US 12221638

Here's a concise summary of US Patent 12221638:

Title: Method for producing recombinant hyaluronidase
Assignee: Alteogen Inc.
Inventors: Soon Jae Park, Kyuwan KIM, Sang Hoon YUN, Jeong Soo CHO, Kibum PARK, Minsoo Byun, Hyung-Nam Song, Ji-Sun KIM, Ki Seok NAM
Filing Date: 2021-08-06
Issue Date: 2025-02-11
Abstract: The patent discloses a method for producing hyaluronidase or a variant thereof. This method involves culturing host cells under specific conditions, including controlling the glucose concentration in the culture medium and decreasing the culture temperature for a defined period. These conditions are designed to alter N-glycan levels, resulting in a recombinant hyaluronidase with increased specific activity (by 10% or more) and improved quality and production yield.

Independent Claims Overview:

• Claim 1 (Method Claim): This claim describes a two-step method for producing hyaluronidase PH20 or a variant.

  1. Step (1): Host cells (which express the hyaluronidase) are initially cultured at a temperature between 35° C. and 38° C. until they reach a certain "integral viable cell density" (IVCD) of 20×10⁶ to 120×10⁶ cells×day/mL.
  2. Step (2): The culture temperature is then lowered to a range of 28° C. to 34° C., and the cells are cultured for an additional 2 to 18 days. During this second step, at least one of two conditions must be maintained:
     • (a): The concentration of residual glucose in the culture medium is kept between 0.001 g/L and 4.5 g/L throughout the culture period.
     • (b): The pH of the culture medium is maintained between 6.8 and 7.2.

• Claim 11 (Product-by-Process Claim): This claim covers a hyaluronidase PH20 or a variant thereof that is produced specifically by the method of Claim 1. A key characteristic of this product is that the sialylation content of its N-glycan is between 1% and 38%.

• Claim 13 (Product Claim): This claim covers a hyaluronidase PH20 or a variant thereof, defined directly by its N-glycan characteristic: it must have a sialylation content in its N-glycan of 1% to 38%. This claim does not limit the product to a specific production method.

Litigation/Docket Information:
The patent family for US12221638 is currently involved in litigation. A PTAB (Patent Trial and Appeal Board) case, IPR2026-00176, has been filed and is pending. Additionally, a global patent litigation dataset by Darts-ip indicates that the family has litigation filed. No direct CAFC 2026 dockets were found, but the IPR proceeding is a relevant legal challenge.

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Note: The numerical values for IVCD, temperature ranges, glucose concentration, pH, and glycan percentages in the claims are stated with a potential 10% error range, as noted in the patent description, due to variations in experimental conditions and measurement.

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Citations:
US12221638B2, Method for producing recombinant hyaluronidase.
https://portal.unifiedpatents.com/ptab/case/IPR2026-00176