US 5462743

I'll search for authoritative information on this specific patent number.

Let me pull the claim set specifically.

Let me attempt to retrieve the actual claim text.

US Patent 5,462,743 — Verification Summary

Important caveat up front: I was able to confirm the bibliographic data, abstract, and status from multiple sources, but I could not retrieve the verbatim, numbered claim set (the authoritative full text supplied to me ends mid‑background section, and my searches did not surface the claims column). The plain-language claim descriptions below are therefore reconstructed from the abstract, the summary-of-invention passages, and the specification's own claim-style recitations — not quoted from the claims. Treat claim scope as provisional pending a primary-source check of the patent's claims column. I found no CAFC litigation or 2026 docket activity naming this patent.

Bibliographic data

Sources: provided Google Patents full text; PubChem patent record (https://pubchem.ncbi.nlm.nih.gov/patent/US-5462743-A); Google Patents (https://patents.google.com/patent/US5462743/en). Assignment of 1994‑03‑25 to MEDIPRO SCIENCES LIMITED from the four named inventors is recorded in the patent's transaction history.

Abstract (verbatim)

"A substance transfer device for topical or transdermal drug delivery to a living body or collection of fluids from a living body, comprises a layer of skin or wound surface compatible adhesive having a surface for contacting the body, and channels therethrough which provide liquid communication with depots of drug or collection means. These channels form discrete, exposed areas of drug composition or drug delivery means, surrounded by the adhesive. The drug contained in the device does not need to pass through the layer of adhesive before contacting the underlying skin. In one arrangement, particularly suitable for delivery of macromolecular drugs, the channels extend through the entire thickness of the adhesive layer, and communicate with reservoirs of drug."

Plain-language overview of the disclosed invention

The core insight is a drug-in-adhesive problem solved by perforating the adhesive:

• Conventional transdermal patches force the drug to diffuse through the skin-contacting adhesive. That constrains adhesive choice to whatever is compatible with the drug, and makes macromolecular delivery (polypeptides, glycoproteins, ~10 kDa and up) impractically slow.
• The patent instead puts the drug in channels that pass through the adhesive layer, so the drug formulation contacts skin directly at discrete exposed openings, while the surrounding adhesive still holds the patch in intimate, continuous contact.
• The channels may be lined (e.g., silicone tubing) to isolate the drug from the adhesive, may contain porous plastic/fibrous "frameworks" or depot bodies, may extend to a reservoir above the adhesive, and may be capped by a porous membrane that passes air but not liquid (to prevent vacuum lock as drug is absorbed).
• Drug can be supplied wet (solution/suspension/gel reservoir) or dry in a depot body that is hydrated immediately before use (longer shelf life for unstable biologics such as erythropoietin), including a two-pouch "lidded pouch" activation system (FIG. 6).
• Descending embodiments use dimpled thermoformed sheets with the dimple bottoms cut away to create lipped wells that hold and position cylindrical or disk-shaped depots (FIGS. 10–15), which also enables continuous, high-speed manufacture (FIGS. 18–20).
• The device is explicitly bidirectional: the same channel/adhesive architecture is described for substance collection (e.g., glucose monitoring, drug-use screening) and, separately, for iontophoretic delivery.

Independent claims — plain-language reconstruction (not verbatim)

Based on the summary-of-invention passage, which is written in claim language and appears to track the independent claims, there appear to be at least two independent claim families:

1. Device claim (apparatus) — A topically applicable substance transfer device for transdermal/topical transfer of substances to and from a living body, having an inner (body-contacting) surface, comprising:

• a layer of skin-compatible adhesive with an inner body-contacting surface;
• at least one channel extending through the entire thickness of the adhesive layer, having an inner opening at the body-contacting side that is not obstructed by adhesive, and an outer opening;
• a substance depot in liquid communication with the inner opening of the channel and adapted to transfer substance to and from that opening;
• the inner surface of the device being composed of discrete areas: the channel's inner opening, and the adhesive layer's inner surface.

1. Process/method claim(s) — Directed to making the device, generating a regular array of drug depots exposed at the surface of the adhesive layer, with reproducible total exposed area from device to device (stated in the specification as necessary for predictable, controllable delivery rates). Family prosecution history for WO 1994009848 refers to process claims in the 39–53 range, but I cannot confirm US claim numbering without the claims column.

Dependent subject matter (identified in the specification) would include: multiple/lined channels; porous support matrices; semi-permeable rate-controlling membranes; dry drug depots with rupturable liquid pouches; dimpled thermoformed depot-holding sheets; iontophoretic electrodes; and collection-mode configurations.

Litigation check

• Searches of CAFC 2026 dockets and general litigation sources returned no case, IPR, or appeal involving US 5,462,743. Note the risk of confusion with the Japanese patent JP 5462743 B2 (a 2014 bumper structure) and with unrelated US applications numbered 14/274,178 — these are not the patent in question.
• The patent's own record shows anticipated expiration 2012‑10‑31, meaning it is long expired and unenforceable, so 2026 litigation activity would be legally impossible regardless.

Stated uncertainties

1. Verbatim claim text not retrieved. Claim count, exact wording, and independent-vs-dependent structure are unverified in this session. Do not rely on the overview above as a literal claim construction.
2. Assignee identity is taken from the patent record and PubChem; I did not verify whether any later chain-of-title transfer occurred after 1994 (PubChem still lists Medipro Sciences Ltd as assignee).
3. Inventor nationality flags "(CA)" come from PubChem; I did not independently verify residency.

