Caliper Life Sciences, Inc.v. Alere Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Caliper Life Sciences, Inc. (Delaware)
  • Defendant: Alere Inc. (Delaware)
  • Plaintiff’s Counsel: Day Pitney LLP
• Case Identification: 1:17-cv-12124, D. Mass., 10/30/2017
• Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because Defendant has a regular and established place of business in the district and has committed the alleged acts of patent infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s epoc® Blood Analysis System infringes six U.S. patents related to the design, fabrication, and operation of microfluidic devices.
• Technical Context: Microfluidics involves the precise control and manipulation of fluids in channels with dimensions at the micro-scale, a foundational technology for modern high-throughput screening, diagnostics, and "lab-on-a-chip" systems.
• Key Procedural History: The complaint was filed after four of the six asserted patents had expired, which may limit remedies for those patents to past damages. Plaintiff alleges it put Defendant on notice of the first four patents-in-suit on February 23, 2017, and the remaining two on September 1, 2017, which forms the basis for the allegations of willful infringement.

Case Timeline

Date	Event
1996-04-16	Earliest Priority Date for U.S. Patent No. 6,238,538
1997-10-09	Earliest Priority Date for U.S. Patent Nos. 5,842,787; 5,957,579; 6,186,660
1998-12-01	Issue Date: U.S. Patent No. 5,842,787
1999-04-14	Priority Date for U.S. Patent No. 6,322,683
1999-09-28	Issue Date: U.S. Patent No. 5,957,579
2001-02-13	Issue Date: U.S. Patent No. 6,186,660
2001-05-29	Issue Date: U.S. Patent No. 6,238,538
2001-11-27	Issue Date: U.S. Patent No. 6,322,683
2002-12-13	Priority Date for U.S. Patent No. 6,881,312
2005-04-19	Issue Date: U.S. Patent No. 6,881,312
2017-02-23	Plaintiff alleges notice was provided to Defendant for four patents
2017-04-14	Expiration Date: U.S. Patent No. 6,238,538
2017-09-01	Plaintiff alleges notice was provided to Defendant for two patents
2017-10-09	Expiration Date: U.S. Patent Nos. 5,842,787; 5,957,579; 6,186,660
2017-10-30	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,238,538 - “Controlled fluid transport in microfabricated polymeric substrates”

The Invention Explained

• Problem Addressed: The patent describes the challenge of moving fluids in microscale devices using electroosmotic flow when those devices are made from polymers. Unlike traditional glass or silica substrates, many polymers have surfaces that do not inherently possess the necessary electrical charge (zeta potential) to support efficient fluid movement when a voltage is applied (’538 Patent, col. 7:15-22).
• The Patented Solution: The invention discloses methods for fabricating microfluidic devices from polymeric substrates and modifying their interior channel surfaces to enable or enhance electroosmotic flow (’538 Patent, Abstract). This can be achieved by selecting polymers with suitable surface properties or by treating the channel surfaces with coatings, such as detergents, that impart a surface charge, thereby allowing for precise, non-mechanical fluid control in low-cost, disposable plastic devices (’538 Patent, col. 7:52–8:22).
• Technical Importance: This technology was significant in enabling the transition from expensive and difficult-to-manufacture glass-based microfluidic chips to mass-producible, disposable plastic devices, broadening their application in research and diagnostics (Compl. ¶8).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" of the ’538 Patent but does not specify which claims are asserted (Compl. ¶18). The complaint does not provide sufficient detail for analysis of specific claim elements.

U.S. Patent No. 5,842,787 - “Microfluidic systems incorporating varied channel dimensions”

The Invention Explained

• Problem Addressed: The patent identifies a "race-track" effect in curved microfluidic channels, where fluid on the outer edge of a turn travels a longer path than fluid on the inner edge. This disparity in travel distance and time distorts discrete plugs of material, which degrades the resolution of separation-based analyses like electrophoresis (’787 Patent, col. 6:12-32).
• The Patented Solution: The invention proposes fabricating microscale channels that are deeper than they are wide, giving them a width-to-depth aspect ratio of less than one. This geometry reduces the volume difference between the inner and outer paths of a turn relative to the channel's total volume, thereby minimizing distortion without significantly increasing electrical resistance or heat generation (’787 Patent, col. 10:4-24; Fig. 4).
• Technical Importance: This channel design allowed for the creation of longer, more complex (e.g., serpentine) channel networks on a compact substrate area while preserving the high resolution necessary for precise analytical separations (’787 Patent, col. 6:49-59).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" of the ’787 Patent but does not specify which claims are asserted (Compl. ¶24). The complaint does not provide sufficient detail for analysis of specific claim elements.

