indefiniteness Archives

PTO: Board to Align Indefiniteness Approach in AIA and District Court Proceedings

by McDermott Will & Emery | Jan 21, 2021 | America Invents Act

On January 6, 2021, US Patent and Trademark Office (PTO) Director Andrei Iancu, Commissioner for Patents Andrew Hirshfeld and Chief Administrative Patent Judge Scott Boalick issued a memorandum to the members of the Patent Trial and Appeal Board to align the Board’s approach when deciding indefiniteness issues under 35 USC § 112 in America Invents Act (AIA) post-grant proceedings more closely with district court proceedings. The memo was issued under the PTO director’s authority to set forth binding agency guidance to govern the Board’s interpretation of statutory provisions. The memo cited to similar recent changes to the approach to claim construction in such proceedings, and stated that aligning “the indefiniteness approach [used] in AIA post-grant proceedings [to district court proceedings] will promote consistency and efficient decision making among coordinate branches of government that decide similar issues in co-pending proceedings.” The instructed approach, per the Supreme Court of the United States’ 2014 decision in Nautilus, applies to post grant review (PGR) and inter partes review (IPR) proceedings, but not to indefiniteness (or claim construction) issues decided outside the context of AIA reviews.

Post-AIA 35 USC § 112(b) (and pre-AIA § 112, second paragraph) require that “[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.” Claims not meeting this requirement are invalid for indefiniteness and may be determined indefinite during PTO examination, on appeal from examination and during AIA post-grant proceedings. In 2014 the US Court of Appeals for the Federal Circuit approved the PTO’s long-standing approach to assessing indefiniteness during patent prosecution in its per curiam In re Packard decision that “[a] claim is indefinite when it contains words or phrases whose meaning is unclear.” At the time, this approach was used agency-wide to analyze questions of indefiniteness, in complement with the office’s broadest reasonable interpretation approach to claim construction.

Despite the Supreme Court’s decision in Nautilus that a claim is unpatentable for indefiniteness if the claim, read in light of the specification delineating the patent and the prosecution history, fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention, the PTO reaffirmed its intent to follow Packard in examination (whether original, appeals or reexamination). In 2018, in the interest of consistency and efficiency, the PTO changed its claim construction standard for post-grant trial proceedings to review a claim of a patent, or a claim proposed in a motion to amend, from the broadest reasonable interpretation to the same Phillips standard that would be used to construe the claim in a district court action.

The memorandum noted that there has been some confusion as to whether the Packard or Nautilus standard should apply in AIA proceedings. While parties to such proceedings argued for one or the other, neither the Board nor the Federal Circuit ruled as to which standard applied. Now, in the interest of clarity, consistency and efficiency, and to “lead to greater [...]

Continue Reading

Glass Half Empty: Patent Reciting “Half Liquid” Is Indefinite

by Mandy H. Kim | Aug 13, 2020 | Patents

The US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the asserted patent claims were invalid as indefinite because the meaning of the term “half-liquid” was not reasonably clear from the record. IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., Case No. 19-2400 (Fed. Cir. July 31, 2020) (Prost, C.J.).

IBSA owns a patent directed to pharmaceutical formulations for thyroid hormones that enable a safe and stable oral administration. IBSA listed in the Orange Book the patent for Tirosint®, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva filed an abbreviated new drug application to market a generic version of Tirosint®, and IBSA responded by filing a lawsuit for patent infringement against Teva.

During claim construction, the parties disputed the construction of the term “half-liquid.” IBSA proposed that “half-liquid” should be construed to mean “semi-liquid,” while Teva argued that the term was indefinite or should be construed as “a non-solid, non-paste, non-gel, non-slurry, non-gas substance.” The district court began its analysis by acknowledging that the parties “agree that the intrinsic record does not define ‘half-liquid.’” IBSA argued that a priority Italian patent application’s use of the word “semiliquido” (translation: semi-liquid) in the same places where “half-liquid” was used in the patent at issue supported its position that the two terms were synonyms. The district court disagreed, noting several differences in the two patents that indicated that the different choice of terms was intentional. Further, the district court noted that the applicant originally used the term “semi-liquid” in a dependent claim during prosecution, but later removed this term, indicating that the applicant understood the terms to be different and intentionally chose not to use “semi-liquid” in the asserted claims. The district court also found IBSA’s extrinsic evidence (e.g., reliance on dictionary definitions, other patents and expert testimony) unpersuasive. The district court accordingly found the asserted patent claims invalid as indefinite because the meaning of “half-liquid” was not reasonably ascertainable from the record. IBSA appealed.

