Posts Tagged: "patentability requirements"

SCOTUS Scraps Vanda’s Bid for Guidance on Obviousness Standard

The U.S. Supreme Court today denied a petition for certiorari seeking clarification from the Court on the proper standard for a showing of obviousness. Vanda Pharmaceuticals filed the petition following the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) May 2023 decision invalidating Vanda’s patent on a method of using the drug tasimelteon to treat Non-24-Hour Sleep-Wake Disorder. The CAFC came to its decision in part because the court said the disclosure of clinical trials was evidence that a person of ordinary skill in the art “would have had a reasonable expectation of success.” Vanda argued in its Supreme Court petition that a “predictable results” standard should be applied instead and maintained that the High Court said as much in KSR v. Teleflex.

Young Sheldon’s Inventorship Woes: Important Lessons for All Young Inventors

As the hit sitcom Young Sheldon comes to an end next month, a look back at the series offers an opportunity for young inventors to learn about inventorship. The coming-of-age show centers around a boy genius, Sheldon, who has run the gamut of growing up in expedited fashion—experiencing high school, college dorm life, and even a first (failed) kiss (attempt), all before being eligible to drive. Another milestone in Sheldon’s life—his first inventorship dispute—shows that it doesn’t take a boy genius to become a young inventor.

CAFC Panel Splits on Reasonable Expectation of Success Analysis

In a precedential decision authored by Judge Lourie, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s final judgment that certain claims of several patents owned by Salix Pharmaceuticals for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious. The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. Norwich cross-appealed from that order and also from the denial of its motion to modify the district court’s final judgment.

USIJ and Medical Device Group Urge Movement on PERA and PREVAIL

The Medical Device Manufacturers Association (MDMA) and the Alliance of U.S. Startups and Inventors for Jobs (USIJ) sent a letter today to the leadership of the Senate Judiciary Committee and the Judiciary Committee’s Subcommittee on Intellectual Property to express their support for both the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) and the Patent Eligibility Restoration Act (PERA). Both PREVAIL and PERA were introduced on June 22, 2023. The PREVAIL Act aims to reform Patent Trial and Appeal Board (PTAB) practices while PERA would eliminate all judicially-created exceptions to U.S. patent eligibility law.

Vidal Vacates Board’s Denial of IPR Institution on Auto Part Patent

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB) on Friday that had denied institution of an inter partes review (IPR) requested by auto parts manufacturer, Mahle Behr Charleston, Inc. U.S. Patent No. RE47,494 E is owned by inventor Frank Amidio Catalano and covers “a device to prevent corrosion [in motor vehicle radiators] caused by electrolysis.” Mahle Behr requested IPR of the patent, arguing that a prior art reference called Godefroy anticipates and renders obvious certain claims.

CAFC Affirms District Court Dismissal of Pro Se Inventor’s Procedural and Patent Claims

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday affirmed a number of district court orders against inventor Urvashi Bhagat, whose patent application  was rejected by the U.S. Patent and Trademark Office (USPTO). Bhagat’s U.S. patent application No. 13/877,847 covers orally-delivered nutritional formulations containing omega-6 fatty acids and antioxidants. The application was filed in 2013 and the USPTO examiner rejected all claims as obvious, two claims as lacking written description, several other claims as indefinite and others for improper dependency. On appeal to the PTAB, the Board summarily affirmed the dependency and indefiniteness rejections, affirmed the obviousness rejection on the merits and reversed the written description rejection. Bhagat then appealed to the U.S. District Court for the Eastern District of Virginia, claiming the USPTO erroneously rejected her patent claims and asking for damages due to the Office’s bad faith and for taking her property.

CAFC Sends Janssen Schizophrenia Treatment Claims Back to District Court for New Obviousness Analysis

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled in a precedential decision authored by Judge Prost on Monday that certain claims of Janssen Pharmaceuticals Inc.’s patent for a schizophrenia drug are not indefinite but vacated and remanded the district court’s finding that Teva Pharmaceuticals had not proven all of the claims obvious.

CAFC: Jury Instructions Must Address Each Objective Indicia of Nonobviousness Raised by Patent Owner

On March 27, the U.S. Court of Appeals for the Federal Circuit issued a precedential ruling in Inline Plastics Corp. v. Lacerta Group, LLC, on appeal from the District of Massachusetts. Judge Richard Taranto authored the opinion and held that an improper jury instruction given at trial by the district court required vacatur of the court’s final judgment that Inline’s patent claims were invalid for obviousness. The Federal Circuit remanded that portion of the case for a new trial so that the jury can properly consider each objective indicia of nonobviousness raised by Inline at trial.

Victory for Virtek Patent as CAFC Schools PTAB on Proper Motivation to Combine Analysis

In a precedential decision authored by Chief Judge Moore, the U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday partially reversed a Patent Trial and Appeal Board (PTAB) ruling that certain claims of Virtek Vision International’s patent on a method for aligning a laser projector were unpatentable, finding the Board erred as a matter of law in its analysis. The court also affirmed the PTAB’s finding that other claims were not proven unpatentable. Aligned Vision challenged various claims of Virtek’s U.S. Patent No. 10,052,734, which is titled “Laser Projector with Flash Alignment,” arguing claims 1, 2, 5, 7, and 10–13 would have been obvious over prior art references titled Keitler and Briggs (Ground 1), and over Briggs and another reference, Bridges (Ground 3). It also argued claims 3–6 and 8–12 would have been obvious over Keitler, Briggs, and  ‘094 Rueb (Ground 2), and over Briggs, Bridges, and ‘094 Rueb (Ground 4).

