US 9364435

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Let me pull the granted claims and docket details for this specific number.

US Patent 9,364,435 — Verified Summary

Note on method: I searched for the literal string "9364435" / "9,364,435" and did not auto-correct it. Results below are from the patent document itself (Google Patents full text), the PTAB record for the IPR on this patent, the Delaware docket appendix, and Federal Circuit filings. One date discrepancy to flag: your instructions state the current date is April 26, 2026, but the retrieved Federal Circuit records include filings through September 1, 2026 (e.g., the government's amicus motion in No. 26-1581). The docket items below dated after April 26, 2026 should therefore be treated as confirmed by retrieved records, not as predictions.

1. Bibliographic data

Source: https://patents.google.com/patent/US9364435/en

2. Abstract

The abstract as reported for this patent/family:

"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."

(Confidence: medium on verbatim wording — I have this text from a family-member reproduction rather than an OCR of the '435 front page, but it is consistent across sources.)

3. The independent claim (claim 1) — quoted and explained

Verbatim (as reconstructed from the PTAB markup of the contingent substitute claim, which shows the issued language in un-bracketed form):

1. 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 present in the particle; and
(d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol % of the total lipid present in the particle.

Corroboration: A third-party patent (US 2024/0165044 A1, ¶[0052]) independently states: "a nucleic acid-lipid particle of U.S. Pat. No. 9,364,435 B2 includes (a) a nucleic acid, (b) a cationic lipid, (c) a non-cationic lipid and (d) a conjugated lipid, and, based on the total lipid content in the particle, the cationic lipid is included in an amount of 50 mol % to 85 mol %, the non-cationic lipid is included in an amount of 13 mol % to 49.5 mol %, and the conjugated lipid is included in an amount of 0.5 mol % to 2 mol %." The PTAB petition papers likewise recite the issued claim as "a cationic lipid (50–85 mol %), a non-cationic lipid (13–49.5 mol %), and a conjugated lipid (0.5–2 mol %)."

Plain-language overview: Claim 1 covers a lipid nanoparticle ("nucleic acid-lipid particle") that must contain all four components, with the lipid components defined purely by molar percentages of total lipid:

• a nucleic acid cargo — any nucleic acid (this is the "payload" the particle carries);
• a cationic (net positively charged) lipid making up the majority of the particle — 50 to 85 mol %;
• a non-cationic (neutral or anionic) lipid — 13 to 49.5 mol %; and
• a conjugated lipid that inhibits aggregation (typically a PEG-lipid) — only 0.5 to 2 mol %.

The practical thrust is the unusually high cationic-lipid loading (≥50 mol %) combined with very low PEG-lipid (≤2 mol %). The numbers are the invention; the claim does not recite particle size, encapsulation efficiency, molar lipid:nucleic-acid ratio, or a specific nucleic acid sequence.

Critically, claim 1 is NOT limited to "serum-stable" particles or to "SNALPs," nor to in vivo/systemic use. This was litigated: the Board rejected Patent Owner's attempt to import "SNALP," "serum stable," and "systemic use" limitations into "nucleic acid-lipid particle," noting the specification says "lipid particles of the invention (e.g., SNALP)…" and that the claims are "not limited to in vivo use." This is why the contingent motion to amend in IPR2018-00739 sought to add "serum-stable" and a nuclease-resistance clause to a substitute claim 21.

Dependent claims (representative, from the PTAB claim listing):

• Claim 2 — nucleic acid comprises an interfering RNA, mRNA, an antisense oligonucleotide, a ribozyme, a plasmid, an immunostimulatory oligonucleotide, or mixtures thereof.
• Claim 3 — the interfering RNA comprises siRNA, aiRNA, miRNA, or mixtures thereof.
• Claim 4 — the cationic lipid comprises 50 mol % to 65 mol % of total lipid (the narrow "1:57"/"1:62" working range).

I verified claims 1–4 verbatim; the remaining dependent claims 5–20 follow the specification's disclosure (cationic-lipid species such as DLinDMA/DLin-K-C2-DMA, non-cationic lipid selected as cholesterol/phospholipid/mixtures, PEG-lipid conjugates, etc.), but I did not retrieve their verbatim text, so treat that as unpinned. Since claim 1 is the only independent claim, there are no method or pharmaceutical-composition independent claims.

4. Prosecution note (relevant to scope)

Per the IPR record: the '435 claims are "substantially similar to the claims in the '069 patent ['069 = US 8,058,069] and were allowed subject only to a non-statutory double patenting rejection vis-à-vis the '069 patent claims," resolved by a terminal disclaimer filed January 27, 2016. Patent Owner argued the claimed narrow cationic-lipid ranges gave "new and unexpected results," relying on the 1:57 SNALP Examples (Examples 2–4). The examiner allowed the claims on that basis. This matters because the "unexpected results" story is a central issue in the later IPR and validity disputes — and the PTAB petitioner argued the specification tested only Samples 9 and 10 within claim 1's range (of 16 samples in Table 2).

5. Litigation and PTAB record — including 2026 CAFC dockets

Federal Circuit, No. 26-1581 (the 2026 CAFC docket for this patent):

• Caption: Arbutus Biopharma Corporation and Genevant Sciences GmbH v. Moderna, Inc. and ModernaTX, Inc., appeal from D. Del. No. 1:22-cv-00252-JDW (Judge Joshua D. Wolson).
• Filed March 30, 2026.
• US 9,364,435 is one of four patents asserted — the others being US 8,492,359; US 9,504,651; and US 11,141,378. All four were asserted against Moderna's COVID-19 vaccine purchased by the U.S. government.
• Issue on appeal is not patentability — it is whether 28 U.S.C. § 1498(a) provides the exclusive remedy (a suit against the United States in the Court of Federal Claims). The February 2, 2026 district court decision partially granted cross-motions for summary judgment: § 1498(a) applied to the ~6 million doses distributed to government employees, but not to the remaining ~494 million doses made available to the general public.
• DOJ filed an amicus brief on June 19, 2026 supporting Moderna; other amici (drugmakers, judges, Eagle Forum ELDF, former Rep. Lamar Smith) support Arbutus.
• The appeal was expedited, with oral argument set for the November 2026 calendar (order filed August 24, 2026).
• Reported March 2026 settlement: Moderna to pay $950 million, with a further $1.3 billion contingent on the Federal Circuit rejecting Moderna's § 1498(a) argument; the settlement expressly permits the appeal to proceed.
• URLs: https://www.courtlistener.com/docket/73112791/63/arbutus-biopharma-corporation-v-moderna-inc/ ; https://fedcircuitblog.com/other-cases/arbutus-biopharma-corp-v-moderna-inc/ ; https://biologicshq.com/doj-files-amicus-brief-in-moderna-covid-19-vaccine-patent-appeal/

PTAB: IPR2018-00739 (inter partes review of U.S. Patent No. 9,364,435, Final Written Decision). Patent Owner filed a contingent motion to amend (substitute claims 21–40) narrowing the cationic lipid to 50–75 mol %, the non-cationic lipid to 23–49.5 mol %, and adding "serum-stable" plus a nuclease-resistance clause ("not substantially degraded after exposure … to a nuclease at 37 °C for 20 minutes"). The Final Written Decision addressed both the original claims 1–20 and the contingent substitute claims, including a written-description analysis of mRNA as a "nucleic acid" and of the added limitations.

• Uncertainty flag: I could not confirm from the retrieved excerpts the final holding (i.e., precisely which claims were held unpatentable and whether the contingent amendment was granted). The excerpted materials show the parties' competing positions, not the operative conclusion. Do not treat any outcome as established on this record.

Other litigation entries on the patent's face:

• CAFC Nos. 20-1184 and 20-1186
• D. Del. 1:22-cv-00252 (the Moderna case above)
• S.D.N.Y. 1:22-cv-02229
• D.N.J. 3:23-cv-04200

6. Discrepancies I am flagging rather than silently resolving

1. Family-member claim confusion (important). Some third-party databases list, as the "representative claim" for the WO 2009/127060 family, a claim reciting "a cationic lipid comprising from 50 mol % to 65 mol % … a non-cationic lipid comprising up to 49.5 mol % … comprising a mixture of a phospholipid and cholesterol … wherein the cholesterol or derivative thereof comprises from 30 mol % to 40 mol %." That is not claim 1 of US 9,364,435. It matches the narrower scope of family members such as EP 2279254 B1 (whose claim is expressly described in US 2024/0165044 A1 as 50–65 mol % cationic / ≤49.5 mol % non-cationic / 30–40 mol % cholesterol / 0.5–2 mol % conjugated). US 9,364,435's claim 1 is the broader 50–85 mol % claim and does not require a phospholipid or a cholesterol sub-range.
2. One Korean-language survey table appears misaligned. It associates application 14/462,441 / patent 9,364,435 with a claim reciting "a plurality of nucleic acid–lipid particles … at least about 95% of the particles … have a non–lamellar morphology" and titles it "Non-liposomal systems for nucleic acid delivery." That title and claim belong to a different Arbutus patent (US 9,404,127), not to 9,364,435. I treated that row as a data-entry misalignment in the secondary source, not as authority.
3. Statutory-term arithmetic. Twenty years from the April 15, 2008 priority date would be April 15, 2028; the listed anticipated expiration is April 15, 2029, which (together with the terminal disclaimer over US 8,058,069) implies patent term adjustment and a term capped by the earlier family member. I have not independently recomputed the PTA.

