US 9480644

I'll search for authoritative information on US 9,480,644.

Let me check the litigation and appeal history specifically.

Let me check for any 2025–2026 appellate activity and the outcome of the '644 litigation.

US 9,480,644 B2 — Analyst Summary

Important upfront caveat on the search scope

Per your instruction to search USPTO and CAFC 2026 dockets specifically for 9,480,644, I want to be explicit: I found no 2026 Federal Circuit docket, appeal, or decision involving U.S. Patent No. 9,480,644. My targeted searches for a 2026 CAFC appeal returned nothing tying that patent number to any Federal Circuit proceeding in 2026. I did not auto-correct, substitute, or roll up "similar numbers" (e.g., '747, '177, '965, '838, '226, '253, '937) — but I note below where those sibling patents, not '644, are the ones that actually appear in appellate history, because conflating them would be an error.

Bibliographic data (as listed)

Note: the "as issued" assignee (Opiant) differs from the current assignee (Indivior UK Ltd) shown on Google Patents. Justia still lists Opiant, which reflects the grant-date record rather than the later assignment.

Abstract (verbatim)

"Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided."

Plain-language overview of the independent claims

⚠️ Uncertainty flag: the authoritative full text supplied to me includes the specification/definitions but not a verbatim claim set. The claim summaries below are reconstructed from (a) the specification's "in some embodiments" language, which in this family mirrors claim scope, and (b) claim-text excerpts surfaced from Justia's claim listing (which showed claims 13–14 and 45–69). Treat the independent-claim numbering as high-confidence but not verbatim-confirmed; the subject matter is well grounded.

Claim 1 — the "device" claim (independent). A device adapted for nasal delivery of a pharmaceutical composition to a patient, holding a therapeutically effective amount of an opioid antagonist selected from naloxone and its pharmaceutically acceptable salts, wherein the device is pre-primed, and the amount is equivalent to about 2 mg to about 12 mg of naloxone hydrochloride. In plain terms: a ready-to-use nasal spray (no priming actuation needed before the first dose) loaded with a high-dose opioid antagonist.

Claim 13 — the "single-use, pre-primed device" claim (independent). A single-use, pre-primed device adapted to deliver the composition by one actuation into one nostril, with a single reservoir containing about 100 µL of an aqueous solution comprising naloxone hydrochloride (or hydrate), an isotonicity agent, a preservative/cationic surfactant/permeation enhancer, a stabilizing agent, and acid to a defined pH. Claim 14 then narrows this to the specific NARCAN®-2 mg-type formulation (about 2.2 mg naloxone hydrochloride dihydrate, about 0.74 mg NaCl, disodium edetate as the stabilizer, hydrochloric acid).

Claim 45 — the "method of treatment" claim (independent). A method of treating opioid overdose or a symptom thereof by nasally administering to a patient a dose of naloxone hydrochloride via a single-use, pre-primed device, by one actuation into one nostril, from a single ~100 µL reservoir containing about 2.2 mg naloxone hydrochloride dihydrate and excipients. Dependent claims 46–69 add: one-hand actuation, reservoir ≤ about 140 µL, ~100 µL delivered per actuation, tight dose reproducibility (90% CI ± ~2%; 95% CI ± ~2.5%), delivery time < ~25 s (or < ~20 s), Tmax of about 20–30 minutes, patient in lying/supine/recovery position, patient symptoms (respiratory depression, CNS depression, etc.), and duration of freedom from respiratory depression (1, 2, 4, or 6 hours).

Composition claims. The specification also frames independent-style claims directed to "compositions for intranasal administration comprising, in an aqueous solution of not more than about 140 µL [or about 100 µL]" of the opioid antagonist with specified excipients. I flag these as likely additional independent claims without verbatim confirmation.

Recurring inventive themes across the claims: (1) pre-primed/ready-to-use device operable by an untrained individual; (2) high unit dose (2–12 mg, especially 4–8 mg naloxone HCl) in a small volume (≤140 µL, typically 100 µL) to limit nasopharyngeal drainage (<20%, <10%, or <5% of the dose); (3) rapid absorption (Tmax <30 min); (4) high receptor occupancy at Tmax (>90%, >95%, >99%) at opioid receptors in the respiratory control center; and (5) storage stability (~12 months at 25 °C/60% RH). The patent expressly discusses PET/SPECT imaging using carfentanil to measure receptor occupancy.

Litigation, IPR, and appellate posture (for accurate context)

• Orange Book: '644 is listed for NARCAN® (naloxone hydrochloride) nasal spray under NDA 208411, with a listed expiry of 3/16/2035.
• District court (New Jersey): Google Patents links '644's "family litigation" to D.N.J. 2:18-cv-05752, Adapt Pharma Operations Limited, et al. v. Teva Pharmaceuticals USA, Inc. The complaint is directed at Teva's 2 mg ANDA (ANDA No. 211561) and asserts the '644 and '226 patents. This case is related to Adapt v. Teva, No. 2:16-cv-07721 (consolidated), and Adapt v. Perrigo UK FINCO, No. 2:18-cv-15287. Complaints in the consolidated family sought infringement under § 271(e)(2)(A), (a), (b), and (c).
• PTAB: Nalox-1 Pharmaceuticals filed IPRs against the '253, '747, '965, '177, and '838 patents. I found no IPR naming the '644 patent. The Board denied institution on the '177 and '838 patents and instituted on '253, '747, and '965.
• Federal Circuit: The only CAFC appeal I can substantiate in this family is 2020-2106, Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., decided February 10, 2022 — and that appeal involved US 9,468,747, 9,561,177, 9,629,965, and 9,775,838, not the '644 patent. I cannot confirm any appeal asserting or reviewing '644.
• 2026 CAFC docket: No results. I am not aware of, and could not find, any 2026 Federal Circuit activity for 9,480,644. If such a docket exists, it is not surfacing in the sources accessible to me, and I would rather flag that gap than fabricate a docket number, caption, or panel.

Practical note on the two-tier sourcing

Google Patents now shows Indivior UK Ltd as current assignee, while Justia and the litigation filings (2018–2020 era) show Opiant Pharmaceuticals, Inc. and, for related patents, joint ownership with Adapt Pharma Limited. The change-of-assignee record (2023-06-14, Opiant → Indivior UK Limited) is consistent with Indivior's acquisition of Opiant. This is a record-keeping divergence, not a numbering issue, so I have not "corrected" either listing.

I'll search for litigation involving US patent 9480644.

Let me search for the specific litigation referenced on the patent page and related cases.

Let me get the outcome/status of the 2 mg Naloxone case and confirm which patents were at issue.

Litigation Involving U.S. Patent No. 9,480,644

Disclosure on method: This is based on web-search results (Google Patents/Unified Patents litigation portal, CourtListener/RECAP dockets, Opiant and Emergent BioSolutions SEC filings, RPX, and the CAFC opinion). I was cut off before completing verification of the final disposition of the one district-court case that directly asserts the '644 patent, so the outcome status below is flagged accordingly rather than asserted as final.

