Invalidity dossier

US 3710795

Drug-delivery device with stretched, rate-controlling membrane

Current assignee: Alza Corp

Added 9/29/2026, 3:24:27 PM

IndustryMedical (M)
At a glanceNo PTAB challengesNo litigation on fileMedical (M)

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Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

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I'll verify the patent details against live sources before summarizing.

Let me check for any active litigation and confirm the bibliographic record.

US Patent 3,710,795 — Verification Summary

Sources consulted: Google Patents full text (https://patents.google.com/patent/US3710795/en), the USPTO-hosted grant PDF (http://patentimages.storage.googleapis.com/18/3e/e4/88943c722a1b6b/US3710795.pdf), uspto.report (https://uspto.report/patent/grant/3,710,795), and FreePatentsOnline class listing. All bibliographic data below is corroborated across those sources.


1. Bibliographic data

Field Value
Patent number US 3,710,795 A
Title Drug-delivery device with stretched, rate-controlling membrane
Inventors Takeru Higuchi; Harold M. Leeper (both of Lawrence, Kansas)
Original assignee / current assignee Alza Corporation, Palo Alto, Calif.
Application number US 76,499 (US00076499A)
Filing date September 29, 1970
Priority date September 29, 1970 (no earlier priority claimed; filing = priority)
Publication/issue date January 16, 1973
Anticipated expiration 1990-01-16; legal status "Expired – Lifetime"
Claims / drawings 9 claims, 3 drawing figures
Classifications A61M31/002, A61M31/00, A61D7/00; US Cl. 128/260, 128/272, 128/130, 424/19, 206/46 SG
U.S. prior art cited on the face 2,713,543 (Peters); 3,429,827 (Ruus); 3,518,340 (Raper)

Related matter noted in the specification: the patent states it is an improvement over copending application Ser. No. 42,786, filed June 2, 1970, assigned to the same assignee, whose disclosure is incorporated by reference.


2. Abstract (verbatim)

"Drug-delivery device for releasing drug at a controlled rate for a prolonged period of time is formed from a solid inner matrix material having drug dispersed therethrough. Surrounding the inner matrix is an intimately contacting outer polymeric membrane, insoluble in body fluids, which contracts about the matrix as the matrix decreases in volume upon drug release. Both the inner matrix material and the outer polymeric membrane are permeable to passage of the drug by diffusion but the drug diffuses through the outer polymer membrane at a lesser rate so that passage through the polymeric membrane is the drug release rate controlling step. The integrity of the intimate contact between the membrane and the matrix is assured even upon matrix depletion immediately following manufacture and for an extended period of time by reason of the reserve elastic recovery stress in the membrane."


3. Plain-language overview of the claims

Only one independent claim exists — claim 1 — and it is drafted in Jepson ("improvement") format, i.e., it concedes a known two-part device (matrix + rate-controlling membrane) as the preamble and claims the specific improvement. Claims 2–9 are all dependent.

Claim 1 (independent). A device for continuously and controllably administering a drug over a prolonged period, of the known type having (a) a solid inner matrix with drug dispersed in it, the matrix being permeable to the drug by diffusion, and (b) an outer polymeric membrane that is insoluble in body fluids, surrounds the matrix, and is the rate-controlling barrier (permeable to the drug, but more slowly than the matrix). The improvement is: the outer membrane is a molecularly oriented, heat-shrunk, stretched polymeric membrane that retains reserve elastic recovery stress. When the device is placed in the environment of use, it meters drug from the matrix to the exterior at a constant, controlled rate over a prolonged period, and intimate membrane–matrix contact is maintained throughout drug release because of that reserve elastic recovery stress (the membrane keeps shrinking onto the matrix as the matrix is depleted). — This is the core novelty: a heat-shrink membrane with leftover (reserve) shrink/stress that keeps the rate-controlling interface intact as the drug-depleted matrix shrinks.

Claim 2. The inner matrix is silicone rubber.

Claim 3. (depends on 2) The membrane is polyethylene.

Claim 4. (depends on 2) The membrane is an ethylene-vinyl acetate copolymer.

Claim 5. (depends on 3) The drug is progesterone (silicone matrix + polyethylene membrane + progesterone).

Claim 6. (depends on 4) The drug is progesterone (silicone matrix + EVA membrane + progesterone).

Claim 7. (depends on 1) The membrane is bi-axially oriented.

Claim 8. (depends on 1) The membrane is cross-linked.

Claim 9. (depends on 8) The cross-linked membrane has a tensile strength of at least about 50 psi at 300 °F — the specification ties this to the "thermoset character" needed to hold the stretched state.

Supporting disclosure worth noting: the membrane "can contract by at least 10 percent and typically from about 25 to 75 percent of its stretched dimension"; heat-shrinking is done by brief exposure (less than ~1 minute) to about 200–400 °F; the matrix should preferably have a drug permeability more than tenfold that of the membrane; and four worked examples are given (progesterone/silicone-PE intrauterine T; progesterone/EVA-tubing cervical torus; bacitracin/gum rubber in rubber hydrochloride film; tetracycline/polybutadiene in radiation-crosslinked ethylene-vinyl chloride film).


4. Litigation / CAFC 2026 docket check — negative result

I searched for any Federal Circuit or district court activity tying the identifier 3,710,795 / 3710795 to a 2026 docket and found none. Specifically:

  • No CAFC 2026 opinion, order, or docket entry referencing this patent number appeared.
  • The Alza v. Mylan matters that surfaced in searching concern different patents (e.g., U.S. 6,919,092 and the oxybutynin '355 patent in Alza Corp. v. Mylan Labs., 349 F. Supp. 2d 1002 (N.D. W. Va. 2004), aff'd in relevant part, 464 F.3d 1295 (Fed. Cir. 2006)) — not 3,710,795.
  • Hits on "3710795" from other databases were coincidental collisions with unrelated identifiers (e.g., a European Commission document number Ares(2020)3710795; a Belgian publication number 3710795 for a climate-control patent; the EPA/PubChem-style numeric strings). These are not references to this U.S. patent.

Practical conclusion: US 3,710,795 has been expired since January 16, 1990 ("Expired – Lifetime" per Google Patents). Live infringement litigation on it in 2026 is not plausible; no CAFC 2026 docket was located.


5. Uncertainty / caveats

  1. Claim count formatting discrepancy. The granted front page states "9 Claims," and I counted 9 in the text, but the Google Patents "Claims (8)" listing enumerates only claims 2–9 — claim 1 is reproduced at the end of the description rather than in that list. I treat 9 total claims, with claim 1 the sole independent claim, as authoritative; the "(8)" is a formatting/OCR artifact in the listing, not a different claim set.
  2. I did not query the USPTO PatentCenter/Public PAIR or CAFC CM/ECF docket systems directly. My litigation check was via web search only. The negative litigation result is therefore strong but not from a primary docketing system; I cannot certify that no obscure 2026 filing exists, though given the 1990 expiration it is very unlikely.
  3. Related-family speculation flagged. U.S. 3,832,252 (Higuchi et al.) surfaced with near-identical specification text, suggesting a related/divisional-style filing arising from the same June 2, 1970 work, and the specification's reference to Ser. No. 42,786 is consistent with that. I have not verified the exact legal relationship (continuation vs. divisional vs. separate application), so treat that as unconfirmed.
  4. No corrections were made to the identifiers. The patent number is rendered throughout as 3,710,795 / 3710795, exactly as supplied, and all bibliographic values above are taken literally from the documents.

Generated 9/29/2026, 3:31:04 PM

Cases on file (0)

Specific litigation cases in our database that name US patent 3710795. The free-form analysis below may also discuss cases beyond this list.

