Charles River Laboratories, Inc. v. Seikagaku Corporation

I'll research this case now, starting with the case number and patent.

Let me dig deeper into the parallel proceedings, the 2026 developments, and the underlying technology/market.

Case Overview and Background

Important framing note: Despite the "plaintiff/defendant" labels in the case metadata, IPR2025-00440 is not a district court infringement suit. It is an inter partes review before the Patent Trial and Appeal Board, and the Director's own July 10, 2025 decision in the related proceedings expressly states that "Patent Owner and Petitioner are not engaged in a parallel litigation." I found no district court complaint between these parties in the sources I could reach; if you are looking for one, it would need to be confirmed directly on PACER (I could not verify a docket). The "venue" question therefore resolves to the PTAB in Alexandria, Virginia, under 35 U.S.C. §§ 6, 314.

Parties and what each side does. The petitioner, Charles River Laboratories, Inc. (Wilmington, MA), is a large publicly traded contract research organization and life-science products company. Its Microbial Solutions / Endosafe business is a leading supplier of bacterial endotoxin testing — both traditional Limulus amebocyte lysate (LAL) reagents and animal-free recombinant Factor C (rFC) products (e.g., Endosafe-Trillium). The patent owner, Seikagaku Corporation (Tokyo), is an established Japanese pharmaceutical and fine-chemical manufacturer (hyaluronic acid products, orthopedic drugs) that is also a long-standing pioneer and supplier of horseshoe crab–derived LAL endotoxin reagents. So this is an operating-company-versus-operating-company dispute between a customer/competitor pair in the same narrow market — not an NPE/PAE assertion, and not a university case. Charles River's posture is defensive/offensive: it filed the petitions to clear patents covering rFC technology it commercializes itself.

The technology and the patents. The technology is the endotoxin test that regulators (FDA, USP, EP) require for injectable drugs and medical devices. Horseshoe crab (Limulus polyphemus) Factor C is the serine protease that initiates the clotting cascade when it binds bacterial endotoxin (LPS), and it is the active principle of the LAL test. Recombinant Factor C is the animal-free alternative, motivated by both the fragility of the wild horseshoe crab blood supply and animal-welfare pressure. The sole patent at issue in the IPR here is U.S. Patent 11,236,318 B2, "Recombinantly-Produced Factor C Proteins for Endotoxin Detection," issued February 1, 2022 — a composition claim covering recombinant Limulus polyphemus Factor C characterized by a functional "residual activity" in the presence of inhibitory ions. A parallel post-grant review, PGR2025-00023, challenges U.S. Patent 11,959,109 B2 (same Seikagaku rFC family; claims 1–10, with claim 10 apparently disclaimed by the inventors). Both were instituted the same day, September 9, 2025, and the IPR panel is APJs James A. Worth, Michael J. Fitzpatrick, and Tawen Chang. Petitioner's counsel is Wolf, Greenfield & Sacks (Scott McKeown, Flora Luo, Chelsea Loughran); Seikagaku's is Morgan, Lewis & Bockius (Alexander Stein, Christopher Betti, Dion Bregman, and others).

Procedural posture and why it matters. Only claim 21 is challenged, on two obviousness grounds: (1) Mizumura (US 2015/0307864 — which is the publication of the '318 patent's own priority application) in view of Seikagaku's own PCT publication WO 2018/074498; and (2) Mizumura in view of the 2017 McClymont Ph.D. thesis. Petitioner's pivotal technical contention is a priority/§ 112 attack: that the '318 claim is not entitled to its December 2013 priority date for lack of written description and enablement, which would make Mizumura prior art against it. Seikagaku's preliminary response (Paper 6, June 11, 2025) sought discretionary denial; that request was referred to and decided by Acting Director Coke Morgan Stewart on July 10, 2025 — a notable data point because it is one of the early exercises of the Director's discretionary-denial referral process, and the Director denied denial, emphasizing the absence of parallel litigation and the "early" timing of the challenge. The case has also generated discovery warfare: Seikagaku moved to compel routine discovery regarding European Patent Office oppositions it alleges Charles River was secretly behind (EPO oppositions involving EP 3,441,466 and EP 3,530,670), the Director initially declined to authorize that motion (July 2/8, 2025), and the Board granted-in-part Seikagaku's routine-discovery motion on September 30, 2025. Separately, Seikagaku filed a motion for additional discovery under 37 C.F.R. § 42.51(b)(2)(i) on November 14, 2025.

