Patent: 8,697,193

Summary for Patent: 8,697,193

Title:	Process and apparatus for coating a porous substrate with a coating liquid
Abstract:	An engagement head for engaging a porous substrate includes at least two pin sets, each pin set including a plurality of pins arranged in a plurality of parallel pin rows at a predetermined pin angle, wherein pins of immediately neighboring pin rows are arranged such that pin angles for the pins in a pin row are inversely symmetrical to pin angles for the pins in a neighboring pin row. The pins of a pin row move collectively in the same direction when a pin set is extended, which direction is determined by the pin angle of the pin row, whereby neighboring pin rows move in opposite longitudinal directions from one another when the pin set is extended. The pin sets may be extended and retracted in unison by a single actuation source.
Inventor(s):	Dey; Clifford (Riegelsville, PA), Bohn; Markus (Stuttgart, DE), Schacht; Hans-Steffen (Grosserlach, DE), DeAnglis; Ashley P. (Skillman, NJ), Van Holten; Robert W. (Flemington, NJ), Looney; Dwayne (Flemington, NJ), Llanos; Gerard (Stewartsville, NJ), Brandes; Avner (New York, NY)
Assignee:	Ethicon, Inc. (Somerville, NJ)
Application Number:	13/775,761
Patent Claims:	see list of patent claims

Patent US8697193: What Process Claims Cover for Uniform Coating of Porous Substrates, and How Strong Is the US Patent Estate Around the Technology?

US Patent 8,697,193 centers on a controlled, sensor-verified coating process for porous substrates using an engagement head with extendable pins arranged in parallel pin rows with inversely symmetrical pin angles in neighboring rows. Dependent claims narrow to an oxidized regenerated cellulose fabric matrix embedding polyglactin 910 fibers and a fibrinogen-thrombin suspension in hydrofluoroether solvent. The core claim is a manufacturing-method combination: load a porous substrate in a coating vessel using an evenly engaged pin array, verify engagement uniformity with a sensor array, then deposit coating liquid and release the substrate with the pins retracted to achieve uniform coating.

Because the claim language you provided is specific and operational, the patent landscape is evaluated as follows: (i) mechanical fixturing and uniformly releasing porous carriers via pin arrays in defined angled row symmetry; (ii) sensor-array feedback to verify engagement uniformity during transfer into a coating vessel; (iii) coating a porous oxidized regenerated cellulose/polyglactin 910 scaffold with a fibrin sealant suspension in a hydrofluoroether solvent.

What patents protect “uniform coating of a porous substrate” using a pinned engagement head with angled pin-row symmetry?

Direct answer: The novelty in US 8,697,193 is not only a “coating method,” but a particular apparatus-assisted process structure combining extendable/retractable pins, fixed geometric pin-angle symmetry across adjacent rows, and sensor-array verification before pouring coating liquid and releasing the substrate for uniform coating.

Independent claim 1 elements and claim construction-critical features

Claim 1 is a step-by-step process tied to specific apparatus structure. Courts typically treat these as limiting, not optional. The main limiting features are:

1. Apparatus and engagement head structure

   • “plurality of extendable and retractable pins”
   • “disposed in a coating vessel”
   • pins arranged in “a plurality of parallel pin rows”
   • each row has pins at “a predetermined pin angle”
   • neighboring pin rows have “pin angles… inversely symmetrical” relative to neighboring rows

2. Process flow anchored to transfer and release

   • extend pins to engage substrate
   • lift substrate out of coating vessel
   • verify “evenly engaged” using sensor array
   • pour coating liquid into the empty vessel
   • lower engaged substrate to “release position”
   • retract pins to “release… evenly into the coating vessel” to enable uniform coating

3. Sensor-array verification

   • “verifying that the substrate is evenly engaged using the sensor array”

Implication for patent scope: An accused process must use:

• an engagement head with retractable pins arranged into parallel rows with the inverse symmetry relationship between adjacent rows’ pin angles, and
• a verification step using a sensor array to confirm even engagement, and
• the coating-liquid pour while the substrate is in an engaged/lifted state followed by lowering and pin retraction for release.

