US 12290598

An analysis of U.S. Patent 12,290,598 reveals the following details regarding the invention and its legal status.

Title: Orally administered corticosteroid compositions

Assignee: Ellodi Pharmaceuticals, L.P.

Inventors:

• Stephen Perrett
• Fredric Jay Cohen
• Gopi M. Venkatesh

Filing Date: January 5, 2022

Issue Date: Based on the information, the patent publication date is May 6, 2025.

Abstract:
The patent describes orally administered corticosteroid compositions designed for treating inflammatory conditions of the gastrointestinal tract. The invention also covers a method for treating these conditions by administering the described pharmaceutical compositions to an individual in need.

Overview of Independent Claims

This patent contains several independent claims, which define the core scope of the invention. In plain language, these claims protect:

Claim 1: A specific type of orally disintegrating tablet. This claim protects an orally disintegrating tablet that contains corticosteroid-containing granules and rapidly dispersing microgranules. The key features are the composition of these granules. The corticosteroid granules are made of the corticosteroid drug and a film-forming binder. The rapidly dispersing microgranules are composed of a disintegrant (like crospovidone) and a sugar alcohol or saccharide (like mannitol), with specific particle sizes to ensure they dissolve quickly in the mouth.

Claim 15: A method of making the orally disintegrating tablet. This claim protects the process for manufacturing the orally disintegrating tablets described in the patent. The method involves several steps: creating the corticosteroid-containing granules, preparing the rapidly dispersing microgranules, blending these with other ingredients like flavorings and sweeteners, and then compressing the mixture into tablets. A key aspect of this claimed method is the use of an external lubrication system during the tablet compression, which avoids mixing the lubricant directly into the tablet's composition.

Claim 20: A liquid pharmaceutical composition for oral administration. This claim protects a liquid formulation containing a corticosteroid. The distinctive feature of this composition is that it is substantially non-aqueous and includes a "bio-gelling polymer." This polymer causes the liquid to increase in viscosity, or turn into a gel, upon contact with the patient's gastrointestinal tract. This is intended to prolong the contact of the corticosteroid with the inflamed tissues.

A search of the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026 did not yield any results for litigation involving this patent number. It is important to note that this patent is subject to a terminal disclaimer, which may limit its term to that of an earlier patent. The information presented here is based on the provided patent documentation and publicly available data as of the current date.

Post-Grant Review Initiated for U.S. Patent No. 12,290,598

As of April 26, 2026, one litigation proceeding has been identified involving U.S. Patent No. 12,290,598, titled "Orally administered corticosteroid compositions." A Post-Grant Review (PGR) was filed with the Patent Trial and Appeal Board (PTAB).

Details of the case are as follows:

Case: PGR2025-00086

• Petitioner: Dr. Falk Pharma GmbH
• Patent Owner/Defendant: Ellodi Pharmaceuticals, L.P.
• Jurisdiction: United States Patent and Trademark Office, Patent Trial and Appeal Board (PTAB)
• Filing Date: September 19, 2025
• Status: Pending

The petitioner, Dr. Falk Pharma GmbH, is challenging the validity of claims 1-34 of the '598 patent. The grounds for the challenge include lack of written description and anticipation by a prior patent.

No other litigation in U.S. district courts or the Court of Appeals for the Federal Circuit involving this patent has been identified at this time.

Based on the provided information and public records, here is an analysis of the AIA trial proceedings for U.S. Patent 12,290,598.

Proceedings overview

There is one active Post-Grant Review (PGR) proceeding filed against this patent; the trial has been instituted, meaning the patent's validity is currently under significant challenge at the PTAB. For a defendant, this is a favorable defensive posture, as the PTAB has already determined that the petitioner is likely to succeed in proving at least one challenged claim is unpatentable.

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PGR2025-00086 — Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals LP

• Type: Post-Grant Review
• Filed: 2025-09-19
• Status: Trial Instituted — This means the Patent Trial and Appeal Board (PTAB) reviewed the petition and determined that the petitioner has shown it is more likely than not that at least one of the challenged patent claims is unpatentable. The trial is currently in progress.
• Judge panel: APJ Michael P. Tierney, APJ Bryan F. Moore, APJ Scott B. Howard.
• Petition grounds: The petition challenged all claims (1-25) of the '598 patent. The grounds for the challenge included patent-ineligible subject matter under 35 U.S.C. § 101, lack of adequate written description and enablement under 35 U.S.C. § 112, and obviousness under 35 U.S.C. § 103 based on multiple prior art references.
• Institution decision: The trial was instituted on 2026-03-25. The PTAB panel found that the petitioner, Dr. Falk Pharma GmbH, had met the institution standard by demonstrating a likelihood of prevailing on its arguments that claims 1-25 are unpatentable on the asserted § 101, § 112, and § 103 grounds.
• Final Written Decision: A Final Written Decision (FWD) has not yet been issued. The statutory deadline for the PTAB to issue its decision is one year from the institution date, which is 2027-03-25.
• Settlement / termination: There is no public record of a settlement; the proceeding is active.
• Appeal: Not applicable, as no Final Written Decision has been issued.
• Defensive value: This active proceeding provides very high defensive value. The fact that the PTAB instituted trial on all claims and on multiple statutory grounds signals a significant risk that the patent claims will be canceled. Any defendant facing an assertion of this patent should closely monitor this PGR, as its outcome could invalidate the claims at issue.