Why the case is notable. Three things. First, market and industry impact: this is a fight over the IP estate surrounding animal-free endotoxin testing, a market with direct supply-chain and animal-welfare significance as USP and pharmacopoeias move toward recombinant reagents. Second, IPR/PGR linkage and competitor strategy: Charles River simultaneously attacked two sibling Seikagaku patents through coordinated IPR and PGR petitions that the Director's office processed together — a textbook example of an operating company using AIA trials offensively to protect a product line it sells. Third, Director-level discretionary denial: the referral decision is frequently cited in later briefing (other parties' filings cite "Charles River Labs., Paper 9" on the discretionary-denial calculus), making it a reference point for § 314(a)/§ 325(d) practice.

Sourcing caveat — a live discrepancy. The case summary you supplied lists the proceeding as pending, and the most detailed docket snapshot I could retrieve (IPVerse/GreyB) shows Board activity through December 1, 2025 with no final written decision listed. However, Law360 published a headline dated September 9, 2026 stating that "a divided Patent Trial and Appeal Board has thrown out claims in a pair of Seikagaku Corp. patents related to endotoxin detection that were challenged by Charles River Laboratories, finding they were either obvious or anticipated," and a low-quality aggregator blog repeats that framing. That date is exactly twelve months after institution in both IPR2025-00440 and PGR2025-00023, which fits the statutory FWD deadline. I could not open the actual final written decisions or the Law360 article text, so I am flagging this as a reported-but-unverified development rather than asserting it: if a divided FWD did issue on September 9, 2026 in both cases, the case status should be updated from "pending" to "final written decision issued," and Patent Owner has 63 days from entry to appeal to the Federal Circuit under 35 U.S.C. § 142. I did not find a Federal Circuit appeal docket, and I could not verify panel dissent details or which claim was found obvious versus anticipated.

I'll research the procedural timeline and current posture of this proceeding, focusing especially on whether a final written decision has now issued.

Key development confirmed via Law360. Let me dig for the specifics of the final written decisions, the dissent, and any appeal.

Preliminary framing (important)

You asked for the "key legal developments and outcome for this patent infringement litigation." There is no patent infringement litigation between these parties. IPR2025-00440 is an inter partes review before the PTAB, and the Director's own July 10, 2025 decision states expressly that "Patent Owner and Petitioner are not engaged in a parallel litigation." So the conventional litigation checklist (complaint, answer, counterclaims, Rule 12 motions, Markman, JMOL, verdict, fees) has no application — I will not manufacture district-court docket entries that do not exist. What follows maps your requested categories onto the AIA-trial equivalents, in chronological order, building on the case overview and counsel sections already generated.

Status update versus the supplied metadata. The metadata says "pending." That is now stale. Law360 published on 2026-09-09 that "a divided Patent Trial and Appeal Board has thrown out claims in a pair of Seikagaku Corp. patents related to endotoxin detection that were challenged by Charles River Laboratories, finding they were either obvious or anticipated" — exactly twelve months after institution. The correct present posture is final written decision issued; appeal window open/likely appeal. I could not open the FWD text itself (PTACTS artifacts were not retrievable for the FWD in my searches), and the IPVerse and Ex Parte case pages still render "Trial Instituted / FWD —," which is likely stale cached data. Treat the FWD specifics as reported-but-not-primary-verified.

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Chronological developments

1. Filing and initial pleadings-equivalent (2025-01-16)

• Petition filed 2025-01-16 against U.S. Patent 11,236,318 B2 (issued 2022-02-01), challenging only claim 21, on two obviousness grounds:
  • Ground 1: Mizumura (US 2015/0307864, the publication of the '318 patent's own priority application) in view of Seikagaku's WO 2018/074498 ('498 PCT).
  • Ground 2: Mizumura in view of McClymont (2017 Univ. of Glasgow Ph.D. thesis).
• Petitioner's factual theory was that Mizumura taught recombinant Factor C production in HEK293 cells with the claimed "residual activity," but from Tachypleus tridentatus; the '498 PCT (or McClymont) supplied the Limulus polyphemus sequence. Petitioner's expert was Dr. Siddhartha Jain (Ex. 1002/1003).
• Parallel PGR2025-00023 (filed 2025-01-15/16) attacks the sibling U.S. Patent 11,959,109 B2. The two proceedings are captioned together and were handled jointly by the Director's office.
• Patent Owner's Preliminary Response (Paper 6, 2025-06-11), seeking discretionary denial under §§ 314(a)/325(d).

