US 9629965

I'll verify the bibliographic data and retrieve the claim set, which isn't included in the text I was given. Let me run several targeted searches.

Let me pull the full claim set and check the patent's current ownership/litigation status.

US 9,629,965 B2 — "Nasal drug products and methods of their use"

Search scope note: My searches covered Google Patents (authoritative full text you supplied, https://patents.google.com/patent/US9629965/en), DrugPatentWatch (last updated Apr 15, 2026), the PTAB docket records for IPR2019‑00694/‑00695/‑00696, the D.N.J. and Federal Circuit records in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., and CAFC docket 20‑2106. I found no 2026 CAFC docket activity involving 9,629,965; the only appellate proceeding I can confirm is 20‑2106, decided Feb. 10, 2022. I cannot claim that search was exhaustive.

1. Bibliographic data

Sources: https://patents.google.com/patent/US9629965/en · https://patents.google.com/patent-exob/9629965 (DrugPatentWatch) · https://www.biospace.com/opiant-pharma-announces-fda-orange-book-listing-for-new-narcan-nasal-spray-patent-[788026](/patent/788026)

2. Abstract

"Drug products adapted for nasal delivery, comprising a pre-printed [sic — read "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."

(Note: the OCR of the printed patent renders "pre-printed"; the specification's own definition section and DrugPatentWatch both give "pre-primed," which is the correct term of art as defined in the patent.)

3. Overview of the independent claims

Claim 1 — Pharmaceutical formulation (verbatim)

"A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 μL:

• about 4 mg naloxone hydrochloride;
• about 0.74 mg NaCl;
• about 0.01 mg benzalkonium chloride;
• about 0.2 mg disodium edetate; and
• an amount of hydrochloric acid sufficient to achieve a pH of 3.5–5.5."

Plain language: A concentrated (~100–140 µL) intranasal naloxone solution of fixed quantitative composition — 4 mg naloxone HCl, saline, a very low level of benzalkonium chloride (BZK, at 0.01 mg this works out to ~0.01% w/v), disodium EDTA as a stabilizer, and HCl to a mildly acidic pH of 3.5–5.5. This quantitative "recipe" limitation is what distinguishes claim 1 from the broader genus claims of the sibling patents in the family.

Claim 9 — Method of treatment (independent)

"A method of treatment of opioid overdose or a symptom thereof, comprising: nasally administering to a patient in need thereof the pharmaceutical formulation of claim 1."

Plain language: Use of the claim‑1 formulation to treat opioid overdose (or a symptom of it) by nasal administration. Dependent claims 10–18 add outcome/patient limitations, e.g.:

• Claim 2: aqueous volume of 100 µL.
• Claims 3–5: minimum mean plasma concentrations of ≥0.2 ng/mL within 2.5 min; ≥1 ng/mL within 5 min; ≥3 ng/mL within 10 min.
• Claims 6–8: naloxone Tmax < 30 min, < 25 min, < 20 min, respectively.
• Claims 10–12: less than about 20% / 10% / 5% of the dose leaves the nasal cavity by drainage into the nasopharynx or externally.
• Claim 13: Tmax of about 20–30 min.
• Claims 14–16: mirror the concentration endpoints of claims 3–5.
• Claim 17: patient is an opioid overdose or suspected opioid overdose patient.
• Claim 18: patient exhibits one or more of respiratory depression, CNS depression, cardiovascular depression, altered level of consciousness, etc.

Remaining independent claims — UNCERTAIN, please verify

I was not able to retrieve the verbatim text of claims 19–30 in this session, so the following is inference from the IPR petition ground structure and the specification, not authoritative claim text:

• The petition in IPR2019‑00694 challenged all of claims 1–30. The IPR2019‑00696 petition's Ground 1 grouped "claims 1–2, 9–12, 17–23, 25–26, and 29–30," with claim 20 argued separately — strongly implying claim 20 is a further independent claim directed to a single-use, pre-primed nasal delivery device whose single reservoir contains ~100 µL of an aqueous naloxone formulation (the specification supports this exact language: "a single-use, pre-primed device adapted for nasal delivery … by one actuation … into one nostril … having a single reservoir comprising about 100 µL of a pharmaceutical composition which is an aqueous solution comprising…").
• The D.N.J. Markman opinion identified claim 29 as containing the disputed "delivery time" limitation (construed as the time from a determination that nasal naloxone delivery is needed to completion of delivery; Teva argued it was indefinite and lost).
• Claims 27–30 appear to form a further group (claimed 24 was challenged in a separate ground, suggesting different dependency/scope).

If you need exact claim language for 19–30, pull the patent PDF directly: https://patentimages.storage.googleapis.com/e1/4f/21/0fde8ddc1c008b/US9629965.pdf

4. Post-grant status

The Board's decision in IPR2019‑00694 expressly noted that the district court's June 2020 judgment held claims 21, 24 and 25 of the ’965 patent invalid while the IPRs challenged all of claims 1–30.

5. Explicit uncertainties

1. Claims 19–30 verbatim — not retrieved; my characterization of any independent device claim (likely claim 20) and the "delivery time" claim (claim 29) is inferential. Do not rely on it for a validity or infringement opinion.
2. Legal status "Expired – Fee Related" — this is Google Patents' machine-generated label, which typically signals lapse for non-payment of maintenance fees. I did not independently verify maintenance-fee payment or any formal lapse/dedication with the USPTO. The listed anticipated expiration remains 2035‑03‑16 despite this label.
3. Assignee — Google Patents and DrugPatentWatch both list Indivior UK Ltd, reflecting a recorded 2023‑06‑14 assignment from Opiant; the printed patent face shows Opiant Pharmaceuticals, Inc. I could not confirm the current chain of title beyond the recorded assignment.
4. No 2026 CAFC activity found — the only appellate case I can confirm is 20‑2106 (2022). I cannot rule out a more recent appeal that my search did not surface.
5. Priority chain — the "2014‑03‑14" date is a provisional (the "’379 provisional" referenced in the IPR petitions); the ’965's immediate parent is US 14/659,472, filed 2015‑03‑16, which issued as US 9,211,253. The terminal disclaimer ties the ’965 term to that family.

I'll research litigation involving US patent 9629965 using multiple sources.

Let me dig deeper into the specific IPR proceedings and district court cases.

Let me search for the remaining district court cases and IPR outcomes.

Litigation Involving U.S. Patent No. 9,629,965 ("Nasal drug products and methods of their use")

Short answer: Yes — there is well-documented litigation. U.S. 9,629,965 (the "'965 patent," current assignee Indivior UK Ltd, formerly Opiant Pharmaceuticals, Inc.) was asserted in the NARCAN® Nasal Spray Hatch‑Waxman / ANDA litigation brought by the Adapt Pharma entities and Opiant against Teva in the District of New Jersey, was held invalid for obviousness (affirmed by the Federal Circuit in 2022), and was separately challenged at the PTAB by Nalox‑1 Pharmaceuticals, LLC, where the claims survived.

I have kept every case number, party name, and identifier exactly as the sources render them (note one source misspells the patent as "9,269,965" — I flag that below rather than silently correcting it).

1. District Court Litigation (D.N.J.)

Note: a later D.N.J. complaint (courtlistener docket 371452) concerns the NARCAN® Nasal Spray 2 mg product (NDA No. 208411) and the same Teva defendants, but I could not confirm that the '965 patent was asserted in that pleading.

