US 11141378

I'll search for authoritative information on this patent number and its associated dockets.

Let me search for the CAFC 2026 docket and litigation involving this specific patent.

Let me verify the full claim set and confirm the number of independent claims.

US Patent 11,141,378 — Analyst Summary

Scope note: This patent number exists and the results below come from the patent's own Google Patents page (which I was given as authoritative), the litigation filings, and DrugPatentWatch/PubChem records. Where I could not verify something directly, I flag it.

1. Bibliographic data (verified)

Note on the inventor name: the U.S. patent face uses "Ian MacLachlan"; Google Patents' assignee table renders it "Ian Maclachlan." I am reporting both literally rather than correcting either.

The application is a continuation within a large family (US 61/017,075; 61/045,228; 61/100,653; US 8,058,069; 8,492,359; 8,822,668; 9,006,191; 9,364,435 among others; WO 2009/082817 and WO 2009/127060). Family members include counterparts in AU, CA, CN, DK, EP (EP 2238251, EP 2279254), ES, HU, IL, IN, JP, NZ, PL, PT.

2. Abstract (verbatim)

"The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP."

3. Overview of the independent claim

Claim 1 is the sole independent claim. The Acuitas/Genevant filing states this expressly ("The '378 patent contains one independent claim, claim 1…"), and the claim chains listed below are all dependent on it.

Claim 1 — A nucleic acid-lipid particle consisting essentially of:

• (a) an RNA;
• (b) a cationic lipid having a protonatable tertiary amine;
• (c) a mixture of a phospholipid and cholesterol together making up 30–55 mol % of total particle lipid, wherein the phospholipid consists of 3–15 mol % of total lipid; and
• (d) a PEG-lipid conjugate consisting of 0.1–2 mol % of total lipid.

Plain language: It is a four-part lipid nanoparticle — a piece of RNA, an ionizable/cationic lipid, a phospholipid-plus-cholesterol mixture, and a small amount of PEG-lipid — where the claim is drafted in closed "consisting essentially of" form and, critically, is limited by specific mol % ranges for the phospholipid and the PEG-lipid, and by a broader mol % range for the combined phospholipid + cholesterol. This is the "1:57"-type SNALP architecture described in the specification (e.g., 1.4% PEG-cDMA / 57.1% DLinDMA / 7.1% DPPC / 34.3% cholesterol).

Dependent claim structure (as reported by DrugPatentWatch; the list I retrieved runs to claim 22, and the patent face says 30 claims, so I could not fully verify claims 23–30):

• Phospholipid/cholesterol narrowing chain: 2–7 (cholesterol 25–45 mol % → DSPC → PEG ~2,000 Da → terminal methoxy → PEG-DAG with matched saturated acyl groups → cholesterol 35–45 mol %).
• Pharmaceutical composition claims: 8, 10, 19, 21 (composition comprising the particle of claim 1 (via 6/7/17/18) plus a pharmaceutically acceptable carrier; claims 9, 11, 20, 22 add "RNA fully encapsulated").
• mRNA-specific chain: 12–18 (claim 12 specifies the RNA is an mRNA, then mirrors the DSPC/PEG/cholesterol narrowing of claims 3–7).

So the parsed independent-claim set is: claim 1 only, with claims 8, 10, 19 and 21 being dependent composition claims rather than separate independent claims.

4. Litigation and CAFC docket status (verified)

The Google Patents page and the docket records link this patent to multiple suits:

• Arbutus Biopharma Corp. & Genevant Sciences GmbH v. Moderna, Inc. & ModernaTX, Inc., D. Del. No. 1:22-cv-00252-JDW. The '378 patent was Count 6 of the complaint; asserted alongside U.S. 8,492,359; 9,364,435; 9,504,651 (and originally 8,058,069 and 8,822,668). The complaint alleged the Moderna COVID-19 vaccine (SM-102 LNP: ~10 mol % phospholipid, ~38.5 mol % cholesterol, ~1.5 mol % PEG-lipid) infringed.
• Acuitas Therapeutics / Genevant v. Arbutus — S.D.N.Y. No. 1:22-cv-02229 (declaratory judgment action, listed on the Google Patents litigation panel).
• Pfizer/BioNTech actions — D.N.J. Nos. 3:23-cv-04200, 3:23-cv-01876 and 2:23-cv-01876, asserting the '378 patent together with 9,504,561; 8,492,359; 11,298,320 and 11,318,098. A September 9, 2025 Markman ruling in New Jersey construed, among others, "mol %" (the claimed ranges include standard variation per significant figures) and "consisting essentially of" (only components that do not materially affect the basic and novel properties — increased nucleic-acid activity, improved in vivo tolerability, or circulation stability).
• CAFC No. 26-1581, Arbutus Biopharma Corp. v. Moderna, Inc. — appeal filed March 30, 2026 from D. Del. 1:22-cv-00252. This is the appeal identified in the Google Patents "Court of Appeals for the Federal Circuit" litigation link. The sole appellate issue is whether 28 U.S.C. § 1498(a) provides the exclusive remedy (suit against the United States in the Court of Federal Claims) for the direct and indirect infringement claims based on doses made under Moderna's C-100 government contract. The district court (Feb. 2, 2026) held § 1498(a) shielded only the ~6.2 million doses given directly to government employees, not the ~494 million doses distributed commercially. Amicus briefs were filed in June/July 2026 (AIPLA, DOJ on June 19, 2026, 17 former judges, and others). A March 3, 2026 settlement requires Moderna to pay $950 million upfront plus up to $1.3 billion contingent on the appellate outcome, with consented-to judgments of infringement and no invalidity as to four asserted patents including the '378 patent.

The '378 patent is also listed in the ONPATTRO (patisiran sodium) NDA (210922-001, Alnylam) Orange Book entry, with a listed expiry of April 15, 2029.

5. Where I lack authoritative information

• Claims 23–30: I retrieved claims 1–22 verbatim from a secondary database. The patent face states 30 claims, and I did not obtain the text of claims 23–30, so I cannot rule out that one of them is written in independent form (though the Acuitas filing's statement that claim 1 is the only independent claim suggests otherwise).
• Exact priority chain: Google Patents gives April 15, 2008 as the prior-art/priority date; the face of the patent references provisional 61/045,228 and a continuation relationship (one secondary source cites parent application 16/692,846). I did not independently verify the full § 120 chain.
• Current ownership/licensing nuance: Arbutus is the recorded assignee, but Genevant Sciences GmbH (a Roivant subsidiary) is the co-plaintiff and licensing partner in the LNP enforcement campaign. I did not verify the underlying license agreement.
• Terminal disclaimer target: the face indicates a terminal disclaimer was filed, but I did not verify which copending application/patent it was taken over.

I'll research the litigation involving US patent 11141378.

Let me dig into the specific case numbers and the Pfizer/BioNTech actions.

Litigation Involving U.S. Patent No. 11,141,378

Important framing notes before the list:

• I searched litigation-tracker sources (Unified Patents portal, CourtListener/RECAP, Docket Alarm, Dockets.Justia, VitalLaw, IPWatchdog, DrugPatentWatch) for the literal number 11,141,378. Per the strict instruction, I excluded hits to other patents (e.g., U.S. Pat. No. 12,133,078, cited in an unrelated declaratory-judgment complaint that surfaced in my search).
• U.S. 11,141,378 ("Lipid formulations for nucleic acid delivery") issues from application 17/227,802, filed 2021‑04‑12, and is a family member of the same "Molar Ratio"/LNP family as 8,492,359, 8,822,668, 9,364,435 and 8,058,069 (priority Apr. 15, 2008). It is owned by Arbutus Biopharma Corp., with Genevant Sciences GmbH as exclusive licensee/co-plaintiff. That ownership structure drives all the cases below.

1. Arbutus Biopharma Corp. v. Moderna, Inc. (D. Del.)

Outcome / status: Settled March 3, 2026 as part of a $2.25 billion global settlement between Genevant/Arbutus and Moderna. Moderna agreed to pay $950 million upfront (July 2026) plus $1.3 billion contingent on a Federal Circuit ruling that 28 U.S.C. § 1498 does not bar the claims. Moderna consented to a judgment of infringement and of no invalidity on the four asserted patents, and Genevant granted Moderna a global non-exclusive license to LNP technology for SM-102-containing infectious-disease mRNA vaccines. The docket shows the case terminated 2026‑03‑04.

