infringement as to U.S. Patents 8,771,058; 8,814,664; 9,355,518; and 9,306,952 based on unpatentability under 35 U.S.C. § 101.

The District Court followed the two-step test set forth by the Supreme Court in which first, a court determines whether the claim is "directed to one of those patent-ineligible concepts."  If not, the analysis ends.  If so, however, a court must consider the elements of each claim "both individually and 'as an ordered combination' to determine whether the additional elements 'transform the nature of the claim' into a patent-eligible application."

All patents relate to various aspects of online gambling, and various details of the four patents at issue are discussed below.

The '058 Patent

The '058 patent is directed to a zone dependent payout percentage gambling system.  Higher payout percentages are offered in certain locations than in other locations.  For example, in certain areas of a casino, such as in mall and shop areas, payout percentages of between 98% and 99% are offered.  In other areas, payout percentages below 96% may be offered.  Figure 6 is reproduced below and illustrates separate zones for the mobile device.

Claim 19 is representative of the '058 patent and is the only claim Plaintiffs have accused Defendants of infringing.  Claim 19 reads in full:

19.  A computer system comprising:
    a processor operable to execute a set of instructions; and
    a memory having stored thereon the set of instructions, in which the set of instructions, when executed by the processor, cause the computer system to perform a method comprising:
        determining a first location of a mobile gaming device,
        determining a first game configuration associated with the first location,
        generating a first game outcome using the first game configuration,
        determining a first payout associated with the first game outcome,
        crediting a player account with a first amount based on the first payout,
        determining a second location of the mobile gaming device, wherein the second location is different from the first location,
        determining a second game configuration associated with the second location, wherein the second game configuration is different from the first game configuration,
        generating a second game outcome using the second game configuration,
        determining a second payout associated with the second game outcome, and
        crediting the player account with a second amount based on the second payout.

The District Court noted that determining game configurations (based on some set of rules, e.g., an algorithm, list, etc.), generating game outcomes based on the configurations (based on some set of rules, e.g., an algorithm, list, etc.), determining payouts based on game outcomes (based on some set of rules, e.g., an algorithm, list, etc.), and crediting players based on payouts (accounting) are abstract ideas that can be conducted in one's mind.

But at least one aspect of the process requires activity outside of one's mind:  determining the physical location of the mobile gaming device.  Claim 19 is limited to using a computer system to locate a mobile gaming device.  The specification notes that location verification technology may be network- or satellite-based and may use methods such as geo-fencing or triangulation.

The District Court found that determining an actual, physical location is not an abstract concept because one cannot perform the function in one's head.  Claim 19 does not simply instruct a practitioner to use a computer to perform calculations using pre-existing location data; it requires as an essential step that the computer actually determine the location of the mobile gaming device.

The District Court found that because claim 19 requires the location of a mobile gaming device via a computer system, that is concrete enough to take the claim outside the scope of Alice Corp.'s "abstract idea" exception to patentability under § 101.  The location of the mobile gaming device via computer is a limited, concrete, physical task.

The District Court found that the argument of whether similar methods of location-based gaming options are well known and long-practiced goes to anticipation or obviousness under §§ 102 or 103, respectively, not patentability under § 101.

The District Court therefore denied the motion to dismiss Claim 19 of the '058 Patent under § 101.

The '664 Patent, '518 Patent, and '952 Patent

Each of the challenged claims in the '664 Patent, '518 Patent, and '952 Patent recites a requirement of physically locating wireless gaming terminals via a computer to perform a function, and the District Court found that these claims are not invalid under § 101 for the same reasons as with Claim 19 of the '058 Patent above.  The District Court summarily determined that such action makes the process sufficiently concrete to survive Alice Corp.

Thus, the motion to dismiss was denied for all patents.

This case easily could have been decided differently, as we have seen many times in the past, by the Court simply identifying the function of location-determination as a well-known feature and then dismissing the feature in the abstract idea analysis.  However, this Court correctly noted that whether the location-determination feature is well known goes to anticipation or obviousness, rather than patentability under § 101.  As a result, all claims reciting the requirement of physically locating the wireless gaming terminal were found to be directed to patentable subject matter.

Order by District Judge Robert C. Jones

USPTO to Hold Roundtables on Subject Matter Eligibility

By Donald Zuhn –-

In a notice published in the Federal Register (81 Fed. Reg. 71485) last month, the U.S. Patent and Trademark Office announced that it will be holding two roundtables in order to obtain public input on patent subject matter eligibility in view of recent decisions by the Supreme Court and Federal Circuit.  The first roundtable will be held from 1:00 to 5:00 pm EST on November 14, 2016 in the Madison Auditorium at the U.S. Patent and Trademark Office in Alexandria, VA, and the second roundtable will be held from 8:00 am to 5:00 pm PST on December 5, 2016 in Paul Brest Hall at Stanford University.  The Office's notice also included a request for written comments regarding the specific topics to be addressed in each roundtable.

In the notice, the Office states that "[o]ver the past six years, the Supreme Court has issued a series of decisions—Bilski, Mayo, Myriad, and Alice—that have significantly impacted patent eligibility law and continue to generate substantial public debate."  The notice briefly summarizes each of these cases, pointing out that:

These cases continue to have a substantial effect on patent eligibility in the United States.  On the one hand, they have overturned decades-old USPTO practice regarding patent eligibility of isolated genes, placing the United States at odds with the practices of major trading partners, including Europe.  On the other hand, the Mayo two-step test has generally raised the bar for patent eligibility in all fields of technology.