2. Federal Circuit Appeal

Opinion PDF: https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf

3. PTAB Proceedings (Inter Partes Review)

Petitioner Nalox-1 Pharmaceuticals, LLC (associated in PTAB filings with Burford Capital Ltd., BCIM PIII Holdings, LLC, Burford Capital Ireland DAC, et al.) filed 15 IPR petitions on Feb. 19, 2019 — three against each of five Narcan-related patents ('253, '747, '177, '965, '838) — against Patent Owner Opiant Pharmaceuticals, Inc.

• Google Patents' litigation sidebar for US9629965 lists all three IPRs above (IPR2019-00694 Final Written Decision; IPR2019-00695 and IPR2019-00696 "Not Instituted – Procedural"). Source: https://patents.google.com/patent/US9629965/en
• Consolidation context: the Board exercised its discretion to deny most of the 15 Nalox‑1 petitions as redundant, instituting only certain "Wyse"-lead petitions — e.g., IPR2019-00685 ('253 patent), IPR2019-00688 ('747 patent), and IPR2019-00694 ('965 patent). See Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., and the D.N.J. opinion at ECF No. 283 (Nov. 13, 2019) discussing the IPRs.
• Note: The D.N.J. opinion at one point transcribes the patent as "9,269,965 ('the '965 patent')" — this appears to be a typographical error for 9,629,965; I have not altered the quoted string.

4. Related Proceedings Not Involving U.S. '965

• Canada: Emergent Biosolutions / its Adapt subsidiaries sued Teva Pharmaceuticals in Canada on July 23, 2020 over Teva's abbreviated new drug submission for a generic NARCAN® Nasal Spray. This concerns the Canadian counterpart patent, not U.S. 9,629,965.
• Orange Book: U.S. 9,629,965 is listed in the Orange Book for NARCAN, NDA 208411 (naloxone hydrochloride, metered nasal spray), with a listed expiration of March 16, 2035.

5. Summary Table

Key sources

• Google Patents, US9629965B2 (litigation sidebar): https://patents.google.com/patent/US9629965/en
• CAFC opinion 20-2106 (Feb. 10, 2022): https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
• D.N.J. Opinion & Order, 2:16-cv-07721 (June 5, 2020) invalidity of '965 claims 21, 24, 25: https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.342.0_1.pdf
• PTAB IPR2019-00694 Institution Decision (Sept. 11, 2019): https://www.docketalarm.com/cases/PTAB/IPR2019-00694/
• PTAB IPR2019-00694 Final Written/Termination Decision (Aug. 21, 2020, Wyse + HPE, claims upheld)
• RPX Insight, Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals Inc IPR of '965: https://insight.rpxcorp.com/ptab/10042-nalox-1-pharmaceuticals-v-opiant-pharmaceuticals-inc-ipr-of-965
• DrugPatentWatch — Litigation for Patent 9,629,965: https://www.drugpatentwatch.com/p/litigation/patent/index.php?query=9629965
• Emergent Biosolutions 10-Q (July 31, 2020) describing the IPR and Canadian proceedings

Caveats

1. I did not have direct PACER access; docket dates above come from CourtListener/Justia RECAP copies, DrugPatentWatch, and Google Patents' family-litigation feed, which can differ by a few days.
2. The disposition of IPR2019-00695 is inconsistent across sources (institution decision vs. "not instituted – procedural" plus a post-institution fee refund). Verify on PTAB E2E before relying on it.
3. I could not confirm whether the '965 patent was asserted in every one of the related D.N.J. dockets (2:17-cv-00864, 2:17-cv-02877, 2:17-cv-05100, 2:18-cv-09880, 2:18-cv-15287). The only '965 claims actually adjudicated were claims 21, 24, and 25 in the consolidated 2:16-cv-07721 action.
4. No litigation by any defendant other than Teva (U.S.) was identified for this specific patent.

I'll research the PTAB proceedings on US 9,629,965 — the patent's own front page flags several IPRs and a Federal Circuit appeal, so let me pull the details.

Good — the structured block's "no proceedings" result is wrong; the patent's own record shows three IPRs and a CAFC appeal. Let me nail down the remaining details.

Let me verify the appeal chain, any post-2022 PTAB activity, and the patent's current fee status.

PTAB Analysis — US 9,629,965 B2 ("Nasal drug products and methods of their use")

Correction to the source data first. The structured "PTAB proceedings on file" block states the ODP API returned no AIA trial proceedings for this patent. That is wrong, and materially so. The patent's own front matter and the PTAB docket show three IPRs filed on 2019-02-19 by Nalox-1 Pharmaceuticals, LLC — IPR2019-00694, -00695, and -00696. I sourced them from the patent record, the PTAB docket (DocketAlarm/PTAB E2E), the petitioner's mandatory notices, and the Board's own decisions. Treat the ODP result as an incomplete ingest (likely because all three proceedings are long since terminated), not as an absence of activity. The "no PTAB activity" default rule stated in my instructions does not apply here.

Proceedings overview

Three AIA trials were filed against US 9,629,965; one was instituted and went to a Final Written Decision in which the Board held no challenged claims unpatentable (claims 1–30 all sustained), and the other two were denied institution. Bottom line for a defendant: this is a PTAB-hardened patent on the formulation/device claims — the obviousness theory built on the Wyse reference (US 9,192,570) lost on the merits after a full trial, and the Board found Wyse teaches away from benzalkonium chloride in intranasal naloxone. The one genuine crack is elsewhere: claims 21, 24, and 25 were held invalid as obvious by the District of New Jersey, and the Federal Circuit affirmed that judgment on 2022-02-10 (Nos. 20-2106). So the patent has a PTAB win and a parallel court loss on a subset of claims — the same reference, opposite outcomes.

IPR2019-00694 — Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc. (with Adapt Pharma Operations Limited)

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Final Written Decision — "Determining No Challenged Claims Unpatentable" under 35 U.S.C. § 318(a). Gloss: petitioner lost outright; the entire claim set survived.
• Judge panel: Erica A. Franklin, Zhenyu Yang, and Michael A. Valek, Administrative Patent Judges. The FWD is captioned with Judge Valek as authoring judge; third-party databases (Patexia) attribute authorship to Judge Yang. The substantive panel is identical either way.
• Petition grounds: Obviousness under § 103 over Wyse (U.S. Patent No. 9,192,570) in view of HPE (Handbook of Pharmaceutical Excipients) — expressly asserted against claims 1–22, 25, 26, 29, and 30 — plus additional Wyse-centred combinations covering the remaining challenged claims. All claims 1–30 were challenged. Petitioner argued Wyse qualifies as prior art under AIA § 102(a)(2); Patent Owner did not contest prior-art status for these proceedings.
• Institution decision: Instituted 2019-09-11 (Paper 10). Because the Board found a reasonable likelihood as to at least one claim, SAS Institute v. Iancu compelled institution on all claims 1–30 — even though the Board noted petitioner had not shown a reasonable likelihood as to claims specifically reciting benzalkonium chloride ("BZK"/"BAC"). The panel expressly flagged the two redundant companion petitions and that petitioner was not a party to the parallel D.N.J. litigation.
• Final Written Decision: 2020-08-21 (Paper 55). Verdict: not one of claims 1–30 held unpatentable. The Board treated the teach-away question as dispositive for the whole set: "Because it is dispositive regarding all the challenged claims, we focus our analysis in this Decision on this issue alone." On the merits, the Board found Wyse "expressly teaches that BAC is unacceptable for use in intranasal naloxone formulations," that a POSA "would have given significant weight to the only naloxone formulation stability data disclosed in Wyse," and that the Wyse/HPE combination therefore "renders [none] of the challenged claims obvious." Independent claim 1 (reciting "about 0.01 mg benzalkonium chloride" and "about 0.2 mg disodium edetate") and independent claim 20 (reciting "between about 0.005 mg and about 0.015 mg of a preservative") were both sustained. Oral hearing held 2020-05-19.
• Settlement / termination: None. This went to a merits FWD; no adverse judgment, no settlement, no disclaimer.
• Appeal: No appeal located. The petitioner lost and did not obtain a docketed CAFC appeal that I can find. (The CAFC appeal in the chain — 20-2106 — arises from the D.N.J. case, not from this IPR.)
• Defensive value: The Wyse-based obviousness theory against the BZK-containing formulation claims is now dead on the PTAB record and, for Nalox-1 and its privies, estopped under § 315(e)(2). If a demand letter or complaint is built on claims 1–20 or 22–30, you cannot expect to win by rerunning the "Wyse teaches BAC" theory that the Board already rejected; you need materially different art or a different statutory theory.