Likely narrowness levers (what could be designed around)

Even if an accused system uses a pin-based handling mechanism, infringement depends on meeting the geometric and process-logic limitations:

• If pin-row angles are not “inversely symmetrical” between adjacent rows, an accused device may avoid claim 1 (depending on claim interpretation of symmetry and whether “inversely” requires angle mirror properties).
• If there is no sensor-array verification step, even with uniform manual placement, claim 1’s verification language is a likely non-infringing gap.
• If the process does not match the pour-and-release sequence, a method that pours coating liquid into the vessel first and then immerses or docks the substrate could avoid the literal sequence, unless claim interpretation treats sequence as non-limiting (generally it is limiting because steps (d) through (g) are specific).

Landscape framing

The relevant competitive IP clusters are typically found in:

• medical device or surgical scaffold coating workflows,
• robotic or semi-automated coating fixtures,
• apparatus-assisted immersion, dip-coating, and controlled-release into coating vessels,
• metrology/sensing for fixturing uniformity during coating.

But the inverse-symmetry pin geometry and sensor-verified even engagement are uncommon enough that the patent most likely attacks a specific industrial coating platform.

How do the dependent claims 2 and 3 narrow infringement exposure to specific fibrin-based coating formulations and specific substrate composition?

Direct answer: Dependent claims 2 and 3 likely shrink enforceability to specific combinations: (1) an oxidized regenerated cellulose fabric matrix embedding polyglactin 910 fibers, and (2) a coating liquid that is a fibrinogen-thrombin suspension in hydrofluoroether solvent.

Claim 2: oxidized regenerated cellulose + embedded polyglactin 910 fibers

Claim 2 requires the porous substrate to be:

• “flexible fabric matrix”
• “oxidized regenerated cellulose fabric backing”
• with “polyglactin 910 fibers… embedded”

This is a materially specific scaffold. In enforcement terms, claim 2 can be used to block competing processes if they coat the same class of substrate with the same method. A design-around is possible through substrate substitution (different biodegradable fibers, different oxidized regenerated cellulose formulation, non-fabric scaffolds, or non-embedded fiber architectures).

Claim 3: coating liquid is fibrinogen-thrombin in hydrofluoroether solvent

Claim 3 requires the coating liquid to be:

• “suspension formed by suspending human fibrinogen and human thrombin”
• in a “hydrofluoroether solvent”

This locks down the coating chemistry: fibrinogen plus thrombin in a hydrofluoroether carrier. If a competitor uses:

• a different carrier solvent,
• lyophilized/rehydrated systems with different intermediate steps,
• buffers or aqueous systems,
• non-human proteins,
• a different fibrin sealing composition, they can fall outside claim 3.

Key litigation-style note on dependent claims

A dependent claim limits the independent claim. An accused infringer that practices claim 1 features but with a different substrate or coating liquid may avoid claims 2 and 3 but still possibly be vulnerable under claim 1. Conversely, if a competitor uses claim 2/3 materials but not the inverse-symmetry pin structure or sensor verification, then it may avoid claim 1.

When does US 8,697,193 lose patent exclusivity in the US?

Direct answer: US 8,697,193 is a granted US patent; its enforceable term is determined by filing date and application status at the time of grant. Without the application filing date, priority data, terminal disclaimers, and any patent term adjustment (PTA) or patent term extension (PTE), no exact expiration date can be produced from the provided information alone.

Because your request requires an exclusivity timeline and expiration dates, and those cannot be calculated reliably from the claim text, a complete and accurate exclusivity answer cannot be provided.

What is the Orange Book status of US 8,697,193 and which FDA-approved products map to the claimed substrate and fibrin coating system?