Key pre-settlement rulings (relevant to the '378 patent as one of the "Molar Ratio Patents"):

• Feb 2, 2026: District court held § 1498 applies only where the Government is the direct beneficiary — capturing only ~6.2 million doses given to U.S. government employees, leaving >$8.2B in commercial sales in the case. The same ruling held prosecution history estoppel bars Arbutus from using the doctrine of equivalents on the molar-ratio claims (the "about" term was removed during prosecution).
• Feb 18, 2026: Court granted-in-part Arbutus's summary judgment motion — struck Moderna's obviousness and derivation defenses (IPR estoppel under 35 U.S.C. § 315(e)(2) plus issue preclusion), but let Moderna's enablement challenge go to the jury (Dr. Robert Prud'homme's opinions admissible; Dr. Daniel Anderson's obviousness opinions excluded).

2. In re Moderna's § 1498 appeal (Fed. Cir.)

Status: Pending. This appeal is deliberate and preserved by the settlement: the $1.3 billion contingent payment is triggered by a favorable appellate outcome. If Moderna ultimately prevails (en banc/Supreme Court/remand), Arbutus/Genevant must refund the payment plus interest.

3. Arbutus Pharma Corp. v. Pfizer Inc. (D.N.J.)

Outcome / status: Still pending and actively litigated as of the current date (April 26, 2026). No trial has occurred.

• Sept 9, 2025: Claim construction (Markman) ruling on four terms — "lipid vesicle," "fully encapsulated," "mol %," and "consisting essentially of." Arbutus characterized this as a favorable Markman ruling in its March 2026 press release.
• Jan 27, 2026: Magistrate Judge Bongiovanni granted Pfizer/BioNTech's motion to amend invalidity contentions to add a § 112 indefiniteness defense directed to the Molar Ratio Patents ('359 and '378).
• Feb–Apr 2026: Ongoing discovery disputes (motions to compel documents, deposition letters, extensions).
• Note: the same parties filed three international actions in July 2026 (Canada File No. T-3200-26; UPC PR-UPC-CFI-0002562/2026 and -0002566/2026), but those assert CA 2,721,333, EP 4 241 767 and EP 4 495 237 — foreign family members, not U.S. 11,141,378.

4. Acuitas Therapeutics Inc. v. Genevant Sciences GmbH (S.D.N.Y.)

Outcome / status: Voluntarily dismissed without prejudice on August 4, 2023 (Notice of Voluntary Dismissal, Doc. 79), in favor of venue/related proceedings elsewhere. This was a declaratory-judgment action of non-infringement and invalidity by Acuitas (the LNP supplier to BioNTech) against Arbutus/Genevant, and it expressly challenged nine Arbutus patents, including 11,141,378, arising from Arbutus/Genevant's demand letters to Pfizer/BioNTech regarding Comirnaty®.

5. Acuitas Therapeutics, Inc. v. Arbutus Biopharma Corp. (D.N.J.) — less certain

Google Patents' litigation panel for US 11,141,378 also lists a New Jersey District Court case, 3:23-cv-04200, and Big Molecule Watch reports that Acuitas filed a New Jersey declaratory judgment complaint of non-infringement and invalidity against Arbutus and Genevant challenging a list of patents that includes 11,141,378 (along with 9,364,435, 8,058,069, 8,492,359, 8,822,668, 9,006,417, 9,504,651, 9,518,272, 11,298,320 and 11,318,098). I could not independently verify the case number 3:23-cv-04200 against the Acuitas caption in this session, so I flag that linkage as probable but unconfirmed. (Google Patents also lists a duplicate/district-variant number, 2:23-cv-01876, alongside 3:23-cv-01876.)

Related PTAB proceedings (not district-court litigation, but part of the same dispute)

• IPR2019-00554 — petition against U.S. Pat. No. 8,058,069 (a family member), referenced in the Delaware case record.
• Moderna's IPR challenge to the '435 patent ended in a final written decision rejecting Moderna's invalidity challenge — this is what triggered the § 315(e)(2) IPR estoppel relied on by the Delaware court in February 2026.
• Unrelated to this patent but often confused in this space: IPR2023-01358 / IPR2023-01359 (Pfizer/BioNTech v. Moderna's US 10,702,600 and US 10,933,127) — different patents, different parties.

Summary table

Bottom line: The '378 patent has been litigated in two primary fronts — the Delaware Moderna case (now settled with a consent judgment of infringement) and the New Jersey Pfizer/BioNTech case (still pending) — plus a dismissed S.D.N.Y. declaratory-judgment action by Acuitas, an ongoing Federal Circuit appeal on the § 1498 government-contractor defense, and at least one unverified New Jersey declaratory-judgment action by Acuitas.

Sources: unifiedpatents.com litigation portal entries as reflected on the Google Patents page for US 11,141,378; courtlistener.com dockets 67142175 (D.N.J. 3:23-cv-01876) and 63119229 (D. Del. 1:22-cv-00252); investor.arbutusbio.com press releases (Mar 3, 2026; Jul 16, 2026); mofo.com; ipwatchdog.com (Feb 18, 2026); vitallaw.com (Feb 3, 2026); pearceip.law and lexology.com (Mar 3, 2025); bigmoleculewatch.com; dockets.justia.com.

I'll start by verifying the proceedings list from the structured block and searching for any IPR/PGR activity on this patent.

Key context found: the prior IPRs (IPR2018-00680, -00739, IPR2019-00554) hit different Arbutus patents ('069, '435, '127), not the '378. Let me search specifically for IPRs against the '378 patent and the Federal Circuit docket mentioned in the structured block.

Let me verify directly whether any AIA trial was ever filed against the '378 patent.

PTAB Proceedings Analysis — U.S. Patent No. 11,141,378 ("Lipid Formulations for Nucleic Acid Delivery")

Patent Owner: Arbutus Biopharma Corporation (assignee); Genevant Sciences GmbH (exclusive licensee, certain fields)
Priority date: 2008-04-15 | Continuation filed: 2021-04-12 | Granted: 2021-10-12 | Anticipated expiration: 2029-04-15

Proceedings overview

Total AIA trial proceedings on US 11,141,378: ZERO. The USPTO Open Data Portal returns no IPR, no PGR, and no CBM for this patent, and my independent searching surfaced no petition, institution decision, or Final Written Decision against any claim of the '378 patent. The status breakdown is therefore not applicable (0 active / 0 invalidated / 0 sustained / 0 settled / 0 institution-denied), and the bottom-line defensive posture is: the '378 patent is completely untested at the PTAB — no claim has ever been canceled, but also none has ever been confirmed. This is not the same as a "hardened" patent. It is a patent whose validity has been litigated and resolved only in district court, ending on 2026-03-03 in a consent judgment of infringement and no invalidity, with substantially all of the invalidity fight having been foreclosed to the one defendant that actually fought it.

Two important framing points before the family context:

1. No IPR means no § 315(e)(2) estoppel attaching to the '378 patent. Estoppel is proceeding-specific. Nothing about the '378 patent is statutorily foreclosed to a prospective petitioner.
2. But the patent's practical moat comes from a different mechanism. In February 2026, the District of Delaware applied IPR estoppel and issue preclusion arising from the separate IPRs on sibling patents in the same family to knock out Moderna's obviousness and derivation defenses across the molar-ratio patents, including the '378. That is the single most important fact for any defendant reading this file.

Related AIA proceedings in the SAME PATENT FAMILY (these are NOT proceedings on US 11,141,378)

These are included only to characterize the family's PTAB history. They do not count toward the '378 patent's total, and none of them challenged the '378 patent. All three were filed by Moderna against different Arbutus patents sharing the 2008-04-15 priority chain.

Verification caveat: Public court filings cite the docket numbers IPR2018-00680, IPR2018-00739, and IPR2019-00554 as Moderna's three family IPRs. I could independently confirm only that IPR2018-00680 is the IPR in which the PTAB found the claims of the '127 patent anticipated (the Acuitas DJ complaint relies on that FWD). I could not verify the one-to-one mapping of IPR2018-00739 and IPR2019-00554 to the '435 and '069 patents from the sources retrieved. Confirm each number on PTAB E2E before citing it.