The notice indicates that at the first roundtable, the Office will be seeking public feedback regarding improvements to the Office's existing subject matter eligibility guidance and training examples.  In particular, the Office is seeking feedback on the following topics:

1.  Suggestions to how to improve the Office's subject matter eligibility guidance, particularly the three recent memoranda discussed above;

2.  Comments on the May 2016 Life Sciences examples and their effect on prosecution of patent applications in the life sciences, and suggestions of additional examples, or technology areas in which examples would be helpful;

3.  Suggestions on how best to make examiners aware of newly issued judicial decisions, and how best to incorporate recent decisions holding claims eligible, such as Enfish, Bascom, Rapid Litigation Management, and McRO, into the Office's subject matter eligibility guidance; and

4.  Concerns on how the Office's subject matter eligibility guidance and training examples, or how court decisions, are being applied by examiners.

Although the deadline to submit a request to speak at the first roundtable has passed, the Office's notice indicates that the public is invited to speak at the first roundtable by appearing in person at the USPTO headquarters in Alexandria, VA or at one of the four USPTO Regional Offices.  An agenda for the first roundtable can be found here.  Written comments regarding the topics to be addressed at the first roundtable can be submitted by e-mail to [email protected].

At the second roundtable, the Office is interested in facilitating a public discussion and receiving public feedback regarding larger questions concerning the legal contours of eligible subject matter under the U.S. patent system.  In particular, at the second roundtable the Office desires (1) "to promote conversation on how the current section 101 jurisprudence is evolving; what the optimum legal contours for patent eligibility should be; and how best to achieve these goals"; (2) "to facilitate discussion and create a public record with relevant information on the actual or perceived impact of existing law on particular technology areas, and the effects on investment in research and development, and innovation generally"; (3) obtain "comments on whether developments in patent-eligibility law should be left primarily to the courts or whether other administrative initiatives are desirable"; and (4) secure input on "whether legislative changes are desirable and, if so, views on the elements of such changes."

The notice provides a list of eighteen questions on which it is interested in receiving views and comments from the public.  The eighteen questions include the following:

1.  How has the Supreme Court's interpretation of 35 U.S.C. 101 in the past several years affected the enforcement of patents and the development of subject-matter-eligibility law?

2.  Should the patent statute be amended to further define the statutory categories of invention, i.e., process, machine, manufacture, and composition of matter?

3.  Do you think there should be exceptions to patentable subject matter?

4.  Should the patent statute be amended to define the judicial exceptions?

6a.  Do you think that title 35 should be amended to revise the definition for the term "invention" and/or provide a definition for the term "discovery" along with specific examples of subject matter that should not be treated as an invention and/or discovery?

7.  Does the concept of preemption, either separately or in the context of the Mayo two-step framework, capture useful insight in guarding against the issuance of overly broad patents?

8.  What does the term "discovery" in sections 100 and 101 mean, and to what extent should a "discovery" be eligible for a patent?

9.  What does the term "invention" in sections 100 and 101 mean, and to what extent should a non-naturally occurring product of human ingenuity qualify as an "invention" to be eligible for a patent?

10.  To what extent should products that have been isolated from their natural surroundings as a result of human ingenuity be eligible for a patent?

11.  To what extent should a "diagnostic method" be eligible for a patent?

12.  Are there lines that can or should be drawn scientifically or legislatively between different types of compositions of matter for purposes of obtaining patent protection (e.g., between human genes and genes of other species)?

13.  What particular inventions or specific types of technologies that should be patent eligible are not patent eligible, or are likely to be challenged as patent ineligible, under Mayo/Myriad?

14.  Should patents be available for methods that do not involve a machine or a transformation?

15.  If you support some form of "machine or transformation test," please identify the best expression of such a test.

16.  To what extent should an invention that involves a business method be eligible for a patent?

17.  To what extent should an invention that involves computer software be eligible for a patent?

18.  What mechanisms, other than the judicial exceptions, can be used to prevent issuance of overly broad software or computer-related patents that cover wide swaths of economic activity?

Additional questions and information being sought by the Office with respect to the above questions can be found in the Office's notice.  Those wishing to submit public feedback regarding any of the above questions are encouraged to review the notice in order to provide as complete and full response as possible.

Those wishing to speak at the second roundtable must submit a request to the Office by November 14, 2016.  The Office's notice also indicates that the public is invited to speak at the second roundtable by appearing in person at the USPTO headquarters in Alexandria, VA or at one of the four USPTO Regional Offices.  Written comments regarding the topics and questions to be addressed at the second roundtable can be submitted by e-mail to [email protected].

Written comments related to either of the roundtables must be submitted by January 18, 2017.  Both roundtables will be available for viewing via webcast.  Additional information regarding the roundtables and submission of written comments can be found in the Office's notice.  An agenda and webcast information for the roundtables can be obtained at the webpage for Roundtable 1 or the webpage for Roundtable 2.

Conference & CLE Calendar

November 8, 2016 - "Clarity of the Record Pilot: A Discussion of Findings" (U.S. Patent and Trademark Office) - 12:00 to 1:00 pm (ET) on 

November 9, 2016 - "Evolution of Patent Litigation: Interface of Judicial and Administrative Patent Proceedings" (Federal Circuit Bar Association) - Northeastern University School of Law, Boston, MA

November 10, 2016 - "Ethics in AIA Post-Grant Proceedings at the PTAB" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

November 10, 2016 - "Patent Prosecution and Defeating Abstractness: Minimizing the Risk of Sect. 101 Rejection -- Lessons From Recent Federal Circuit Court Decisions" (Strafford) - 1:00 to 2:30 pm (EDT)

November 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)

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