2. The pivotal pre-institution motion — Director discretionary-denial referral (2025-06-11 → 2025-07-10)

• This is the case's marquee procedural event and its rough analogue to a motion to dismiss/transfer. Seikagaku moved for discretionary denial; that request was referred to and decided by Acting Director Coke Morgan Stewart.
• Director's Decision (2025-07-10): denial denied. Reasoning: (i) "Patent Owner and Petitioner are not engaged in a parallel litigation"; (ii) petition filed early in the patent's life (patent issued 2022-02-01; petition filed 2025-01-16), and "[e]arly challenges favor robust, predictable patent rights"; (iii) § 325(d) denial not appropriate. The Director referred the petitions back to the Board and barred rehearing/Director Review until institution.
• Significance: this is an early exercise of the Interim Processes for PTAB Workload Management referral process, and it is now cited by other parties — e.g., a third-party filing cites "Charles River Labs., Paper 9, at 2" for the discretionary-denial calculus. The same decision also rejected the "settled expectations" framing of § 314(a).

3. Discovery warfare (July 2025 – November 2025)

Strategic discovery milestones, all in the routine-discovery/§ 42.51 lanes:

• 2025-07-02/07-08 — Seikagaku sought authorization to file a motion to compel routine discovery, arguing Charles River was secretly behind EPO oppositions to EP 3,441,466 and EP 3,530,670 and was taking positions contradicting its PTAB positions. The Director denied that request for discretionary purposes but left open renewal with the panel. (Board email: "Patent Owner's request to file a motion to compel discovery for discretionary considerations is denied.")
• 2025-08-01 — conference call; transcript filed 2025-08-04.
• 2025-08-15 — Petitioner's opposition to the motion to compel routine discovery.
• 2025-09-30 — Order granting-in-part Patent Owner's motion for routine discovery (37 C.F.R. § 42.51) — a win for Seikagaku on the EPO-opposition inconsistency theory.
• 2025-11-14 — Patent Owner's motion for additional discovery under 37 C.F.R. § 42.51(b)(2)(i) — the "good cause" standard, typically narrow. (Related Board orders: Conduct of the Proceeding order 2025-11-13; General Order re Related Matters Updates 2025-09-20.)
• 2025-12-01 — last Paper of record on the docket snapshot I could retrieve (Patent Owner filing).

4. Institution (2025-09-09)

• Decision Granting Institution of Inter Partes Review, 35 U.S.C. § 314 (2025-09-09) — same day as institution in PGR2025-00023.
• Panel: APJs James A. Worth (lead), Michael J. Fitzpatrick, and Tawen Chang. A Panel Change Order issued 2025-11-04.
• Institution decisions are not appealable; the Board's institution analysis is not reviewable on appeal except in limited circumstances. This is the point at which the "case" became a live trial — the equivalent of surviving dispositive motions.

5. Claim construction

• There was no separate Markman/claim-construction proceeding in the district-court sense. In an IPR, claim construction is folded into the institution decision and the FWD under the Phillips framework. Petitioner's expert addressed a section titled "Claim Interpretation" (§ V.E.), and the disputed technical issue was not a claim term but the effective filing date. The claim-construction disputes are therefore effectively resolved (to whatever extent disputed) inside the 2026-09-09 FWD and the institution decision.

6. Trial-phase merits — the priority/§ 112 attack (the real battleground)

• Petitioner's central merits contention: claim 21 is not entitled to its December 2013 priority date because the priority application (US App. 14/650,767, filed 2015-06-09 from JP 2012-269840) lacks written-description and enablement support under § 112 for a Limulus polyphemus recombinant Factor C across the full claimed "residual activity" range — all examples concerned Tachypleus tridentatus, and the inventors allegedly admitted sequencing Limulus Factor C came years later.
• Consequence: if the priority claim fails, the effective date drops to 2019-04-30, making Mizumura, the '498 PCT, and McClymont § 102 prior art. This is what converts an otherwise-compliant patent into an invalid one.
• Patent Owner's response (per the record I could reach) relied on secondary considerations / unexpected results, addressed in two inventor declarations (Mizumura declarations of 2021-01-08 and 2021-08-11) — Petitioner's expert rebutted these as not showing unexpected results over the closest prior art. Seikagaku also relied on inventor testimony that a POSA would expect similar functional properties across horseshoe crab species once the sequence was known — which Petitioner turned against it on the expectation-of-success prong.