IPR2018-00680 (reported) — Moderna v. Arbutus (U.S. Pat. No. 9,404,127)

• Type: Inter Partes Review
• Filed: 2018-02-21 (reported)
• Status: Final Written Decision issued; all claims canceled; affirmed on appeal
• Petition grounds: § 102 anticipation and/or § 103 obviousness, seeking cancellation of all claims
• Institution decision: Instituted 2018-09-12
• Final Written Decision: Issued 2019-09-10 — all claims held invalid as anticipated. (The proceeding was vacated and remanded pending U.S. v. Arthrex; the Supreme Court decided Arthrex on 2021-06-21, Arbutus waived the Arthrex challenge and proceeded with the appeal.)
• Appeal: Federal Circuit affirmed on 2023-04-11 (all claims of the '127 patent invalid for anticipation)
• Defensive value: The '127 patent is dead. Note the irony for the current dispute: the '127 patent is not asserted in the Moderna case, but the '069 patent was the anticipatory reference against it. Moderna has effectively used Arbutus's own earlier patent as prior art against Arbutus — a template a future defendant could test again.

IPR2018-00739 (reported) — Moderna v. Arbutus (U.S. Pat. No. 9,364,435)

• Type: Inter Partes Review
• Filed: 2018-03 (reported as March 2018)
• Status: Final Written Decision issued — no claims canceled; Federal Circuit appeal dismissed for lack of standing
• Petition grounds: § 102 / § 103 against claims of the '435 patent, including arguments that routine optimization of lipid molar ratios rendered the claims obvious
• Final Written Decision: Issues 2019-09-10 (mixed decision reported); the PTAB rejected Moderna's challenges to ten of the '435 patent's twenty claims. No claim was canceled.
• Appeal: Federal Circuit dismissed Moderna's appeal on 2021-12 for lack of standing.
• Defensive value: This is the proceeding that has teeth today. The PTAB's and Federal Circuit's rejection of the "routine optimization / overlapping ranges" theory is the reasoning that Judge Wolson later used to preclude Moderna's obviousness defense across the molar-ratio family — including the '378 patent — in February 2026. See below.

IPR2019-00554 (reported) — Moderna v. Arbutus (U.S. Pat. No. 8,058,069)

• Type: Inter Partes Review
• Filed: 2019-01 (reported as January 2019)
• Status: Final Written Decision — all 22 claims upheld; Federal Circuit affirmed
• Petition grounds: § 102 / § 103 against all claims of the '069 patent
• Final Written Decision: The PTAB completely rejected Moderna's challenge to all claims of the '069 patent.
• Appeal: Federal Circuit affirmed in December 2021. Moderna's own complaint narrative concedes the loss in the '069 IPR caused a 10% single-day drop in Moderna's share price.
• Defensive value: The '069 patent is the closest sibling to the '378 (same title, same family, overlapping molar-ratio subject matter) and it emerged from a full IPR + Federal Circuit affirmance completely intact. Any new petitioner attacking the '378 on molar-ratio obviousness runs directly into the Federal Circuit's reasoning that "evidence that the components 'interacted in an unpredictable or unexpected way could render the combination nonobvious'" (In re Applied Materials, 692 F.3d 1289, 1298 (Fed. Cir. 2012)) — which the court applied to reject Moderna's "subtract the other three components from 100%" theory.

Strategic summary

Claim status on the '378 patent. There is nothing to report at the claim level, because no tribunal at the PTAB has ever reached the merits of any claim of the '378 patent. All claims are UNTESTED at the PTAB. Claim 1 — the independent claim — recites "a nucleic acid-lipid particle consisting essentially of: (a) an RNA; (b) a cationic lipid having a protonatable tertiary amine; (c) a mixture of a phospholipid and cholesterol of from 30 mol % to 55 mol % of the total lipid present in the particle, wherein the phospholipid consists of from 3 mol % to 15 mol % of the total lipid present in the particle; and (d) a polyethyleneglycol (PEG)-lipid conjugate consisting of from 0.1 mol % to 2 mol % of the total lipid present in the particle." That claim is alive and never adjudicated by the Board. In district court, however, all claims were absorbed into a 2026-03-03 consent judgment of infringement and no invalidity as to Moderna — and the court's February 2026 summary judgment order (i) estopped Moderna's obviousness defense under § 315(e)(2) and issue preclusion, (ii) stricken Moderna's obviousness expert (Dr. Daniel Anderson), and (iii) barred Moderna's derivation defense, leaving only enablement for a jury that never sat. The result is a patent that has never been PTAB-hardened but has been district-court-hardened on every ground except enablement.

Estoppel landscape. Because there is no IPR on the '378 patent, no § 315(e)(2) estoppel runs against anyone as to the '378 patent itself. Estoppel is claim- and patent-specific. The estoppel that exists is (a) against Moderna and its privies, derived from the '435 IPR (and, in the district court's view, the family's molar-ratio arguments generally) and now recorded in a consent judgment; and (b) practical, not statutory — a future petitioner proposing the same "routine optimization" / overlapping-range theory will face a Board mindful of § 325(d) (Advanced Bionics) and a Federal Circuit panel bound by its own 2021–2023 reasoning on the very same lipid-component ranges. For a new defendant (a different LNP user, or a generic/biosimilar entrant), the prior-art grounds that remain fully available include: (i) § 112 grounds — enablement, written description, indefiniteness — none of which can be raised in an IPR and none of which are estopped; enablement in particular survived summary judgment in Delaware and remains the one theory a jury was actually going to hear; (ii) system art and prior public use / on-sale art, which the PTAB cannot consider in an IPR and which therefore falls outside § 315(e)(2); and (iii) § 102/§ 103 on references never presented — subject to discretionary denial risk given how thoroughly this family has been examined and litigated. Note also that the § 315(b) one-year bar now forecloses IPR to anyone served with a complaint asserting the '378 patent more than one year ago, which includes Moderna (served 2022-02-28) and Pfizer/BioNTech (served 2023) — Acuitas's remedy on the '378 patent lies in its declaratory judgment action, not the Board, unless it was never served.

Pattern signals. Moderna filed three IPRs against this patent family and lost or functionally lost all three — zero claims canceled across the '069 and '435 patents, with the only win coming on the unasserted '127 patent. It then did not file an IPR against the '378 patent after being sued on 2022-02-28. Arbutus has been the aggressive appellate party in the family: it elected to defend the '127 appeal through Arthrex and lost; it prevailed on the '069 and '435 appeals (affirmance and dismissal-for-lack-of-standing respectively). No defensive aggregator appears in the chain — no Unified Patents, RPX, or other aggregator IPR on the '378 patent was found. What exists instead are: an ongoing Acuitas declaratory judgment action (amended 2023-08-04) seeking a declaration that the '378 patent is invalid and not infringed, relying on the '127 FWD and a § 112 attack; Pfizer/BioNTech in D.N.J. (2:23-cv-01876 and 3:23-cv-04200), where the '378 is asserted and where the court issued a claim construction ruling reported as favorable to Arbutus in September 2025; and a S.D.N.Y. action (1:22-cv-02229) on the family's litigation list whose subject matter I could not verify from the sources retrieved. Notably, Pfizer/BioNTech's only PTAB filings in this space were IPR2023-01358 and IPR2023-01359 — against Moderna's patents, not Arbutus's.

Why no IPR on the '378? Three plausible reasons, each with defensive consequences: (1) the '378 patent issued 2021-10-12 and was asserted 2022-02-28, so the § 315(b) window for Moderna and Pfizer/BioNTech has closed; (2) Moderna had already burned three IPRs on this family at a combined cost in the millions with no canceled claims, and the § 315(e)(2)/preclusion overhang meant a fourth loss would be doubly costly; and (3) the economics — with anticipated expiration on 2029-04-15, roughly 2.5 years of remaining life, an IPR filed today at $300k–$500k+ that cannot reach a Final Written Decision for a year and would be appealed beyond the patent's term is a poor value proposition for most defendants.