IPR2019-00695 — Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Not Instituted – Procedural. Gloss: the Board exercised its § 314(a) discretion and refused to institute the redundant Wang-based petition. Opiant's own 10-Q confirms: "on October 1, 2019, the PTAB denied institution of IPR Nos. 2019-00695 and 2019-00696."
• Judge panel: Same panel as -00694 (Franklin, Yang, Valek).
• Petition grounds: Obviousness under § 103 with Wang (Chinese Patent No. 1,575,795) as the lead reference, ranked third of three petitions. Per Patent Owner, all three petitions relied on HPE (not Wyse) for the BZK teaching, and the petitions contained word-for-word identical passages on critical issues (spray volume, naloxone dose, choice of BZK and EDTA excipients). Challenged claims: 1–30.
• Institution decision: Denied 2019-10-01 (Paper 10). The Board had issued a 2019-07-31 Order (Paper 7) directing the parties to address the redundancy of the three petitions under General Plastic / the August 2018 Trial Practice Guide Update, noting petitioner had challenged five patents with fifteen petitions "filed at or about the same time." The Board then denied institution of the two non-Wyse petitions. (Docket artifacts: PTAB E2E mislabels the 2019-10-01 document type as a "Trial Instituted Document" — the substance is a denial. Petitioner's request for refund of post-institution fees was filed 2019-10-03 and approved 2019-10-21, consistent with non-institution.)
• Final Written Decision: N/A — no trial.
• Settlement / termination: N/A.
• Appeal: None. Institution denials are non-appealable (Cuozzo).
• Defensive value: The Wang reference remains untested by the PTAB — a denial for redundancy is not a merits holding, so there is no patentability determination and no estoppel on Wang. In principle a future petitioner could raise Wang-based art, though the Board's redundancy rationale signals it will look hard at follow-on petitions.

IPR2019-00696 — Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.

• Type: Inter Partes Review
• Filed: 2019-02-19
• Status: Not Instituted – Procedural. Same discretionary-denial event as -00695 (2019-10-01), per the patent owner's mandatory notices and Opiant's 10-Q.
• Judge panel: Same panel (Franklin, Yang, Valek).
• Petition grounds: Obviousness under § 103, Davies (WO 00/62757) as lead reference, ranked second of three. From the petition's own ground table: claims 3–5 and 14–16 obvious over Davies + HPE + Bahal + Kushwaha + Wyse; claims 6–8 and 13 over Davies + HPE + Bahal + Kushwaha + Wyse or Wang + POSA knowledge or Wermeling 2013; and claims 27–28 over Davies + Djupesland + HPE + Bahal + Kushwaha + the '291 patent. Challenged claims: 1–30. Petitioner also advanced a certified human translation of Wang versus the machine translation before the examiner, arguing non-redundancy.
• Institution decision: Denied 2019-10-01 (same discretionary-denial order as -00695). Patent Owner's characterization — accepted by the Board — was that Davies and Wang taught fewer limitations than Wyse, i.e. were strictly weaker references.
• Final Written Decision: N/A — no trial.
• Settlement / termination: N/A.
• Appeal: None.
• Defensive value: The Davies reference is likewise untested. Uninstituted grounds carry no estoppel against the petitioner, and none against third parties.

Related Federal Circuit appeal — Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc. (No. 20-2106)

• Type: CAFC appeal from D.N.J. bench judgment (not a PTAB FWD appeal)
• Filed / docketed: 2020-08-03
• Status: Decided and affirmed — 2022-02-10. Opinion by Judge Stoll, joined by Judge Prost; Judge Newman dissenting.
• Underlying judgment: D.N.J. 2:16-cv-07721-BRM-JAD (consolidated), final judgment in June 2020 holding claims 21, 24, and 25 of the '965 patent invalid as obvious (along with claims of the sibling '747, '177 and '838 patents). Note a minor record discrepancy: the '965 FWD states final judgment was entered 2020-06-22, while the companion '747 FWD and the D.N.J. docket state 2020-06-26.
• Disposition: The Federal Circuit affirmed the invalidity judgment, rejecting Adapt's arguments on motivation to combine, teach-away, and objective indicia. The majority held Wyse's criticism of BZK did not teach away because BZK was commonly used in intranasal formulations and the prior art as a whole did not discourage the combination. Judge Newman dissented, calling the reasoning "a classical example of judicial hindsight."
• The conflict to brief: The same Wyse reference produced opposite outcomes in the two forums — the PTAB found teach-away and sustained all claims, the district court and CAFC found no teach-away and invalidated the asserted claims. The preponderance (PTAB) vs. clear-and-convincing (court) standards cut the other way, which is exactly the anomaly Adapt pressed on appeal and in its en banc petition.
• Post-appeal: A petition for rehearing/rehearing en banc was filed (a copy of the 20-2106 petition is publicly posted). I could not confirm the disposition of that petition from the sources retrieved — verify on the CAFC docket before relying on finality.
• Defensive value: Claims 21, 24, and 25 have been adjudicated invalid by a district court and affirmed on appeal. Any infringement theory resting on those three claims is very weak. Everything else (claims 1–20, 22–23, 26–30) remains standing.

Strategic summary

Claim-level status. Splitting the claim set by forum outcome:

• Sustained / PTAB-cleared (all 30 claims, but only against the Wyse + HPE and redundancy-displaced grounds): claims 1–30 were all challenged in IPR2019-00694 and none was cancelled. The Board's FWD expressly concludes petitioner "has not established by a preponderance of the evidence that claims 1–30 of the '965 patent are unpatentable."
• Judicially invalidated: claims 21, 24, and 25 — held invalid as obvious by D.N.J. and affirmed in Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 20-2106 (Fed. Cir. 2022-02-10). These are the only '965 claims that were actually adjudicated invalid.
• Untested: claims 2–4, 5, 6, 8, 10–19, 22, 23, 26–30 were never the subject of a final merits holding; the Wang (IPR2019-00695) and Davies (IPR2019-00696) attacks died at the institution stage, so those references carry no PTAB patentability determination.
• Net: the surviving, PTAB-tested core is claims 1–20 and 22–23, 26–30, with 21, 24, 25 removed by the affirmed court judgment.

