Prior art — US Patent 11878049

The most relevant prior art for US patent 11878049, based on its citations and the stated priority date of June 14, 2019, are patents and publications that disclose the use of mitapivat (also known as AG-348) for the treatment of pyruvate kinase deficiency (PKD), sickle cell disease (SCD), and thalassemia. These references establish the foundational knowledge upon which US11878049 builds, specifically concerning the therapeutic application of mitapivat.

However, for a prior art reference to anticipate a claim under 35 U.S.C. § 102, it must disclose every single element of that claim, either explicitly or inherently. The distinguishing features of US11878049's independent claims involve methods of treating these diseases by either:

Co-administering mitapivat with an effective amount of a CYP3A4/5 inducer, a CYP3A4/5 inhibitor, or a p-glycoprotein (p-gp) inhibitor.
Administering mitapivat in the absence of such modulators.
Implying that these approaches are specifically for managing drug-drug interactions and optimizing mitapivat exposure.

While the prior art listed below establishes the therapeutic use of mitapivat for the claimed diseases, it is presumed that these references do not explicitly teach or suggest the nuanced drug-drug interaction management strategies (i.e., co-administration with, or administration in the absence of, specific CYP3A4/5 or p-gp modulators to adjust mitapivat dosage or exposure) that form the specific limitations of the independent claims of US11878049. Therefore, while they broadly establish the therapeutic context of mitapivat, they are unlikely to fully anticipate the specific methods of modulation or non-modulation claimed in US11878049 under 35 U.S.C. § 102, but would be highly relevant for an obviousness analysis under 35 U.S.C. § 103.

Here are some of the most relevant prior art references:

1. US10064887B2

Full Citation: US 10,064,887 B2, titled "Methods for treating pyruvate kinase deficiency using AG-348".
Publication/Filing Date: Published: September 4, 2018. Application filed: January 31, 2017.
Brief Description: This patent describes methods and pharmaceutical compositions for treating pyruvate kinase deficiency (PKD) in a subject. The primary active agent disclosed is AG-348, which is also known as mitapivat, a pyruvate kinase R (PKR) activator. The patent focuses on the therapeutic administration of AG-348 to alleviate symptoms or modify the disease course of PKD.
Potential Anticipation (35 U.S.C. § 102): This patent potentially anticipates the fundamental element of "A method of treating pyruvate kinase deficiency (PKD) in a subject, comprising administering to the subject an effective amount of mitapivat or a pharmaceutically acceptable salt thereof." This general method is the starting point for claims such as Claims 1, 16, 22, 37, 95, and 102 of US11878049. However, unless US10064887B2 further discloses the specific co-administration of CYP3A4/5 modulators, p-gp inhibitors, or the explicit administration in their absence with the purpose of managing drug interactions, it would not anticipate the entirety of these claims.

2. US10064888B2

Full Citation: US 10,064,888 B2, titled "Methods for treating pyruvate kinase deficiency using AG-348".
Publication/Filing Date: Published: September 4, 2018. Application filed: January 31, 2017.
Brief Description: This patent, a family member of US10064887B2, also covers methods and compositions for the treatment of pyruvate kinase deficiency (PKD) using AG-348 (mitapivat) as a PKR activator. Its disclosure on the therapeutic use of mitapivat for PKD is substantially similar to its sibling patent.
Potential Anticipation (35 U.S.C. § 102): Similar to US10064887B2, this patent potentially anticipates the broad concept of treating PKD with mitapivat, which is an initial element in claims such as Claims 1, 16, 22, 37, 95, and 102 of US11878049. Full anticipation of these claims would require the explicit disclosure of the specific drug-drug interaction management strategies that involve CYP3A4/5 or p-gp modulators.

3. US10076510B2

Full Citation: US 10,076,510 B2, titled "Pyruvate kinase activators for treating beta-thalassemia".
Publication/Filing Date: Published: September 18, 2018. Application filed: May 23, 2017.
Brief Description: This patent describes the use of pyruvate kinase activators, including AG-348 (mitapivat), for the treatment of beta-thalassemia. It details methods for administering these compounds to subjects to improve hematological parameters and alleviate symptoms associated with beta-thalassemia.
Potential Anticipation (35 U.S.C. § 102): This patent potentially anticipates the general method of "treating thalassemia in a subject, comprising administering to the subject an effective amount of mitapivat or a pharmaceutically acceptable salt thereof." This broad concept is an initial element in claims such as Claims 65, 74, 80, 89, 117, and 124 of US11878049. As with the PKD-focused patents, full anticipation would hinge on whether US10076510B2 explicitly discloses the specific CYP3A4/5 or p-gp modulation strategies to manage mitapivat exposure.

4. WO2019104134A1

Full Citation: WO 2019/104134 A1, titled "Pharmaceutical compositions and methods of use".
Publication/Filing Date: Published: May 30, 2019. International Filing Date: November 27, 2018.
Brief Description: This international patent application describes pharmaceutical compositions containing mitapivat or its pharmaceutically acceptable salts, and their use in treating various conditions, including pyruvate kinase deficiency (PKD), sickle cell disease (SCD), and thalassemia. Notably, US11878049 itself states that "mitapivat or a pharmaceutically acceptable salt thereof is formulated as a tablet composition together with a pharmaceutically acceptable carrier, in accordance with the disclosures of International Patent Application No. W02019/104134."
Potential Anticipation (35 U.S.C. § 102): Given the explicit cross-reference in US11878049, WO2019104134A1 clearly serves as prior art for the general use of mitapivat (including its tablet formulations) for treating PKD, SCD, and thalassemia. This would potentially anticipate the elements of administering "an effective amount of mitapivat or a pharmaceutically acceptable salt thereof" for treating these diseases, found in all independent claims (Claims 1, 16, 22, 37, 43, 50, 54, 61, 65, 74, 80, 89, 95, 102, 108, 113, 117, 124). However, for full anticipation of the claims of US11878049, WO2019104134A1 would need to explicitly disclose the specific drug-drug interaction management strategies involving CYP3A4/5 or p-gp modulators, or administration in their absence for pharmacokinetic management.