Prior art

US patent 12123035B2, titled "PH20 polypeptide variants, formulations and uses thereof," was granted on October 22, 2024, from an application filed on December 19, 2022, and claims priority back to December 30, 2011.

The provided patent text does not explicitly list the numbered claims of US12123035B2. Therefore, the analysis of potential anticipation under 35 U.S.C. § 102 will refer to the general subject matter described in the "Definitions" section of the patent, which outlines the scope of the invention as modified PH20 hyaluronidase polypeptides, formulations, and uses thereof, particularly emphasizing increased stability and/or activity.

Based on a review of prior art citations for US12123035B2, the following patent documents, published or filed before the earliest priority date of December 30, 2011, are identified as potentially relevant prior art:

Most Relevant Prior Art Patent Citations

1. US 2004/0265979 A1

   • Full Citation: US 2004/0265979 A1: "Methods and Compositions for Enhancing the Delivery of Therapeutic Agents" to Frost, G.I. et al.
   • Publication/Filing Date: Published December 30, 2004 (Filed June 15, 2004).
   • Brief Description: This patent application describes compositions containing hyaluronidase and methods for enhancing the delivery of various therapeutic agents, including insulin and chemotherapeutic agents, through the extracellular matrix. It focuses on using hyaluronidase as a dispersing agent to improve the bioavailability of other drugs.
   • Potential Anticipation (35 U.S.C. § 102): This reference potentially anticipates claims generally directed to compositions containing hyaluronidase for enhancing the delivery of therapeutic agents, as well as methods of using hyaluronidase to increase the bioavailability of drugs. It lays groundwork for the application of hyaluronidase in drug delivery, which is a broad use case also covered by US12123035B2.

2. US 2006/0104968 A1

   • Full Citation: US 2006/0104968 A1: "Soluble Human PH20" to Shepard, H.M. et al.
   • Publication/Filing Date: Published May 18, 2006 (Filed November 16, 2005).
   • Brief Description: This patent application describes soluble forms of human PH20 hyaluronidase, particularly C-terminally truncated variants that lack the GPI anchor attachment site and are secreted from cells. It covers the identification, production, and characterization of these soluble human PH20 polypeptides.
   • Potential Anticipation (35 U.S.C. § 102): This reference directly anticipates claims generally directed to soluble human PH20 polypeptides, especially C-terminally truncated variants, as well as methods for their production. US12123035B2 specifically defines soluble PH20 polypeptides (e.g., SEQ ID NOs: 3 or 32-66) as potential unmodified forms for further modification, making this a highly relevant disclosure of foundational subject matter.

3. US 7,723,310 B2

   • Full Citation: US 7,723,310 B2: "Methods and Compositions for Enhancing the Delivery of Therapeutic Agents" to Frost, G.I. et al.
   • Publication/Filing Date: Published May 25, 2010 (Filing date December 30, 2005, a continuation of US 2004/0265979 A1).
   • Brief Description: This granted patent elaborates on compositions and methods using hyaluronidase to enhance the diffusion and delivery of various therapeutic agents. It covers the administration of hyaluronidase with other active agents, including a focus on increasing the rate of absorption and bioavailability.
   • Potential Anticipation (35 U.S.C. § 102): Similar to US 2004/0265979 A1, this patent anticipates claims broadly related to methods and pharmaceutical compositions for enhancing drug delivery using hyaluronidase, particularly with co-administered therapeutic agents. US12123035B2 claims formulations and uses of modified PH20 polypeptides in combination with other therapeutic agents (e.g., insulin), which finds antecedent basis in this prior art.

4. US 7,767,429 B2

   • Full Citation: US 7,767,429 B2: "Recombinant Human PH20 Hyaluronidase" to Shepard, H.M. et al.
   • Publication/Filing Date: Published August 3, 2010 (Filing date November 16, 2005, a divisional of US 2006/0104968 A1).
   • Brief Description: This patent claims recombinant human PH20 hyaluronidases, particularly soluble forms, including specific amino acid sequences (e.g., SEQ ID NO: 3, which is also a reference sequence in US12123035B2). It covers methods of producing these recombinant enzymes and their use.
   • Potential Anticipation (35 U.S.C. § 102): This patent directly anticipates claims generally directed to the recombinant soluble human PH20 polypeptides themselves, including specific sequences like SEQ ID NO: 3, which serves as a reference for modifications in US12123035B2. Claims related to methods of producing such polypeptides would also be anticipated. This is highly relevant as it describes the "unmodified" PH20 forms that US12123035B2 seeks to improve.

5. WO 2008/027961 A2

   • Full Citation: WO 2008/027961 A2: "PH20 Variants" to Ge, W. et al.
   • Publication/Filing Date: Published March 6, 2008 (Filed August 28, 2007).
   • Brief Description: This international application describes variants of PH20 polypeptides that exhibit increased thermal stability, increased specific activity, and/or increased resistance to proteolysis. It discloses specific amino acid modifications to achieve these properties.
   • Potential Anticipation (35 U.S.C. § 102): This reference is highly relevant as it directly anticipates claims generally directed to modified PH20 polypeptide variants with altered properties like increased stability (e.g., thermal stability) and increased activity. The core inventive concept of US12123035B2, which revolves around modified PH20 polypeptides with increased stability and/or activity, is significantly addressed here, including specific types of modifications and improved properties. Many of the positions and types of modifications claimed in US12123035B2 might find prior art disclosure or motivation for modification in this document.

6. US 2008/0241121 A1

   • Full Citation: US 2008/0241121 A1: "Stabilized Hyaluronidase" to Bookbinder, L. et al.
   • Publication/Filing Date: Published October 2, 2008 (Filed March 27, 2008).
   • Brief Description: This patent application describes stabilized hyaluronidase formulations, including compositions containing hyaluronidase and at least one stabilizing agent (e.g., a polyol, a salt). It addresses challenges related to hyaluronidase stability in pharmaceutical preparations.
   • Potential Anticipation (35 U.S.C. § 102): This reference potentially anticipates claims generally directed to stabilized hyaluronidase compositions and formulations. While US12123035B2 focuses on modified polypeptides themselves for intrinsic stability, formulations containing these modified polypeptides (e.g., with excipients and preservatives) could be anticipated in their broader scope of stability, particularly if the prior art discloses similar stabilizing agents or formulation strategies.

Many other US patents cited by US12123035B2 (e.g., US9447401B2, US10865400B2, US11041149B2) share the same title "PH20 polypeptide variants, formulations and uses thereof" and are identified within the patent text as continuations or divisionals of earlier applications in the same family, claiming priority to the same provisional applications. These are typically not considered prior art under 35 U.S.C. § 102 against claims to which US12123035B2 properly claims priority, as they represent different stages or claims within the same invention family. They are cited primarily to establish the chain of priority.