Estoppel landscape. § 315(e)(2) estoppel runs against Nalox-1 Pharmaceuticals, LLC and its privies/real parties in interest (the Burford Capital–linked funding entities listed in the 2019 petition notices). Nalox-1 is estopped from asserting in any later civil action any ground it raised or reasonably could have raised in IPR2019-00694 — that sweeps in the Wyse + HPE combination and any obviousness theory built on Wyse's preservative disclosures. The institution denials in -00695 and -00696 generate no estoppel at all (and denials are non-appealable). Critically for a new defendant: you are not Nalox-1's privy merely by being another ANDA filer or generic competitor. Teva ran its own obviousness case in district court and won, despite Nalox-1's parallel IPR loss, and the Board expressly noted Nalox-1 "is not a party to these litigations." So a fresh defendant retains the Davies and Wang references, the district court's Davies/Strang/Kerr combinations, and any art not within Nalox-1's petition scope — while being realistically blocked from re-running Wyse-only theories that the Board already rejected.

Pattern signals. A single petitioner, Nalox-1 Pharmaceuticals, LLC, fired fifteen petitions across five NARCAN Orange Book patents (Nos. 9,211,253; 9,468,747; 9,561,177; 9,629,965; 9,775,838) on 2019-02-19 — "three against each" patent, one led by Wyse, one by Davies, one by Wang. The Board responded with a coordinated General Plastic / § 314(a) discretionary-denial sweep, instituting only one Wyse-led petition per patent; institution decisions clustered 2019-08-27 to 2019-10-01, and the three instituted trials produced parallel FWDs on 2020-08-21, all finding no claims unpatentable. This is not a defensive-aggregator (Unified Patents) or operating-company challenge — the petitioner entity is associated with Burford Capital litigation funding vehicles, and the Board itself noted petitioner was not a party to the underlying Hatch-Waxman litigation. That matters: the entity with the strongest § 315(e)(2) estoppel is a non-practicing challenger, so the estoppel has limited deterrent value against ordinary defendants. Patent Owner side: Adapt/Opiant litigated the D.N.J. case to a merits judgment and appealed to the Federal Circuit, which it lost; no PTAB FWD appears to have been appealed (the patent owner won those).

One item to verify before you build a defense on it. Google Patents lists the current legal status of US 9,629,965 as "Expired - Fee Related" despite an anticipated expiration of 2035-03-16. If that status is accurate, the patent lapsed for failure to pay a maintenance fee (the 7.5-year fee would have fallen around 2024-2025), which would be dispositive — but it could equally be a mislabeled status field, and a lapsed patent can be revived by petition under 35 U.S.C. § 41(c). I could not confirm the fee status from the retrievable record, so check the USPTO Patent Center maintenance-fee and revival record directly before relying on it. Assignee history is also worth noting: the patent moved from Opiant Pharmaceuticals to Indivior UK Limited by assignment recorded 2023-06-14, so any demand letter today should come from Indivior, not Opiant.

Recommended next steps

1. Do not treat this patent as IPR-free. The ODP "AIA trial proceedings" query returned nothing; the correct picture is three IPRs. Re-query PTAB E2E directly at https://ptacts.uspto.gov/ptacts/home for application/patent 9,629,965 and pull Papers 10 and 55 of IPR2019-00694.
2. Anchor on the FWD. The dispositive document is the IPR2019-00694 Final Written Decision, 2020-08-21, which states: "we conclude Petitioner has not established by a preponderance of the evidence that claims 1–30 of the '965 patent are unpatentable." Retrieve and quote it verbatim: https://www.docketalarm.com/cases/PTAB/IPR2019-00694/Inter_Partes_Review_of_U.S._Pat._9629965/docs/08-21-2020-Board/Termination_Decision_Document-55-Termination_Decision_Document.pdf
3. Map your claim exposure against the court judgment. If the asserted claims are 21, 24, or 25, lead with the D.N.J. judgment and the CAFC affirmance: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. 20-2106 (Fed. Cir. Feb. 10, 2022), opinion at https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf. Validate finality (en banc petition disposition) on the CAFC docket first. The D.N.J. claim-chart of what was at issue is at https://storage.courtlistener.com/recap/gov.uscourts.njd.[340302](/patent/340302)/gov.uscourts.njd.340302.283.0_1.pdf.
4. If the asserted claims are 1–20 or 22–30, you cannot rely on the Wyse teach-away theory — the Board already ruled against it, and your best path is Davies- or Wang-based art (never merits-tested by the PTAB) or the specific Davies/Strang/Kerr combinations that beat the patent in district court. Note the CAFC majority's holding that the prior art as a whole (not Wyse alone) failed to teach away — that is the template that worked.
5. No live PTAB milestones to calendar. All three proceedings are terminated — the sole trial completed with the 2020-08-21 FWD well inside the § 316(a)(11) one-year deadline from the 2019-09-11 institution. There is no pending institution deadline, oral hearing, or FWD due date on this patent.
6. Verify two administrative facts: (a) current maintenance-fee status / any revival at USPTO Patent Center, given the "Expired - Fee Related" flag; and (b) confirm Indivior UK Limited as the current owner via the USPTO Assignment database, since the 2023-06-14 recordation post-dates all three IPRs.

Evidence limits, stated plainly: I confirmed the existence, parties, filing dates, institution outcomes, panel, and the FWD's bottom line for IPR2019-00694, and the non-institution of -00695 and -00696. I did not retrieve the complete ground-by-ground table for IPR2019-00694 (so I have not enumerated which claims each non-Wyse ground covered), the full text of the two denial decisions, or the disposition of the en banc petition in No. 20-2106. Those are the gaps to close from PTAB E2E and the CAFC docket before filing anything.

I'll research the assignment record for US 9629965 across the sources named. Let me start with parallel searches.

Good context. Now let me try to pin down reel/frame numbers, the correspondent of record, and the PTAB challenger identity.

I've hit the search-retrieval limit, so I'm writing up based on what I could verify. One important structural caveat up front, and I'll keep it explicit rather than paper over it.

US 9,629,965 — Ownership & Assignment Reconstruction

Scope note / data caveat. I was able to retrieve the event-level assignment data (assignor, assignee, dates) from Google Patents' legal-events record, which mirrors the USPTO Assignment Center. I was not able to retrieve the fields you specifically asked for — reel/frame numbers and the correspondent of record — from the public sources available to me. I will not invent them. Every reel/frame and correspondent slot below is marked not retrieved and must be pulled directly from Assignment Center (search by patent number): https://assignmentcenter.uspto.gov/ (indexed at https://assignment.uspto.gov/patent/index.html).

Inventors

Unusual-pattern check: No "inventors depart within 12 months" pattern. The opposite is true — Crystal is identified in Opiant's own SEC filings and board disclosures as CEO through the entire relevant period, i.e., an inventor-executive who stayed and ran the company, which is the signature of a genuine operating-company program, not a burn-and-sell inventor set.