Direct answer: US 8,697,193 cannot be mapped to an FDA Orange Book listing, because Orange Book status requires linking the patent to an NDA/BLA and listed drug product(s). That linkage is not derivable from the claim text alone.

A complete and accurate response would require the Orange Book patent listing table for the relevant application(s), which is not provided in the input.

How strong is the patent estate for this coating method: mechanical/fixturing claims versus formulation/substrate-specific claims?

Direct answer: The strength splits into two different enforcement regimes.

Regime A: Process mechanics (claim 1) is likely the broader enforcement hook

Claim 1 covers:

• apparatus-assisted engagement with pins arranged in a structured inverse-symmetry pattern,
• sensor-array verification of even engagement,
• a specific transfer and release sequence tied to pouring the coating liquid.

Strength factors that improve enforceability:

• explicit apparatus limitation tied to the method steps,
• multiple limiting features in combination, not a single broad “coating process.”

Strength factors that may reduce enforceability:

• the scope may be narrowed to a particular geometry (“inversely symmetrical pin angles”),
• the necessity of sensor verification could be argued away if interpreted narrowly or if competitors implement different verification methods not matching “sensor array.”

Regime B: Claims 2 and 3 are formulation/substrate-specific, improving novelty but narrowing coverage

• Substrate specificity (oxidized regenerated cellulose fabric + embedded polyglactin 910 fibers) narrows to a particular scaffold class.
• Solvent/formulation specificity (human fibrinogen + human thrombin suspension in hydrofluoroether solvent) narrows to a specific composition.

Strength factors:

• high likelihood of distinguishing prior art if competitors use aqueous systems or different carrier solvents,
• strong argument against “mere functional” similarity because the claim requires material definitions.

Weakness factors:

• competitors can change substrate and solvent without changing fixturing mechanics.

What prior art most directly challenges claim 1’s combination of angled pin rows and sensor-array verification?

Direct answer: The most likely invalidity targets are prior art coating/handling systems combining (i) mechanical fixturing with arrays of pins, (ii) angular or patterned engagement to reduce substrate warping, and (iii) some feedback mechanism to verify substrate positioning or engagement.

Likely invalidity themes to look for in the record

Without searching the patent record, only the themes can be stated:

1. Pin-array fixturing for porous carriers
   • prior art for dip-coating, spray coating, spin coating, or fluid deposition using pin supports
2. Geometric patterns to ensure uniform contact
   • angled pins, staggered pin patterns, or symmetrical arrangements to distribute forces
3. Sensors used to verify positioning
   • optical, capacitive, tactile, load-cell, or vision-based verification used for fixturing during manufacturing
4. Coating vessel sequence
   • removing a substrate from a vessel, dispensing coating liquid into an empty vessel, then immersing or releasing back for uniform coating

Critical novelty pinch point

The standout novelty is the inverse symmetry between neighboring pin rows, coupled with sensor-array verification before pouring. If prior art lacks either:

• the inverse-symmetry geometric requirement, or
• the sensor-array verification of even engagement, then claim 1 may be harder to invalidate on a single reference.

If multiple references can be combined, then obviousness risk rises if:

• one reference teaches inverse symmetry pin arrays for uniform engagement, and
• another teaches sensor verification, and
• a third teaches the specific coating vessel pour/release workflow. But that depends on what the record actually contains.

What patent litigation or Paragraph IV challenges affect US 8,697,193?

Direct answer: The question requires known litigation dockets, parties, and outcomes. Those facts are not in the prompt, and they cannot be generated from the claim text alone in a way that would be complete and accurate.

What generic entry risks exist for the claimed technology (method patents and coated medical scaffolds)?

Direct answer: Method patents do not map to FDA “generic” entry in the same way as composition-of-matter patents. The risk framework is:

• If a generic or biosimilar process practices the same method steps while using the same scaffold and coating liquid compositions, exposure to process infringement is possible.
• If competitors change either the scaffold composition (claim 2) or solvent/formulation system (claim 3), dependent claims are harder to enforce.
• If competitors modify apparatus geometry or omit sensor-array verification, claim 1 may be avoided.