No cases on file mention this patent. Upload a CSV or add a case manually in Admin → Manage litigation cases.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll research litigation records for US patent 3710795. Let me run several searches.

Search Results: Litigation Involving US Patent 3,710,795

Bottom line: I found no litigation involving US Patent 3,710,795. I searched the sources you identified (Unified Patents portal, CourtListener/RECAP, DrugPatentWatch, Stanford NPE Litigation Database, Justia/FreePatentsOnline, Google Patents) plus general web queries. Nothing surfaced tying this patent number to any filed case. Below is the record of what I checked and why the negative result should be read with one important caveat.

Patent identification (for the record)

  • US 3,710,795 A, "Drug-delivery device with stretched, rate-controlling membrane"
  • Inventors: Takeru Higuchi; Harold M. Leeper (both of Lawrence, Kansas)
  • Original assignee: Alza Corporation (Palo Alto, Calif.)
  • Appl. No. 76,499; filed September 29, 1970; granted January 16, 1973
  • 9 claims; priority/expiration: anticipated expiration January 16, 1990 (status listed as "Expired – Lifetime")
  • Source: https://patents.google.com/patent/US3710795/en

What I searched and what turned up

Source Result
Google Patents (US3710795A) No litigation section; only prosecution/assignment, classifications, forward citations
Unified Patents portal Only a bibliographic listing of US-3710795-A as prior art cited on a later Halozyme patent page (https://portal.unifiedpatents.com/patents/patent/US-[11952600](/patent/11952600)-B2). No litigation entry.
DrugPatentWatch — Alza party litigation page Alza cases listed concern modern patents (e.g., US 8,163,798), not 3,710,795
Stanford NPE Litigation Database — Alza Corporation Five case listings (Alza v. Mylan, 2:02-cv-00020 D.Vt.; Alza v. Mylan, 2:02-cv-00230 W.D.Pa.; Alza v. Wyeth, 9:06-cv-00156 E.D.Tex.; Alza v. Impax, 1:11-cv-00395 D.Del., etc.). None assert 3,710,795
CourtListener / RECAP No hit for the 7-digit number as an asserted patent
General web searches on "3,710,795" + infringement/lawsuit/Alza/Higuchi Only prior-art citation lists in later patents (e.g., EP prosecution citations; RU2465272C2 reference list at 3598123 / 3710795 / 3731683 …) — citation lists, not litigation

False positives identified and excluded (per your instruction)

I did not count these, because they are different identifiers:

  1. "the '371 patent" in NICE Systems, Inc. v. Witness Systems, Inc. — CourtListener's opinion uses the reporter shorthand "'371" for a 1993-filed digital audio logger patent (claim construction of "buffer," "digital audio tape"). That is an entirely different patent number and technology. https://www.courtlistener.com/opinion/[2523402](/patent/2523402)/nice-systems-inc-v-witness-systems-inc/
  2. "3710795" in a Belgian/EU register — a European publication number (11) 3710795 for a climate-control/air-conditioning application (Nortek Air Solutions Canada), unrelated to US 3,710,795. https://economie.fgov.be/.../recueil-brevets-2025-13.pdf
  3. "3710795" as an FEI number on a Florida nonprofit filing, and a CourtListener financial-disclosure investment ID — unrelated numeric coincidences.
  4. "3710795" in an EU JRC document number (chromium propionate feed-additive report) — an internal document reference, not a patent.

Important caveat on the negative finding

US 3,710,795 expired January 16, 1990. The major public litigation databases (PACER-derived RECAP/CourtListener, Unified Patents, DrugPatentWatch, Stanford NPE) are effectively reliable only from roughly the mid-1990s onward. Any infringement suit or declaratory-judgment action asserting this patent would almost certainly have been filed in the 1973–1989 window, and would therefore be poorly or not at all represented in the databases above. So the correct statement is:

  • No litigation is recorded in the searchable electronic sources I could access, and
  • I cannot rule out 1970s–1980s litigation that exists only in paper records.

If you need a definitive check, the authoritative routes would be:

  1. 35 U.S.C. § 290 notices — district court clerks are required to notify the USPTO of patent actions; those notices were published in the Official Gazette and filed in the patent's File Wrapper / Assignment record (now via USPTO Patent Center for this patent).
  2. The paper docket indexes of the districts where Alza and its licensees (e.g., N.D. Cal., D. Del., S.D.N.Y.) would have sued, for 1973–1990.
  3. Westlaw/Lexis "all federal cases" full-text search for "3,710,795" — this covers pre-1990 reported opinions that free databases do not.

I want to be explicit rather than speculate: I have no high-confidence knowledge of any pre-1990 case asserting US 3,710,795, and I will not fabricate a plaintiff/defendant/case-number entry. On the evidence available to me, the answer is that no litigation is known.

Generated 9/29/2026, 3:31:03 PM

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.

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.

✓ Generated

I'll verify the canonical list against public sources before writing anything up.

Let me run a couple more targeted checks before concluding.

One more check on litigation/enforcement history.

PTAB Proceedings on File — US 3,710,795

Patent: US 3,710,795 — Drug-delivery device with stretched, rate-controlling membrane
Inventors: Takeru Higuchi; Harold M. Leeper · Assignee: Alza Corporation
Filed / Priority: 1970-09-29 · Granted: 1973-01-16 · Anticipated expiration: 1990-01-16
Claims: 9 (claim 1 is the sole independent "improvement" claim; claims 2–9 depend from it) · Legal status: Expired – Lifetime


Proceedings overview

Total AIA trial proceedings on file: 0. The USPTO Open Data Portal structured block returns an empty set (0 IPR, 0 PGR, 0 CBM — so a breakdown of active / invalidated / sustained / settled / institution-denied is not applicable), and targeted web searches for PTAB petitions, decisions, or appeals naming this patent surfaced nothing. The bottom line for a defendant is stronger than any IPR outcome could give you: there is no defensive posture to plan, because there is no live patent to defend against. US 3,710,795 expired 1990-01-16, and AIA trials did not exist as a forum until 2012-09-16. No amount of PTAB luck or unluck is relevant here — a demand letter citing this patent is citing a patent that has been unenforceable for roughly 36 years.

Because there are zero proceedings, the per-proceeding template (proceeding number, petitioner, panel, institution decision, FWD, appeal) has no content to populate. I am not filling it in with placeholders or invented numbers.


Why the zero is structural, not a signal

The usual instruction — "well-asserted patents eventually attract IPRs, so an empty PTAB file is itself a signal" — does not apply to this patent, and it's worth being precise about why:

Event Date Consequence
Patent granted 1973-01-16 17-year term begins
Anticipated expiration 1990-01-16 Enforceable term ends
AIA trials (IPR/PGR/CBM) available 2012-09-16 PTAB jurisdiction begins

The patent expired 22 years and 8 months before the PTAB could hear an IPR. The absence of proceedings is therefore a calendar artifact, not evidence about whether the patent was ever worth attacking. (Technically the Board can institute review of an expired patent — claims are construed under Phillips, and the patent owner cannot amend — but no commercially rational petitioner spends $300k–$500k invalidating claims that expired over three decades ago and cannot be asserted.)

I found no evidence of district court enforcement litigation either, and no ex parte or inter partes reexamination. Beyond extensive web searching, no litigation or Office proceeding referencing US 3,710,795 as the patent-in-suit was identified; the only hits were this patent appearing as a cited prior-art reference in later filings (e.g., EP 1,635,824; EP 3,265,123; EP 1,955,700; EP 862,396; RU 2,465,272). That is the expected profile of a landmark 1973 Alza reference, not of an asserted patent.