U.S. Patent No. 5,957,579 - “Microfluidic systems incorporating varied channel dimensions”

• Technology Synopsis: As a continuation of the ’787 Patent, this patent further describes microfluidic systems designed to counteract material distortion in curved channels (’579 Patent, col. 1:56–col. 2:4). The solution centers on using channels that are deeper than they are wide (aspect ratio less than 1) to maintain the cohesion of fluid plugs as they navigate turns, thereby preserving analytical resolution (’579 Patent, Abstract).
• Asserted Claims: The complaint asserts infringement of "at least one claim" of the ’579 Patent (Compl. ¶30).
• Accused Features: The complaint alleges that the channels in the accused epoc System vary in dimension, with at least a portion having an aspect ratio (width/depth) of less than 1 (Compl. ¶15).

U.S. Patent No. 6,186,660 - “Microfluidic systems incorporating varied channel dimensions”

• Technology Synopsis: This patent, also in the family of the ’787 Patent, discloses microfluidic devices employing channels with varied dimensions, particularly those with a width-to-depth aspect ratio less than 1 (’660 Patent, col. 2:1-8). This channel geometry is described as a solution to mitigate sample distortion in channel turns and to enable more efficient mixing and analysis within a compact device footprint (’660 Patent, Abstract).
• Asserted Claims: The complaint asserts infringement of "at least one claim" of the ’660 Patent (Compl. ¶36).
• Accused Features: The complaint alleges that the accused epoc System contains microscale channels with at least a portion having an aspect ratio of less than 1 (Compl. ¶15).

U.S. Patent No. 6,322,683 - “Alignment of multicomponent microfabricated structures”

• Technology Synopsis: This patent addresses the technical challenge of precisely aligning multiple layers or components during the fabrication of microfluidic devices (’683 Patent, col. 1:15-21). The invention discloses the use of alignment structures, such as wells, notches, or alignment keys, that are fabricated directly into the substrate layers to ensure that channels, reservoirs, and external components are accurately positioned relative to one another (’683 Patent, Abstract).
• Asserted Claims: The complaint asserts infringement of "at least one claim" of the ’683 Patent (Compl. ¶42).
• Accused Features: The complaint does not identify specific features of the accused epoc System alleged to infringe the ’683 Patent.

U.S. Patent No. 6,881,312 - “Ultra high throughput microfluidic analytical systems and methods”

• Technology Synopsis: This patent describes integrated systems for performing high-throughput analysis using microfluidic devices. The invention includes features such as modular interfaces that connect a microfluidic chip to analytical instruments, multiple parallel channels for simultaneous assays, and advanced optical detection systems, all configured to enable rapid and automated screening of many samples (’312 Patent, Abstract).
• Asserted Claims: The complaint asserts infringement of "at least one claim" of the ’312 Patent (Compl. ¶48).
• Accused Features: The complaint alleges the accused epoc System includes an "analytical instrument and an interface structure having a heater element...and a fluid control interface," features common in integrated microfluidic systems (Compl. ¶16).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Alere's epoc® Blood Analysis System (“epoc System”) (Compl. ¶15).

Functionality and Market Context

The complaint, citing Alere's promotional materials and Plaintiff's own inspection, describes the epoc System as a blood analysis device that includes a microscale substrate made with a polymer layer (Compl. ¶15). This substrate allegedly contains interconnected microscale channels, sources for test compounds, and is sealed with a cover layer containing apertures (Compl. ¶15). Key alleged technical features include channels that vary in dimension, with some portions having a width-to-depth aspect ratio of less than 1, and an associated analytical instrument with an interface for heating fluid and controlling its movement (Compl. ¶15-16). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not assert specific claims or provide claim charts mapping claim elements to accused functionalities. It instead presents a narrative theory of infringement by describing features of the accused product that correspond to the general technologies of the patents-in-suit.

For the ’538 Patent, the infringement theory appears to rest on the allegation that the epoc System is constructed from a "microscale substrate with at least a polymer layer," which is "sealed by a flat cover layer" (Compl. ¶15). This corresponds to the ’538 Patent’s focus on devices fabricated from polymeric materials.

For the ’787 Patent (and its family members, the ’579 and ’660 patents), the infringement theory is more specific, alleging that the channels in the epoc System "vary in shape and size, with at least a portion having an aspect ratio (width/depth) less than 1" (Compl. ¶15). This allegation directly tracks the core technical solution disclosed in the ’787 Patent family for preventing sample dispersion in channel turns.

