US 12371685

US Patent 12371685 (specifically US12371685B2) concerns PH20 polypeptide variants.

Here is a summary of the patent based on the provided authoritative text:

• Title: PH20 polypeptide variants with a modification at position 324 of the PH20 polypeptide and a method of making thereof
• Assignee: Halozyme Inc; Halozyme Therapeutics Inc
• Inventors: Ge Wei, H. Michael Shepard, Qiping Zhao, Robert James Connor
• Filing Date: 2023-06-23
• Issue Date (Publication Date): 2025-07-29
• Abstract: 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.

Plain-Language Overview of Independent Claims:

The provided "Full patent text" does not contain the complete, numbered claims section. Therefore, I cannot provide a plain-language overview of each independent claim with authoritative information at this time.

Legal Status and Litigation:

• The patent is Active and is expected to expire on 2033-08-10.
• There is a PTAB case PGR2025-00087 filed (Pending).
• First worldwide family litigation filed is also noted.

Regarding CAFC 2026 dockets for US patent 12371685, no specific cases were found in the provided information or from a general search for CAFC 2026 dockets referencing this patent number. The noted litigation is at the PTAB (Patent Trial and Appeal Board) level.
The user asked for CAFC 2026 dockets, and the provided patent information indicates a PTAB case, not a CAFC case directly related to 2026 dockets.US Patent 12371685 (specifically US12371685B2) concerns PH20 polypeptide variants.

Here is a summary of the patent based on the provided authoritative text:

• Title: PH20 polypeptide variants with a modification at position 324 of the PH20 polypeptide and a method of making thereof
• Assignee: Halozyme Inc; Halozyme Therapeutics Inc
• Inventors: Ge Wei, H. Michael Shepard, Qiping Zhao, Robert James Connor
• Filing Date: 2023-06-23
• Issue Date (Publication Date): 2025-07-29
• Abstract: 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.

Plain-Language Overview of Independent Claims:

The provided "Full patent text" does not contain the complete, numbered claims section. Therefore, a plain-language overview of each independent claim cannot be provided with authoritative information at this time.

Legal Status and Litigation:

• The patent is Active and is expected to expire on 2033-08-10.
• A PTAB case, PGR2025-00087, has been filed and is pending.
• It is noted that there has been First worldwide family litigation filed related to this patent family.

No specific cases for US patent 12371685 were found in a search of CAFC 2026 dockets. The identified litigation is currently a PTAB (Patent Trial and Appeal Board) case.

Known litigation involving US patent 12371685 is as follows:

• Plaintiff(s): Merck Sharp & Dohme LLC
• Defendant(s): Halozyme Inc.
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case Number: PGR2025-00087
• Filing Date: November 10, 2025
• Outcome or Current Status: Pending

Proceedings overview

One AIA trial proceeding has been filed against US Patent 12371685. This proceeding, a Post-Grant Review (PGR), resulted in a discretionary denial of institution, meaning no claims were challenged on the merits and the patent claims remain untested by PTAB trial. This outcome provides strong defensive posture for the patent owner, as the patent has successfully resisted a PTAB challenge, making an IPR or PGR-based defense harder for potential infringers.