Note on the one discrepancy in the source data: the Google Patents page renders the heading "Claims (8)" while separately listing claims 1 through 9. The claim text is authoritative and runs 1–9. This is a rendering/data-quality quirk, not a claim cancellation — do not read it as eight surviving claims.


Strategic summary

Claim status. Not one claim of US 3,710,795 has ever been canceled, confirmed, or construed by the PTAB, because no AIA trial was ever filed. All nine claims are UNTESTED in the PTAB sense — and simultaneously all nine are expired and unenforceable. To be explicit: there are no "surviving claims" to narrow your defense to, because there is no cause of action. Claim 1 (the improvement claim reciting "a molecularly oriented, heat shrunk, stretched polymeric membrane having reserve elastic recovery stress"), and dependent claims 2–9 (silicone rubber matrix; polyethylene membrane; ethylene-vinyl acetate copolymer membrane; progesterone; bi-axial orientation; cross-linking; ≥50 psi tensile strength at 300 °F) are all equally moot.

Estoppel landscape. § 315(e)(2) estoppel is a non-issue. Estoppel only attaches to a petitioner who filed an IPR or PGR that reached a final written decision. With zero petitioners, zero estoppel, and zero preclusion — for anyone. Conversely, there is no IPR record to borrow: no institution decision, no FWD, no PTAB claim construction, no Board finding that any reference teaches a limitation. If you need prior art for a different purpose (e.g., invalidating a later Alza-family patent that claims priority to or cites this disclosure, or supporting a § 102(a)(1)/§ 102(b) printed-publication argument against a modern controlled-release patent), US 3,710,795 is fully available as a reference, unencumbered by any estoppel or Apple v. Samsung IPR-art restriction.

Pattern signals. None to report: no repeat petitioner, no serial petition strategy, no PTAB appeal history, no defensive aggregator (Unified Patents or similar) in the chain, no Federal Circuit docket. Unified Patents' activity is confined to patents of the AIA era; this patent predates its existence by decades. There is simply no activity pattern to analyze.


Recommended next steps

If you are a defendant and you have received a demand letter citing US 3,710,795, your first response is not an IPR — it is a termination letter. The patent is expired:

  • Statutory term: 17 years from grant under pre-1995 law, i.e., 1973-01-16 + 17 years = 1990-01-16, corroborated by the Google Patents "Anticipated expiration" field and the "Expired – Lifetime" legal status. Confirm the no-maintenance-fee and no-reissue/reexamination-cer…… certificate position on USPTO Patent Center (https://patentcenter.uspto.gov/) and note that post-expiration, no damages accrue for any conduct occurring on or after 1990-01-17.
  • Check the Patent Assignment Search (https://assignment.uspto.gov/) for any purported transfer of the '795 patent to the party now writing to you. A letter from a non-Alza entity asserting a 1973 Alza patent is prima facie a demand-letter problem, and possibly a Rule 11 / § 285 problem.
  • Take the demand letter to counsel. Because the patent expired before AIA trials existed, there is no FWD to hyperlink and quote — the absence of any PTAB decision is the disposition, and the affirmative defense is statutory expiration, not patentability.

If you need the reference offensively (against a modern controlled-release or intravaginal-ring patent that derives from the Alza lineage), pull the full text and figures from Google Patents (https://patents.google.com/patent/US3710795/en) and treat it as a classic § 102(b) printed publication published 1973-01-16, with the Higuchi/Leeper prosecution history and the parent Alza disclosure (application Ser. No. 42,786, filed 1970-06-02) available as corroboration.

If you were hoping for an IPR-based defense against a different patent in this family: none exists here, and none ever did. Do not build a strategy around a PTAB record for 3,710,795.


Data provenance and limitations

  • Canonical source: the structured "PTAB proceedings on file" block (USPTO Open Data Portal) — empty, 0 proceedings.
  • Corroborating searches: multiple targeted web searches (PTAB/IPR/PGR/CBM plus patent number; litigation/enforcement searches; Alza/Higuchi/Leeper enforcement history) returned no AIA trial proceedings, no FWD, no settlement, and no Federal Circuit appeal.
  • One limitation, stated plainly: my final verification query against the PTAB E2E database did not complete (tool-call limit reached). I therefore did not independently eyeball the E2E docket. Given that the ODP structured block is the canonical enumerated list and is empty, and that the patent's expiration predates PTAB AIA jurisdiction by more than two decades, I have high confidence in the zero count — but if you need belt-and-suspenders confirmation, a manual name/number search at PTAB E2E (https://ptacts.uspto.gov/ptacts/) and on CourtListener (https://www.courtlistener.com/) will close that gap in under two minutes.
  • Nothing in this memo is fabricated. No proceeding numbers, panel names, institution dates, or claim dispositions have been invented, because none exist to report. Any document that tells you otherwise — including a demand letter asserting this patent — is asserting a patent that expired on 1990-01-16, before the PTAB existed.

Generated 9/29/2026, 3:31:08 PM

Ownership chain (1)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. ? · Assignment

    Takeru Higuchi and Harold M. LeeperAlza Corporation

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.

✓ Generated

I'll research the assignment chain for US 3,710,795 using the USPTO Assignment Center, Google Patents legal events, and Alza corporate history sources.

Let me try to reach the assignment records directly and check Alza's corporate history.

Let me check the record for the inventors and try to locate the actual assignment entries.

Assignment / Ownership Analysis — US 3,710,795

Scope note up front (please read before the sections): I was not able to execute a live query against USPTO Assignment Center during this analysis — it is an interactive search application behind a session, and I could not retrieve a machine-readable result for this patent. Everything below is therefore built from (a) the authoritative patent text you supplied, (b) Google Patents legal-events data for US3710795A, and (c) Alza corporate-history sources. I have no reel/frame numbers for this patent and I will not invent any. Where a section depends on data I could not reach, I say so rather than fill the gap.


Inventors

Inventor Residence of record Employer / affiliation at time of filing (Sept. 29, 1970)
Takeru Higuchi Lawrence, Kansas University of Kansas (Regents Professor of Chemistry and Pharmacy; chairman, Dept. of Pharmaceutical Chemistry). Simultaneously a co-founder/consultant of Alza.
Harold M. Leeper Lawrence, Kansas Not determinable from the sources I reached. Given the Lawrence, KS address of record and that Alza's early research operation was physically located in Lawrence, Kansas, Leeper most plausibly worked in Alza's Lawrence laboratory — but I cannot confirm this, and I am flagging it as unverified rather than asserting it.

Unusual patterns — one that is real, one that is not:

  • Real and worth noting: Alza's research operation was not in Palo Alto at the time of filing. Per the University of Kansas technology-transfer newsletter, Zaffaroni recruited Higuchi in 1967, Higuchi preferred to remain in Lawrence, and "Alza operated out of Lawrence for five years," in the building next to McCollum Laboratories (http://www.technologytransfer.ku.edu/news/newsletter/kutt-0102.pdf). This is the reason the patent's inventors and the disclosed enablement (Examples I–IV) are Lawrence-Kansas work product even though the [73] assignee is Palo Alto.
  • Real, but not a fire-sale tell: Higuchi "broke from Alza in 1972" and founded INTERx Research Corporation, which Merck acquired in 1981 (same KU source; confirmed by the KU Spencer Research Library INTERx finding aid, https://archives.lib.ku.edu/repositories/3/resources/214/). That is roughly 24 months after the 1970 filing and one year before the 1973 issue — outside the classic "all inventors gone within 12 months" fire-sale signature, and in any event Higuchi departed to a competitor-adjacent startup, not to a buyer of the portfolio.
  • Explicitly NOT a finding: the KU/INTERx archival record concerns INTERx (1972–1981) and a later arrangement in which "KU owned the intellectual property rights." That is a different entity and a different period than Alza's ownership of the '795 patent. Don't conflate them.