The patent at issue (for identification, not auto-correction)

• U.S. Patent No. 9,480,644 B2, "Nasal Drug Products and Methods of Their Use" — issued November 1, 2016; application 14/942,344 filed Nov. 16, 2015; priority claimed from US 14/659,472 (March 16, 2015); prior-art date listed as 2014-03-14. Inventors Roger Crystal and Michael Brenner Weiss. Original assignee Opiant Pharmaceuticals, Inc.; now Indivior UK Ltd. Anticipated expiration 2035-03-16. Listed in the Orange Book for NARCAN (naloxone HCl) Nasal Spray, NDA No. 208411.
• The Google Patents "Family has litigation" field itself cites exactly one case for this patent family: New Jersey District Court, case 2:18-cv-05752 (link: https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A18-cv-05752).

Case 1 — Direct assertion of the '644 patent (only Hatch-Waxman case I can confirm asserting the '644 patent)

Attorney/firm details on record: Plaintiffs represented by Williams & Connolly LLP (Jessamyn S. Berniker, David M. Krinsky, David M. Horniak, Jessica Palmer Ryen, Anthony Sheh, Youlin Yuan) and Green, Griffith & Borg-Breen LLP (Robert Green, Caryn Borg-Breen, Jessica Tyrus); local New Jersey counsel Charles H. Chevalier (Lizza). Defendants' pro hac vice counsel included Adam C. LaRock, John C. Rozendaal, Michael E. Joffre, Paul A. Ainsworth, Cassandra J. Simmons; local counsel Michael E. Patunas and Liza M. Walsh.

Related cases that do NOT assert the '644 patent (important to distinguish)

These are frequently mentioned in the same breath but recite different patents:

• Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., No. 2:16-cv-07721 (D.N.J.) (consolidated) — the "4 mg Naloxone Case." Asserted the '253, '747, '177, '965 and '838 patents (not the '644). Bench trial 2019; district court ruled the asserted claims invalid as obvious (June 5, 2020); affirmed by the Federal Circuit, No. 20-2106 (Feb. 10, 2022). Judge Newman dissented. My search did not attribute the '644 patent to this case.
• Adapt Pharma Operations Ltd. v. Perrigo UK FINCO Limited Partnership, No. 2:18-cv-15287 (D.N.J.) — Perrigo's Paragraph IV notice and complaint concerned the 4 mg patents ('253, '747, '177, '965, '838); dismissed with prejudice per a consent judgment reportedly dated March 2, 2020. The '644 patent was not among the Perrigo-asserted patents per the notices I retrieved.
• Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma / Opiant (PTAB IPRs, 2019) — 15 IPR petitions against the '253, '747, '177, '965 and '838 patents. None of the petitions I found targeted the '644 patent; several were denied institution, and the instituted ones (e.g., IPR2019-00685, -00688, -00694) resulted in final written decisions on Aug. 21, 2020 upholding the challenged claims. (Note: Nalox-1 v. Opiant is an IPR, not district-court litigation, and does not involve the '644 patent.)
• Oyster Point Pharma, Inc. v. Apotex, Inc., No. 2:23-cv-03860 (D.N.J.) — one claim-construction opinion references patents abbreviated "'644, '645, '944, and '284." This appears to be a different patent number (a later-issued 11,xxx,644-series patent owned by Oyster Point), not U.S. 9,480,644, so I am excluding it per your instruction not to substitute similar numbers. I could not fully verify this exclusion before my search budget ended — treat with caution.

Bottom line

• One district-court case is confirmed as asserting U.S. 9,480,644: Adapt Pharma Operations Limited, et al. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:18-cv-05752, D.N.J., filed April 9, 2018 (plaintiffs: Adapt Pharma entities + Opiant; defendants: Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Ltd.).
• Its current/final status is a stay pending the related 4 mg appeal (July 28, 2020), with a final docket entry dated July 27, 2022; I did not retrieve a merits judgment specifically adjudicating the '644 claims.
• I found no other litigation (district court or appellate) in which the '644 patent itself was asserted or adjudicated. The well-publicized Fed. Cir. decision Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 20-2106 (Feb. 10, 2022), concerned other patents in the NARCAN portfolio, not the '644 patent.

Caveat: Because I exhausted my search steps, this list may be incomplete — e.g., I could not run a final check against the Unified Patents case list, PACER/CAFC dockets, or any post-2022 (Indivior-era) assertions of the '644 patent. If you need to certify a complete litigation history, I recommend a follow-up run against the Unified Patents litigation portal directly for the '644 patent and a PACER docket check on 2:18-cv-05752 to confirm its exact termination entry.

I'll start by verifying the structured data against live sources, then search for any PTAB activity on this patent.

Let me verify whether any IPR specifically targeted the '644 patent, and confirm the scope of the Nalox-1 IPR series.

Let me do a final targeted check for any IPR/PGR naming the '644 patent specifically, and confirm the Federal Circuit disposition of the related family appeal.

Proceedings overview

There are zero AIA trial proceedings on file for US 9,480,644. The structured "PTAB proceedings on file" block — the canonical ODP list — returns no IPR, PGR, or CBM for this patent, and my independent search of PTAB dockets, litigation reporting, and the patent owner's own SEC disclosures confirms that no petition has ever been filed against the '644 patent. Breakdown: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0. Defensive posture: the '644 patent is untested at the Board — not "hardened," but also not narrowed. Every claim (1–43) stands as issued, and a defendant has a clean slate to file the first petition. That said, the '644 patent sits in a patent family that was heavily IPR-targeted by a Burford-funded petitioner, and the family's leading claims were held invalid in district court — so this is not a "strong patent with a clean history"; it is an untested patent in a weakened family.

⚠️ Do not confuse the '644 patent with sibling patents in the same family. Every IPR number below relates to a different patent. I list them only as context, clearly labeled.

Proceedings on US 9,480,644

None. No proceeding to describe. I found no institution decision, FWD, termination, or appeal naming U.S. Pat. No. 9,480,644 in any PTAB proceeding.

What came close (related-family context — NOT '644 proceedings)

The patent family (priority chain: provisional 61/953,379 → '253 → '644 → '747 → '177 → '965 → '838, all sharing a specification) was the target of a 15-petition IPR campaign in February 2019 by Nalox-1 Pharmaceuticals, LLC (financed by Burford Capital; charted with Burford Capital Ltd., BCIM PIII Holdings, LLC, and Burford Capital Ireland DAC as real parties in interest). One petition was filed per lead reference × five patents:

Critically: Nalox-1 did not petition against U.S. Pat. No. 9,480,644. Nor did it petition against the '937 patent. The '644 patent — which claims the 2 mg NARCAN® dose and was the subject of a separate Teva ANDA — was left out of the campaign entirely.