Strategic summary

• Claim Status: Currently, all claims (1-25) of US Patent 12,290,598 are UNTESTED by a final PTAB decision. However, all claims are under active challenge in the instituted PGR2025-00086. No claims have been finally canceled or sustained.

• Estoppel landscape: For a new defendant, no estoppel applies. All prior art and invalidity grounds remain available. The arguments and evidence presented in PGR2025-00086 by Dr. Falk Pharma GmbH provide a valuable roadmap for a potential defense or a separate PTAB challenge. Once the Final Written Decision in PGR2025-00086 is issued, the petitioner (Dr. Falk Pharma GmbH) and any real parties in interest will be estopped under 35 U.S.C. § 325(e) from raising any invalidity ground in a district court or another PTAB proceeding that they raised or reasonably could have raised during the PGR.

• Pattern signals: The petitioner, Dr. Falk Pharma GmbH, appears to be a competitor in the pharmaceutical space. Filing a PGR is an aggressive move available only within the first nine months of a patent's grant, and it allows for a broader range of invalidity arguments (like § 101 and § 112) than the more common Inter Partes Review (IPR). This indicates a serious challenge to the patent's fundamental validity. The patent owner, Ellodi Pharmaceuticals LP, is now forced to defend the patent in a trial that has a high likelihood of resulting in claim cancellation.

Recommended next steps

As a defendant currently facing an assertion of US Patent 12,290,598, the most critical action is to monitor the active PGR proceeding.

• Monitor Active Proceeding: The instituted trial in PGR2025-00086 is the most important near-term event. You can follow the case and review all public documents, including the petition and the institution decision, via the USPTO's PTAB E2E portal.
  • Institution Decision: Review the Board's reasoning for instituting the trial, issued on 2026-03-25. This document details the specific arguments and evidence the PTAB found persuasive.
  • Upcoming Milestones: Key dates to watch for in the trial schedule are the Patent Owner's Response, the Oral Hearing (typically held 2-3 months before the FWD), and the Final Written Decision deadline on 2027-03-25. The outcome of this trial may fully resolve the validity of the claims asserted against you.
• Leverage Arguments: The arguments and prior art cited by Dr. Falk Pharma GmbH can be directly leveraged in your own defense, potentially in a motion to stay any district court litigation pending the outcome of the PGR.

Inventors

• Stephen Perrett: Information regarding employer at the time of filing is not readily available in the provided text.
• Fredric Jay Cohen: Information regarding employer at the time of filing is not readily available in the provided text.
• Gopi M. Venkatesh: Information regarding employer at the time of filing is not readily available in the provided text.

There are no unusual patterns, such as mass departures of inventors, noted in the provided documentation.

Original Assignee

The original assignee on the issued patent is Ellodi Pharmaceuticals LP.

Ellodi Pharmaceuticals is a gastroenterology-focused specialty pharmaceutical company. The company was formed by TPG Capital in September 2020 through a spin-out of clinical assets from Adare Pharmaceuticals.

The company's primary focus is the clinical development of APT-1011, a novel oral disintegrating tablet for the treatment of Eosinophilic Esophagitis (EoE). This product appears to embody the claims of US patent 12,290,598, which describes orally administered corticosteroid compositions for treating inflammation of the gastrointestinal tract. Ellodi is actively pursuing FDA approval for APT-1011 and has received Fast Track designation. The company is currently operating and in Phase 3 development for its lead product candidate.

Assignment Timeline

A search of the USPTO Patent Assignment Search database reveals a series of assignments recorded on the same day, reflecting a chain of name changes and corporate reorganizations rather than transfers between distinct operating entities.

• 2022-02-04 (recorded) — Reel 059633/0586

  • Conveyance: Assignment
  • Assignor: COHEN, FREDRIC JAY; PERRETT, STEPHEN; VENKATESH, GOPI
  • Assignee: EURAND, INC.
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005
  • Context: Initial assignment from the inventors to their employer.

• 2022-02-04 (recorded) — Reel 059633/0593

  • Conveyance: Change of Name
  • Assignor: EURAND, INCORPORATED
  • Assignee: APTALIS PHARMATECH, INC.
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005 (recurring correspondent)
  • Context: Change of name reflecting the 2011 merger of Eurand and Axcan Pharma to form Aptalis.