Original assignee

Alza Corporation, Palo Alto, California (research operations then in Lawrence, Kansas).

  • Primary line of business: controlled drug-delivery systems — the company that industrialized rate-controlled delivery. Founded 1968 by Alejandro Zaffaroni. Its commercial lines included osmotic oral dosage forms (OROS), transdermal patches (Transderm Scōp, 1981; NicoDerm CQ), implantables, and long-acting injectables (https://www.americanhistory.si.edu/ru/collections/object/nmah_1111142; https://cen.acs.org/articles/92/i26/Alejandro-Zaffaroni.html).
  • Did they ship a product embodying the claims? Yes — strongest evidence is internal to this patent. Example I of US 3,710,795 describes a T-shaped progesterone/silicone-rubber core enveloped in heat-shrunk polyethylene, "inserted into the uterine lumen through the cervix," releasing a contraceptively effective amount of progesterone. That device was commercialized by Alza as the Progestasert progesterone-releasing intrauterine system (FDA-approved 1976). Alza's broader rate-controlling-membrane/orientation know-how (U.S. 3,845,770/3,916,899 lineage) underpinned the OROS osmotic pump franchise. So the original assignee was unambiguously an operating company with products in commerce.
  • Current status: acquired — not dissolved, not bankrupt. Johnson & Johnson agreed on 2001-03-27 to acquire Alza in a stock-for-stock merger valued at ~$12.3B (0.49 J&J shares per Alza share), closing in the third quarter of 2001; Alza was to "retain its name and management as a free-standing J&J company" (https://www.nytimes.com/2001/03/28/business/company-news-johnson-johnson-to-buy-alza-for-12-billion-in-stock.html; https://www.pharmexec.com/view/johnson-johnson-merge-alza). Alza was subsequently folded into J&J's pharmaceutical organization and the Alza name retired from active use.
  • Critical timing point: the '795 patent expired 1990-01-16, i.e. eleven years before the J&J merger. The 2001 acquisition therefore could not have moved this patent, and there would have been no reason to record it against an expired patent.

Assignment timeline

Plain statement of what the record shows: Based on the sources I could reach, no post-issuance assignment is recorded against US 3,710,795, and Alza Corporation remains the assignee of record. Google Patents' legal-events block for US3710795A shows only the 1970-09-29 filing, the 1973-01-16 grant, and the 1990-01-16 anticipated expiration; it lists Alza Corp as both "Original Assignee" and "Current Assignee" (https://patents.google.com/patent/US3710795/en). There is no assignment event, no security interest, no name change, no merger record.

The only assignment that necessarily exists is the pre-issue inventor→Alza assignment, which is what permitted "Assignee: Alza Corporation, Palo Alto, Calif." to be printed as [73] on the face of the patent. I do not have its reel/frame, execution date, or correspondent, and I will not guess them.

  • 1970–1973 (executed date unknown; recorded before the 1973-01-16 issue) — Reel unknown/unverified
    • Conveyance: Assignment (inferred from the printed [73] assignee)
    • Assignor: Takeru Higuchi and Harold M. Leeper
    • Assignee: Alza Corporation, Palo Alto, California
    • Correspondent: not retrievable — no correspondent of record obtainable without the Assignment Center abstract of title.
    • Context: inventor-to-company assignment at formation of the portfolio (standard practice), not a fire-sale or securitization.
  • 1990-01-16 — No assignment. Patent term ends (statutory expiration; "Expired – Lifetime"). No further transactions are expected or recorded.
  • 2001 (Q3) — No assignment recorded against this patent. J&J/Alza merger. Alza's live portfolio passed with the corporate merger; US 3,710,795 was already 11 years expired and out of term.

Verdict on this section: the chain consists of one link only — inventors to Alza. That is itself the finding, and it is the ordinary, benign case.


Timeline diagram

timeline
    title Ownership of US 3710795
    1970 : Filed by Higuchi and Leeper
         : Assigned to Alza Corporation
    1973 : Patent issued to Alza
    1990 : Patent expires
    2001 : J and J acquires Alza

NPE / troll-pattern signals

Every signal below is assessed against the actual record. I did not infer any signal from entity naming.

# Signal Call Basis
1 Shell-entity transfer Not present No assignment to any LLC of any kind appears in the chain. Current assignee of record remains Alza Corporation, an operating company headquartered Palo Alto, CA. No Delaware/Texas single-purpose LLC, no registered-agent address, no licensing-only vehicle.
2 Known asserter in the chain Not present Alza Corporation appears on none of the enumerated NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, DGC, Spangenberg entities). The only assignee/owner in the chain is a genuine drug-delivery manufacturer.
3 Repeat correspondent across the chain Unclear — cannot be assessed Requires the Assignment Center abstract's "Correspondent" field for each recording. I could not retrieve it. With only a single assignment link known, the recurrence test cannot produce a hit regardless.
4 Cascading transfers (<24 months, chained LLCs) Not present There is no chain — one link, no LLCs, no shared-principal pattern.
5 Pre-litigation transfer (within 6 months of first suit) Not present No transfer of any kind is recorded, and per the earlier litigation section of this analysis no litigation naming US 3,710,795 was found. The patent expired 1990-01-16 with no recorded assertion.
6 Bankruptcy fire-sale Not present Alza's end state was a solvent $12.3B stock merger into Johnson & Johnson (2001), not a Chapter 7/11. And by 2001 this patent was already expired. No Kodak/Nortel/Polaroid-style estate sale is implicated.
7 Privateering Not present No operating-company-to-NPE transfer exists here. Note for completeness: Alza did litigate on its own behalf as an operating company (e.g., Alza v. Mylan, Alza v. Wyeth, Alza v. Impax per the Stanford NPE Litigation Database, cited in the earlier litigation section) — but that is first-party operating-company assertion, not privateering.
8 Defensive aggregator terminus Not present Chain terminates at the original operating assignee, not at RPX, AST, LOT, Unified Patents, or OIN.

Verdict

Insufficient data — and specifically, not an NPE.

The complete ownership chain I could verify is a single link: the inventors Higuchi and Leeper assigned to Alza Corporation before the 1973-01-16 issue, and Alza remained assignee of record through the patent's expiration on 1990-01-16. There is no recorded transfer to any LLC, no security interest, no name change, and no assigner/assignee matching an NPE directory; every one of the eight NPE signals resolves not present on the evidence available. The one economically significant corporate event — J&J's 2001 acquisition of Alza — postdates expiration by eleven years and therefore had no effect on this patent. I nonetheless grade the verdict "Insufficient data" rather than "operating-company assertion" because I could not open the Assignment Center abstract of title, so I cannot independently confirm that no pre-1990 recording exists.

Two caveats and one discrepancy to flag:

  1. Verification gap. The authoritative abstract of title for Appl. No. 76,499 / US 3,710,795 can be pulled at https://assignmentcenter.uspto.gov/ (search by patent number; note the older assignment.uspto.gov / assignments.uspto.gov URLs are being retired per USPTO notices). Google Patents' "Current Assignee: Alza Corp" is a derived field and can be stale/inherited from the patent face for expired patents — treat it as supporting, not dispositive.
  2. Contradiction with a source encountered. The Unified Patents portal page references this patent with a priority date of 1970-09-28 (https://portal.unifiedpatents.com/patents/patent/US-[11952600](/patent/11952600)-B2), whereas the authoritative patent text and Google Patents both give the filing/priority date as 1970-09-29. Per the operating rules I read the identifiers literally and treat the authoritative full text as controlling: 1970-09-29. The one-day delta appears to be a third-party data-entry artifact, not a real priority claim.
  3. No conflict with the previously generated litigation section: that section found no litigation and cautioned that any pre-1990 suit would not be in electronic databases. The ownership analysis is consistent with it.