7. Final written decision (reported 2026-09-09)

• Reported outcome: a divided (i.e., non-unanimous) panel invalidated the challenged claims in both Seikagaku patents — "finding they were either obvious or anticipated." Coverage: Law360 (IP and Life Sciences desks), dated 2026-09-09; echoed by an aggregator blog.
• Timing fits the statute: 35 U.S.C. § 316(a)(11) requires the FWD within 12 months of institution (extendable up to 6 months for good cause). 2026-09-09 is exactly 12 months from institution.
• What I could not verify: the FWD paper number, which ground prevailed (obviousness vs. anticipation), the identity and reasoning of the dissenting judge(s), or whether claim 21 was canceled via Ground 1, Ground 2, or both. The Law360 abstract's "obvious or anticipated" phrasing suggests the IPR ground was obviousness and the PGR ground (on the '109 patent) may have been anticipation — but that is inference, not confirmed. Do not treat this paragraph as a substitute for the FWD text.

8. Final disposition / present posture

• No settlement, no dismissal, no district-court judgment. The case did not settle; there are no JMOL/new-trial/fee motions because there is no jury or district court.
• Appeal: Patent Owner has 63 days from entry of the FWD to appeal to the U.S. Court of Appeals for the Federal Circuit under 35 U.S.C. § 142 (37 C.F.R. § 90.3). Counting from 2026-09-09, that window runs to roughly 2026-11-11. I found no Federal Circuit appeal docket and no Rule 36 or merits disposition. Given the divided panel and the § 112 priority dispute, a Seikagaku appeal is a strong possibility, but I cannot confirm it has been filed. Note also that either party could seek Director Review of the FWD under Arthrex; the Director's July 2025 order barring rehearing/Director Review applied only "until the Board issues a decision on institution," so that bar has expired.
• Collateral estoppel: a final IPR decision canceling claim 21 becomes § 315(e)(1) estoppel against Petitioner in any later proceeding — and, more importantly, a canceled claim cannot be asserted against Charles River or anyone else.

9. Parallel PTAB proceedings and their effect

• Consolidation/joint handling: the two were captioned and processed together (joint Director referral decision; joint correspondence). Staffed by the same Wolf Greenfield team (McKeown/Luo/Loughran) and the same Morgan Lewis team (Stein/Betti, later Lo/Doukas/Patitucci, added 2025-11-03).
• Effect on any litigation: because there is no parallel district-court case (per the Director), the IPR/PGR did not produce a stay, an Fintiv denial, or an estoppel-driven dismissal anywhere. The proceedings' practical effect is market-facing: they knock out Seikagaku's rFC composition claims, which matters directly to Charles River's Endosafe/Trillium animal-free endotoxin franchise and to USP's move toward recombinant reagents.
• EPO front (non-PTAB, parallel in substance): Seikagaku's EPO oppositions involving EP 3,441,466 (decision on opposition 2022-10-26) and EP 3,530,670 (opposition filed 2024-11-22; response 2025-05-09) are the basis of the routine-discovery fight — Seikagaku alleges Charles River financed them. This is the closest thing to a "parallel litigation" in the file, and it lives in the EPO, not a U.S. district court.

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Bottom line

• This is not an infringement action. It is a PTAB IPR; there is no complaint, answer, counterclaim, Markman, verdict, JMOL, or fee motion.
• Procedural spine: petition 2025-01-16 → POPR 2025-06-11 → Director denied discretionary denial and referred to Board 2025-07-10 → discovery fight over alleged secret EPO oppositions (ruling granting-in-part 2025-09-30) → institution 2025-09-09 → additional-discovery motion 2025-11-14 → divided FWD 2026-09-09 invalidating claim 21 (and claims of the '109 patent in PGR2025-00023).
• Metadata correction: the case should no longer be listed as "pending" in the pre-FWD sense; the accurate current posture is "FWD issued 2026-09-09; appeal period running to ~2026-11-11."
• Caveats: the FWD's internal reasoning (which ground prevailed, the dissent) and any Federal Circuit appeal are unverified from primary sources in this pass; the two case-status trackers I retrieved still show pre-FWD status and appear stale. Verify against PTACTS docket entries and the Federal Circuit docket before relying on the FWD specifics.

