In an inter-partes review proceeding (IPR), a challenger can rely only on patents and printed publications to challenge the validity of a patent claim. In contrast, in a post grant review (PGR) proceeding, a challenger can rely on any ground related to patentability, including prior sale, to challenge a patent claim.  In particular, 35 U.S.C. §102(a)(1) bars a person from receiving a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”
Continue Reading Supreme Court Holds That AIA On-Sale Bar Applied to Secret Sales

In an inter partes review proceeding, a challenger cannot raise patent-eligibility as a ground of invalidity.  Rather, the invalidity grounds are limited to lack of novelty and obviousness.  Notwithstanding, in construing claim terms, the PTAB can decide not to give patentable weight to certain claim limitations that are not patent-eligible. In Praxair Distribution., Inc. v. Mallinckrodt Hospital Products IP Ltd., No. 2016-2616, 2016-2656 (Fed. Cir. May 16, 2018) the PTAB had employed the so-called “printed matter doctrine” not to give patentable weight to certain limitations as merely “providing information”  and the CAFC affirmed the PTAB’s claim construction.

Mallinckrodt is the owner of U.S. Patent No. 8,846,112, which is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications.

Claim 1 recites a method of providing pharmaceutically acceptable nitric oxide gas, which includes obtaining a cylinder containing compressed nitric oxide gas, supplying the cylinder to a medical provider who is responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction. Claim 1 further includes the step of providing to the medical provider “(i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with preexisting left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema.”

Independent claim 7 includes a “recommendation that, if pulmonary edema occurs in a patient who has pre-existing [LVD] and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued” (the “recommendation” limitation). Claim 9 depends on claim 7 and further comprises the following steps: performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction; treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema; and in accordance with the recommendation of [claim 7], discontinuing the treatment with inhaled nitric oxide due to the neonatal patient’s pulmonary edema. Id.

The Board applied the printed matter doctrine to interpret the providing information, evaluating, and recommendation claim limitations “to be either printed matter or purely mental steps not entitled to patentable weight, as those limitations lacked a functional relationship to the other claim limitations except in claim 9.” In particular, the PTAB was not persuaded by Mallinckrodt’s argument that the recitation of “a pharmaceutically acceptable nitric oxide gas” in the preamble of the claims would require considering information provided in the label of the supplied product.  Rather, the PTAB construed this limitation as simply “nitric oxide gas that is suitable for pharmaceutical use.”
Continue Reading CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction

On May 23, 2018, in XY, LLC v. Trans Ova Genetics, L.C., CAFC held that its affirmance of PTAB’s invalidity decision regarding certain claims of a patent owned by XY in a separate appeal involving a different defendant must be given “immediate issue preclusive effect” with respect to the same claims in the present

On May 9, 2018, U.S. Patent and Trademark Office (PTO) issued a notice of proposed rule for changing the standard for construing claims in unexpired patents in inter partes review (IPR), post-grant review (PGR), and transitional covered business method (CBM) proceedings from current broadest reasonable interpretation (BRI) to the same claim construction standard that is

In a recent decision, the Court of Appeals for the Federal Circuit (CAFC) affirmed decisions in two inter-partes review (IPR) proceedings that patents owned by ICOS Corporation directed to tadalafil formulations (used in the erectile dysfunction drug, Cialis, and the pulmonary arterial hypertension drug, Adcirca) were invalid as obvious. (CAFC Decision Nos. 17-1071 and 1018,

In an inter partes review (IPR) proceeding, a patent owner may file one motion to amend the patent in one or more of the following ways: (a) cancel any challenged patent claim, or (b) for each challenged claim, propose a reasonable number of substitute claims.  35 U.S.C. §316(d).  1290.  With regard to substitute claims, the

An en banc panel of the Court of Appeals for the Federal Circuit (CAFC) in the case of Aqua Products, Inc. v. Matal recently held that in an inter-partes (IPR) proceeding, the burden of persuasion rests with the challenger to persuade the PATB that substitute claims proposed by a patent owner in a motion to

In an inter partes review (IPR) proceeding, the meaning of terms used in challenged claims of an unexpired patent are given their broadest reasonable interpretation in light of the claim language and the specification. The Court of Appeals for the Federal Circuit (CAFC) recently reversed the Board’s interpretation of a claim term in an IPR proceeding (IPR2015-00460) in which Samsung had challenged the validity of certain claims of U.S. Patent No. 6,146,997 of Home Semiconductor Corp. (“Home”) because it found that Board had adopted a claim construction “without regard to the context” in which the term was used in the claims and the specification. In a decision written by Judge Lourie last month, the Federal Circuit panel found that the PTAB had adopted an erroneous interpretation and reversed the decision stating that the PTAB’s finding of invalidity based by anticipation of claim 2 was “not supported by substantial evidence.” (See, Home Electronics v. Samsung Electronics, CAFC Decision No. 2016-2215, July 25, 2017).

