Patents by Inventor Michael Heartlein

Michael Heartlein has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • Publication number: 20250257046
    Abstract: Disclosed are cationic lipids comprising a vitamin substructure and an ionizable nitrogen-containing group. Cationic lipids provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
    Type: Application
    Filed: January 16, 2025
    Publication date: August 14, 2025
    Inventors: Yi Zhang, Shrirang Karve, Saswata Karmakar, Frank DeRosa, Michael Heartlein
  • Patent number: 12377053
    Abstract: Disclosed are cationic polymers comprising monomers such as those described in Formula (I), Such polymers can be useful for the preparation of therapeutic compositions (e.g., compositions comprising nucleic acids such as mRNA). Additionally, therapeutic compositions comprising these cationic, biodegradable polymers can have improved properties and reduced toxicity.
    Type: Grant
    Filed: April 3, 2024
    Date of Patent: August 5, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Frank DeRosa, Michael Heartlein, Shrirang Karve, Zarna Patel
  • Patent number: 12370238
    Abstract: The present invention provides, among other things, methods and compositions for treating primary ciliary dyskinesia (PCD) based on mRNA therapy. The compositions used in treatment of PCD comprise an mRNA comprising a dynein axonemal heavy chain 5 (DNAH5) coding sequence and are administered at an effective dose and an administration interval such that at least one symptom or feature of PCD is reduced in intensity, severity, or frequency or has a delayed onset. mRNAs with optimized DNAH5 coding sequences are provided that can be administered without the need for modifying the nucleotides of the mRNA to achieve sustained in vivo function.
    Type: Grant
    Filed: December 6, 2022
    Date of Patent: July 29, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Anusha Dias, Darshan Parekh, Jeffrey S. Dubins, Christian Cobaugh, Shrirang Karve, Zarna Patel, Sara J. Dunaj, Frank DeRosa, Michael Heartlein
  • Patent number: 12370262
    Abstract: The present invention provides, among other things, methods and compositions of formulating nucleic acid-containing nanoparticles for efficient delivery of payload in vivo such that the method and compositions can be used to generate mRNA vaccines.
    Type: Grant
    Filed: March 28, 2022
    Date of Patent: July 29, 2025
    Assignee: Translate Bio, Inc.
    Inventors: Shrirang Karve, Zarna Patel, Ashish Sarode, Yi Zhang, Frank DeRosa, Michael Heartlein
  • Publication number: 20250197463
    Abstract: The present invention provides, among other things, an improved method of treating cystic fibrosis (CF) in a human subject. The method comprises administering a composition comprising an mRNA encoding a Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein at a concentration of 0.5 mg/mL or greater to a human subject via nebulization. The composition is aerosolized using a nebulizer and a nominal dose of the mRNA is administered to the human subject via the nebulizer over a period of time, typically at least 30 minutes, at a suitable nebulization rate, e.g., at least 0.2 mL/minute.
    Type: Application
    Filed: November 26, 2024
    Publication date: June 19, 2025
    Inventors: Shrirang Karve, Frank DeRosa, Michael Heartlein, Zarna Patel
  • Patent number: 12331005
    Abstract: Disclosed herein are novel compounds, pharmaceutical compositions comprising such compounds and related methods of their use. The compounds described herein are useful, e.g., as liposomal delivery vehicles to facilitate the delivery of encapsulated polynucleotides to target cells and subsequent transfection of said target cells, and in certain embodiments are characterized as having one or more properties that afford such compounds advantages relative to other similarly classified lipids.
    Type: Grant
    Filed: August 7, 2024
    Date of Patent: June 17, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Frank DeRosa, Braydon Charles Guild, Michael Heartlein
  • Publication number: 20250161221
    Abstract: Disclosed herein are novel compounds, pharmaceutical compositions comprising such compounds and related methods of their use. The compounds described herein are useful, e.g., as liposomal delivery vehicles to facilitate the delivery of encapsulated polynucleotides to target cells and subsequent transfection of said target cells, and in certain embodiments are characterized as having one or more properties that afford such compounds advantages relative to other similarly classified lipids.
    Type: Application
    Filed: January 17, 2025
    Publication date: May 22, 2025
    Applicant: Translate Bio, Inc.
    Inventors: Braydon Charles Guild, Michael Heartlein, Frank DeRosa, Jerry Chi Zhang
  • Publication number: 20250152735
    Abstract: Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.
    Type: Application
    Filed: January 17, 2025
    Publication date: May 15, 2025
    Applicant: Translate Bio, Inc.
    Inventors: Frank DeRosa, Braydon Charles Guild, Michael Heartlein
  • Publication number: 20250152739
    Abstract: The present invention provides, among other things, methods of treating ornithine transcarbamylase deficiency, including administering to a subject in need of treatment a composition comprising an mRNA encoding an ornithine transcarbamylase protein at a low dose and at an administration interval such that at least one symptom or feature of the OTC deficiency is reduced.
    Type: Application
    Filed: January 16, 2025
    Publication date: May 15, 2025
    Inventors: Kim Askew, Jou-Ku Chung, Frank DeRosa, Michael Heartlein, Shrirang Karve, Thomas McCauley, Lianne Smith, Ann J. Barbier
  • Publication number: 20250145577
    Abstract: Provided, in part, is a composition comprising one or more chemical entities of formula I, each of which is a compound of formula I: a pharmaceutically acceptable salt thereof, a solvate thereof, or a solvate of a pharmaceutically acceptable salt thereof, the composition characterized in that greater than a first threshold amount of the total amount of chemical entities of formula I in the composition: are chemical entities of formula I.a, wherein the first threshold amount is 50%; or are chemical entities of formula I.b.1, wherein the first threshold amount is 25%; or are chemical entities of formula I.b.2, wherein the first threshold amount is 25%, wherein the chemical entities of formula I.a, I.b.1, and I.b.2, are described herein, and methods of using such compositions, for example, for the delivery of a polynucleotide in vivo.
