Invalidity dossier
US 3845770
Osmatic dispensing device for releasing beneficial agent
Current assignee: Celgene Corporation
Added 9/24/2026, 6:00:11 AM
Active provider: DeepSeek · deepseek-flash
Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll search for authoritative information on this specific patent number.
Let me search specifically for any CAFC 2026 docket activity and USPTO records for this patent.
Let me retrieve the exact claim set to identify the independent claims precisely.
US Patent 3,845,770 — Analyst Summary
Search scope note: I queried for the literal number 3845770 / 3,845,770 only, and did not return results for adjacent numbers (e.g., 3,845,769, 3,845,771, 3,845,772). One important negative finding up front: I found no CAFC 2026 docket activity for Patent 3,845,770. The only litigation/appeal records surfaced are older (see "Litigation & post-grant activity" below). I could not locate a USCourts/CAFC 2026 docket carrying this patent number.
Bibliographic data (authoritative, from the patent front page)
| Field | Value |
|---|---|
| Patent number | 3,845,770 (US3845770A) |
| Title (literal) | "Osmatic dispensing device for releasing beneficial agent" — note the title as issued spells it "Osmatic," not "Osmotic"; I am not auto-correcting it |
| Inventors | Felix Theeuwes, Los Altos, Calif.; Takeru Higuchi, Lawrence, Kans. |
| Assignee | Alza Corporation, Palo Alto, Calif. |
| Application No. | 259,469 |
| Filed | June 5, 1972 |
| Issued / published | November 5, 1974 |
| Priority date | 1972-06-05 |
| Claims / figures | 15 claims, 8 drawing figures |
| Classifications (as printed) | U.S. Cl. 128/260, 128/130, 222/389, 424/15, 424/37; Int. Cl. A61m 31/00 |
| Legal status | Expired – Lifetime; anticipated expiration 1991-11-05 |
Abstract (verbatim)
"A wall surrounding and forming a compartment for containing a useful composition of matter and having a passageway for dispensing the composition is disclosed. The wall is comprised in at least a part of a material permeable to an external fluid. The composition is soluble in the fluid and exhibits an osmotic pressure gradient against the fluid or the composition has limited solubility and is admixed with an osmotically effective compound soluble in the fluid that exhibits an osmotic pressure gradient against the fluid. In operation, composition is dispensed from the device by fluid permeating into the compartment producing a solution of the soluble composition or a solution of the osmotically effective compound containing the composition, which solution in either operation is released through the passageway to the exterior of the device at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall of the device."
Brief context
The specification frames the invention as an improvement over diffusion-controlled delivery (e.g., U.S. Pat. No. 3,279,996) and over earlier osmotic devices requiring movable parts, a carried water supply, or a separate osmotic solute (citing Austral. J. Exp. Biol. Vol. 33, pp. 415–420, 1955; U.S. Pat. No. 3,604,417; and copending applications Ser. Nos. 106,131 and 106,161 filed Jan. 13, 1971). The stated objects include minimum number of parts, high agent loading without leaching, shelf-stable solid/semisolid drug cores, heat-sterilizable forms, and zero-order release. Worked examples cover ocular, intrauterine, anal, oral, and other body-cavity embodiments.
Plain-language overview of the claims
Note on numbering / uncertainty: The Google Patents full text renders the claim set with some OCR/transcription garble (e.g., a dependent claim that appears to cite "claim 2" while evidently depending on claim 1). The official Gazette entry confirms 15 claims with claim 1 as the principal independent claim. I identify the independent claims below with a caveat on exact numbering.
Claim 1 — the core independent claim (cornerstone of the patent family):
An osmotic device for continuously dispensing an active agent, comprising four elements:
- (a) a shaped wall of substantially imperforate, semipermeable material that keeps its integrity during dispensing, is permeable to external fluid, and is essentially impermeable to the agent, the wall surrounding and forming;
- (b) a compartment containing an active agent that is soluble in the external fluid and itself exhibits an osmotic pressure gradient across the wall (i.e., the drug serves as its own osmotic driving solute);
- (c) an osmotic passageway through the wall connecting compartment to exterior, sized and designed for osmotically pumping agent out; and
- (d) a functional statement: in use, external fluid is continuously imbibed through the wall toward osmotic equilibrium at a rate set by wall permeability and the osmotic gradient, dissolving the agent, which is then pumped out through the passageway at a controlled rate over a prolonged period.
Dependent claims (roughly claims 2–6 in the printed set):
- Agent of limited solubility co-formulated with an osmotically effective solute that provides the gradient (the "two-component" variant).
- Device adapted as an oral / gastrointestinal device.
- Wall formed of an imperforate erodible (bioerodible) material that degrades after the dispensing period.
- Wall essentially insoluble in the external fluid.
- Device shaped and adapted for release in the mouth.
Independent claim on the ocular device (appears in the 7–8 range):
An osmotic ocular drug delivery device with the same three structural elements (imperforate semipermeable shaped wall; compartment containing ophthalmic drug; osmotic passageway), plus the functional limitation that eye fluid is imbibed through the wall at a rate proportional to wall permeability and the osmotic gradient, dissolving drug that is pumped out at a controlled rate over a prolonged period. (An associated claim recites the same ocular operation with the wall remaining intact during use.)
Independent claim on the "beneficial agent" device (the printed text cross-refers to claim 12):
An osmotic device for continuously dispensing a beneficial agent, again comprising a shaped, integrity-maintaining wall of imperforate semipermeable material (permeable to fluid, impermeable to agent), a compartment containing the agent, and an osmotic passageway sized for osmotic pumping. A dependent claim (referenced as "according to claim 12") covers the composite wall variant — part of the wall imperforate/permeable-to-fluid, the remainder imperforate and impermeable to both fluid and agent.
Final independent claim (appears near the end of the set, likely claim 14 or 15):
An osmotic device whose wall is of substantially pore-free semipermeable material, whose compartment contains "means for producing pressure therein" — namely an active agent soluble in the external fluid and exhibiting an osmotic gradient across the wall to internally pressurize the compartment — and whose passageway includes "means for maintaining said pressure in the compartment during the dispensing period." The functional clause repeats the imbibition/dissolution/pumped-release behavior.
Overall gist of the claim set: a semipermeable-wall osmotic pump in which the drug itself (or drug plus osmagent) is the osmotic engine, dispensed through a pre-formed passageway at a zero-order rate, adapted variously for the eye, mouth, GI tract, uterus, and other body cavities, optionally using bioerodible or composite walls.
Litigation & post-grant activity surfaced
- District of New Jersey — case 2:19-cv-15343 (Unified Patents litigation data)
- District of New Jersey — case 3:18-cv-11213 (Unified Patents litigation data)
- Court of Appeals for the Federal Circuit — case 21-2335 (Unified Patents litigation data)
- The patent was cited as prior art (Exhibit 1017) in PTAB IPR2017-01648, an Inter Partes Review of U.S. Pat. No. 6,866,866.
None of these are 2026 CAFC dockets. Because the patent's anticipated expiration date is 1991-11-05, any 2026 appellate activity specifically on 3,845,770 would be unexpected; my searches returned no such docket.
Family / foreign counterparts (from the record)
Priority filings listed include GB1415210A, DE2328409C3, FR2188568A5, JP (JPS596843B2), CA1028212A, SE402532B, DK134922B, NL163721C, IL42418A, AU466503B2, IT986408B, ES415568A1, AT332563B, BE800485A, CH578464A5, ZA733734B, AR199301A1, BR7304196D0, IE39952B1.
Explicit statement of uncertainty
- Exact independent-claim numbering: The patent's claim text as rendered online is partly garbled, so my mapping of "which claim number is independent" (beyond claim 1) is inferred from the claim sequence and cross-references, not from an error-free official claim print. It should be verified against the USPTO PatentCenter / Official Gazette PDF (the Gazette text I found confirms 15 claims and reproduces claim 1 verbatim).
- CAFC 2026 dockets: I found no 2026 CAFC filing bearing patent 3,845,770. If one exists, it was not reachable via my searches, and I will not assert one exists.
- I have not independently confirmed current USPTO assignment/ownership records; assignee is given as printed on the patent (Alza Corporation).
Generated 10/1/2026, 12:22:30 AM
Cases on file (1)
Group view →Specific litigation cases in our database that name US patent 3845770. The free-form analysis below may also discuss cases beyond this list.
- Celgene Corporation v. Dr. Reddy's Laboratories, Ltd. et al.filed Jul 12, 20192:19-cv-15343U.S. District Court for the District of New Jerseyterminated Feb 23, 2022judgment
Defendants: Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search for litigation involving US patent 3845770 across the sources you mentioned.
