Prior art

Analysis of Prior Art Cited for U.S. Patent No. 12,290,598

The following is an analysis of the most relevant prior art for U.S. Patent No. 12,290,598, focusing on references that could potentially anticipate its claims under 35 U.S.C. § 102. The analysis is based on the patent's own description and publicly available patent data.

Patent Family (Prior Applications)

The patent's own text establishes a direct lineage from earlier applications, which constitute significant prior art.

• U.S. Patent No. 8,771,729 (issued Jul. 8, 2014)

  • Full Citation: US 8,771,729 B2
  • Filing Date: October 1, 2010
  • Brief Description: This patent is the parent of a series of continuations and divisionals leading to the '598 patent. It discloses orally administered corticosteroid compositions, including orally disintegrating tablets (ODTs), for treating inflammatory conditions of the gastrointestinal tract. The core invention of an ODT with a corticosteroid for topical esophageal delivery is described.
  • Potential Anticipation: As the foundational patent in this family, its disclosure is highly likely to anticipate the fundamental concepts in the claims of the '598 patent, which is a continuation of this lineage. Specifically, it describes the solid pharmaceutical composition with a corticosteroid that disintegrates rapidly.

• U.S. Patent No. 9,387,167 (issued Jul. 12, 2016)

  • Full Citation: US 9,387,167 B2
  • Filing Date: June 23, 2014 (as a divisional of the application leading to 8,771,729)
  • Brief Description: This patent continues the subject matter of the '729 patent. It further refines the claims related to the orally administered corticosteroid compositions for treating conditions like eosinophilic esophagitis.
  • Potential Anticipation: This patent would anticipate claims in the '598 patent that are not meaningfully different from its own claims, as they share a common specification. It describes the core ODT formulation and its intended use.

• U.S. Patent No. 9,849,084 (issued Dec. 26, 2017)

  • Full Citation: US 9,849,084 B2
  • Filing Date: July 8, 2016 (as a continuation of the application leading to 9,387,167)
  • Brief Description: This patent is also part of the same family and shares the same core disclosure. The claims continue to be directed towards orally disintegrating corticosteroid tablets for topical treatment of the GI tract.
  • Potential Anticipation: Similar to the other patents in the family, its detailed description of the ODT composition, including disintegrants, sugar alcohols, and corticosteroids like fluticasone and budesonide, would anticipate the foundational claims of the '598 patent.

• U.S. Patent No. 10,632,069 (issued Apr. 28, 2020)

  • Full Citation: US 10,632,069 B2
  • Filing Date: November 17, 2017 (as a continuation of the application leading to 9,849,084)
  • Brief Description: As a direct predecessor in the continuation chain leading to the '598 patent, this patent's disclosure is substantively identical. It describes orally disintegrating tablets containing corticosteroids for treating inflammatory GI conditions.
  • Potential Anticipation: This patent is highly likely to anticipate the majority of the claims in the '598 patent, given that the '598 patent is a continuation. It explicitly details the formulation of ODTs with specific excipients and their rapid disintegration properties.

Other Relevant Prior Art

The specification of the '598 patent and its family members cite several other patents that are relevant to the technology of orally disintegrating dosage forms.

• U.S. Patent Application Publication No. US 2005/0232988

  • Full Citation: US 2005/0232988 A1
  • Filing Date: April 19, 2004
  • Brief Description: This application describes the creation of orally disintegrating tablets using rapidly dispersing microgranules and taste-masked microcapsules. The technology for creating a fast-disintegrating tablet with a pleasant mouthfeel is a key focus.
  • Potential Anticipation: This reference could anticipate claims related to the specific formulation of the ODT, particularly the use of rapidly dispersing microgranules made from a sugar alcohol and a disintegrant. While it may not specify a corticosteroid for GI inflammation, it discloses the core ODT platform technology that the '598 patent utilizes. The '598 patent text itself refers to the methods described in this application for preparing its rapidly dispersing microgranules.

• U.S. Patent No. 6,316,027

  • Full Citation: US 6,316,027 B1
  • Filing Date: June 1, 1999
  • Brief Description: This patent, referenced in the '598 patent text, relates to the ZYDIS® lyophilization technology for preparing orally disintegrating or dissolving dosage forms. It describes a process for creating a lyophilized, fast-dissolving wafer.
  • Potential Anticipation: This could anticipate claims directed specifically to a lyophilized wafer embodiment of the corticosteroid composition. It teaches the method of making a fast-dissolving solid dosage form, a key feature of the '598 patent's claims.

• U.S. Patent No. 6,596,298

  • Full Citation: US 6,596,298 B2
  • Publication Date: July 22, 2003
  • Filing Date: September 14, 1999
  • Brief Description: This patent, also referenced in the '598 patent's text, describes fast-dissolving orally consumable films for delivering various agents to the oral cavity, including pharmaceutically active agents.
  • Potential Anticipation: This reference could anticipate claims of the '598 patent that are broad enough to cover a film dosage form. It discloses the technology of a rapidly dissolving oral dosage form which is a central concept of the '598 patent.