I'll research litigation involving US patent 5462743 across patent litigation databases and court records.

Let me search more targeted litigation databases.

Let me check the Google Patents litigation tab and CourtListener directly.

Litigation Search — U.S. Patent No. 5,462,743

No litigation involving U.S. Patent No. 5,462,743 was found.

I searched for the specific patent number (both as "5462743" and "5,462,743") across general web sources, the Google Patents record, Justia Patents, PubChem's patent record, and patent-litigation-related documents (including Unified Patents, PTAB, and Docket Alarm materials surfaced in results). None of these turned up any district court action, ITC investigation, PTAB proceeding, or CAFC appeal naming the '743 patent.

What the record shows for this patent

The only "litigation-adjacent" results involving the number were:

• Prior-art citations — the '743 patent is cited as background art in later patents (e.g., US 8,481,059; US 9,259,504; EP 1,596,842; WO 2017/140017).
• Assignment records — an assignment from the inventors to Medipro Sciences Limited (recorded 1994-03-25), not litigation.
• Trademark file — Medipro's "EPITRANS" mark (Serial No. 74347567), abandoned 1994. Not litigation.

No case names, docket numbers, or court documents tying this patent to an infringement suit appeared.

Important caveats and limitations

1. My search was web-search based only. I was not able to directly query PACER, CourtListener's RECAP docket search, Lex Machina, Docket Alarm's litigation database, or the Unified Patents litigation portal case list, and I hit a research step limit before completing every planned query. Those are the authoritative places to confirm a negative.
2. The patent is old and expired (anticipated expiration 2012-10-31; status now "Expired – Fee Related"). Any litigation would necessarily predate expiration, and older, settled, or voluntarily dismissed cases from the mid-1990s through the 2000s are often poorly indexed in free web sources.
3. Absence of evidence is not conclusive proof of no litigation. A quiet or quickly settled case could exist without a publicly indexed opinion.

Recommended verification steps

To definitively confirm whether any litigation exists, I would run the following direct queries:

• CourtListener / RECAP docket search — https://www.courtlistener.com/?q=%225462743%22 (search both party names and patent number).
• Unified Patents litigation portal — https://portal.unifiedpatents.com/litigation (filter by patent number 5462743).
• PACER Case Locator — https://pcl.uscourts.gov (search "Medipro Sciences" as party).
• USPTO Patent Center / Assignment — for any recorded security interests or judgment liens.
• Lex Machina / Docket Alarm / Westlaw KeyCite — the fastest way to catch settled cases and pre-2010 filings.

Bottom line: Based on the available evidence, I found no known litigation involving U.S. Patent No. 5,462,743. I cannot state with certainty that none ever occurred, given the research limitations above, and recommend the targeted database checks listed to confirm.

I'll verify the structured data against live sources before reporting.

PTAB Activity Report — U.S. Patent No. 5,462,743

Patent: “Substance transfer system for topical application” (Turner, Murray, Zuccolin & Li; assignee Medipro Sciences Ltd., Canada)
Priority: 1992-10-30 · Filed: 1993-08-06 · Granted: 1995-10-31 · Term ended: 2012-10-31
Source of record: Google Patents U.S. 5462743 A — https://patents.google.com/patent/[US5462743](/patent/US5462743)/en

Proceedings overview

Total AIA trial proceedings on file: 0. There are no inter partes reviews, no post-grant reviews, and no covered business method reviews — active, instituted, or terminated — naming U.S. Patent No. 5,462,743 as the challenged patent. The USPTO Open Data Portal returns an empty AIA-trial set, and independent web searches for IPR/PGR/CBM petitions, Federal Circuit appeals, and E2E docket entries on this patent number likewise returned nothing.

The bottom-line defensive posture is therefore not “the patent is hardened by surviving IPRs” and not “the claims are canceled.” It is simpler and stronger: the patent is expired and has never been tested at the PTAB. Any assertion of this patent today faces a threshold defense that has nothing to do with claim validity — the statutory term ran out on 2012-10-31, and the machine-readable status is “Expired - Fee Related.”

Proceeding-by-proceeding

None. No proceeding numbers exist to report, and I will not manufacture any. For completeness, here is the structural explanation for the empty docket, which is itself the actionable finding.

(No proceedings) — Why the docket is empty

• Type: N/A
• Filed: N/A
• Status: No AIA trial activity on file.
• Timing math (the dispositive fact): The AIA’s trial mechanisms (IPR, CBM) became available only for petitions filed on or after 2012-09-16. US 5,462,743’s term ended 2012-10-31. That left a live-patent window of roughly 45 days — from 2012-09-16 to 2012-10-31 — during which any AIA trial petition could even be directed at an enforceable claim. In practice this patent was 19 years, 10½ months into its term when IPR existed at all.
• Judge panel: N/A
• Petition grounds: N/A
• Institution decision: N/A
• Final Written Decision: N/A — no claim of 5,462,743 has ever been canceled, confirmed, or construed by the Board.
• Settlement / termination: N/A
• Appeal: N/A. No CAFC appeal exists; a search of CourtListener and docket sources for “5462743” surfaced no appellate matter.
• Defensive value: The absence of IPR activity is explained by the calendar, not by the patent’s strength. Because the patent expired on 2012-10-31 and no suit appears to have been filed within six years of that date, 35 U.S.C. § 286 now bars recovery for the entire remaining damages period — a defendant’s motion practice should turn on expiration, § 286 and Rule 12(b)(6), not on invalidity.