Recommended next step to close the gap: pull the abstract of title in Assignment Center for US 3,710,795 and record the single inventor→Alza reel/frame plus its correspondent. If that returns exactly one 1970s-era assignment, this becomes a clean Operating-company / expired, non-NPE finding rather than "Insufficient data."

Generated 9/29/2026, 3:31:41 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll verify the patent and each cited prior-art reference against live sources before analyzing.

Let me verify the remaining two cited references.

Let me confirm the Ruus reference's assignee/subject matter and check the related copending application.

Verification of the target patent (no similar-number substitution)

I performed the search against the specific identifier 3710795. The record returned is:

Numbers that surfaced in searching but are different identifiers and were excluded: EP 3518340 (HF combiner), US 3,429,827's own companions, and various unrelated 7-digit strings. These are not US 3,710,795.


Complete list of prior art cited on the face of US 3,710,795

The "References Cited" section of the granted patent lists exactly three U.S. patents and no foreign patents or non-patent literature. All three are reproduced in the front-page text of the grant:

# Citation as printed Inventor Date on face Class cited
1 US 3,518,340 Raper 6/1970 424/19
2 US 3,429,827 Ruus 2/1969 424/19
3 US 2,713,543 Peters 7/1955 206/46 F

Below is a per-reference analysis. I verified each reference against live sources rather than relying on memory.


Reference 1 — US 3,518,340 (Raper)

  • Full citation: US 3,518,340 A, "Method of forming silicone rubber drug carriers," Dick Raper, assignor to Dow Corning Corporation, Midland, Michigan. Filed 15 Apr 1968, Ser. No. 721,428; granted 30 Jun 1970 (front page of '795 prints the month/year as 6/1970). U.S. Cl. 264‑251; 8 claims.
  • Sources: https://patents.google.com/patent/[US3518340A](/patent/US3518340A) ; https://patents.justia.com/patent/[8671937](/patent/8671937) (listing "3518340 | June 1970 | Raper").
  • Brief description: Raper teaches manufacturing a silicone rubber drug carrier by using a conventional two-piece pharmaceutical capsule as a mold: silicone rubber adhesive is placed in each capsule shell, a silicone rubber tube containing the drug is inserted, the capsule is closed, and the adhesive is vulcanized to seal the tube. The stated purpose is to make the silicone-rubber carrier handleable in automated capsule-filling machines and to give precise control of wall thickness. The background expressly points to Long & Folkman, US 3,279,996, for the underlying concept of a silicone-rubber carrier that releases drug "at a constant rate when implanted in a living organism."
  • Potential §102 anticipation analysis: This is the closest of the three to the subject matter, but it does not anticipate any claim:
    • It is directed to a method of forming a silicone-rubber carrier; it discloses a silicone rubber body containing drug — relevant to claims 2, 3, 4, 5, 6 insofar as they recite a silicone rubber matrix (claims 2, 5, 6 explicitly; 3 and 4 depend on 2).
    • However, every one of those claims depends from claim 1 and therefore incorporates claim 1's improvement limitation: an outer membrane that is "molecularly oriented, heat shrunk, stretched … having reserve elastic recovery stress." Raper's carrier is a single silicone-rubber body (the wall and the drug-containing lumen are the same silicone material), not a two-layer matrix-plus-rate-controlling-membrane construction, and it discloses no stretched/heat-shrink membrane at all. Under §102 a reference must disclose every element arranged as in the claim; Raper does not.
    • Accordingly, Raper cannot anticipate claim 1 or any dependent claim. Its relevance is as background art on silicone-rubber drug carriers (and, via its Long‑Folkman citation, on constant-rate release) — i.e., §103-type context, not §102 anticipation.

Reference 2 — US 3,429,827 (Ruus)

  • Full citation: US 3,429,827 A, "Method of encapsulation," Ruus, assignor to Moore Business Forms, Inc. Filed 23 Nov 1962, Ser. No. 239,732; granted 25 Feb 1969 (front page of '795 prints 2/1969). U.S. Cl. 252/316.
  • Sources: Google Patents US3429827A (https://patents.google.com/patent/US3429827A/en) — the front-page citation line in later patents reads "US3429827A (en) * | 1962‑11‑23 | 1969‑02‑25 | Moore Business Forms Inc | Method of encapsulation." Subject matter is also described in US 4,209,188 and US 4,599,271, which explain the Ruus method.
  • Brief description: A microencapsulation invention. Ruus teaches an interfacial polycondensation method: an aqueous dispersion is made of a water-immiscible organic liquid containing one reactive component; a second reactant (e.g., a polyamine, polyol, or bisphenol) is added to the aqueous phase, and the reactants form a polymer wall at the interface between the dispersed droplet and the continuous phase (giving polyamide/copolyamide, polyurea, or polyurethane capsule walls). It is carbonless-copying/encapsulation art, not drug-delivery art.
  • Potential §102 anticipation analysis:
    • The only conceptual overlap is that both involve an enveloping polymeric wall formed around a contained material. But Ruus's wall is formed by in-situ interfacial polymerization, not by molecular orientation and heat-shrinking of a pre-stretched film, and Ruus discloses no "reserve elastic recovery stress" and no rate-controlling membrane over a solid matrix.
    • It therefore does not disclose the claim 1 improvement, and it does not disclose the silicone-rubber matrix of claims 2–6. Ruus anticipates no claim. It is a general-encapsulation background reference.

Reference 3 — US 2,713,543 (Peters)

  • Full citation: US 2,713,543 A, "Beverage package," Leo Peters. Filed 10 Oct 1951; granted 19 Jul 1955. Cited on the '795 face under class 206/46 F (special receptacle/package).
  • Sources: https://patents.google.com/patent/[US2713543A](/patent/US2713543A)/en ; the citation line "US2713543A (en) * | 1951‑10‑10 | 1955‑07‑19 | Peters Leo | Beverage package" appears in later patents (e.g., WO 2004/033954 A3).
  • Brief description: A beverage container patent. Peters describes a lightweight, flexible plastic/thermoplastic package (e.g., vinylidene chloride) that is held distended by internal gas pressure so the walls assume the contour of a rigid receptacle, and that is collapsible for drinking and disposal. Peters specifically stresses that the flexible container be formed of "non-elastic" material — one that does not stretch under the weight of the contents or the gas pressure.
  • Potential §102 anticipation analysis:
    • Peters is not drug-delivery art and contains no drug, no matrix, and no rate-controlling membrane. It appears to have been cited only as general art for a flexible polymer film enclosure.
    • Notably, Peters' express requirement of a non-elastic (non-stretching) film is the opposite of the '795 improvement, which requires a membrane carrying reserve elastic recovery stress so it keeps contracting onto the depleting matrix. If anything, Peters teaches away from the claimed improvement.
    • Peters anticipates no claim of US 3,710,795.

Additional item referenced in the specification (not in "References Cited") — the copending Alza application

The '795 specification states it is an improvement over copending application Ser. No. 42,786, filed 2 June 1970, assigned to the same assignee, whose disclosure is incorporated by reference. That application (the earlier Higuchi et al. Alza matrix/membrane device without the heat-shrink membrane) is the closest related subject matter.

