Nanoen Tek Inc v. Bio Rad Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: NanoEnTek, Inc. and Digital-Bio Technology Co., Ltd. (Republic of Korea)
  • Defendant: Bio-Rad Laboratories, Inc. (Delaware)
  • Plaintiff’s Counsel: Stities & Harbison, PLLC; Edwards Angell Palmer & Dodge LLP
• Case Identification: 2:11-cv-00427, E.D. Va., 08/02/2011
• Venue Allegations: Defendant is alleged to have transacted business in the Eastern District of Virginia by offering to sell, selling, or using a product made by a process patented in the United States.
• Core Dispute: Plaintiffs allege that Defendant’s cell counting slides are manufactured by a process that infringes a patent related to a method for bonding plastic microchips.
• Technical Context: The technology pertains to the manufacturing of microfluidic devices, often called "lab-on-a-chip," which are critical for biotechnology applications such as rapid, small-volume sample analysis.
• Key Procedural History: The complaint is the initial pleading in this litigation. No prior litigation, inter partes reviews, or licensing history is mentioned in the document.

Case Timeline

Date	Event
2003-12-18	’157 Patent Priority Date
2010-11-30	U.S. Patent No. 7,842,157 Issues
2011-08-02	Complaint Filed

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

U.S. Patent No. 7,842,157 - “Method for Bonding Plastic Micro Chip”

• Patent Identification: U.S. Patent No. 7,842,157, “Method for Bonding Plastic Micro Chip,” issued November 30, 2010.

The Invention Explained

• Problem Addressed: The patent’s background section describes problems with prior art methods for bonding the plastic layers of a microchip, such as ultrasonic bonding. These methods can create irregular bonding surfaces, making it "difficult to control the channel to have a predetermined height," which can lead to analytical errors, sample leakage, or the introduction of air bubbles into the sample channel (’157 Patent, col. 2:5-17).
• The Patented Solution: The invention claims to solve this problem by creating "recesses" or a "fine channel" in the bonding region that circumscribes the main sample-filling space. An organic solvent is then introduced into these recesses, where it flows via capillary action to melt and fuse the upper and lower plastic substrates together, creating a precise and perfectly sealed bond without affecting the central sample channel (’157 Patent, Abstract; col. 2:45-56). The overall structure is illustrated in the patent’s figures, such as Figure 5 (’157 Patent, Fig. 5).
• Technical Importance: This method provides a way to "precisely and correctly bond the upper and lower substrates" of a microchip, a manufacturing step described as essential for the chip to "perfectly function" (’157 Patent, col. 1:40-45).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶16). Independent claim 1 is representative of the patented method.
• Independent Claim 1: A method of bonding an upper and a lower substrate to manufacture a plastic microchip, comprising the essential steps of:
  • Forming recesses in each of the side lower ends of a bonding region of the upper substrate, where the bonding region is a circumference region of the sample filling space.
  • Overlapping the upper and lower substrates and introducing an organic solvent into the recesses to bond them.
  • The recesses are "open channels" and the solvent is introduced by "capillary phenomenon."
  • The bonding region is bonded by the solvent introduced into the recesses.
• The complaint does not explicitly reserve the right to assert dependent claims, though this remains a possibility as the case proceeds.

III. The Accused Instrumentality

Product Identification

• The "TC10™ Automated Cell Counter" and "TC10™ Counting Slides" (Compl. ¶8). The infringement allegations focus on the "Counting Slides" as the product "made by a process patented in the United States" (Compl. ¶9, ¶16).

Functionality and Market Context

• The complaint alleges the accused products are used for automated cell counting (Compl. ¶16). It does not provide further technical detail on their operation but asserts that Defendant "manufactures, uses, offers for sale, sells and/or imports" the products throughout the United States (Compl. ¶8).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed, element-by-element mapping of the accused process to the patent claims. The infringement theory is instead presented in narrative form, alleging on "information and belief" that Defendant infringes by using the patented process and by making, selling, or using the TC10 Counting Slides, which are products made by that process (Compl. ¶16). No probative visual evidence provided in complaint beyond the patent exhibit itself. The patent exhibit includes Figure 5, a plan view of the microchip which illustrates the claimed 'fine channel' (30) surrounding the central 'sample filling space' (10) (’157 Patent, Fig. 5).