Two other trial mechanisms are categorically unavailable on this patent:

• PGR — created by AIA § 6(d), applies only to patents issuing from applications filed on or after 2013-03-16. US 5,462,743 was filed 1993-08-06 and is far outside that window.
• CBM — limited to patents claiming a “financial product or service” (AIA § 18(d)(1)), and sunset on 2020-09-16. A transdermal patch claiming adhesive layers with drug-delivery channels is technology, not finance; CBM was never an available vehicle here.

Pre-AIA vehicles that were available and appear unused: inter partes reexamination (available 1999-11-29 through 2012-09-16) and ex parte reexamination (any time). I found no evidence of either on this patent. This is a negative finding from web sources, not a file-wrapper-level confirmation — the only reexamination records my searches surfaced were for unrelated patents (e.g., 95/001,544, Realtime Data’s U.S. 7,400,274), and those must not be attributed to this patent.

Strategic summary

Claim status: UNTESTED — all of it. No claim of 5,462,743 has been canceled, confirmed, narrowed by certificate, or construed in a Board decision, because no AIA trial was ever instituted. That is not the same as “sustained” or “hardened.” A defendant should not argue that the claims have been upheld — they have not been examined by the PTAB at all. The correct characterization is that the entire claim set became unenforceable through expiration before the Board could ever have reached it. The bilateral family is WO 9409848 A1 (PCT/CA1993/000461, filed 1993-10-27), AU 5413894 A, CN 1089168 A (CN 93119744, filed 1993-10-30), and MX 9306790 A — none of which has any bearing on U.S. trial practice.

Estoppel landscape: irrelevant, and § 315(e)(2) gives a defendant nothing to worry about. Because no IPR or PGR was instituted, no party is subject to the § 315(e) estoppel that would ordinarily bar a petitioner from re-litigating grounds it raised or reasonably could have raised. Conversely, there is also no petitioner-side institution record for a defendant to inherit. Any prior-art challenge to this patent — whether in a district court invalidity case, an ex parte reexamination, or a declaratory-judgment action — faces no estoppel barrier. (The practical caveat: none of that matters much, because § 286 time-bars the damages case.)

Pattern signals: none. There is no repeat petitioner, no serial-IPR filer, and no defensive aggregator (no Unified Patents-style entity) anywhere in the record. Medipro Sciences Ltd. never acted as a PTAB patent owner, so there is no track record of aggressive PTAB appeals or of the patent owner conceding claims adversarially. What the record does show is that this patent is a cited reference, not an asserted asset: it appears as a prior-art/IDS citation in later hydrogel and transdermal-microprojection filings (e.g., US 8,481,059 and US 9,259,504 “Hydrogel compositions”; US 12,377,044 “Method and device for transdermal delivery of parathyroid hormone using a microprojection array,” per Justia’s citation tables), and the Chinese family member CN 1089168 A (Medipro Sciences / 梅地普洛科学有限公司) was cited in category “A” in an ISA search report on PCT/CN2016/078241 (published as WO 2017/140017 A1). Citation density in later art is a validity exposure, not a defensive upside.

Recommended next steps

1. If you are a defendant and a demand letter cites US 5,462,743, do not build an IPR strategy. There is no AIA proceeding to inherit and no live patent to attack. Plead expiration and the § 286 bar: all acts of infringement necessarily ceased by 2012-10-31, and more than six years have elapsed since that date (six years from 2012-10-31 ran out on 2018-10-31; today is 2026-09-29). Any damages claim on this patent is time-barred in its entirety. Confirm status directly from the source of record: https://patents.google.com/patent/US5462743/en (status “Expired - Fee Related”; anticipated expiration 2012-10-31).
2. Verify against the file wrapper before filing. My conclusion rests on the structured ODP block plus web searching; the absence of AIA activity is documented there, but the absence of a pre-AIA ex parte reexamination is a negative finding I could not close from public search. Pull the patent’s full file wrapper via Patent Center (https://patentcenter.uspto.gov/) and the PTAB E2E / PTAB-API docket (https://e2e.uspto.gov/ and https://developer.uspto.gov/ptab-api/) before relying on it in a brief.
3. Do not rely on the family’s other members as if they were proceedings. Nothing in WO 9409848 A1, AU 5413894 A, CN 1089168 A, or MX 9306790 A is a PTAB outcome; treat the CN “A” citation above as prior-art currency only.
4. If you are looking for a citable FWD disposition, there isn’t one. No Final Written Decision, institution decision, or appeal disposition exists for this patent, so there is no claim-level holding to quote and no PTAB E2E or CourtListener link to provide for an opinion. State that plainly rather than importing results from the unrelated matters (Realtime Data’s 95/001,544 / Appeal 2013-007871; Torrent v. Merck Frosst, IPR2014-00559; the ’609/’431 Daikin-Chemours appeals) that my searches incidentally returned.

Research caveats: Searches were run 2026-09-29 against Google Patents, PubChem’s patent record, Justia patent citation tables, PTAB-hosted documents, and general web sources. I found no AIA trial, no Federal Circuit appeal, and no district court action asserting this patent. I cannot rule out a district court suit that never generated a searchable public docket reference, and I could not independently verify the reexamination history from the file wrapper; both should be confirmed at Patent Center before you tell a client anything categorical.

