1:21-cv-00833
Becton Dickinson Co v. Beckman Coulter Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Becton, Dickinson and Company (New Jersey)
- Defendant: Beckman Coulter, Inc. (Delaware)
- Plaintiff’s Counsel: Quinn Emanuel Urquhart & Sullivan, LLP
- Case Identification: 1:21-cv-00833, D. Del., 07/21/2021
- Venue Allegations: Venue is asserted based on Defendant’s incorporation in the State of Delaware, establishing residency within the district.
- Core Dispute: Plaintiff alleges that Defendant’s CytoFLEX line of flow cytometry analyzers and cell sorters infringes four patents related to optical detection systems, fluidic components, and beam-adjusting optics.
- Technical Context: Flow cytometry is a foundational technology in biomedical research and clinical diagnostics for high-throughput analysis and sorting of cells and other microscopic particles.
- Key Procedural History: The complaint alleges Defendant had pre-suit knowledge of all four patents-in-suit. Notably, for U.S. Patent No. 7,787,197, knowledge is alleged to stem from Defendant’s 2014 acquisition of Xitogen Technologies Inc., the company founded by the patent’s sole inventor, who subsequently became Defendant’s Chief Technical Officer and was involved in the development of the accused products. Knowledge of the other patents is alleged based on citations in Information Disclosure Statements and USPTO examiner actions during the prosecution of Defendant's own patent applications.
Case Timeline
| Date | Event |
|---|---|
| 2001-08-28 | Priority Date for '314 Patent and '505 Patent |
| 2002-09-27 | Priority Date for '875 Patent |
| 2004-01-27 | Issue Date for '314 Patent |
| 2006-10-31 | Issue Date for '505 Patent |
| 2007-04-10 | Issue Date for '875 Patent |
| 2007-09-14 | Priority Date for '197 Patent |
| 2010-08-31 | Issue Date for '197 Patent |
| 2010-09-08 | Alleged knowledge of '314 and '505 Patents by Defendant |
| 2014-01-01 | Alleged knowledge of '197 Patent by Defendant via acquisition |
| 2015-05-01 | Alleged launch of Accused Analyzer Products |
| 2015-05-04 | Alleged knowledge of '875 Patent by Defendant |
| 2015-06-05 | Alleged knowledge of '314 and '197 Patents by Defendant via IDS filing |
| 2021-03-04 | Alleged launch of Accused Cell Sorter Products |
| 2021-07-21 | Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,683,314 - "Fluorescence detection instrument with reflective transfer legs for color decimation," issued January 27, 2004
The Invention Explained
- Problem Addressed: The patent describes a need for improved systems in bioanalytical instruments to detect fluorescent light with multiple colors from a target, which requires a greater number of detectors than was available in prior art systems to enable deeper multiplexing and higher throughput analysis ('314 Patent, col. 1:19-25, col. 2:60-64).
- The Patented Solution: The patent discloses an optical instrument where fluorescent light collected from a sample is split into multiple color bands using a series of dichroic mirrors. The key innovation is an arrangement where the reflected light from a mirror serves as the "transfer leg" to the next mirror in the series, while the transmitted light goes to a detector ('314 Patent, col. 3:19-24). Because reflection is often more efficient than transmission for the relevant optical coatings, this design purports to reduce signal loss as light cascades through the system, allowing for a compact, polygonal arrangement of many detectors ('314 Patent, Fig. 5-6; col. 7:29-39).
- Technical Importance: This optical architecture was designed to increase the number of distinct fluorescent signals that could be simultaneously measured from a single sample, enhancing the data-gathering capacity of instruments like flow cytometers ('314 Patent, col. 3:1-5).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶24).
- The essential elements of independent claim 1 include:
- An optical instrument for fluorescence analysis comprising a plurality of lasers and a light collector.
- A plurality of dichroic mirrors arranged to receive a transfer beam from the light collector.
- The mirrors have a partially reflective surface that splits light into a "transfer leg" and a "transmitted detector leg."