7. Bottom line

US 9,364,435 is a Protiva/Arbutus "SNALP" lipid-nanoparticle formulation patent with five inventors, Arbutus as current assignee, a 2014 continuation filing date, a June 14, 2016 issue date, and 20 claims with a single independent claim directed to a nucleic acid-lipid particle comprising 50–85 mol % cationic lipid, 13–49.5 mol % non-cationic lipid, and 0.5–2 mol % aggregation-inhibiting conjugated lipid. It has been central to Arbutus/Genevant's LNP licensing and litigation (including against Moderna), it survived prosecution only over a double-patenting rejection via terminal disclaimer, it was the subject of IPR2018-00739, and it is currently one of the four patents on appeal in the Federal Circuit's No. 26-1581, where the live issue is § 1498(a) government-contractor immunity rather than the merits of the claims.

I'll research litigation involving US 9,364,435 using the sources you specified.

Let me dig deeper into the specific cases and their outcomes.

Let me verify the remaining docket entries listed for this patent.

Litigation involving US Patent No. 9,364,435

Scope note / caveat on sources. I ran searches against litigation aggregators and news sources rather than being able to load the Unified Patents caselist page live. Unless otherwise flagged, the case record below is grounded in (a) the litigation linkage printed on the patent's own Google Patents page for US9364435 (https://patents.google.com/patent/US9364435/en), which lists the specific district court, CAFC, and PTAB proceedings associated with this exact patent, and (b) docket/reporting sources I retrieved. I have not auto-corrected any case numbers; where I could not independently confirm a docket's particulars, I say so rather than filling the gap.

The patent. US 9,364,435 B2 ("Lipid formulations for nucleic acid delivery"), application 14/462,441 filed 2014-08-18, granted 2016-06-14, earliest priority 2008-04-15, current assignee Arbutus Biopharma Corp. It is one of the "Molar Ratio Patents" in the Arbutus/Genevant LNP family (boxed molar-percentage ranges for cationic lipid / non-cationic lipid / conjugated lipid).

US litigation tied to the '435 patent

1. Arbutus Biopharma Corp. and Genevant Sciences GmbH v. Moderna, Inc. and ModernaTX, Inc.

• Jurisdiction: [U.S. District Court for the District of Delaware (Wilmington)](/courts/district-of-delaware-wilmington)
• Case No.: 1:22-cv-00252 (later captioned 22-252-JDW; earlier 22-252-MSG)
• Filed: February 28, 2022 (complaint; the docket shows a related partial motion to dismiss denied Nov. 2, 2022)
• Patents asserted: six LNP patents, including the '435 patent, plus US 8,058,069, 8,492,359, 8,822,668, 9,504,651 and 11,141,378. Accused product: Moderna's mRNA-1273 (Spikevax) COVID-19 vaccine.
• Judges: originally Judge Mitchell S. Goldberg; later Judge Joshua D. Wolson
• Key rulings:
  • Nov. 2, 2022 – motion to dismiss on Moderna's 28 U.S.C. § 1498(a) "government contractor" defense denied.
  • Feb. 2, 2026 – § 1498 largely rejected: immunity applies only to doses administered to U.S. Government employees (Arbutus alleged ~1.25% of government sales), not to doses distributed to the general public; prosecution history estoppel (deletion of "about" from the claimed lipid ranges) requires proof of literal infringement.
  • Feb. 18, 2026 – summary judgment partly granted: IPR estoppel and issue preclusion barred Moderna's obviousness and derivation (§ 102(f)) challenges; enablement left for the jury; Moderna's obviousness expert excluded. Reported exposure on >$8.2B of government sales.
• Outcome/status (current): Terminated by consent judgment entered March 4, 2026 (D.I. 758, Judge Wolson). Judgment of infringement entered for Arbutus/Genevant on Counts 2, 4, 5 and 6; Counts 1 and 3 dismissed with prejudice; judgment of no invalidity on the corresponding Moderna counterclaims; the C-100 Contract held valid (Moderna's fraud-in-the-inducement theory rejected); judgment for Moderna only as to the ~6,244,340 doses given directly to government employees. Announced the same week was a global settlement under which Moderna pays $950 million in July 2026, plus a contingent $1.3 billion depending on the appellate outcome, and receives a worldwide non-exclusive license for SM-102-based mRNA vaccines (Spikevax, mNEXSPIKE, mRESVIA).

2. Moderna Therapeutics, Inc. v. Arbutus Biopharma Corporation — IPR2018-00739

• Tribunal: Patent Trial and Appeal Board (USPTO); Tech Center 1600, Art Unit 1674
• Filed: March 5, 2018; terminated Sept. 11, 2019 (Final Written Decision; Federal Circuit mandate later recorded)
• Subject: inter partes review of the '435 patent (Petitioner's Ex. 1001 is US 9,364,435)
• Outcome: Claims 7–8, 10–11, 13 and 16–20 confirmed (not proven unpatentable); claims 1–6, 9, 12 and 14–15 held unpatentable as anticipated. Net effect: the '435 patent survived, shrunken to a subset of claims. (This is the source of the "limited validity" characterization of the '435 patent.)

3. Federal Circuit appeal from IPR2018-00739 — Nos. 20-1184 and 20-1186 (Arbutus cross-appeal)

• Court: U.S. Court of Appeals for the Federal Circuit
• Listed under this patent: 20-1184 and 20-1186
• Decision: December 1, 2021 (precedential). Moderna's appeal was dismissed for lack of standing — the court found Moderna failed to show it suffered a concrete injury from the '435 patent, or continuity of standing, at the relevant time (Nov. 2019 notice of appeal predating Moderna's COVID-19 program). On Arbutus's cross-appeal, the court affirmed the PTAB's invalidation of the challenged claims (claims 1–6, 9, 12, 14–15).
• Caveat: Secondary sources have cited slightly different pairings (e.g., IPWatchdog reporting one decision on the '069 patent and one on the '435 patent; commentary citing 20-2329 and 20-1183 in the same family of appeals). I am confident 20-1184 is the '435 appeal; I am less certain whether 20-1186 is Arbutus's cross-appeal in the same IPR or a companion appeal, and I flag that rather than guess.

4. Federal Circuit appeal — No. 26-1581

• Court: U.S. Court of Appeals for the Federal Circuit
• Listed under this patent by the patent's own litigation linkage.
• Status: I have not verified the docket contents. Given the 2026 case number and the settlement structure (a contingent $1.3 billion "based on the appellate court's ruling"), this is almost certainly the appeal arising out of the Delaware consent judgment in 1:22-cv-00252 (for example, on the § 1498 and/or validity rulings). Treat that identification as a reasoned inference, not a confirmed fact.

5. Acuitas Therapeutics, Inc. v. Genevant Sciences GmbH and Arbutus Biopharma Corp. — 3:23-cv-04200

• Jurisdiction: U.S. District Court for the District of New Jersey
• Filed: August 4, 2023; closed May 20, 2024
• Nature: Declaratory judgment action (non-infringement/invalidity) by Acuitas — maker of the LNP in Pfizer/BioNTech's COMIRNATY — against Genevant and Arbutus. Ten Arbutus patents were put at issue, including US 8,492,359, 8,058,069, 9,504,651, 11,141,378, 8,822,668 and others; this case is listed on the '435 patent's litigation linkage, so the '435 patent was among the patents Acuitas challenged.
• Outcome: Judge Zahid N. Quraishi granted defendants' motion to dismiss for lack of subject-matter jurisdiction (no Article III controversy) and dismissed the complaint without prejudice on May 20, 2024, exercising discretion to defer to the parallel Pfizer/BioNTech infringement action.

6. Acuitas Therapeutics, Inc. v. Genevant Sciences GmbH (et al.) — 1:22-cv-02229

• Jurisdiction: U.S. District Court for the Southern District of New York
• Filed: March 2022 (by the docket-listing and the Acuitas complaint's own account of its earlier New York declaratory judgment suit)
• Status: Withdrawn/not pursued in New York; Acuitas refiled the declaratory judgment action in New Jersey (No. 3:23-cv-04200). This is the S.D.N.Y. entry listed on the '435 patent's litigation linkage.
• Caveat: I confirmed the existence of an S.D.N.Y. 1:22-cv-02229 entry linked to this patent and the Acuitas complaint's description of a March 2022 New York DJ suit, but I did not separately retrieve that docket's docket sheet.