    Type: Application
    Filed: September 20, 2024
    Publication date: May 8, 2025
    Inventors: Frank DeRosa, Shrirang Karve, Michael Heartlein
  • Patent number: 12280147
    Abstract: The compounds disclosed herein (e.g., compounds having a structure according to Formula (I/(II)/(III)/(IV), and (V)) are polymers wherein an organic polymeric segment (e.g., a polyethylene glycol (PEG) group) comprises covalent attachments to two or more lipid substructures, and each lipid substructure independently comprises a hydrophobic moiety and a hydrophilic moiety. The compounds provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
    Type: Grant
    Filed: November 7, 2019
    Date of Patent: April 22, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Shrirang Karve, Yi Zhang, Frank DeRosa, Michael Heartlein
  • Patent number: 12280117
    Abstract: The present invention provides, among other things, compositions and methods of formulating nucleic acid-containing nanoparticles comprising no more than three distinct lipids components, one distinct lipid component being a sterol-based cationic lipid. In some embodiments, the present invention provides compositions and methods in which the lipid nanoparticles further comprise helper lipids and PEG-modified lipids. The resulting formulation comprises a high encapsulation percentage for nucleic acids.
    Type: Grant
    Filed: April 23, 2021
    Date of Patent: April 22, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Frank DeRosa, Michael Heartlein, Shrirang Karve
  • Patent number: 12268754
    Abstract: The present invention provides, among other things, methods of treating ornithine transcarbamylase deficiency, including administering to a subject in need of treatment a composition comprising an mRNA encoding an ornithine transcarbamylase protein at a low dose and at an administration interval such that at least one symptom or feature of the OTC deficiency is reduced.
    Type: Grant
    Filed: September 27, 2021
    Date of Patent: April 8, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Kim Askew, Jou-Ku Chung, Frank DeRosa, Michael Heartlein, Shrirang Karve, Thomas McCauley, Lianne Smith, Ann J. Barbier
  • Publication number: 20250108126
    Abstract: Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of amcliorating diseases associated with protein or enzyme deficiencies.
    Type: Application
    Filed: August 15, 2024
    Publication date: April 3, 2025
    Applicant: Translate Bio, Inc.
    Inventors: Frank DeRosa, Braydon Charles Guild, Michael Heartlein
  • Publication number: 20250101481
    Abstract: The present invention provides, among other things, methods for purifying mRNA based on normal flow filtration for therapeutic use.
    Type: Application
    Filed: August 5, 2024
    Publication date: March 27, 2025
    Inventors: Joseph Parella, Kimberly Gillis, Jonathan Abysalh, Travis Jeannotte, Erik Held, Frank DeRosa, Michael Heartlein, Rebecca Powell
  • Publication number: 20250099384
    Abstract: Disclosed are cationic lipids which are compounds of Formula (I), (II), (III), (IV), (V), or (VI). Cationic lipids provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
    Type: Application
    Filed: July 31, 2024
    Publication date: March 27, 2025
    Inventors: Yi Zhang, Shrirang Karve, Frank DeRosa, Michael Heartlein
  • Patent number: 12247046
    Abstract: Disclosed are messenger RNA molecules and related compositions incorporating a 4?-thio modification in the furanose ring of at least one nucleotide residue, and methods of using these mRNAs to produce an encoded therapeutic protein in vivo and to treat or prevent diseases or disorders. In certain embodiments, the 4?-thio modified mRNA provides for enhanced stability and/or reduced immunogenicity in in vivo therapies.
    Type: Grant
    Filed: August 10, 2022
    Date of Patent: March 11, 2025
    Assignee: Translate Bio, Inc.
    Inventors: Frank DeRosa, Michael Heartlein
  • Patent number: 12240824
    Abstract: Disclosed are cationic lipids comprising a vitamin substructure and an ionizable nitrogen-containing group. Cationic lipids provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
    Type: Grant
    Filed: May 29, 2019
    Date of Patent: March 4, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Yi Zhang, Shrirang Karve, Saswata Karmakar, Frank DeRosa, Michael Heartlein
  • Patent number: 12234446
    Abstract: The present invention provides, among other things, methods of purifying messenger RNA (mRNA) including the steps of subjecting an impure preparation comprising in vitro synthesized rnRNA to a denaturing condition, and purifying the rnRNA from the impure preparation from step (a) by tangential flow filtration, wherein the mRNA purified from step (b) is substantially free of prematurely aborted RNA sequences and/or enzyme reagents used in in vitro synthesis.
    Type: Grant
    Filed: November 24, 2020
    Date of Patent: February 25, 2025
    Assignee: TRANSLATE BIO, INC.
    Inventors: Michael Heartlein, Frank DeRosa, Anusha Dias, Shrirang Karve
  • Publication number: 20250049954
    Abstract: The present invention provides an improved compositions and processes for preparing mRNA-loaded lipid nanoparticles (mRNA-LNPs). In some embodiments, the present invention provides mRNA-LNPs with exceptional stability and is particularly useful in cases where LNPs comprising low or no PEG-modified lipids are desired.
    Type: Application
    Filed: October 9, 2024
    Publication date: February 13, 2025
    Inventors: Shrirang KARVE, Frank DEROSA, Michael HEARTLEIN, Natalia VARGAS MONTOYA, Priyal PATEL, Ashish SARODE