Let me investigate the specific litigation references listed on the patent page.
Summary of findings
I searched for litigation specifically involving US patent 3,845,770 ("Osmatic dispensing device for releasing beneficial agent," Theeuwes & Higuchi, Alza Corp., filed June 5, 1972, granted Nov. 5, 1974). Here is what I can state with confidence, and what I cannot.
1. What the patent record itself shows
The Google Patents page for US3845770 lists three litigation entries (with Unified Patents portal links, no party names shown):
| # | Jurisdiction | Case number | Link |
|---|---|---|---|
| 1 | D.N.J. | 2:19-cv-15343 | portal.unifiedpatents.com/.../case/2%3A19-cv-15343 |
| 2 | D.N.J. | 3:18-cv-11213 | portal.unifiedpatents.com/.../case/3%3A18-cv-11213 |
| 3 | Court of Appeals for the Federal Circuit | 21-2335 | portal.unifiedpatents.com/.../case/21-2335 |
(Note: US3845770's legal status is "Expired – Lifetime," with an anticipated expiration of November 5, 1991.)
2. What I could independently verify
Case 2:19-cv-15343 (D.N.J.) — verified, but it does NOT appear to involve US3845770 as an asserted patent.
- Plaintiff: Celgene Corporation
- Defendants: [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.) and Dr. Reddy's Laboratories, Inc.
- Jurisdiction: U.S. District Court for the District of New Jersey (Judges Esther Salas and Michael A. Hammer)
- Case number: 2:19-cv-15343
- Filed: July 12, 2019
- Subject matter: ANDA/Hatch-Waxman litigation over pomalidomide (POMALYST®) patents — e.g., U.S. Pat. Nos. 8,198,262; 8,735,428; 8,828,427; 9,993,467 (source: CourtListener docket 15918136; UniCourt case summary; complaint analysis).
- Outcome/status: Closed — final judgment entered February 23, 2022.
Important caveat: I found no indication that US3845770 was asserted or substantively at issue in 2:19-cv-15343. Given that US3845770 expired in 1991, it could not have been asserted in a 2019 case. The association most likely arises because the patent is cited somewhere in the complaint/record (Google Patents litigation data frequently links patents that merely appear in complaint documents, not only asserted patents). I cannot confirm the exact basis for the linkage.
Case 3:18-cv-11213 (D.N.J.) — NOT verified. My searches for this specific case number returned no results. I cannot confirm the parties, subject matter, filing date, or outcome. I will not guess.
CAFC 21-2335 — NOT verified. My searches for this specific appeal number returned no confirmable results. I cannot confirm the parties, the underlying district court case, or the outcome. (Note: 21-2335 could be an appeal from the 2019 Celgene case or from another matter, but I have no evidence — I will not speculate.)
3. Bottom line
- I cannot confirm any infringement litigation in which US3845770 itself was asserted. Based on the record, no such litigation is known to me, and the patent has been expired since 1991.
- The only specific D.N.J. case I could tie to the patent-page listing (2:19-cv-15343) is a Celgene v. Dr. Reddy's pomalidomide case that does not appear to involve the '770 patent.
- The other two references (D.N.J. 3:18-cv-11213 and Fed. Cir. 21-2335) could not be verified with the available search results.
Recommended next steps for confirmation
Because the party data is incomplete in my results, to lock this down you should pull the source dockets directly:
- Unified Patents litigation portal entries linked above (case lists for D.N.J. and the Federal Circuit).
- PACER / RECAP dockets for D.N.J. 2:19-cv-15343, D.N.J. 3:18-cv-11213, and Fed. Cir. 21-2335.
- Note: any US3845770 reference in these dockets is most likely a cited reference rather than an asserted patent, since the patent expired November 5, 1991.
Caveat on sourcing: The case-number associations come from the Google Patents page and Unified Patents-derived data, which are known to include incidental citations. Please treat the 2:19-cv-15343 association as citation-based, not an assertion, unless the docket shows otherwise.
Generated 10/1/2026, 12:22:30 AM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
Current assignee: Celgene Corporation
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll verify the structured ODP data against public sources before finalizing.
Proceedings overview
There are zero AIA trial proceedings on US 3,845,770 — no IPR, no PGR, no CBM, and nothing on appeal from a PTAB trial. The canonical ODP-derived tally is 0 active / 0 claims-invalidated / 0 claims-sustained / 0 settled / 0 institution-denied. There is therefore no PTAB-driven claim cancellation to hand a defendant. But the absence is not a "hardened patent" signal in the usual sense — it is an artifact of the patent having issued on 1974‑11‑05, expired (anticipated) on 1991‑11‑05, and long since passed out of force. For a defendant today, the bottom line is far better than "claims 1‑5 have been canceled": the entire patent is dead, all 15 claims with it, and any demand letter invoking it is meritless on its face.
Verification note: I searched Google Patents, USPTO PTAB materials, and general web sources for any IPR/PGR/CBM keyed to this patent number and found none. I also note one anomaly worth flagging rather than relying on — the Google Patents "litigation" panel for US3845770A lists New Jersey District Court matters (2:19‑cv‑15343; 3:18‑cv‑11213) and a Federal Circuit appeal (21‑2335), sourced from Unified Patents litigation data. I could not verify that these matters actually concern US 3,845,770; they are chronologically inconsistent with a patent that expired in 1991 and appear to be database/metadata attributions rather than confirmed assertions of this patent. Do not treat them as evidence of assertion activity against your client without independently pulling the dockets.
No proceedings to list
There is no proceeding number, petitioner, panel, institution decision, final written decision, settlement, or appeal to report. I will not manufacture one. To be explicit about what the record does and does not show:
- Type: N/A — no IPR, PGR, or CBM was ever instituted against this patent in the indexed record.
- Why the AIA-trial universe is narrow for this patent anyway: PGR is unavailable (it reaches only patents with a first‑inventor‑to‑file effective filing date on or after 2013‑03‑16; this patent's priority date is 1972‑06‑05). CBM sunset for new petitions in 2020 and was limited to covered business-method patents — inapplicable here. Practically, the only AIA tool ever available against the '770 patent was IPR under § 102/§ 103 on patents and printed publications.
- Claim-level outcome: None. No claim of US 3,845,770 was ever canceled, confirmed, or construed in an AIA proceeding because none occurred. The claims stand as issued only in the historical sense — the patent expired on 1991‑11‑05.
- Federal Circuit: I found no CAFC appeal arising from a PTAB trial on this patent. (The 21‑2335 entry on the Google Patents page is not verifiable as an appeal in this patent's chain; flagging only.)
Corroborating links: US3845770A on Google Patents · PTAB E2E / PTAB Center · USPTO Patent Center · CourtListener for any future CAFC activity.
Strategic summary
Claim status. All 15 claims are expired, not canceled. Expiry is not the same as invalidation — the claims were never adjudicated unpatentable — but for defensive purposes the distinction is academic in most post‑1991 scenarios. The patent's anticipatory expiration date per the structured data is 1991‑11‑05, i.e., 17 years from the 1974‑11‑05 grant under the pre‑URAA term rules. Any infringement claim would have to rest on acts occurring on or before that date, and even the six-year damages lookback under § 286 closed decades ago. There are no "surviving claims" to map, because the patent itself is gone; the real-world defensive question is not which claims survive but whether the patent can be asserted at all, and it cannot, for any current or recent conduct.
Estoppel landscape. § 315(e)(2) estoppel is irrelevant here — it attaches only to a petitioner in an IPR "that results in a final written decision under section 318(a)," and no such proceeding exists. No party is estopped by anything, and correspondingly no party has had the benefit of a PTAB adjudication foreclosing the patent owner. That said, the more powerful bar is temporal, not estoppel-based: the patent's term ran out in 1991, so there is no live infringement theory to defend against. If a plaintiff nonetheless pleaded this patent, the threshold attack is that it is expired and unassertable — a motion-to-dismiss/§ 101-style standing-and-merits argument, not an IPR.
Pattern signals. No petitioner has filed on this patent — not once, not multiply. No defensive aggregator appears in the PTAB chain; the only third-party entity name appearing anywhere near this patent number is Unified Patents, and only as the source of the litigation metadata on the Google Patents page, not as an IPR petitioner. Alza (now Johnson & Johnson / Alza Corp.) never had to defend this patent at the PTAB. The telling pattern is the opposite of a troll patent: this is the foundational elementary osmotic pump patent (Theeuwes & Higuchi, priority 1972‑06‑05), cited ubiquitously by later Alza and third-party osmotic-delivery patents (e.g., US 4,552,561; US 4,439,196; US 4,522,625; US 5,340,590) and by foreign counterparts, i.e., a pioneering reference rather than an assertion vehicle.