Original assignee

• Entity on the issued patent: Opiant Pharmaceuticals, Inc. (Delaware/Nevada specialty pharma; incorporated 2005 as Madrona Ventures, Inc. → renamed Lightlake Therapeutics Inc. on 2009-09-16 → renamed Opiant Pharmaceuticals, Inc. on 2016-01-28, per the company's own 10-K narrative).
• Did they ship a product embodying the claims? Yes, indirectly. Opiant developed the claimed intranasal naloxone product and exclusively licensed it to Adapt Pharma Operations Limited (deal announced December 2014). That product launched as NARCAN® (naloxone HCl) Nasal Spray — FDA-approved November 2015, launched by Adapt in the US in February 2016, and Orange Book-listed under NDA 208411 with the '965 patent as a listed patent (expiry 2035-03-16). Opiant monetized the royalty stream (not the patent) to SWK Funding LLC in December 2016 (up to $17.5M, plus a further $3.75M Aug 2017). The patent itself was not assigned in the SWK transaction — that is a common misread; SWK took royalties, Opiant kept title.
• Primary line of business: Specialty pharma developing opioid-antagonist treatments for addiction/overdose and eating disorders.
• Current status: Acquired — Indivior PLC completed its acquisition of Opiant on 2023-03-02 for ~$145M upfront plus CVRs; Opiant stock ceased trading on Nasdaq. Opiant was subsequently merged into the Indivior group. Not dissolved in bankruptcy, not an NPE shell.

Assignment timeline

Two recorded assignment events are visible in the legal-events record for this patent.

• Executed date not shown in my sources / recorded 2017-01-26 — Reel not retrieved/not retrieved

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: WEISS, MICHAEL BRENNER; CRYSTAL, Roger (individually)
  • Assignee: OPIANT PHARMACEUTICALS, INC.
  • Correspondent: not retrieved (must be pulled from Assignment Center)
  • Context: Ordinary inventor-to-company assignment perfecting title in the applicant; near-contemporaneous with the 2016-10-26 filing.

• Executed on or about the 2023-03-02 merger closing / recorded 2023-06-14 — Reel not retrieved/not retrieved

  • Conveyance: Assignment (result of merger/business combination — Indivior's acquisition of Opiant)
  • Assignor: OPIANT PHARMACEUTICALS, INC.
  • Assignee: INDIVIOR UK LIMITED
  • Correspondent: not retrieved. Note the transaction correspondents are of record elsewhere: Covington & Burling LLP acted for Indivior and Latham & Watkins LLP for Opiant on the 2022–23 deal; whether either filed this specific recordation is unverified.
  • Context: Acquisition / upstream reorganisation into the acquirer's UK IP-holding company. Follow-on evidence of the Indivior-internal structure appears in a 2024-11-20 Patent Assignment Agreement (Aegis Therapeutics, LLC → Indivior UK Limited, filed as an exhibit in Indivior filings) which recites that Opiant was acquired 2023-03-02 and thereafter merged into Indivior and that Indivior UK acquired "Opiant's Patents." That exhibit concerns a different patent family (Aegis absorption technology) — I mention it only as confirmation of the corporate chain, not as an assignment of the '965 patent.

No other assignees appear in the chain. Specifically, there is no assignment to Adapt Pharma, Emergent BioSolutions, or SWK Funding — their relationship to this patent is license/royalty, not title.

Timeline diagram

timeline
    title Ownership of US 9629965
    2005 : Opiant founded as Madrona Ventures
    2016 : Application 15 335 145 filed
         : Inventors assign to Opiant
    2017 : Patent US 9629965 granted
    2019 : IPRs filed by Nalox-1 Pharmaceuticals
    2023 : Opiant acquired by Indivior UK Limited

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The chain runs Opiant Pharmaceuticals, Inc. → Indivior UK Limited. Indivior UK Limited is a wholly-owned operating subsidiary of LSE/Nasdaq-listed Indivior PLC (principal place of business: The Chapleo Building, Henry Boot Way, Priority Park, Hull HU4 7DY, UK — a real pharmaceutical site), not a Delaware/Texas single-purpose LLC at a registered-agent address. The group ships products (SUBOXONE, SUBLOCADE, PERSERIS, OPVEE). A large-cap pharma parking IP in a UK holding company is routine tax/structuring, not shell behaviour. (Mild nuance: the recorded assignee is the UK entity rather than Indivior PLC, but the owner is unambiguously within an operating group.)

2. Known asserter in the chain — NOT PRESENT. Neither Opiant Pharmaceuticals nor Indivior UK Limited appears on the RPX / Unified Patents / Acacia / Marathon / IV / Wi-LAN-style high-frequency-plaintiff lists. Both are identified operating pharmaceutical companies with SEC (Opiant) and LSE (Indivior) reporting histories.

3. Repeat correspondent across the chain — UNCLEAR / NOT DETERMINABLE. I could not retrieve the correspondent of record for either recording, so the recurrence test cannot be run. This is a genuine gap, not a negative finding — verify at Assignment Center before drawing any conclusion.

4. Cascading transfers — NOT PRESENT. Two recorded events only, ~6.3 years apart (2017-01-26 → 2023-06-14), and the second is a merger closing, not a chained LLC hop-scotch.

5. Pre-litigation transfer — NOT PRESENT. The enforcement campaign came before the only title change: NJ District Court cases 2:16-cv-07721 (Nov 2016), 2:17-cv-05100, and 2:18-cv-15287, plus PTAB IPR2019-00694/00695/00696 (petitioner Nalox-1 Pharmaceuticals, LLC), and the Federal Circuit appeal 20-2106 (decision 2022-02-10 in Adapt Pharma Operations Ltd. v. Teva, affirming invalidity of the asserted claims). The 2023 Indivior transfer is post-litigation and plainly deal-driven.

6. Bankruptcy fire-sale — NOT PRESENT. Opiant exited via a solvent ~$145M all-cash acquisition (plus $8/share CVRs), not a Chapter 7/11 sale.

7. Privateering — NOT PRESENT. Adapt Pharma (later part of Emergent BioSolutions) enforced the patent as Opiant's exclusive licensee and co-plaintiff against actual generic ANDA filers (Teva, Perrigo). Enforcing a licensed product patent against generic competitors is textbook operating-company assertion, not an operating company farming litigation out to a shell.

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified, or OIN. If anything, the inverse is notable: this patent was the target of a defensive challenge — PTAB IPR2019-00695 (filed 2019-02-19 by Nalox-1 Pharmaceuticals, LLC, institution 2019-10-01) and the related Nalox-1 petitions, with Unified Patents hosting the docket data. Nalox-1 Pharmaceuticals, LLC is the challenger, not an owner in this chain, so it is irrelevant to the ownership verdict but worth recording because it is the closest thing to an NPE-shaped entity anywhere near this patent — and it is on the defence side.

Verdict

Operating-company assertion.

The ownership chain for US 9,629,965 is a two-step, ordinary operating-company chain: the inventors assigned to Opiant Pharmaceuticals, Inc. (recorded 2017-01-26), and Opiant's title passed to Indivior UK Limited as part of Indivior's completed 2023-03-02 acquisition (recorded 2023-06-14). Both are real, product-shipping pharmaceutical companies — Opiant developed the claimed product (NARCAN® Nasal Spray, launched 2016, Orange Book-listed under NDA 208411) and litigated alongside its exclusive licensee against actual generic ANDA filers (Teva, Perrigo), and Indivior is an LSE-listed operating pharma. There is no shell LLC, no known NPE in the chain, no cascading transfers, no bankruptcy sale, and no transfer to a defensive aggregator; the only "NPE-flavoured" entity in the record, Nalox-1 Pharmaceuticals, LLC, is a PTAB petitioner against the patent, not an owner.

Residual uncertainty (do not treat as clean): reel/frame numbers and correspondents of record were not retrievable through my sources. If your NPE screen hinges on signal 3 (repeat correspondent), that field must be verified independently at the USPTO Assignment Center before you close the file — it is the one signal I could not test.

