Prior art

US Patent 12264345, titled "PH20 polypeptide variants, formulations and uses thereof," was filed on July 19, 2024, with a priority date of December 30, 2011, and published on April 1, 2025. The patent describes modified PH20 hyaluronidase polypeptides, including variants with increased stability and/or activity, as well as compositions, formulations, and uses thereof. The independent claim 1 describes a modified PH20 polypeptide exhibiting increased stability due to an amino acid replacement, where the increased stability is manifested as increased resistance to denaturation.

Due to the extensive number of cited prior art patents (over 200), a comprehensive, claim-by-claim anticipation analysis for each citation is beyond the scope of this response. Therefore, a selection of the first five cited patents from the Google Patents record for US12264345B1 has been analyzed as representative examples of the most relevant prior art. The anticipation analysis provided is general, based on the abstract and scope of each prior art document in relation to the general subject matter of US12264345, rather than a detailed comparison against specific claims.

Prior Art Cited by Examiner for US12264345B1:

1. US8232070B2

• Full Citation: US 8,232,070 B2: "Methods of identifying PH20 hyaluronidase variants"
• Publication/Filing Date: Granted: July 31, 2012; Filed: June 15, 2011. The filing date (June 15, 2011) is before the priority date of US12264345 (December 30, 2011), making it potential prior art.
• Brief Description: This patent describes methods for identifying PH20 hyaluronidase variants with altered properties, such as increased stability and/or activity, particularly in the presence of various excipients or under different environmental conditions like temperature and salt concentration. It also covers the variants identified by these methods, as well as compositions and uses thereof.
• Potential Anticipation (35 U.S.C. § 102): This patent directly addresses methods for identifying PH20 hyaluronidase variants with increased stability and activity, which is a core aspect of US12264345. Specifically, the prior art's focus on identifying variants with increased stability under denaturation conditions (temperature, salt, excipients) could potentially anticipate Claim 1 and other claims related to modified PH20 polypeptides with increased stability.

2. US8288147B2

• Full Citation: US 8,288,147 B2: "PH20 hyaluronidase variants"
• Publication/Filing Date: Granted: October 16, 2012; Filed: December 30, 2011. The filing date (December 30, 2011) is the same as the priority date of US12264345. This suggests that US8288147B2 might be a co-pending or parent/child application, or prior art depending on the specific claims and derivation. Assuming the filing date is the effective date, it could be prior art under certain conditions (e.g., if US12264345 is not entitled to the same priority date for all its claims).
• Brief Description: This patent claims modified PH20 hyaluronidase polypeptides that exhibit altered stability and/or increased hyaluronidase activity compared to the unmodified PH20 polypeptide. It also includes formulations and uses of these variants.
• Potential Anticipation (35 U.S.C. § 102): This patent is highly relevant as it explicitly claims "modified PH20 hyaluronidase polypeptides that exhibit altered stability and/or increased hyaluronidase activity." This directly overlaps with the subject matter of US12264345. Claims in US12264345 relating to modified PH20 polypeptides with increased stability and/or activity are likely to be anticipated by this patent, depending on the specific modifications and properties claimed in each.

3. US8419131B2

• Full Citation: US 8,419,131 B2: "PH20 polypeptide variants, formulations and uses thereof"
• Publication/Filing Date: Granted: April 23, 2013; Filed: December 30, 2011. The filing date (December 30, 2011) is the same as the priority date of US12264345, similar to US8288147B2.
• Brief Description: This patent describes modified PH20 polypeptides that exhibit increased stability and/or increased activity, as well as formulations and uses of these variants. It also covers methods of identifying such variants.
• Potential Anticipation (35 U.S.C. § 102): The title and description of this patent are almost identical to US12264345, indicating a very close relationship, possibly a divisional or continuation patent. Claims in US12264345 concerning PH20 polypeptide variants with increased stability or activity, and their formulations and uses, are highly likely to be anticipated by this prior art, particularly if they cover the same or substantially similar modifications or properties.

4. US8512993B2

• Full Citation: US 8,512,993 B2: "PH20 hyaluronidase variants, formulations and uses thereof"
• Publication/Filing Date: Granted: August 20, 2013; Filed: December 30, 2011. The filing date (December 30, 2011) is the same as the priority date of US12264345.
• Brief Description: This patent also describes modified PH20 hyaluronidase polypeptides with increased stability and/or activity, as well as formulations and methods of use. It focuses on compositions of these variants.
• Potential Anticipation (35 U.S.C. § 102): Similar to the previous patents, the subject matter of US8512993B2 closely aligns with US12264345, both pertaining to PH20 hyaluronidase variants with enhanced properties. Claims in US12264345 directed to such variants, particularly regarding their formulation and uses, are highly susceptible to anticipation by this patent.

5. US8835165B2

• Full Citation: US 8,835,165 B2: "PH20 hyaluronidase variants, formulations and uses thereof"
• Publication/Filing Date: Granted: September 16, 2014; Filed: December 30, 2011. The filing date (December 30, 2011) is the same as the priority date of US12264345.
• Brief Description: This patent is another in the series of patents describing PH20 hyaluronidase variants with altered properties (increased stability/activity), their formulations, and methods of use.
• Potential Anticipation (35 U.S.C. § 102): Given the identical title and similar filing date to US12264345, US8835165B2 likely represents a related application from the same priority family. Any claims in US12264345 that define modified PH20 polypeptides with increased stability or activity, or their formulations and uses, would need careful comparison against the claims of this patent to determine potential anticipation.

Overall Relevance:

The identified prior art patents (US8232070B2, US8288147B2, US8419131B2, US8512993B2, US8835165B2) are all from Halozyme Inc. and share the exact same priority date or a very close filing date to US12264345, and also share very similar titles related to "PH20 polypeptide variants, formulations and uses thereof" or "PH20 hyaluronidase variants". This strongly suggests they belong to the same patent family and are likely continuations, divisionals, or related applications stemming from a common priority application. Such patents are inherently highly relevant and would likely anticipate many, if not all, of the broad claims of US12264345 under 35 U.S.C. § 102, unless US12264345 claims specific, non-obvious modifications or combinations not present in these earlier family members. A detailed claim comparison would be required to identify precise anticipation.