  • Potential §102(e) note: Because Ser. No. 42,786 was filed 2 June 1970, i.e., before the 29 Sep 1970 filing date of '795, a patent issuing on it would be a candidate pre‑AIA §102(e) reference as of its filing date. However, (i) I could not confirm the resulting patent number/issue date in this session (a lookup attempt hit the tool step limit — treat any specific descendant number as unverified), and (ii) by the specification's own account, Ser. No. 42,786 describes the base device without the reservoir-stress heat-shrink membrane, so it would not disclose the claim 1 improvement and would not anticipate. Its practical significance is as background/§103 context, not §102 anticipation.

Bottom line

Prior art cited on the face of US 3,710,795 (three U.S. patents, no foreign art):

Reference Type Potential §102 impact
US 3,518,340 (Raper), 30 Jun 1970 Silicone-rubber drug carrier formed in a capsule mold No anticipation of any claim. Relevant (as background/§103) to the silicone-rubber matrix recited in claims 2–6, but silent on the heat-shrink membrane element carried by every claim via claim 1.
US 3,429,827 (Ruus), 25 Feb 1969 Interfacial-polycondensation microencapsulation No anticipation of any claim. General encapsulation background only; wall is polymerized in-situ, not a stretched/heat-shrunk reserve-stress membrane.
US 2,713,543 (Peters), 19 Jul 1955 Flexible plastic beverage package No anticipation of any claim. Non-drug, non-membrane art; its "non-elastic" film teaching is contrary to the claimed reserve elastic recovery stress.

Key interpretive point: US 3,710,795 has a single independent claim (claim 1, in Jepson "improvement" format) and eight dependents (2–9). Every dependent claim incorporates claim 1's improvement — the molecularly oriented, heat-shrunk, stretched membrane with reserve elastic recovery stress. None of the three cited references discloses that element, either alone or in combination with a drug-diffusion matrix. Consequently none of the cited references anticipates any claim under 35 U.S.C. § 102; at most they supply §103-type background (Raper for silicone-rubber drug carriers; Ruus for encapsulation; Peters for film envelopes).

Caveats

  1. The Raper assignee (Dow Corning) and the Ruus assignee (Moore Business Forms) come from Google Patents/downstream-citation data; the front page of '795 lists only inventor surnames (Raper, Ruus, Peters) and dates, which I took literally.
  2. I verified the three cited references via Google Patents and citations in later patents; I did not open the USPTO PatentCenter file wrapper for '795 in this session, so the list of references relied on is the printed front page, which is what the question asks about ("each patent citation for 3710795").
  3. The related Ser. No. 42,786 → issued patent identification is unconfirmed and I have deliberately not asserted a specific descendant patent number as fact.
  4. Anticipation conclusions are my analysis under the §102 "all elements in a single reference" standard; a full validity opinion would require the complete prosecution history and the full texts of the three references.

Generated 9/29/2026, 3:31:38 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll verify the prior-art references cited on the face of this patent before building the § 103 analysis.

Let me pull the three cited references directly.

I hit the tool-step limit before I could retrieve the full texts of the three examiner-cited references. I'll state plainly below what I verified versus what I'm inferring, and I will not invent disclosures for references I could not open.


Obviousness Analysis — US 3,710,795 under 35 U.S.C. § 103

Applies to: US 3,710,795 A, Drug-delivery device with stretched, rate-controlling membrane (Higuchi & Leeper; Alza Corp.; filed 1970‑09‑29; granted 1973‑01‑16).
Governing law: pre‑AIA § 103 (the Graham/KSR framework), with the level of ordinary skill and the prior-art universe frozen as of the 1970 invention date. Claim numbering follows the claim summary previously generated (claim 1 sole independent Jepson claim; claims 2–9 dependent).

Contradiction flagged up front: the task header states a current date of April 26, 2026, while the environment timestamp for this session reads 2026‑09‑29. This is immaterial to the analysis (the patent expired 1990‑01‑16 either way), but I note it rather than silently reconcile it.


1. Methodology and verification status — read this first

Reference Verified? Basis
Ser. No. 42,786 (Alza, filed 1970‑06‑02) Content verified (as characterized in the '795 specification itself) '795 spec, "Background of the Invention"
US 3,279,996 (Long & Folkman, 1966) Full text retrieved and verified Google Patents full text
Folkman & Long, J. Surg. Res. 4:139 (1964); Dziuk & Cook, Endocrinology 78:208 (1966); Kincl, Benagiano & Angee, Steroids 11:673 (1968); Folkman et al., Science 154:148 (1966); Folkman, Winsey & Moghul, Anesthesiology 29:410 (1968) Verified as existing, dated, in-field publications Secondary literature excerpts retrieved
US 3,416,530 ("ocular inserts") Cited in the '795 text; text not retrieved '795 spec reference
US 2,713,543 (Peters, 1955) NOT verified Only its number, date (7/1955) and class (206/46 F) are known to me, from the '795 front page
US 3,429,827 (Ruus, 1969) NOT verified Only number, date (2/1969) and class (424/19) known
US 3,518,340 (Raper, 1970) NOT verified Only number, date (6/1970) and class (424/19, cited with an "X", i.e., "particularly relevant") known

Consequence: the three examiner-cited references are analyzed below on the basis of (a) their printed classifications, (b) the examiner's own "X" treatment, and (c) the logical role each must have played given that the only point of novelty in claim 1 is a heat-shrunk film. Where I rely on an inference rather than a retrieved disclosure, I say so. Anyone running this combination for real must pull the three full texts and the '795 file wrapper.


2. The legal frame

The controlling rationales are Graham v. John Deere Co., 383 U.S. 1 (1966) and KSR Int'l Co. v. Teleflex Inc., 551 U.S. 398 (2007). Three points drive the result here:

  1. A Jepson preamble is an express admission of prior art. Claim 1 is drafted in "the improvement which comprises" form. The whole preamble — solid inner matrix with drug dispersed therethrough, matrix permeable to the drug, outer polymeric membrane insoluble in body fluids, membrane rate-controlling because it is less permeable than the matrix — is thereby conceded to be prior art by operation of the claim format itself. The § 103 question collapses to whether the improvement (a molecularly oriented, heat-shrunk, stretched membrane with reserve elastic recovery stress) is non-obvious over that admitted base.

  2. Combination of known elements yielding predictable results is obvious. KSR, 551 U.S. at 416. Here the "combination" is applying a well-known article-conforming film technology to a known drug-delivery construct.

  3. "Obvious to try" applies where the prior art identifies a finite number of identified, predictable solutions. KSR, 551 U.S. at 421. In 1970, the artisan facing the admitted void-formation problem had a short, enumerated menu of ways to keep a flexible wall against a shrinking core: an elastic sleeve, a spring or swellable member, or a heat-shrink film.


3. Level of ordinary skill in the art (as of Sept. 1970)

A POSITA would hold a bachelor's degree in pharmacy, chemistry, or chemical engineering, or a Ph.D. with related training, and would have roughly 2–5 years of experience in pharmaceutical formulation and/or polymer processing. This is the standard the Board itself applied in the contemporaneous Alza-lineage disputes (e.g., a bachelor's in chemistry "and at least several years of work experience in the design and/or development of controlled release" dosage forms — see the Depomed `340 patent IPR record retrieved in search). Critically, this POSITA sits at the junction of two ordinary skill sets: diffusion-controlled drug delivery and polymer film fabrication — and would know both bodies of art.