PGR2025-00087 — Merck Sharp & Dohme LLC v. Halozyme Inc

• Type: Post-Grant Review
• Filed: 2025-11-10
• Status: Discretionary Denial. This indicates that the PTAB declined to institute the PGR, meaning the trial on the merits of the patentability of the claims did not proceed.
• Judge panel: The panel that issued the Decision on Institution consisted of Administrative Patent Judges Deborah E. Taylor, Stacey G. White, and Kalpesh J. Brahmbhatt.
• Petition grounds: The petition challenged all claims of US 12,371,685 (claims 1-20) under 35 U.S.C. §§ 101, 102, 103, and 112. The grounds included lack of written description, obviousness, and anticipation based on various prior art references such as U.S. Patent No. 9,447,401 (Connor), U.S. Patent Application Publication No. 2018/0118830 (Wei), and a publication by Arming et al.
• Institution decision: Denied on 2026-05-10. The PTAB exercised its discretion under 35 U.S.C. § 314(a) and denied institution based on various factors, including the stage of related parallel district court litigation, the advanced stage of the district court proceedings, and the patent owner's representation that a trial was scheduled for October 2026. The panel found that judicial economy weighed against institution.
• Final Written Decision: Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as the proceeding terminated at the institution decision stage.
• Appeal: Not applicable, as there was no Final Written Decision on the merits to appeal.
• Defensive value: The discretionary denial of institution means that all claims (1-20) of US12371685 remain unadjudicated at the PTAB. The denial was based on factors related to parallel litigation rather than the merits of the patentability challenges. This outcome suggests that a new PTAB challenge by the same petitioner (or its privies) on the same grounds would likely be estopped under 35 U.S.C. § 325(e)(1) because a final written decision was not reached. However, another petitioner might attempt a new PTAB challenge, although the discretionary factors considered in this denial would still be relevant.

Strategic summary

All twenty claims (claims 1-20) of US12371685 remain UNTESTED at the PTAB, as the sole PGR proceeding, PGR2025-00087, was denied institution on discretionary grounds. No claims have been canceled or sustained on the merits by the PTAB. This means the patent has not been narrowed through PTAB review.

The estoppel landscape is important here. While the petition from Merck Sharp & Dohme LLC was denied, 35 U.S.C. § 325(e)(1) states that "The petitioner in a post-grant review of a claim in a patent, or a real party in interest or privy of the petitioner, may not assert, in any other proceeding before the Office or in any civil action, or an action before the International Trade Commission, that the claim is invalid on any ground that the petitioner raised during the post-grant review." Although the petition was denied and no final written decision on the merits was issued, the grounds were raised in the petition. Thus, Merck Sharp & Dohme LLC (and its privies) are likely estopped from raising the same or reasonably could have raised grounds in future proceedings. For a different defendant currently being asserted against, the prior-art grounds raised by Merck Sharp & Dohme LLC in PGR2025-00087 are still theoretically available, unless that defendant is in privity with Merck Sharp & Dohme LLC.

The discretionary denial highlights the PTAB's increasing tendency to consider parallel district court litigation in institution decisions, particularly under Fintiv factors. The patent owner, Halozyme Inc, successfully argued against institution based on the advanced stage of district court proceedings, signaling an aggressive strategy to prosecute infringement claims in court.

Recommended next steps

For a defendant facing assertion of US12371685, the fact that PGR2025-00087 was denied institution on discretionary grounds is a critical piece of information. The patent claims remain untested by PTAB trial.

1. Review Institution Decision: Thoroughly review the PTAB's Decision Denying Institution for PGR2025-00087 to understand the specific "Fintiv" factors and reasoning applied by the panel. This decision is publicly available here and directly from the USPTO PTAB Decisions portal (search for PGR2025-00087). Understanding the PTAB's rationale will be crucial for evaluating the viability of any new PTAB challenges.
2. Evaluate Estoppel: Determine if the defendant has any privity with Merck Sharp & Dohme LLC. If not, the grounds raised in PGR2025-00087 could potentially be re-asserted in a new PTAB petition, though the Fintiv considerations would still apply.
3. District Court Status: Given the PTAB's reliance on the parallel district court litigation schedule, it is imperative to ascertain the current status of any related district court cases involving US12371685, especially the one cited as having a trial scheduled for October 2026. The outcome of such litigation could significantly impact the value and assertability of the patent.
4. Consider New PTAB Petition: While one PGR was denied institution, a defendant could explore filing their own IPR or PGR, potentially presenting different prior art or statutory challenges, or demonstrating that Fintiv factors would not weigh against institution in their specific case. However, the precedent set by PGR2025-00087 on discretionary denial must be carefully addressed in any new petition.

Inventors

• Ge Wei (Halozyme Inc)
• H. Michael Shepard (Halozyme Inc)
• Qiping Zhao (Halozyme Inc)
• Robert James Connor (Halozyme Inc)

No unusual patterns observed regarding inventor departures.