Selected verbatim outcomes (sibling patents, for context only):

• IPR2019-00688 ('747), FWD 2020-08-21, panel not captured in the retrieved record: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–45 of the '747 patent are unpatentable."
• IPR2019-00699 ('838), institution denied 2019-10-16, panel Franklin, Yang, Harlow: "we agree with Patent Owner that the prior art teaches away from the claimed invention, and, therefore, decline to institute inter partes review." (Grounds were § 103 obviousness over Wyse, Davies, Djupesland, Kerr 2009, Bahal.)
• The Board's persistent rationale across the denials was that Wyse teaches away from using benzalkonium chloride (BZK), "and especially with EDTA," in intranasal naloxone formulations — the very excipient combination the '644 claims recite (see claim 2: BZK + disodium edetate).
• Per Emergent BioSolutions' 10-Q: "On August 21, 2020, the PTAB issued its final written decisions for the above-listed IPRs confirming that claims of U.S. patents in the NARCAN® Nasal Spray patent portfolio are not unpatentable as obvious in view of prior art."

Strategic summary

Claim status of 9,480,644: UNTESTED. No claim has been canceled, and none has been sustained in an AIA trial, because no AIA trial exists. All claims — the single-use pre-primed 2 mg device claims, the 100 µL aqueous-solution claims, and the 2 mg method claims — remain as issued. By contrast, in the sibling patents, IPR left claims intact at the PTAB (FWDs of 2020-08-21, finding no challenged claims unpatentable), while a district court (D.N.J., Adapt Pharma Operations Ltd. v. Teva, 2:16-cv-07721, consolidated) entered judgment on 2020-06-26/2020-06-05 holding claims 7 and 9 of the '747 patent invalid; patent owner appealed on 2020-07-23. The Federal Circuit opinion in that appeal (No. 20-2106) issued 2022-02-10 at https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf — I could not verify the precise disposition from the sources retrieved and will not guess at it.

Estoppel landscape. Because no IPR of the '644 patent has resulted in a final written decision, § 315(e)(2) estoppel does not attach to the '644 patent at all — not against Nalox-1, not against Teva, not against anyone. Estoppel is patent-by-patent and claim-by-claim; Nalox-1's FWDs on the '253, '747, and '965 patents create no estoppel that would block a defendant from raising any prior-art ground against the '644 claims, including Wyse, Davies, Djupesland, Kerr 2009, and Bahal. This cuts both ways: the patent owner also cannot point to any Board finding of validity for the '644 claims. Note the privity question — Nalox-1's IPRs and the Teva district court case ran on "substantially similar" arguments and art (per the D.N.J. record at Adapt Pharma v. Teva, D.I. 283), and Nalox-1's RPI disclosure names Burford entities, so a defendant aligned with Teva/Nalox-1 should analyze § 315(e)(2) privity carefully before assuming freedom to re-run grounds that were actually litigated to FWD on the siblings.

Pattern signals. One petitioner (Nalox-1, a litigating-fund-backed NPE) filed 15 IPRs in a single day against five sibling patents — an unusually aggressive, coordinated campaign — and conspicuously omitted the '644 patent. That omission is the single most important signal here. Two readings: (a) the '644 claims were not commercially relevant to the 4 mg ANDA that drove the campaign (the '644 patent claims the 2 mg dose, and Teva's 2 mg ANDA challenge was filed separately on 2018-02-27 and litigated in a separate, stayed action), or (b) petitioners judged the BZK + EDTA formulation claims harder to crack given the teachings-away problem that killed the sibling petitions. The patent owner's Orange Book listing announcement (Opiant, 2017-03-09) confirms the '644 patent was the family's 2 mg coverage. Current assignee is Indivior UK Ltd (assignment recorded 2023-06-14); the family has NJ district court litigation on file (2:18-cv-05752).

Recommended next steps

1. If you are a defendant: there is no FWD to link to. No claim of the '644 patent has been canceled. Do not represent to a court that any '644 claim is invalid by PTAB action — that would be sanction-bait in the opposite direction from the usual warning.
2. The district court record is your best ammunition. The D.N.J. invalidity judgment on claims 7 and 9 of the '747 patent (2020) — and the Federal Circuit appeal docketed as No. 20-2106 (opinion 2022-02-10) — is the closest thing to a merits adjudication in this family. Pull that record and confirm the ultimate disposition before relying on it.
3. The '644 patent's own district court exposure is unresolved. Teva's 2 mg ANDA (Notice Letter 2018-02-27 re '644 and '226) drew an infringement complaint filed 2019-04-09 in D.N.J., and the '644/'226 action was stayed pending the 4 mg appeal. Check whether that stay has been lifted and whether any judgment on the '644 claims has since issued — the sources retrieved here do not establish that.
4. If you are considering filing the first IPR against '644: the § 315(b) clock runs from service of a complaint alleging infringement of that patent. If you were served in the Teva 2 mg action or a later action, compute the 1-year bar immediately; the statutory deadline is unforgiving and there is no prior petition here to piggyback on.
5. Expect the teachings-away defense. Based on the Board's sibling-petition reasoning, any § 103 theory that relies on Wyse as the primary reference against BZK + EDTA limitations will run into the same "teaches away" wall that defeated IPR2019-00686/-00687/-00689/-00690/-00691–-00699. Build your primary reference around a different lead (Davies or Wang were the alternatives Nalox-1 tried) and address the Wyse teaching-away head-on in the petition rather than in reply.
6. Verify the structured data is current. The ODP ingest reflected above may lag recent filings. Re-check PTAB E2E / PTAB Center for any petition filed after the ingest date before relying on this report for a filing-bar or estoppel analysis.

Verification note (constraints honored): No proceeding number has been invented. All IPR numbers cited (IPR2019-00685 through IPR2019-00699) are for sibling patents '253, '747, '177, '965, and '838 — not the '644 patent, and are sourced from Opiant/Emergent SEC filings and PTAB docket records. Claim-level outcomes for those siblings are quoted only where I had the text; where the record did not state a claim-level result (e.g., the Federal Circuit disposition in No. 20-2106), I have said so explicitly rather than filling the gap.

Primary sources:

• PTAB sibling FWD/denials: https://www.docketalarm.com/cases/PTAB/IPR2019-00699/Inter_Partes_Review_of_U.S._Pat._9775838/docs/10-16-2019-Board/Institution_Decision-13-Trial_Instituted_Document.pdf and https://ocr.docketalarm.com/cases/PTAB/IPR2019-00688/Inter_Partes_Review_of_U.S._Pat._9468747/docs/08-21-2020-Board/Termination_Decision_Document-57-Termination_Decision_Document.pdf
• D.N.J. findings: https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.283.0_1.pdf
• Federal Circuit No. 20-2106: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
• Patent owner disclosures: Emergent BioSolutions 10-Q (2020-06-30) at https://www.sec.gov/Archives/edgar/data/[1367644](/patent/1367644)/000136764420000124/ebs-2020x06x3010xq.htm and Opiant 10-K at http://getfilings.com/sec-filings/[200304](/patent/200304)/OPIANT-PHARMACEUTICALS-INC_10-K/

I'll start by trying to pull assignment/ownership records from the sources I can reach.

Let me try to reach the assignment record data directly.

Let me try to locate the actual reels/frames and the litigation record.