- A majority of the dichroic mirrors receive light from the partially reflective surface of another dichroic mirror.
- A plurality of detectors are positioned to receive light from the detector leg of an associated mirror.
- The complaint reserves the right to assert other claims (Compl. ¶24).
U.S. Patent No. 7,129,505 - "Fluorescence detection instrument with reflective transfer legs for color decimation," issued October 31, 2006
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the '314 patent, the '505 patent addresses the same technical challenge of enabling more robust and higher-plex multicolor fluorescence detection than prior art systems allowed ('505 Patent, col. 1:11-16, col. 2:65-col. 3:2).
- The Patented Solution: The '505 patent claims a "detector apparatus" that uses a similar optical architecture as the '314 patent. An output beam from a light collector is collimated along a projected optical axis. A plurality of dichroic mirrors are disposed along this axis, each separating light into a reflected beam and a transmitted beam. For each mirror, one beam is a transfer leg to the next mirror, and the other leads to a detector, with a majority of mirrors receiving a reflected beam from a preceding mirror ('505 Patent, Claim 1; Fig. 5).
- Technical Importance: The invention provides a modular and efficient design for separating and detecting many colors of light, supporting the advancement of high-parameter flow cytometry.
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶41).
- The essential elements of independent claim 1 include:
- A detector apparatus with a light collector and a "means for collimating" the output beam along a "projected optical axis."
- A plurality of dichroic mirrors disposed along the axis, each separating light into a reflected and a transmitted beam.
- At each mirror, one beam is a "transfer leg" to the next mirror, and the other carries light to a detector.
- A majority of the mirrors receive light from a reflected beam from another mirror.
- The complaint reserves the right to assert other claims (Compl. ¶41).
U.S. Patent No. 7,201,875 - "Fixed mounted sorting cuvette with user replaceable nozzle," issued April 10, 2007
Technology Synopsis
The patent addresses the operational problem of component alignment in flow cytometers, which often requires frequent and complex user adjustments ('875 Patent, col. 2:24-33). The invention is a flow cell with a nozzle mounted on a user-removable "nozzle key" that inserts into a "registered position," which is defined by hard planar surfaces. This design allows for precise, repeatable placement of the nozzle after removal for cleaning or replacement, without requiring realignment of the flow cell or associated optics ('875 Patent, Abstract; col. 6:40-50).
Asserted Claims
Independent claim 1 is asserted (Compl. ¶57).
Accused Features
The complaint alleges that the CytoFLEX SRT Cell Sorter products include a flow cell with a removable nozzle positioned on a nozzle holder that is held in a registered position by contact with hard planar surfaces, thereby infringing the '875 patent (Compl. ¶¶58-65).
U.S. Patent No. 7,787,197 - "Beam-adjusting optics," issued August 31, 2010
Technology Synopsis
The patent addresses the need for precise, high-resolution adjustment of a laser's focal spot onto the core stream in an optical analyzer ('197 Patent, col. 1:40-45). The invention proposes "beam-adjusting optics," such as a movable long-focal-length lens, placed in the light path between the laser source and the primary focusing lens. Moving this adjusting lens in a plane perpendicular to the light path provides a de-magnified, and therefore very fine, adjustment of the final focal spot's position, simplifying the alignment process ('197 Patent, Abstract; col. 2:8-17).
Asserted Claims
Independent claim 1 is asserted (Compl. ¶75).
Accused Features
The complaint alleges the accused products contain beam-adjusting optics, including an adjustable lens, positioned between the laser source and the focusing lens that satisfy the patent's claimed mathematical relationships for focal lengths and distances (Compl. ¶¶79-82).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant’s CytoFLEX, CytoFLEX S, and CytoFLEX LX Flow Cytometer analyzer products ("Accused Analyzer Products"), and the CytoFLEX SRT Benchtop Cell Sorter products ("Accused Cell Sorter Products") (Compl. ¶¶13-14).