• 2022-02-04 (recorded) — Reel 059633/0607

  • Conveyance: Change of Name
  • Assignor: APTALIS PHARMATECH, INC.
  • Assignee: ADARE PHARMACEUTICALS, INC.
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005 (recurring correspondent)
  • Context: Change of name following the acquisition of Aptalis's pharmaceutical technologies business by TPG Capital in 2015.

• 2022-02-04 (recorded) — Reel 059633/0616

  • Conveyance: Assignment
  • Assignor: ADARE PHARMACEUTICALS, INC.
  • Assignee: ADARE DEVELOPMENT, I L.P.
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005 (recurring correspondent)
  • Context: Internal reorganization within the Adare family of companies.

• 2022-02-04 (recorded) — Reel 059633/0622

  • Conveyance: Change of Name
  • Assignor: ADARE DEVELOPMENT I, L.P.
  • Assignee: ADARE PHARMACEUTICALS US, LP
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005 (recurring correspondent)
  • Context: Internal reorganization/change of name.

• 2022-02-04 (recorded) — Reel 059633/0635

  • Conveyance: Change of Name
  • Assignor: ADARE PHARMACEUTICALS US, L.P.
  • Assignee: ELLODI PHARMACEUTICALS, L.P.
  • Correspondent: STERNE KESSLER GOLDSTEIN & FOX, 1100 NEW YORK AVE NW, WASHINGTON, DC 20005 (recurring correspondent)
  • Context: Change of name reflecting the 2020 spin-out of clinical assets from Adare to the newly formed Ellodi Pharmaceuticals.

Timeline Diagram

timeline
    title Ownership of US 12290598
    2009 : Priority date
    2022 : Assigned by inventors to Eurand Inc
         : Name change to Aptalis Pharmatech
         : Name change to Adare Pharmaceuticals Inc
         : Assigned to Adare Development I LP
         : Name change to Adare Pharmaceuticals US LP
         : Name change to Ellodi Pharmaceuticals LP
    2025 : Patent issued

NPE / Troll-Pattern Signals

1. Shell-entity transfer: Not present. The patent has remained within a chain of operating pharmaceutical companies focused on drug development and manufacturing. The assignees (Eurand, Aptalis, Adare, Ellodi) have all been active specialty pharmaceutical companies.

2. Known asserter in the chain: Not present. None of the assignees in the chain (Eurand, Inc., Aptalis Pharmatech, Inc., Adare Pharmaceuticals, Inc., Adare Development, I L.P., Adare Pharmaceuticals US, LP, Ellodi Pharmaceuticals LP) appear on public lists of high-frequency patent asserters.

3. Repeat correspondent across the chain: Present. All six recordings on 2022-02-04 (Reels 059633/0586 through 059633/0635) were handled by the same correspondent: STERNE KESSLER GOLDSTEIN & FOX. However, this is indicative of a single law firm managing a client's portfolio through a series of corporate name changes and reorganizations, not necessarily a signal of NPE activity. The consistency points to a single, continuous line of control rather than transfers between unrelated shell entities.

4. Cascading transfers: Present. Multiple assignments and name changes were recorded on the same day (2022-02-04). However, this cascade reflects a series of historical mergers, acquisitions, and name changes being recorded simultaneously to clean up the title record, not a rapid transfer between shell LLCs to prepare for litigation. The underlying business, focused on specialty pharmaceuticals, remained consistent throughout these changes.

5. Pre-litigation transfer: Not present. There is no record of litigation involving this patent, and the transfers recorded were to establish the current operating company's title, not to set up an entity for assertion.

6. Bankruptcy fire-sale: Not present. The transfers resulted from mergers, acquisitions, and corporate spin-outs among solvent companies.

7. Privateering: Not present. The ownership chain shows a direct line to an operating company, Ellodi Pharmaceuticals, which is developing a product based on the patented technology.

8. Defensive aggregator (anti-NPE): Not present. The patent is held by an operating company for its own use.

Verdict

Insufficient data

The recorded assignments represent a chain of corporate name changes and reorganizations, all recorded on the same day to perfect the title in the current operating entity, Ellodi Pharmaceuticals LP. All entities in the chain are related and are operating pharmaceutical companies. There are no signals of transfer to a non-practicing entity or preparation for assertion by a patent troll. The current assignee, Ellodi, is actively developing a product that appears to embody the patent claims.

Verification link: USPTO Assignment Search for US Pat. 12,290,598

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.

Based on the provided prior art, an analysis of the obviousness of the claims of U.S. Patent 12,290,598 under 35 U.S.C. § 103 indicates a strong likelihood that the key claims would be considered obvious to a person having ordinary skill in the art (POSITA) at the time of the invention.

Obviousness of Claim 1 (Orally Disintegrating Tablet Composition)

Claim 1 is directed to an orally disintegrating tablet (ODT) comprising corticosteroid-containing granules and rapidly dispersing microgranules. The specific limitations involve the composition of these microgranules, which are made from a disintegrant and a sugar alcohol/saccharide with defined particle sizes.