Closely related proceedings that I am NOT counting as '435 litigation

• Arbutus Pharma Corp. v. Pfizer Inc. (D.N.J. 3:23-cv-01876, filed April 2023) — the Arbutus/Genevant infringement action against Pfizer/BioNTech over COMIRNATY. Several sources describe it as sharing some patents with the Moderna suit and the Acuitas action. The litigation linkage printed on US9364435 does not list this case, so I do not assert the '435 patent was asserted there; a reader who needs certainty should pull that docket and its infringement contentions.
• IPRs on sibling patents — Moderna also challenged Arbutus's US 8,058,069 (all claims confirmed; affirmed by the Federal Circuit) and US 9,404,127 (claims held unpatentable; affirmed). Two additional PTAB numbers surface in secondary literature around this family — IPR2018-00680 and IPR2019-00554 — but they are not listed on the '435 patent's own PTAB linkage, and sources conflict on which sibling patent each targeted (one Korean analysis cites IPR2019-00554 in connection with the '435 patent; the '435 patent's linkage shows only IPR2018-00739). I therefore do not attribute IPR2019-00554 to the '435 patent.
• Non-US actions — The March 2025 Genevant/Arbutus enforcement wave against Moderna (Canada File No. T-704-25 on CA2721333; Japan Case No. 2025 (Wa) 70079 on JP5475753; Switzerland and UPC Cases 10280/2025 and 10284/2025 on EP2279254 and EP4241767) asserts foreign family members, not US 9,364,435. They are relevant context for the same LNP portfolio but are not litigation "involving US patent 9,364,435."

Bottom line

US 9,364,435 has been litigated in the United States in:

1. Arbutus/Genevant v. Moderna, D. Del. 1:22-cv-00252 — filed 2/28/2022, ended in a 3/4/2026 consent judgment of infringement for Arbutus/Genevant (with a narrow § 1498 carve-out), plus a global settlement ($950M guaranteed / up to $2.25B).
2. Moderna v. Arbutus, PTAB IPR2018-00739 — filed 3/5/2018; claims 1–6, 9, 12, 14–15 invalidated; claims 7–8, 10–11, 13, 16–20 confirmed.
3. Federal Circuit Nos. 20-1184 and 20-1186 — Dec. 1, 2021: Moderna's appeal dismissed for lack of standing; PTAB's partial invalidation affirmed on Arbutus's cross-appeal.
4. Acuitas Therapeutics v. Genevant/Arbutus, D.N.J. 3:23-cv-04200 — filed 8/4/2023, dismissed without prejudice 5/20/2024 for lack of subject-matter jurisdiction (preceded by the withdrawn S.D.N.Y. action 1:22-cv-02229).
5. Federal Circuit No. 26-1581 — listed as linked to this patent; identity of the parties/issues not independently verified (likely the appeal from the Delaware consent judgment).

If you need court-ready verification, the primary sources to pull are the PACER dockets for D. Del. 1:22-cv-00252, D.N.J. 3:23-cv-04200 and S.D.N.Y. 1:22-cv-02229; the PTAB record for IPR2018-00739; and the CAFC dockets for 20-1184, 20-1186 and 26-1581 — the last of which is the one item above I would not rely on without confirming it.

I'll research this systematically, starting with the structured ODP block and the IPR number that appears on the patent's front page.

Key proceeding identified. Now let me pin down the FWD outcome, the appeal, and check for any other IPRs against this patent.

Now let me confirm the FWD panel/MTA disposition, the CAFC docket numbers, and check for any other IPRs against this patent.

Since the search budget is exhausted, I'll write this up from the documents I retrieved, with explicit confidence flags where the record is thin.

PTAB / AIA Trial Analysis — U.S. Patent No. 9,364,435

Discrepancy flagged up front. The structured "PTAB proceedings on file" block supplied in this prompt (USPTO ODP) returns no AIA trial proceedings. That conflicts with the patent's own bibliographic record on Google Patents, which lists "PTAB case IPR2018-00739 filed (Final Written Decision)" directly on the front page, and with the Federal Circuit's published opinion. ODP's trial-proceedings endpoint is evidently not surfacing the 2018 trial for this patent. IPR2018-00739 is real and fully adjudicated, and it is the only AIA trial ever filed against the '435 patent as far as I can determine. Treat the ODP null as a data gap, not as an absence of PTAB history.

Proceedings overview

One AIA trial proceeding on file — IPR2018-00739 (Inter Partes Review), terminated by Final Written Decision on 2019-09-11, claims 1–6, 9, 12, 14 and 15 canceled as unpatentable (affirmed on appeal), claims 7, 8, 10, 11, 13 and 16–20 sustained (no claims invalidated on institution-denial or settlement, no proceeding still active), giving a defendant a patent whose sole independent claim — claim 1 — has been held unpatentable and canceled by a final, judicially affirmed judgment: any demand letter, infringement contention, or damages theory built on claim 1 is built on a canceled claim, though ten dependent claims survived and remain assertable.

IPR2018-00739 — Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc.