I'll research the assignment record and corporate history before drafting. Let me run several targeted searches.

Let me dig into the corporate entity, litigation history, and any NPE-related activity.

Let me check the patent's front-page attorney of record and the corporate status of Medipro Sciences.

Ownership & Assignment Analysis — US 5,462,743

Patent: Substance transfer system for topical application
App.: 08/102,786 · Filed: 1993-08-06 · Priority: 1992-10-30 (CIP of 07/969,721, now abandoned) · Granted: 1995-10-31 · Status: Expired — Fee Related (anticipated expiration 2012-10-31)

Sourcing caveat (important): I was unable to retrieve the raw USPTO Assignment Center records for this patent — no reel/frame numbers, correspondent-of-record fields, or execution dates beyond what Google Patents mirrors in its "Legal Events" block are available to me. The assignment detail below comes from Google Patents' legal-events feed of the USPTO assignment database. I have not invented reel/frame numbers or correspondents; where a field is unavailable I say so explicitly. Verify at the USPTO Assignment Center and assignment.uspto.gov by searching patent number 5462743.

Inventors

Unusual-pattern check: No evidence that any inventor departed the assignee within 12 months of filing. The four inventors jointly executed the assignment to Medipro Sciences, recorded 1994-03-25 (~7 months post-filing, ~19 months post-priority). That is a routine employee/contractor confirmatory assignment, not a distressed-divestiture signature. I have no data on inventor departure dates; call that unclear, not absent.

Original assignee

Medipro Sciences Limited (also styled "Medipro Sciences Ltd"), 466 McNicoll Avenue, Willowdale, Ontario M2H 2E1, Canada (address per the parallel EP prosecution file).

• Primary line of business: small Canadian biomaterials / wound-care developer. Its patent estate is wound-dressing centric — hydrogel-forming wound dressings and skin coatings (US 4,920,158), coprecipitated polymer-complex adhesive coverings (EP 0 544 778 / AU 649,475), and this transdermal/topical substance-transfer patch.
• Did they ship a product embodying the claims of '743? Not established. The company clearly had a wound-dressing product line, but I found no commercial transdermal-patch product reading on the '743 claims, and no marketing collateral, 510(k), or package insert tying a Medipro patch to this patent. The Examples are all in vitro / hairless-guinea-pig bench work.
• Current status: Unclear / effectively defunct. No evidence of active operation surfaced. The strongest circumstantial indicator is that the entire '743 term was allowed to lapse for failure to pay maintenance fees (Google Patents: "Expired - Fee Related," anticipated expiration 2012-10-31) — an owner that is still commercially exploiting a patent rarely abandons it mid-term for non-payment. I could not confirm dissolution, acquisition, or bankruptcy; treat status as unverified rather than "dissolved."

Assignment timeline

Only one assignment event is recorded in the sources available to me. Full record as retrievable:

• 1994-03-25 (recorded) — Reel/Frame [not retrievable from available sources — see caveat above]
  • Conveyance: Assignment of Assignors' Interest (per Google Patents legal-events wording: "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
  • Assignors: Turner, Josephine S.; Li, Ruey Seng; Murray, D. Gary; Zuccolin, John D.
  • Assignee: Medipro Sciences Limited
  • Correspondent: Not available. I could not retrieve the attorney/agent who filed the recording. (Note for the record, but not a substitute: the EP family representative of record was Geoffrey Corlett Woods, a Canadian patent agent — that is a prosecution agent on the EP counterpart, not the US assignment-recording correspondent, and should not be reported as one.)
  • Context: Confirmatory inventor-to-company assignment (employment/consultancy vesting), executed pre-grant. Not a fire-sale, reorg, securitization, or transfer-to-asserter.

No other recorded assignments appear: no merger, no change of name, no security agreement, no release, no correction, and — critically — no post-issuance transfer to any third party. The patent appears to have remained with Medipro Sciences Limited from 1994 until the fee lapse in 2012. If the Assignment Center shows additional reel/frame entries, they post-date my retrievable data and should be added.

Timeline diagram

timeline
    title Ownership of US 5462743
    1992 : Priority application filed
    1993 : CIP application filed
    1994 : Inventors assign to Medipro Sciences
    1995 : Patent granted
    2012 : Patent lapses for unpaid fees

NPE / troll-pattern signals

1. Shell-entity transfer — not present. No assignment to any "IP / Patents / Licensing / Holdings / Ventures" entity is recorded. The sole transfer runs inventors → operating wound-care company.
2. Known asserter in the chain — not present. Neither Medipro Sciences Limited nor any successor appears on the Acacia / Marathon / Intellectual Ventures / IPNav / Wi-LAN / Conversant / Vringo / Pendrell / Innovatio / MPHJ / Lumen View / Round Rock / Document Generation / Spangenberg lists. No RPX or Unified Patents "high-frequency plaintiff" hit surfaced for this patent or its owner.
3. Repeat correspondent across the chain — not present / unevaluable. With only one recorded event and no retrievable correspondent field, there is no recurrence to test. This signal is not established, not "cleared."
4. Cascading transfers — not present. One recorded assignment in the entire 18-year term; no chained LLC hopscotch.
5. Pre-litigation transfer — not present. No infringement action naming US 5,462,743 was found. I checked litigation sources and every "'743" decision surfaced belongs to an unrelated patent — Schering's K-Dur patent US 4,863,743, a NuVasive '743, a Novartis '743, etc. There is no suit, therefore no transfer preceding one.
6. Bankruptcy fire-sale — not present. No Chapter 7/11 proceeding or court-supervised patent sale involving Medipro surfaced. The 2012 outcome was a fee lapse, not a docketed sale.
7. Privateering — not present. No operating-company-to-NPE transfer; nothing in any SEC filing (there are no SEC filings — Medipro is a private Canadian company) evidences an assertion arrangement.
8. Defensive aggregator (anti-NPE) — not present. Chain does not terminate at RPX, AST, LOT, Unified, or OIN. The chain terminates in abandonment.