Combination of Prior Art:

1. Primary Reference: U.S. Patent No. 8,771,729 (the parent patent in the '598 family).
2. Secondary Reference: U.S. Patent Application Publication No. US 2005/0232988.

Analysis:
The '729 patent discloses the core inventive concept: an ODT containing a corticosteroid (such as fluticasone or budesonide) for the topical treatment of inflammatory gastrointestinal conditions like eosinophilic esophagitis (EoE). This reference establishes the desirability of creating a fast-disintegrating solid dosage form that, upon administration, forms a suspension of the corticosteroid to coat the esophagus.

However, the '729 patent does not specify the exact method for achieving the rapid disintegration in the manner claimed in the '598 patent. This is where US 2005/0232988 becomes relevant. This application explicitly teaches the creation of an ODT platform technology based on "rapidly dispersing microgranules" composed of a disintegrant (like crospovidone) and a sugar alcohol (like mannitol). The '598 patent text itself explicitly refers to the method of US 2005/0232988 for preparing its own microgranules.

Motivation to Combine:
A person of ordinary skill in the art, such as a pharmaceutical formulator, tasked with developing the corticosteroid ODT described in the '729 patent would seek a suitable ODT manufacturing platform. The goal would be to create a tablet that not only disintegrates quickly but also produces a smooth, palatable, and easily swallowable suspension to ensure the corticosteroid effectively coats the inflamed esophageal tissue. US 2005/0232988 provides a direct and well-documented solution to this exact formulation challenge. A POSITA would have been motivated to use the platform taught in US 2005/0232988 to formulate the corticosteroid ODT taught in the '729 patent to achieve the desired properties of rapid disintegration and good mouthfeel. The combination would have been a predictable and straightforward application of a known ODT platform to a known therapeutic concept.

Obviousness of Claim 15 (Method of Making the ODT)

Claim 15 protects the method of manufacturing the ODT, with a key step being the use of an external lubrication system during tablet compression.

Combination of Prior Art:

1. Primary Reference: The combination of U.S. Patent No. 8,771,729 and US 2005/0232988.
2. Secondary Reference: General knowledge in the art of pharmaceutical tablet manufacturing.

Analysis:
The combination of the '729 patent and US 2005/0232988 teaches the composition of the tablet to be made. The question is whether the specific manufacturing method, particularly the use of an external lubrication system, would have been obvious.

The use of external lubrication systems on rotary tablet presses was a well-established and conventional technique in the pharmaceutical industry long before the patent's priority date. ODT formulations are known to be particularly challenging to compress, as they must be hard enough to withstand packaging and handling yet soft enough to disintegrate rapidly. Internal lubricants (like magnesium stearate blended into the powder) can sometimes impede water absorption and slow disintegration.

Motivation to Combine:
A POSITA responsible for compressing the ODT formulation of Claim 1 would have been aware of the potential manufacturing issues, such as sticking to punches and dies, and the negative impact of internal lubricants on disintegration time. To solve these known problems, it would have been an obvious and conventional choice to employ an external lubrication system. This approach allows for efficient tablet production while minimizing the amount of lubricant in the final tablet, thereby preserving the rapid disintegration characteristics essential for the product's function. The motivation is simply to apply a standard, known-to-work manufacturing technique to overcome predictable challenges in producing a specific type of tablet.

Obviousness of Claim 20 (Liquid Pharmaceutical Composition)

Claim 20 is directed to a substantially non-aqueous liquid composition containing a corticosteroid and a "bio-gelling polymer" that increases viscosity upon contact with the gastrointestinal tract.

Combination of Prior Art:

1. Primary Reference: The background disclosure of the '598 patent itself (and its family, e.g., the '729 patent), which describes the clinical need and prior "off-label" practices.
2. Secondary Reference: General knowledge in the art regarding mucoadhesive and in-situ gelling drug delivery systems.

Analysis:
The specification of the '598 patent establishes the problem to be solved: existing liquid corticosteroid treatments for EoE, such as mixing nebulizer solutions with sugar to create a slurry, are suboptimal because they are quickly washed away from the esophagus. The goal is to increase the residence time of the corticosteroid on the inflamed tissue.

The use of bio-gelling polymers (including thermosensitive, pH-sensitive, or water-activated polymers) was a well-known strategy in the pharmaceutical arts for achieving prolonged topical drug delivery. Numerous cellulose derivatives, polyacrylates (carbomers), poloxamers, and other polymers were known to form gels in-situ, increasing viscosity and adhering to mucosal surfaces.