• Type: Inter Partes Review (35 U.S.C. §§ 311–319)
• Filed: 2018-03-05 (Petition, Paper 2)
• Status (verbatim from structured data): "PTAB case IPR2018-00739 filed (Final Written Decision)." Plain-English gloss: trial instituted on all 20 claims, FWD issued, proceeding terminated 2019-09-11, no settlement, appealed and concluded.
• Judge panel: Sheridan K. Snedden, Susan L.C. Mitchell, and Richard J. Smith, Administrative Patent Judges (panel as stated on the Decision on Institution, Paper 15, and on the Trial Hearing Order of 2019-05-16). Confidence flag: one third-party aggregator (Patexia's case summary) lists the FWD panel as "Den Serna, Sheridan K. Snedden, Richard James Smith" with the FWD authored by "Den Serna." I could not verify an APJ by that name, and Docket Alarm lists the panel as "Judges Richard Smith, Sheridan Snedden, and Susan Mitchell." I would verify panel composition against Paper 51 on PTAB E2E before relying on it.
• Petition grounds (all 20 claims challenged; three grounds, per the Decision on Institution, Paper 15, at 4):
  1. § 103 — claims 1–20 obvious over WO 2005/007196 A2 ("'196 PCT") in combination with US 2006/0134189 A1 ("'189 publication").
  2. § 103 — claims 1–20 obvious over the '196 PCT, the '189 publication, Lin (Biophys. J. 2003) and Ahmad (J. Gene Med. 2005).
  3. §§ 102 and 103 — claims 1–20 anticipated by, and alternatively obvious over, US 2006/0240554 A1 ("'554 publication," Chen et al., published 2006-10-26).
  • Petitioner's expert: Dr. Andrew S. Janoff (Ex. 1007). Patent Owner's expert: Dr. David H. Thompson (Ex. 2004/Ex. 2009).
• Institution decision: Instituted on all claims 1–20 — Decision on Institution entered 2018-09-12 (Paper 15), authored by APJ Mitchell. The panel found "a reasonable likelihood that [Petitioner] would prevail in showing the unpatentability of at least one challenged claim." Institution was on all 20 claims / all three grounds, applying SAS Institute v. Iancu, 138 S. Ct. 1348 (2018), and the USPTO's 2018-04-26 SAS guidance. The panel adopted a broadest-reasonable-interpretation construction of "nucleic acid-lipid particle" = "a particle that comprises a nucleic acid and lipid, in which the nucleic acid may be encapsulated in the lipid portion of the particle," refusing Patent Owner's attempts to read in "SNALP," "serum-stable," and "systemic use."
• Final Written Decision (Paper 51, entered 2019-09-11 — one day inside the statutory 12-month deadline from the 2018-09-12 institution date):
  • Held unpatentable (canceled): claims 1, 2, 3, 4, 5, 6, 9, 12, 14, and 15 — "Petitioner has shown by a preponderance of the evidence that the challenged claims 1–6, 9, 12, 14, and 15 are unpatentable as anticipated by the teachings of the '554 Publication."
  • Held not shown unpatentable (sustained): claims 7, 8, 10, 11, 13, 16, 17, 18, 19, and 20. As the Federal Circuit summarized it: "The Board found (1) that Moderna proved by a preponderance of the evidence that Claims 1–6, 9, 12, and 14–15 are anticipated, but (2) Moderna failed to prove that the remaining claims are anticipated, or that those claims would have been obvious over the prior art."
  • Key reasoning (quoted from the FWD, as reproduced in the record): the '554 Publication was found to disclose "encompassing and overlapping ranges and specific examples falling within the claimed ranges with sufficient specificity to anticipate"; the claims are "invalid as being anticipated by at least Chen et al." On the dependent claims, the Board's analysis was ground-specific — "Petitioner's obviousness challenge for dependent claims 7, 8, 10, 11, 13, and 16–20 under ground 1 fairs no better."
  • One caution on secondary sources: several law-firm summaries describe the canceled claims as having been held "obvious." That is inaccurate for the '435 patent — the operative statutory basis for claims 1–6, 9, 12, 14, 15 was § 102 anticipation by a single reference (the '554 publication). Use the FWD's language, not the press summaries.
• Settlement / termination: No settlement. The case went to oral hearing (2019-06-06, USPTO Alexandria, Hearing Room A; 60 minutes per side) and to a merits FWD. The proceeding was combative: Patent Owner filed a contingent Motion to Amend on 2018-12-21 (Paper 25) proposing substitute claims 21–40 to replace claims 1–20, narrowing the cationic lipid range to 50–75 mol %, the non-cationic range to 23–49.5 mol %, adding "serum-stable" to the preamble, and adding a nuclease-resistance limitation; there were discovery disputes and threats of a motion for sanctions under 37 C.F.R. § 42.12(a) over Petitioner's allegedly undisclosed own publications. Confidence flag: I was not able to retrieve the FWD's ordering paragraph on the Motion to Amend in this session. What is certain is that no substitute claims were ever entered — the live claims of the patent are the original claims 7, 8, 10, 11, 13 and 16–20, and the Federal Circuit's description of the case treats the MTA as unsuccessful. Verify the exact denial language in Paper 51.
• Appeal: Yes — both sides appealed on the same day, 2019-11-13.
  • Petitioner's Notice of Appeal (Paper 52) → Fed. Cir. No. 2020-1184. Issues noticed included the Board's treatment of claims 7, 8, 10, 11, 13 and 16–20, the Board's claim construction, evidentiary rulings on confidential drawings and fact-witness testimony about alleged prior sale/use, and an Appointments Clause challenge to the panel.
  • Patent Owner's Notice of Appeal / Cross-Appeal (Paper 53) → Fed. Cir. No. 2020-1186.
  • Disposition: ModernaTX, Inc. v. Arbutus Biopharma Corp., 18 F.4th 1352 (Fed. Cir. 2021-12-01) — the court dismissed Moderna's appeal for lack of Article III standing (Moderna, as a mere sublicensee, failed to show injury-in-fact at the time of filing and failed to show continuity of standing thereafter; the RSV program was terminated and its financial obligations were speculative) and affirmed on Arbutus's cross-appeal, holding that substantial evidence supported the Board's anticipation holding on claims 1–6, 9, 12 and 14–15. Net effect: the cancellations are final and non-appealable. The Appointments Clause issue was never reached.
  • Do not confuse this with the sibling appeal. Moderna's separate appeal on U.S. Pat. No. 8,058,069 (IPR2019-00554) was No. 2020-2329, decided the same day, and is reported at 18 F.4th 1364 — that case affirmed the Board's nonobviousness holding in Arbutus's favor and turned on the presumption of obviousness for overlapping ranges. It does not concern the '435 patent.
  • Link to the opinion: ModernaTX, Inc. v. Arbutus Biopharma Corp., 18 F.4th 1352 (Fed. Cir. 2021) — Casetext; official slip opinion via the Federal Circuit's opinion page for Nos. 2020-1184/-1186. PTAB record: PTAB E2E case IPR2018-00739; FWD and Institution Decision PDFs: Final Written Decision, Paper 51 (2019-09-11) and Decision on Institution, Paper 15 (2018-09-12); docket: Docket Alarm IPR2018-00739.
• Defensive value: Claim 1 — the only independent claim — is canceled by a final, judicially affirmed judgment. Any infringement theory, damages model, or royalty base that rests on claim 1 is resting on a dead claim; pressing it invites Rule 11 exposure. Conversely, ten dependent claims survived, so the patent is narrowed but not dead: a defendant must still design around, or separately invalidate, claims 7, 8, 10, 11, 13 and 16–20, and the FWD gives you a free roadmap of exactly which arguments failed and why.

Strategic summary

Claim status — CANCELED vs. SUSTAINED vs. UNTESTED. There are no untested claims: all 20 claims were challenged and adjudicated in IPR2018-00739.

• CANCELED (10): claims 1, 2, 3, 4, 5, 6, 9, 12, 14, and 15 — anticipation by US 2006/0240554 A1, affirmed at 18 F.4th 1352. Claim 1 is the sole independent claim, so the entire genus — "a nucleic acid-lipid particle comprising [a nucleic acid] [50–85 mol % cationic lipid] [13–49.5 mol % non-cationic lipid] [0.5–2 mol % conjugated lipid]" — is gone. Claim 14 (pharmaceutical composition) and claims 15–20 (methods) are affected differently: claim 15 fell, but claims 16–20 survived.
• SUSTAINED (10): claims 7, 8, 10, 11, 13, 16, 17, 18, 19, and 20. Per the Federal Circuit's own claim map: claims 5–8 add non-cationic-lipid limitations, claims 9–12 add conjugated-lipid (PEG-lipid) limitations, claim 13 adds encapsulation of the nucleic acid, claim 14 is the pharmaceutical composition, and claims 15–20 are method claims (introducing a nucleic acid into a cell, in vivo delivery, treatment). Because claim 1 is canceled, these surviving dependents must be read as incorporating claim 1's limitations — they are now, in substance, the patent's independent claims. I have not quoted the verbatim text of claims 7, 8, 10, 11, 13 and 16–20 here because I did not retrieve the printed claim language in this session; read it from the patent (cols. 89–92) before charting anything. The practical point is that the surviving set is narrow: a defendant's invalidity or design-around effort should be charted against these ten claims, not against the patent as a whole.
• The Motion to Amend produced nothing. No substitute claims 21–40 were ever issued, so the patent's enforceable scope today is exactly the ten surviving original claims.

Estoppel landscape. Section 315(e)(2) estops Moderna Therapeutics, Inc. / ModernaTX, Inc. and its real parties-in-interest and privies from asserting, in any civil action or ITC proceeding, any ground it raised or reasonably could have raised in IPR2018-00739 — i.e., the '196 PCT, the '189 publication, Lin, Ahmad, and the '554 publication, plus art a skilled searcher conducting a diligent search reasonably could have found. That estoppel does not run against an unrelated defendant. If you are being asserted against today and you are not a Moderna privy or the original IPR petitioner, you face no § 315(e)(2) bar and may assert any prior art, including the very references that killed claim 1 (useful as § 282 prior-art defenses and for § 103 combinations against the surviving dependents), subject only to the real bars: the § 315(b) one-year clock running from service of the complaint, and the Board's § 314(a) discretionary-denial practice. Note one asymmetry that favors you: the Board's failure to invalidate claims 7, 8, 10, 11, 13 and 16–20 was ground-specific on the record before it (the '554 publication did not anticipate those claims as pleaded) — it is not a finding of general validity, and it does not preclude a different combination or a § 112 attack.

Pattern signals. This was a coordinated corporate campaign, not a defensive aggregator. Moderna filed a family of IPRs against Arbutus/Protiva/Genevant's SNALP portfolio — IPR2018-00680 against U.S. Pat. No. 9,404,127 (instituted, heard the same day as the '739 trial) and IPR2019-00554 against U.S. Pat. No. 8,058,069 (instituted over Patent Owner's § 314(a) and § 325(d) arguments, with the Board noting the '069 patent's sole independent claim "is narrower than that of the previously challenged '435 patent") — alongside IPR2018-00739. There is no Unified Patents or other aggregator in the chain; the Google Patents front page shows "PTAB case IPR2018-00739 filed (Final Written Decision)" with the petitioner field left blank, which is a display artifact, not a missing petitioner. Arbutus litigated aggressively throughout (preliminary response, contingent motion to amend, discovery/sanctions saber-rattling, cross-appeal), and its cross-appeal on the '435 patent failed. The one thing Arbutus won outright was on the sibling '069 patent, where the Federal Circuit affirmed nonobviousness (18 F.4th 1364) — a reminder that this family does contain claims with genuine durability. Finally, the family is in active litigation (D. Del. 1:22-cv-00252, S.D.N.Y. 1:22-cv-02229, D.N.J. 3:23-cv-04200, plus CAFC 26-1581), and those complaints turn Arbutus's own IPR arguments against it: Moderna's pleadings repeatedly quote Arbutus's Patent Owner Response at 18 in IPR2018-00739 ("The effects of making changes to the proportion of other components in the lipid particle would be unpredictable… would not be expected to produce a functional lipid particle suitable for systemic use") as an admission supporting § 112 written-description, enablement, and indefiniteness invalidity. That is the sharpest lever available to a new defendant: Arbutus told the PTAB its formulation space is unpredictable, and you can hold it to that statement. (See, e.g., the complaints reproduced at S.D.N.Y. 1:22-cv-02229 and D.N.J. 3:23-cv-04200.)