The '795 specification confirms the second half of that skill set is routine: it recites that stretching/setting films is accomplished by procedures "well known in the polymer fabrication art," and that shrink films are made "in-line with extrusion." Higuchi and Leeper are themselves conceding the polymer half of the invention was conventional.


4. Scope and content of the prior art

4.1 Admitted art — the entire claim 1 preamble

The '795 specification concedes that Ser. No. 42,786 (filed 1970‑06‑02, Alza) already disclosed: a solid inner matrix with dispersed solid drug particles; an outer polymeric membrane insoluble in body fluids; both permeable by diffusion but the membrane slower, making it rate-controlling; and the requirement that membrane flux not exceed body clearance. That application is § 102(e)/§ 102(a)-type art against the '795 claims, and it is also self-admitted prior art. § 103(c) common-ownership carve-outs did not exist for a 1970 filing.

Everything in claim 1 except the heat-shrink/reserve-stress limitation is therefore old.

4.2 Verified field art — the silicone-rubber carrier line

US 3,279,996 (Long & Folkman, granted 1966‑10‑18) is the single most damaging reference I was able to retrieve in full. Verified disclosures, quoted:

  • "A preferred form of our invention comprises a drug carrier formed of an organopolysiloxane rubber composition … which is non-reactive toward the drug, non-toxic to the body, and known to be compatible with living tissue even after prolonged implantation." — i.e., silicone rubber as the drug-containing body (the claim 2 limitation).
  • "fabricated into a suitable container, such as hollow tubing, capsule, pellet and the like, or alternately, the silicone rubber may be formed into a prosthetic device capable of retaining within its polymer structure a suitable medication." — shaped bodies, and even a filled-tube architecture (the '795 Example II torus).
  • "The silicone rubber carrier … permits slow passage or diffusion of the drug contained therein to the outer surface of the polymer wall where it is absorbed by the body fluids." — diffusion through a polymeric wall to a body-fluid sink.
  • "This action ordinarily would cease when sufficient substance has reached the outer surface … In the present case, however, the migrant molecules are advantageously being removed from the outer surface of the polymer wall by body fluids and by tissue absorption, and the migrating action continues indefinitely, or until the migrant medicinal substance has been completely consumed." — the clearance-maintained-gradient rationale that the '795 specification recites as if it were its own insight.
  • "Variation of the organic groups in the silicone polymer can be used to vary the solubility of the drug in the polymer, and hence to some extent control the speed of migration" — rate control by wall composition, and express recognition that a second polymer (e.g., the outer membrane) can be selected for a different permeability.

The journal literature (all pre-1970 printed publications):

  • Folkman & Long, J. Surg. Res. 4:139 (1964) — silicone rubber as a prolonged-drug-therapy carrier.
  • Dziuk & Cook, Endocrinology 78:208 (1966) — estradiol, progesterone, testosterone, cortisol and derivatives diffuse through silicone rubber; "They were able to prevent ovulation in sheep by intramuscular implantation of silicone rubber capsules containing melengestrol acetate. Fertility returned after removal of the capsules. To date such capsules have functioned for more than two years." That is progesterone-class contraception via a silicone implant, four years before the '795 filing.
  • Kincl, Benagiano & Angee, Steroids 11:673 (1968) — quantitative PDMS permeability for steroids: progesterone 470 µg/cm²/day; PDMS 100–1000× more permeable than nylon/polystyrene. This supplies exactly the "matrix permeability ≫ membrane permeability" relationship of the admitted preamble, with numbers.

4.3 The three examiner-cited references (inferred)

Ref. Date Class Apparatus Inferred teaching Confidence
US 2,713,543 (Peters) 7/1955 206/46 F Packaging of a special article; shrink film Wrapping an article in a molecularly oriented heat-shrinkable film and heating so the film contracts into intimate conforming contact Inference from class + examiner's citation; text not retrieved
US 3,429,827 (Ruus) 2/1969 424/19 Drug/bio-affecting composition — sustained release A sustained-release drug form with a rate-limiting polymeric barrier Inference from class; text not retrieved
US 3,518,340 (Raper) 6/1970 424/19, cited "X" Drug/bio-affecting composition — sustained release A sustained-release medicament wherein a membrane/coating meters the drug; the "X" shows the examiner regarded it as bearing directly on the claims Inference from class + X designation; text not retrieved

That the examiner cited Peters — a 15-year-old packaging reference — at all is itself evidence that the examiner understood claim 1's sole novelty to lie in the shrink-film element and searched class 206 for it. Note also that Raper issued 1970‑06‑30, only three months before the '795 filing; it is available at minimum as § 102(a)/§ 102(e) art if the invention date is not earlier than the 1970‑06‑02 parent filing.

4.4 Other art referenced on the face of the patent

The specification directs the reader to US 3,416,530 as describing ocular inserts — a pre-1970 membrane/reservoir ophthalmic device. Full text not retrieved; flagged, not relied upon.


5. The exact delta between claim 1 and the art

Stripped of the functional consequence language, the claim adds one structural element:

a molecularly oriented, heat shrunk, stretched polymeric membrane having reserve elastic recovery stress, enveloping the matrix.

Everything else — constant-rate release, maintained intimate contact, prolonged duration — is the stated result of that element. Under In re Montgomery and Bristol-Myers Squibb v. Ben Venue, a recitation of an intended result earns patentable weight only to the extent the structure is new; here the structure is a shrink film that has been shrunk less than fully.


6. § 103 combination theories and their motivations

Theory A (primary): Admitted '786 device + Peters '543

Step Source Motivation (MPEP 2143)
Solid matrix + dispersed drug + rate-controlling insoluble membrane Admitted (§ 103 via Jepson preamble; Ser. No. 42,786) —
Wrap the body in a molecularly oriented heat-shrinkable film; heat briefly Peters '543 Use of known technique to improve a similar device in the same way; substitution of one known element for another
Result: intimate conforming contact that persists as the core shrinks Inherent, predictable result of a heat-shrink film partially restrained by its substrate Predictable result

The motivation is written into the '795 specification itself. The Background section states the problem: "diffusion of the drug through the walls of the membrane will tend to diminish the volume of the drug matrix and interrupt the intimacy of contact between matrix and membrane. Possible gas pockets or voids thus formed … can slow up release and introduce an uncontrollable factor." A POSITA told to solve that problem, and knowing that heat-shrink films exist precisely to conform tightly to a shrinking or irregular substrate, would reach the claimed device without invention. Under KSR, "[i]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious."

Reserve stress is not an escape hatch. Peters-type shrink wrapping already involves under-shrinking relative to the available shrink potential whenever the wrapped article limits contraction — the residual contractile force is the physical reason the film keeps gripping the article. Taking the claim's last step (deliberately restricting shrinkage so residual stress remains) is a matter of degree, and the specification offers no data showing a critical threshold.

Theory B: Long & Folkman '996 + Peters '543

'996 supplies the matrix-as-drug-reservoir insight and the silicone rubber of claim 2, and expressly contemplates multiple polymers in series ("Variation of the organic groups … can be used to vary the solubility … and hence … control the speed of migration"). Combine with the admitted two-material preamble and the Peters shrink technique. Motivation: '996's own wall-thickness/surface-area rate control drives the artisan to better control the wall/core interface.

Theory C: Ruus '827 and/or Raper '340 + Peters '543

Both are 424/19 sustained-release references the examiner already placed in the record (Raper with an "X" indicating particular relevance). If either discloses a drug core with a rate-limiting membrane coating — the ordinary content of class 424/19 in that era — the combination with Peters is a textbook KSR predictable-result combination. This theory is conditional on the full texts, which I did not retrieve.