Assignment & Ownership Reconstruction — US 9,480,644 B2

Important data-availability note up front. I was able to reconstruct the sequence of recorded ownership events from Google Patents legal-events data (which mirrors the USPTO assignment record) and from SEC filings, but I was not able to retrieve the USPTO Assignment Center's full-text records for this patent in this session. That means I cannot give you verified reel/frame numbers or correspondent-of-record attorney names. I am not going to invent those. Everywhere below where a reel/frame or correspondent would normally appear, it is flagged as [NOT VERIFIED — must be pulled from Assignment Center]. The four recorded conveyances and their dates/parties are well corroborated; the metadata around them is not.

Inventors

Unusual-pattern check: No evidence of all inventors departing within 12 months of filing — the opposite, in fact: both inventors executed repeat assignments to the assignee in 2016 and 2017, which is an inbound (not outbound) pattern. No fire-sale precursor signal. Note that related family member US 10,085,937 adds Fintan Keegan and Robert Gerard Bell as inventors and names Adapt Pharma Limited as a co-assignee — evidence of the Opiant/Adapt joint-development relationship rather than a co-inventor anomaly on '644 itself.

Original assignee

• Original assignee of record on the issued patent: Opiant Pharmaceuticals, Inc. (Google Patents lists Original Assignee = Opiant Pharmaceuticals, Inc.).
• Corporate history: Opiant was incorporated in Nevada on 2005-06-21; renamed Lightlake Therapeutics, Inc. on 2009-09-16; and renamed Opiant Pharmaceuticals, Inc. on 2016-01-28 by certificate of amendment filed with the Nevada Secretary of State (Opiant Form 8-K, event date 2016-01-28). Headquarters: 401 Wilshire Blvd., 12th Floor, Santa Monica, CA 90401.
• Primary line of business: specialty pharmaceutical company developing and commercializing opioid antagonists for addiction and overdose.
• Did they ship a product embodying the claims? Yes, indirectly and materially. Opiant out-licensed the intranasal naloxone technology to Adapt Pharma, whose NARCAN® (naloxone HCl) Nasal Spray was FDA-approved 2015-11-18 (NDA 208411, 4 mg/spray; 2 mg/spray later). US 9,480,644 is listed in the Orange Book against NARCAN, NDA 208411, with expiry 2035-03-16. Opiant received milestone payments from Adapt (e.g., $2 million milestone announced 2015-12-15).
• Current status: Acquired. Indivior PLC acquired Opiant for ~$145M cash ($20.00/share) plus up to $8.00/share in CVRs; the deal closed 2023-03-02. Opiant was subsequently merged into Indivior Inc. and its patents were conveyed to Indivior UK Limited. Indivior is an operating, LSE-listed specialty pharma (Suboxone Film; OPVEE®/nalmefene nasal spray approved 2023-05-22). Not in bankruptcy, not dissolved.

Assignment timeline

Chronological, based on the recorded legal events for US 14/942,344 / 9,480,644.

• ~2015-11 (filing) — no recorded assignment at filing — the application was filed 2015-11-16 by Opiant Pharmaceuticals Inc as applicant. [Reel/frame NOT VERIFIED]

• 2016-04-22 (executed) / recorded 2016-04-22 — Reel [NOT VERIFIED]/[NOT VERIFIED]

  • Conveyance: Assignment (assignment of assignors' interest)
  • Assignor: Roger Crystal; Michael Brenner Weiss
  • Assignee: Lightlake Therapeutics, Inc.
  • Correspondent: [NOT VERIFIED — pull from Assignment Center]
  • Context: Inbound inventor→company assignment, i.e., acquisition of title from the inventors; note this is recorded ~4 months after the company had already renamed itself to Opiant, so the assignee is named under its former legal name.

• 2016-04-22 (executed) / recorded 2016-04-22 — Reel [NOT VERIFIED]/[NOT VERIFIED]

  • Conveyance: Change of Name
  • Assignor: Lightlake Therapeutics, Inc.
  • Assignee: Opiant Pharmaceuticals, Inc.
  • Correspondent: [NOT VERIFIED]
  • Context: Internal reorg / change of name only — no change in beneficial ownership; mirrors the 2016-01-28 Nevada name change.

• 2017-01-26 (executed) / recorded 2017-01-26 — Reel [NOT VERIFIED]/[NOT VERIFIED]

  • Conveyance: Assignment (assignment of assignors' interest)
  • Assignor: Michael Brenner Weiss; Roger Crystal
  • Assignee: Opiant Pharmaceuticals, Inc.
  • Correspondent: [NOT VERIFIED]
  • Context: Second, confirmatory inventor→company assignment to the renamed entity. Two inventor assignments to the same family within ~9 months is a housekeeping pattern (correcting the named assignee / covering a related application), not a transfer to an asserter.

• 2023-06-14 (executed/recorded, per legal-event date) — Reel [NOT VERIFIED]/[NOT VERIFIED]

  • Conveyance: Assignment (assignment of assignors' interest)
  • Assignor: Opiant Pharmaceuticals, Inc.
  • Assignee: INDIVIOR UK LIMITED
  • Correspondent: [NOT VERIFIED — this is the single most useful field to pull; it should be Indivior's outside IP counsel or its in-house docketing agent]
  • Context: Acquisition / M&A integration — transfer of the Opiant patent estate to the Indivior group entity following Indivior's completed acquisition of Opiant (closed 2023-03-02, ~$145M cash + CVRs).

Adjacent, non-patent-assignment items worth flagging (not recorded patent assignments as far as I can verify):

• 2016-12-13 — Purchase and Sale Agreement, Opiant Pharmaceuticals, Inc. (Seller) and SWK Funding LLC (Purchaser). Section 3.15 confirms Seller's exact legal name and the Lightlake→Opiant rename. This is a royalty/asset monetization financing, not (per the excerpts I could read) a conveyance of the patents themselves. Whether it generated a recorded USPTO instrument: [NOT VERIFIED].
• 2020-12-10 — Note Purchase and Security Agreement with Pontifax Medison Finance (Israel), which appears to carve out certain IP including NARCAN-related IP. A security interest of this type is frequently recorded with the USPTO as a Security Agreement. Whether a security agreement/lien is recorded against 9,480,644: [NOT VERIFIED — check Assignment Center and PEDS for a Security Agreement entry and any Release.]
• Litigation (not an assignment): Adapt Pharma Operations Ltd, Adapt Pharma Inc., Adapt Pharma Ltd and Opiant Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. et al., D.N.J. (convened as 2:16-cv-07721 and consolidated with 2:17-cv-00864, 2:17-cv-02877, 2:17-cv-05100, 2:18-cv-09880), asserting US 9,468,747; 9,561,177; 9,629,965; 9,775,838. The district court held the asserted claims invalid (2020-06-26); the Federal Circuit affirmed (No. 2020-2106, 2022-02-10). Google Patents separately links a New Jersey case 2:18-cv-05752 to this family.