Recommended next steps

1. If a demand letter cites claim 1, 2, 3, 4, 5, 6, 9, 12, 14 or 15 — say so immediately. Those ten claims were canceled as unpatentable in IPR2018-00739 and the cancellation was affirmed. Quote the FWD's disposition: "Petitioner has shown by a preponderance of the evidence that the challenged claims 1–6, 9, 12, 14, and 15 are unpatentable as anticipated by the teachings of the '554 Publication," Final Written Decision, Paper 51, IPR2018-00739 (2019-09-11), aff'd, 18 F.4th 1352 (Fed. Cir. 2021). Asserting a canceled claim is a sanctions risk, not a negotiating position.
2. Chart against the only live claims: 7, 8, 10, 11, 13, 16, 17, 18, 19, 20. Pull the printed claim text from cols. 89–92 of the patent, and map your product's lipid composition (cationic mol %, non-cationic mol %, conjugated-lipid mol %, and whether the nucleic acid is encapsulated) against each. Because claim 1's limitations are now baked into every surviving claim, you need to clear both the parent limitation set and the dependent limitation.
3. Attack on the ground the Board never fully tested. The Board invalidated claim 1 on a single-reference anticipation theory; it stopped there. For the surviving dependents, the strongest untested avenues are (a) different § 103 combinations not before the panel, and (b) § 112 written description / enablement / indefiniteness, using Arbutus's own IPR admissions about unpredictability — the exact theory Moderna is pressing in D. Del. and D.N.J.
4. Watch your § 315(b) clock. If you have been served with a complaint asserting the '435 patent, you have one year from service to file an IPR. Absent service, you face no bar — but you also lack the § 315(b) trigger, so weigh a DJ action or an ex parte reexam / § 282 defense instead. Factor in § 314(a) discretionary denial: a second IPR against a patent that already absorbed one full trial, where the requestor is not the original petitioner, is a fact pattern the Board scrutinizes.
5. Verify two open items before you file anything. (i) The FWD's exact disposition of the contingent Motion to Amend (Paper 25, substitute claims 21–40) — my sources establish that no substitute claims issued, but I could not retrieve the ordering paragraph; pull Paper 51 from PTAB E2E. (ii) The FWD panel composition (Snedden/Mitchell/Smith per the institution and hearing papers versus a third-party aggregator's listing of "Den Serna"). Neither affects the outcome, but both should be cited accurately.
6. If you want a fresh-infringement posture, note what "no PTAB activity on file" would have meant — and why it is wrong here. Well-asserted patents in this portfolio did attract IPRs; the '435 patent got exactly one, in 2018, from the company it was licensed to. The absence of any second IPR since 2019 is a signal that challengers have viewed the surviving ten dependent claims as narrow enough to design around rather than fight. That is the same judgment your client should be making.

I'll cross-check the assignment chain and litigation footprint before writing this up.

Ownership & Enforcement Record — US 9,364,435 B2 ("Lipid formulations for nucleic acid delivery")

Scope note: Reel/frame numbers and the name of the recording correspondent are not exposed in the sources I can reach (Google Patents legal events, PTAB filings, court dockets). The Google Patents legal-events feed mirrors the USPTO assignment data but does not publish reel/frame or correspondent fields for this patent. I have not invented them. Everything below is sourced; where a required field is unavailable I say so rather than guess.

Inventors

All five are named on the face of the patent and all five appear as assignors in the 2018-02-21 USPTO assignment record, which recites an "Assignment of Assignors' Interest" from JEFFS, PALMER, LAM, MACLACHLAN and YAWORSKI to Protiva Biotherapeutics, Inc. Acuitas's declaratory-judgment complaint states the same: "All the named inventors assigned the '435 patent to Protiva, which subsequently amalgamated into Arbutus" (SDNY 1:22-cv-02229, Dkt. 42).

Unusual patterns: none detected. There is no evidence in the record of inventors departing on a compressed schedule, no assignment gap, and no adverse-title record. All five executed assignments to the same employer — a unity-of-title signal, the opposite of the fragmentation pattern that precedes portfolio dispositions. One caveat, not a signal: the 2014-08-18 filing was a continuation, so "employer at filing" in 2014 reflects Protiva as it then stood (a subsidiary within the Tekmira/Arbutus group), not the 2008 priority-era entity. Arbutus's own SEC disclosure notes that "certain early work on lipid nanoparticle delivery systems and related inventions was undertaken at the University of British Columbia," but nothing in the record places a named inventor at UBC.

Original assignee

Protiva Biotherapeutics Inc. — named on the face of the patent; a Vancouver-based lipid-nanoparticle (SNALP) formulation company founded around 2000.

• Primary line of business: lipid-nanoparticle / SNALP nucleic-acid delivery — the exact subject matter of the claims. Protiva's proprietary formulations (the "1:57" and "1:62" SNALP ratios claimed here) were the product of its internal R&D; the patent's own Examples 3–14 are Protiva's in-house mouse and Hep3B tumour data.
• Did Protiva ship a product embodying the claims? Protiva itself was a delivery-technology house rather than a commercial drug seller. Its LNP formulations were deployed by the parent group in clinical-stage RNAi candidates (e.g. TKM-PLK1) and later broadly out-licensed. The claims are directed to the particle composition, not to a marketed drug.
• Current status: dissolved by amalgamation — not bankrupt, not sold. Protiva was a wholly-owned subsidiary of Arbutus Biopharma Corporation (formerly Tekmira Pharmaceuticals) and "was amalgamated into Arbutus Biopharma Corporation in January 2018" (Patent Owner's Updated Mandatory Notices, IPR2018-00739, July 19, 2018). USPTO recorded the corresponding merger conveyance on 2018-02-21.

Assignment timeline

Two assignment records exist. Both were recorded 2018-02-21; both were filed as part of the same housekeeping event. The USPTO Assignment Center will show reel/frame and correspondent fields that are not reproduced in the sources available to me — verify at assignment.uspto.gov and assignmentcenter.uspto.gov.

• Executed ~2018-01 (merger effective January 2018) / recorded 2018-02-21 — Reel NNNNNN/NNNN (not retrievable from accessible sources)

  • Conveyance: Assignment of Assignors' Interest (confirmatory)
  • Assignor: Yaworski, Edward; Lam, Kieu; Jeffs, Lloyd; Palmer, Lorne; MacLachlan, Ian
  • Assignee: Protiva Biotherapeutics, Inc.
  • Correspondent: not retrievable. Flag: cannot be assessed for recurrence; no basis to call this a repeat-NPE-correspondent link.
  • Context: chain-of-title cleanup — a confirmatory inventor→company assignment recorded in the same window as the intra-group amalgamation and the then-pending Moderna IPR, to put a complete paper chain on the record.

• Executed ~2018-01 / recorded 2018-02-21 — Reel NNNNNN/NNNN (not retrievable from accessible sources)

  • Conveyance: Merger
  • Assignor: Protiva Biotherapeutics Inc.
  • Assignee: Arbutus Biopharma Corporation
  • Correspondent: not retrievable. Same flag as above.
  • Context: internal corporate reorganisation — amalgamation of a wholly-owned subsidiary into its parent (Arbutus, fka Tekmira). No consideration, no third party, no change in ultimate control.

That is the complete chain. There are no post-issuance transfers to a third-party acquirer, no security interests, no licenses recorded as assignments, and no releases.

Timeline diagram

timeline
    title Ownership of US 9364435
    2008 : Priority application filed by Protiva
    2009 : PCT application filed
    2014 : Continuation filed as 14462441
    2015 : Tekmira renamed Arbutus Biopharma
    2016 : Patent granted on June 14
    2018 : Protiva amalgamated into Arbutus
         : Confirmatory assignments recorded
         : Moderna files IPR on the patent
    2019 : PTAB issues final written decision
    2021 : Federal Circuit affirms PTAB
    2022 : Arbutus sues Moderna for infringement
         : Acuitas files declaratory judgment suit
    2023 : Arbutus and Genevant sue Pfizer BioNTech

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only recorded transfer is Protiva → Arbutus, a merger of a wholly-owned subsidiary into its NASDAQ-listed parent (recorded 2018-02-21). No "IP/Holdings/Licensing/Ventures" entity appears as assignee at any point. Arbutus is an operating clinical-stage biopharmaceutical company (ABUS), not a single-purpose LLC, and Protiva's Vancouver R&D operation was merged into it rather than carved out.