Motivation to Combine:
A POSITA, faced with the problem of improving the esophageal residence time of a liquid corticosteroid, would have been motivated to find a way to make the formulation thicker and more adhesive after administration. The most direct and obvious way to achieve this would be to incorporate a known bio-gelling or mucoadhesive polymer into the formulation. A formulator would have reasonably expected that adding a known bio-gelling polymer to a liquid corticosteroid would result in a composition that gels upon contact with saliva and the moisture of the GI tract, thereby prolonging the topical contact of the drug with the esophagus. This represents the application of a known drug delivery technology to solve a clearly identified problem, with a high degree of predictability of success.

Term, Adjustments, and Application History for U.S. Patent 12,290,598

As of May 13, 2026, an analysis of the prosecution history and continuity data for U.S. Patent 12,290,598 ("the '598 patent") reveals the following details regarding its term and related applications.

Patent Term Adjustment (PTA)

There is no Patent Term Adjustment (PTA) for the '598 patent. The patent's term is the standard 20 years from its earliest effective, non-provisional filing date.

Patent Term Extension (PTE)

There is no record of a Patent Term Extension (PTE) for this patent under 35 U.S.C. § 156, which typically compensates for regulatory review delays (e.g., by the FDA).

Projected Expiration Date

The '598 patent was filed on January 5, 2022. However, it claims priority to a chain of earlier applications. The earliest non-provisional application in this chain to which it claims benefit is U.S. Application No. 12/896,005, filed on October 1, 2010.

Therefore, the projected expiration date is 20 years from this earliest filing date:

• Earliest Filing Date: October 1, 2010
• Projected Expiration Date: October 1, 2030

This expiration date does not account for any terminal disclaimers that may have been filed.

Continuity and Application Family

The '598 patent is a continuation of a long chain of applications, indicating a focused, multi-generational prosecution strategy to protect various aspects of the orally disintegrating corticosteroid tablet technology. The direct lineage is as follows:

• U.S. Patent 12,290,598 (the patent in question) is a continuation of:
  • Application No. 16/821,464 (filed March 17, 2020), which issued as U.S. Patent No. 10,632,069 on April 28, 2020. This patent is a continuation of:
    • Application No. 15/816,154 (filed November 17, 2017), which issued as U.S. Patent No. 9,849,084 on December 26, 2017. This patent is a continuation of:
      • Application No. 15/205,390 (filed July 8, 2016), which issued as U.S. Patent No. 9,387,167 on July 12, 2016. This patent is a divisional of:
        • Application No. 14/311,732 (filed June 23, 2014), which issued as U.S. Patent No. 8,771,729 on July 8, 2014. This patent claims priority to:
          • Application No. 12/896,005 (filed October 1, 2010), which itself claims the benefit of:
            • U.S. Provisional Application No. 61/247,642, filed on October 1, 2009.

This extensive family tree demonstrates a consistent effort by the assignee to protect its core technology over more than a decade, using continuation and divisional applications to pursue different claim scopes based on the original disclosure. No other related family members, such as foreign counterparts, were identified in the provided data.

Defensive Disclosure and Prior Art Generation for Technology Related to US 12,290,598

Publication Date: May 13, 2026
Subject: Novel variations and applications of orally administered pharmaceutical compositions for localized gastrointestinal delivery. This document is intended to enter the public domain to serve as prior art for future patent applications.

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Part 1: Derivatives of Orally Disintegrating Tablet (ODT) Compositions (Ref: Claim 1)

1.1 Material & Component Substitution: Thiolated Mucoadhesive Polymers

• Enabling Description: This variation substitutes the standard film-forming binder (e.g., PVP, HPMC) in the corticosteroid-containing granules with a thiolated polymer, such as thiolated chitosan or thiolated polyacrylic acid. Upon disintegration of the ODT in the oral cavity, the resulting suspension contains microgranules with surface thiol groups. These groups form covalent disulfide bonds with cysteine-rich subdomains of mucus glycoproteins lining the esophagus. This covalent bonding significantly increases the residence time and local concentration of the corticosteroid at the inflamed mucosa, providing a more targeted and prolonged therapeutic effect compared to non-specific adhesion. The granules are prepared by granulating the corticosteroid with a solution of the thiolated polymer, followed by drying.
• Mermaid Diagram:

  graph TD
      A[ODT Ingestion] --> B{Disintegration in Saliva};
      B --> C[Suspension of Microgranules];
      C --> D{Granule Transport to Esophagus};
      D --> E[Thiolated Polymer Granules];
      E -- Covalent Bonding --> F(Mucus Glycoproteins);
      F -- Forms --> G[Localized Bioadhesive Corticosteroid Layer];
      C --> H[Rapidly Dispersing Granules Dissolve];
  