Recommended next steps
- If you received a demand letter or complaint citing US 3,845,770, the correct response is not an IPR — it is a merits/extinction challenge. The patent's term expired 1991‑11‑05 (Google Patents legal-status entry: "Anticipated expiration 1991‑11‑05; Expired – Lifetime"). Pre-1991 conduct is time-barred by § 286; post-1991 conduct cannot infringe an expired patent. There is no FWD to link because none exists — do not let opposing counsel or a third-party report imply otherwise.
- Do not file an IPR even for completeness. Beyond the futility of challenging an expired patent, the current Director's discretionary-denial regime (settled-expectations and related factors, per the March 26, 2025 Interim Processes memorandum and subsequent Director practice) makes institution on a multi-decade-old, expired patent effectively a non-starter. Senior PTAB practitioners are seeing exactly this posture denied at the discretionary gate.
- If you are researching the family, not defending a case, shift focus to the live descendants: US 3,916,899 (Theeuwes et al., same Alza osmotic line) and the later OROS patents (e.g., the 8,163,798 / 9,144,549 / 6,919,373 cluster litigated in Alza v. Andrx and Alza v. Mylan). Those are where actual assertion and invalidity risk sits.
- If you believe the NJ/CAFC entries on the Google Patents page are real, pull the dockets independently (PACER for 2:19‑cv‑15343 and 3:18‑cv‑11213; CAFC for 21‑2335) and check the "patent-in-suit" fields before drawing conclusions. I could not confirm any link between those matters and US 3,845,770, and the 1991 expiry makes a genuine assertion of this patent implausible.
Caveat on completeness: I am reporting a verified absence based on the structured ODP block plus targeted web verification. I cannot rule out an unindexed, decades-old pre‑AIA inter partes reexamination by a third party (a different mechanism from AIA trials) — public web sources did not surface one, but I would not state affirmatively that none ever occurred without a direct PTAB/CRU docket pull.
Generated 10/1/2026, 12:22:40 AM
Ownership chain (1)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · Assignment
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll research the assignment record before writing anything.
Ownership Reconstruction — US 3,845,770
Data-access caveat up front. This session had web search only; I could not execute a live query against the USPTO Assignment Center UI (https://assignmentcenter.uspto.gov/) or the legacy Assignment Search (https://assignment.uspto.gov/patent/index.html), which are interactive JavaScript applications. Repeated searches for 3845770 + assignment/reel/frame terms returned only citation and family references — no assignment record, reel/frame, assignor/assignee entry, or correspondent of record was surfaced for this patent. Accordingly I report no reel/frame numbers and no correspondent names, because I did not retrieve any and will not invent them. Verification link: https://assignmentcenter.uspto.gov/ (search basic query 3845770).
Inventors
| Inventor | Address of record | Employer at time of filing |
|---|---|---|
| Felix Theeuwes | Los Altos, California | Alza Corporation — high confidence; Theeuwes was a senior Alza scientist and one of the company's most prolific inventors on the OROS platform. |
| Takeru Higuchi | Lawrence, Kansas | University of Kansas (Regents Professor), concurrently Alza co-founder and scientific advisor — moderate confidence on the exact dual role at filing; the Lawrence, KS address of record is consistent with the KU affiliation, and both inventors assigned to Alza. |
Source: US 3,845,770 front page, [75] Inventors: Felix Theeuwes, Los Altos, Calif; Takeru Higuchi, Lawrence, Kans.; [73] Assignee: Alza Corporation, Palo Alto, Calif. (https://patents.google.com/patent/[US3845770A](/patent/US3845770A)/en).
Unusual-pattern check: Not present. The prompt's red flag — all inventors leaving the original assignee within 12 months of filing, presaging a portfolio fire-sale — has no support here. Both inventors are named on the patent as assigning to Alza, and Theeuwes remained at Alza for decades (he appears as inventor on the entire OROS lineage, e.g. US 3,916,899 issued 1975, US 4,327,725, US 4,326,525). There is no evidence of inventor flight.
Original assignee
- Entity on the issued patent: Alza Corporation, Palo Alto, California (
[73]). - Product embodying the claims: Yes. US 3,845,770 is the foundational patent of Alza's OROS® (oral osmotic) delivery platform — a semipermeable wall, an osmotic core, and a delivery passageway. Google Patents classifies it under A61K9/0004 ("Osmotic delivery systems; Sustained release driven by osmosis") and it is the single most frequently cited antecedent in osmotic-dosage-form prior-art tables, including use of the OROS trade name with "Alza Corporation, Mountain View, CA." Alza shipped OROS products commercially; the best-known are Procardia XL (nifedipine GITS) and the later OROS line (e.g., Glucotrol XL, Covera-HS, Ditropan XL, Concerta). This specific patent expired 1991-11-05, so it is not the patent that covered those later commercial products — it is the platform/origin patent that the later, in-force Alza OROS patents build on.
- Primary line of business: Drug-delivery R&D and specialty pharmaceutical products (rate-controlled dosage forms: OROS, transdermal, implantable osmotic pumps). Alza was a public company from 1969.
- Current status: Acquired. Johnson & Johnson acquired Alza Corporation in 2001 (roughly a $10.5B transaction, completed mid-2001), and Alza continued to operate as a J&J subsidiary with its Mountain View / Palo Alto, CA address appearing on later filings (e.g., "ALZA CORPORATION, 1900 Charleston Road, Mountain View, CA" with agents "c/o Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ" in WO 2005/044243). Important timing point: the J&J acquisition post-dates this patent's 1991 expiry by a decade, so US 3,845,770 was already in the public domain and was not an asset conveyed in that deal. Google Patents lists the current assignee as "Alza Corp" (with its standard disclaimer that listed assignees may be inaccurate).
Assignment timeline
The Assignment Center record could not be retrieved for this patent (see data-access caveat). On the authoritative document I do have:
- The only assignment evidenced anywhere in the available record is the original pre-issuance assignment from inventors Theeuwes and Higuchi to Alza Corporation, reflected on the printed front page as
[73] Assignee: Alza Corporation, Palo Alto, Calif.— executed on or before the 1974-11-05 grant. Its reel/frame is not available to me, so I do not state one. - The Google Patents legal-events listing for US 3,845,770 contains no post-issuance "Assigned to" entries. The recorded events are: 1972-06-05 priority to US00259469A; 1972-06-05 application filed by Alza Corp; 1973-05/06 foreign priority filings (IL, NL, AU, DK, SE, DE, GB, ZA, CA, IT, ES, AR, BR, IE, BE, AT, JP, FR, CH); 1974-11-05 publication and grant; 1991-11-05 anticipated expiration; status "Expired - Lifetime."
Also flagging a litigation-data anomaly rather than an assignment. The Google Patents page lists three US litigation entries against this record: D.N.J. 2:19-cv-15343, D.N.J. 3:18-cv-11213, and Fed. Cir. 21-2335 (all sourced to "Unified Patents Litigation Data"). I verified 2:19-cv-15343: it is Celgene Corporation v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.), an ANDA/pomalidomide case asserting US 8,198,262, US 8,828,427 and US 9,993,467 — patents unrelated to Alza or osmotic devices. A patent that expired 1991-11-05 cannot be asserted in 2018/2019 litigation. The most plausible explanation is a citation-based data artifact (later pharmaceutical specifications routinely cite "U.S. Patent Nos. 3,845,770 … OROS (Alza Corporation)" as background, and citation-matching engines can mis-join a docket to such a reference). I therefore treat these entries as not a genuine assertion of this patent, and I note it as a data-quality finding, not an ownership finding.
No assignments to report beyond the original. Per the operating instruction, if there is no post-issuance chain, that is itself the finding: it means the original assignee (Alza Corporation) is the owner of record — which is exactly what every freely available source shows (originally assigned to Alza Corp; currently assigned to Alza Corp).
Timeline diagram
timeline
title Ownership events for US 3845770
1968 : Alza Corporation founded
1972 : Application filed by Alza Corporation
1973 : Foreign priority filings in 20 countries
1974 : Patent issued with Alza as assignee
1991 : Patent expired by operation of law
2001 : Johnson and Johnson acquires Alza Corporation
Note on reading the diagram: the 1968 and 2001 entries are corporate-history events for the owner of record; they are not recorded patent assignments, and the 2001 acquisition did not convey this already-expired patent. Nothing in the diagram between 1974 and 1991 should be read as a transfer — no such transfer is in the record.
NPE / troll-pattern signals
Shell-entity transfer — not present. No transfer of this patent to any "IP / Patents / Licensing / Holdings / Ventures" entity appears in the retrievable record; the assignee of record is Alza Corporation, an operating drug-delivery company. No single-purpose Delaware or Texas LLC, no registered-agent service address, on the record I can see. (The only registration-style address associated with Alza — "c/o Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ" — appears on later Alza filings as the PCT agent contact, which is ordinary corporate-parent housekeeping, not a shell-entity tell.)
Known asserter in the chain — not present. No current or prior assignee matches the supplied NPE list (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities, etc.). The chain is Alza → Alza. No Unified Patents or RPX high-frequency-plaintiff name appears in the ownership record.
Repeat correspondent across the chain — unclear / not assessable. The whole point of this signal is recurrence of a filing attorney across multiple links. Here there is either one or zero post-issuance links, and the correspondent of record was not retrievable for even the original assignment. I decline to name a correspondent. Note the one visible recurring agent string on the OROS family is Alza's own in-house channel ("YIP, Philip et al.; Alza Corporation, c/o Johnson & Johnson," WO 2005/044243) — that is an operating company's patent department, not an NPE recording firm.
Cascading transfers — not present. The prerequisite is ≥2 consecutive assignments through chained LLCs within 24 months. The record shows no post-issuance assignments at all, let alone a cascade.
Pre-litigation transfer — not present. There is no assignment at all within 6 months (in fact within 27 years) of any litigation date. The 2018/2019 docket entries attributed to this patent by Google Patents/Unified Patents are explained above as an artifact and, independently, are legally impossible to assert against a patent that expired 1991-11-05.
Bankruptcy fire-sale — not present. Alza's owner change was a negotiated public-company acquisition by Johnson & Johnson (2001), not a Chapter 7/11 sale of patent assets. No Kodak/Nortel/Polaroid-style asset sale touching this patent is in the record.
Privateering — not present. No transfer from Alza to an NPE asserting on Alza's behalf appears in the record. (Independent point: Alza was itself a plaintiff against perceived infringers in the 1990s–2000s, but that was an operating company asserting its own patents, and no such action on US 3,845,770 is evidenced post-expiry.)
Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It is not neutralized by acquisition into a defensive pool.
Verdict
Insufficient data (no retrievable Assignment Center record, and only the original assignment evidenced).
Justification: the only ownership facts supportable on the available evidence are (i) the original pre-issue assignment from inventors Felix Theeuwes and Takeru Higuchi to Alza Corporation, Palo Alto, CA, as printed at [73] on the 1974-11-05 grant, and (ii) a continuous Alza assignment of record thereafter, with Google Patents listing both the original and current assignee as Alza Corp and showing no post-issuance assignment events before the 1991-11-05 expiry. Because I could not retrieve the reel/frame-level Assignment Center entries, and because a 17-year patent that expired over three decades ago cannot be part of a live assertion chain, there is no evidentiary basis to call this an NPE holding — every enumerated NPE signal is either "not present" or "not assessable," and none is affirmatively supported. Verify at the USPTO Assignment Center, https://assignmentcenter.uspto.gov/ (query 3845770), cross-checked against https://patents.google.com/patent/US3845770A/en.
Analyst note on the litigation data: if a future run with live Assignment Center access finds reel/frame entries dated 2017–2019, do not accept them at face value for this patent without reconciling the 1991-11-05 expiry and the verified identity of D.N.J. 2:19-cv-15343 as Celgene v. Dr. Reddy's (pomalidomide ANDA, US 8,198,262 / 8,828,427 / 9,993,467). That mismatch is the strongest single indicator that the litigation linkage on this record is a data artifact.
Generated 10/1/2026, 12:23:04 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll analyze US patent 3845770 and its prior art citations. Let me search for supporting information to verify the references.
Let me gather details on the specific cited references to verify their dates and content.
Prior-Art Analysis — US 3845770
1. Patent identification (as the identifier literally reads)
- Patent number: US 3845770 (also rendered in some databases as US 3,845,770)
- Title (literal): "Osmatic dispensing device for releasing beneficial agent" (the title as issued/OCR'd spells it "Osmatic"; I am not auto-correcting it)
- Inventors: Felix Theeuwes (Los Altos, CA); Takeru Higuchi (Lawrence, KS)
- Assignee: Alza Corporation, Palo Alto, CA
- Application No.: US 259,469; Filed: June 5, 1972; Granted/Published: November 5, 1974
- Int. Cl.: A61m 31/00; U.S. Cl.: 128/260; 15 Claims, 8 Drawing Figures
- Source: https://patents.google.com/patent/US3845770/en
Note on attribution: one secondary listing (FreePatentsOnline, https://www.freepatentsonline.com/[8603520](/patent/8603520).html) credits "3845770 … Higuchi" alone. Per the authoritative front page of the patent itself, the inventive entity is Theeuwes and Higuchi (assignors to Alza). I am reporting the patent's own front page as controlling.
2. The claim set (abbreviated, to anchor the § 102 discussion)
The patent's base independent claim (claim 1) requires:
- (a) a shaped wall of substantially imperforate, semipermeable material permeable to an external fluid and essentially impermeable to the agent;
- (b) a compartment containing an active agent soluble in the external fluid that exhibits an osmotic pressure gradient across the wall;
- (c) an osmotic passageway in the wall communicating compartment-to-exterior, sized for osmotic pumping; and
- (d) in operation, fluid is imbibed, dissolves the agent, and the agent is pumped through the passageway at a controlled rate.
Dependent/subgeneric claims cover: admixture of the agent with a separate osmotically effective solute; an oral/GI-tract device; an erodible wall; a wall insoluble in the external fluid; a mouth-adapted device; an osmotic ocular drug delivery device (eye fluid imbibed, drug pumped); a beneficial-agent variant where only part of the wall is fluid-permeable and the remainder is impermeable to both fluid and agent (dependent on claim 12); and a "substantially pore-free" semipermeable-wall variant whose compartment contains an agent that internally pressurizes the compartment.
Key point for anticipation: the signature feature across the claims is a single semipermeable/imperforate wall that (i) admits the environmental fluid while blocking agent, and (ii) permits the agent itself (or the agent + solute) to serve as the osmotic driving material, discharged through a passageway — with NO moving piston and NO separate self-contained water/salt compartment. Prior art that relies on a moving piston or an independent osmotic-solute chamber therefore cannot, as a single reference, disclose the full combination of claim 1.
3. References cited on the face of the patent ([56] "References Cited")
The patent lists the following U.S. patents (exactly as printed in the front page and confirmed by the Official Gazette text at https://archive.org/stream/officialgazette928unit/officialgazette928unit_djvu.txt):
| # | Citation | Date | Class | Brief description | Potential § 102 relevance |
|---|---|---|---|---|---|
| 1 | US 1,023,499 — Bell | 4/1912 | 128/260 | A medicated body-insert/applicator-type dispensing article. (Full text not retrievable with confidence; characterization is inferred from the class and the "X" conventions.) | Cannot anticipate claim 1 — no semipermeable wall, no osmotic gradient, no osmotic passageway. Old art; § 102/§ 103 background only. |
| 2 | US 1,279,564 — McClure | 9/1918 | 128/272 | Vaginal/uterine or body-cavity applicator-type device. (Content inferred; not confirmed.) | No osmotic mechanism; background art only. |
| 3 | US 1,434,531 — Cyrenius | 11/1922 | 128/272 | Body-cavity/dilator-type device. (Content inferred; not confirmed.) | No osmotic mechanism; background art only. |
| 4 | US 2,846,057 — Polin | 8/1958 | 206/.5 | Article/package of the "carrier for a mass" type. | Structural packaging art; cannot anticipate any of the osmotic claims. |
| 5 | US 2,962,023 — Chappaz et al. | 11/1960 | 128/260 | Medicament-carrier/insert device. | No osmotic driving mechanism; background art only. |
| 6 | US 3,093,831 — Jordan | 6/1963 | 128/260 (X) | Body-insert drug-delivery article (cited with an "X" notation, indicating examiner interest). | Predates semipermeable-membrane osmotic devices; cannot disclose claim 1's fluid-imbibing wall + osmotic passageway. § 103 backdrop. |
| 7 | US 3,146,169 — Stephenson et al. | 8/1964 | 424/15 | Drug-preparation/medicament-formulation patent (Class 424 = drug, bio-affecting). | A formulation reference, not a device; cannot anticipate device claims 1–6 or the ocular/beneficial-agent claims. |
| 8 | US 3,416,530 — Ness | 12/1968 | 128/260 | Drug-dispensing ocular insert — the direct antecedent of Alza's Ocusert work (expressly identified in Higuchi's US 3,630,200 as an Alza-assigned ocular insert "that truly acts as a depot or drug reservoir … insoluble in tear liquid"). | Closest ocular-field reference. But it releases drug by diffusion/leaching from a flexible polymer body, with no semipermeable wall, no osmotic pressure gradient serving as motive force, and no osmotic passageway. Cannot anticipate the ocular claims (which require eye fluid to be imbibed through the wall and the drug to be osmotically pumped). |
| 9 | US 3,574,820 — Johnson et al. | 4/1971 | 424/37 (X) | Sustained/timed-release drug dosage-form patent (Class 424/37 = sustained release). Cited with "X". | A diffusion-type sustained-release system; no semipermeable osmotic wall/passageway. § 103 backdrop at most. |
| 10 | US 3,630,200 — Higuchi | 12/1971 | 128/260 | Ocular insert (Alza). Inner drug core + soft hydrophilic outer layer; drug "gradually diffuses through or is leached by tear liquid." | The most pertinent patent reference in the ocular field and the closest structural sibling to Fig. 2/3–6 of US 3845770. But release is diffusional/leaching, not osmotic; it lacks the imperforate semipermeable wall and the osmotic passageway. Does not anticipate claim 1 or the ocular claims; strongest as § 103/§ 102-background art. |
Take-away on the [56] list: taken individually, none of the ten cited U.S. patents discloses every element of claim 1 (imperforate semipermeable wall + soluble-agent osmotic gradient + osmotic passageway + no moving parts). They are principally § 103 (obviousness) and background references. The two ocular inserts (US 3,416,530 Ness; US 3,630,200 Higuchi) are the most topically relevant because US 3845770 also claims an ocular embodiment, but both are diffusion devices and so cannot anticipate the osmotic claims.
4. Prior art discussed in the specification but not printed in the [56] box
These are the references that are actually closest to the osmotic invention, and they appear in the Background:
(a) Rose & Nelson, "A Continuous Long-Term Injector," Austral. J. Exp. Biol., Vol. 33, pp. 415–420 (1955) — non-patent literature.
- Earliest osmotic pump. Consists of three compartments: a partially collapsed rubber bag of saturated Congo red (osmotically effective solute) separated by a cellophane semipermeable membrane from a self-contained water compartment, plus a drug compartment; expansion of the rubber bag mechanically ejects drug solution through a nipple.
- § 102: As a single reference it does not anticipate claim 1 — it requires a separate, self-contained water supply, a separate osmotic solute other than the product, and a movable rubber member/mechanical (piston-like) action. US 3845770 expressly distinguishes these deficiencies (no self-carried water; product itself may be the solute; no moving parts). Highest-value § 103 reference, and the foundational art for the whole field.
(b) US 3,604,417 — Stolzenberg (filed 1971; granted Sept. 14, 1971) — "Osmotic fluid reservoir for osmotically activated long-term continuous injector device."
- Osmotic-pressure-actuated injector: medicament chamber + injection orifice, a freely sliding piston, a concentrated Congo-red osmotic solution capped by a semipermeable membrane, and a second (solvent) chamber.
- § 102: Does not anticipate claim 1 — it explicitly relies on a movable piston separating two chambers and a separate osmotic solution, exactly the structure US 3845770 characterizes as complicated. Strong § 103 reference; cited by many later patents (e.g., EP 0259013, US 5,279,608).
(c) US 3,279,996 — Long, Jr. et al. (filed Aug. 28, 1962; granted Oct. 18, 1966) — "Polysiloxane carrier for controlled release of drugs and other agents."
- Silicone-rubber sealed container/pellet through whose walls drug diffuses at a "constant" rate; also RTV in-situ implants.
- § 102: Pure diffusion device — no semipermeable wall, no osmotic gradient, no passageway. Cannot anticipate any claim; representative of the diffusion prior art the patent seeks to improve upon (cited in the Background alongside US 3,279,996).
(d) Higuchi and Leeper copending applications, Ser. No. 106,130 and Ser. No. 106,131, both filed Jan. 13, 1971 (issued as US 3,732,865 and US 3,760,805 respectively; the patent text also references Ser. No. 106,161).
- Two-compartment osmotic dispensers (drug compartment + semipermeable osmotic-salt compartment separated by a piston/barrier) — i.e., the Higuchi–Leeper pump design.
- § 102: These are the patentee's own earlier, moveable-part designs. They require a separate osmotic-solute compartment and a movable barrier/piston and therefore do not disclose claim 1's unitary wall/agent-as-solute/passageway combination. Background/§ 103 relevance; the "prior art" the present patent improves on.
5. Most relevant prior art — overall assessment
Ranked by relevance to the osmotic claims of US 3845770:
- Rose & Nelson (1955) — NPL. Seminal osmotic pump; discloses the osmotic driving principle but uses a separate water compartment, a separate solute, and mechanical (rubber/piston) expulsion. Closest conceptual art; not an anticipatory reference under § 102 for claim 1.
- US 3,604,417 (Stolzenberg). Osmotic actuated injector with piston; same § 102/§ 103 profile as Rose–Nelson.
- Higuchi & Leeper Ser. Nos. 106,130 / 106,131 (→ US 3,732,865; US 3,760,805). Patentee's own prior two-compartment, moving-part osmotic designs.
- US 3,279,996 (Long, Jr. et al.). Diffusion-controlled implant — representative of the art the patent overcomes.
- US 3,630,200 (Higuchi) and US 3,416,530 (Ness). Prior ocular inserts (diffusion/leaching); most relevant patent art in the ocular field because US 3845770 also claims an ocular embodiment, but neither discloses osmotic pumping.
Bottom line on anticipation (§ 102): None of the cited references — whether from the [56] box or from the Background — is a true § 102 anticipation of the base claim. Each lacks at least one essential element of claim 1 (typically the imperforate semipermeable wall acting as the fluid-imbibing/agent-blocking member, the agent-itself-as-osmotic-solute feature, and/or the absence of a moving part and a separate water/salt compartment). Their real force is under § 103 (obviousness of building a simpler, piston-free osmotic device from the osmotic art of Rose–Nelson/Stolzenberg combined with the membrane and ocular-insert art of Long/Stephenson/Ness/Higuchi), which is consistent with the patent having issued with 15 claims.
6. Confidence and caveats
- The identity, dates, inventors, assignee, filing/grant dates, and the ten [56] U.S. citations are taken directly from the authoritative full text of US 3845770 (Google Patents) and corroborated by the USPTO Official Gazette entry for 3,845,770; these are high-confidence.
- Detailed content is high-confidence for US 3,630,200, US 3,604,417, US 3,279,996, US 3,416,530 (via US 3,630,200 and US 3,990,307's citation lists), and for Rose & Nelson (via US 3,995,631/US 3,995,632). It is lower-confidence/inferred for the very old references US 1,023,499 (Bell), US 1,279,564 (McClure), US 1,434,531 (Cyrenius), US 2,846,057 (Polin), US 2,962,023 (Chappaz), US 3,093,831 (Jordan), and US 3,146,169 (Stephenson), for which I relied on the class designations and the examiner's notations rather than verified full texts. I have flagged this explicitly rather than assert details I could not confirm.
- "Potential anticipation" above reflects my technical judgment that the listed claim requires all elements in a single reference; where a reference supplies only some elements it is, in my view, § 103 rather than § 102 material. This is an analytical opinion, not a legal conclusion of validity or invalidity.
Generated 10/1/2026, 12:23:08 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll ground this §103 analysis by pulling the actual cited references and their disclosures before combining them.
Good grounding on the key references. Let me verify the remaining front-page cited references so I can characterize each accurately.
Obviousness Analysis — US 3,845,770 under 35 U.S.C. § 103
Scope note: Per the task instruction I used the prior art of record for this patent — i.e., the front-page "References Cited" list and the references discussed in the specification under "Background of the Invention" / "Prior Art." A tool-step limit was reached partway through verification, so I flag below exactly which citations I re-verified this session and which rest on my own knowledge. I did not auto-correct any identifier: note, for example, that the citation list of an unrelated later patent (US 5,279,608) contains 3,845,777 (Gilson), which is a different patent than 3,845,770 — a real adjacent-number trap in this art.
I. The claims to be tested
Building on the earlier claim mapping (which I do not repeat in full), the § 103 analysis turns on these groupings:
| Group | Claim(s) | Core limitation added beyond the genus |
|---|---|---|
| A | Claim 1 (independent) | Imperforate semipermeable wall + compartment containing agent soluble in external fluid and itself the osmotic driver + osmotic passageway + imbibe/dissolve/pump functional clause |
| B | Dep. claims (the "claim 2"-dependent set) | (i) limited-solubility agent + separate osmotically effective solute; (ii) oral/GI adaptation; (iii) erodible/bioerodible wall; (iv) wall insoluble in external fluid; (v) adapted for release in the mouth |
| C | Ocular independent claim(s) | Same structure, eye-fluid embodiment |
| D | "Beneficial agent" independent + composite-wall dependent | Genus restated; part imperforate/fluid-permeable + remainder impermeable to both fluid and agent |
| E | Final independent claim | Wall of substantially pore-free material; compartment contains "means for producing pressure therein"; passageway includes "means for maintaining said pressure" |
Flagged inconsistency (carried forward): the online claim text is OCR-garbled and one dependent claim cross-references "claim 2" while evidently depending on claim 1. My grouping is inferred from claim sequence; it should be checked against the USPTO PatentCenter/Official Gazette print before being relied on in a validity opinion.
Preliminary point on legal posture: because the patent's anticipated expiration is 1991-11-05, a § 103 attack today is academic for enforcement purposes. It remains live in one real sense: the '770 document itself is prior art — it was submitted as Exhibit 1017 in IPR2017-01648 (a review of U.S. 6,866,866). So this analysis matters chiefly for how much weight the '770 disclosure carries as art against later filings, and for reconstructing the 1972–74 examination.
II. Governing framework
The application was filed June 5, 1972, so pre-AIA § 103(a) governs, with pre-AIA §§ 102(a)/(b)/(e)/(g) defining the art. The Graham v. John Deere factors apply: scope/content of the art, differences from the claims, PHOSITA level, and secondary considerations. Under KSR v. Teleflex, a combination is obvious where the elements were known and combined "according to known methods" with predictable results; where design need/market pressure produced a finite number of identified, predictable solutions; or where the art taught the problem the patentee claims to have solved. MPEP 2143 supplies the supporting rationales: (A) combining prior art elements, (B) simple substitution, (C) use of a known technique to improve a similar device, (D) applying a known technique to a known device ready for improvement, (F) obvious to try.
PHOSITA (my construction): a person with a pharmaceutical/chemical-engineering background and 2–3 years in sustained-release dosage-form development, familiar with (a) osmotic pumping literature, (b) reverse-osmosis/semipermeable membrane art, and (c) ocular inserts and implantable devices.
III. Prior art of record — characterization
Front-page "References Cited" (10 U.S. patents):
| Ref. | Date | Verified this session? | Character |
|---|---|---|---|
| 1,023,499 — Bell | 4/1912 | No (step limit) | Class 128/260; medicinal carrier/support art |
| 1,279,564 — McClure | 9/1918 | No | Class 128/272 (fluid/medicament holder) |
| 1,434,531 — Cyrenius | 11/1922 | No | Class 128/272 |
| 2,846,057 — Polin | 8/1958 | No | Class 206/.5 (package/unit-dose container) |
| 2,962,023 — Chappaz et al. | 11/1960 | No | Class 128/260 |
| 3,093,831 — Jordan | 6/1963 | No | Class 128/260 |
| 3,146,169 — Stephenson et al. | 8/1964 | No | Class 424/15 |
| 3,416,530 — Ness | 12/1968 | Yes (via the '200 citation list) | Alza ocular insert — the "depot/reservoir" insert that "truly acts as a depot," insoluble polymer retaining integrity in tear fluid |
| 3,574,820 — Johnson et al. | 4/1971 | Partially (appears on the '770 front page as reproduced in Ex. 1017) | Class 424/37; sustained-release/medicament carrier art |
| 3,630,200 — Higuchi | 12/1971 | Yes — https://uspto.report/patent/grant/3630200 | Alza "Ocular Insert." Co-inventor Higuchi is a '770 inventor. Inner hydrophobic drug core + soft hydrophilic outer layer, inserted in the cul-de-sac; explicit "complete dosage regime for a particular time period, on the order of 24 hours or longer." Diffusion/leaching mechanism, not osmotic. |
Specification-discussed art (also part of this patent's "prior art" section):
| Ref. | Verified | Character |
|---|---|---|
| Rose & Nelson, Austral. J. Exp. Biol. 33:415–420 (1955) | Yes — https://pubmed.ncbi.nlm.nih.gov/13269346/ (and companion paper 33:411–413, PMID 13269345) | The first osmotic pump: water chamber / semipermeable (cellophane) membrane / Congo-red (solid + saturated solution) salt chamber / impermeable collapsible rubber bag / drug compartment / release nipple. Establishes (i) osmotically-driven, constant-rate delivery, (ii) use of a solid excess solute in a saturated solution as the engine. |
| U.S. 3,279,996 — Long et al. | Yes (via US 3,992,518 discussion) | Silicone-polymer implantate, drug capsule/matrix; release ∝ T^1/2; expressly characterized as diffusion-controlled |
| U.S. 3,604,417 — Stolzenberg | Yes — https://patents.google.com/patent/[US3604417](/patent/US3604417) and https://uspto.report/patent/grant/3604417 | Osmotic fluid reservoir for an osmotically activated long-term continuous injector. Semipermeable membrane 14; osmotic chamber 12 with saturated Congo Red + excess solid; movable piston 10 driving medicament through orifice 9; second piston 4. "Very slow and continuous injection," as low as 0.12 ml/day. |
| Copending U.S. Ser. No. 106,131 (filed Jan. 13, 1971) | Yes (family) — US 3,760,804, https://patentimages.storage.googleapis.com/96/4b/ba/924a603fc41ed2/US3760804.pdf | Higuchi & Leeper, Alza: osmotic dispenser with semipermeable membrane, movable separator, osmagent chamber (MgSO₄/MgCl₂ + excess solid), dispensing head with orifice |
| Copending U.S. Ser. No. 106,161 (filed Jan. 13, 1971) | Partially — surfaced via a later family discussion tying DE 2,201,533 to Ser. No. 106,161 | Two-flexible-receptacle design — medicament receptacle compressed by an osmotically active receptacle. Mapping of this Ser. No. to a specific U.S. patent number was not confirmed this session; flagging as uncertain. |
| Membrane art cited in the spec: U.S. 3,133,132; 3,276,586; 3,173,876; 3,541,005; 3,541,006; 3,546,142 | Not re-verified this session | Osmosis / reverse-osmosis membranes; ionically associated polyelectrolytes and polycation-polyanion co-precipitates. From my own knowledge, 3,133,132 is the Loeb–Sourirajan high-flux cellulose-acetate RO membrane patent — a water-permeable, salt-rejecting, effectively non-porous barrier. I could not re-verify it in this session's searches, so treat it as a knowledge-based (not search-verified) characterization. |
Framing (verified): the art itself already narrated this invention's problem and its partial solutions. US 3,995,631 (Higuchi/Theeuwes) describes Rose–Nelson and recites its drawbacks — carried water compartment, drug must be in solution, complex construction, restriction to Congo red + cellophane. US 4,612,008 (Alza) states: "The next quantum leap in dosage forms came in 1972 with the invention of the osmotic delivery system by inventors Theeuwes and Higuchi as disclosed in U.S. Pat. Nos. 3,845,770 and 3,916,899." And the UNSW review describes the EOP explicitly as "essentially a drug core surrounded by a semi-permeable coating with an orifice" — "the Higuchi–Theeuwes pump was further simplified by discarding the salt layer and instead relying on the drug itself to provide a concentration gradient" (https://unsworks.unsw.edu.au/...). That sentence is, in substance, the case for obviousness stated by the secondary literature.
IV. Element-by-element mapping of claim 1
| Claim 1 element | Where disclosed in the art |
|---|---|
| (a) Shaped wall, substantially imperforate, semipermeable, integrity-maintaining, fluid-permeable, agent-impermeable | Rose–Nelson (semipermeable membrane, water-in/solute-out); Stolzenberg membrane 14; the RO membrane art (3,133,132-type cellulose acetate) supplies the imperforate (non-porous, diffusional) character and the water-permeable/solute-rejecting property |
| (b) Compartment with agent soluble in the external fluid and exhibiting an osmotic pressure gradient | Rose–Nelson: the Congo-red chamber is exactly a compartment whose soluble content exhibits an osmotic gradient vs. water. The claim's substitution of the active agent itself for Congo red is a simple substitution of one known osmotically active solute for another (MPEP 2143.B) — and the spec itself lists the claimed drugs (ephedrine HCl, pilocarpine nitrate, etc.) as "osmotically effective as solutes" |
| (c) Osmotic passageway through the wall, "designed and sized for osmotically pumping" | Rose–Nelson's drug release nipple; Stolzenberg's orifice 9; Higuchi's dispensing head with orifice. The sizing limitation is functional; the art's rate equations (Q/t ∝ permeability × Δπ / thickness) make sizing a routine optimization |
| (d) Imbibe → dissolve → pump at controlled rate over prolonged period | Rose–Nelson and Stolzenberg both claim/describe constant, gradual, long-term delivery (Stolzenberg: 0.12 ml/day) |
| "Minimum number of components" premise of the spec | Achieved by omitting the water reservoir (use environmental fluid) and the movable piston/separator — i.e., by deletion of elements under a recognized design need. KSR teaches that "the omission of an element and the retention of the function" of the remaining elements is a classic obviousness rationale |
V. The combinations
I set out five; the strongest is Combination A/B, and I regard Combination B as the most likely to succeed, with Combination D as the strongest on the ocular claims.
Combination A — Rose & Nelson (1955) + Higuchi US 3,630,200 (ocular insert) [→ ocular claim]
- What the combination supplies: Rose–Nelson supplies every functional element of osmotic pumping; Higuchi '200 supplies the finished physical form factor for the eye (cul-de-sac placement, bean/ellipsoid shape, 4–20 mm × 1–12 mm × 0.1–1 mm, removal after the programmed period) and — critically — the motivation and the very problem the '770 ocular embodiment solves: applying drug continuously to the eye for 24 h+ without repeated instillation.
- Motivation: same field (ophthalmic sustained release), same assignee (Alza), and an overlapping inventor (Higuchi — an inventor of both '200 and '770). Higuchi '200 expressly identifies the failing of prior ophthalmic dosing ("the drug is washed away rapidly by tears, leaving the eye without medication"), which is precisely the problem an osmotically metered, tear-fluid-driven insert solves. KSR rationale (C): use of a known technique (osmotic metering) to improve a similar device (ocular insert) in the same way.
- Reasonable expectation of success: high. Tear fluid is an aqueous medium; Rose–Nelson's semipermeable-membrane/Congo-red engine works against any aqueous hypotonic environment.
- Weakness: Higuchi '200 is a diffusion/leaching device; there is no teaching that the eye's tear fluid could serve as the osmotic source. An examiner would need to import that teaching from Rose–Nelson/Stolzenberg. That is a straightforward combination, but not a naked one-reference case.
Combination B — Rose & Nelson (1955) or Stolzenberg US 3,604,417 + Higuchi–Leeper copending Alza applications (Ser. Nos. 106,131 / 106,161) [→ claim 1 and most dependents] ⭐ strongest
- What the combination supplies: Stolzenberg '417 supplies the semipermeable wall + osmagent chamber + orifice + movable piston architecture and the explicit "very slow and continuous injection" result. The Higuchi–Leeper applications (Alza, filed Jan. 13, 1971, ~17 months before the '770 filing) supply the same architecture with a rigid housing, semipermeable membrane on a porous support, excess solid salt in the osmagent chamber, and an active-agent formulation — i.e., they show the osmagent chamber, the semipermeable wall, and the orifice in one Alza device.
- Motivation: The Higuchi–Leeper line was explicitly directed at simplifying Rose–Nelson and at eliminating the carried-water compartment — the very deficiency the '770 spec recites as its own point of novelty. The '770 specification itself concedes these applications "represent an improvement to the art" while complaining that "they are designed with moving parts that tend to complicate their manufacture and they require, in addition to the product, the constant presence of an osmotically effective solute." That is a statement of the problem to be solved, and under KSR the recitation of a known problem plus an obvious route (delete the moving part; let the drug be the osmagent) supports obviousness.
- Reasonable expectation of success: the only thing the '770 does relative to the copending applications is (i) remove the piston/separator and (ii) in the "soluble agent" species, remove the separate osmagent — with the result that the drug itself pressurizes the compartment. Both are design simplifications with predictable outcomes.
- Decisive § 102(e)/§ 103 point: the copending applications were filed before the '770 filing and matured into U.S. patents (e.g., US 3,760,804, granted Sept. 25, 1973). As a matter of law, the pre-AIA § 103(c) common-ownership exception reaches only art qualifying under § 102(f) and (g) — it does not reach § 102(e) art. So common ownership by Alza does not necessarily disqualify these references. This is the single most potent line of attack on the '770. I flag as a caveat that the application of § 103(c) to a patent filed in 1972 (as opposed to a patent in reexamination/IPR today) is a legal question I have not resolved this session; it should be briefed.
Combination C — Stolzenberg US 3,604,417 + Long US 3,279,996 [→ dependent claim on limited-solubility agent + osmagent]
- Long '996 supplies a drug-containing implantable reservoir; Stolzenberg supplies the solubility-independent osmotic engine (saturated Congo red with excess solid). The dependent claim's teaching — where the agent has limited solubility, admix it with a soluble osmotically effective solute — is literally the Stolzenberg/Rose–Nelson configuration with the drug substituted for the dye. Simple substitution (MPEP 2143.B), and the spec lists the usable osmagents (MgSO₄, MgCl₂, NaCl, KCl, LiCl, K₂SO₄, Na₂CO₃, Na₂SO₃) as known.
- Weakness: Long '996 is diffusion art, so its role is only to supply the "drug reservoir" concept; it is not needed if Combination B is available.
Combination D — Combination B + the RO-membrane art (3,133,132-type) [→ the "imperforate" and composite-wall limitations]
- The contested phrase is "substantially imperforate." Rose–Nelson used cellophane — a water-swollen membrane, arguably not "imperforate." The reverse-osmosis membrane art (the "commercially available unplasticized cellulose acetate, plasticized cellulose acetate, reinforced cellulose acetate, cellulose diacetate, cellulose triacetate" list the '770 spec itself lifts verbatim from the membrane literature) supplies a non-porous, diffusional barrier that passes water while rejecting dissolved solute.
- Motivation (KSR rationale D): the RO membrane art was a known technique ready for improvement, and applying it wherever "a membrane permeable to solvent but not to solute" was needed is a predictable use.
- This is the combination that meets dependent-element (ii)-type limitations — the composite wall (part fluid-permeable, remainder impermeable to fluid and agent) is nothing more than the standard practice in the osmotic/RO art of masking part of a membrane, and is also explicitly foreshadowed by Higuchi '200's sandwiched inner-core/outer-layer laminate.
- Weakness: the "imperforate" characterization invites a claim-construction fight (does "substantially imperforate" exclude microporous membranes? The '770 spec says the wall "can be formed of a material that is microporous" — see the portion of the description describing micropores — which arguably reads the limitation out of the claim and helps the challenger).
Combination E — Combination B + Higuchi '200 + Ness '346,530 [→ the "pore-free wall"/"means for maintaining pressure" independent claim]
- For the final independent claim, the challenger maps "means for producing pressure therein" (§ 112(f)) onto Stolzenberg's osmotically pressurized chamber 12 and "means for maintaining said pressure" onto Stolzenberg's excess solid Congo Red (or the Higuchi–Leeper excess-solid salt bed), plus a structurally rigid wall. The Ness/Higuchi inserts supply the integrity-maintaining-wall disclosure. The functional clause adds nothing patentable over the corresponding structures.
- Weakness: the "pore-free" limitation is narrower; the challenger must rely squarely on the RO membrane art (Combination D) to reach it, and must rebut any argument that "pore-free" is a deliberate exclusion of the microporous embodiments of Rose–Nelson.
VI. Rebuttal case (why a defender would survive some claims)
The patentee's best non-obviousness positions, and my assessment:
- Teaching away. The '770 specification, and the later Alza patents, dwell on the drawbacks of Rose–Nelson — "cumbersome," "literally restricted to a Congo red solution… and to a cellophane osmotic membrane," "demands of a movable material." A teaching away argument requires that the art direct PHOSITA not to pursue the path. Here the art does the opposite: it identifies the drawbacks as the problem to be solved and (in the Higuchi–Leeper and Higuchi–Theeuwes lines) actually solves them. Under KSR, criticism of a reference's defects is normally a motivation to improve, not a teaching away. This defense is weak.
- Criticality of "removing everything." The genuinely new thing in the '770 (elementary osmotic pump) is that it contains no separate osmagent and no moving parts — a "true innovation… achieved by leaving things out," in the words of the J. Controlled Release review (https://www.sciencedirect.com/science/article/abs/pii/016836599500013X). Defenders will argue that omission was not obvious because the art (including Alza's own copending applications) consistently kept the osmagent and the separator. Counter: KSR rationale — "omission of a component and retention of function" plus a finite number of identified, predictable solutions (keep piston / delete piston; keep osmagent / delete osmagent). Moderate strength, claim 1/ocular only.
- Unexpected results / secondary considerations. The spec asserts (a) high drug loading without leaching, (b) shelf-stable solid/semisolid cores, (c) heat-sterilizability, (d) true zero-order release, (e) optional bioerosion. Defenders would need evidence, not attorney argument, plus nexus to the claimed invention. Note the tension: the spec also argues these advantages flow from the very deletion of parts that the prior art suggested deleting — which weakens nexus. Commercial success of Alza's OROS® line is real and famous, but OROS is a tablet platform (coated core) that post-dates the '770; the nexus mapping must be built claim-by-claim. The strongest available defense, but evidentiary.
- § 103(c) common ownership (Combination B only). If the copending Alza applications qualify only as § 102(f)/(g) art, the common-ownership exception removes them. As noted, that exception does not reach § 102(e) art, so if the references were "prior art only under § 102(e)," the exception is unavailable. Genuinely contested legal ground — worth a real brief.
- "Substantially imperforate" / "pore-free" construction. Because the '770 spec contemplates microporous walls, the defender can argue these words do not exclude the REFERENCES (which is what the challenger needs), and simultaneously try to keep them narrow for infringement. Claim-construction leverage only; not a true validity argument given the spec's breadth.
VII. Claim-by-claim outlook
| Group | Likely § 103 outcome | Basis |
|---|---|---|
| Claim 1 (genus, soluble-agent species) | Likely obvious | Rose–Nelson/Stolzenberg + Higuchi–Leeper applications (Comb. B); KSR omission/design-choice and finite-solutions rationales |
| Limited-solubility + osmagent dependent | Clearly obvious | Stolzenberg/Rose–Nelson disclose the exact configuration (Comb. C); mere substitution of drug for dye |
| Erodible-wall dependent | Likely obvious | Bioerodible polymers (polylactic/polyglycolic) were known; substituting an erodible for an insoluble wall is a known design choice with predictable effect ("erode in situ after the dispensing period") |
| Oral/GI and "mouth" dependents | Likely obvious | Adaptation of a known device to a known use; Alza's own osmotic papers expressly contemplate oral/bolus/IUD/vaginal/suppository forms |
| Ocular independent claim(s) | Likely obvious | Comb. A and/or D; Higuchi '200 (same inventor/assignee) supplies the eye form factor and the ophthalmic problem statement |
| "Beneficial agent" independent + composite-wall dependent | Likely obvious | Comb. B + D; composite-wall masking is routine in the membrane art |
| Final "pore-free"/pressure-means independent | Probably obvious, but contestable | Comb. D/E; § 112(f) means map onto Stolzenberg's pressurized chamber and excess-solid bed. The "pore-free" wording is the hard edge |
Overall: I would expect a challenger to prevail on claim 1 and most dependents, with the outcome on the ocular and "pore-free" independents turning on (i) how "substantially imperforate"/"pore-free" is construed against a 1974 specification that also embraces microporous walls, and (ii) the § 103(c) question for the commonly owned copending applications.
VIII. Confidence, caveats, and contradictions
- Confidence: moderate-to-high on the analysis structure and on the characterizations of Rose–Nelson, Stolzenberg '417, Higuchi '200, Long '996, and the Higuchi–Leeper line — all verified this session via the URLs cited above.
- Not verified this session (tool-step limit reached): the subject matter of Bell 1,023,499; McClure 1,279,564; Cyrenius 1,434,531; Polin 2,846,057; Chappaz 2,962,023; Jordan 3,093,831; Stephenson 3,146,169; Johnson 3,574,820, and the membrane patents 3,133,132; 3,276,586; 3,173,876; 3,541,005; 3,541,006; 3,546,142. I characterized these only from their printed U.S. classes and from my own prior knowledge, and I say so rather than assert their contents. The Loeb–Sourirajan identification of 3,133,132 is knowledge-based, not search-confirmed in this session.
- Uncertain mapping: I did not confirm that copending Ser. No. 106,161 corresponds to a specific U.S. patent number; the two-flexible-receptacle description came from a later family discussion tying it to DE 2,201,533. Ser. No. 106,131 → US 3,760,804 is the mapping I saw in the family record.
- Contradiction flagged: nothing in this session's searches contradicts the prior sections. The earlier sections' findings stand — in particular, no CAFC 2026 docket for 3,845,770, expired-lifetime status, and the unverified Federal Circuit 21-2335 / D.N.J. 3:18-cv-11213 entries. One new item that reinforces the earlier caution: the "Referenced Cited" table of US 5,279,608 lists 3,845,777 (Gilson), a different patent from 3,845,770 — a reminder that adjacent-number confusion is real in this family.
- Date discrepancy: the task header states the current date as April 26, 2026, while the system date I was given is 2026-10-01. This does not affect the analysis (the patent expired in 1991 either way), but I note it rather than silently reconciling it.
- Legal caveat: I am not offering a legal opinion. The § 103(c)/§ 102(e) issue and the § 112(f)-versus-§ 103 treatment of the "means" language in the final claim are questions that require the applicable-version analysis and, ideally, a full claim chart against the complete texts of the Higuchi–Leeper applications, neither of which I can complete within this session's constraints.
Generated 10/1/2026, 12:23:40 AM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
Keep exploring
More patents asserted by Celgene Corporation
- US 8198262I'll search for authoritative information on US 8,198,262, including any 2026 CAFC activity, then summarize. Let me check specifically for any 2026 Federal Circuit docket activity involving this patent. Let me confirm the exact claim set…
- US 8735428I'll verify the patent record and check for CAFC 2026 litigation activity. Let me check the specific litigation and Orange Book/regulatory record. I have the bibliographic and litigation record. Now let me try to retrieve the actual claim…
- US 8828427I'll verify the patent details against live sources and check for any CAFC 2026 docket activity. Let me specifically check for any 2026 Federal Circuit docket activity involving this patent. US Patent 8,828,427 — Verification Summary Note…
- US 9993467I'll verify the patent details against live sources and check for any CAFC 2026 activity. Let me check the granted claims and any 2026 appellate activity. Let me confirm the granted claim text and check the Federal Circuit docket…
- US 10555939I'll run targeted searches for this patent number and any related CAFC docket activity. Let me look for the actual claim text and any CAFC activity specifically naming this patent. Let me confirm the full claim set and check the Federal…
- US 8673939I'll search for authoritative information on this patent and any 2026 CAFC activity. Let me look for CAFC docket activity and the actual claim text. Let me search specifically for 2026 CAFC/appellate docket activity involving this patent…
- US 8158262I'll search for this specific patent number across the requested sources. Let me check for any CAFC litigation dockets and confirm the patent's official record. Search coverage and confidence I ran targeted searches for the literal number…
- US 7393939I'll search for authoritative information on US patent 7393939, including any 2026 CAFC docket activity. Let me run a couple more targeted searches to check for any litigation or CAFC activity specific to this patent. US Patent 7,393,939 —…
Other patents in Medical (M)
- US 10076367I'll run targeted searches for this patent number and its litigation/appeal status. Let me check the specific CAFC docket and litigation status. Let me verify whether US 10,076,367 itself has any PTAB or CAFC 2026 activity (as distinct…
- US 10376386I'll search for this specific patent and any related 2026 docket activity. Let me run several targeted queries. I have good initial results. Let me dig deeper on the specific claims of the '386 patent and the 2026 docket activity. US…
- US 10251643I'll search for authoritative information on US 10,251,643 and its litigation/docket history. Let me check whether US 10,251,643 itself appears in any CAFC docket and confirm the PTAB outcome. Let me verify the second CAFC docket number…
- US 10307268I'll research this patent across the requested sources. Let me search specifically for the CAFC 2026 docket activity and the patent's claims. Let me check the second CAFC docket (24-1753) and retrieve the '268 patent's actual claim text…
- US 10076376I'll run searches against the specific patent number and any 2026 CAFC dockets, then cross-check against the authoritative patent text provided. Let me run a couple more targeted checks on litigation/CAFC dockets and the family members. US…
- US 10028740I'll verify the bibliographic data and check for 2026 CAFC activity before summarizing. Let me verify the docket numbers and confirm whether the 2026 CAFC appeals actually involve this patent. Let me check the second 2026 appeal (24-1753)…
- US 5023269Patent Overview: US5023269A — 3-aryloxy-3-substituted propanamines Title: 3-aryloxy-3-substituted propanamines Patent number / application: US5023269A; application US07/499,940, filed 1990-03-27. Assignee: Eli Lilly and Co (current and…
- US 6344470I'll search for this specific patent number and any related litigation. Let me verify the abstract, full claim set, and check for any 2026 appellate activity. US Patent 6,344,470 — Analyst Summary Method note / scope: I could not reach a…
This patent in court (1)
1 tracked lawsuit name US 3845770.