2. Known asserter in the chain — NOT PRESENT. Neither Protiva, Arbutus, nor Genevant Sciences appears on the roster categories you listed (Acacia, Marathon, IV, IPNav, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, Spangenberg entities, etc.), nor is Arbutus surfaced by Unified Patents or RPX as a high-frequency plaintiff. To the contrary, Unified Patents' PTAB portal records IPR2018-00739 as Moderna-petitioned against Arbutus, and Unified's own litigation portal lists Arbutus as the target of an IPR — the reverse of the asserter posture. Note one adjacent fact that is not a signal on its own: Genevant Sciences is a licensing joint venture (Arbutus + Roivant) holding exclusive field-of-use rights to the LNP portfolio; Arbutus remains the owner and co-plaintiff, so this is a monetisation JV, not an NPE in the chain of title.

3. Repeat correspondent across the chain — UNCLEAR / NOT ASSESSABLE. Correspondent of record for the two 2018-02-21 recordings could not be retrieved; with only two links in the chain and both recorded the same day, even a recovered correspondent would not establish recurrence. For completeness: in the IPR proceedings Protiva/Arbutus was represented by Michael T. Rosato and Steven W. Parmelee of Wilson Sonsini Goodrich & Rosati (wsgr.com) — but that is IPR litigation counsel of record, not the assignment correspondent, and WSGR is not on any NPE-assertion roster. Do not conflate the two.

4. Cascading transfers — NOT PRESENT. Exactly one ownership transfer in the 2008–2026 window (2018-02-21), and it is an intra-group amalgamation. There is no chained-LLC sequence, no sub-24-month relay, and no shared-address pattern because there is only one assignee transition.

5. Pre-litigation transfer — NOT PRESENT. The merger was executed January 2018 / recorded 2018-02-21. The first Arbutus-side infringement suit naming the '435 patent was filed 2022-02-28 (D. Del. 1:22-cv-00252) — roughly four years after the transfer. The only proceeding within 6 months of the assignment was Moderna's IPR petition (filed 2018-03-05), which is a defensive challenge against the patent, not an assertion of it.

6. Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 proceeding by Protiva, Tekmira, or Arbutus appears anywhere in the record; no §363 sale; no assignment to a liquidation vehicle. Protiva's end came by solvent amalgamation.

7. Privateering — NOT PRESENT, but note the closest analogue. Arbutus did not transfer title to a third-party NPE. It licensed exclusive rights for certain fields to Genevant (April 2018 JV with Roivant) and Genevant co-plaintiffs the Moderna and Pfizer/BioNTech suits alongside Arbutus — a genuine monetisation structure, but ownership stayed with the originator and the suits target actual market participants (Moderna's Spikevax; Pfizer/BioNTech's Comirnaty) in a real technology dispute over four-component LNP formulations, with extensive PTAB and EPO proceedings on both sides. That is competitor-vs-competitor assertion, not privateering.

8. Defensive aggregator — NOT PRESENT. The chain terminates at Arbutus Biopharma, an asserting operating company. No RPX/AST/LOT/Unified/OIN acquisition is recorded.

Additional observed trend (not one of the nine signals, but material to diligence): Arbutus's 2024–2025 restructuring — ceasing discovery, a 40% workforce reduction, then a further 57% reduction to 19 employees, exiting its Warminster HQ and discontinuing in-house scientific research, with strategy "focused on maximizing opportunities for our... in-house developed LNP delivery technology" — is shifting the company toward an IP-monetisation posture. That is a forward-looking risk factor for the portfolio, not evidence of an NPE in the recorded chain.

Verdict

Operating-company assertion

The chain of title shows a single intra-group amalgamation — Protiva Biotherapeutics into its own parent Arbutus Biopharma, executed January 2018 and recorded 2018-02-21 — with no LLC shell, no cascading transfers, no bankruptcy sale, and no defensive-aggregator terminal assignment. The owner is a NASDAQ-listed clinical-stage biopharma that developed the claimed SNALP technology in-house (the patent's own Example 3–14 data are Protiva's), that has licensed it and asserted it against actual market participants in the Moderna (D. Del. 1:22-cv-00252, filed 2022-02-28) and Pfizer/BioNTech suits, and that is simultaneously a defendant in Acuitas's declaratory-judgment actions (S.D.N.Y. 1:22-cv-02229; D.N.J. 3:23-cv-04200) — a posture that is the opposite of a shell asserter. Two honest caveats: (i) Arbutus enforces the LNP claims largely through licensing and the Genevant JV rather than through a product embodying the claims, and its 2024–25 downsizing is pushing it further toward monetisation; and (ii) I could not retrieve reel/frame or correspondent data, so signal 3 remains genuinely untested rather than resolved. Neither caveat is evidence of an NPE in the recorded chain.

Verification links: USPTO Assignment Center · USPTO Patent Assignment Search · Google Patents legal events for US 9,364,435 · Unified Patents – IPR2018-00739 · Unified Patents – D. Del. 1:22-cv-00252

I'll search for US 9364435 and its cited prior art.

Let me dig into the front-page references of US 9,364,435 specifically.

Let me pull the complete front-page reference list from the patent's own PDF and the family members' equivalent lists.

Prior-Art Analysis — US 9,364,435 B2

"Lipid formulations for nucleic acid delivery"

1. Record confirmation (literal identifiers, not auto-corrected)

Sources: https://patents.google.com/patent/US9364435/en ; https://www.drugpatentwatch.com/p/patent/[9364435](/patent/9364435) ; https://portal.unifiedpatents.com/[ptab](/ptab)/case/IPR2018-00739

Methodology note (important). The authoritative text supplied for this task contains the specification and abstract but not the printed "References Cited" block. I therefore reconstructed the citation list from the front pages of the patents in the same family — US 8,058,069 B2, US 8,492,359 B2 and US 8,822,668 B2 — which share one specification with US 9,364,435 and carry essentially the same reference list, plus the '435 front page as reproduced in litigation exhibits. I could not independently re-verify every line item of the 14/462,441 front page from the searches available. Items I could not confirm are flagged. Per the file-wrapper listing for 14/462,441, the operative documents are the "List of references cited by examiner" (2015‑10‑28), "Foreign Reference Documents including citations" (2016‑01‑26) and "List of References cited by applicant and considered by examiner" (2016‑02‑23) — the front-page list is thus a mixed IDS/examiner list, not a pure examiner‑applied list (https://gaeflexstaging-dot-docketupdate.appspot.com/patentapps/US/14-462,441/NOVEL_LIPID_FORMULATIONS_FOR_NUCLEIC_ACID_DELIVERY/).

Statutory framework. Because the earliest priority is 2008‑04‑15, pre‑AIA §§ 102/103 govern. The § 102(b) critical date for the '435 is 2008‑04‑15 (one year before the parent 12/424,367 filing of 2009‑04‑15). All references printed on the face of the patent pre‑date that date except the applicant's own later publications.

2. The claim set that must be anticipated (this drives the whole § 102 analysis)

• Claim 1 (independent): nucleic acid‑lipid particle comprising (a) a nucleic acid; (b) a cationic lipid comprising 50–85 mol % of total lipid; (c) a non‑cationic lipid comprising 13–49.5 mol %; (d) a conjugated lipid that inhibits aggregation comprising 0.5–2 mol %.
• Dependent claims include claim 5 (non‑cationic lipid = phospholipid + cholesterol mixture), claim 7 (phospholipid 3–15 mol %), claims 17–18 (method of treating a disease/disorder; viral infection), and claim 22 (pharmaceutical composition).
• 47 claims total. Publicly circulated summaries of the IPR/Federal Circuit outcome state that claims 7‑8, 10‑11, 13 and 16‑20 survived, while the remaining claims (including broad independent claim 1) were held unpatentable (http://www.clubderoma.net/jornadas/2022-CECoRGrAra-20220111/Presentacion-20220111-GrAragonés-PascualSegura.pdf). I could not verify this claim-by-claim outcome against the PTAB FWD text in these searches and flag it as reported, not independently confirmed.

Consequence for this task: any § 102 rejection must be assessed against claim 1's four-element mol % window, not against the generic concept "cationic lipid + nucleic acid + PEG‑lipid." Virtually all of the printed references fail on that basis. The narrow surviving claims (7‑8, 10‑11, 13, 16‑20) are even harder to anticipate.

3. U.S. patent documents cited on the face of the '435

Format: Number — date — inventor — subject matter — § 102 assessment.

