Details for Patent: 7,316,067

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Summary for Patent: 7,316,067

Title:	Forming a perforate membrane by laser drilling and a subsequent electro-polishing step
Abstract:	A method of forming a perforate membrane (1) is disclosed for use in a liquid transport device. The membrane has at least plural nozzles (10) formed therethrough. Each of those nozzles has a throat portion (12) opening at opposite end through opposite surface (2′) of the perforate membrane and a smoothly curved outwardly diverging portion (11) extending from the first end of the throat portion to the first surface (2) of the perforate membrane. Laser energy is applied selectively to the first surface (2) of the membrane in the form of a pulsed, focused beam to form the nozzles (10) and thereafter the first surface (2) of the membrane and the surface of the diverging portion (11) of the nozzles (10) are electro-polished to remove surface imperfections. The electro-polishing is controlled so as to remove material from the surface of the diverging portion (11) of the nozzles to a depth less than the length of the throat portion (12).
Inventor(s):	David Mark Blakey
Assignee:	Technology Partnership PLC
Application Number:	US10/489,327
Patent Claim Types: see list of patent claims	Use; Device;

United States Patent 7,316,067: Claim Scope, Expiration, Litigation Risk and Patent Landscape

US Patent 7,316,067 covers the manufacture and structure of laser-drilled, electropolished perforate membranes used in liquid transport devices, including vibrating-mesh aerosol generators, pumps and filters. The central inventive combination is a pulsed focused laser process that creates a nozzle with a narrow throat and smoothly diverging entry region, followed by controlled electropolishing that removes surface defects without enlarging the throat.

The patent is a device-manufacturing patent, not a drug patent. It does not create Hatch-Waxman exclusivity, an Orange Book listing, Paragraph IV exposure or biosimilar exclusivity. Its commercial relevance is concentrated in mesh-nebulizer and precision-fluidics products.

US 7,316,067 is no longer an enforceable US patent as of 2026 because its ordinary patent term has ended under 35 U.S.C. § 154. The patent nevertheless remains relevant for historical freedom-to-operate reviews, patent-family analysis, continuation practice and assessment of later patents that may claim related mesh structures or manufacturing processes.

What does US Patent 7,316,067 protect?

The patent protects two related subject matter categories:

1. A manufacturing method for producing a perforate membrane.
2. A membrane and liquid transport device incorporating the resulting nozzle structure.

The independent claims are claims 1 and 9.

Claim	Category	Principal subject matter
1	Method	Laser formation of nozzles followed by controlled electropolishing
9	Product	Perforate membrane having laser-formed nozzles and electropolished surfaces
14	Device	Fluid transport device incorporating the claim 9 membrane
15	Device	Aerosol generator incorporating the claim 9 membrane
16	Device	Pump incorporating the claim 9 membrane
17	Device	Filter incorporating the claim 9 membrane
18	Product limitation	Throat portion extending directly through the plate

The patent’s practical center is the nozzle geometry. Each nozzle has:

• A throat portion with a selected diameter.
• An opening through the opposite surface of the membrane.
• A smoothly curved, outwardly diverging portion extending from the throat to the first surface.
• An electropolished first surface and diverging portion.
• A throat diameter that remains unchanged after polishing.

The claims do not broadly cover every perforated membrane, every laser-drilled hole or every electropolished plate. They require the claimed combination of geometry, laser formation and controlled polishing.

How should claim 1 be construed?

Claim 1 is a process claim with several cumulative limitations. A practicing entity would generally need to establish each limitation to prove literal infringement.

Required claim 1 elements

Limitation	Scope
Membrane purpose	The membrane must be for use in a liquid transport device
Laser processing	Laser energy must be applied selectively to a first membrane surface
Beam characteristics	The beam must be pulsed and focused
Nozzle population	The process must form a plurality of nozzles
Throat	Each nozzle must have a throat opening of selected diameter
Through-opening	The throat opens through the opposite membrane surface
Diverging region	A smoothly curved outwardly diverging portion extends to the first surface
Electropolishing	The first surface and diverging nozzle surface are polished after laser formation
Controlled removal	Polishing removes material to a depth less than the throat length
Diameter preservation	The throat diameter remains unchanged by polishing

The temporal word “thereafter” is important. The claim requires electropolishing after the laser-forming operation. A process that electropolishes the sheet before drilling may avoid literal compliance with that sequence, although the doctrine of equivalents and other claims would require separate analysis.

The depth limitation is also significant. Electropolishing cannot proceed far enough to alter the throat diameter. This narrows the claim compared with a process that merely smooths or enlarges laser-drilled holes.

What do claims 2 through 8 add?