But the “how likely” risk profile and whether any ANDA or 505(b)(2) filing is likely to infringe cannot be stated without identifying the mapped FDA products and their manufacturing processes.

Claim-by-claim infringement mapping checklist for US 8,697,193 (useful for freedom-to-operate and licensing)

Claim 1 mapping

• Does the accused process use an apparatus with:
  • extendable/retractable pins on an engagement head?
  • pins arranged in parallel rows?
  • a predetermined pin angle for pins within a row?
  • adjacent rows with pins at angles that are inversely symmetrical to neighboring row angles?
• Is the porous substrate placed on a platform disposed in a coating vessel?
• Is the substrate engaged by extending pins and then lifted out before pouring coating liquid into the empty vessel?
• Is a sensor array used to verify “evenly engaged” before coating liquid is poured?
• Is the engaged substrate lowered to a release position and released by retracting pins so that it uniformly coats in the vessel?

Claim 2 mapping

• Is the porous substrate a flexible fabric matrix with:
  • oxidized regenerated cellulose fabric backing?
  • polyglactin 910 fibers embedded?

Claim 3 mapping

• Is the coating liquid a suspension of human fibrinogen and human thrombin in hydrofluoroether solvent?

Key Takeaways

• US 8,697,193 enforces a coating-manufacturing sequence tied to a specific pin-array geometry: parallel pin rows with inversely symmetrical pin angles in neighboring rows.
• Claim 1 is anchored by sensor-array verification of even substrate engagement, plus a pour-then-lower-and-retract release workflow inside a coating vessel.
• Claims 2 and 3 narrow enforceability to specific substrate architecture (oxidized regenerated cellulose fabric backing with embedded polyglactin 910 fibers) and a specific coating liquid (human fibrinogen + human thrombin suspension in hydrofluoroether).
• Design-around pathways likely exist through: changing pin geometry/symmetry logic, omitting or substituting the sensor verification step, using a different porous scaffold, or using a different fibrin coating solvent system.
• A US exclusivity timeline, Orange Book mapping, and litigation/Paragraph IV assessment cannot be produced accurately from the provided claim text alone.

FAQs

1. Does US 8,697,193 cover dip coating generally or only the specific pin-row inverse-symmetry release sequence?
It is limited to the structured engagement head and sensor-verified even engagement plus the specific lift-pour-lower-release sequence.

2. Can a coating process that uses pinned fixturing but no sensor array still infringe claim 1?
Claim 1 requires verifying even engagement using a sensor array, so a process without that verification step is outside the literal claim language.

3. If a competitor uses the same oxidized regenerated cellulose/polyglactin 910 substrate but a different fibrin solvent, does claim 3 apply?
Claim 3 requires hydrofluoroether as the solvent/carrier for the fibrinogen-thrombin suspension, so different solvents avoid claim 3.

4. If a competitor uses the same fibrinogen-thrombin hydrofluoroether coating liquid but a different porous scaffold, does claim 2 apply?
Claim 2 requires the specific oxidized regenerated cellulose fabric matrix with embedded polyglactin 910 fibers; different scaffolds avoid claim 2.

5. Are method patents like US 8,697,193 “generic-entry” blocking like composition-of-matter patents?
The enforcement mechanism is process infringement, tied to whether the manufacturing steps are practiced by the competitor, not solely FDA approval status.

References (APA)

No sources were provided or cited in the input, and no patent record, Orange Book listing, or litigation docket information was included; therefore no numbered reference list can be generated from cited materials.

Details for Patent 8,697,193

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	January 16, 2009	8,697,193	2033-02-25
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	June 07, 2017	8,697,193	2033-02-25
Instituto Grifols, S.a.	VISTASEAL	fibrin sealant (human)	Frozen	125640	November 01, 2017	8,697,193	2033-02-25