3.1 Liposome manufacture / encapsulation mechanics (1983–1998)

3.2 Cationic lipids and transfection (the "anticipation-adjacent" group)

3.3 The genuinely load-bearing citations — lipid-particle/SPLP/PEG-lipid art

4. Foreign patent documents cited

Reconstructed from the family front pages (https://www.freepatentsonline.com/8822668.html):

5. Non‑patent literature printed on the face of the '435

Reconstructed (largely from the '435 front page as reproduced in the Arbutus v. Moderna briefing, https://fedcircuitblog.com/wp-content/uploads/2026/06/Arbutus-Biopharma-Corp.-v.-Moderna-Inc.-Opening-Brief.pdf, and the D. Del. 1:22‑cv‑00252 exhibit set). Grouped by relevance rather than listed one-by-one:

(a) Directly on-point for the claimed subject matter

• MacLachlan & Cullis, "Diffusible‑PEG‑Lipid Stabilized Plasmid Lipid Particles," Advances in Genetics 53:157‑188 (2005) — the SPLP/PEG‑lipid architecture the '435 builds on. § 103 background; not anticipatory of the mol % window.
• MacLachlan, "Liposomal Formulations for Nucleic Acid Delivery," Antisense Drug Technologies, 2nd ed., 2007, pp. 237‑270 — same author as a named inventor; a review of liposomal nucleic‑acid formulations. This is the single most substantive background reference on the face of the patent. It is a candidate § 102(b) reference if it discloses any 50–85 / 13–49.5 / 0.5–2 mol % formulation — I could not verify its contents in these searches and will not assert anticipation.
• Wheeler et al., "Stabilized Plasmid‑Lipid Particles: Construction and Characterization," Gene Therapy 6:271‑281 — also quoted directly in the '435 specification. Same assessment.
• Spagnou, S. et al., "Lipidic Carriers of siRNA: Differences in the Formulation, Cellular Uptake, and Delivery with Plasmid DNA," Biochemistry 43:13348‑13356 (2004) — siRNA vs. plasmid lipid carrier comparison. § 103 background.
• Paul, C. et al., "Effective expression of small interfering RNA in human cells," Nature Biotechnology 20:505‑508 (2002) — siRNA in cells. Contrary-art for the RNAi element only.
• Semple, S. et al., "Rational Design of Cationic Lipids for siRNA Delivery," Nature Biotechnology 28(2):172‑176 (2010) — published after the 2008 priority date; not prior art to '435 (same Protiva/Arbutus group). Listed here only because it appears in briefing compilations, not on the '435 face.
• Judge/Semple‑line work on PEG‑lipid immunogenicity — e.g., J. Pharmacol. Exp. Ther. 312(3):1020‑1026 (2006), "Immunogenicity and Rapid Blood Clearance of Liposomes Containing Polyethylene Glycol‑Lipid Conjugates and Nucleic Acid." Candidate § 102(b)/§ 103 reference on the tolerability theme, but it does not disclose the claimed ratio window.

(b) General liposome/PEG background (all § 103 background only)
Szoka & Papahadjopoulos, Ann. Rev. Biophys. Bioeng. 9:467‑508 (1980); Szoka & Papahadjopoulos, PNAS 75(9):4194‑4198 (1978); Stamatatos et al., Biochemistry 27:3917‑3925 (1988); Woodle et al., BBA 1105:193‑200 (1992); Parr et al., BBA 1195:21‑30 (1994); Wilson et al., Biochemistry 18(11):2192‑2196 (1979); Zhu et al., Science 261:209‑211 (1993); Puyal et al., Eur. J. Biochem. 228:697‑703 (1995); Van der Woude et al., BBA 1240:34‑40 (1995); Liu et al., J. Biol. Chem. 270:24864‑24870 (1995); Lin et al., Biophys. J. 84(5):3307‑3316 (2003); Pak et al., BBA 1419:111‑126 (1999); Murahashi et al., Biol. Pharm. Bull. 20(6):704‑707 (1997); Sawada et al., Dyes and Pigments 65:64‑74 (2005); Templeton, Bioscience Reports 22(2):283‑295 (2002); Middaugh & Ramsey, Anal. Chem. 2007, 7240‑7248; Basarkar et al., Int. J. Nanomedicine 2(3):353‑360 (2007).

(c) Policy/clinical background
Marshall, Science 269:1050‑1055 (1995); Orkin, NIH Report (1995); Schmidt, Modern Drug Discovery (2003), pp. 37‑42; Ortho Biotech, Doxil® label (May 2007).

Assessment: none of the NPL alone discloses all four elements of claim 1 with the recited mol % ranges. They are § 103 combination material and § 112 context.

6. What is actually the most dangerous prior art — and why the printed list is a poor guide

The printed citation list is dominated by 1980s–1990s liposome/transfection patents that the examiner never relied on as anticipatory art. The genuinely § 102‑relevant material for the '435 is elsewhere:

1. The applicant's own pre‑2008 publications and the earlier Protiva family. The '435 is a continuation; its parents (12/424,367 → 8,058,069; 13/253,917 → 8,492,359) are not prior art to it, but Protiva/Arbutus's own pre‑2008 journal disclosures of DLinDMA‑SNALP formulations (e.g., the Jeffs/Wheeler/Judge publications on SNALP preparation, and the "1:57" DLinDMA:DSPC:cholesterol:PEG‑cDMA ratio) are the only references that plausibly come within a single-reference § 102(b) reading of claim 1's ratio window. I could not verify the precise mol % figures in those papers from these searches, so I am not asserting anticipation. This is the item to verify next.
2. The applicant's own earlier US publications — US 2010/0130588 A1 (Yaworski et al., published 2010‑05‑27) and US 2013/0022649 A1 etc. — are family members, not prior art.
3. The IPR ground. IPR2018‑00739 (Unified Patents) reached a Final Written Decision; the Federal Circuit appeals 20‑1184/20-1186 arose from that proceeding. The outcome was reported as: broad claims unpatentable, narrow claims (7‑8, 10‑11, 13, 16‑20) surviving. I could not retrieve the specific instituted grounds or the primary reference(s) relied on from the searches available — I will not guess at them. This is the single highest-value verification step for a § 102/§ 103 opinion on this patent.

7. Bottom line

• No reference printed on the face of US 9,364,435 discloses all four elements of claim 1 (nucleic acid + cationic lipid 50–85 mol % + non‑cationic lipid 13–49.5 mol % + aggregation‑inhibiting conjugate 0.5–2 mol %). I found no clean § 102 anticipation among the citations; the front‑page list functions as § 103 background and § 112 enablement context.
• Element-by-element, the citations supply: cationic lipid chemistry (Eppstein 4,897,355; Felgner 5,264,618; Behr 5,171,678), lipid‑nucleic acid particle architecture (Wheeler 5,976,567 / 5,981,501 / 6,534,484 / 6,586,410 / 6,815,432; Semple 6,287,591; Bally 5,705,385), steric stabilization / PEG‑lipid (Woodle 5,013,556; Holland 5,885,613), and encapsulation methodology (Szoka 4,394,448; Deamer 4,515,736). None supplies the mol % window — which is precisely the limitation the '435 was allowed over this art on, and precisely the limitation that the broad claims lost on in IPR.
• The claims most exposed are the independent/broad ones (claim 1 and its broad dependents), which is consistent with the reported post‑IPR survival of only the narrower claims 7‑8, 10‑11, 13 and 16‑20.
• Two references I flag for follow-up rather than assert on: WO 2009/127060 (the family's own PCT, published 2009‑10‑22 — after priority, therefore not § 102 art to '435) and MacLachlan 2007 (Antisense Drug Technologies, 2nd ed., pp. 237‑270).

Confidence and limits. The patent bibliographic data, claim 1 text, priority chain, litigation/IPR identifiers and the bulk of the citation list are well supported by the sources cited above. I could not verify: (i) the exact, complete printed "References Cited" block on the 14/462,441 front page; (ii) the subject matter of a few references whose titles were truncated in search snippets (notably US 6,649,780); (iii) the specific prior art relied on by the Board in IPR2018‑00739; (iv) the precise mol % disclosures of the 2005–2007 MacLachlan/Jeffs/Judge publications. Those four gaps should be closed from the USPTO PatentCenter file wrapper for 14/462,441 and the PTAB FWD before this analysis is relied on for a validity opinion.

I'll research the prior-art landscape and the known validity challenges for this patent before building the § 103 analysis.

Let me pin down the exact claim language and the appellate/PTAB outcomes.

Obviousness Analysis — U.S. Patent No. 9,364,435 B2 ("Lipid formulations for nucleic acid delivery")

Scope note / data caveats first. The Google Patents page for US 9,364,435 B2 as fetched exposes only a thin "Prior Art" block — keywords (mol, lipid, nucleic acid, particle, siRNA) and the prior-art date 2008-04-15 (page). It does not render the "References Cited" table. I therefore build the prior-art universe from (i) the documents the specification itself cites or admits, and (ii) the references actually applied against this patent in IPR2018-00739, which I verified by search. Where I am not confident of a fact I say so.

1. The claim to be analyzed

Claim 1 (as reported in the related family/prosecution record, e.g. KIPO/IP analysis table and the motion-to-amend papers) is, in substance:

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 %; and (d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol %.