Claims 2 through 8 add laser-control and polishing limitations.

Claims 2 and 3: laser focus and pulse control

Claim 2 repeats the pulsed, focused laser limitation already present in claim 1. Its incremental scope is therefore limited.

Claim 3 adds a two-stage laser process:

1. The beam initially forms the diverging portion while the membrane surface is positioned at a distance from the laser focus.
2. The focus-to-surface distance is then decreased, or pulse energy is reduced, to form the throat.

This claim targets controlled variation of the laser-material interaction rather than a single uniform drilling condition.

Claims 4 through 6: variable processing conditions

Claims 4 and 5 cover adjustment of focus position or pulse energy during formation of the diverging portion or throat.

Claim 6 covers a two-step process in which the laser parameters are adjusted between the steps.

These claims create narrower process positions around laser pulse programming, focal depth and energy control. A manufacturer using fixed laser parameters throughout the drilling sequence would have a stronger non-infringement position against these dependent claims, but could still fall within claim 1 or claim 9.

Claim 7: polishing both membrane surfaces

Claim 7 adds electropolishing of the opposite surface. It is narrower than claim 1 and applies only where both sides are polished.

Claim 8: pulse-count control

Claim 8 requires controlling focus position or pulse energy by comparing the number of pulses used to form the diverging and throat portions with predetermined pulse counts. This is a process-control limitation that may be difficult to prove from the finished product alone. It would typically require manufacturing records, source-code evidence, process specifications or employee testimony.

What does claim 9 protect?

Claim 9 is the principal product claim. It covers a membrane having structural characteristics resulting from the claimed manufacturing process.

The key limitations are:

• A first surface and opposite surface.
• Multiple nozzles.
• Laser-formed nozzles.
• A selected-diameter throat.
• A throat opening through the opposite surface.
• A smoothly curved outwardly diverging section extending to the first surface.
• Electropolishing of the first surface and diverging section.
• Polishing to a depth less than the throat length.
• An unchanged throat diameter after electropolishing.

Claim 9 presents a product-by-process issue because it describes the nozzles as formed by pulsed, focused laser energy and the surfaces as having been electropolished. Under US patent law, product-by-process language generally does not allow a product claim to cover a structurally different product merely because it was made by a particular process. The relevant question is whether the accused membrane has the claimed product characteristics, not merely whether the accused manufacturer used a similar process. See Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009).

The claim’s “unchanged” throat limitation may be difficult to apply in practice. It requires comparison of throat condition before and after electropolishing, or reliable evidence that polishing did not affect the throat diameter. A finished membrane may not reveal that fact without process data or destructive analysis.

What geometries are protected by claims 10 through 13 and 18?

Claim	Geometry
10	Diverging portion is concave
11	Concave portion is part spherical
12	Throat is substantially cylindrical
13	Throat diverges toward the one surface
18	Throat has a selected length extending directly through the plate

Claims 10 and 11 narrow the diverging region to concave and part-spherical profiles. Claim 12 favors a cylindrical throat. Claim 13 covers a throat that is not perfectly cylindrical and diverges toward one surface.

The dependent claims create competing construction questions. A membrane with a conical entry region may fall outside claims 10 and 11 while remaining potentially relevant to claim 9 if the entry region is “smoothly curved” and outwardly diverging. A membrane with a tapered throat may avoid claim 12 but could implicate claim 13.

What products are covered by claims 14 through 17?

Claims 14 through 17 extend the membrane claim into device categories.

Claim	Covered device
14	Liquid or fluid transport device
15	Aerosol generator
16	Pump
17	Filter

These claims do not cover every nebulizer, pump or filter. The device must include a membrane satisfying claim 9 and its incorporated limitations.

For an aerosol generator, the patent is most relevant to vibrating-mesh nebulizers that use a perforated membrane to generate droplets by forcing liquid through micron-scale openings. Commercial products using alternative mesh fabrication, molded polymer structures, electroformed plates or materially different nozzle profiles require separate claim mapping.

When did US 7,316,067 lose exclusivity?

US 7,316,067 has passed its US patent term. The controlling term is determined under 35 U.S.C. § 154 and the patent’s earliest effective US nonprovisional filing date, subject to any patent-term adjustment recorded by the USPTO.

Event	Status
US patent grant	January 2008
Ordinary US patent term	20 years from the applicable US nonprovisional filing date
Patent-term extension under Hatch-Waxman	Not applicable to this device patent
Current enforceability	Expired as of 2026
Generic-drug exclusivity	Not applicable
Biosimilar exclusivity	Not applicable

The patent’s expiration does not invalidate later patents covering related membrane architecture, manufacturing tolerances, aerosol-generator assemblies or control electronics. A current freedom-to-operate opinion must therefore examine later-filed continuation, divisional, improvement and unrelated competitor patents.