Verdict

Insufficient data — only the original assignment is of record.

The entire documented chain is a single pre-grant vesting assignment, executed and recorded 1994-03-25, of Josephine S. Turner, Ruey Seng Li, D. Gary Murray, and John D. Zuccolin to Medipro Sciences Limited of Willowdale, Ontario — the original assignee named on the face of the patent. No subsequent transfer, security interest, merger, or assertion appears in any source I could reach, and no infringement suit naming this patent could be found; the only "'743" litigation in the wild involves unrelated patents. The one affirmative datapoint about end-state is the 2012-10-31 fee lapse, which indicates the original assignee simply let the patent die rather than monetizing or asserting it — the opposite of an NPE profile. This is not a clean bill of health (the assignment-center correspondent fields were unavailable to me, so signal 3 is simply untested), which is why the verdict is "insufficient data" rather than "defensive / non-asserting."

Verify at: https://assignmentcenter.uspto.gov/ (search 5462743) — and cross-check https://patents.google.com/patent/US5462743/en (Legal Events) for any posting after this analysis.

I'll search for the specific patent and its cited prior art.

Let me dig into the specific citation lists for this patent.

Let me search for the front-page patent citations more specifically.

Analysis: US Patent 5,462,743 — "Substance Transfer System for Topical Application"

1. Confirmation of the Patent Identified

Disambiguation note (per the literal-interpretation rule): A separate, unrelated document — JP 5462743 B2 (a Japanese granted patent concerning a bumper structure, published 2014-04-02) — shares the same numeric string "5462743". It is not the subject of this analysis and must not be conflated with US 5,462,743. Likewise, "5462745" (Enscore et al.) appears alongside it in citation tables but is a different patent.

2. Important Limitation on Source Data

I must flag a material gap rather than fabricate around it:

• The authoritative full text supplied for this task includes the abstract and description (truncated mid-sentence) but does not include the front-page "References Cited" / "Patent Citations" list (the examiner-cited U.S. and foreign patent documents) or the granted claim set.
• My web searches of Google Patents, Justia, and PubChem for US 5,462,743 returned the bibliographic data, classification (CPC A61K9/7084, A61F13/02, A61K9/70), the family members, and the forward citations ("Cited By"), but not the examiner's back-citation list.
• I therefore cannot state with high confidence the complete, literal list of examiner-cited references on the 5,462,743 front page. The references below are those I can verify from the record; anything else would be speculation.

3. References I Can Verify From the Record

3.A — Prior art cited by the applicants in the specification (by name)

3.B — Non-patent literature cited

3.C — Reference cited during prosecution of the PCT counterpart (WO 94/009848 A1)

⚠️ The specific string is recorded in the record only as "DE-U-870…". Treat the truncated number literally as provided and do not auto-complete it.

3.D — Not prior art (listed to prevent confusion)

The following are forward citations ("Cited By") — later documents that cite 5,462,743. They are not prior art against it and cannot anticipate it:

• US 5,558,664 A (Sarzaud, 1996)
• DE 19849823 A1 (Lohmann Therapie-Systeme, 2000)
• DE 10121471 A1 (Beiersdorf, 2002)
• US 8,604,076 B2 (UCB Pharma, 2013)
• WO 2017/216633 A1; GB 2 579 651 A; EP 4 356 885 A1; EP 4 356 884 A1

4. Anticipation Analysis Under 35 U.S.C. § 102

For anticipation under § 102, a single reference must disclose every element of a claim, arranged as in the claim. My assessment is necessarily provisional, because (i) the granted claims of 5,462,743 were not in my source material, and (ii) the complete examiner citation list could not be retrieved.

Against the references I could verify:

Functional summary of the § 102 landscape:

• The novelty-defining feature of 5,462,743 is the discrete channel passing through the entire thickness of the skin-compatible adhesive layer, surrounded by adhesive, providing a path by which drug contacts the body surface without diffusing through adhesive (abstract; FIG. 1 channel 20; claim language "the inner surface of the device being comprised of discrete areas constituted respectively by the inner opening of said at least one channel and by the inner surface of said adhesive layer").
• None of the verified references 1–4 discloses that limitation. Accordingly, on the verified record, no § 102(a)/(b)/(e) anticipatory reference can be confirmed for the channel-through-adhesive claims.

5. Honest Statement of What I Could Not Determine

Per the operating rule to state uncertainty explicitly rather than fabricate:

1. I could not retrieve the front-page examiner citation list ("References Cited") for US 5,462,743. Any claim-by-claim § 102 anticipation mapping to examiner-cited patents would be guesswork and I am not supplying one.
2. I could not retrieve the granted claim set of 5,462,743 (the supplied text truncates during the Background/Description). Claim-by-claim anticipation mapping therefore cannot be performed rigorously.
3. The full identity of the "DE-U-870…" reference is incomplete in the available record. I have not auto-completed the number.
4. The searches I ran returned Google Patents, Justia, PubChem, and EPO/WO family data — not a USPTO PatentCenter "References Cited" extract. If you need the definitive examiner citation list, the authoritative source is the USPTO PatentCenter / USPTO Assignment record for application 08/102,786 (linked from the patent page).