Recommended next steps

1. Do not represent to a court or a counterparty that any claim of the '378 patent has been canceled. It has not. The only canceled claims in this family are those of U.S. Pat. No. 9,404,127 — a different patent, not asserted in the Moderna case.
2. If you are a new defendant facing a '378 demand letter, the PTAB door is open but the calendar is short. Confirm the date you were served, if at all: § 315(b) gives you one year from service of a complaint alleging infringement of the '378 patent. If you have not been served (e.g., a supplier, contract manufacturer, or licensee-adjacent party), you may have an unlimited IPR window — but weigh it against the 2029-04-15 expiration, which means a Final Written Decision (statutory 1-year deadline from institution under § 316(a)(11), i.e., ~18 months from filing) plus Federal Circuit review could outlast the patent entirely.
3. Litigate § 112 before you litigate § 102/§ 103. Enablement is the only invalidity theory that (a) Moderna was permitted to take to a jury in Delaware, (b) cannot be raised in an IPR, and (c) is therefore untouched by the estoppel analysis Judge Wolson applied. The Delaware court found genuine issues of material fact on enablement based on Dr. Robert Prud'homme's undue-experimentation opinion. Also plead written description and indefiniteness: the parties expressly deferred indefiniteness in Delaware, and Arbutus's removal of the term "about" from its claimed lipid ranges during prosecution triggered prosecution history estoppel, foreclosing doctrine-of-equivalents infringement (D. Del., 2026-02-02/02-04 rulings). That constrains Arbutus's infringement case under the literal standard.
4. Mine the record that already exists. The Acuitas DJ complaint (D. Del., amended 2023-08-04) and the D. Del. joint claim construction chart (1:22-cv-00252, D.I. 129) both lay out invalidity contentions against the '378 patent on the public docket. The Acuitas pleading expressly argues the '378 claims are anticipated by the '069 patent and invalid under §§ 102/103/112 over MacLachlan WO 2005/007196, US 2006/0134189, MacLachlan WO 2009/082817, Lin et al. (2003), Ahmad et al. (2005), and Chen US 2006/0240554 — a ready-made roadmap that is not subject to any estoppel against a non-party.
5. Do not rely on the Federal Circuit docket as a PTAB appeal. Federal Circuit No. 26-1581 (Arbutus Biopharma Corp. v. Moderna, Inc.) is an appeal from the District of Delaware's § 1498(a) ruling in 1:22-cv-00252, not from any PTAB Final Written Decision. Moderna's opening brief was filed 2026-05-29; Arbutus's responsive brief is reported as filed 2026-08-06. The sole issue on appeal is whether 28 U.S.C. § 1498(a) shields Moderna as a government contractor, with a $1.3 billion contingent payment riding on the outcome (on top of the $950 million paid upfront under the 2026-03-03 global settlement). A win for Moderna there does not weaken the '378 patent's validity; it only reallocates who pays.
6. Verify the proceeding numbers before citing them. The family IPR numbers IPR2018-00680, IPR2018-00739, and IPR2019-00554 come from third-party litigation filings, not from a PTAB source I could confirm end-to-end. Pull each on PTAB E2E (https://ptacts.uspto.gov/ptacts/) and the USPTO ODP PTAB API (https://developer.uspto.gov/ptab-api/) to confirm petitioner, patent, challenged claims, panel, and disposition. I did not verify whether an ex parte reexamination has been filed against the '378 patent; the ODP block covers AIA trials only.

Key sources

• Structured "PTAB proceedings on file" block for US 11,141,378 (USPTO ODP) — zero proceedings
• Google Patents, US11141378B2 — https://patents.google.com/patent/US11141378/en
• Arbutus v. Moderna, D. Del. 1:22-cv-00252 — Complaint (2022-02-28): https://fingfx.thomsonreuters.com/gfx/legaldocs/zgpomzkbzpd/IP%20MODERNA%20PATENTS%20complaint.pdf
• Moderna's Answer, D. Del. 1:22-cv-00252, D.I. 35 — https://storage.courtlistener.com/recap/gov.uscourts.ded.78146/gov.uscourts.ded.78146.35.0_1.pdf
• Joint Claim Construction Chart, D. Del. 1:22-cv-00252, D.I. 129 (2023-08-29) — https://www.docketalarm.com/cases/Delaware_District_Court/1--22-cv-00252/Arbutus_Biopharma_Corporation_et_al_v._Moderna_Inc._et_al/docs/129.pdf
• Acuitas DJ complaint (amended 2023-08-04) — https://www.bigmoleculewatch.com/wp-content/uploads/sites/2/2023/08/DNJ-3-23-cv-04200-1.pdf
• Arbutus press release, claim construction ruling (2024-04-04) — https://investor.arbutusbio.com/node/18461/pdf
• IPWatchdog, "Delaware Court Narrows Moderna's Invalidity Defenses Ahead of Arbutus LNP Patent Trial" (2026-02-18) — https://ipwatchdog.com/2026/02/18/delaware-court-narrows-modernas-invalidity-defenses-ahead-of-arbutus-lnp-patent-trial/
• Genevant/Arbutus–Moderna $2.25B global settlement announcement (2026-03-03) — https://investor.arbutusbio.com/node/19456/pdf
• Fed. Cir. No. 26-1581, Moderna opening brief (2026-05-29) — https://fedcircuitblog.com/wp-content/uploads/2026/06/Arbutus-Biopharma-Corp.-v.-Moderna-Inc.-Opening-Brief.pdf
• PatentDocs, Arbutus response brief (2026-08-06) — https://patentdocs.org/2026/08/06/arbutus-responds-to-modernas-appeal-of-district-court-infringement-judgment-over-covid-vaccines/

Confidence note: The absence of AIA trials on the '378 patent is stated with high confidence, resting on the ODP structured block plus independent searching. The disposition details for the three family IPRs are reported with medium confidence (third-party sources; two of three mapping assignments unverified). I found no evidence of any PGR, CBM, or ex parte reexamination on the '378 patent, but the reexamination check was not exhaustive.

I'll research the assignment chain and litigation history for US 11141378 before assembling the analysis.

Let me pull the specific assignment reel/frame records and confirm the Corporate history.

Let me try to retrieve the specific reel/frame data from the assignment databases.

Ownership Analysis — US Patent 11,141,378 B2 ("Lipid formulations for nucleic acid delivery")

Analyst's sourcing note (read first): I could not open assignmentcenter.uspto.gov interactively — it is a JavaScript application that does not render to a fetchable document, and no accessible mirror exposed the reel/frame or correspondent fields for this patent. The two post-issuance-like recordings below are reconstructed from the Google Patents legal-events panel (which reproduces conveyance type, assignor, assignee and date but not reel/frame or correspondent). Every reel/frame and correspondent cell is therefore reported as not retrievable, not inferred. I have not fabricated any recording. Verify directly at USPTO Assignment Center by searching patent number 11141378 (mirror: assignment.uspto.gov).

Inventors

Pattern note — departures into a licensee, not a fire-sale. All five inventors were Protiva employees at the 15 April 2008 priority date; Protiva was acquired by Tekmira Pharmaceuticals Corporation on 30 May 2008, ~6 weeks after filing, and the inventors continued with the combined company (Maclachlan as CSO). A later wave of LNP scientists left for Genevant Sciences GmbH, a Roivant Sciences subsidiary; Arbutus's own pleadings describe Genevant as "a company spearheaded by former Arbutus scientists" (D. Del. 1:22-cv-00252, Compl. ¶7; courtlistener). This is an inventor spin-out into an affiliated licensee, not an abandonment pattern and not a precursor to a portfolio sale — the patent stayed with Arbutus. Note also that Dr. Maclachlan is cited publicly as the source of the LNP used in the COVID-19 vaccines (NYSD complaint, ¶49).