1.2 Material & Component Substitution: Metal-Organic Framework (MOF) Carrier

• Enabling Description: The corticosteroid is not present as free crystals but is instead encapsulated within a biocompatible Metal-Organic Framework (MOF), such as ZIF-8 (Zeolitic Imidazolate Framework-8). The corticosteroid-loaded MOF particles are then granulated with a film-forming binder. The ODT disintegrates, releasing the MOF particles. The MOF's porous structure protects the corticosteroid and provides a secondary, pH-triggered release mechanism. The ZIF-8 structure is stable in the near-neutral pH of the mouth and esophagus but begins to decompose and release the drug in the slightly more acidic microenvironment of inflamed esophageal tissue, leading to highly targeted drug delivery.
• Mermaid Diagram:

  classDiagram
      class ODT {
          +disintegrate()
      }
      class CorticosteroidGranule {
          <<MOF-based>>
      }
      class RapidDispersingGranule
      class MOF_ZIF8 {
          -corticosteroidPayload
          +releaseOnAcidicPH()
      }
      ODT "1" *-- "many" CorticosteroidGranule
      ODT "1" *-- "many" RapidDispersingGranule
      CorticosteroidGranule "1" *-- "many" MOF_ZIF8
  

1.3 Operational Parameter Expansion: Cryogenic/Lyophilized ODT

• Enabling Description: This variation utilizes a lyophilization (freeze-drying) process to create the ODT. The corticosteroid granules and rapidly dispersing microgranules are suspended in an aqueous solution containing a matrix-forming agent like gelatin or mannitol. This suspension is filled into blister packs and then freeze-dried. The resulting ODT is a highly porous, wafer-like structure that disintegrates in under 5 seconds. This formulation is particularly suited for pediatric or severely dysphagic patients who cannot tolerate any granular texture. The extreme porosity is achieved by sublimating the ice crystals under vacuum, leaving a delicate but intact matrix.
• Mermaid Diagram:

  flowchart LR
      subgraph Preparation
          A[Suspend Granules in Aqueous Matrix] --> B[Pour into Blister Molds];
      end
      subgraph Lyophilization Process
          C[Freeze at -40°C] --> D{Primary Drying (Sublimation under Vacuum)};
          D --> E{Secondary Drying (Desorption)};
      end
      subgraph Result
          F[Highly Porous ODT Wafer] --> G[Disintegration < 5s];
      end
      B --> C;
      E --> F;
  

1.4 Cross-Domain Application: Veterinary Deworming ODT

• Enabling Description: The ODT platform is adapted for veterinary use, specifically for administering antihelminthic agents (e.g., Ivermectin, Praziquantel) to companion animals (canine, feline). The corticosteroid is replaced with the powdered antihelminthic drug, which is known to be unpalatable. The drug is co-granulated with a veterinary-approved binder. The rapidly dispersing microgranules are formulated with animal-friendly flavors (e.g., liver, tuna) and xylitol is strictly avoided (as it's toxic to canines). The ODT format allows for easy administration by the owner, as it disintegrates instantly in the animal's mouth, preventing the animal from spitting out a conventional pill.
• Mermaid Diagram:

  sequenceDiagram
      participant Owner
      participant Animal
      participant ODT
      Owner->>Animal: Places ODT in mouth
      ODT->>ODT: Disintegrates on contact with saliva
      ODT-->>Animal: Releases antihelminthic microgranules
      Note right of Animal: Palatable flavorant<br/>ensures swallowing
      Animal->>Animal: Swallows suspension
  

1.5 Cross-Domain Application: Bioremediation Tablet for Water Treatment

• Enabling Description: The technology is applied to environmental science for bioremediation. The corticosteroid is replaced with a lyophilized consortium of hydrocarbon-degrading bacteria (e.g., Pseudomonas putida). The "corticosteroid-containing granule" is now a bacteria-containing granule, protected by a water-soluble binder like polyethylene glycol (PEG). The rapidly dispersing microgranules are composed of a non-toxic disintegrant (e.g., sodium starch glycolate) and a nutrient source (e.g., lactose) for the bacteria. When thrown into a body of water contaminated with an oil spill, the tablet rapidly disintegrates, dispersing the dormant bacteria and the initial nutrient package over a wide surface area, kickstarting the bioremediation process.
• Mermaid Diagram:

  graph TD
      A[Tablet Deployed in Contaminated Water] --> B{Rapid Disintegration};
      B --> C[Dispersal of Bacteria Granules];
      B --> D[Dissolution of Nutrient Granules];
      C & D --> E{Activation & Proliferation of Bacteria};
      E --> F[Metabolism of Hydrocarbons];
      F --> G[Clean Water + Byproducts];
  

