Business people standing in line under a magnifying glass, as a metaphor for employee performance evaluation, EPS 8 vector illustration, no transparencies The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.”  Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations.  Thus, rather than deciding whether a regulation is permissible as reasonably related to the purposes of the enabling legislation, by amending 5 U.S.C. § 706, the bill will require a reviewing court to “decide de novo all relevant questions of law, including the interpretation of constitutional and statutory provisions, and rules made by agencies.”  To eliminate any doubt about its intent, the amendment specifically states that the court shall not interpret any gap or ambiguity in a statue or regulatory provision as an implicit delegation of legislative rulemaking authority to an agency, and the court shall not defer to an agency’s interpretation on a question of law.  As a result, rather than simply deciding whether an agency’s construction of silent or ambiguous statutory provisions are permissible as a matter of statutory interpretation, the reviewing court must make its own, independent interpretation.  The change in the statute would mean that prior court approvals of agency rules, applying Chevron deference, will not dictate the outcome of future challenges under the doctrine of stare decisis.
Continue Reading Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

logo-minThe PTAB Bar Association held its first conference in Washington DC March 1-3, 2017 with more than 400 attendees and a wait list of interested individuals. PTAB Chief Judge David Ruschke gave the keynote address.

Chief Judge Ruschke began by acknowledging why we are now at a point where there is an interest in having a PTAB Bar Association. Specifically, he noted that the PTAB has become a vital component of the patent system. We have seen that reflected in an incredible rise in appeals to the Federal Circuit from the PTAB and also that post-grant proceedings are now an important tool for every patent litigator.
Continue Reading PTAB Bar Association Conference Kicks Off with Keynote Address

Phenylephrine Hydrochloride (resized)The first final written decision in a post-grant review of a patent arising from Art Unit 1600 issued November 14, 2016, in Altaire Pharm. Inc.. v. Paragon Bioteck, Inc., PGR2015-00011.  PGRs allow challenge based on enablement, written description, indefiniteness, and subject matter eligibility, in addition to the novelty and obviousness bases available in IPRs, permitting petitioners to rely on arguments commonly used to invalidate biotechnology and pharmaceutical patents in litigation.  Here, however, the PTAB instituted PGR based only on obviousness grounds, and ultimately determined that the petitioner did not meet its burden in proving the unpatentability of the challenged claims.
Continue Reading PTAB Issues First Biotech/Pharma Post-Grant Review Final Written Decision – All Claims Survive

In Apple, Inc. v. Ameranth, Inc. (Fed. Cir. 2016), the Federal Circuit reviewed the final written decisions in CBM reviews of three related patents owned by Ameranth, Inc., directed to computerized systems for generating and displaying menus for use in the restaurant industry.  The court determined that the PTAB properly construed all disputed claim terms, determined that the patents are CBM patents, and determined that most challenged claims were unpatentable under § 101, but that the PTAB erred in concluding that some dependent claims were not unpatentable under § 101.

More specifically, the claims in the disputed Ameranth patents are directed to a “first menu that has categories and items, and software that can generate a second menu from the first menu by allowing categories and items to be selected.” 
Continue Reading PTAB Should Have Canceled All Challenged Claims in CBM Reviews

Digital Billboard (12-6-16 Post)Galaxia Electronics Co., Ltd. v. Revolution Display, LLC, PGR2016-00021, Galaxia sought post-grant review of Revolution’s U.S. Design Patent No. D736,750, entitled “Modular Video Support Frame Member.” The patented design was directed to a support frame for video monitors used in large-scale LED video image displays, such as those used on-stage at rock concerts, on the sides of buildings, or at amusement parks.  Galaxia sought cancellation of the claimed design on grounds of non-joinder of proper inventors, and lack of ornamentality under 35 U.S.C. § 171.  On November 2, 2016, the PTAB denied institution of the PGR. 
Continue Reading It All Depends On How You Frame It

To date, only 43 petitions for Post-Grant Review have been filed with the PTAB.  Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter.  The PTAB recently instituted the third ever PGR for a biotech-related patent in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018.

The petitioner requested PGR of claims 1-12 of U.S. Patent No. 9,091,698, directed to a method for the advanced detection of sepsis in a systemic inflammatory response syndrome (SIRS)-positive subject involving measuring procalcitonin levels and one or more clinical markers over multiple time points, wherein an increase in the amount of procalcitonin from a previous amount over a 24-hour interval detects sepsis. 
Continue Reading PTAB Institutes Third Biotech/Pharma Post-Grant Review

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In considering a novel issue of Post-Grant Review (PGR) eligibility, the Patent Trial and Appeal Board followed the straightforward language of the America Invents Act (“AIA”), and longstanding precedent, holding that post-filing amendments to a pre-AIA patent application do not change its effective filing date and, thus, do not make it eligible for PGR.  David O.B.A. Adebimpe v. Doang-Trang T. Vu & The Johns Hopkins Univ., Case PGR2016-00020, Paper No. 14 (P.T.A.B. July 25, 2016).
Continue Reading Post-Filing Claim Amendments Don’t Change the Effective Filing Date for Post Grant Review

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Neither the Federal Circuit nor the PTAB has provided much guidance concerning the proper application of the one-year time-bar for filing IPRs when privity is alleged.  Recently, however, in AM General LLC v. UUSI, LLC, Case IPR2016-01049, Paper 14 (PTAB November 7, 2016), the PTAB has provided some guidance.

On May 18, 2016, Petitioner AM General LLC filed a Petition requesting inter partes review of various claims of U.S. Patent No. 5,570,666 (“the ‘666 Patent”).  In its Preliminary Response to the Petition, filed on August 19, 2016, the Patent Owner, UUSI, LLC, urged denial of the Petition, contending the petition was time barred. 
Continue Reading Petitioner Not Time-Barred By Service of COFC Complaint

Privilege Stamp 1In its Notice of Proposed Rulemaking published on October 18, 2016, the USPTO proposes to amend the rules of practice before the PTAB to “recognize that, in connection with discovery conducted in certain proceedings at the [USPTO], communications between U.S. patent agents or foreign patent practitioners and their clients are privileged to the same extent as communications between clients and U.S. attorneys.” 81 Fed. Reg. 71653 (Oct. 18, 2016).  The rule would apply to the various PTAB proceedings that entail discovery, including IPRs, PGRs, the transitional program for CBMs, and derivation proceedings.
Continue Reading Proposed Rule to Recognize Patent Agent Privilege in PTAB Proceedings

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In the October 3, 2016, Federal Register, the Patent Office published a notice of proposed rulemaking to adjust various fees the Office charges for its services, including 18% to 56% increases for AIA trial fees (as shown below).

According to the notice, the Patent Trial and Appeal Board has received more than 4,700 AIA trial petitions since 2012, and it received over 1,900 in the fiscal year that ended September 30, 2016. In setting the fee structure for administering those trials, the Patent Office had to estimate the demand and workload based on limited data from its administration of inter partes reexamination and interference proceedings.
Continue Reading Patent Office Proposes to Increase AIA Trial Fees