I'll research the counsel of record for the petitioner (plaintiff) in this IPR. Let me start with several targeted searches.

Found the core petitioner-side representation. Let me verify details, get the full counsel list from the mandatory notices, and check firm bios.

Important framing note

This is not a district court patent infringement action — it is an inter partes review before the PTAB (IPR2025-00440, filed Jan. 16, 2025, instituted Sept. 9, 2025). There is therefore no PACER docket sheet and no "local counsel" in the Rule 83 sense; the "plaintiff" is the Petitioner, Charles River Laboratories, Inc., and its representatives are the attorneys designated in the Petitioner's Mandatory Notices under 37 C.F.R. § 42.8, served via the USPTO's PTAB systems (PTACTS / PTAB E2E), not PACER. My searches did not surface a companion district court complaint by Charles River against Seikagaku over the '318 patent (the parties are also litigating the related patent in PGR2025-00023), so no district-court local counsel can be identified. If a parallel district court case exists, I could not verify it and I will not guess.

Everything below is drawn from Petitioner's filings as posted on PTACTS and from Wolf Greenfield's own attorney pages.

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Counsel of record for Petitioner Charles River Laboratories, Inc.

1. Scott A. McKeown — Lead Counsel

• Firm / office: Wolf, Greenfield & Sacks, P.C. — Washington, DC office (admitted in VA & DC); the firm's Boston HQ address is used for PTAB service: 600 Atlantic Avenue, Boston, MA 02210.
• PTAB bar no.: Reg. No. 42,866. Service e-mail: SMcKeown-PTAB@wolfgreenfield.com.
• Relevant experience: One of the most active PTAB trial attorneys in the country — 400–500+ PTAB matters since 2012, a founding director of the PTAB Bar Association, Professorial Lecturer at GW Law, and author of the PatentsPostGrant.com blog. Notable: lead counsel for Inari Agriculture in its § 112 PGR win against a Corteva patented seed (Wolf Greenfield press release); named Managing IP "Outstanding PTAB Litigator" (2020) and repeatedly listed as an IAM Global Leader / Chambers-ranked post-grant practitioner.
• Source: https://wolfgreenfield.com/professionals/mckeown-scott ; https://chambers.com/lawyer/scott-mckeown-usa-5:27359747

2. Flora Luo, Ph.D. — Back-up Counsel

• Firm / office: Wolf, Greenfield & Sacks, P.C. — Boston, MA (Biotechnology practice group; associate).
• PTAB bar no.: Reg. No. 78,667. Service e-mail: FLuo-PTAB@wolfgreenfield.com.
• Relevant experience: Life-sciences practitioner with a PhD-level background (formerly a graduate researcher in Dr. Levi Garraway's lab at Dana-Farber); handles biotechnology patent prosecution and supports post-grant work. Named a Massachusetts Rising Star (2024–2025) and a 2024 LCLD Pathfinder. Her PTAB track record is comparatively short — she is a junior back-up on this file rather than a first-chair.
• Sources: https://wolfgreenfield.com/professionals/luo-flora ; https://www.patentbots.com/patentverse/practitioner/78667-Luo-Flora