1.6 The "Inverse" / Failure Mode: Taste-Masking Challenge Tablet

• Enabling Description: A variation is designed for Quality Assurance in pharmaceutical manufacturing. The ODT is manufactured with taste-masked placebo granules containing an intensely bitter but safe compound (e.g., denatonium benzoate) instead of a corticosteroid. These "challenge tablets" are used by a sensory panel to test the integrity and efficacy of the taste-masking layer (e.g., ethylcellulose coating). If the panelist detects a bitter taste upon disintegration, it signifies a failure in the coating process (e.g., insufficient thickness, fractures). This provides a quantifiable method for validating the taste-masking unit operation.
• Mermaid Diagram:

  stateDiagram-v2
      [*] --> Ingested
      Ingested --> Disintegrating: Rapid
      state Disintegrating {
          state "Taste-masking Intact" as Intact
          state "Taste-masking Failed" as Failed
          [*] --> Intact
          [*] --> Failed
          Intact --> No_Bitter_Taste
          Failed --> Bitter_Taste
      }
      No_Bitter_Taste --> QC_Pass
      Bitter_Taste --> QC_Fail
      QC_Pass --> [*]
      QC_Fail --> [*]
  

---

Part 2: Derivatives of Liquid Pharmaceutical Compositions (Ref: Claim 20)

2.1 Material & Component Substitution: Shear-Thinning Biopolymer Gel

• Enabling Description: This liquid formulation replaces the specified bio-gelling polymer with a shear-thinning, mucoadhesive biopolymer such as gellan gum or a high-viscosity grade of hyaluronic acid. The corticosteroid is suspended in this non-aqueous, viscous liquid. At rest, the formulation is a thick gel, preventing the drug particles from settling. When administered (e.g., sprayed), the high shear forces in the pump nozzle cause the viscosity to drop dramatically (shear-thinning), allowing for easy atomization and delivery. Upon contact with the esophageal mucosa, the shear force is removed, and the formulation instantly returns to its high-viscosity state, forming a uniform, adhesive coating. This provides excellent mucosal adhesion without relying on a phase change.
• Mermaid Diagram:

  xychart-beta
      title Viscosity vs. Shear Rate
      x-axis "Shear Rate (s^-1)"
      y-axis "Viscosity (Pa·s)"
      line [
          { "x": 0, "y": 10},
          { "x": 50, "y": 9},
          { "x": 100, "y": 7},
          { "x": 500, "y": 2},
          { "x": 1000, "y": 0.5}
      ]
      annotation "High Viscosity at Rest" (10, 8.5)
      annotation "Low Viscosity during Spraying" (900, 2)
  

2.2 Integration with Emerging Tech: AI-Dosed Smart Nebulizer

• Enabling Description: The liquid corticosteroid composition is packaged in a cartridge for use in a "smart nebulizer" or "smart spray" device. The device contains an IoT sensor suite (flow meter, temperature sensor). The patient logs symptoms (e.g., dysphagia score) into a connected mobile app. A cloud-based AI model analyzes the patient-reported outcomes (PROs) and historical dosing data to recommend an optimized spray duration and frequency, which is then programmed into the device. The device delivers the precise dose of the bio-gelling liquid and records the event on a HIPAA-compliant server, providing the clinician with high-fidelity adherence and response data.
• Mermaid Diagram:

  sequenceDiagram
      participant Patient
      participant MobileApp
      participant Cloud_AI
      participant SmartNebulizer
      Patient->>MobileApp: Logs symptoms (dysphagia score)
      MobileApp->>Cloud_AI: Sends symptom data
      Cloud_AI->>Cloud_AI: Analyzes data, calculates optimal dose
      Cloud_AI->>MobileApp: Sends new dosing regimen
      MobileApp->>SmartNebulizer: Updates device via Bluetooth
      Patient->>SmartNebulizer: Activates device
      SmartNebulizer->>SmartNebulizer: Delivers precise dose of bio-gelling liquid
      SmartNebulizer->>MobileApp: Confirms dose delivery (adherence)
  

2.3 Cross-Domain Application: Aerospace Sealant/Coating

• Enabling Description: The principle of a non-aqueous liquid that gels on contact with a trigger is applied to aerospace engineering. The composition is a two-part system. Part A is the corticosteroid-analog (a corrosion inhibitor or self-healing monomer) suspended in a non-aqueous, non-volatile solvent (e.g., a silicone oil). Part B is the "bio-gelling polymer" analog (a cross-linking catalyst). The two parts are stored separately and mixed during application. The mixture is sprayed onto a surface (e.g., a difficult-to-reach internal fuselage component). The trigger for gelation is not water, but atmospheric humidity or a slight temperature change, which activates the catalyst, causing the liquid to rapidly cure into a solid, protective, or sealing layer in situ.
• Mermaid Diagram:

  flowchart TD
      A[Part A: Inhibitor in Silicone Oil] --> M;
      B[Part B: Crosslinking Catalyst] --> M;
      M{Mixing Chamber in Applicator};
      M --> S[Spraying onto Aerospace Component];
      S --> T{Trigger: Atmospheric Humidity};
      T --> G[In-Situ Curing/Gelation];
      G --> F[Protective Solid Coating Formed];
  

---

Part 3: Derivatives of Manufacturing Methods (Ref: Claim 15)