Functionality and Market Context
The accused products are analytical instruments that use lasers to excite fluorescently labeled particles, such as cells, as they pass through a flow cell (Compl. ¶19). The emitted light is then collected and analyzed. The complaint alleges these products incorporate a "Wavelength Division Multiplexer (WDM)" module containing optical filters and detectors to separate and measure fluorescent signals of different colors (Compl. ¶28). The Accused Cell Sorter Products are further alleged to include a removable nozzle assembly for generating droplets used in cell sorting (Compl. ¶¶20, 64). The complaint alleges these products are marketed for use in research and clinical applications and represent an extension of Defendant's flow cytometry platform (Compl. ¶¶16, 19). An instructional diagram from Defendant's materials shows how the nozzle module is inserted into the sorter until it locks into place with a click (Compl. ¶65).
IV. Analysis of Infringement Allegations
'314 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an optical instrument for fluorescence analysis...comprising, a plurality of lasers...a light collector | The Accused Products are optical instruments for fluorescence analysis that include two to six lasers and a fiber ferule that functions as a light collector. | ¶25-27 | col. 6:28-40 |
| a plurality of dichroic mirrors arranged to receive the transfer beam...having a partially reflective surface splitting the light into a transfer leg and a transmitted detector leg | The Accused Products contain a Wavelength Division Multiplexer (WDM) module with optical filters alleged to function as dichroic mirrors, splitting light into a reflected beam and a transmitted beam. | ¶28-29 | col. 6:45-56 |
| a majority of the dichroic mirrors receiving light from the partially reflective surface of another dichroic mirror | As illustrated in a diagram from Defendant's technical documents, each optical filter in the WDM module (other than the first) allegedly receives a reflected beam from the previous optical filter. | ¶30 | col. 7:6-14 |
| a plurality of detectors...to receive light from the detector leg thereof | The WDM module includes a plurality of fiber array photo detectors (FAPDs), each associated with an optical filter and positioned to receive the transmitted beam. | ¶31 | col. 7:14-21 |
Identified Points of Contention
- Scope Questions: A central question may be whether the "optical filters" within the accused WDM module meet the claim limitation of "dichroic mirrors." The analysis will likely focus on whether the term should be limited to specific structures disclosed in the patent's embodiments or given a broader functional meaning.
- Technical Questions: The infringement theory relies heavily on the assertion that the accused WDM uses the reflected beam as the primary transfer leg. Evidence for this appears to come from Defendant's own product diagram (cited at Compl. ¶29). A key factual question will be whether this diagram accurately reflects the physical operation of the device and whether a majority of the mirrors in the cascade operate in this specific manner as required by the claim.
'505 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A detector apparatus...comprising a light collector that collects light...and forms an output beam for analysis | The Accused Products are a detector apparatus and include a fiber ferule that collects fluorescent light from the flow cell and forms an output beam. | ¶42-43 | col. 5:29-33 |
| a means for collimating said output beam, the collimated output beam having a projected optical axis | The WDM module receives collected light via a fiber optic cable and collimates the output beam for analysis. | ¶44 | col. 6:41-45 |
| a plurality of dichroic mirrors disposed along the projected optical axis...each...separates light into a reflected beam and a transmitted beam | Optical filters in the WDM module are alleged to operate as dichroic mirrors, separating light into a reflected beam and a transmitted beam. | ¶45 | col. 7:46-51 |
| wherein, at each mirror, one of the...beams is a transfer leg carrying the beam further to the next dichroic mirror and the other is a leg carrying light to a detector | In the WDM module, each optical filter allegedly splits the beam into a reflected leg (carried to the next filter) and a transmitted leg (carried to a detector). | ¶46 | col. 8:1-5 |
| wherein a majority of the dichroic mirrors receives light from a reflected beam coming from another dichroic mirror | Each optical filter in the WDM module (other than the first) is alleged to receive light from a reflected beam coming from the previous optical filter. | ¶47 | col. 8:6-9 |
Identified Points of Contention
- Scope Questions: The analysis will turn on the construction of "means for collimating said output beam." Under 35 U.S.C. § 112(f), this term's scope is limited to the corresponding structure described in the specification (a "collimating lens 145") and its equivalents. The court will first need to determine the claimed function and corresponding structure before assessing whether the accused WDM module contains an equivalent structure.