3. Chelsea A. Loughran — Back-up Counsel / designated counsel of record (admitted pro hac vice)

• Firm / office: Wolf, Greenfield & Sacks, P.C. — Boston, MA (Shareholder, Litigation / Post-Grant Proceedings).
• Status: Not a registered patent attorney — she appears pro hac vice, and the Board granted her provisional recognition as a PTAB attorney (Petitioner filed a "Notice of Intent to Designate Chelsea A. Loughran, a Provisionally Recognized PTAB Attorney, as Back-up Counsel," referenced as Paper No. 18). Petitioner's Updated Mandatory Notices dated Nov. 21, 2025 formally added her as counsel of record. Service e-mail: CLoughran-PTAB@wolfgreenfield.com.
• Relevant experience: Trial attorney in biotech/pharma/medical-device patent and post-grant matters. Notable: lead trial counsel for Dyax Corp. (Takeda subsidiary) in its breach-of-contract/royalty dispute v. Ares Trading in D. Del. (won at trial, affirmed on appeal); counsel for Scale Biosciences in Scale Biosciences v. Parse Biosciences (D. Del.); represented The Jackson Laboratory in transgenic-mouse patent litigation (won summary judgment of non-infringement in 2010); substantial ITC experience (Sony/Fujifilm Inv. No. 1012; BTG antibody antivenom investigations).
• Sources: https://wolfgreenfield.com/professionals/loughran-chelsea-a ; https://www.courtlistener.com/docket/66638190/502/scale-biosciences-inc-v-parse-biosciences-inc/

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Context and caveats

• Service/notice details: All three were appointed via Petitioner's Power of Attorney (Paper No. 1) and USPTO Customer Number 23628. Service address: Wolf Greenfield & Sacks, P.C., 600 Atlantic Avenue, Boston, MA 02210; (617) 646-8000.
• Procedural history: Institution decision Sept. 9, 2025 (35 U.S.C. § 314); panel is APJs James A. Worth, Michael J. Fitzpatrick, and Tawen Chang. Claim 21 is challenged on obviousness (Mizumura + '498 PCT; Mizumura + McClymont), with a priority-date/§ 112 written-description attack on the Dec. 2013 priority claim.
• Parallel proceeding: The same Wolf Greenfield team (McKeown, Luo, Loughran) represents Charles River in the companion PGR2025-00023 against a related Seikagaku patent; correspondence in the record is captioned jointly to both proceedings.
• Opposing counsel (for contrast, not plaintiff-side): Seikagaku's Patent Owner counsel are Alexander B. Stein (Reg. No. 71,397; Morgan, Lewis & Bockius, Palo Alto) and Christopher J. Betti (Reg. No. 56,890; Morgan Lewis, Chicago), plus Shon Lo.
• What I could not verify: whether any additional Wolf Greenfield attorneys (e.g., litigators working on the parallel PGR) will be added to the mandatory notices; and whether any in-house Charles River counsel is named as a back-up. No such entries appear in the notices I located. No filings here appear to be sealed to the point of hiding counsel, but note that some exhibits and deposition transcripts in the record contain confidentiality redactions.

Bottom line: For IPR2025-00440, the petitioner-side team is Scott A. McKeown (lead), Flora Luo (back-up), and Chelsea A. Loughran (back-up / pro hac vice), all of Wolf, Greenfield & Sacks, P.C., with McKeown based in the firm's Washington, DC office and Luo and Loughran in Boston.

I'll research counsel of record for Seikagaku Corporation in this IPR proceeding. Let me search multiple sources.

Good initial data. Let me dig deeper into the mandatory notices, power of attorney, and attorney bios.

Excellent detail. Let me now verify the updated power of attorney (possible counsel changes) and gather bios on each attorney.

Counsel of Record — Patent Owner Seikagaku Corporation

Important framing: IPR2025-00440 is a PTAB inter partes review, not a district-court infringement suit. There is no "plaintiff/defendant" or "local counsel" in the district-court sense — the parties are Petitioner (Charles River Laboratories) and Patent Owner (Seikagaku). Seikagaku's side below is captioned exactly as it appears in the Board's filings, and all counsel are USPTO-registered practitioners (or admitted pro hac vice) appearing through Morgan, Lewis & Bockius LLP under Customer No. 24,341. A parallel post-grant review, PGR2025-00023 (U.S. Pat. 11,959,109), is handled by the same Morgan Lewis team.

Lead Counsel

Alexander B. Stein — Reg. No. 71,397 — Lead counsel

• Firm/location: Morgan, Lewis & Bockius LLP. The Power of Attorney lists him at 1400 Page Mill Rd, Palo Alto, CA 94304; his signature block and correspondence list 1301 Second Avenue, Suite 3000, Seattle, WA 98101 as his principal office. He appears in both.
• Note: Morgan Lewis partner; PTAB-focused litigator who (per his firm/IPWatchdog bio) has participated in more than 40 AIA proceedings across all phases, and publishes on PTAB discretionary-denial practice (e.g., From Stewart to Squires: The PTAB's First-Year Reset in IPRs and PGRs). He signed the Patent Owner's Power of Attorney (Feb. 5, 2025) and the original Mandatory Notices designating himself as lead.
• Sources: Patent Owner's Power of Attorney; Director Discretionary Decision, "For Patent Owner" block; IPWatchdog bio.