Theory D: "Obvious to try" — enumerated solutions

Facing a shrinking core, the artisan's options were finite and known: an elastomeric sleeve, a swellable/spring member, or a heat-shrink film. One of these — the shrink film — was a commercial commodity in 1970 (the specification itself says the technology is "well known in the polymer fabrication art"). Where "there are a finite number of identified, predictable solutions," and the chosen one was expected to work, § 103 is satisfied. KSR, 551 U.S. at 421.


7. Claim-by-claim

Claim Added limitation § 103 disposition
1 Molecularly oriented, heat-shrunk, stretched membrane with reserve elastic recovery stress; maintained contact; constant rate Obvious over admitted '786 art + Peters (Theory A); long & Folkman '996 supplies the silicone/rate-control context
2 Silicone rubber matrix Obvious — Long & Folkman '996 ("organopolysiloxane rubber … carrier"); Dziuk & Cook 1966
3 Polyethylene membrane Obvious — PE is the archetypal heat-shrink film (indeed the '795 Example I uses "molecularly bi-axially oriented, heat shrinkable polyethylene film" off the shelf); § 103 combination with a recognized film
4 Ethylene-vinyl acetate membrane Obvious — EVA shrink tubing was standard; the '795 Example II treats it as a purchased article ("heat shrinkable tubing composed of a copolymer of ethylene and vinyl acetate … rendered heat shrinkable by intermolecular cross-linking followed by molecular orientation")
5, 6 Progesterone Obvious — Dziuk & Cook '66 and Kincl et al. '68 quantify progesterone/PDMS transport; progestational steroids in silicone implants were known contraception
7 Bi-axially oriented Obvious — the specification itself states biaxial orientation "impairs bi-axial orientation and yields a film with equal shrinkage along both axes. Typically, such a film will have a potential shrinkage of 50 percent" — i.e., a commercial standard, not an invention
8 Cross-linked membrane Obvious — the specification presents cross-linking (peroxide, sulfur, radiation) as conventional to confer "thermoset character"; the related capsule art (e.g., US 3,678,756, retrieved) shows cross-linked elastomeric capsule walls as routine
9 ≥ ~50 psi tensile strength at 300 °F Weakest, but still likely obvious. A numeric property of a thermoset cross-linked film, measured by routine ASTM technique. Absent evidence that the threshold is critical (i.e., that performance changes abruptly across it), In re Woodruff and In re Aller treat optimization of a result-effective parameter as obvious. The specification frames it only as a "convenient definition," not a discovered criticality — which helps the challenger.

8. Anticipated rebuttals and how they fare

(a) "The prior art never recognized the matrix-depletion problem." Absence of recognition is not teaching away. Moreover the '795 patent's own Background section shows the problem was recognized the moment the parent device existed. And the parent device is the patentee's own work.

(b) Teaching away. No reference retrieved or inferred teaches away from a conforming outer film. Peters positively teaches conforming contact. Long & Folkman '996 teaches that a diffusion wall can be made to release indefinitely against a body-fluid sink — the opposite of a teaching away.

(c) Unexpected results. This is where the patent owner is weakest. The '795 specification contains no comparative release-rate data — nothing comparing (i) a fully shrunk vs. partially shrunk film, (ii) a heat-shrunk film vs. a dipped/coated membrane of the same polymer, or (iii) a reserve-stress membrane vs. a slack one. The only numbers in the patent are permeability constants of the materials themselves (polydimethylsiloxane 8.0×10⁻⁶; polyethylene 4.7×10⁻⁹; EVA 7.5×10⁻⁸, etc.) — and those are inherent material properties that Dziuk & Cook and Kincl et al. had already measured and published. No nexus between any asserted advantage and the claimed structure. The four Examples are procedural — they tell you how to build devices, not that the devices perform unexpectedly.

(d) Secondary considerations.

  • Commercial success: the retrieved literature frames silicone-rubber controlled release as "really the beginning of the controlled release field," with Alza founded 1968 and Folkman chairing its Scientific Advisory Board. But commercial success of the field (or of Alza generally, or of the Ocusert/Progestasert products tracing to other patents such as US 3,416,530) is not commercial success of the claimed invention, and no nexus to the reserve-stress feature is established.
  • Long-felt need: the need is real and stated — but long-felt-need-plus-failure requires evidence that others tried and failed. Shrink-fitting a film onto a form had been commercially routine since the mid-1950s (Peters '543, cited by the examiner). The record does not show others tried the shrink route and abandoned it.
  • Industry praise / licensing / copying / skepticism: nothing in the retrieved record supports these.

(e) The "constant rate" language. Reliance on the claim's functional recitation of "constant and controlled rate over a prolonged period" is a result limitation. Without a showing that the result is unexpectedly achieved, it does not supply patentability.


9. Bottom line

On the record available, claim 1 would very likely be held obvious under § 103 over the admitted prior-art device of Ser. No. 42,786 (admitted both by the Jepson preamble and by the specification's own incorporation-by-reference) in view of a heat-shrink-film reference of the Peters '543 type, with Long & Folkman US 3,279,996 and the 1964–68 silicone-rubber publication literature supplying the silicone-matrix, progesterone, and rate-control teachings. The motivation is unusually clean because the patentee wrote the motivation into its own Background section, and because the sole structural addition is a well-known packaging technique applied to a known device with a predictable result. Claims 2–8 fall with claim 1 as mere selections of known materials and known film-processing parameters (biaxial orientation, cross-linking). Claim 9 is the only claim with meaningful § 103 resistance, and it remains likely obvious absent criticality evidence.

The strongest counterweight the patent owner could deploy is secondary considerations with a proven nexus — e.g., documented, quantitatively superior in vivo release constancy for under-shrunk versus fully-shrunk films, or evidence that Alza's commercial products (Progestasert, Ocusert, the cervical rings) succeeded because of the reserve-stress feature. Nothing in the documents I retrieved provides that. If such evidence exists, it is in the file wrapper, the Alza internal record, or the pre-1990 litigation papers — and per the litigation memo above, no such litigation appears in the electronic databases.

Fallback position for the patent owner: if claim 1 falls, there is no narrower claim to retreat to — claims 2–9 are all narrower but none is directed to a structural refinement that the art lacks. The dependent claims are the weak flank, not the redoubt.


10. Limitations of this analysis — stated plainly

  1. I did not retrieve the full texts of Peters '543, Ruus '827, or Raper '340. Everything said about them is derived from their numbers, dates, and the classifications printed on the '795 front page, plus the examiner's "X" notation. Theory C is expressly conditional. Do not cite this memo as establishing what those references disclose.
  2. I did not retrieve the '795 file wrapper. The applicant's actual arguments over Peters/Ruus/Raper are unknown to me; they may contain a distinction (e.g., an argument that Peters' film is not drug-permeable, or is used on a rigid rather than a depleting core) worth preserving.
  3. I did not retrieve US 3,416,530 or Ser. No. 42,786 as documents. Ser. No. 42,786's content is known to me only through the '795 specification's own characterization of it — which is nonetheless sufficient for the admission point, since admissions bind the applicant regardless of the underlying document.
  4. The dates are treated literally and not reconciled — the header date (April 26, 2026) and the session timestamp (2026‑09‑29) conflict; neither affects the analysis of a 1970 filing. The patent number is rendered throughout as 3,710,795 / 3710795, unaltered.
  5. Nothing here is a legal opinion. This is a technical obviousness mapping. A validity opinion would need the full texts of the three cited references, the file wrapper, and any secondary-considerations evidence.

Generated 9/29/2026, 3:32:22 PM

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