Because the complaint lacks the specificity for a tabular analysis, a summary of the core allegation and resulting points of contention is provided below.

• Narrative Infringement Theory: The central allegation is that the TC10 Counting Slides are manufactured using a method that includes the steps claimed in the ’157 Patent, namely the bonding of the slide's plastic layers using an organic solvent introduced into peripheral recesses or channels.
• Identified Points of Contention:
  • Evidentiary Question: A primary issue for discovery will be determining the actual manufacturing process used by Defendant for its TC10 Counting Slides. The complaint is based on "information and belief," and Plaintiffs will need to obtain evidence of the specific bonding technique employed.
  • Technical Question: The key technical question is whether Defendant’s actual manufacturing process includes steps that meet the limitations of the asserted claims. Specifically, does the process involve (1) forming "recesses" or a "fine channel" at the periphery of the sample area, and (2) introducing an "organic solvent" that bonds the substrates through "capillary phenomenon," as required by Claim 1?

V. Key Claim Terms for Construction

• The Term: "recesses"

• Context and Importance: This structural term is foundational to the asserted independent claim. The configuration of these "recesses" enables the claimed capillary action of the solvent. Practitioners may focus on this term because its scope will likely determine whether Defendant's manufacturing process, once revealed, falls within the claim.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: Claim 1 uses the general term "recesses" without specifying dimensions or shape, which could support an argument for a meaning not strictly limited to the embodiments (’157 Patent, col. 5:24).
  • Evidence for a Narrower Interpretation: The claim requires the recesses to be "open channels" that allow for introduction of a solvent by "capillary phenomenon" (’157 Patent, col. 5:30-33). The specification also provides a preferred height for the related "fine channel" of "about 100 µm or less," which could be used to argue for a more structurally limited definition (’157 Patent, col. 3:9-11).

• The Term: "organic solvent"

• Context and Importance: The function of this solvent is critical to the bonding process. The dispute may turn on whether the term is limited to solvents that act in a specific way (i.e., by dissolving the plastic).

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The claim language itself does not restrict the type of organic solvent beyond its function of bonding the substrates (’157 Patent, col. 5:28-29).
  • Evidence for a Narrower Interpretation: The specification states that "Any organic solvent capable of dissolving the material of the substrates may be used" and that the solvent "melts the upper substrate 120 and the lower substrate 140," thereby bonding them (’157 Patent, col. 3:28-29, col. 4:49-52). This language suggests the term could be construed to require a solvent that functions by dissolving the plastic, rather than one that acts as a carrier for a separate adhesive.

VI. Other Allegations

• Indirect Infringement: The complaint makes passing reference to Defendant "causing its customers to use" the accused product (Compl. ¶16) and the prayer for relief mentions items that "instruct its customers to infringe" (Relief Requested ¶(d)). However, the complaint pleads no specific facts to support the knowledge and intent required for a claim of induced infringement.
• Willful Infringement: The complaint does not explicitly allege willful infringement. It requests attorneys' fees under 35 U.S.C. § 285 for an exceptional case but does not plead facts suggesting pre- or post-suit knowledge of the patent and deliberate infringement (Relief Requested ¶(f)).

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

• A central issue will be evidentiary and factual: Can Plaintiffs, through discovery, produce evidence that the manufacturing process for Bio-Rad's TC10 Counting Slides practices the specific steps of the asserted claims? The case’s viability hinges on whether the Defendant’s confidential process aligns with the patent's teachings.
• The case will also turn on a question of claim construction: How will the court define the term "recesses"? The outcome will depend on whether the term is interpreted broadly to encompass various types of surface features or is narrowly construed to require a specific structure designed to facilitate the "capillary phenomenon" described in the patent specification.