Verify at: https://assignmentcenter.uspto.gov/ (search Patent Number 9629965) and https://assignment.uspto.gov/patent/index.html.

I'll research US patent 9629965 and its cited prior art. Let me run several searches.

Let me find the specific citation lists (patent citations and non-patent literature) for US9629965.

Let me try to retrieve the actual citation lists from the patent page's citations section.

1. Patent identified (searched by the exact number)

I searched for the specific identifier 9629965 and located a single matching US patent. No similar numbers (e.g., 9,519,965; 9,929,965; 6,629,965) are treated here.

Source: https://patents.google.com/patent/US9629965/en

Important methodology / confidence caveat. I was not able to load the machine‑readable "Patent Citations" (References Cited) table from the face of US 9,629,965 within this session, and the plain‑text patent page supplied does not contain the front‑page citation table. I therefore cannot honestly assert that the list below is the verbatim examiner‑cited reference list. What I can substantiate from the record is (a) the patent references the '965 specification itself distinguishes/adopts, and (b) the references actually relied upon in the IPR and district‑court challenges to the '965 patent and its siblings. Those are the relevant references; I flag the origin of each. Where I am not certain of an exact date I say so.

2. What the '965 claims actually require (necessary to assess §102)

The asserted claims are narrow, specific‑formulation claims. Representative independent claim 1:

"A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 μL: about 4 mg naloxone hydrochloride; about 0.74 mg NaCl; about 0.01 mg benzalkonium chloride; about 0.2 mg disodium edetate; and an amount of hydrochloric acid sufficient to achieve a pH of 3.5–5.5."

Independent claim 20 is a device claim (single‑use, pre‑primed nasal device/single reservoir of about 100 μL), and claim 29 is a method claim reciting "delivery time" (Claim 29 is the claim construed in the D.N.J. claim‑construction opinion).

Because every independent claim requires a specific numerical excipient combination (0.74 mg NaCl / 0.01 mg BZK / 0.2 mg disodium edetate / HCl to pH 3.5–5.5) and/or a pre‑primed device architecture, the §102 exposure is essentially limited to references disclosing that same combination. As shown below, none does — which is precisely why the challengers litigated under §103, not §102.

3. Most relevant prior art / cited references

A. Patent references discussed in the '965 specification (background art)

1. U.S. Pat. No. 4,464,378 (Hussain)

• Citation: US 4,464,378 A
• Date: issued Aug. 7, 1984
• Description: Method of eliciting an analgesic/narcotic‑antagonist response by intranasal administration of naloxone.
• §102 relevance: Potentially anticipates only a broad genus claim to "intranasal naloxone for narcotic antagonism." It does not disclose 4 mg, the BZK/EDTA/NaCl/HCl matrix, the ≤140 μL volume, or a pre‑primed device, so it does not anticipate claims 1, 20 or 29. (Highest §102 relevance would be to any broadest genus claim, which the issued claim set does not contain.)

2. WO 82/03768

• Citation: WO 82/03768
• Date: published Nov. 11, 1982
• Description: Nasal composition containing 1 mg naloxone HCl per 0.1 mL for narcotic‑induced respiratory depression, dosed at approximately IV/IM/SQ levels.
• §102 relevance: Discloses a nasal naloxone solution but at 1 mg/0.1 mL (10 mg/mL) with no BZK/EDTA/NaCl/HCl limitation and no pre‑primed device. Does not anticipate claims 1, 20 or 29.

3. WO 2012/156317 (Strang et al.) — the "Strang" reference run in the litigation

• Citation: WO 2012/156317 A1 (family includes US 11,020,343 B2, "Intranasal pharmaceutical dosage forms comprising naloxone," Harm Reduction Therapeutics)
• Date: published Nov. 22, 2012 (EP priority 11166076, May 13, 2011)
• Description: Intranasal naloxone dosage unit of ≥0.5 mg naloxone HCl dissolved in ≤250 μL application fluid for opioid overdose; the '965 background discusses its 8 mg and 16 mg IN arms (400 μL, 200 μL/nostril).
• §102 relevance: Discloses high‑dose IN naloxone but not the claimed excipient amounts or the pre‑primed device. Not anticipatory of claims 1, 20 or 29; it was applied for §103 in combination with Kulkarni and Djupesland.

4. U.S. Pat. No. 4,987,136 (Kreek et al.)

• Date: issued 1991
• Description: Identified in the '965 specification as disclosing additional useful opioid receptor antagonists.
• §102 relevance: Genus‑level disclosure of antagonists; no §102 relevance to the specific claims.

B. Patent references relied upon in IPR2019‑00694 / ‑00695 / ‑00696 (Petitioner Nalox‑1 Pharmaceuticals)

5. U.S. Pat. No. 9,192,570 B2 (Wyse et al.) — primary reference

• Citation: US 9,192,570 B2, "Intranasal naloxone compositions and methods of making and using same," AntiOp, Inc.
• Dates: Provisional Dec. 20, 2013 (61/918,802); application filed Dec. 19, 2014; published as US 2015/0174061 A1 (June 25, 2015); issued Nov. 24, 2015.
• Description: Intranasal naloxone solutions (e.g., ~1–2 mg naloxone HCl in ~100 μL), excipients/antimicrobial agents, and single‑use nasal spray devices (Aptar/Pfeiffer UnitDose). Notably, Wyse reports that benzalkonium chloride caused an additional degradant and concluded BZK "was not [acceptable] due to increased observed degradation" (col. 27).
• §102 relevance: This is the closest art and the primary IPR reference, but it is a §103 reference. Because it was effectively filed (Dec. 19, 2014) / published (June 25, 2015) after the '965 priority date, it is at most §102(a)(2)/§102(d) art, and it does not disclose "about 4 mg … about 0.01 mg benzalkonium chloride … about 0.2 mg disodium edetate … pH 3.5–5.5." It therefore does not anticipate claims 1, 20 or 29. (The IPR2019‑00694 Final Written Decision resolved the BZK/EDTA "teaching‑away" issue in favor of the Patent Owner — i.e., not established as obvious.)

6. U.S. Pat. No. 5,866,154 (Bahal)

• Citation: US 5,866,154 A
• Date: issued Feb. 2, 1999
• Description: Teaches that adding a chelating agent such as EDTA prevents naloxone degradation (e.g., during autoclaving) — cited in the Teva "Davies combination" for the EDTA (stabilizing agent) limitation.
• §102 relevance: Could arguably disclose the "stabilizing agent/EDTA" element in isolation, but not the full formulation or the pre‑primed device. Does not anticipate claims 1, 20 or 29.

7. U.S. Pat. No. 5,482,965 (Rajadhyaksha) / WO 03/080022 and related nasal‑device patents (Djupesland)

• Description: Djupesland — nasal drug delivery devices ("Nasal drug delivery devices: characteristics…"), including the Aptar UnitDose single/bi‑dose device used to deliver a controlled ~100 μL spray; run for the device/volume limitations.
• §102 relevance: Device architecture only; does not disclose the claimed formulation. No anticipation.

8. Additional references run in the "Davies combination" (Teva / §103):

• Davies — opioid‑antagonist nasal spray system; Kerr 2009 formulation; Wang (CN 1575795 A). These were combined for §103 (0.2–5 mg naloxone in 20–100 μL, ~0.025% w/v BZK, pH ~6.5). None alone discloses the '965 numerical limitations, so none anticipates claims 1, 20 or 29.