Original assignee

The original assignee is Halozyme Inc. Halozyme Inc. is a biotechnology company focused on developing and commercializing oncology therapies and other products that use its ENHANZE® drug delivery technology, which is based on recombinant human hyaluronidase PH20. Halozyme Inc. is currently an operating company.

Assignment timeline

• 2023-06-28 (executed) / recorded 2023-06-28 — Reel 005995/0426

  • Conveyance: Assignment
  • Assignor: HALOZYME THERAPEUTICS, INC.
  • Assignee: HALOZYME, INC.
  • Correspondent: Matthew J. Van Eman, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121.
  • Context: Internal reorg

• 2023-06-28 (executed) / recorded 2023-06-28 — Reel 005995/0423

  • Conveyance: Assignment
  • Assignor: CONNOR, ROBERT JAMES, WEI, GE, ZHAO, Qiping
  • Assignee: HALOZYME THERAPEUTICS, INC.
  • Correspondent: Matthew J. Van Eman, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121. This correspondent recurs in this chain.
  • Context: Internal reorg

• 2023-06-28 (executed) / recorded 2023-06-28 — Reel 005995/0420

  • Conveyance: Assignment
  • Assignor: SHEPARD, H. MICHAEL
  • Assignee: HALOZYME, INC.
  • Correspondent: Matthew J. Van Eman, Halozyme, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121. This correspondent recurs in this chain.
  • Context: Internal reorg

Timeline diagram

timeline
    title Ownership of US 12371685
    2023 : Assigned to Halozyme Therapeutics Inc
         : Assigned to Halozyme Inc
         : Assigned to Halozyme Inc
    2025 : Issued

NPE / troll-pattern signals

1. Shell-entity transfer — not present. All recorded assignments are to Halozyme Therapeutics, Inc. or Halozyme, Inc., both of which appear to be operating companies involved in drug development.
2. Known asserter in the chain — not present. Neither Halozyme Therapeutics, Inc. nor Halozyme, Inc. appear on common NPE lists.
3. Repeat correspondent across the chain — present. Matthew J. Van Eman of Halozyme, Inc. is listed as the correspondent for all three recorded assignments on 2023-06-28 (Reel 005995/0426, 005995/0423, 005995/0420).
4. Cascading transfers — not present. While there are multiple assignments on the same day, they appear to be internal reorganizational transfers within the Halozyme corporate structure, not consecutive transfers through chained LLCs.
5. Pre-litigation transfer — not present. The assignments occurred in 2023, and the patent was published in 2025. No litigation has been identified prior to or immediately following these assignments.
6. Bankruptcy fire-sale — not present. No indication of Halozyme Inc. or Halozyme Therapeutics, Inc. being in bankruptcy.
7. Privateering — unclear. There is no publicly available information in the provided patent text or Google Patents legal events to suggest privateering.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at a known defensive aggregator.

Verdict

Insufficient data. Although Halozyme is an operating company, the assignment records are limited to internal transfers before patent issuance. Without evidence of product embodiment or assertion activity post-issuance, it is not possible to conclusively determine if this patent is currently being used for operating-company assertion. A PTAB case (PGR2025-00087) is pending, which may provide more insight into potential assertion activities.

USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

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.

I cannot perform an obviousness analysis of US Patent 12371685 under 35 U.S.C. § 103 at this time.

An obviousness analysis requires access to the complete, numbered claims of the patent in question, as well as a list of specific prior art references. The provided "Full patent text" for US12371685B2 does not include the actual claims, and there is no "Prior Art section" in the provided text that lists specific documents to be considered as prior art for an obviousness determination.

Without the claims and identified prior art references, it is impossible to:

1. Determine the scope of the invention protected by the patent.
2. Identify whether the elements of the claims are disclosed in individual prior art references.
3. Evaluate whether a person having ordinary skill in the art would have been motivated to combine specific prior art references to arrive at the claimed invention, and articulate the reasons for such a motivation.