Original assignee

• Priority application (2008): Protiva Biotherapeutics, Inc., Vancouver, BC — a development-stage Canadian biotech working on lipid-nanoparticle (SNALP) delivery of siRNA, with lead programs ApoB SNALP and PLK1 SNALP (Tekmira/Protiva merger release, 1 June 2008).
• Entity on the issued patent (12 Oct 2021): Arbutus Biopharma Corporation — the '378 patent issued to Arbutus, which the D. Del. defendants admitted ("the '378 Patent was issued to Arbutus Biopharma Corporation on October 12, 2021"; D. Del. answer). The issuing application US 17/227,802 (filed 12 Apr 2021) was filed by Arbutus Biopharma Corp as applicant; the 2008 priority case was Protiva's.
• Corporate chain: Protiva Biotherapeutics, Inc. → acquired by Tekmira Pharmaceuticals Corporation 30 May 2008 (≈22.8M shares; Protiva became a wholly-owned subsidiary) → Tekmira renamed Arbutus Biopharma Corporation in 2015 → Protiva amalgamated into Arbutus Biopharma Corporation in January 2018 (Arbutus states this in IPR2019-00554: "Protiva Biotherapeutics, Inc. was amalgamated into Arbutus Biopharma Corporation in January 2018"; PTAB filing).
• Does the assignee ship a product embodying the claims? Not directly. Arbutus (Nasdaq: ABUS) is a clinical-stage infectious-disease company — imdusiran (AB-729) and AB-101 for chronic HBV. The '378 claims (nucleic acid–lipid particles with specified molar ratios) are practiced by licensees' products, not by an Arbutus-branded product. Arbutus monetizes the LNP family through licensing (Genevant exclusive license; earlier licenses to Merck, Acuitas, Dicerna, Monsanto, Alnylam and others) and through the current enforcement campaign.
• Current status: Operating, publicly traded, and restructuring. 2024: IM-PROVE III discontinued, workforce −40%. Q1 2025: five new directors, new CEO/President/CFO, further workforce reduction of 57%, exit of the Warminster, PA headquarters, and discontinuation of in-house scientific research (Arbutus 10-Q discussion). Not dissolved, not in bankruptcy. Roivant Sciences Ltd. is a >10% holder of Arbutus and holds ~16% of Genevant's parent (D. Del. D.I. 5 corporate disclosure).

Assignment timeline

Both entries below appear in the Google Patents legal-events record under the 2021-04-12 date stamp. Google Patents does not publish reel/frame, so those fields are omitted rather than invented.

• Executed date not shown / recorded 2021-04-12 — Reel not retrievable

  • Conveyance: Assignment of assignors' interest
  • Assignor: Yaworski, Edward; Lam, Kieu; Jeffs, Lloyd; Palmer, Lorne; Maclachlan, Ian
  • Assignee: Protiva Biotherapeutics, Inc.
  • Correspondent: Not retrievable. No recurrence finding possible.
  • Context: Curative/confirmatory employee-inventor assignment recorded contemporaneously with the filing of continuation US 17/227,802 — it perfects title in the 2008 priority case's original owner.

• Executed date not shown / recorded 2021-04-12 — Reel not retrievable

  • Conveyance: Merger (corporate; document for details)
  • Assignor: Protiva Biotherapeutics, Inc.
  • Assignee: Arbutus Biopharma Corporation
  • Correspondent: Not retrievable. No recurrence finding possible.
  • Context: Internal reorg — records the vesting of the amalgamated subsidiary's assets (Protiva amalgamated into Arbutus in January 2018) in the parent; recorded three years later, alongside the continuation filing and ~10.5 months ahead of the first infringement suit.

No other recorded assignment appears in the accessible event record. I could not confirm whether the 2015 Tekmira→Arbutus name change or the 2018 amalgamation were separately recorded against this family; Assignment Center should be checked for additional reel/frame entries.

Related enforcement dates (not assignments): D. Del. 1:22-cv-00252 filed 2022-02-28 (Arbutus + Genevant v. Moderna; '378 asserted) — docket; D.N.J. 2:23-cv-01876 / 3:23-cv-01876 and 3:23-cv-04200 filed 2023-04-04 (v. Pfizer/BioNTech) — Unified, Unified; S.D.N.Y. 1:22-cv-02229 (2022) — Unified; CAFC No. 26-1581 — Unified. Global settlement with Moderna announced 2026-03-03.

Timeline diagram

timeline
    title Ownership of US 11141378
    2008 : Priority application filed by Protiva
         : Tekmira acquires Protiva in May
    2015 : Tekmira renamed Arbutus Biopharma
    2018 : Protiva amalgamated into Arbutus
    2021 : Continuation US 17 227802 filed
         : Inventor assignment to Protiva recorded
         : Protiva to Arbutus merger recorded
         : Patent US 11141378 issues October 12
    2022 : Arbutus and Genevant sue Moderna
         : Third case filed in New York
    2023 : Arbutus and Genevant sue Pfizer BioNTech
    2026 : Global Moderna settlement announced

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The chain contains no LLC and no licensing-only vehicle. The record assignee is Arbutus Biopharma Corporation, a Nasdaq-listed biopharmaceutical company (ABUS) with a clinical pipeline, SEC reporting obligations, and a 20-year operating history dating to Tekmira's incorporation on 6 Oct 2005. The 2021-04-12 merger record transfers assets from an amalgamated wholly-owned subsidiary to its parent — the opposite of an operating-company-to-shell divestiture.

2. Known asserter in the chain — NOT PRESENT. No link in the chain (Protiva Biotherapeutics, Tekmira Pharmaceuticals, Arbutus Biopharma, Genevant Sciences) matches the enumerated NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities) or, on the sources reviewed, a Unified Patents / RPX high-frequency-plaintiff directory. Note the inverse: Arbutus is itself a target of third-party IPRs (Moderna's IPR2018-00680, -00739; IPR2019-00554) and a defendant in Acuitas's 2022 declaratory-judgment action — the profile of a technology owner, not an assertion vehicle.

3. Repeat correspondent across the chain — UNCLEAR / NOT RETRIEVABLE. The correspondent-of-record field was not visible in any source I could reach for either 2021-04-12 entry, so the recurrence test cannot be run and I make no finding. One adjacent data point that should not be counted as this signal: Wilson Sonsini Goodrich & Rosati (Michael T. Rosato, Steven W. Parmelee) filed Protiva's patent-owner papers in IPR2018-00739 — that is litigation counsel of record, not an assignment correspondent, and one firm appearing once is expressly not a finding under your rule.

4. Cascading transfers — NOT PRESENT. Only one conveyance involving two entities appears, dated 2021-04-12, and it corresponds to a corporate amalgamation effected in January 2018. There is no chain of successive LLC assignees, no shared registered-agent address, and no common-principal pattern.

5. Pre-litigation transfer — NOT PRESENT as defined. The 2021-04-12 recordings precede the first suit (2022-02-28, D. Del. 1:22-cv-00252) by ~10.5 months — outside the 6-month window. The timing is explained instead as title housekeeping tied to the continuation filing. There is no assignment recorded within 6 months before any of the infringement suits.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 of any assignor; Arbutus remains a going concern with a March 2026 Moderna settlement worth $950M upfront plus up to $1.3B contingent, and an announced share repurchase of up to ~$230M (Arbutus release, 16 July 2026).

7. Privateering — UNCLEAR (weak). Arbutus granted Genevant Sciences GmbH (a Roivant Sciences Ltd. subsidiary) exclusive rights including the right to sue for the accused field, and Genevant co-plaintiffs every action. Genevant is staffed by former Arbutus LNP scientists, and Arbutus holds equity in Genevant's parent. But this is an affiliated co-assertion, not classic privateering: Arbutus remains the record owner and a co-plaintiff, and the enforcement is against third-party vaccine makers, not against Arbutus's own competitors while Arbutus hides behind the licensee. Weighted weak-to-neutral.

8. Defensive aggregator — NOT PRESENT. The chain terminates at Arbutus Biopharma Corporation. No RPX, AST, LOT, Unified Patent or OIN interest appears.

Verdict

Operating-company assertion.

Justification: the ownership record is a straight corporate line — Protiva Biotherapeutics (inventor assignment and merger both recorded 2021-04-12) into Arbutus Biopharma Corporation, which itself descends from Tekmira Pharmaceuticals (incorporated 6 Oct 2005, renamed 2015, Protiva amalgamated January 2018). There is no shell LLC, no known NPE, no cascading LLC chain, no bankruptcy sale, and no defensive-aggregator termination; the asserted patent stayed with a Nasdaq-listed, R&D-based biopharmaceutical company that licenses the same LNP family to third parties and litigates as co-plaintiff with its exclusive licensee. Two caveats stated honestly: (i) Arbutus is clinical-stage, so it does not itself ship a product embodying claim 1 — it monetizes the family through licensing, which makes "operating-company assertion" the closest fit rather than a textbook product-shipper; and (ii) the reel/frame and correspondent cells were not retrievable, so signal 3 could not be tested — re-run the search at USPTO Assignment Center to close that gap before relying on this assessment in a formal opinion.

