Extensions

To provide a detailed analysis of US Patent 12031894, I will use the information available from the patent text and recent search results.

US Patent 12031894: Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles

• Publication Number: US12031894B2
• Filing Date: 2023-11-20
• Publication Date (Issue Date): 2024-07-09
• Original Assignee: Genzyme Corp.

Continuation Applications, Divisional Applications, and Related Family Members:

The patent text explicitly states that US12031894 is a continuation of several earlier applications, forming a family:

• Continuation of: U.S. patent application Ser. No. 18/188,176, filed March 22, 2023.
• Which is a continuation of: U.S. patent application Ser. No. 16/547,144 (now U.S. Pat. No. 11,639,887), filed August 21, 2019.
• Which is a continuation of: U.S. patent application Ser. No. 15/544,498 (now U.S. Pat. No. 10,429,288), which adopts the international filing date of January 19, 2016.
• Which is a National Phase application under 35 U.S.C. § 371 of: International Application No. PCT/US2016/013947, filed January 19, 2016.
• Which claims priority to: U.S. Provisional Application No. 62/105,714, filed January 20, 2015.

This chain of applications indicates that US12031894 is part of a larger patent family, with its earliest priority date stemming from the U.S. Provisional Application No. 62/105,714 filed on January 20, 2015.

Patent Term Adjustments (PTA):

Patent Term Adjustment (PTA) extends the term of a U.S. patent to compensate for delays by the USPTO during prosecution. The general term for a U.S. utility patent is 20 years from its effective filing date, which for continuing applications is the earliest non-provisional filing date in the priority chain. Since US12031894 is a utility patent, it is eligible for PTA. However, the exact amount of PTA is determined by a complex calculation that accounts for specific delays in the prosecution of the application and any applicant-caused delays. Without direct access to the official USPTO patent record for US12031894 detailing the prosecution history and any PTA calculation, the specific amount of PTA cannot be definitively stated.

Patent Term Extensions (PTE):

Patent Term Extension (PTE) is available for certain patents covering products that undergo regulatory review, such as human drugs, biologics, and medical devices, to compensate for time lost during the approval process. The patent describes methods for characterizing recombinant viral particles, which are relevant to gene therapy products. Given that some claims relate to evaluating processes for the production of recombinant viral particles used in gene therapy, it is possible that this patent could be eligible for PTE if a product covered by the patent requires regulatory approval. For instance, recent news indicates that this patent is associated with gene therapy products like Elevidys®. However, an actual PTE can only be determined after regulatory approval has been granted and the appropriate application for extension has been filed with the USPTO and FDA. No information is currently available to confirm if a PTE has been applied for or granted for US12031894.

Projected Expiration Date:

The anticipated expiration date listed on the Google Patents page for US12031894B2 is 2036-01-19. This date is consistent with a 20-year term from the earliest non-provisional filing date of January 19, 2016 (from International Application No. PCT/US2016/013947, which is the national phase entry for the earliest priority claim, excluding the provisional application filing date) [cite: Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2015-01-20]. The basic patent term for a U.S. utility patent is 20 years from the earliest non-provisional filing date. Therefore, 20 years from January 19, 2016, would be January 19, 2036. This projected expiration date would then be adjusted by any awarded PTA or PTE. Without the specific PTA value, the 2036-01-19 date is the most accurate available estimate.