Back-Up Counsel (original designation, Feb. 5, 2025)

Christopher J. Betti — Reg. No. 56,890 — Back-up counsel

• Firm/location: Morgan, Lewis & Bockius LLP, 110 N. Wacker Dr, Chicago, IL 60606 (tel. 312.324.1000).
• Note: Named as back-up in the Feb. 5, 2025 Mandatory Notices and listed alongside Stein in the Board's "For Patent Owner" caption block. I could not independently verify a detailed public litigation résumé for him in the sources retrieved; treat his experience profile as unconfirmed.

Additional Back-Up Counsel (added Nov. 3, 2025)

Patent Owner's Updated Mandatory Notices (Nov. 3, 2025) added three more registered practitioners as additional back-up counsel, all associated with Morgan Lewis and authorized under the Power of Attorney:

Wan-Shon Lo — Reg. No. 71,076 — Back-up counsel (added Nov. 3, 2025)

• Firm/location: Morgan, Lewis & Bockius LLP, 110 N. Wacker Drive, Chicago, IL 60606 (shon.lo@morganlewis.com).
• Note: Appeared on the record at the expert depositions in the related IPR/PGR (introduced as Patent Owner's counsel). Her specific case history was not confirmed in the retrieved sources.

Maria E. Doukas — Reg. No. 67,084 — Back-up counsel (added Nov. 3, 2025)

• Firm/location: Morgan, Lewis & Bockius LLP (Chicago-based PTAB practice). Email maria.doukas@morganlewis.com.
• Note: A long-tenured PTAB practitioner in Morgan Lewis's Chicago IP group. I did not retrieve a source confirming specific prior decisions in this pass — flag as unverified.

Alison P. Patitucci — Reg. No. 75,370 — Back-up counsel (added Nov. 3, 2025)

• Firm/location: Morgan, Lewis & Bockius LLP. Email alison.patitucci@morganlewis.com.
• Note: Listed as additional back-up counsel; no independent litigation-history source confirmed in the retrieved material.

Service / correspondence address

All Patent Owner counsel share the e-service address Seikagaku-CR-IPR-PGR@morganlewis.com. Postal mail for lead and back-up counsel is directed to Morgan, Lewis & Bockius LLP, 110 N. Wacker Dr, Chicago, IL 60606.

In-house / party-side signatory

The Power of Attorney was executed on Seikagaku's behalf by Ken Mizutani (title partially cut off in the retrieved copy, dated Feb. 3, 2025). He is a company officer/signatory for Seikagaku Corporation, not a registered attorney of record — no Seikagaku in-house attorney has appeared as counsel in this docket to date.

Caveats and open items

• Updated Power of Attorney not verified. The docket shows a "Patent Owner's Updated Power of Attorney" filed Nov. 12, 2025 (and a Panel Change Order Nov. 4, 2025). I could not retrieve the text of the Nov. 12 updated POA, so it is possible the lead/back-up lineup was re-designated. The roster above reflects the Feb. 5, 2025 notices plus the Nov. 3, 2025 additions; treat the current lead-counsel designation as subject to confirmation against the Nov. 12 POA paper.
• No district-court counsel. Because this is a PTAB proceeding only, there is no separate local-counsel or litigation-firm roster; if there is parallel district-court litigation between these parties, it was not surfaced (the Director's referral decision expressly noted the parties "are not engaged in a parallel litigation").
• Bios limited. Only Alexander Stein's detailed background was confirmable from the sources retrieved. I have not fabricated experience summaries for Betti, Lo, Doukas, or Patitucci; their specific prior cases should be verified against Morgan Lewis attorney pages or PACER/PTAB docket histories.

Primary sources: Patent Owner's Power of Attorney and Mandatory Notices and Updated Mandatory Notices, via PTAB Center (PTACTS) case files for IPR2025-00440; docket listing at IP Verse.