Rader’s Ruminations – Patent Eligibility II: How the Supreme Court Ignored Statute and Revived Its Innovation-Killing Two-Step

The Supreme Court has never quite grasped the distinction between patent eligibility and patentability. Eligibility involves entire subject matter categories or fields of inventive enterprise, like the categories “process, machine, [article of] manufacture, or composition of matter.” 35 U.S.C. 101. Ascertaining eligibility should therefore require little more than checking the patent title and ensuring that, in the words of the venerable Judge Giles Rich, “[the invention] produces a useful, concrete and tangible result.”  State Street Bank v. Signature Fin. Group, 149 F. 3d 1368 (Fed. Cir. 1998). In simple terms, Section 101 requires little more for eligibility than a showing that an invention has applied natural principles to achieve a concrete purpose within the expansive categories articulated by Thomas Jefferson in 1793. Patentability, on the other hand, proceeds as a detailed claim-by-claim, feature-by-feature examination of “the conditions and requirements of this title.” 35 U.S.C. 101. Ironically this fundamental distinction that eludes the Supreme Court is explicit in the statutory language of 35 U.S.C. 101 itself.

SCOTUS Denies Petition to Review CAFC Precedent on Justification for Primary Reference Selection

The U.S. Supreme Court on Monday, March 18, denied a petition filed by patent owner Jodi A. Schwendimann asking the Court to review a decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) that affirmed a Patent Trial and Appeal Board (PTAB) determination that Schwendimann’s patents were obvious. The petition specifically asked the Court to review the CAFC’s holding that Schwendimann’s argument that “justification for selection of a primary reference is a necessary step to guard against hindsight bias for the motivation to combine references” was unsupported by Federal Circuit case law.

Responding to Obviousness Rejections in Light of the USPTO’s New Guidance

The United States Patent and Trademark Office (USPTO) recently released new guidance to patent examiners on making obviousness rejections. The guidance focuses on post-KSR precedential jurisprudence from the U.S. Court of Appeals for the Federal Circuit. Some of the guidance is fairly mundane, some of it is not. The purpose of this article is to propose a few responses one might use to counter rejections that apply certain problematic aspects of the new guidance.

Federal Circuit Says Narrowing Limitation Does Not Create a Contradiction Leading to Indefiniteness

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today reversing the Western District of Texas district court’s indefiniteness analysis and explaining that it improperly found a contradiction between two claim limitations to arrive at its indefiniteness holding. Amperex Technology Limited filed an action seeking declaratory judgment of noninfringement and challenged the validity of certain claims of Maxell, Ltd.’s U.S. Patent No. 9,077,035 for a rechargeable lithium battery and Maxell asserted infringement of the patent in a separate action. The two actions were consolidated in the Western District of Texas and the court ultimately held that two of the “wherein” clauses of the sole independent claim 1 of the ‘035 patent contradicted one another.

Rader’s Ruminations – Patent Eligibility, Part 1: The Judge-Made ‘Exceptions’ are Both Unnecessary and Misconstrued

In supreme irony, the U.S. Supreme Court lists the three exceptions to statutory patent eligibility in Chakrabarty, Diamond v. Chakrabarty, 447 U.S. 303 (1980) — the case most famous for the observation that Thomas Jefferson’s statutory language from the 1793 Act (still in place today) covers “anything under the sun made by man.” Id. at 309. While construing Jefferson’s “broad” statutory language in 35 U.S.C. 101 with “wide scope,” the Court noted: “The laws of nature, physical phenomena, and abstract ideas have been held not patentable.” Id. The Court tries to support this listing with a string citation to several cases — each standing for something different than an exception from statutory language. Still, to ensure clarity, the Court gives examples: “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Likewise, Einstein could not patent his celebrated law that E=mc2, nor could Newton have patented the law of gravity.”  Id. So far so good, but this classic example of the Court trying to sound informed and competent out of its comfort zone reemerges 30 years later to replace (and effectively overrule) the statutory rule that governed for over 200 years and remains in Title 35.

USPTO Issues Updated Obviousness Guidance Tracing 15 Years of Case Law Following KSR

On February 27, the U.S. Patent and Trademark Office (USPTO) published a notice in the Federal Register providing updated guidance for agency decision-makers on making proper determinations of obviousness under the U.S. Supreme Court’s 2007 ruling in KSR International Co. V. Teleflex Inc. While the USPTO’s examiner guidance doesn’t constitute substantive rulemaking, it traces 15 years of case law from the U.S. Court of Appeals for the Federal Circuit to clarify several areas of confusion stemming from the Supreme Court’s calls for a flexible approach to the obviousness analysis for patent validity.