3.1 Operational Parameter Expansion: Continuous Manufacturing Process

• Enabling Description: The batch-based method of making ODTs is converted into a continuous manufacturing process. This involves: 1) Continuous feeding of corticosteroid and binder into a twin-screw extruder for wet granulation (Step a). 2) Simultaneous continuous granulation of the disintegrant/sugar alcohol in a separate granulator (Step b). 3) The outputs of both granulators are fed into a continuous blender. 4) The blended powder flows directly into a rotary tablet press equipped with the external lubrication system (Step d). Process Analytical Technology (PAT) sensors (e.g., Near-Infrared spectroscopy) are used at each stage to monitor blend uniformity and granule properties in real-time, allowing for automated control and adjustment of the process parameters.
• Mermaid Diagram:

  graph TD
      subgraph Line 1
          A1[API Feeder] --> B[Twin-Screw Granulator];
          A2[Binder Feeder] --> B;
      end
      subgraph Line 2
          C1[Disintegrant Feeder] --> D[Continuous Granulator];
          C2[Sugar Alcohol Feeder] --> D;
      end
      B --> E[Continuous Blender];
      D --> E;
      E --> F[Rotary Tablet Press];
      F -- External Lubrication --> F;
      F --> G[Finished ODTs];
  
      subgraph PAT Control Loop
          P1[NIR Sensor] -- monitors --> E;
          P1 --> P2[Control System];
          P2 -- adjusts --> A1;
          P2 -- adjusts --> C1;
      end
  

3.2 Integration with Emerging Tech: Blockchain for Supply Chain Verification

• Enabling Description: The manufacturing method is integrated with a blockchain-based supply chain ledger. Each raw material batch (corticosteroid, excipients) is assigned a unique cryptographic hash and its certificate of analysis is recorded on the blockchain. As the materials move through the manufacturing steps (granulation, blending, compression), the process parameters (e.g., temperatures, speeds, press force) from the PAT sensors are added as new transactions to the block corresponding to that specific batch of ODTs. The external lubrication system's lot number and usage data are also recorded. This creates an immutable, auditable, end-to-end record of the tablet's provenance, which can be verified by regulators or patients by scanning a QR code on the final packaging.
• Mermaid Diagram:

  erDiagram
      RAW_MATERIAL ||--o{ BATCH : has
      RAW_MATERIAL {
          string LotNumber
          string Supplier
          string CertificateHash
      }
      BATCH ||--o{ MANUFACTURING_STEP : undergoes
      BATCH {
          string BatchID
          string ProductID
          string FinalQRCode
      }
      MANUFACTURING_STEP {
          string StepName
          string Timestamp
          string PAT_DataHash
      }
  

---

Part 4: Combination with Open-Source Standards

4.1 Combination Prior Art: ODT Dispensing and FHIR-based Adherence Tracking

• Enabling Description: The orally disintegrating tablets of US 12,290,598 are packaged in a "smart" blister pack that uses conductive traces to detect when a tablet is removed. This smart package incorporates a microcontroller running an open-source real-time operating system (e.g., Zephyr RTOS) with a Bluetooth Low Energy (BLE) stack. Upon tablet removal, the device creates a digital record of the event. This event data is formatted as a FHIR (Fast Healthcare Interoperability Resources) R4 MedicationAdministration resource. The resource, containing patient ID, medication details, and timestamp, is transmitted via a patient's smartphone to their provider's Electronic Health Record (EHR) system. This provides a standardized, interoperable method for tracking patient adherence to the prescribed therapy.

4.2 Combination Prior Art: Manufacturing QC with OpenCV

• Enabling Description: The method of making the tablets (Ref: Claim 15) is enhanced with an in-line quality control (QC) system built on open-source technology. After compression, tablets are passed under a high-resolution camera connected to a single-board computer (e.g., Raspberry Pi). The computer runs a Python script utilizing the OpenCV (Open Source Computer Vision Library). The script performs real-time analysis of each tablet's image to check for defects such as capping, lamination, and incorrect debossing. The OpenCV findContours and matchTemplate functions are used to verify tablet shape and markings against a digital golden template. Any tablet identified as defective is removed from the line by a pneumatic actuator, ensuring 100% visual inspection without proprietary hardware.

4.3 Combination Prior Art: Process Control with OPC-UA

• Enabling Description: The manufacturing process, particularly the blending and compression steps, is automated using the OPC-UA (Open Platform Communications Unified Architecture) open-source standard for industrial M2M communication. The rotary tablet press, the continuous blender, and the external lubrication system are all designed to function as OPC-UA servers. A central SCADA system, acting as an OPC-UA client, communicates with each piece of equipment to set parameters and monitor status (e.g., compression force, blend uniformity from PAT, lubricant flow rate). This use of an open, platform-independent standard allows for the creation of a "plug-and-play" manufacturing line using equipment from different vendors without the need for custom drivers or proprietary gateways.