- Technical Questions: As with the '314 patent, a core factual question is whether the accused WDM module's actual light path relies on the reflected beam as the transfer leg for a majority of its optical elements, as alleged in the complaint.
V. Key Claim Terms for Construction
Term: "dichroic mirror" (asserted in '314 and '505 patents)
- Context and Importance: The infringement allegations for both the '314 and '505 patents depend on the accused "optical filters" being construed as "dichroic mirrors." Practitioners may focus on this term because Defendant could argue that its components are standard "band pass filters" that do not meet the structural or functional characteristics of the "dichroic mirrors" arranged in the novel reflective cascade taught by the patents.
- Intrinsic Evidence for a Broader Interpretation: The specification uses "dichroic mirror" and "beam splitter" almost interchangeably, suggesting a functional definition related to splitting light by wavelength. For example, it states "a first beam splitting element 151 which is a dichroic mirror" ('314 Patent, col. 6:45-46).
- Evidence for a Narrower Interpretation: The patent describes the mirrors as having specific "coatings which allows transmission of one band of optical signals, while reflecting light in another band" and being arranged in specific polygonal or zigzag patterns ('314 Patent, col. 6:52-56; Figs. 5-6). A party could argue the term is limited by these disclosed embodiments.
Term: "a majority of the dichroic mirrors receiving light from the partially reflective surface of another dichroic mirror" (asserted in '314 patent; similar language in '505 patent)
- Context and Importance: This limitation defines the core novelty of the reflective transfer leg architecture. The dispute will center on the factual question of how the accused WDM module functions. Practitioners may focus on this term because it is the central technical distinction over prior art that used the transmitted leg for transfer.
- Intrinsic Evidence for a Broader Interpretation: The claim language is functional. Any arrangement where more than half of the mirrors in a series pass a reflected beam to the next mirror could be argued to fall within its scope. The patent abstract describes the invention broadly as "using reflective transfer legs from multiple beam splitters" ('314 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification only discloses embodiments with specific zigzag (Fig. 5) or star-shaped (Fig. 6) reflective paths. A defendant might argue the claim should be limited to these specific compact polygonal arrangements and not read on any arbitrary series of mirrors.
VI. Other Allegations
Indirect Infringement
The complaint alleges active inducement of infringement for all four patents. The allegations are based on Defendant providing customers with instructional and promotional materials, such as user manuals, product literature, and websites, that allegedly instruct on the use of the accused products in a manner that directly infringes the patents-in-suit (Compl. ¶¶34-35, 50-51, 68-69, 85-86).
Willful Infringement
The complaint alleges willful infringement for all four patents, asserting that Defendant had pre-suit knowledge of the patents and the infringing nature of its products. This knowledge is alleged to have been established through Information Disclosure Statements filed during prosecution of Defendant's own patents ('314, '505, '197 patents), an examiner citation ('875 patent), and, most notably, Defendant's acquisition of the '197 patent inventor's company and subsequent employment of the inventor as CTO (Compl. ¶¶33, 49, 67, 84).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical mapping: Does the optical architecture of Defendant's WDM module, as evidenced by its product documentation and physical operation, functionally align with the central inventive concept of the '314 and '505 patents—namely, the use of a reflected beam as the primary transfer leg for a majority of mirrors in a color-decimation cascade?
- A second key issue will be one of structural scope and equivalence: For the '875 patent, does the accused sorter's "nozzle holder" constitute the claimed "removable nozzle key" held in a "registered position" with the specified hard planar contacts? For the '197 patent, do the accused optics possess the specific lens arrangement and satisfy the mathematical relationships between focal lengths and distances required by the claims?
- A significant question for damages will be willfulness, particularly for the '197 patent: The court will examine what knowledge and intent can be imputed to Defendant based on its acquisition of the inventor's company and the inventor's subsequent role as a CTO involved in the development of the accused products.