• Identified Points of Contention:
  • Evidentiary Questions: A primary factual dispute will likely concern the physical dimensions and material composition of the epoc System's microfluidic substrate. The complaint’s allegation of a channel aspect ratio less than 1 is based on "Plaintiff's inspection" (Compl. ¶15) and will require technical evidence to substantiate.
  • Scope Questions: The case may turn on the construction of key claim terms. For the patents to read on the accused device, the scope of terms like "polymeric substrate" (’538 Patent) and "aspect ratio...less than 1" (’787 Patent) will be critical. The lack of specific infringement allegations for the ’683 (alignment) and ’312 (system) patents raises the question of whether the accused product practices the specific methods or structures claimed in those patents.

V. Key Claim Terms for Construction

While no specific claims are asserted, the dispute will likely center on terms that define the core technologies alleged to be infringed.

The Term: "aspect ratio (width/depth) less than 1"

Context and Importance

This term is central to the infringement allegations for three of the six patents (’787, ’579, ’660) and is the most specific technical feature of the accused product identified in the complaint (Compl. ¶15). Its construction will determine whether the physical structure of the epoc System's channels falls within the scope of these patents.

Intrinsic Evidence for Interpretation

• Evidence for a Broader Interpretation: The ’787 Patent specification provides a direct mathematical definition: ""aspect ratio," refers to the ratio of a channel's width to that channel's depth" (’787 Patent, col. 10:27-29). This language may support an interpretation where any portion of a channel that is deeper than it is wide meets the limitation, regardless of its specific function or location.
• Evidence for a Narrower Interpretation: The specification repeatedly discusses this channel geometry as a solution to the "race-track" effect that occurs in "turning microscale channel[s]" (’787 Patent, col. 6:17-24). Language tying the invention to solving this specific problem in channel turns could be used to argue that the term should be construed to apply only to channel portions that include curves or turns.

The Term: "polymeric substrate"

Context and Importance

The ’538 Patent is directed to devices fabricated from polymeric materials, and the complaint alleges the epoc System contains a "polymer layer" (Compl. ¶15). The definition of this term is fundamental to establishing infringement of the ’538 Patent.

Intrinsic Evidence for Interpretation

• Evidence for a Broader Interpretation: The ’538 Patent specification lists a wide variety of "polymeric materials, e.g., plastics, such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON™), polyvinylchloride (PVC), [and] polydimethylsiloxane (PDMS)" (’538 Patent, col. 3:60-64). This broad, exemplary list may support a construction covering most common plastics used in medical devices.
• Evidence for a Narrower Interpretation: The patent's background and detailed description focus on polymers that are compatible with microfabrication techniques and, critically, whose surfaces can be modified to support electroosmotic flow (’538 Patent, col. 7:15-30). This context may support an argument that the term is limited to polymers possessing specific chemical or physical properties suitable for the claimed fluid control methods, not just any polymer.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement for all six patents. The allegations are based on Defendant allegedly making and selling the epoc System with knowledge of the patents and with the specific intent to encourage its customers' infringing uses, supported by the dissemination of "promotional and marketing materials" (e.g., Compl. ¶19, ¶25, ¶31).
• Willful Infringement: Willfulness is alleged for all six patents, based on alleged pre-suit knowledge. The complaint alleges that Defendant was put on notice of four patents on February 23, 2017, and the remaining two on September 1, 2017, and continued its alleged infringement thereafter (Compl. ¶19, ¶43, et al.).

VII. Analyst’s Conclusion: Key Questions for the Case

The resolution of this dispute will likely depend on the answers to several central questions for the court:

• A core issue will be one of physical characterization: does the accused epoc® Blood Analysis System, as a matter of technical fact, incorporate microchannels with a width-to-depth aspect ratio of less than 1, as required by the '787 patent family and as alleged based on Plaintiff's inspection?
• A key legal question will be one of claim scope: how should the term "aspect ratio less than 1" be construed? Will it be given its plain mathematical meaning, or will it be limited by the specification's context to apply only to curved or turning channel segments designed to mitigate sample dispersion?
• A significant procedural and evidentiary question will be one of sufficiency of allegations: can the Plaintiff substantiate its broad, system-level infringement allegations against the ’683 (alignment structures) and ’312 (high-throughput systems) patents with specific evidence linking features of the accused product to the elements of the asserted claims?