The ’997 Patent concerned “a simplified method for forming a self-aligned contact hole,” in which a conductive plug can be formed to electrically connect the semiconductor device to other circuit elements. Independent claim 1 of the ‘997 Patent recites a method of forming a self-aligned contact hole in a semiconductor substrate having a gate electrode and a diffusion region by

forming a conformal layer of etch barrier material overlying the substrate surface including the diffusion region and the upper surface and the sidewalls of the gate electrode,

forming an insulating layer overlying the barrier layer, etching an opening through the insulating layer self-aligned and borderless to the diffusion region by using the barrier layer as an etch stop, and

anisotropically etching the barrier layer underneath the opening, thereby exposing the diffusion region and simultaneously forming a spacer of the etch barrier material on the sidewall of the gate electrode.

Claim 2 of the ‘997 Patent, which depends on claim 1, further recites “forming an oxide layer over the diffusion region and on the sidewalls of the gate electrode by thermal oxidation prior to forming the barrier layer.”

The construction of the phrase “forming an oxide layer over the diffusion region” was at issue in this proceeding. The Patent Owner, Home, argued that this phrase should mean “forming an oxide layer covering the diffusion region,” while the Petitioner, Samsung, argued that the broadest reasonable construction of this phrase is “forming an oxide layer above the diffusion region.” Samsung argued that construing “over” as “covering” was too narrow a reading for a person of ordinary skill in the art. The Board adopted Samsung’s proposed construction for this term and hence held that claims 2 and 9-14 of the ‘997 Patent were anticipated by U.S. Patent No. 6,277,720 (“Doshi”).

The CAFC held that the Board’s construction of “over” as meaning “above” is unreasonable in light of the claim language and the specification. The CAFC noted that “[i]n adopting the ‘full breadth’ of the term as advocated by Samsung, the Board focused on the word ‘above,’ rather than the claim term ‘over.’ That was error.” The CAFC further emphasized that “[e]ven when giving the claim term the broadest reasonable interpretation, the Board cannot construe the claims ‘so broadly that its constructions are unreasonable under general claim construction principles.’”

The CAFC reasoned that the language at issue “is not simply ‘over,’ but is ‘forming an oxide layer over the diffusion region,” and the use of the term ‘over’ in ‘forming an oxide layer over the diffusion region’ connotes more than an insignificant or incidental vertical overlap between the oxide layer and the diffusion region. Although ‘over’ and ‘above’ can be interchangeable in certain contexts, they are not coextensive here, and the full scope of ‘above,’ which is not a claim term, cannot be adopted to give meaning to the actual claim term ‘over’ if that adoption would result in an unreasonable interpretation of the claim term in the context.”
Continue Reading CAFC Finds Another PTAB Claim Construction Unreasonable and Again Reverses an Invalidity Holding

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes review proceeding, a petitioner can rely only on prior art patents and printed publications to challenge the validity of one or more claims of a third-party patent, in a post-grant review proceeding, a petitioner can raise any statutory ground of invalidity including the on-sale bar provision of 35 U.S.C. 102(a).  This statutory provision, as modified by America Invents Act (AIA), bars patenting a claimed invention if the “claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed inventions.”

Prior to the enactment of AIA, it was well established that the sale of a claimed invention more than one year from the effective filing date of a patent application, even if the sale did not involve disclosing the underlying invention, would bar patenting the invention. However, the change in the wording of this statutory provision introduced by AIA, and particularly, the use of the phrase “otherwise available to the public” immediately following “on sale” created ambiguity about whether a sale of a claimed invention without disclosing the underlying invention would trigger the on-sale bar provision.

Recently, in the case of Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the CAFC cleared up this ambiguity and held that the on-sale bar provision of 35 USC 102(a) applies to the sale of a claimed invention even if the sale did not involve disclosing the underlying invention.  This decision can provide yet another tool for challenging patents in a post-grant proceeding.   
Continue Reading AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention