US 4769027

I'll search for authoritative information on US 4,769,027, including any 2026 CAFC docket activity.

Let me run additional targeted searches on litigation/docket activity and current USPTO status.

Let me check the related reissue patent and any litigation history involving this family.

US 4,769,027 — Verification Summary

Search scope note: I did not have direct access to USPTO PatentCenter/PAIR, the USPTO assignment database, or the CAFC/PACER docket system in this session. Findings below rest on the authoritative full patent text you supplied (Google Patents, fetched 2026‑09‑24), plus publicly indexed secondary sources (Google Patents, uspto.report, DrugPatentWatch). Where these conflict with each other, I flag it.

Bibliographic data

Assignee — one conflict to note

The Google Patents record lists the current assignee as "SmithKline Beecham Corp" (the successor-in-interest to Burroughs Wellcome), while uspto.report lists the assignee simply as Burroughs Wellcome Co. Google Patents expressly disclaims the accuracy of its own assignee lists. Both are reported here; the SmithKline Beecham chain is plausible as corporate successor but I cannot confirm it against an assignment record in this session.

Abstract (as issued)

Prills of pharmaceutically acceptable material are coated first with a water-permeable polymeric matrix containing a water-soluble pharmaceutically beneficial agent and then overcoated with a water-permeable film containing dispersed therein a water-soluble, particulate pore-forming material.

Independent claim — plain language

The patent issued with 4 claims; only claim 1 is independent. (The description contains a "what we will claim" list lettered (a)–(f), but those proposed paragraphs — including two method claims — were not granted as claims.)

Claim 1 — a coated pellet (an osmotic "prill"):

• The pellet must be small: longest dimension 0.1 to 4.0 mm.
• It has three parts, nested:
  1. A core (any material — no water-solubility limit stated in the claim itself).
  2. A first film overcoating the core, made of a water-permeable polymer that contains the beneficial agent. The agent is loaded heavily: its weight must be about 0.5 to about 5.0 times the weight of the polymer in that first film.
  3. A second film overlying the first film, made of a water-permeable polymer containing water-soluble, particulate pore-forming material — with the requirement that the pore-former particle size be less than the film's thickness (so particles span the film and dissolve out to leave through-pores).
• Plain reading: instead of drilling a delivery hole, you sprinkle soluble particles into an outer membrane; when they leach out, they leave the passages through which the osmotically driven drug solution escapes.

Dependent claims (2–4):

• Claim 2: the first (drug-loaded) film's polymer is more water-permeable than the second (pore-forming) film's polymer — matching the specification's stated preference.
• Claim 3: the core is water-soluble.
• Claim 4: the printed text is identical to claim 3 — "in which the core is water-soluble." This is almost certainly a typographical error in the issued patent (the specification's proposed paragraph (c) contemplates a water-insoluble core, and the patent elsewhere distinguishes the two cases). Literal reading governs under your rules: as issued, both claims 3 and 4 recite a water-soluble core, so claim 4 adds no discernible scope. Do not treat this as "water-insoluble" without checking the printed original/errata.
• No method claims issued, despite the description's proposed paragraphs (e) and (f).

Technology context (for the record)

The patent describes coating sugar/starch prills (Nu‑Pareil™ 20/25 mesh) in a fluidized bed — first with cellulose acetate (CA 398‑10) plus drug (e.g., d‑pseudoephedrine HCl, 36 g drug : 12 g polymer, i.e. 3:1, within the claimed 0.5–5.0× range), then overcoating with cellulose acetate + PEG (Polyglycol E‑400) + suspended sodium carbonate or impalpable lactose as the pore-former. Examples report release rate varying with external osmotic pressure (90 → 10 mg/hr as NaCl went 0% → 20%) and ~90% aspirin release over 8 hours.

Related family member (relevant, distinct patent)

• US RE33,994 ("Pharmaceutical delivery system"), application 07/390,518, filed 1989‑08‑04, reissued 1992‑07‑14, inventors Baker and Brooke (no Smith), assignee Burroughs Wellcome Co. DrugPatentWatch states the reissue arose from reexamination request 90/001,344, filed 1987‑10‑05, and is a tablet-based sibling (added claim 7 recites a bupropion HCl release profile for oral administration). Its foreign priority is UK 8322007, 1983‑08‑16. This is a separate patent from US 4,769,027 — do not conflate them. DrugPatentWatch's RE33,994 page also lists an unexplained secondary assignee, "ATK Launch Systems LLC"; I could not verify that and flag it as unconfirmed.

CAFC 2026 dockets — no match found

I searched for a 2026 Federal Circuit docket or appeal tied to 4,769,027 / 4769027 and found none. Given the patent's status — Expired – Lifetime with anticipated expiration on 2005‑09‑06 — a modern appeal is highly unlikely; a live 2026 appeal would be unusual.

Uncertainty statement: I could not query PACER or the CAFC docket system directly, so I cannot affirmatively certify a negative. To confirm, check the CAFC docket search at cafc.uscourts.gov and USPTO PatentCenter (Application 07/016,966) directly.

False positives filtered out (per your "literal ID" rule)

Several hits contained the digit string "4769027" but are not this patent and should not be cited as such: a Lithuanian business-registry notice ("Pranešimo Nr. 4769027"), a Russian-language RU2404750C2 passage citing "№ 4769027," and Google Patents' own forward-citation list, which mixes unrelated later patents.

Sources: https://patents.google.com/patent/US4769027/en ; https://uspto.report/patent/grant/4769027 ; https://www.drugpatentwatch.com/p/patent-claims/[RE33994](/patent/RE33994) ; https://patents.justia.com/patent/RE33994

I'll search for litigation involving US patent 4769027 across patent litigation databases.

Let me search litigation-specific databases.

Summary of Findings

I could not locate any litigation involving U.S. Patent No. 4,769,027. Based on the sources reachable through web search — including patent portals, litigation-document repositories (e.g., RPX Insight, Docket Alarm, CourtListener/Justia materials), USPTO/PTAB dockets, and CAFC opinion archives — there is no record of any lawsuit, declaratory-judgment action, ITC proceeding, or PTAB post-grant proceeding in which U.S. 4,769,027 was asserted, challenged, or otherwise at issue.

Important caveat on the "no results" conclusion

Please read this as "not found," not as "proven to be zero." Reasons for caution:

1. I could not directly query the specific litigation trackers you named. Searches for the Unified Patents litigation caselist and for CourtListener/RPX-specific case pages for this number did not return a case-level docket. Public litigation databases also historically index older, pre-2000s cases inconsistently.
2. The patent is long expired. Per the authoritative Google Patents record, US 4,769,027 has a priority date of 1984-08-15, was filed 1987-02-24 as a continuation of Ser. No. 641,058 (filed 1984-08-15, now abandoned), granted 1988-09-06, with an anticipated expiration of 2005-09-06 and legal status "Expired – Lifetime." Any assertion window was roughly 1988–2005, a period when electronic docket coverage was sparse and today's litigation databases are least complete. An absence of hits is therefore weak evidence, not conclusive.

Critical disambiguation — false positives to ignore

The searches surfaced several cases involving a different "’027 patent" that is not US 4,769,027. These should not be attributed to this patent:

• Pfizer v. Aurobindo (ANDA litigation referencing a "'027 patent" and "RE'783" — a small-molecule drug patent, not an osmotic-delivery patent).
• Fresenius Medical Care Holdings, Inc. v. Baxter Int'l, Inc., Nos. 2008-1306, -1331 (Fed. Cir.) — the hemodialysis touch-screen "'027 patent."
• A graphics-processing "'027 patent" (MacInnis / Broadcom-related proceedings) and others.

None of these concern Burroughs Wellcome's "Delivery system" patent, which claims an osmotically driven coated prill/pellet.

What I can confirm about US 4,769,027 (for context, since litigation often tracks ownership)

• Prosecution/ownership: Original assignee Burroughs Wellcome Co. (USA); inventors Richard W. Baker, Kelly L. Smith, James W. Brooke; current listed assignee SmithKline Beecham Corp (the corporate successor).
• Related family member worth noting: U.S. RE33,994 E ("Pharmaceutical delivery system," Burroughs Wellcome Co.), granted 1992-07-14 — a reissue in the same corporate family, which the record lists as citing US 4,769,027. It does not appear in the sources as the subject of litigation either.
• Cited art (patents cited against/within it): U.S. 2,099,402; 3,577,512; GB 1,326,995; U.S. 3,845,770; 4,455,143; 4,576,604; 4,586,922. These are citations, not litigation.
• The patent appears frequently as a prior-art citation in later patents (osmotic/controlled-release formulations), which is why it appears in search results — this is citation activity, not enforcement activity.

Recommended verification steps (if you need a definitive answer)

Because I cannot confirm a negative from the sources available to me, I recommend the following targeted checks, which are the authoritative places where any such case would appear:

1. USPTO Patent Assignment / litigation-notice records (35 U.S.C. § 290 filings) for patent 4,769,027 — these would list any district-court action.
2. Docket Alarm / UniCourt / PACER query on "4,769,027" and "4769027" limited to 1988–2005.
3. Westlaw/Lexis "Patent No. 4,769,027" full-text docket search across all U.S. district courts and the CAFC.
4. ITC EDIS (Section 337) search.
5. Defensive/assertion check against Burroughs Wellcome / SmithKline Beecham / Glaxo Wellcome as patented and their known osmotic-pump drug products (e.g., pseudoephedrine HCl and bupropion HCl sustained-release products implicated in this patent's Examples).

Bottom line: No litigation involving US 4,769,027 was found in any accessible source; the cases the searches returned involve unrelated patents that merely share the "’027" suffix. Given the patent's pre-2005 expiration and incomplete historical docket coverage, I cannot state with certainty that no such case ever existed — only that none is discoverable in the sources available.

I'll verify the structured data with targeted searches before writing.

Proceedings overview

Total AIA trial proceedings on file for US 4,769,027: zero. The USPTO Open Data Portal returns no IPR, PGR, or CBM proceeding for this patent, and my web searches surfaced no proceeding number, institution decision, or Final Written Decision tied to it — no active proceedings, no claims invalidated, no claims sustained through trial, no settlements, no institution denials. That is not an oversight: US 4,769,027 issued 1988-09-06, expired 2005-09-06, and AIA trials did not exist until 2012-09-16, so the entire seven-year window in which this patent was enforceable predates the PTAB's trial jurisdiction. The bottom-line defensive posture is therefore not "the patent is hardened by surviving IPRs" — it is that this patent is expired and out of enforcement, and a demand letter citing it is a red flag about the sender, not a validity problem to solve. There is nothing for a defendant to petition against and no live claim to invalidate.

Per-proceeding detail

None to report. I will not manufacture proceeding numbers, panels, or dispositions that do not exist. For the record, the structured "PTAB proceedings on file" block controls the count (zero), and my independent searches returned only: (i) the Google Patents record for US4769027A, (ii) third-party patents citing US 4,769,027 as background art in their specification reference lists, and (iii) unrelated hits where the string "4769027" matches other databases (e.g., an OSTI nuclear-reactor record). No PTAB E2E / PTAB Center docket entry, no Final Written Decision, no Federal Circuit appeal of any PTAB decision.

One adjacent item worth distinguishing, because a careless search will surface it: US RE33,994 E ("Pharmaceutical delivery system," Burroughs Wellcome, priority 1983-08-16, reissued 1992-07-14) appears in the "Cited By" list for US 4,769,027. A reissue is an Office proceeding on a different patent, not an AIA trial on 4,769,027, and it is not a PTAB proceeding. Do not represent it as one.

Strategic summary

Claim status. All four issued claims are untested before the PTAB — not canceled, not sustained, simply never challenged in an AIA trial. For the record, the claim set is narrow and small: claim 1 recites a pellet 0.1–4.0 mm long with a water-permeable polymer first film containing a beneficial agent at 0.5–5.0× the film polymer weight, overcoated with a second water-permeable polymer film containing water-soluble particulate pore-former sized smaller than the film thickness; claims 2–4 are narrow dependents (claim 2, higher water permeability in the first film; claims 3 and 4 both recite a water-soluble core — as printed, claim 4 repeats claim 3, which is itself a useful drafting-defect talking point if anyone ever asserted this family). Because the patent expired 2005-09-06, claim-level nuance is largely academic: there is no term left to enjoin and no ongoing royalty base.

Estoppel landscape. Section 315(e)(2) estoppel is not a live constraint here, because no petition was ever filed — there is no petitioner, no privity chain, and no instituted ground. The practical consequence is inverted from the usual case: a defendant does not need to scan for IPR estoppel carve-outs, because it faces no PTAB-based estoppel exposure at all. Any invalidity theory a defendant would want to run would have to be run in district court, and the strongest theory available is the simplest one — the patent has expired, so there is no infringement cause of action for post-expiration conduct and no prospective relief.

Pattern signals. None of the classic markers are present: no repeat petitioner, no serial IPR filings, no patent-owner appeal activity, no defensive aggregator (Unified Patents, RPX, etc.) in the chain. The patent's citation footprint is as background art in later formulation and biologics patents (e.g., hyaluronidase/PH20 and NMDA-antagonist formulation filings cite US 4,769,027 in their reference lists), and the current assignee of record is SmithKline Beecham Corp. / Glaxo-lineage — consistent with a long-since-abandoned 1980s osmotic-prill platform, not an active assertion campaign.

Recommended next steps

• If you are a defendant: the correct response to any assertion of US 4,769,027 is a standing/expiration defense, not an invalidity petition. Confirm the expiration on the face of the Google Patents record ("Anticipated expiration 2005-09-06"; legal status "Expired – Lifetime") at https://patents.google.com/patent/US4769027/en, and demand the plaintiff identify the accused acts occurring before 2005-09-06. There is no Final Written Decision to link or quote, because none exists.
• Verify independently before relying on this: run the patent number through USPTO PTAB Center / PTAB E2E (https://ptacts.uspto.gov/) and the USPTO Open Data Portal proceeding endpoint yourself. I found no proceedings, but PTAB dockets are the authoritative source and I would not want you to rely solely on a search-based null result.
• If the assertion cites a different patent number that looks similar — most likely a related reissue or a later Glaxo/SmithKline-family formulation patent — re-run this analysis on that number. The absence of PTAB activity on 4,769,027 says nothing about any sibling patent.
• Do not treat the absence of IPRs as a signal of strength. Here the absence is explained entirely by the patent's age and 2005 expiration. There was never a litigation or assertion window overlapping the AIA trial era in which an IPR would have made economic sense.

Confidence note: I am highly confident there are no AIA trial proceedings on US 4,769,027, based on both the structured ODP block and independent searches. I could not retrieve a PTAB E2E docket page directly for this patent (no such page exists in the results), so I am not representing a docket URL.

I'll search for the assignment record and ownership history for US 4,769,027.

Let me try targeted searches on the assignment databases and legal-events records.

Let me check Justia's patent page and the USPTO assignment API directly.

Assignment & Ownership Reconstruction — US 4,769,027

⚠️ Data-access caveat (read first)

I was unable to retrieve the actual assignment records for US 4,769,027 in this session. I could not query the USPTO Assignment Center search API/interface (assignmentcenter.uspto.gov / assignment.uspto.gov) directly, and web searches did not surface any indexed reel/frame entry, correspondent of record, or conveyance document for this patent number. The only ownership data recoverable from indexed sources is:

• Google Patents' machine-generated fields — "Original Assignee: Burroughs Wellcome Co USA" and "Current Assignee (listed): SmithKline Beecham Corp" — with Google's own express disclaimer of accuracy; and
• uspto.report, which lists the assignee as Burroughs Wellcome Co. only.

No reel/frame numbers, execution dates, recording dates, or correspondents are available to me for this patent. Per your constraint ("don't fabricate assignments"), I will not invent them. Everything below that is not a recorded assignment is labeled as inference. The section's headline finding is therefore a data gap, and the verdict is driven by that gap — not by any affirmative NPE evidence.

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Inventors

Unusual pattern to flag (inference, not a recorded fact): the earliest application in this family predates the 1984-08-15 filing, and the patent carries a U.K. priority of 1983-08-16 (GB 8322007) per the sibling reissue RE33,994. The three inventors' listed residences (California and central Oregon) are inconsistent with the assignee's headquarters in Research Triangle Park, North Carolina. Two of the three inventors give Oregon addresses in the Bend/Sisters area, which is the locale historically associated with the independent contract-research firm Bend Research, Inc. Richard W. Baker is publicly associated with membrane/osmotic-delivery research in that milieu. This is consistent with a contract-research arrangement — outside inventors assigning their rights to Burroughs Wellcome — rather than in-house discovery at the assignee. I could not verify this against an assignment document, and I am not asserting it as recorded fact.

I found no evidence of the classic "inventors depart the assignee within 12 months" fire-sale precursor. Because the inventors do not appear to have been employees of the assignee, that signal is largely inapplicable here.

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Original assignee

Burroughs Wellcome Co. (USA) — named on the issued patent (per uspto.report and Google Patents' "original assignee" field). Research Triangle Park, North Carolina.

• Primary line of business: fully integrated brand pharmaceutical R&D and manufacturing (antibiotics, antivirals, CNS and respiratory products). Burroughs Wellcome was the U.S. arm of The Wellcome Foundation Ltd. and is well known as the originator of AZT/Retrovir (zidovudine) and Zovirax (acyclovir).
• Did they ship a product embodying these claims? Unclear. The patent's own examples use d-pseudoephedrine hydrochloride and aspirin, and the specification contemplates sustained-release prill-in-capsule products. I found no evidence that Burroughs Wellcome commercialized an osmotic-prill product reading on the issued claims. The claim set is narrow (0.1–4.0 mm pellet, dual-film, 0.5–5.0× drug:polymer load) and, on the accessible record, this appears to be a platform/defensive filing in the osmotic-delivery space rather than a product patent.
• Current status: not an operating company. Corporate lineage:
  • Burroughs Wellcome Co. → acquired by Glaxo in a deal announced January 1995, approved late March 1995, forming Glaxo Wellcome plc (confirmed by FTC panel testimony and multiple independent histories).
  • Glaxo Wellcome plc → merged with SmithKline Beecham plc in 2000, forming GlaxoSmithKline plc.
  • This lineage is the likely origin of Google Patents' "SmithKline Beecham Corp" current-assignee entry, which would be registered internally as the GlaxoSmithKline successor entity. This remains unconfirmed against any assignment record.
  • No bankruptcy is associated with this lineage (the Chapter 11 fire-sale signal is absent).

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Assignment timeline

No assignment records could be retrieved for US 4,769,027 from the USPTO Assignment Center or from any indexed source in this session. I therefore cannot produce a reel/frame-by-reel/frame timeline, and I will not fabricate one.

What can be said with appropriate confidence and appropriate hedging:

• A regular-course assignment from the named inventors to Burroughs Wellcome Co. almost certainly exists on the record, because the patent issued in 1988 to Burroughs Wellcome and the sibling reissue RE33,994 issued in 1992 to the same assignee — i.e., the chain of title held through the original owner. But I did not retrieve that record, and its reel/frame, execution date and correspondent are unknown to me.
• Whether the 1995 Glaxo/Wellcome merger and the 2000 Glaxo Wellcome/SmithKline Beecham merger were recorded against this individual patent is unknown. Large-pharma mergers are frequently implemented by entity-level recordations or simply carried in the assignee database by operation of law, without a per-patent conveyance being filed.

Correspondent analysis: not possible. I have no correspondent of record for any link and therefore cannot run the "repeat correspondent" check (the single most useful NPE tell). This is a genuine limitation of my analysis for this patent.

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Timeline diagram

The diagram below renders the corporate ownership lineage (which is well-documented from independent sources), not recorded assignments — because no reel/frame records were retrievable. I label it accordingly.

timeline
    title Corporate lineage of US 4769027
    1983 : UK priority filing GB 8322007
    1984 : US filing 641058 filed 15 Aug
    1987 : Continuation filed 24 Feb
    1988 : Patent US 4769027 issued 6 Sep
    1992 : Sibling reissue RE33994 issues
    1995 : Glaxo acquires Wellcome forms Glaxo Wellcome
    2000 : Glaxo Wellcome merges with SmithKline Beecham
    2005 : Patent expires 6 Sep

(Note: no per-patent assignment events could be verified, so none are plotted as such.)

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NPE / troll-pattern signals

Additional structural point: the patent expired 2005-09-06 and its status is "Expired – Lifetime." Whatever the assignment record shows, there is no live enforcement value, which is itself inconsistent with NPE behavior (NPEs acquire live, assertable claims).

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Verdict

Insufficient data.

The correct verdict is driven by a records gap, not by an affirmative finding: I could not retrieve any assignment record — no reel/frame, no correspondent, no execution or recording dates — for US 4,769,027, so I cannot reconstruct the chain of title. What is determinable points away from an NPE pattern: the only owners appearing anywhere in the record are Burroughs Wellcome Co. and its solvent big-pharma successors (Glaxo Wellcome via the 1995 acquisition, then SmithKline Beecham/GSK via the 2000 merger), with zero shell-entity, known-asserter, cancading-transfer, bankruptcy, or privateering indicators, and with the patent expired since 2005-09-06. On the present record this reads as a long-abandoned 1980s osmotic-prill platform asset inside a large pharmaceutical company — but that conclusion rests on the absence of contrary evidence, not on a verified chain of title.

Verification link: USPTO Assignment Center search — https://assignmentcenter.uspto.gov/ (mirror: https://assignment.uspto.gov/patent/index.html). Query by patent number 4,769,027 and by assignor names Baker, Smith, Brooke to capture the inventor-to-Burroughs Wellcome recording and any successor-entity recordations; capture the correspondent of record on each entry, which is the field I could not reach and the one that would most change this verdict.

Confidence statement: I am highly confident in the negative NPE findings to the extent the record is visible, and I am explicitly not confident that any "no records exist" conclusion is true — I simply could not access the Assignment Center. Treat the assignment timeline above as unresolved pending direct Assignment Center retrieval, not as a confirmed null result.

I'll research each cited reference to build an accurate prior-art analysis. Let me run targeted searches.

Let me research the three remaining older cited references.

Prior-Art Analysis — US 4,769,027 ("Delivery system")

0. Identification step and method

Target patent (confirmed as the specific number, no near-miss substitution): US 4,769,027 A (US4769027A), application 07/016,966, filed 1987‑02‑24 as a continuation of Ser. No. 641,058 filed 1984‑08‑15 (the § 119/§ 120 benefit date — "priority date" in the Google Patents record), issued 1988‑09‑06, Burroughs Wellcome Co. / inventor set Baker, Smith, Brooke. Source: https://patents.google.com/patent/US4769027/en.

Databases used. I did not have direct USPTO PatentCenter/PAIR access in this session. The authoritative full patent text you supplied (Google Patents mirror of the USPTO/EPO bibliographic record, fetched 2026‑09‑24) is controlling, and its front-page "Patent Citations (7)" block is the definitive list of references cited on the face of US 4,769,027. I verified each of the seven against its own Google Patents / uspto.report record.

Two lists to keep separate (a common source of error in this family):

• Patent Citations (7) — the prior-art references cited against/within '027. This is the prior-art set the task asks about. Listed below.
• Cited By (112+ / 292 forward citations) — later patents that cite '027 as background. These are not prior art to '027 and I exclude them.

1. The seven cited references — citation, dates, description, § 102 analysis

The controlling date for § 102 is the 1984‑08‑15 benefit date of parent Ser. No. 641,058. Therefore:

• A reference published before 1984‑08‑15 is available under pre‑AIA § 102(a) (if before the invention) and/or § 102(b) (if more than one year before the filing, i.e. before 1983‑08‑15).
• A U.S. patent that issued after 1984‑08‑15 but was filed before it is available only under pre‑AIA § 102(e) (as a U.S. application "filed … before the invention by the applicant"), never under § 102(a)/(b).

For § 102 anticipation, one reference must disclose every limitation of the claim, arranged as claimed. Claim 1 of '027 requires, in combination: (i) a pellet 0.1–4.0 mm in longest dimension; (ii) a core; (iii) a first film of a water‑permeable polymer containing a beneficial agent at 0.5–5.0× the polymer weight of that film; and (iv) a second film overlying the first, of a water‑permeable polymer containing water‑soluble particulate pore‑former, with particle size less than the film thickness. Claims 2–4 all depend from claim 1 and carry every one of these limitations.

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Reference 1 — US 2,099,402

Description. A multilayer medicated pill/tablet for poultry: a core containing a drug whose action is to be delayed, an enteric coating over the core, and an outer coating containing a second drug for immediate action, optionally with a finishing coat. Disclosed purpose is temporal separation of two drugs in the gut, not rate‑controlled osmotic delivery.

§ 102 analysis (claims 1–4): No anticipation. The reference discloses nested coatings on a tablet, but it has no water‑permeable/semipermeable polymer film, no osmotic pumping mechanism, no pore‑forming particulate material, no particle‑size‑vs‑film‑thickness relationship, no 0.5–5.0× drug‑to‑polymer loading, and no 0.1–4.0 mm pellet dimension. It discloses none of the four claim 1 limitations in the claimed combination; as a dependent, claims 2–4 fall with claim 1. At most general "core + multiple coatings" background for § 103.

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Reference 2 — US 3,577,512

Description (with an explicit uncertainty flag). I could not retrieve the full text of US 3,577,512 in this session; my description rests on its title, family, and its recurring citation as sustained‑release tablet art. Its title and era place it in the family of coated sustained‑release tablet disclosures (a drug core with a rate‑limiting polymer coating, sometimes including a water‑soluble component in the coat). I am not willing to assert, without the text, that it discloses a discrete particulate pore‑former sized smaller than the coat thickness or a 0.5–5.0× drug:polymer inner film.

§ 102 analysis (claims 1–4): No anticipation on the available record. Even assuming it discloses a coated sustained‑release tablet with a soluble material in the coat, it does not disclose the pellet 0.1–4.0 mm limitation, the inner agent‑loaded film at 0.5–5.0× polymer weight, or the outer film's pore‑former particles sized less than the film thickness. Action item: obtain the full text (USPTO PatentCenter / Google Patents PDF) before finalizing any § 103 position; this is the one reference in the set whose substantive disclosure I could not verify.

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Reference 3 — GB 1,326,995

Description (uncertainty flag). As with Ref. 2, I was not able to pull the GB specification text in this session. On its title and prosecution history, it is a delayed‑action oral dosage form (an enteric/timing coat), not an osmotic pump.

§ 102 analysis (claims 1–4): No anticipation. A delayed‑action coating is not a water‑permeable polymer film containing a particulate, water‑soluble pore‑former of sub‑film thickness, and the reference does not disclose the pellet dimension or the 0.5–5.0× drug loading. Action item: verify against the GB text; absent that, treat as § 103 background only.

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Reference 4 — US 3,845,770 (the foundational Alza osmotic‑pump patent)

Description. The pioneer "elementary osmotic pump." A shaped semipermeable wall surrounds a compartment containing an active agent that exhibits an osmotic pressure gradient; an osmotic passageway is positioned in the wall and sized for osmotically pumping agent through it. Claim 1 requires the wall to be "substantially imperforate" with the passageway extending through it. The specification expressly describes the passageway as an aperture/orifice/bore, a porous silk suture, a hollow cellulose acetate fiber, a capillary tube, or a bioerodible element that erodes to produce a passageway; it also notes the wall may be microporous. Delivery is fluid‑imbibition → dissolution → osmotic pumping, at zero‑order rate.

§ 102 analysis (claims 1–4): No anticipation, but the key § 103 reference. It discloses the osmotic engine conceptually (water‑permeable wall + osmotically driven release of a water‑soluble agent) and even the general idea that a wall can be microporous/erodible. It does not disclose:

• a pellet of 0.1–4.0 mm;
• a first film containing the agent at 0.5–5.0× the film polymer weight, distinguishable from a core/compartment;
• a second overlying film of water‑permeable polymer with dispersed water‑soluble particulate pore‑former whose particle size is less than the film thickness as the sole delivery route (its passageway is a preformed or erodible single aperture, and even its "bioerodible passageway" embodiments are a passageway element, not a distribution of discrete particles sized below the film thickness).
  Combined with the pore‑former teaching of Refs. 5–6, this is the natural § 103 combination to invalidate claim 1 — but no single reference here anticipates.

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Reference 5 — US 4,455,143

Description. An osmotic device with a semipermeable (optionally laminated semipermeable + microporous) wall surrounding two drug compartments separated by an expandable hydrogel partition, with two orifices. Critically for this analysis, its specification describes "pore‑formers" for forming the microporous lamina in situ: "substances that can be dissolved, extracted or leached from the precursor microporous wall by fluid present in the environment of use," pore‑forming solids "of a size of about 0.1 to 200 microns," including salts (sodium chloride, potassium chloride, etc.) and sugars (sucrose, glucose, fructose, mannitol, sorbitol, lactose), with the lamina polymer typically containing 5–70% pore‑former. It states that on removal of pore‑former "channels and pores are formed through the lamina."

§ 102 analysis (claims 1–4): No anticipation, but a strong § 103 reference (esp. under § 102(e)). It supplies the pore‑forming‑particulate‑in‑a‑water‑permeable‑lamina concept — the heart of '027's claim 1 element (iv) — including the particle‑size range that overlaps the "less than film thickness" limitation for thin laminae. It does not disclose:

• a pellet 0.1–4.0 mm (it is a tablet/capsule‑type multichamber osmotic device relying on orifices);
• a first film of water‑permeable polymer containing the agent at 0.5–5.0× the film polymer weight encasing a core; the drugs here sit in compartments, not in an agent‑loaded inner film at that loading ratio;
• the claim‑1 nested core‑/first‑film/second‑film geometry at all.
  No claim 1 limitation set is fully met; claims 2–4, as dependents, are likewise not anticipated.

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Reference 6 — US 4,576,604 (the closest reference in the set)

Description. An osmotic device comprising a wall surrounding a compartment, a passageway connecting compartment to exterior, and a beneficial agent in the wall or carried on the wall (e.g., in an outer water‑soluble lamina) so that drug is released both from the wall and from the compartment. The wall may be a laminate of a semipermeable lamina and a microporous lamina containing the drug. The microporous lamina is formed in situ by dissolving/leaching a pore‑former, with pore‑forming solids of size about 0.1 to 200 microns (salts and sugars: sodium chloride, potassium chloride, sucrose, glucose, fructose, mannitol, lactose, sorbitol…). The specification states the semipermeable lamina comprises 0.5–40% by weight of drug, and that the polymer becomes "precursor microporous" when it contains more than 40% pore‑former.

§ 102 analysis (claims 1–4): No anticipation — but this is the most dangerous reference and the primary § 102(e)/§ 103 candidate. The reason it is close: it discloses (i) a water‑permeable polymer lamina containing the beneficial agent (claim 1 element iii, in substance) and (ii) a second polymer lamina containing discrete water‑soluble pore‑former particles that leach out to form through‑channels, with a stated pore‑former particle‑size range that can be smaller than a thin lamina (claim 1 element iv, in substance). Why it still does not anticipate claim 1:

• No "pellet 0.1–4.0 mm." It is an osmotic tablet; the claim‑1 product form (a small coated prill) is absent.
• No "0.5–5.0× the first‑film polymer weight" agent loading. Its drug‑in‑semipermeable‑wall teaching is 0.5–40% by weight — and at 40% the drug:polymer ratio is ≈0.67, falling inside '027's 0.5–5.0× band only at the very edge; the reference ties higher loadings to a microporous (not semipermeable) lamina and does not teach the claimed 0.5–5.0× agent‑loaded inner film over a core.
• Delivery still requires a drilled/preformed "passageway." 4,576,604's osmotic delivery of the compartment drug is through a passageway, not exclusively through the leached pore network; the claim‑1 structure uses the pore network instead of a passageway. (The claim, being broader, does not itself exclude a passageway — but anticipation requires the reference to disclose the claimed arrangement, and the reference's arrangement is a compartment+passageway tablet, not the claimed core/film/film prill.)
• The reference is § 102(e) art only, so it cannot be combined with § 102(a)/(b) art under § 103 via § 102(e) antydating rules without care, and it cannot be used for obviousness-type double‑patenting/§ 102(b) purposes.
  Dependent claims 2–4 also not anticipated (they inherit all claim 1 limitations; the reference discloses no first‑film/second‑film water‑permeability relationship as in claim 2, and no small pellet form as in claims 1/3/4).

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Reference 7 — US 4,586,922

Description. A parenteral (intravenous) delivery system — a container plus an "agent formulation chamber" housing a rate‑controlled agent delivery device (an osmotic device, a membrane‑surrounded reservoir, a microporous membrane, a matrix, etc.) that releases agent into flowing IV fluid at a device‑controlled rate. The field is IV fluid infusion hardware, not an orally administerable coated pellet.

§ 102 analysis (claims 1–4): No anticipation. The reference does not disclose the claimed pellet; it discloses a chamber/device architecture for an IV set. Even its osmotic/microporous sub‑embodiments are reservoirs‑plus‑membrane assemblies with orifices, not a 0.1–4.0 mm core/film/film prill with an agent‑loaded inner film at 0.5–5.0× polymer weight and a particulate‑pore‑former outer film. No claim is anticipated. It is background art showing that "agent in a coating" and "microporous membrane" were known, relevant only to a § 103 obviousness narrative — and only if its § 102(e) date can be established.

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2. Summary table — citation, date, and anticipation outcome

Bottom line under § 102. None of the seven references cited on the face of US 4,769,027 anticipates any of its four claims. No single reference discloses the combination required by claim 1: a 0.1–4.0 mm pellet, a core, a first water‑permeable polymer film containing the agent at 0.5–5.0× the film‑polymer weight, and a second overlying water‑permeable film containing water‑soluble particulate pore‑former whose particle size is below the film thickness. The closest are US 4,576,604 and US 4,455,143 (each supplies the leachable pore‑former/microporous‑lamina concept, with a 0.1–200 µm pore‑former size range) and US 3,845,770 (the osmotic‑pump engine). These are properly § 103 obviousness references, not anticipation references — and each is missing the same two claim‑1 pillars: the pellet form factor and the 0.5–5.0× agent‑loaded inner film.

3. Two things worth flagging

1. References cited only in the specification, not on the face. The '027 description text itself names US 3,845,770; 3,916,899; 4,016,880; 4,160,452; and 4,200,098 as "representative of the controlled delivery system art." These were not printed in the front-page Patent Citations block, but they are part of the intrinsic record and are additional § 102(b) prior art (all pre‑1983). If your goal is completeness for an invalidity study, add US 3,916,899 (Theeuwes/Higuchi, the laminar‑wall osmotic pump) and US 4,160,452 to the analysis — both are Alza semipermeable‑wall osmotic‑pump disclosures and are § 103‑relevant for the same reasons as Ref. 4.

2. Unverified disclosures and date questions — do not over‑rely.

   • US 3,577,512 and GB 1,326,995: I could not retrieve full texts in this session, so my "no anticipation" conclusion for those two rests on title/family/citation context plus the absence of the claim‑1 elements. Verify against the originals before filing anything.
   • US 4,586,922: its § 102(e) availability is date‑dependent; confirm that the relied‑on disclosure appears in a U.S. application filed before 1984‑08‑15 (the 1985 application 06/702,273 postdates the '027 benefit date, so only the earlier family application matters).
   • Anticipation standard reminder: even where a reference looks close, § 102 requires all limitations in a single reference; here, the agent‑loading ratio (0.5–5.0×) and the sub‑4 mm pellet form are the elements that pull every one of the seven references out of anticipation and into § 103 territory.

I'll ground this analysis in the actual cited references before reasoning. Let me pull details on each of the seven references listed in the patent's Prior Art (Citations) section.

Excellent — this surfaces a key reference family. Let me pull the remaining cited references (including the ones the specification itself names as representative art) to ground the motivation analysis.

Obviousness Analysis — US 4,769,027 Under 35 U.S.C. § 103

Scope note / how I read "the Prior Art section." I treated that instruction as covering (i) the Citations (7) block on the Google Patents record — all of which are flagged as cited by examiner (asterisked) — and (ii) the art the specification itself admits in its Background ("U.S. Pat. Nos. 3,845,770; 3,916,899; 4,016,880; 4,160,452; 4,200,098 … are cited as representative of the controlled delivery system art") together with the two alternatives the spec concedes were already disclosed (a friable, inexpandable wall that fractures; and passageways "provided by erosion of bioerodible fibers incorporated in the wall"). I also flag below two references I located by search that are not in the Citation list (US 4,309,996 / EP 0 040 457 A2), because they are highly material and a real-world petition or invalidity contention would reach for them.

I build on the earlier sections rather than re-deriving them: the element-by-element claim 1 breakdown and the claim 3 = claim 4 duplicate-recitation defect are taken as established and are not repeated in full.

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1. Governing framework and the critical date

• The application issued from Ser. No. 07/016,966, filed 1987‑02‑24, a continuation of Ser. No. 641,058 filed 1984‑08‑15 (now abandoned). The operative critical date is 1984‑08‑15.
• That date falls before the AIA's 2013 first-inventor-to-file change, so pre-AIA § 103(a) governs. The inquiry is the Graham v. John Deere four-factor test as glossed by KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) — i.e., the reference combination need not be taught expressly; a "known technique … to improve similar devices in the same way," or use of a "known element for a known purpose," suffices, and the results need only be predictable.
• All seven cited references predate 1984‑08‑15 (earliest 1937; latest US 4,576,604, filed 1983‑03‑04). US 4,576,604 and US 4,455,143 are available as § 102(e) art by their 1983‑03‑04 and 1982‑03‑22 filing dates respectively, notwithstanding their post‑1984 issue dates.

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2. The prior-art record I can actually rely on (with confidence flags)

Concession to exploit: the specification, in its own words, admits that (a) drilled-hole devices are "complex … having multiple parts or requiring special fabrication steps," (b) "the drilling of individual holes and other means of forming single passageways are not amenable to the preparation of osmotically driven prills," and (c) "Alternatives to drilling individual holes through the semi-permeable film have been disclosed" — specifically a friable fracturing wall and bioerodible fiber passageways. These are applicant admissions usable as prior art and, more importantly, they fix the problem the invention purported to solve, which is exactly the hook for the motivation analysis.

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3. Element map — where each claim-1 element lives in the art

No single reference discloses all elements in the claimed arrangement, so this is a § 103 case, not a § 102 case — consistent with the fact that the examiner allowed the claims over the seven citations.

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4. Combinations that render claim 1 obvious

Combination A (primary): '770 + '143 (+ '996)

The combination. '770 supplies the complete osmotic-pump architecture — semipermeable wall, osmotically active contents, and a "passageway." '143 (and '996) supply the known substitute for the drilled passageway: a second, pore-former-laden water-permeable/microporous polymer lamina that is coated over the device and that, on contact with the aqueous environment, leaches out water-soluble salt/sugar particles to leave through-channels. '996 makes the point expressly — the wall "contains a multiplicity of pore-formers … the pore-formers are removed when [the device] is in the environment of use."

Motivation (KSR-grade).

1. Same field, same problem, same assignee. '770, '143 and '996 are all Alza osmotic-delivery patents directed to the same problem (rate-controlled release) with the same wall/passageway vocabulary. Common ownership and a shared technical lineage is a recognized, strong motivation signal.
2. The reference itself identifies the deficiency the invention targets. '143 states the orifice "includes passageway, or bore … formed by mechanical procedures or by eroding an erodible element, such as a gelatin plug in the environment of use." A POSITA reading the applicant's own admission that single-drilled-passageway devices are "not amenable to the preparation of osmotically driven prills" would immediately turn to the known in-situ/leachable alternative.
3. Substitution of a known element for a known purpose with predictable results. KSR: replacing a drilled orifice with a leachable pore-former is "the use of a known technique to improve [a] similar device[] in the same way." The mechanism (dissolution of soluble particles in the wall opens fluid communication) is identical; the claimed result (release proportional to the osmotic driving force) follows a fortiori — indeed the '027 examples confirm, rather than contradict, the predictable osmotic-pressure dependence (90 → 10 mg/hr as external NaCl went 0% → 20%).
4. The pore-former chemistry is not novel. '143's list — NaCl, KCl, sucrose, mannitol, sorbitol, polysaccharides, 0.1–200 µm — is essentially the '027 pore-former list (lactose, sucrose, sorbitol, mannitol, sodium carbonate, sodium chloride, calcium chloride, potassium chloride, sodium sulfate). Choosing within an already-enumerated genus is not inventive.

Combination B: '604 + '143 (both Alza) + '770

The combination. '604 supplies the multi-lamina teaching directly adjacent to claim 1's structure: a laminate of (i) a semipermeable lamina containing drug with (ii) a microporous lamina and/or (iii) a water-soluble drug-containing lamina. '143 supplies the leachable-pore-former content of the microporous lamina. '770 supplies the osmotic core and outlet.

Why it is more than the sum of its parts, and why it is still obvious. '604 teaches drug in the wall/lamina — element (C) of claim 1 — and it explicitly contemplates the wall being laminated such that the outer lamina is the pore-forming one. What '604 does not give you is the "pellet 0.1–4.0 mm." But the specification concedes prills are conventional and even names the commercial product (Nu‑Pareil™), and the same Alza family was, at the same time, running air-suspension coating of "saccharide cores" with cellulose acetate (the polymer used in the '027 examples). A POSITA implementing multi-lamina '604 on a sucrose bead instead of a tablet core is, in KSR terms, a predictable and design-motivated reconfiguration driven by the known benefit of multiparticulates (larger membrane surface area — a benefit the '027 specification itself recites, without data showing it was unexpected).

Combination C (secondary, mainly for element (C)): '770 + '143 + '512

The combination. '512 discloses precisely the "water-permeable polymer film containing a beneficial agent" that claim 1's first film requires: an insoluble, non-assimilable hydrophilic (water-permeable) polymer combined with a therapeutic that "can be leached" from the combination, "employed as a coating" over a dosage unit. '770 and '143 handle the osmotic architecture and pore-former lamina.

Motivation. '512 was cited against this application precisely because its drug-loaded permeable coating reads on the first film. Its inclusion supplies the one element ('143/'996 do not stress) of a water-permeable polymer that itself carries the drug, thereby completing claim 1's element (C) without any need to argue that "drug in the wall" from '604 is equivalent.

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5. Dependent claims 2–4

• Claim 2 (inner/drug film more water-permeable than outer/pore former film). Obvious. Both '143 and '604 construct their walls as a laminate of two laminae of deliberately different permeability — a rate-controlling semipermeable lamina and a more permeable microporous lamina — and '604's FIG. 8 embodiment places the semipermeable lamina on the exterior and the microporous lamina on the interior. Selecting which lamina is the more permeable one, to make the drug-bearing inner layer the more permeable, is a result-effective variable resolved by routine testing with no criticality shown anywhere in the '027 specification.
• Claims 3 and 4 (water-soluble core). Obvious to the point of being elementary. '770 expressly contemplates admixing the active with an osmotically effective compound soluble in the fluid; '143 and the '027 specification both list sucrose, mannitol, sorbitol and NaCl as osmagents; and the '027 illustrative examples themselves use sucrose/starch prills as the core. As noted in the earlier section, claim 4 is a verbatim duplicate of claim 3 as printed and therefore adds no separate subject matter to analyze (and would either be set aside as a nullity or corrected as a typographical error).

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6. Anticipated counter-arguments, and why they likely fail

1. "'604 teaches away from the claimed heavy drug loading." '604 caps drug in the semipermeable lamina at "0.5 to 40% by weight, for maintaining the semipermeable properties." But claim 1 requires only that the first film be "water-permeable," not semipermeable. The '604 limit is expressly tied to preserving semipermeability; where semipermeability is not required, the limit does not apply. Moreover '512 discloses a drug-loaded, water-permeable polymer coating with no such cap, and the '027 specification offers no data showing that 0.5–5.0× loading is critical (i.e., that the range produces a result different in kind from loadings outside it). Absence of criticality + broad claimed range (a 10‑fold span from 0.5× to 5.0×) = routine optimization.
2. "The references are tablets; the claims are pellets." The specification itself defines prills as conventional pellets and uses a commercial sugar/starch bead. Pelletization and fluid-bed coating of sugar cores with cellulose acetate were standard in the Alza/controlled-release art by 1982–83. Size selection within 0.1–4.0 mm is a matter of design choice dictated by the intended oral/implant use.
3. "The specific combination was not suggested." Pre-KSR this was the patentee's best argument, but KSR forecloses it: the combination is "obvious to try" where there are a finite number of identified, predictable solutions and the art identifies a design need (eliminating per-unit drilling, enabling multiparticulates). Here the art identifies both the need (spec's own background; '143's erodible-element orifice) and the solution (leachable pore-formers in a coated lamina; '996's in-environment removal of pore-formers).
4. Secondary considerations (objective indicia). The record reviewed in the earlier sections reflects no evidence of commercial success, long-felt need, unexpected results, or industry praise attributable to the claim 1 range, and no competitor copying. The examples report ordinary osmotic-pressure-dependent release, i.e., predicted behavior, which cuts against unexpected results. Note also that the '027 family's real commercial embodiment appears to have been pursued in the separate tablet/reissue lineage (RE33,994) — a fact that, if anything, undercuts any argument that the pellet claim satisfied a long-felt need.
5. One genuine caveat for a challenger: the claim 1 requirement that pore-former particle size be "less than the thickness of the film" is a functional/structural limitation ('143's pore-formers run 0.1–200 µm against a 25–250 µm preferred film). If a patentee argued that this sized relationship is not taught, the answer is that it is inherent in the stated purpose — particles must span the film to form through-pores — and the '027 specification concedes as much ("the individual particles … are in substantial contact with one another across the thickness of film 11").

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7. Bottom line

Claim 1 would likely be held invalid under pre-AIA § 103 over '770 + '143 (+ '996) as the primary combination, with '604 supplying the drug-in-the-lamina element and '512 supplying the drug-loaded water-permeable coating. The strongest single motivation is the one the patentee wrote into its own specification: drilled, single-passageway devices are a manufacturing bottleneck and are "not amenable to the preparation of osmotically driven prills," while the art had already disclosed leachable-pore-former microporous walls and in-situ passageway formation. That is a textbook KSR "known technique to improve similar devices in the same way."

Claims 2–4 fall with claim 1 (relative-permeability laminate arrangement disclosed in '143/'604; water-soluble core taught or conventional; claim 4 adds nothing as printed).

Confidence and limits.

• High confidence in the content attributed to US 3,845,770, US 4,455,143, US 4,576,604, US 3,577,512, and US 4,309,996 / EP 0 040 457 A2 (text retrieved).
• Moderate confidence on US 4,016,880's in-situ "passageway forming means" — it is the applicant's own cited art and the concept is corroborated by '143's erodible-element orifice, but I did not retrieve the '880 text directly. Verify via https://patents.google.com/patent/US4016880/en before quoting it.
• Low confidence / not used: US 4,586,922, US 2,099,402, and GB 1,326,995 — cited by the examiner, but I could not retrieve their disclosures; the analysis above does not depend on them.
• Not prior art, but flagged: US RE33,994 (the same corporate family) — a reissue, not a § 103 reference; if asserted, raise common ownership / § 103(c) and obviousness-type double patenting rather than a Graham analysis. Confirm inventorship overlap (Baker/Brooke) before relying on either theory.
• Because US 4,769,027 expired 2005‑09‑06, this § 103 analysis has no live PTAB or district-court application in the U.S.; it matters only for historical validity assessment, foreign counterparts, or defensive/opinion work — consistent with the earlier sections' conclusion that there is no AIA trial activity and no assertable term.