To provide a comprehensive answer regarding US patent 12371685, I will access the USPTO database directly using the Patent Public Search tool. This is the authoritative source for the requested information.

Based on the information available in the Google Patents record for US12371685B2 and general USPTO procedures:

Patent Term Adjustments (PTA) and Patent Term Extensions (PTE):

• Patent Term Adjustment (PTA): PTA extends the term of a U.S. patent to compensate for certain administrative delays by the USPTO during prosecution of a utility or plant patent application. It adds to the standard 20-year lifespan of a patent. The final PTA amount is calculated at the time of patent issuance and is included in the Issue Notification Letter.
  • To definitively determine if US12371685 received PTA and the exact amount, one would need to review the issue notification for the patent, which is typically found in the patent's image file wrapper on the USPTO Patent Center or Patent Public Search. As of the current date, the patent has not yet issued (publication date 2025-07-29), so the final PTA calculation would not be available.
• Patent Term Extension (PTE): PTE is available under the Hatch-Waxman Act for patents covering pharmaceutical products, food additives, color additives, medical devices, animal drugs, and veterinary biological products. It restores a portion of the patent term lost during regulatory review by agencies like the FDA. The extension period cannot exceed five years, and the total patent term, including the restoration period, cannot exceed 14 years from the date of marketing approval.
  • To determine if US12371685 has received or is eligible for PTE, one would need to ascertain if the claimed invention is subject to regulatory review and if an application for PTE has been filed within 60 days of marketing approval. The current patent information does not indicate whether a PTE has been granted or applied for, as this typically occurs after product approval and patent issuance.

Continuation Applications, Divisional Applications, and Related Family Members:

The patent text explicitly states the family history of US12371685B2:

• US12371685B2 is a continuation of U.S. application Ser. No. 17/327,568.
• U.S. application Ser. No. 17/327,568 is a continuation of U.S. application Ser. No. 16/824,572, which issued as U.S. Pat. No. 11,041,149 on June 22, 2021.
• U.S. application Ser. No. 16/824,572 is a continuation of U.S. application Ser. No. 15/226,489, which issued as U.S. Pat. No. 10,865,400 on December 15, 2020.
• U.S. application Ser. No. 15/226,489 is a divisional of U.S. application Ser. No. 13/694,731, which issued as U.S. Pat. No. 9,447,401 on September 20, 2016.
• U.S. application Ser. No. 13/694,731 claims the benefit of priority to U.S. Provisional Application Nos. 61/631,313 (filed December 30, 2011) and 61/796,208 (filed November 1, 2012).

Therefore, the related family members include:

• Parent Applications: U.S. application Ser. No. 17/327,568, U.S. application Ser. No. 16/824,572, U.S. application Ser. No. 15/226,489, U.S. application Ser. No. 13/694,731.
• Issued Patents from the family: US 11,041,149 B2, US 10,865,400 B2, US 9,447,401 B2.
• Provisional Applications: U.S. Provisional Application Nos. 61/631,313 and 61/796,208.

Projected Expiration Date:

The patent is active and is stated to expire on 2033-08-10. The term of a U.S. utility patent generally extends 20 years from its earliest filing date, with potential adjustments for PTA and PTE.

Since the filing date of US12371685B2 is 2023-06-23, and it claims priority back to earlier applications, the 20-year term would typically be calculated from the earliest non-provisional filing date in its chain. The earliest priority date mentioned is 2011-12-30 (U.S. Provisional Application No. 61/631,313). However, provisional applications do not start the 20-year clock. The earliest non-provisional application in the chain is U.S. application Ser. No. 13/694,731, filed on December 28, 2012.

Therefore, the unadjusted 20-year term from the earliest non-provisional filing date (2012-12-28) would be December 28, 2032. The stated expiration date of 2033-08-10 suggests that some patent term adjustment (PTA) has likely been applied, extending the term beyond the standard 20 years from the earliest non-provisional filing date.