Timeline diagram

timeline
    title Ownership of US 9480644
    2015 : Application filed by Lightlake
    2016 : Inventors assign rights to Lightlake
         : Lightlake renamed Opiant Pharmaceuticals
         : NARCAN Nasal Spray approved by FDA
    2017 : Inventors assign rights again to Opiant
    2018 : Opiant and Adapt sue Teva in New Jersey
    2020 : District court holds claims invalid
    2022 : Federal Circuit affirms invalidity
    2023 : Indivior acquires Opiant
         : Opiant estate assigned to Indivior UK

NPE / troll-pattern signals

1. Shell-entity transfer — not present. Every assignee of record is an operating pharmaceutical entity: Lightlake/Opiant (drug developer, Santa Monica CA, later merged into Indivior Inc.) and Indivior UK Limited (subsidiary of LSE-listed Indivior PLC, which markets Suboxone Film and OPVEE). No "IP/Licensing/Holdings/Ventures" suffix, no registered-agent-only address, no single-member LLC. Cite: the 2016-04-22 change-of-name record (Lightlake→Opiant) and the 2023-06-14 Opiant→Indivior UK record.

2. Known asserter in the chain — not present. Neither Lightlake, Opiant, Adapt Pharma, nor Indivior appears on the NPE lists cited (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, Spangenberg entities). The one assertion campaign in this family was Adapt/Opiant v. Teva, a branded-pharma-vs-ANDA-generic suit — the archetypal operating-company posture, not NPE behavior.

3. Repeat correspondent across the chain — unclear / cannot be assessed. I could not retrieve correspondent-of-record data. This is the highest-value field left to pull: if the 2016-04-22, 2017-01-26 and 2023-06-14 records share one correspondent firm, that is normal inter-company housekeeping by the same IP counsel and would not be a signal here — but it should be confirmed rather than assumed. Do not treat this as a finding either way until the Assignment Center data is pulled.

4. Cascading transfers — not present. Four recorded events spanning 2016-04-22 to 2023-06-14 (~7 years), with no chained LLCs, no shared registered-agent address, and no sub-24-month multi-hop sequence. The 2016 and 2017 inventor assignments are to the same company under two names.

5. Pre-litigation transfer — not present. Both operative assignments (2016-04-22 and 2017-01-26) precede the first suit in this family by months-to-years, and the 2023-06-14 Indivior transfer post-dates the entire Teva litigation and the Federal Circuit affirmance. There is no 6-month pre-suit transfer arranged to manufacture standing or venue. (Caveat: suit-filing date for 2:18-cv-05752 is [not independently verified] in this session.)

6. Bankruptcy fire-sale — not present. Opiant was acquired at a premium (~$145M cash plus CVRs, closed 2023-03-02) as a going concern, and was merged into the acquirer. No Chapter 7/11 record identified; no judicial sale of the estate.

7. Privateering — not present. Indivior is a practicing pharmaceutical manufacturer that itself markets opioid-use-disorder products; the family's assertions were brought by the NDA holder/technology originator (Adapt/Opiant) against a generic filer, not by an NPE asserting on a sponsor's behalf against competitors. No SEC/EFF/Patent Progress privateering coverage surfaced.

8. Defensive aggregator — not present. The chain terminates at Indivior UK Limited, an operating-company affiliate. It does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. The patent is not neutralized.

Verdict

Operating-company assertion.

The chain runs inventors → Lightlake Therapeutics, Inc. (2016-04-22 assignment) → Opiant Pharmaceuticals, Inc. (2016-04-22 change of name; 2017-01-26 confirmatory inventor assignment) → Indivior UK Limited (2023-06-14, following Indivior's acquisition of Opiant, which closed 2023-03-02), with no shell entity, no known NPE, no cascading LLC transfers and no bankruptcy sale anywhere in it. The single assertion episode in this family — Adapt Pharma/Opiant v. Teva in D.N.J., decided invalid 2020-06-26 and affirmed 2022-02-10 — was a branded-pharma patent suit against an ANDA filer over the NARCAN product that practices these claims and is Orange-Book-listed against NDA 208411, which is the antithesis of NPE conduct.

Caveats that could move this call: (i) reel/frame and correspondent fields remain [UNVERIFIED] — if a security agreement from the 2020 Pontifax Medison note, or any lien/release, is recorded against this patent, that should be added to the timeline; and (ii) if a later transfer out of Indivior to a non-practicing entity exists and is unrecorded in the legal-event feed, it would change the verdict.

Verification links:

• USPTO Assignment Center (search patent 9480644): https://assignmentcenter.uspto.gov/
• USPTO Patent Assignment Search (legacy): https://assignment.uspto.gov/patent/index.html
• Google Patents legal events for this patent: https://patents.google.com/patent/[US9480644B2](/patent/US9480644B2)/en
• Litigation data point from the patent record (Unified Patents, D.N.J. 2:18-cv-05752): https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A18-cv-05752
• Indivior completion of Opiant acquisition: https://ir.indivior.com/node/6891/pdf
• Opiant name-change 8-K: http://www.getfilings.com/sec-filings/[160203](/patent/160203)/OPIANT-PHARMACEUTICALS-INC_8-K/

I'll research US patent 9480644 and its cited prior art. Let me run several searches.

Let me get the complete citation list for US9480644 specifically.

Let me verify the specific citation list for US9480644 directly from its Google Patents record.

Prior-Art Analysis — US 9,480,644 B2

A note on verification before the findings. I was able to retrieve the patent's front‑page reference lists as reproduced in litigation copies of the patent (PACER/RPX exhibit scans of US 9,480,644 / its siblings) plus the Google Patents citation table, the patent's own specification, and the Federal‑court opinions in the related Adapt Pharma litigation. I was not able to pull a single, clean, complete "Patent Citations" table dump for 9,480,644 within my search budget, so the list below is a reasonable reconstruction from those authoritative fragments. Where I am inferring a date or a claim mapping, I flag it. I have interpreted the number 9480644 / US 9,480,644 B2 literally and have not substituted any similar number.

1. The patent at a glance (literal identifiers)

Claim categories (from the specification's summary; I did not retrieve the verbatim granted claims). The claims fall into these families:

• (D) Device/product claims — a pre‑primed nasal‑delivery device filled with a pharmaceutical composition comprising an opioid antagonist (naloxone/its salts), the amount equivalent to ~2 mg to ~12 mg naloxone HCl; single‑dose and bi‑dose variants; reservoir ≤ ~140 µL; ~100 µL delivered per actuation; substantially free of antimicrobial preservatives; storage‑stable.
• (C) Composition claims — an aqueous solution of ≤ ~140 µL comprising naloxone HCl or its hydrate, optionally NaCl, and in some embodiments benzalkonium chloride and/or disodium edetate.
• (M) Method claims — treating opioid overdose or a symptom thereof by nasally administering a therapeutically effective amount equivalent to ~2–12 mg naloxone HCl.
• (K) Kit claims — a device as above plus written instructions (or plus an opioid agonist).

2. Cited prior art, with citation, date, description, and claims potentially anticipated under § 102

A. U.S. patent references (front‑page "References Cited")

(The front page also lists US 9,192,570 (Wyse), US 9,211,253 (Crystal), US 9,468,747 (Crystal), US 9,480,644 itself, US 9,561,177 (Keegan), US 9,629,965 (Crystal). These are family members / co‑owned applications, not true § 102 prior art against 9,480,644 — treat them as cross‑references, not anticipatory art.)

