Prior art

To identify the most relevant prior art for US patent 12371685, I will search the USPTO database for the patent and examine its cited references. "Prior art" refers to any public information existing before the effective filing date of a patent application that could suggest the invention isn't new or is obvious.

As the provided patent text does not include the claims, a definitive anticipation analysis under 35 U.S.C. § 102 for each claim cannot be performed. However, I can provide a description of the cited prior art and highlight potential areas of overlap based on the provided abstracts and descriptions of the cited patents and publications.

The USPTO Patent Public Search tool is the definitive resource for this task.

Based on the provided information within the patent text and the PTAB challenge details for PGR2025-00087 (which challenged claims 1-20 of US 12,371,685), the following prior art references were cited or mentioned as grounds for challenge:

1. U.S. Patent No. 9,447,401 (Connor)

• Full Citation: US 9,447,401 B2.
• Publication/Filing Date: Issued on September 20, 2016. It claims benefit of priority to U.S. Provisional Application Nos. 61/631,313 (filed December 30, 2011) and 61/796,208 (filed November 1, 2012).
• Brief Description: This patent describes modified PH20 hyaluronidase polypeptides that exhibit increased stability and/or activity, as well as related compositions, formulations, and uses thereof. It particularly focuses on PH20 polypeptides with amino acid replacements that confer increased resistance to protein denaturing conditions. The patent provides exemplary C-terminal truncated variants of full-length human PH20.
• Potential Anticipation (35 U.S.C. § 102): Given the shared title, inventors, assignee, and similar abstract language regarding "modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity", US 9,447,401 B2 is highly relevant. It appears to be a direct predecessor or closely related patent from the same intellectual property family, claiming priority from earlier provisional applications. Depending on the specific claims of US 12,371,685, particularly those related to the general concept of modified PH20 polypeptides with increased stability/activity, and especially if any claims relate to modifications at positions disclosed in US 9,447,401 B2, it could potentially anticipate some claims. The PTAB petition PGR2025-00087 specifically cited US 9,447,401 as prior art against US 12,371,685.

2. U.S. Patent Application Publication No. 2018/0118830 (Wei)

• Full Citation: US 2018/0118830 A1.
• Publication/Filing Date: Not explicitly provided in the snippets, but the PTAB details indicate it was cited as prior art.
• Brief Description: No direct description found in the provided text.
• Potential Anticipation (35 U.S.C. § 102): Without the abstract or description for this specific publication, a detailed analysis is difficult. However, its citation in the PGR suggests it likely pertains to PH20 polypeptide variants or related technologies. Given that "Wei" is also an inventor on US 12,371,685, it is probable that this publication is part of the same patent family or covers very similar subject matter.

3. U.S. Patent No. 10,865,400 (Wei, Shepard, Zhao, Connor)

• Full Citation: US 10,865,400 B2.
• Publication/Filing Date: Issued on December 15, 2020. It is a continuation of U.S. application Ser. No. 15/226,489, filed on August 2, 2016.
• Brief Description: This patent describes "Modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity, are provided. Also provided are compositions and formulations and uses thereof." It specifically mentions "amino acid replacement(s) in a PH20 polypeptide that contains the sequence of amino acid residues as set forth in any of SEQ ID NOs: 3, 7, 10, 12, 14, 24, 32-66, 69, 72, 857, 859, 861, 870 or a sequence of amino acids that is at least 80%, 85%... identical to any of SEQ ID NOs: 3, 7, 10, 12, 14, 24, 32-66, 69, 72, 857, 859, 861, or 870."
• Potential Anticipation (35 U.S.C. § 102): This patent shares the same inventors and a nearly identical abstract with US 12,371,685. It is explicitly mentioned as a continuation in the family history of the parent application leading to US 12,371,685, making it a highly relevant prior art. It could potentially anticipate claims in US 12,371,685 if those claims cover PH20 variants or modifications already disclosed in US 10,865,400 B2.

4. U.S. Patent No. 11,041,149 (Wei, Shepard, Zhao, Connor)

• Full Citation: US 11,041,149 B2.
• Publication/Filing Date: Issued on June 22, 2021. It is a continuation of U.S. application Ser. No. 16/824,572, filed March 19, 2020.
• Brief Description: The patent is titled "PH20 POLYPEPTIDE VARIANTS, FORMULATIONS AND USES THEREOF." The abstract states: "Modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity, are provided. Also provided are compositions and formulations and uses thereof."
• Potential Anticipation (35 U.S.C. § 102): Similar to US 10,865,400, this patent shares the same inventors and a very similar abstract, indicating a close relationship within the same patent family. It is also mentioned as a continuation in the family history. Therefore, it is a highly relevant prior art and could potentially anticipate claims in US 12,371,685 that disclose PH20 variants or modifications previously covered.

5. Publication by Arming et al. (1997) Eur. J. Biochem., 247:810-814

• Full Citation: Arming et al. (1997) "In vitro mutagenesis of PH-20 hyaluronidase from human sperm." Eur. J. Biochem., 247:810-814.
• Publication/Filing Date: August 1, 1997.
• Brief Description: This publication describes in vitro mutagenesis of PH-20 hyaluronidase from human sperm. The authors mutated five positions, changing three acidic amino acids and two arginine residues conserved in mammalian PH-20 polypeptides. They found that mutants like [Gln113]PH-20, [Gln249]PH-20, and [Thr252]PH-20 had no detectable enzymatic activity, while [Asn111]PH-20 had about 3% activity, and [Gly176]PH-20 had only about 1% activity. This work suggested that acidic amino acids are part of the active site and arginine residues are essential for substrate binding.
• Potential Anticipation (35 U.S.C. § 102): This publication is significant as it predates the priority date of US 12,371,685 and directly discusses PH20 hyaluronidase mutagenesis and the impact of specific amino acid changes on enzymatic activity. If any claims in US 12,371,685 describe modifications at the positions studied by Arming et al. (e.g., D111, E113, R176, E249, R252) or claim the resulting polypeptides with residual or no activity, it could anticipate those claims. The patent itself references this publication when discussing amino acid mutations D111N, E113Q, R176G, E249N, and R252T, and their effect on enzymatic activity.

The PTAB challenge for PGR2025-00087 against US 12,371,685 specifically included grounds of anticipation and obviousness under 35 U.S.C. §§ 102 and 103, citing these references. This reinforces their relevance as prior art.