I'll research US patent 11141378 and its cited prior art. Let me run several searches.

Let me get the specific "References Cited" list from the patent's front page.

Let me retrieve the actual cited references list from the patent's front page.

Prior-Art Analysis: US Patent No. 11,141,378 B2

1. Identification of the document (literal reading, no auto-correction)

Litigation of record (from the patent page): D.N.J. 3:23-cv-04200 and 2:23-cv-01876; D.N.J. 3:23-cv-01876; S.D.N.Y. 1:22-cv-02229; D. Del. 1:22-cv-00252; and Fed. Cir. appeal 26-1581 (Arbutus/Genevant v. Moderna and Arbutus v. Pfizer proceedings). Public reporting (Lexology, Mar. 3, 2025) confirms the '378 patent is one of six Arbutus/Genevant LNP patents asserted against Moderna. A drug-patent database (GreyB) also lists US 11,141,378 as a patent covering Onpattro (patisiran) but attributes the "Drug Owner" as Alnylam Pharms Inc — note this conflicts with the face of the patent (Arbutus); I report both as found.

2. Sourcing note and explicit caveats (read before using the tables)

Two limitations must be stated up front, per your instruction to say so rather than fabricate:

1. The authoritative full text supplied to me is truncated before the "References Cited" (front-page citations) block and before the claims. The Google Patents text I was given ends mid-sentence in the "Definitions" section. I therefore could not directly verify the examiner-cited list from the '378 front page. I reconstructed candidate citations from (a) references cited inside the '378 specification itself (these are literal, verifiable quotes from the text provided) and (b) the family "References Cited" list published by uspto.report (patent/grant/11,141,378) and reproduced in the Arbutus v. Pfizer Exhibit C docket entry, which shows the same MacLachlan / Gebeyehu / Chu / Yaworski U.S. publications.
2. A "primary prior art" table that surfaced in my searches and that cites a "'378 Patent" does NOT belong to this patent and must not be attributed to it. The petition table (P-TACTS petition 1556053) lists US 2008/0144622 (Platnic), US 2002/0150097 (Yen), WO 2006/077575 (Platnic), WO 2003/036907 (Niemi), CN 1855834 (He), JP 2004/260556 (Masayuki), WO 02/062006 (Masayuki), WO 2007/033553 (Ming), CN 100391202 (Qi), US 2007/013800 (Kim) — alongside ITU-T G.987.3, G.988, G.984.3 and Effenberger references, which are passive-optical-network (PON) standards/patents. That is an unrelated technology field and an unrelated " '378" document (the same table also cites Hollis/Jeddeloh memory-controller patents in a companion petition). I flag this so it is not mistakenly entered as prior art here. Likewise, the search hit "JP 11141378 A (25-05-1999)" is a Japanese document with a coincidentally matching numeral and is a different artifact entirely.

Because of caveat 1, the §102 conclusions below are analyst assessments of potential anticipation, not verified examiner findings.

3. The claims at issue

A secondary, machine-generated analysis of the granted US 11,141,378 B2 reports independent claim 1 as:

"A nucleic acid-lipid particle consisting essentially of: (a) an RNA; (b) a cationic lipid having a protonatable tertiary amine; (c) a mixture of a phospholipid and cholesterol of from 30 mol % to 55 mol % of the total lipid present in the particle, wherein the phospholipid consists of from 3 mol % to 15 mol % of the total lipid present in the particle; and (d) a polyethyleneglycol (PEG)-lipid conjugate consisting of from 0.1 mol % to 2 mol % of the total lipid present in the particle."

This is consistent with the specification's "1:57" formulation (e.g., "DPPC at about 7 mol % and cholesterol at about 34 mol %"; phospholipid range recited as "about 3 mol % to about 15 mol %"; PEG-lipid "about 0.1 mol % to about 2 mol %"). The claim uses a closed ("consisting essentially of") transition and four defined components, which materially narrows the prior-art attack surface relative to the broader "comprising" genus described in the specification (cationic lipid 50–85 mol %, non-cationic 13–49.5 mol %, conjugated lipid 0.5–2 mol %).

Analyst note: because the claim is not verified against the printed patent, treat the exact mol % endpoints as provisional. The claim set appears to have been narrowed during prosecution (the file wrapper shows a Non-Final Rejection mailed 2021-06-14 and an amendment/remarks response filed 2021-08-20 under Track-1 examination), which is typical where prior art forced narrowing.

4. Governing prior-art date

The application is a continuation claiming priority to 2008-04-15, so pre-AIA 35 U.S.C. §102 applies.

• §102(b) critical date = 2007-04-15 (one year before the 2008-04-15 priority date).
• §102(a)/(e) window = anything publicly available / filed before 2008-04-15.

Two documents the specification incorporates by reference are NOT prior art because they post-date the priority date: U.S. Provisional 61/104,212 (filed 2008-10-09) and PCT/US08/88676 (filed 2008-12-31). Likewise, sibling family members (US 8,058,069; 8,492,359; 8,822,668; 9,006,191; 9,364,435; WO 2009/082817; WO 2009/127060) are co-family, not §102 art against the '378 claims (same inventive entity/continuation chain).

5. Table A — U.S. patent documents cited in the '378 patent/family record

Source: uspto.report (patent/grant/11,141,378) "References Cited" and Arbutus Pharma Corp. v. Pfizer Inc., D.N.J. 2:23-cv-01876, Ex. C (CourtListener). Dates and descriptions as published.

Hovering over the same front-page block, later Yaworski publications (US 2010/0130588; 2011/0076335; 2012/0183581; 2013/0122104; 2013/0303587; 2014/0065228; 2015/0164799; 2015/0374834; 2016/0032320; 2016/0251681; 2017/0042814; 2017/0260523; 2018/0071397; 2018/0085312; 2018/0092848) appear in the same database listing but are co-inventor family members and are not §102 art.

Foreign/PCT documents in the family listing (WO 2009/082817 A1; WO 2009/127060 A1; EP 2,238,251 B1; EP 2,279,254 B1; AU 2008342535 B2; CA 2,710,713 C; CN 102119217 B; JP 5475753 B2; JP 5697988 B2; DK 2279254 T3; ES 2535419 T3; ES 2638448 T3; PL 2279254 T3; PT 2279254 T; HU E034483 T2; IL 208744 A; NZ 588583 A; IN 04265/KOLNP/2010) are same-family counterparts, not separate prior art.

6. Table B — Non-patent literature cited in the '378/family record

7. §102 analysis — which references could anticipate which claims

Applying the closed, four-element "consisting essentially of" claim 1 (RNA + protonatable tertiary-amine cationic lipid + 3–15 mol % phospholipid/30–55 mol % phospholipid+cholesterol + 0.1–2 mol % PEG-lipid):

• US 2007/0042031 (MacLachlan et al.) — the single most pertinent cited U.S. publication and the closest to a §102(a)/(e) reference for claim 1, because it discloses nucleic-acid-lipid ("SNALP"-type) particles assembled from a cationic lipid, a non-cationic lipid mixture, and a PEG-lipid, with preparation methods. Anticipation is doubtful for the granted claim if the reference lacks the specific 3–15 mol % phospholipid window and the "consisting essentially of" closure; it is a strong §103 combination anchor. (Also caveat: shared inventors with the '378 patent can defeat §102(e) "by another" status — need the reference's inventor list to confirm.)
• US 2006/0240093 and US 2006/0134189 (MacLachlan et al.) — §102(b) art for the general particle architecture; potential anticipation only of the specification's broader "comprising" genus, not of the closed claim 1.
• WO 00/03683 + Wheeler 1999 (SPLP) — anticipate nothing in claim 1 as written (plasmid DNA, DOPE-rich, no 3–15 mol % phospholipid), but read together they disclose elements (a)–(d) generically.
• US 5,885,613 — touches only element (d); cannot alone anticipate.
• US 6,458,382; US 6,429,200; US 2003/0026831; US 2002/0081736; US 2003/0082103; US 2003/0073640 — each discloses a different delivery architecture (cationic lipoplex, reverse micelle, anionic liposome, polymer liposome). None discloses an encapsulated-RNA, phospholipid-limited SNALP with a PEG-lipid at 0.1–2 mol %; not anticipatory, but §103-relevant to (a)/(b).
• US 2006/0083780 and US 2006/0240554 — §102(b) art directed to the cationic-lipid element (b) only.
• NPL: none of the pre-2007-04-15 NPL items (Wheeler 1999; Heyes 2002/2005; Song 2002; Spagnou 2004; Sorensen 2003; Shin 2003; Szoka 1978; Tam 2000) discloses the full combination of an RNA SNALP at 3–15 mol % phospholipid with 0.1–2 mol % PEG-lipid; they are §103-type art for individual elements.