The Federal Circuit affirmed. The Court first found that the intrinsic record failed to establish the boundaries of the term “half-liquid.” The Court agreed with the district court’s analysis, finding that neither the claims nor the specification supported IBSA’s proposed construction. The Court also explained that the prosecution history reinforced the conclusion that the applicant understood “half-liquid” to be different from “semi-liquid,” because the applicant intentionally removed the term “semi-liquid” in a dependent claim during prosecution. The Court disagreed with IBSA’s suggestion that the district court refused to consider the foreign Italian priority document—rather, “when discrepancies between a foreign priority document and the U.S. filing exist, it may be proper to view the discrepancies as intentional.”

Turning to the extrinsic record, the Federal Circuit found that the district court did not clearly err in its analysis of the presented dictionary definitions, other patents and expert testimony. The Court noted that IBSA identified no scientific dictionaries containing the term despite IBSA’s argument that “half-liquid” would be a recognizable term [...]

Continue Reading

Claims Need Only Inform a Skilled Artisan of the Metes and Bounds with Reasonable Certainty

by McDermott Will & Emery | Apr 23, 2020 | Patents

In a case involving claims with functional language and means-plus-function limitations, the US Court of Appeals for the Federal Circuit found that the district court erred in its determination that three claim terms were indefinite, but agreed with the district court that a fourth term was not indefinite. Nevro Corp. v. Boston Sci. Corp., Case Nos. 18-2220; -2349 (Fed. Cir. Apr. 9, 2020) (Moore, J.).

Nevro owns patents for improved technologies for high-frequency spinal cord stimulation therapy to alleviate pain, while avoiding side effects associated with conventional stimulation therapies. Several of the asserted claims recite systems and devices in which the stimulation therapy signals are “paresthesia-free,” meaning they do not cause a tingling, pins-and-needles sensation. The district court found the claimed “paresthesia-free” systems and devices to be indefinite because infringement of the claim depends on the effect of the system on the patient, so a skilled person cannot understand the metes and bounds of the claim with reasonable certainty. Nevro appealed.

(more…)

En Banc Federal Circuit Leaves ‘Consisting Essentially Of’ High and Dry

by McDermott Will & Emery | Mar 12, 2020 | Patents

In an 8–4 decision, the en banc US Court of Appeals for the Federal Circuit issued a per curiam order upholding its earlier panel decision finding a claim using the transitional phrase “consisting essentially of” to be indefinite because of inconsistences in the manner in which the patent specification explained the meaning of “better drying time” in connection with use of the claimed formulation. The Court denied plaintiff’s petition for panel rehearing and for rehearing en banc. HZNP Fin. Ltd. v. Actavis Labs. UT, Inc., Case No. 17-2149 (Fed. Cir. Feb. 25, 2020) (per curiam) (Lourie, J, joined by Newman, O’Malley and Stoll, JJ, dissenting). Judge Newman also dissented in the original panel decision. (more…)

PTAB May Not Cancel Indefinite Claims in IPR, No Matter What

by Paul Devinsky | Feb 13, 2020 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit imposed limits on what the Patent Trial and Appeal Board (PTAB) is authorized to do by statute when dealing with challenged claims in an inter partes review (IPR) that it finds to be too indefinite to apply prior art. Samsung Elecs. Am., Inc. v. Prisua Eng’g Corp., Case Nos. 19-1169, -1260 (Fed. Cir. Feb. 4, 2020) (Bryson, J).

(more…)