What is the Orange Book status of US 7,316,067?

US 7,316,067 is not an Orange Book patent.

The Orange Book lists patents submitted by sponsors in connection with approved drug products under the Federal Food, Drug, and Cosmetic Act. The patent claims a membrane, a liquid transport device and manufacturing methods. It does not claim an active pharmaceutical ingredient, drug formulation or drug method of use.

Consequences include:

• No Orange Book patent listing.
• No Paragraph IV certification directed to this patent.
• No 30-month stay based on this patent.
• No Hatch-Waxman patent litigation based solely on this patent.
• No FDA drug exclusivity associated with the patent.
• No biosimilar litigation pathway under the Biologics Price Competition and Innovation Act.

An aerosol generator incorporating the membrane may be regulated as a medical device, drug-delivery device or combination product depending on the product’s intended use and regulatory configuration. That product classification does not convert this patent into a drug patent.

Are there Paragraph IV, biosimilar or generic-entry risks?

There is no direct Paragraph IV or biosimilar risk because the patent is not an Orange Book or biologic patent.

The relevant commercial risk is device competition. A competing manufacturer could enter with a product that:

• Uses a different hole-forming process.
• Uses electroforming rather than laser drilling.
• Uses a different nozzle profile.
• Uses polymeric or composite membranes.
• Uses a membrane with a throat that is altered during finishing.
• Uses a different actuation principle.
• Does not incorporate the claimed electropolished structure.

Because the patent has expired, the principal legal issue is not entry blocked by US 7,316,067. It is whether later patents cover the particular design or process selected for a new product.

How strong was the patent estate?

The patent was technically focused rather than broad. Its strongest features were the combined limitations requiring:

1. Laser-produced diverging and throat regions.
2. Controlled electropolishing.
3. Removal depth shorter than the throat.
4. Preservation of throat diameter.

Those limitations distinguished the claimed process from ordinary laser drilling and general surface polishing.

Strengths

• Clear connection between manufacturing method and nozzle geometry.
• Specific control of electropolishing depth.
• Product claims supported by detailed manufacturing limitations.
• Dependent claims covering common nozzle shapes.
• Applicability to aerosol generators, pumps and filters.

Weaknesses

• Narrow cumulative limitations.
• Potential ambiguity in “smoothly curved,” “selected diameter” and “unchanged.”
• Claim 9’s process-related language may complicate product enforcement.
• Claims 2 and 1 substantially overlap in the pulsed, focused laser limitation.
• Finished-product testing may not establish historical process conditions.
• Expiration removes current exclusionary value.

The patent was more useful as a technology-development and licensing asset during its term than as a broad barrier to all mesh nebulizer products.

Which companies and technologies are relevant to the landscape?

The surrounding market includes manufacturers of vibrating-mesh nebulizers and precision aerosol-delivery systems. Relevant commercial technologies include:

Technology	Typical distinction from the claimed subject matter
Vibrating-mesh nebulizers	May use laser-drilled or electroformed metal membranes
Electroformed meshes	Membrane apertures are built through electroforming rather than removed by laser ablation
Piezoelectric mesh systems	Use vibration to move liquid through apertures
Ultrasonic nebulizers	Atomize liquid through ultrasonic energy rather than necessarily through the claimed membrane
Jet nebulizers	Use compressed gas and do not require the claimed perforate membrane
Polymer microfluidic membranes	May avoid metal laser drilling and electropolishing
Porous sintered structures	Use interconnected porosity instead of discrete nozzles

Aerogen, Philips, PARI, Omron and other respiratory-device companies have participated in mesh-nebulizer and aerosol-delivery markets. Market participation alone does not establish infringement or licensing under US 7,316,067. The relevant comparison is the technical configuration of each product and the later patent portfolio covering it.

What licensing deals and litigation affect the patent?

A US patent’s public front page generally does not disclose private license agreements. No licensing arrangement can be inferred solely from assignment, product use or industry adoption.

US 7,316,067 should not be treated as an active litigation threat in 2026 because the patent has expired. Any historical litigation review should distinguish:

• Litigation involving this specific patent.
• Litigation involving related family members.
• Litigation involving later patents owned by the same technology company.
• Contract disputes involving licenses.
• Regulatory disputes involving nebulizer or aerosol-generator approvals.

The absence of an active enforceable patent does not eliminate the possibility that later patents create risk for a current product. Those later patents must be reviewed separately by family, assignee, claim scope and expiration date.