Recommended next step to close the gap: pull the front page of the granted patent (PDF) or the USPTO PatentCenter "References Cited" tab for application 08/102,786; that will yield the literal examiner-cited U.S. and foreign patent documents, at which point a defensible claim-by-claim § 102 table can be produced.

I'll start by checking what prior-art references are actually associated with this patent, since the fetched page includes "prior art keywords" but I want to ground the specific reference list.

Let me look for the actual examiner-cited prior art list on the patent's Google Patents/EPO pages.

I have the family, but not the examiner's cited-reference table. Let me try to pull the actual citation list and the PCT search report for the family.

I've hit my tool-call budget, so here is the analysis — with an important caveat about the record first.

Obviousness Analysis — US 5,462,743 (35 U.S.C. § 103, pre‑AIA)

1. What the "Prior Art" section of this record actually contains — and what it does not

Before analyzing, I have to be precise about the evidentiary base, per my operating rules.

What the fetched page gives me:

• A "Prior art keywords" field: drug, skin, adhesive, channels, layer, drug delivery, liquid, adhesive layer, communication, fluid, material, barrier function, plastic, solid, method, foam, membrane, matrix material, drug formulation, diffusion process, filler, particle (source: US5462743A on Google Patents).
• A CPC/IPC classification set including A61K9/7084 ("Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers"), A61K9/7092 (multiple drug layers or reservoirs), A61F2013/00646, A45D2200/1045.
• The specification's own admissions and named references (US 4,920,158 Murray et al.; U.S. Ser. Nos. 07/920,665 and 07/973,101, both Murray et al., both now abandoned; Siegel & Langer, Pharm. Res. (1984)).

What the fetched text does not contain: the examiner's "Patent Citations" table. The page was retrieved as a definitions/keywords dump; no numbered US/EP/JP/WO citation list, and no PCT/CA1993/000461 search report, appears in it. My searches surfaced family and citation-by data but not the examiner's cited-art list for this patent.

Consequence: I will not invent reference numbers or attribute specific disclosures to specific patents I cannot verify. Where I name a reference, I flag my confidence. Where I reason from art categories (which the keywords and the applicant's own background section legitimately supply), I say so. If you can paste the citation table, I can convert § 5–12 below into a reference-by-reference mapping with claim charts.

2. The claim construct to be tested (§ 103 analysis requires the claims)

The claims themselves were not included in the fetched text. Reconstructed from the abstract and the summary passage in the record, claim 1 appears to require:

(a) a topically applicable substance transfer device having an inner (body-contact) surface;
(b) a layer of skin-compatible adhesive with an inner body-contact surface and at least one channel extending through the entire thickness of the adhesive layer;
(c) a substance depot in liquid communication with the inner opening of the channel, adapted to transfer substance to and from that opening (i.e., delivery and collection);
(d) the device's inner surface being discrete areas — the channel opening(s) and the adhesive's inner surface — such that no adhesive lies between the depot and the body surface.

Dependent features indicated in the record: plurality of channels; channel as the sole reservoir; liners around channels; porous/capillary matrices; dimpled thermoformed sheet with cut‑away dimple bottoms; rate-controlling/semipermeable membrane; dry-drug reservoirs activated just before use; and iontophoretic use.

Critical-date nuance: This is a CIP of Ser. No. 07/969,721 (filed 1992‑10‑30). Claims supported only by matter added in the Aug 6, 1993 CIP (e.g., the FIGS. 14–20 well/lip/dimpled-sheet and lidded-pouch structures) get an effective filing date of 1993‑08‑06, which shifts the § 102/§ 103 window and admits mid‑1993 art against those claims.

Also note: Ser. No. 07/973,101 (Murray et al., filed 1992‑11‑02) post-dates the 1992‑10‑30 priority date. It is not prior art to the parent claims; whether it is usable against CIP-only claims depends on the 1993‑08‑06 date. Ser. No. 07/920,665 (filed 1992‑07‑28) is prior-dated, is commonly owned by Medipro, and was, pre‑AIA, not shielded by § 103(c) to the extent it qualifies as a § 102(e) reference (pre‑AIA § 103(c) reached only § 102(f)/(g) art). Practically, it is a strong candidate reference for the "compromise the stratum corneum first" teaching.

3. Governing standard

Graham v. John Deere: (1) scope/content of prior art; (2) differences; (3) PHOSITA level; (4) secondary considerations. KSR Int'l v. Teleflex supplies the rationales: (A) combining known elements by known methods to yield predictable results; (B) substitution of a known element for another to obtain a predictable result; (C) use of a known technique to improve a similar device in the same way; (D) applying a known technique to a known device ready for improvement; (E) "obvious to try" from a finite number of identified, predictable solutions; (F) design incentives/market forces; (G) express teaching, suggestion, or motivation.

PHOSITA here: a formulator/device engineer with a pharmacy or biomaterials background and ≥2–3 years in transdermal systems, familiar with pressure-sensitive adhesive (PSA) laminates, rate-controlling membranes, blister/thermoform packaging, and (for the iontophoresis claims) electrotransport hardware.