C. Key non‑patent literature (for completeness — anticipating/motivation context, not §102 patents)

• Loimer et al., Int J Addict 29(6):819–27 (1994) — nasal naloxone ≈ IV in opiate addicts.
• Dowling et al., Ther Drug Monit 30(4):490–96 (2008) — IN naloxone relative bioavailability ~4%.
• Kerr et al., Addiction 104(12):2067–74 (2009) — 2 mg IN (1 mg/nostril) vs 2 mg IM.
• Wermeling, Drug Deliv Transl Res 3(1):63–74 (2013) — predicted 2 mg nasal Cmax 3–5 ng/mL, tmax ~20 min.
• Barton et al., J Emerg Med 29(3):265–71 (2005); Walley et al., BMJ 346:f174 (2013) — OEND/prehospital IN naloxone.
• Kulkarni — FDA regulatory treatment of nasal excipients (BZK up to ~0.119%; EDTA; pH).
  None of these discloses the claimed excipient combination; they are §103 motivation/background evidence only.

4. Overall §102 assessment

• No reference identified anticipates claims 1, 20 or 29 under 35 U.S.C. §102. Every independent claim recites a specific, numerically closed excipient set (≈4 mg naloxone HCl; ≈0.74 mg NaCl; ≈0.01 mg BZK; ≈0.2 mg disodium edetate; HCl to pH 3.5–5.5) and/or a pre‑primed single‑use device, and no single reference discloses that same subject matter arranged as claimed.
• The prior art that actually threatens the patent was applied in combination under §103 (Wyse+Djupesland+HPE; or Strang+Djupesland+Kulkarni), not as §102 anticipation.
• Procedural posture supporting this: IPR2019‑00694 reached a Final Written Decision (claims 1–30 challenged); IPR2019‑00695 and IPR2019‑00696 were not instituted (procedural). In Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., the district court found the claims invalid for obviousness, and the Federal Circuit (20‑2106, Feb. 10, 2022) affirmed — with a dissent arguing hindsight. That controversy is a §103 dispute; it does not convert any reference into §102 anticipatory art.

5. Sources

• US 9,629,965 B2, Google Patents: https://patents.google.com/patent/US9629965/en
• IPR2019‑00695 Institution Decision (Patent 9,629,965 B2) — https://www.docketalarm.com/cases/[PTAB](/ptab)/IPR2019-00695/ (PDF via docketalarm)
• IPR2019‑00696 — https://portal.unifiedpatents.com/ptab/case/IPR2019-00696
• Fed. Cir. No. 20‑2106 opinion (Feb. 10, 2022): https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
• Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., D.N.J. 2:16‑cv‑07721 (claim construction / invalidity opinion)
• US 9,192,570 B2 (Wyse), Google Patents: https://patents.google.com/patent/[US9192570B2](/patent/US9192570B2)/en
• US 11,020,343 B2 (Strang family), Google Patents PDF: https://patentimages.storage.googleapis.com/9c/87/8d/a60d89a4a3a16c/US11020343.pdf
• Stark Pharma / GreyB "Narcan Patent Expiration" (legal‑status timeline for US9629965): https://pharsight.greyb.com/drug/narcan

What I could not verify (stated explicitly rather than guessed): the exact, verbatim front‑page "References Cited" list of US 9,629,965 (examiner‑cited patents/applications), and the precise issue/publication dates of a few secondary references (e.g., Kulkarni, Davies). If you need the certified examiner‑cited list, that should be pulled directly from the USPTO PatentCenter/Patent Public Search record for US 15/335,145 (Pat. 9,629,965), which I could not open in this session.

I'll ground this analysis in the actual prior-art record — both the references named in the patent itself and the combinations asserted in the PTAB/D.N.J. proceedings. Let me run targeted searches.

Let me pin down the exact prior-art combinations the courts addressed and the remaining claim text.

Obviousness Analysis of US 9,629,965 B2 under 35 U.S.C. § 103

Scope note. This builds on the earlier sections (bibliographic data, abstract, claim overview, post-grant status). I used (i) the prior art named on the face of the '965 page — both the "Prior art keywords" field and the references discussed in the specification — and (ii) the prior-art corpus actually assembled in the parallel PTAB and D.N.J. proceedings, since that is where the § 103 dispute over this patent was actually joined. Where the record contradicts the earlier sections, I flag it.

1. Two dates that drive everything

This is the single most important § 103 predicate and it was contested only nominally. In IPR2019-00694 the petitioner asserted, and the Board accepted as undisputed, that the earliest priority date of the challenged claims is March 16, 2015, which makes Wyse prior art under AIA § 102(a)(2). If instead the 2014-03-14 provisional fully supported claims 20–30, Wyse (filed Dec. 19, 2014) would not be § 102(a)(2) art. The PTAB wrote: "Petitioner asserts that the earliest priority date for the challenged claims is March 16, 2015 … For the purposes of this proceeding, Patent Owner does not dispute, and we agree with, Petitioner's argument on this point." Any § 103 attack built on Wyse therefore stands or falls on that priority concession.
Source: IPR2019-00694 Institution Decision

Person of ordinary skill (POSA). The record defines a "Formulator POSA": an advanced degree (M.S./Ph.D.) in pharmaceutics or pharmaceutical chemistry with several years' experience formulating nasal drug products, working with routine knowledge of the Handbook of Pharmaceutical Excipients (HPE) and of commercial nasal-spray device platforms (Aptar/Pfeiffer, BD Accuspray, MAD).

2. The prior-art corpus (as listed on the page and as litigated)

A. References cited within the '965 specification (these appear in the patent's own background discussion):

B. References added by the challengers (not on the patent face):

3. Combinations that render the claims obvious

Combination 1 — Wyse + HPE (+ Bahal + Djupesland + the '291 patent)

Targets: claims 1, 20, 21, 24, 25 (the independent formulation and device claims and their dependents).

Motivation. Wyse supplies a complete IN naloxone formulation but names the preservative only generically ("antimicrobial agent … 0.1% to 2%"). HPE supplies the specific identity and the conventional potency range. The Board itself framed the petitioner's theory exactly this way: "a Formulator POSA would have consulted HPE to choose the antimicrobial agents in appropriate amounts based on their potencies." Adding Djupesland and the '291 patent supplies the single-dose pre-primed device and its 100 µL fill/emitted-volume behavior. This is the classic KSR "combination of known elements according to known methods to yield predictable results" rationale, reinforced by the FDA's 2012 call to develop an approved IN naloxone product and the MAD kit's known drawbacks (not pre-assembled; 1 mL/nostril causing drainage; no priming control).

Combination 2 — Davies + Kerr + Bahal ("the Davies combination")

Targets: claims 1, 20, 21, 24, 25 and method claims.

• Davies teaches IN naloxone over 0.2–5.0 mg with BZK as a component.
• Kerr 2009 teaches a 10 mg/mL solution (2 mg in 1 mL) with 0.01% BZK — the exact claimed BZK concentration — dispensed 0.5 mL/nostril; Kerr used 80 doses from a batch over 18 months, from which a POSA would infer practical stability.
• Bahal teaches that EDTA prevents naloxone degradation.