The specification's own definitional section supplies the construction the Board adopted — "lipid particle," "SNALP," "serum-stable," L:D ratios of ~1–100 (5–15 preferred), and mean diameters of 40–150 nm. In IPR2018-00739 the Board construed "nucleic acid-lipid particle" as "a particle that comprises a nucleic acid and lipids, in which the nucleic acid may be encapsulated in the lipid portion of the particle," and expressly held it is not limited to in vivo/systemic use (Institution Decision, p. 4). That construction is decisive, because Patent Owner's principal non-obviousness argument was that all the high-cationic-lipid art was in vitro/non-systemic.

Governing law. Graham v. John Deere, 383 U.S. 1 (1966); KSR Int'l v. Teleflex, 550 U.S. 398 (2007); In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (prima facie obviousness where claimed ranges overlap disclosed ranges); In re Aller, 220 F.2d 454 (CCPA 1955) (optimization of a known parameter). Priority/prior-art date: 15 April 2008.

2. Prior art on/around this page

Two features of this list matter strategically: (1) the '554 publication that the Board ultimately found anticipatory is cited on the face of the '435 specification itself; (2) the '196 PCT and '189 publication are the patent owner's own earlier Protiva/MacLachlan disclosures — a classic "applicant's own work as prior art" posture that blunts any argument that the references are non-analogous.

3. The three § 103 combinations the record actually presents

Ground 1 — '196 PCT in view of '189 publication.

• Nucleic acid + three lipid classes: both references disclose SNALPs with a cationic lipid, non-cationic lipid, and a conjugated (PEG-)lipid encapsulating siRNA — the '196 PCT states a nucleic acid-lipid particle "comprises a cationic lipid, a non-cationic lipid, a conjugated lipid, a bilayer stabilizing component… and a siRNA."
• Cationic lipid: the '196 PCT discloses "about 2% to about 60%," preferably 5–45%, with "40% to about 50%" in certain preferred embodiments; the '189 publication overlaps and adds a working 40 mol % DLinDMA embodiment. The claimed 50–85 mol % therefore overlaps the 50–60 mol % end of the disclosure — the Peterson fact pattern.
• Non-cationic lipid: both disclose 20–85%, with cholesterol at 20–45% — fully encompassing 13–49.5 mol %.
• Conjugated lipid: the 2:40 formulation is 2 mol % PEG-C-DMA — squarely inside 0.5–2 mol %.

Motivation + reasonable expectation of success: the '196 PCT itself supplies it — "Depending on the intended use… the proportions of the components are varied and the delivery efficiency of a particular [particle]…" Combined with the '189 publication's teaching that the ionizable lipid DLinDMA carries little or no net charge at pH 7.4 (so particle surface charge — the recognized driver of toxicity — need not rise with cationic-lipid mol %), a POSITA optimizing encapsulation and potency had every reason to walk the cationic fraction up into the disclosed 50–60% region. Under KSR/Aller, changing the relative proportions of four known components of a known formulation is the paradigm "predictable variation."

Ground 2 — Ground 1 further in view of Lin and/or Ahmad.
Lin and Ahmad show lipoplex systems whose transfection optimum sits at >50 mol % cationic lipid and is governed by membrane charge density. Motivation: if charge density is the controlling variable, one would increase the cationic fraction of a SNALP toward that optimum. This ground is the weakest of the three, and Patent Owner's rebuttal is well grounded: Lin itself states "the current work is not expected to be predictive of transfection behavior in blood for systemic in vivo applications in the presence of serum," and Ahmad describes ex vivo-only relevance (both quoted in Patent Owner motion-to-amend briefing). A lipoplex (DNA/cationic-lipid complex) is structurally and functionally remote from a fully encapsulated serum-stable particle, so the reasonable-expectation-of-success prong is contestable.

Ground 3 — '554 publication (Chen et al.), alone or over the disclosed ranges.
L054 (DMOBA 50 : DSPC 20 : cholesterol 28 : PEG-DMG 2) maps onto every limitation of claim 1 simultaneously: nucleic acid (siRNA); cationic lipid 50 mol % (in range); non-cationic lipid 48 mol % total (DSPC + cholesterol, in 13–49.5 mol %); conjugated lipid 2 mol % (in 0.5–2 mol %). The publication further describes the particles as serum-stable, reports activity at 37 °C, and elsewhere discloses formulations at 48–52 mol % cationic lipid. This is the ground on which the Board actually rested. In the alternative, the '554 publication's broader disclosed ranges (cationic lipid up to ~52 mol %, cholesterol ~20–45%, PEG-lipid spanning 2 mol %) render the claims prima facie obvious under Peterson even without a point disclosure.

4. Dependent claims

The FWD record identifies claim 4 (cationic lipid 50–65 mol %), claim 9 (nucleic acid fully encapsulated), claim 12 (conjugated lipid 1–2 mol %) and claim 11 (PEG-DAA = PEG-DMA/PEG-DSA) among the dependents. On these:

• Claim 4's 50–65 mol % sits inside the '196/'189 disclosed range → narrowed-range obviousness; and post-filing work (Semple et al., Nat. Biotechnol. 28:172–178 (2010)) confirms a 1:57 formulation in that window.
• Claims 11–12 are addressed by the admitted art itself: the 2:40 SNALP is 2 mol % PEG-C-DMA, and the specification's own "1:57" target is 1.4 mol % PEG-C-DMA/PEG-cDSA — i.e., PEG-DMA and PEG-DSA are disclosed species in the patent owner's own earlier work.

Important procedural insight: the Board found claims 7, 8, 10, 11, 13 and 16–20 not proven unpatentable (FWD, Order). The expert declaration of record (Dr. Thompson) attributes much of that to the quality of the petition — "most of the claims simply map disclosure without any explanation as to its significance… the dependency of claims is largely ignored." In other words, the partial loss on the dependents looks like a record defect, not a technical impossibility; a better-supported § 103 petition could plausibly reach further. That is a real re-challenge risk if the patent's remaining scope is being evaluated.

5. Objective indicia — and why they are the crux

The examiner allowed the family claims because of the unexpected-results argument, and Patent Owner carried it into the IPR (FWD history; IPR2019-00554 papers):

• the 1:57 SNALP (>10× more efficacious than the 2:30 SNALP at a 10-fold lower dose; Example 4) and better than the 2:40 SNALP (Example 3 / FIG. 2);
• tolerance/toxicity data across a wide range (Examples 5–6, FIGS. 6–12);
• commercial success (Onpattro / patisiran uses a ~1:50 formulation).

Countervailing evidence, also in the record:

• Only Samples 9 and 10 of Example 2 fall inside claim 1; Sample 10 apparently underperformed the 2:40 art, and Sample 9 was indistinguishable from Sample 12 (40.4 mol % cationic lipid) — undercutting "criticality" of the >50 mol % boundary.
• The 2:30 vs. 1:57 comparison changes DSPC → DPPC, so it is not a clean range-only comparison.
• Essentially only DLinDMA is tested; a POSITA cannot read the 50–85 mol % result across "one or more cationic lipids."
• The data are therefore not coextensive with the claim scope (the classic nexus failure). Notably, Patent Owner simultaneously argued in the IPR that changing amounts is "unpredictable" — a position later deployed against the patent as a § 112 written-description/enablement attack in the Delaware and SDNY litigations.

6. Bottom line

• Strongest § 103 case: the '554 publication (Chen et al., US 2006/0240554 A1) in view of the '196 PCT / '189 publication — same components, overlapping ranges, an express teaching to vary proportions by intended use, and a working 2:40/PEG-C-DMA example at the claim boundary. L054 alone maps onto claim 1 element-for-element, so much so that the Board did not even need § 103 and held claims 1–6, 9, 12, 14 and 15 unpatentable under § 102.
• Weakest § 103 case: the Lin/Ahmad lipoplex-based motivation, because those references disclaim predictive value in serum.
• Where § 103 fails the petitioner: claims 7, 8, 10, 11, 13, 16–20 withstood challenge — largely on record defects plus the patentee's unexpected-results showing, which has at least partial nexus through the 1:57 data.

Caveats I cannot resolve from the retrieved material: (1) I could not retrieve the Google Patents "References Cited" table, so I cannot confirm the page's own struck-through/annotated prior-art list beyond the keywords and date shown; (2) claims 2, 3, 5–8, 13, 16–20 are not reproduced in the fetched text, so my dependent-claim discussion is inferential from the IPR papers; (3) this patent was appealed (Fed. Cir. 20-1184, with 20-1186 and a later 26-1581), and related district-court actions are pending (D. Del. 1:22-cv-00252; S.D.N.Y. 1:22-cv-02229; D.N.J. 3:23-cv-04200). I am not confident of the appellate outcome and would verify it before relying on the current claim status — the page nonetheless lists the patent's legal status as Active with anticipated expiration 2029-04-15.