4. The prior-art landscape

4.1 Applicant-admitted prior art (the most defensible base here)

The specification itself concedes most of the structural genus:

These admissions alone collapse the hardware novelty: dimpled thermoform stock, PSAs, barrier films, semipermeable membranes, and blister sealing are all expressly acknowledged as known.

4.2 Named / verified references

Explicit limitation: I cannot confirm which references the examiner actually cited. Anything below labeled "Candidate" needs a disclosure check.

5. Combination 1 — The core claim: apertured/adhesive-free drug path

Proposed combination: [A] a conventional reservoir-type transdermal laminate (backing + PSA + drug reservoir, per the applicant's admitted art) + [B] a reservoir-to-skin passage through the adhesive, as taught by a "channels through skin" reference such as Gerstel-type art or by the general apertured-web/blister art.

Why a PHOSITA would combine: The specification states the precise problem: the adhesive layer "should not deleteriously interfere with the drug's properties, nor with its migration to the skin surface," and macromolecular diffusion "through conventional skin adhesives is normally too slow to be therapeutically beneficial," while swelling the adhesive with solvent "will impair its adhesion properties." This is a recognized, articulated problem with a known finite set of solutions: (i) permeation enhancers, (ii) solvent-swollen adhesives, (iii) increased drug loading, (iv) remove the adhesive from the diffusion path. Option (iv) is the mechanically simplest and requires only a punching step on a known laminate — a known technique (aperturing) applied to a known device ready for improvement (KSR rationale D), yielding the predictable result that the drug contacts skin directly with higher flux.

Anticipation of the counter-argument: The patentee will argue that prior channeled devices used rigid skin-penetrating elements, whereas claim 1 uses channels through the adhesive itself with the adhesive forming the continuous body-contact surface. That is a dimensional/structural difference, not a functional one, and KSR rationale C (using a known technique to improve a similar device in the same way) squarely applies. This is likely the weakest set of claims — anything reciting merely "at least one channel through the entire thickness of the adhesive layer in communication with a depot."

6. Combination 2 — Porous/capillary matrix or liner in the channel

Candidate combination: Combination 1 + known open-cell foam, porous plastic (sintered HDPE), fibrous mat, or a tubing liner occupying the channel.

Motivation: The record itself frames the choice as routine: "the drug solution… may be held in the channel in a suitable support such as a porous plastic, open cell foam, pad, fibrous mat etc., chosen in each individual instance with consideration to the viscosity and surface properties of the drug formulation." That is a textbook recitation of routine optimization of a known material to a known use (§ 103 obviousness; KSR rationale B). Porous plastics for liquid retention (Porex-type sintered HDPE) and open-cell foams were commodity materials, and the art of Example 4 (Hydrophilic HDPE, Porex No. X‑4899/X‑4916) is cited as off-the-shelf.

Note also: Channel liners made from silicone tubing are described in Example 1 as Silastic No. 602‑155 — a commercially standard medical-grade tube. Using a tube as a barrier between a reservoir and a PSA is a simple substitution for a pre-formed aperture wall (rationale B).

7. Combination 3 — Dimpled/cut thermoform sheet as the depot holder (FIGS. 10–15)

This is where the § 103 case is strongest, thanks to the applicant's own admission:

"dimpled sheets with a pill sealed in each dimple are widely used in the pharmaceutical industry. They can be created by forming a thermoplastic film at a temperature at which the thermoplastic is soft. They can be vacuum or pressure formed into a mold with depressions… They can be cold formed."

Proposed combination: (i) admitted prior-art blister/dimpled thermoformed sheet (unit-dose packaging; also used as a drug-holding array) + (ii) admitted prior-art skin-compatible PSA laminate + (iii) Combination 1's perforate-to-register step.

Motivation/rationale: (C) known technique (thermoform + register-perforate + laminate) to improve a similar device in the same way; (D) a known device (blister web) ready for improvement — the specification concedes the purpose: "FIGS. 10 and 11… take advantage of the easy manufacture and availability of dimpled thermoplastic sheets by the pharmaceutical industry for drug packaging purposes." Using an available, cheap, array-formatting web as the depot carrier to obtain reproducible depot geometry and total skin-contact area is exactly the predictable use of a known article. The patent's own stated goal — "each specific device… has substantially the same total skin contact area of all the drug delivery depots" — is a manufacturing-tolerance objective, a classic design incentive (rationale F).

Cutting the dimple bottoms to open them (§ FIG. 12) and leaving inwardly protruding lips to retain the depot (FIG. 13, lip 118/120, ~0.5 mm) are likewise mechanical expedients: the record describes them as "readily accomplished by passing the sheet over a stationary knife." A knife-cut to a desired height is not an inventive contribution.

8. Combination 4 — Rate control

Candidate combination: any of Combinations 1–3 + a semipermeable or microporous rate-controlling membrane (e.g., EVA, microporous PE, silicone) between reservoir and channel mouth.

Motivation: The record itself states the two classical mechanisms: "the rate of drug delivery can be maintained constant by placing a semi-permeable membrane around the drug reservoir layer or body," and a saturated solution containing undissolved drug sustains zero-order flux. Both are textbook Higuchi/zero-order reservoir design. The Example 5 device uses CoTran #9710 microporous PE (3M) and Cotran #9872 PGTA transfer adhesive — again off-the-shelf. The result (constant release rate) is predictable (rationale A/B).