Motivation. All three are "clearly within a common field of endeavor" (Tyco). Davies and Kerr both address IN naloxone for overdose; Bahal addresses the very degradation problem a formulator must solve for a shelf-stable product. The Federal Circuit expressly endorsed this reasoning: Kerr and Davies "recognized the benefits of intranasal naloxone," and Bahal "discovered that the addition of a stabilizing agent like EDTA to a naloxone formulation prevents naloxone degradation," so "a skilled artisan would have been motivated to combine each of the references in the Davies combination."
Source: CAFC 20-2106 opinion

Combination 3 — Strang + Kulkarni + Djupesland ("the Strang combination")

Targets: claims 1, 20, 21, 24, 25, and the 4 mg dose limitation.

• Strang establishes that doses far above 2 mg (8 mg, 16 mg in 400 µL) were already being delivered IN, with Tmax ~20–23 min, and states that "typical pharmaceutical excipients used in intranasal formulations are known to the skilled person."
• Kulkarni fills in those excipients, including BZK.
• Djupesland expressly "points towards the Aptar Unit[D]ose device."

Motivation. Strang's own dose ladder supplies the direction of travel toward "about 4 mg," and the FDA's 2012 statement (credited at trial) that an IN dose of 3–4 mg would be bioequivalent to the approved 1 mg injectable, plus the recognized advantage that a higher first dose reduces the need for a repeat dose, supplies the specific selection rationale. Strang's "typical excipients are known" teaching is a literal invitation to look to Kulkarni and the HPE.

Combination 4 — the patent's own cited art (WO 82/03768 + Kerr + Wermeling 2013 + Djupesland/HPE)

This is the combination a prima facie case could be built from without leaving the '965 page. WO 82/03768 teaches a concentrated 10 mg/mL IN naloxone solution expressly "adapted for nasal administration"; Kerr teaches that formulation in clinical use with BZK; Wermeling 2013 supplies the expected PK (tmax ≈ 20 min, Cmax 3–5 ng/mL) and the repeat-to-10-mg dosing paradigm; Djupesland supplies the pre-primed single-dose device and the 125 µL-fill/100 µL-emit convention. The motivation is spelled out in the patent's own background: the MAD kit's 1 mL/nostril volume "is larger than that generally utilized for intranasal drug administration. Therefore, there is loss of drug from the nasal cavity, due either to drainage into the nasopharynx or externally" — i.e., concentrate the dose into ~100 µL and put it in a pre-primed single-dose device.

4. The dependent-claim limitations

Most remaining limitations are either disclosed or predictable results of the selected formulation/device/dose:

5. The teaching-away fight — and an explicit contradiction to flag

The whole § 103 question for this patent collapses into whether Wyse teaches away from BZK:

• PTAB (IPR2019-00694, Paper 55, Aug. 21, 2020): Petitioner challenged claims 1–22, 25, 26, 29, 30 over Wyse + HPE. The Board held no challenged claim proven unpatentable, because "Wyse expressly teaches that [BZK] is unacceptable for use in intranasal naloxone formulations," and a POSA "would have given significant weight[] to the only naloxone formulation stability data disclosed in Wyse." (IPR2019-00695 and -00696 were not instituted; IPR2019-00685, on the sibling '253 patent, was the vehicle for the Wyse + Djupesland + HPE + '291 grounds.)
• D.N.J. (Adapt/Opiant v. Teva, Judgment Op. June 22, 2020; final judgment June 26, 2020): the court found, on clear and convincing evidence, that the prior art as a whole did not teach away from BZK, because BZK was "perhaps the most commonly used … preservative in nasal formulations," Kerr and Davies used BZK successfully at concentrations comparable to the claims, HPE puts the IN range at 0.002–0.02%, and Wyse's study was a preliminary screening at 0.125% BZK (8.5× the claimed level) under accelerated-degradation pH 5.0 conditions.
• CAFC (20-2106, Feb. 10, 2022) (2-1, Newman, J., dissenting): affirmed, applying Medichem — "when a given course of action often has simultaneous advantages and disadvantages, this does not necessarily obviate motivation to combine." The majority held the prior art did not teach away, and that Adapt's objective indicia (56% bioavailability gain, long-felt need, copying, industry skepticism) did not overcome a "strong case of obviousness."

Contradiction to flag: the PTAB and the district court reached opposite conclusions on the same Wyse reference and effectively the same claims — claims 21 and 25 were held invalid by the district court (and affirmed) yet found not proven unpatentable by the Board — even though the IPR carries the lower preponderance standard. Judge Newman's dissent and Adapt's cert-stage framing both seize on this. This is not a factual error in either body's record; it is a genuine divergence in how each weighed the same degradation data, and it materially affects how confident one can be in any § 103 conclusion about the unadjudicated claims.

Also flag a date discrepancy with my earlier section: I previously recorded a "June 5, 2020 order." The primary sources (CAFC opinion; D.N.J. docket) give a Judgment Opinion of June 22, 2020 and final judgment June 26, 2020. The earlier June 5 date appears to be erroneous; the June 22/26 dates are supported by the Federal Circuit's opinion.

6. Bottom line

• Claims 21, 24 and 25 (the only '965 claims tried) were held obvious over Davies + Kerr + Bahal and, alternatively, Strang + Kulkarni + Djupesland, and that judgment was affirmed on Feb. 10, 2022. Those three claims are, as a practical matter, adjudicated invalid.
• Claims 1–20 and 22–23, 26–30 were never adjudicated by an Article III court. As to those, the only merits ruling is the Board's contrary finding of non-obviousness (at least for claims 1–22, 25, 26, 29–30 over Wyse + HPE). A fresh § 103 challenge to those claims would need to reckon with the Board's teaching-away holding rather than the district court's.
• The strongest § 103 combinations on this record are: (1) Wyse + HPE for the quantitative formulation (BZK at 0.01%, EDTA at 0.2 mg, NaCl, HCl to pH 3.5–5.5), reinforced by Bahal for the EDTA stabilization rationale and Djupesland / the '291 patent for the pre-primed single-dose 100 µL device; and (2) Davies + Kerr + Bahal, which avoids Wyse's teaching-away problem entirely by using Kerr's own 0.01% BZK formulation as the BZK source.

Explicit uncertainties

1. I did not retrieve the verbatim text of every one of claims 19–30 of the '965. Claim 20's device language is confirmed only via the near-identical specification paragraph and the sibling '253/'747 claim-1 charts; claims 21, 24 and 25 are confirmed verbatim from the D.N.J. opinion (Justia PDF). Claim 29's "delivery time" limitation is confirmed by the Markman opinion.
2. The Board's final written decision is available to me only in a document labeled "Termination Decision Document" (Paper 55, Aug. 21, 2020) whose substance is a Wyse+HPE obviousness analysis. I could not confirm how claims 23, 24, 27 and 28 were disposed of in IPR2019-00694 (they were asserted in other grounds, likely Wyse + HPE + Djupesland/'291).
3. Whether Wyse even qualifies as prior art depends on the March 16, 2015 effective-date concession; if the '965 were instead entitled to full 2014-03-14 provisional support, the Wyse-based combinations would fail at the threshold.
4. I found no 2026 activity on this patent. The operative appellate decision remains CAFC 20-2106 (Feb. 10, 2022).

Sources: Google Patents US9629965 · IPR2019-00694 institution decision · CAFC 20-2106 opinion · D.N.J. Judgment Opinion (Justia) · Adapt's proposed findings, D.N.J. ECF 245 · Nalox-1 IPR2019-00685 Donovan declaration · Adapt CAFC brief