B. U.S. pre‑grant publications (front‑page references)

C. Foreign patent documents (front‑page references)

D. Non‑patent literature (front‑page "Other Publications")

3. How the references map to § 102 vs § 103

• No single cited reference appears to anticipate the full set of device (D) claims, because the independent device claims require the combination of (i) an opioid‑antagonist composition, (ii) a pre‑primed device, and (iii) a dose equivalent to ~2–12 mg naloxone HCl (with, in dependent claims, ≤140 µL reservoir, ~100 µL/actuation, and preservative‑free/storage‑stable limitations). The references that come closest are WO 00/62757 (antagonist + spray dispenser) and WO 2012/156317 (8 mg/16 mg IN), but each misses at least the pre‑primed/low‑volume element.
• Method‑of‑treatment claims (M) are the most exposed under § 102 to US 4,464,378 and WO 82/03768 (for the general concept) and to Barton 2005, Kerr 2009, and Doe‑Simkins 2009 (for 2 mg IN naloxone in an overdose setting).
• Composition claims (C) are most exposed to US 5,866,154 (Bahal) and WO 00/62757.
• In the parallel litigation (Adapt Pharma v. Teva, D.N.J.), the district court found the asserted claims obvious (§ 103) over two combinations — (1) Strang + Djupesland + Kulkarni and (2) Davies / Kerr 2009, Kerr Formulation / Bahal — i.e., the art was treated as § 103 art, not clean § 102 anticipation. Note that Strang, Kulkarni, and Davies are prior art asserted in litigation and are not all on the 9,480,644 front page, so they are worth pulling separately if you want the full novelty attack.

4. Caveats / uncertainties (stated explicitly as required)

1. I was not able to retrieve, in one clean pass, the exact, complete 27‑item "Patent Citations" table printed on US 9,480,644's own front page. The list above is reconstructed from (a) the patent's own specification, (b) the front‑page "References Cited" reproduced in litigation exhibit scans of the patent and its siblings, and (c) the Google Patents citation table. A handful of dates (e.g., for US 7,977,376, the 2015–2016 PCT items) are from memory or context and should be confirmed against the printed patent.
2. I could not retrieve the verbatim granted claim text of US 9,480,644 within this session. The "claims potentially anticipated" column therefore maps to claim categories (device / composition / method / kit) derived from the specification's summary, not to specific numbered claim language.
3. The item WO 2002051380 / WO 02/051380 appears with both a "2002‑05‑13" and a "2002‑07‑04" rendering in different sources; I have used the number as cited without correcting it.
4. Anticipation (§ 102) requires a single reference to disclose every element; several references above are realistically § 103 (obviousness) art rather than true § 102 anticipation, and I have said so.

Bottom line: The most legally significant cited prior art for US 9,480,644 is US 4,464,378 / WO 82/03768 (IN naloxone method), WO 00/62757 (opioid antagonist + spray dispenser), WO 2012/156317 (high‑dose IN naloxone, Tmax data), US 5,866,154 (Bahal) (stabilized naloxone formulation), and the clinical NPL of Barton 2005, Kerr 2009, Dowling 2008, and Wermeling 2013. None of these, standing alone, appears to disclose a pre‑primed nasal device delivering ~2–12 mg naloxone HCl in ~100 µL, which is the core of the device claims; the strongest validity challenge to 9,480,644 is a § 103 combination, consistent with the district court's obviousness holdings in the related Adapt Pharma litigation.

I'll verify the claim scope and litigation/prior-art context before building the § 103 analysis.

Let me pin down the exact claim text of the '644 patent and the prior-art combinations that have already been adjudicated for this family.

Obviousness Analysis — U.S. Patent 9,480,644 B2 under 35 U.S.C. § 103

0. Scope, sourcing, and caveats (read first)

• Authority used: The prior-art section of the US 9,480,644 page (https://patents.google.com/patent/US9480644/en) supplies the reference list analyzed here. Where the page's background section quotes a reference without a number (e.g., the "compositions for IN or oral (PO) administration … single or multiple doses … 0.2 to 5 mg" passage), I map it to the corresponding exhibit in the litigation on this family, which quotes the identical text verbatim (Davies / "Nalox1009," https://www.docketalarm.com/cases/[PTAB](/ptab)/IPR2019-00685/Nalox-1_Pharmaceuticals_LLC_v._Opiant_Pharmaceuticals_Inc/docs/02-19-2019-Petitioner/Exhibit-1002-Nalox1002_Donovan_Declaration.pdf). I flag that mapping as an inference.
• Claim text caveat: The provided corpus contains the specification and definitional material but not the numbered claims of US 9,480,644. My claim mapping below is reconstructed from (a) the specification's own statement of its independent claims, (b) Opiant's 8-K characterizing the '644 as covering "nasal spray formulations, devices, and methods of treatment covering the two-milligram dose of NARCAN" (https://getfilings.com/sec-filings/[170309](/patent/170309)/OPIANT-PHARMACEUTICALS-INC_8-K/v461504_ex99-1.htm), and (c) a secondary complaint analysis mapping the '644's independent device claim (https://ai-lab.exparte.com/case/dct/njd/2:18-cv-05752/doc/analysis/1). The conclusions below do not turn on the exact numeric boundaries (2 mg vs. "about 2–12 mg"), because every value in that range is disclosed or suggested by the art of record.
• Priority/date caveat (legally important): The page lists the prior-art date as 2014-03-14, but the '644 (App. 14/942,344, filed 2015-11-16) is a continuation-in-part of App. 14/659,472 (filed 2015-03-16, issued as US 9,211,253). The district court in the companion case treated March 2015 as the operative date (findings framed as "prior to March 2015"). Subject matter first appearing in the '644 gets only the 2015-11-16 date. This matters for what the § 103 art is; it does not change the analysis because all principal references pre-date March 2015.

1. Legal standard and the person of ordinary skill

The controlling framework is Graham v. John Deere Co., 383 U.S. 1 (1966), as applied in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and In re Kahn/ KSR ("articulated reasoning with some rational underpinning"). Under KSR, a claim is obvious where (i) the elements are found in the prior art and a POSA had a reason to combine them, (ii) the combination is "the predictable use of prior art elements according to their established functions," or (iii) the prior art discloses "a finite number of identified, predictable solutions."

POSITA: a person with an advanced degree (M.S., Pharm.D., Ph.D., or M.D.) in pharmaceutics, pharmaceutical sciences, pharmacology, or a related discipline, and at least ~3–5 years of experience developing nasal drug formulations and/or nasal delivery devices, including familiarity with nasal spray pumps (metered multi-dose, single-dose, bi-dose), excipient selection for nasal solutions, and pharmacokinetic parameters (Cmax, Tmax, AUC, bioavailability). This level of skill is consistent with the experts credited in the family's litigation (Dr. Smyth for the challenger; Dr. Illum for the patentee).

2. The claimed subject matter (reconstructed)

3. The prior art of record (from the '644 background, with the family's litigation art as corroboration)

4. Combinations that render the claims obvious

Combination A — the primary device combination: Strang (WO 2012/156317) + Davies + the single-dose nasal device art (Aptar UDS / BD Accuspray)

Covers: L1, L2, L3, L4, L6, L7, L8 (device and product claims; largely L5).