9. Combination 5 — Iontophoretic embodiments

Candidate combination: a channeled-reservoir patch (Combinations 1–3) + a bioelectrode/pouch with a semipermeable membrane and an electrode, as in US 4,250,878 (Jacobsen) + a remote grounding electrode.

Motivation: Iontophoresis was a mature art by 1992 (the EP 0011813 search report fetched here lists Jacobsen's bioelectrode and several earlier electrodelivery patents from 1937–1981). A PHOSITA seeking to drive a charged macromolecule (e.g., dexamethasone sodium phosphate — used in this patent's own Example 6) would foresee that placing an electrode in contact with a liquid-filled depot increases flux; that is the entire premise of iontophoresis. Substituting the patch's reservoir as the iontophoretic donor compartment is rationale B, with a predictable result.

Caveat for the § 103 case: if any claim recites a specific structural interrelation between the electrode and the channel array (e.g., electrode contacting the depots through a cap sheet while air spaces 136 vent), there is a modest non-obviousness argument. But the record's own Example 6 simply lays a commercial Trans Q1/Q2 reservoir pad on top of the 12-depot patch — which reads as an admission that the combination was routine.

10. Combination 6 — Substance collection (reverse flux)

Claim 1(d) is drafted bidirectionally ("transfer substance to and from said opening"), and the abstract/claims encompass fluid collection.

Obviousness position: Once the structural genus (channel through adhesive → depot) is established, the reversal is a change of direction of a concentration gradient, not a change of structure. A PHOSITA monitoring blood analytes would foresee that the same diffusion path operates outward. The record itself reasons this way for both passive migration and convective/iontophoretic extraction.

Strongest patentee counter-argument (this claim set has the best survival odds): the enabling requirements differ materially — collection requires (a) preventing evaporative loss from the collection depot, (b) avoiding back-diffusion of analyte into skin, (c) biocompatibility/sterility over days, (d) larger effective sampling area, and (e) correlation/calibration to blood levels. If the claims require anything beyond the bare structural reversal — e.g., a sealed collection reservoir, a specified geometry for convective glucose collection, or automatic electronic feedback to insulin dosing — the § 103 attack weakens considerably. The bare "derived from the delivery embodiment by reversing flow" claim is, however, vulnerable under rationales C/E.

11. Combination 7 — Hyaluronic acid as carrier / targeting

The spec asserts HA "with molecular weight of approximately 500,000 daltons, is apparently able to penetrate intact skin and to carry with it drug incorporated therein," and that HA "preferentially accumulates" in stressed tissue.

Position: HA–drug association (ionic/physical, non-covalent) and HA's targeting to arthritic/inflamed/surgical sites was known before 1992 — the search results surfaced contemporaneous HA-associate art, e.g. Richter Gedeon's "Compositions containing hyaluronic acid associates" (US 6,458,774, priority 1989‑02‑24) and Falk's HA-related family (CA 1,340,994, priority 1989‑09‑21). However, I flag these as low-to-medium confidence without disclosure review, and note the absence of a verified record citation. If HA is claimed as a specific transdermal carrier, the § 103 case turns on whether the skin-penetration of high-MW HA was known — which the specification hedges with "apparently," suggesting the patentee itself did not consider it established. That hedge is a double-edged sword: it undermines the patent's own support and suggests the applicant believed the point was not well established.

12. Summary: likely outcomes by claim type

Secondary considerations to probe (none appear in the record): unexpected results (does channel-based delivery of a ≥10 kDa macromolecule actually work? — the record's own tests were on dextran and model compounds on stratum-corneum-removed hairless guinea pig skin, not on a therapeutic macromolecule on intact human skin); long-felt need (macromolecular transdermal delivery was a recognized unmet need); and commercial success. Note the record's candid admission that "Less than ideal intimate contact between the adhesive and the epidermal surface of the skin was achieved throughout the period of the testing" — mitigating the strength of any unexpected-results argument.

13. Verification checklist before this becomes an office-action-grade position

1. Obtain and paste the examiner's Patent Citations table and the PCT/CA1993/000461 search report — I could not retrieve either. Several "Candidate" references above would likely become "Primary."
2. Confirm the actual claim set — the claim text was absent from the fetched record, so § 12 maps onto a reconstructed claim 1.
3. Verify the disclosure of US 3,964,482 (Gerstel) and US 5,088,978 (Gensia) — both are prior-dated relative to 1992‑10‑30 and both are potentially closer art than anything in the applicant's admitted background.
4. Resolve the effective date per claim (1992‑10‑30 vs. 1993‑08‑06) before asserting any particular reference against CIP-only subject matter.
5. Address Ser. Nos. 07/920,665 and 07/973,101 timing and the pre-AIA § 103(c) scope (only § 102(f)/(g) art shielded in 1992–93; note the post‑1999 amendment does not apply retroactively to these).

Bottom line: On the structural core — an apertured skin-adhesive layer with a depot communicating through it so that no adhesive intervenes between drug and skin, plus the dimpled-thermoform depot array and the rate-controlling membrane — the claims appear highly likely to be obvious under § 103, largely because the specification itself concedes the individual elements and the motivation (adhesive interference with macromolecular flux). The most defensible claims are those reciting collection-specific sealing/feedback features and any claim whose enabling data is confined to the CIP's Aug 1993 disclosures.