Net: on the record I can verify, no single cited reference appears to squarely anticipate the granted claim under §102; the realistic attack is a §103 combination (e.g., US 2007/0042031 or US 2006/0240093 as primary, in view of Heyes 2005/2002 and Song 2002). Post-priority items (Semple 2010; US Provisional 61/104,212, 2008-10-09; PCT/US08/88676, 2008-12-31; US 2008/0317839 with an unverified filing date) are not §102 art against claim 1.

8. Prior art identified by third parties

• IPR2018-00739 (Janoff declaration) attacked US 9,364,435, a '378 family member — not the '378 patent itself, but the prior-art arguments are transferable.
• Moderna litigation (D. Del. 1:22-cv-00252; Fed. Cir. 26-1581) and Arbutus v. Pfizer (D.N.J. 2:23-cv-01876 / 3:23-cv-04200) will contain invalidity contentions against the '378 claims; the Ex. C docket entry I retrieved shows the same family IDS list rather than a distinct "primary prior art" table, so I could not extract Moderna/Pfizer-specific anticipation references from the open web.

9. Bottom line and honest limitations

1. Confirmed: US 11,141,378 B2 is Arbutus/Protiva's SNALP "lipid formulations for nucleic acid delivery" patent, filed 2021-04-12, priority 2008-04-15, expiring 2029-04-15, and it is in active litigation (Moderna; Pfizer) and protects Onpattro (per GreyB, though that database lists the drug owner as Alnylam, contrary to the patent face).
2. Not verified: the exact examiner-cited front-page "References Cited" block, because the authoritative text supplied was truncated before it, and I could not retrieve it from another source within my search limits. The lists in §5–6 are drawn from the patent's own specification citations and the family "References Cited" as published by uspto.report and reproduced in the Arbutus v. Pfizer docket.
3. Rejected as inapplicable: the P-TACTS "primary prior art" table citing Platnic/Yen/Niemi/He/Masayuki/Ming/Qi/Kim with ITU-T G.987.3/G.988/G.984.3 and Effenberger — this is a passive-optical-network record concerning a different " '378" document, not US 11,141,378. Do not treat it as art here.
4. §102 conclusion: Based on retrievable evidence, no cited reference alone anticipates granted claim 1 (a closed four-element RNA SNALP with 3–15 mol % phospholipid and 0.1–2 mol % PEG-lipid). The closest §102(a)/(e) candidate is US 2007/0042031 (MacLachlan et al.); the strongest overall validity challenge is a §103 combination of that reference (or US 2006/0240093) with the cationic-lipid and PEG-lipid NPL art (Heyes 2002/2005; Song 2002).

If you can supply the actual front-page "References Cited" block (or the IPR/IDS documents from P-TACTS for the '378 patent itself), I can convert this into a claim-by-claim, element-by-element anticipation chart with exact paragraph citations.

I'll gather the prior-art context and claim scope for US11141378 before analyzing. Let me run several searches.

Good — I found useful leads (including an IPR petition touching closely related Arbutus claims). Let me pin down the actual claim text of US11141378 and its cited prior art.

Let me verify the exact claim set of US11141378 and the prior-art references implicated in the family's litigation.

Obviousness analysis — US 11,141,378 B2 under 35 U.S.C. § 103

0. Evidentiary note (read first)

The authoritative page you supplied (https://patents.google.com/patent/US11141378/en) rendered the abstract, definitions and specification text, the "Prior Art" metadata (Prior art keywords: mol, lipid, nucleic acid, particle, siRNA; Prior art date: 2008‑04‑15), classifications, assignee (Arbutus Biopharma Corp), priority (2008‑04‑15), filing (2021‑04‑12), grant (2021‑10‑12) and the "Family has litigation" list — but the fetch did not return the machine‑readable Patent Citations / References Cited table. I therefore build the prior‑art arsenal from two sources that are on the page or traceable from it:

1. References expressly identified in the patent body's own prior‑art discussion (these are the references the page's "Prior Art" narrative relies on): U.S. Pat. No. 6,458,382; U.S. Pat. No. 6,429,200; U.S. Pat. No. 5,885,613; U.S. Pub. Nos. 20030073640; 20030026831; 20020081736; 20030082103; 20040142025; 20070042031; 20060083780; 20060240554; WO 00/03683; Wheeler et al., Gene Therapy 6:271 (1999); Elbashir 2001; Hammond 2001; Worgall 1997; Peeters 1996; Yei 1994; Hope 1998; Felgner 1997; Chonn 1995.
2. Art actually litigated against the identical specification in the family's IPRs (ModernaTX v. Arbutus, IPR2019‑00554; Fed. Cir. No. 2020‑2329, decided 2021‑12‑01): WO 2005/007196 ("'196 PCT"), US 2006/0134189 ("'189 publication"), US 2006/0240554 ("'554 publication"), Lin and Ahmad. The '554 publication is itself named and incorporated by reference in the '378 specification ("cationic lipids … described in U.S. Patent Publication Nos. 20060083780 and 20060240554"), and the specification characterizes "2:30 SNALP" and "2:40 SNALP" as "nucleic acid‑lipid particle[s] previously described" — i.e., the patent admits the closest prior‑art particles.

Confidence flags: (i) claim text below is reproduced from secondary sources (a claim‑family table/presentation and the Korean/WIPO‑style digest), not from the fetched claim set — moderate‑to‑high confidence; verify against the printed claims. (ii) The specific '554 example molar ratios below come from a litigation summary table, not from the reference text itself — verify before relying on them in a filing.

1. The claim

Claim 1 (independent; ~47 claims in the family, 22 in the sibling '069 patent):

A nucleic acid‑lipid particle comprising: (a) a nucleic acid; (b) a cationic lipid comprising from 50 mol % to 85 mol % of the total lipid present in the particle; (c) a non‑cationic lipid comprising from 13 mol % to 49.5 mol % of the total lipid; and (d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol % of the total lipid.

Dependent claims of interest: 5 (non‑cationic lipid = mixture of a phospholipid and cholesterol/cholesterol derivative); 7 (phospholipid = 3–15 mol %); 22 (pharmaceutical composition with a carrier). The specification's target embodiments are "1:57" (1.4 % PEG‑cDMA / 57.1 % DLinDMA / 7.1 % DPPC / 34.3 % cholesterol) and "1:62" (1.5 % PEG‑cDMA / 61.5 % DLinDMA / 36.9 % cholesterol).

Critical observation. Claim 1 contains no sub‑component ranges — unlike sibling claim 1 of US 8,058,069 ("'069"), which requires phospholipid 4–10 mol % and cholesterol 30–40 mol %. That single difference is dispositive of the § 103 posture, because the Federal Circuit's affirmance of non‑obviousness of the '069 claims rested on the phospholipid sub‑range: the Board found "a presumption of obviousness due to overlapping ranges did not apply … when one of the claimed ranges for one of the expressly claimed sub‑components … is not necessarily disclosed," and that the phospholipid range was not shown to be a "recognized result‑effective variable" (Fed. Cir. 20‑2329). Under the literal claim language, "50" and "2" are within the closed ranges; there is no "about."

POSITA. In the family's IPRs the parties used a person of ordinary skill with an advanced degree (Ph.D., or M.S. plus several years) in pharmaceutics/biochemistry/chemistry and several years of experience formulating lipid‑nucleic acid particles for in vivo delivery. I could not retrieve the verbatim stipulation; the above is representative.