• Strang teaches the same drug, same route, same indication, and — critically — the same concentrations: 8 mg/400 µL = 20 mg/mL and 16 mg/400 µL = 40 mg/mL. The claimed 2 mg/100 µL and 4 mg/100 µL are exactly those concentrations with the total volume divided by four. Scaling dose and fill volume is, at most, routine optimization of a disclosed range. The Fed. Cir. in the sibling case endorsed exactly this reasoning (claimed concentration ranges arrived at by "routine optimization"), https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf.
• Davies supplies the unit-dose 0.2–5 mg nasal spray applicator with a 20–100 µL shot volume, i.e., the 2 mg/100 µL unit itself.
• The specification's own discussion of the BD/Aptar single-dose devices supplies L2 and L4 as a matter of admission (MPEP 2129; Constant v. Advanced Micro-Devices): the UDS "consist[s] of a reservoir, a piston, and a swirl chamber"; the spray forms on the first actuation with no priming step; 100 µL is emitted from a 125 µL fill; the device is one-hand held. The specification even reasons that priming is a drawback of metered-dose pumps and that "for … drugs intended for single administration or sporadic use … single-dose or bi-dose spray devices are preferred."

Motivation (KSR factors): (1) Known problem/design incentive — the page itself states the unmet need for "durable, easy-to-use, needleless devices with storage-stable formulations, that can enable untrained individuals to quickly deliver a therapeutically effective dose"; the 2012 FDA meeting specifically solicited an approved intranasal naloxone product (Fed. Cir. op. at 4). (2) Same field, same problem — Strang, Davies, Wermeling, Kerr, Barton and the device art are all "clearly within a common field of endeavor." (3) Predictable substitution — replacing a multi-dose metered pump with a known, commercially marketed, FDA-approved single-dose nasal unit-dose device is the substitution of a known element to perform its known function. (4) Finite predictable solutions — the page frames the field as being between (a) multi-dose pumps (priming, preservatives, overfill) and (b) single/bi-dose devices (pre-filled, sterile-fill, no preservative), and expressly identifies the single-dose approach as preferred for sporadic single administration. (5) Low volume to reduce drainage — the page expressly criticizes the MAD's ~1 mL/nostril and attributes drug loss to drainage, supplying the motivation for L7.

Combination B — the primary method combination: U.S. 4,464,378 + WO 82/03768 + Kerr 2009 (+ Barton 2005)

Covers: L1, L3, L7, L10 (method-of-treatment claims).

• U.S. 4,464,378: IN naloxone to reverse narcotic effects. WO 82/03768: a 100 µL nasal unit of naloxone HCl. Kerr: 2 mg IN efficacy statistically comparable to 2 mg IM (72.3% response <10 min; 8.0 vs. 7.9 min). Barton: 2 mg IN in "found down" (i.e., lying/supine) patients. Together these disclose every element of a method of treating opioid overdose in a patient found in a lying position by administering ~2 mg naloxone in ~100 µL intranasally.
• Motivation: the 0.2–5 mg range of Davies plus Kerr/Barton's demonstrated 2 mg efficacy plus Loimer's IV-comparability gives a POSA a finite, identified set of options; the OEND literature (DOPE Project; Massachusetts OEND) supplies the demand for lay administration, and the page's own statement that naloxone "has a relatively short half-life … [so] there is often the need to re-administer" supplies the motivation for the higher (4 mg) endpoints within the claimed range.

Combination C — the preservative-free/formulation combination: Davies + Strang + the sterile-fill/single-dose device teaching

Covers: L5 in its "substantially free of antimicrobial preservatives" embodiment ("less than 1% w/w," and the species claims at 0.01%/0.001% w/w) and L4.

• The page itself concedes both halves of the motivation: "Metered-dose spray pumps … replace the emitted liquid with air, and preservatives are therefore required"; "pump manufacturers … have developed different spray systems that avoid the need for preservatives"; and "With sterile filling, the use of preservatives is not required, but overfill is required." A single-dose, terminally/aseptically filled device therefore renders the preservative-free claims obvious.
• This combination immunizes the analysis against the strongest non-obviousness argument in the family (Wyse's BKC-degradation teaching away), because the claims expressly embrace a preservative-free product.

Combination D — excipient selection: Strang or Davies + Bahal + Kulkarni/FDA IIG + Handbook of Pharmaceutical Excipients

Covers: L5 (NaCl isotonicity agent; EDTA stabilizer; HCl for pH 3.5–5.5).

• Where the claims recite conventional excipients in conventional amounts, the challenger need only show that each excipient was known for the same function in nasal (or parenteral naloxone) formulations. The Fed. Cir. expressly credited the district court's finding that the "interrelated teachings" of Bahal (EDTA prevents naloxone degradation; albeit injectable) and Kulkarni (common intranasal excipients listed in the FDA's IIG) supplied the reason to select each ingredient. Note the specification itself lists BKC, methylparaben, sodium benzoate, benzoic acid, phenyl ethyl alcohol, polysorbates, etc. as known nasal formulation ingredients — an admission of the excipient universe.

Combination E — performance/clinical-parameter claims: Wermeling 2013 + Strang + Rabiner 2011 (+ the '644's own FIG. 1–2 data)

Covers: L8 (Tmax), L9 (occupancy), L2/L6 (delivery time, one-hand operation), L10.

• Tmax: Wermeling predicts tmax ≈20 min for a 2 mg nasal dose; Strang measured Tmax 20.4/23.4 min for 8/16 mg IN. A Tmax of "less than 30 minutes" / "about 20 minutes" is squarely disclosed, and any remaining difference is a result-effective variable inherent in the disclosed route.
• Occupancy: Rabiner 2011 discloses the [11C]carfentanil PET method for measuring µ-opioid receptor occupancy and time to onset, and the page itself proposes using PET "for comparing nasal delivery of naloxone using the devices and at the doses described herein." A POSA armed with Rabiner's method and the Wermeling/Strang PK profiles could determine occupancy as a matter of routine measurement. This is the weakest link in the obviousness chain — the claims recite specific numeric occupancy thresholds (>90/95/99%) that no single reference states, and a patentee could argue non-obviousness on the ground that the art predicted only low plasma concentrations (Wermeling predicted Cmax of only 3–5 ng/mL), so the achievement of near-quantitative receptor occupancy was unexpected. I would not predict invalidity of these claims with high confidence absent PK/PD evidence linking the claimed plasma profile to the claimed occupancy.
• Delivery time/one-hand: the page admits the Aptar/BD devices are held thumb-on-actuator with a pressure-point mechanism for reproducible actuation — i.e., one-handed and fast. A POSA would recognize these as inherent properties of the disclosed device, not an inventive contribution.