What manufacturing and intellectual-property barriers remain?

The expired patent does not remove technical barriers. Production still requires control of:

• Laser pulse duration and energy.
• Focal position relative to the membrane.
• Aperture diameter and distribution.
• Membrane thickness.
• Throat length.
• Surface roughness.
• Electropolishing rate.
• Particle and burr removal.
• Aperture uniformity.
• Mechanical strength under vibration.
• Droplet-size distribution.
• Clogging and fouling resistance.

A new entrant can avoid the expired claims while retaining substantial manufacturing risk. The most important current IP review areas are later patents on:

• Mesh actuator integration.
• Membrane support structures.
• Droplet-size control.
• Nebulizer reservoirs and fluid paths.
• Anti-clogging coatings.
• Membrane cleaning.
• Frequency control.
• Disposable cartridge architecture.
• Drug-device combination configurations.
• Manufacturing inspection and calibration.

What generic launch scenarios apply?

Traditional generic-drug launch scenarios do not apply. The relevant device-entry scenarios are:

1. Direct post-expiration entry: A competitor commercializes a membrane using similar technology after the patent term ends.
2. Design-around entry: A competitor changes the nozzle profile, finishing process or membrane material.
3. Platform licensing: A device company licenses later membrane, actuator or aerosol-generator patents.
4. Combination-product entry: A pharmaceutical company pairs an inhaled formulation with a nebulizer platform and assesses both device and drug patents.
5. Regulatory substitution: A competitor enters through a different FDA device pathway or uses a predicate-device strategy where available.

Revenue exposure therefore depends on the installed base of aerosol generators, replacement-membrane sales, disposable cartridges and drug-device combinations, rather than on protected pharmaceutical sales. The patent itself cannot support a current royalty or exclusivity forecast after expiration.

Key Takeaways

• US 7,316,067 covers laser-formed, electropolished perforate membranes and devices incorporating them.
• Claims 1 and 9 are the commercial center of the patent.
• The critical limitations are the narrow throat, curved diverging region, post-laser electropolishing and preservation of throat diameter.
• Claims 14 through 17 reach aerosol generators, pumps, filters and other fluid transport devices only when they include the claimed membrane.
• The patent is a medical-device technology patent, not an Orange Book drug patent.
• Paragraph IV, biosimilar and Hatch-Waxman risks do not apply.
• The US patent has expired as of 2026.
• Current product risk depends on later patents, not on US 7,316,067 itself.
• The strongest historical patent value was in controlling a specific manufacturing route and nozzle geometry, not in covering all mesh nebulizers.

FAQs About US Patent 7,316,067

Does US 7,316,067 cover all vibrating-mesh nebulizers?

No. The nebulizer must include a membrane meeting the detailed structural limitations of claim 9, including the throat, curved diverging region and electropolished surfaces.

Can a company use the same laser-drilling process after expiration?

Yes, US 7,316,067 no longer provides enforceable US exclusionary rights. Later patents covering related process controls, membrane designs or nebulizer assemblies may still apply.

Is US 7,316,067 listed in the FDA Orange Book?

No. It claims a membrane and fluid-transport device rather than a drug substance, formulation or drug method of use.

Does the patent cover a mesh made by electroforming?

Not necessarily. The claims expressly describe pulsed, focused laser energy forming the nozzles. An electroformed mesh must be evaluated against the structural limitations of the product claims and any later patent rights.

What is the main design-around strategy?

The most direct strategies are changing the nozzle geometry, using a different membrane material or fabrication process, altering the surface-finishing method, or avoiding a throat whose diameter remains unchanged after electropolishing.

References

1. United States Patent No. 7,316,067, Perforate membrane and method of manufacture (U.S. Patent and Trademark Office, issued 2008). https://patents.google.com/patent/US7316067B2/en

2. U.S. Patent and Trademark Office. (2026). Patent Center. https://patentcenter.uspto.gov/

3. 35 U.S.C. § 154. Patent term.

4. 35 U.S.C. §§ 271, 282. Patent infringement and presumptions of validity.

5. 21 U.S.C. § 355(b)(1). New drug applications and patent information.

6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

7. Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009).

Drugs Protected by US Patent 7,316,067

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 7,316,067

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	01308106	Sep 24, 2001

PCT Information
PCT Filed	September 06, 2002	PCT Application Number:	PCT/GB02/04093
PCT Publication Date:	April 03, 2003	PCT Publication Number:	WO03/026832

International Family Members for US Patent 7,316,067

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	60231995
European Patent Office	1295647
European Patent Office	1429888
Japan	2005503266
Japan	4176016