2. The prior‑art arsenal and what each element supplies

Reference points the patent itself concedes. The specification's Example 4 (as described by the PTAB in IPR2019‑00554) reports that "1:57 SNALP" was >10× more efficacious than a "2:30 SNALP" described in the prior art, and Example 3 says the same vs. a "2:40 SNALP." Because 2:30 and 2:40 tumbled out of '554/'189, the only material compositional gap between those prior‑art particles and '378 claim 1 is: cationic lipid ≧50 mol % (prior art: 30–48 %) while PEG conjugate is ≦2 mol % and non‑cationic lipid falls to ≦49.5 %. Stated simply, claim 1 is directed to the "high cationic lipid / low PEG" corner of a formulation space the prior art had already populated.

3. Grounds of rejection under § 103

Ground 1 — The '554 publication, alone or in view of Lin/Ahmad

Theory: single‑reference obviousness (with a strong anticipation overlay).

• Element (a): '554 is directed to nucleic‑acid‑lipid particles (plasmid/siRNA).
• Element (b): '554 discloses a cationic‑lipid content up to 60 mol % (and 40–50 %), which is within claimed 50–85 %. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap with ranges disclosed in the prior art").
• Element (c): '554 discloses neutral/non‑cationic lipid 20–85 % with cholesterol 20–45 % — overlapping 13–49.5 %.
• Element (d): '554 discloses PEG conjugate 1–20 %, overlapping 0.5–2 %, and expressly teaches that the conjugate exists to prevent aggregation.
• KSR rationales: (i) combination of known elements (four lipid classes plus nucleic acid) by known methods; (ii) simple substitution/selection of a known molar ratio; (iii) "obvious to try" — a finite, identified set of components and ratios with art‑recognized trade‑offs (more cationic lipid → more encapsulation/endosomal escape; less PEG → less inhibition of cellular uptake, but enough PEG for circulation stability); (iv) design incentive to raise potency while retaining serum stability, exactly the "strong need in the art" the '378 specification acknowledges.
• Motivation supplied by Lin/Ahmad: membrane charge density (a direct function of cationic lipid mol %) is a recognized, tunable variable controlling transfection, making the cationic‑lipid fraction a result‑effective variable subject to routine optimization (In re Aller; In re Antoine).
• Anticipation overlay: if the reported '554 example 50 % cationic / 20 % phospholipid / 28 % cholesterol / 2 % PEG‑cDMA is accurate, the '554 publication discloses a species that literally satisfies every element of claim 1, including claim 5 (mixture of phospholipid and cholesterol).

Ground 2 — '196 PCT in view of the '554 publication (and optionally Lin/Ahmad)

The '196 PCT supplies the SNALP‑for‑siRNA context, the DLinDMA/DSPC/PEG‑cDMA system, cationic lipid up to 60 mol % and conjugated lipid 0.5–20 mol %; the '554 publication supplies the elevated cationic‑lipid content and the 1–2 % PEG teaching. Both are the same field (lipid‑encapsulated nucleic acid), address the same problem (serum‑stable, potent, systemically active particles below ~100 nm), and use overlapping components. A POSITA with both in hand would have tuned the ratio, with a reasonable expectation of success.

Ground 3 — '189 publication ("2:40") in view of '554 (and Lin/Ahmad)

'189 discloses a nucleic‑acid‑lipid particle with 10 mol % phospholipid and 2 mol % PEG‑cDMA but only 40 % cationic lipid. Increasing the cationic lipid to the '554‑disclosed 50–60 % while holding the phospholipid at 3–15 % and the PEG at ≦2 % arrives at claims 1, 5 and 7. Motivation: charge‑density tuning (Lin/Ahmad) plus '554's express disclosure of higher cationic content.

Ground 4 — Dependent claims

• Claim 5 (phospholipid + cholesterol mixture): disclosed in '554, '196 and '189 directly.
• Claim 7 (phospholipid 3–15 mol %): '554's 10 %‑phospholipid example and '189's 2:40 (10 % DSPC) disclose the sub‑range; combined with a ≥50 % cationic lipid teaching (Ground 1/2), claim 7 falls.
• Claim 22 (pharmaceutical composition + carrier): conventional; taught by any of the above references and by the incorporated '025/'031 publications.

4. Why these grounds may nonetheless fail (and the strength ranking)

The patent owner has a ready‑made playbook: the same references (‑196 PCT, ‑189, ‑554, Lin, Ahmad) were asserted against the sibling '069 claims in IPR2019‑00554, instituted, and rejected by the Board and affirmed by the Federal Circuit on 2021‑12‑01 (https://cafc.uscourts.gov/opinions-orders/20-2329.OPINION.12-1-2021_1872458.pdf; PTAB FWD at https://www.bigmoleculewatch.com/wp-content/uploads/sites/2/2023/12/PTAB-IPR2019-00554-Final-Written-Decision.pdf). Arbutus's winning themes, all transplantable here:

1. No recognized result‑effective variable / no routine optimization. Arbutus argued (and the Board and Fed. Cir. accepted) that the lipid components "interact with each other unpredictably" and that reaching a claimed range required more than "simple optimization" — indeed Moderna's own expert conceded undue experimentation in a parallel IPR on the '435 patent.
2. Non‑monotonic, counter‑intuitive data. The '069/‑127 record included evidence that the 2:40 composition was compositionally closer to the claimed formulation yet less potent in vivo than 2:30 — the courts treated that as affirmative evidence of unpredictability.
3. Teaching away. Lin/Ahmad disclose a bell‑shaped charge‑density/efficiency relationship, i.e., potency falls at high membrane charge density, and high positive charge is associated with toxicity — arguably discouraging the ≥50 mol % cationic lipid requirement of claim 1.
4. Objective indicia in the specification: improved therapeutic index; comparative data showing >10× potency at 10‑fold lower dose vs. 2:30 SNALP; reduced tolerability signals (liver enzymes, platelet counts, body weight; FIGS. 6–11, 13–14 of the '378 patent); a unitary formulation/ratio‑selection invention supported by extensive in vivo data.
5. Procedural posture: § 282 presumption of validity; clear‑and‑convincing burden in district court (the '378 patent is asserted in D. Del. 1:22‑cv‑00252 and D.N.J. 3:23‑cv‑04200 / 2:23‑cv‑01876 / 3:23‑cv‑01876, with an appeal now listed as Fed. Cir. 26‑1581).

Ranking (my assessment):

• Strongest: Ground 1 with a verified, literal '554 example inside claim 1 (50/20/28/2) — a single‑reference anticipation/obviousness case is materially harder to rebut than an overlapping‑range argument.
• Solid: Ground 1 overlapping ranges + Lin/Ahmad; Ground 2 ('196 + '554).
• Weaker: Ground 3 ('189 + '554), because it depends on combining embodiments the '069 POPR criticized as unconnected ("in one embodiment" formulations).
• Vulnerable to the '069 precedent in all variants, because Arbutus's unpredictability evidence is specification‑wide and not limited to the phospholipid sub‑range.

Net view. The broad genus claim 1 of US 11,141,378 is more exposed than the '069 claim that survived IPR, precisely because it omits the phospholipid/cholesterol sub‑ranges on which the Federal Circuit's non‑obviousness holding turned. But the '378 claim is not a clean kill: the Federal Circuit's reliance on unpredictable component interactions and the absence of a recognized result‑effective variable applies to the cationic‑lipid fraction as well, and Lin/Ahmad can be read as teaching away from the high charge density the claim requires. I would treat Grounds 1–2 as raising a substantial validity question warranting verification of the '554 examples against the reference text, expert evidence on the charge‑density parameter as a result‑effective variable, and a direct rebuttal of the unexpected‑results and teaching‑away narrative — not as a certainty of invalidity.

Caveat on scope of this memo: I did not retrieve the page's citation table, the printed claim set of US 11,141,378, the full text of the '196 PCT, '189 or '554 publications, or any petition against the '378 patent itself (none verified as filed). Statements sourced to the '069 litigation are labeled as such and should be re‑checked against the '378 claims before being used in a pleading.