Combination F — kit claims: any of A–E + the OEND rescue-kit art (DOPE Project; Massachusetts OEND)

Covers: L11. The background discloses community naloxone rescue kits, distribution to lay bystanders, and the police-confiscation rationale for a pre-filled, unremarkable device. Packaging a known device with written instructions (or with an opioid agonist, given the page's discussion of co-prescription and tamper-resistant opioid formulations) is a conventional packaging expedient with a predictable result.

5. Reasons a POSITA would have combined the references (summary)

1. Common problem, common field: every reference addresses intranasal naloxone for opioid overdose.
2. Known, specific deficiency in the prior art: the MAD kit required two-handed assembly, delivered ~1 mL/nostril (causing drainage), and was not FDA-approved; multi-dose pumps required priming and preservatives. The page states these drawbacks itself.
3. Regulatory pull: the 2012 FDA public meeting explicitly encouraged an approved intranasal naloxone product and indicated exposure comparable to injectable naloxone was the goal.
4. Consumer/market pull: OEND/DOPE distribution to untrained bystanders, need for a "ready-to-use" product, and the police-confiscation concern.
5. Finite, predictable solutions: the art identified the options (dose 2–4 mg in 100 µL; single- vs. bi-dose device; preserved vs. preservative-free; Na/Cl tonicity adjustment; EDTA stabilizer; HCl pH).
6. Reasonable expectation of success: Kerr and Barton had shown 2 mg IN works; Strang had shown 8/16 mg IN is absorbed with a ~20 min Tmax; the device and excipients were all marketed for nasal use.

6. Counterarguments, teaching away, and objective indicia

Teaching away (patentee's best ground).

• Dowling 2008 (4% relative IN bioavailability; no measurable concentrations after ~1 h) is on the '644 page and could be argued to "criticize, discredit, or otherwise discourage" the claimed path. Rebuttal: Dowling criticized a specific low-volume intranasal preparation; Kerr (2009), Barton (2005), Loimer (1994) and Strang all demonstrated clinical adequacy, so the art as a whole does not "lead in a direction divergent." Under the teaching-away standard as applied in this very family (Medichem; DuPont v. Synvina), a reference that merely identifies a disadvantage does not foreclose a combination.
• Wyse is not on the '644 page but is the patentee's strongest argument in the family (Wyse reports BKC produces an "additional degradant" in naloxone nasal formulations). Critically: (i) the D.N.J. found Wyse did not teach away and the Fed. Cir. affirmed, deferring to the finding that a POSA would be dissuaded only from high BKC concentrations, not from BKC at the claimed 0.01% w/v; (ii), and more decisively for the '644, the claims expressly cover a preservative-free solution, so Wyse cannot supply a teaching away as to those claims (7, 8). The PTAB reached the opposite conclusion on teaching-away for the '253/'747/'965 (IPR2019-00685/688/694, Aug. 21, 2020), which is a genuine split the patentee would exploit.

Objective indicia. Commercial success of NARCAN (the '644's stated commercial embodiment is the 2 mg product), FDA approval/fast-track, OEND adoption, industry skepticism about doses >2 mg, alleged copying by Teva's ANDA, and long-felt need are all available. But the Federal Circuit in the sibling case found the same class of evidence insufficient to overcome a "strong case of obviousness," and it expressly rejected (as clear error but harmless) the district court's long-felt-need analysis. Any '644 trial would very likely reach the same result for overlapping limitations. Also expect nexus attacks, since the claims cover a device/dose, and NARCAN's commercial success is partly attributable to OEND distribution programs and the 2015 approval rather than to the claimed device per se.

Priority/§ 102 nuance to raise: because the '644 is a CIP filed 2015-11-16, any subject matter new to the '644 (e.g., specific claim language or data not in the 14/659,472 disclosure) gets only the 2015 filing date, potentially exposing it to art published between March and November 2015.

7. Real-world corroboration from this family's record

• D.N.J. (No. 16-7721), June 22, 2020: the court found the asserted claims of the '253, '747, '177, '965, and '838 patents invalid as obvious over two three-reference sets of prior art (the "Davies combination" and the "Strang combination," with Wyse, Kerr 2009, Bahal, Kulkarni, Djupesland, and the Handbook of Pharmaceutical Excipients), and found the secondary considerations insufficient (https://cases.justia.com/federal-district-courts/new-jersey/njdce/2:2016cv07721/[340302/344](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=340302-0344)/0.pdf).
• Fed. Cir. (No. 20-2106), Feb. 10, 2022: affirmed, holding there was no clear error in the motivation-to-combine findings and that the objective evidence did not overcome "the strong case of obviousness." Notably, the affirmed claims included the '838 method claim reciting delivery "from a pre-primed device," i.e., the same L2 limitation central to '644 (https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf; commentary: https://wolfgreenfield.com/articles/federal-circuit-affirms-as-obvious-suite-of-patents-directed-to-methods-of-treating-opioid-overdose). Judge(s) dissented on teaching-away/objective indicia.
• PTAB, Aug. 21, 2020: final written decisions in IPR2019-00685/688/694 upheld the '253, '747, and '965 claims against obviousness (accepting the BKC teaching-away argument) (https://emergentbiosolutions.gcs-web.com/static-files/334d83f6-2ecf-4f02-be59-6d35de858afd).
• Position of '644 specifically: the '644 was asserted in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 2:18-cv-05752 (D.N.J., the "2 mg Naloxone Case," Teva ANDA 211561), filed 2018-04-09; that case was stayed pending the 4 mg appeal and terminated 2022-07-27 after the Federal Circuit mandate (https://www.courtlistener.com/docket/[7102018](/patent/7102018)/84/adapt-pharma-operations-limited-v-teva-pharmaceuticals-usa-inc/; https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A18-cv-05752). Nalox-1's fifteen IPR petitions covered the '253, '747, '177, '965, and '838 — not the '644 (and not the '937). I could not verify from the retrieved record that the '644's claims were ever formally adjudicated or cancelled; I would describe the '644 as litigated but not finally judged, though it is bound by the same specification and substantially the same art as patents that were held invalid.

8. Conclusion / claim-by-claim risk scorecard

Bottom line: every element of the device, method, formulation, and kit claims finds a home in the references appearing in the '644's own prior-art discussion (U.S. 4,464,378; WO 82/03768/Davies; Loimer; Barton; Kerr; WO 2012/156317/Strang; Wermeling; Kreek; the MAD kit; the Aptar UDS / BD Accuspray single-dose device art; the DOPE/OEND literature), and each combination is supported by a documented motivation (FDA 2012 call for an approved intranasal naloxone product; the MAD kit's size, assembly, and drainage defects; multi-dose pumps' priming/preservative requirements; OEND lay-bystander distribution and police-confiscation concerns; and a finite, enumerated set of design options). A § 103 challenge to the '644 would be strong, and is materially strengthened by the Federal Circuit's affirmance of invalidity of overlapping sibling claims that recited the identical "pre-primed" limitation. The best patentee defenses are (a) the narrow, occupancy-limited claims, (b) the Wyse teaching-away point on BKC (which the PTAB accepted and the Federal Circuit rejected in parallel proceedings), and (c) nexus-bearing objective evidence on the 2 mg product — but the last two have already failed once in this family on a fuller record than the '644 would generate on its own.