DCT

1:17-cv-00600

Thermo Fisher Scientific Inc v. Agilent Tech Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00600, D. Del., 06/07/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation, transacts business in the state, maintains a registered agent there, and has allegedly committed acts of infringement in or directed at Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s inductively coupled plasma mass spectrometer (ICP-MS) products infringe three patents related to methods and apparatuses for removing unwanted interfering ions to improve analytical accuracy and sensitivity.
  • Technical Context: The technology at issue is mass spectrometry, a highly sensitive analytical technique used to determine the elemental composition of samples, which is critical in fields such as environmental testing, semiconductor manufacturing, and pharmaceutical analysis.
  • Key Procedural History: The complaint details extensive pre-suit history, including a November 2012 notice letter from Plaintiff to Defendant regarding alleged infringement. Following correspondence in which Defendant challenged patent validity, Plaintiff initiated reissue proceedings for two of the original patents ('470 and '788), which subsequently reissued as the '386 and '553 patents-in-suit after the USPTO considered prior art submitted by Defendant. This history is central to the allegations of willful infringement.

Case Timeline

Date Event
1998-09-16 Priority Date for U.S. Patent Nos. RE45,386 and 7,230,232
2002-05-13 Priority Date for U.S. Patent No. RE45,553
2007-04-10 Issue Date of U.S. Patent No. 7,202,470 (predecessor to '386)
2007-05-01 Issue Date of U.S. Patent No. 7,211,788 (predecessor to '553)
2007-06-12 Issue Date of U.S. Patent No. 7,230,232
2009-01-01 Agilent allegedly began marketing the 7700 Series
2012-01-01 Agilent allegedly began marketing the 8800 ICP-QQQ
2012-11-09 Plaintiff sent notice letter to Defendant alleging infringement
2013-09-19 Plaintiff submitted '470 and '788 patents for reissue proceedings
2014-01-01 Agilent allegedly began marketing the 7900 ICP-MS
2015-01-01 Agilent allegedly began marketing the 7800 ICP-MS
2015-02-24 Issue Date of U.S. Reissue Patent No. RE45,386 ('386 Patent)
2015-06-09 Issue Date of U.S. Reissue Patent No. RE45,553 ('553 Patent)
2016-01-01 Agilent allegedly began marketing the 8900 ICP-QQQ
2017-05-24 Original Complaint filed
2018-06-07 Third Amended Complaint filed

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

U.S. Reissue Patent No. RE45,386 - “Means for Removing Unwanted Ions from an Ion Transport System and Mass Spectrometer”

The Invention Explained

  • Problem Addressed: In inductively coupled plasma mass spectrometry (ICP-MS), ion sources generate both desired analyte ions and unwanted "artefact ions" (e.g., from the argon plasma gas). When an artefact ion has the same mass-to-charge ratio as an analyte ion (an "isobaric interference"), it becomes difficult to distinguish the two, impairing measurement accuracy (RE45,386 Patent, col. 1:35-48). Furthermore, using a standard collision cell to remove these initial artefact ions can inadvertently create new interfering ions inside the cell itself (RE45,386 Patent, col. 2:27-34).
  • The Patented Solution: The patent describes a tandem mass spectrometer (MS/MS) architecture that places a first mass filter (an "ion optical device") before the collision cell. This first filter is configured to pre-select only ions having the target mass-to-charge ratio, rejecting other ions that could potentially react within the collision cell to form new interferences (RE45,386 Patent, col. 10:45-67). The collision cell then removes the original artefact ions that passed through the first filter, and a second mass analyzer detects the purified analyte ions. This pre-filtering is designed to "substantially to minimize the formation in the collision cell of interfering artefact ions" (RE45,386 Patent, col. 10:60-63).
  • Technical Importance: This approach significantly enhances detection sensitivity and accuracy for elements prone to isobaric interferences, a fundamental limitation in conventional single-quadrupole ICP-MS instruments (Compl. ¶44, 46).

Key Claims at a Glance

  • The complaint asserts independent apparatus claim 28 and independent method claim 13.
  • Independent Claim 28 (Apparatus):
    • An inductively coupled plasma ion source generating first atomic ions and interfering artefact ions.
    • An ion optical device configured to mass select ions at the first mass-to-charge ratio, thereby removing other ions.
    • A collision cell to receive the mass-selected ion beam and remove the artefact ions.
    • The ion optical device is configured substantially to minimize the formation of new interfering artefact ions in the collision cell.
    • A mass analyzer to receive the ion beam from the collision cell and detect the first atomic ions.
  • Independent Claim 13 (Method):
    • Generating an ion beam including analyte and unwanted ions.
    • Mass selecting the ion beam at the analyte mass-to-charge ratio.
    • Transmitting the selected beam into a collision cell.
    • The mass selecting step is effective to substantially minimize formation of new interfering ions in the cell.
    • Receiving the beam from the cell at a mass analyzer and analyzing it at the same mass-to-charge ratio.
  • The complaint reserves the right to assert additional claims (Compl. ¶37).

U.S. Patent No. 7,230,232 - “Means for Removing Unwanted Ions from an Ion Transport System and Mass Spectrometer”

The Invention Explained

  • Problem Addressed: The performance of ICP-MS instruments is degraded by two main factors: unwanted neutral gas components from the plasma source that create background noise, and the "gas load" from the source that increases pressure in the collision cell, potentially creating new artefact ions ('232 Patent, col. 2:45-54).
  • The Patented Solution: The invention introduces an "ion optical device" upstream of the collision cell specifically configured to "reduce gas loading" from the ion source ('232 Patent, col. 8:43-47). This is achieved in part by creating an intermediate, separately pumped vacuum chamber between the source and the collision cell, which allows the neutral gas to disperse and be pumped away before reaching the cell ('232 Patent, Fig. 2; col. 7:36-44). The solution also involves deflecting the ion beam off its original axis, which separates the charged ions from neutral particles that continue on a straight path, thereby reducing background noise ('232 Patent, col. 8:10-20).
  • Technical Importance: By isolating the collision cell from the high gas load of the plasma source and filtering out neutral particles, this design reduces noise and unwanted side reactions, leading to improved sensitivity and more reliable measurements (Compl. ¶78, 80).

Key Claims at a Glance

  • The complaint asserts apparatus claim 13 (dependent on 1, 11, 12) and method claim 32 (dependent on 23, 30). The analysis focuses on the independent base claims.
  • Independent Claim 1 (Apparatus):
    • An ion source generating a beam with unwanted gas and artifact ions.
    • A collision cell to receive the beam and be pressurized to remove artifact ions.
    • An ion optical device upstream of the collision cell configured to reduce gas loading from the source on the cell.
    • A mass-to-charge ratio analyzer to receive the beam from the collision cell and produce a mass spectrum.
  • Independent Claim 23 (Method):
    • Generating an ion beam with unwanted components.
    • Reducing gas loading from the source on a collision cell, occurring upstream of the cell.
    • Pressurizing the collision cell to remove artifact ions.
    • Receiving in the cell an ion beam substantially free of neutral gas components from the source.
    • Receiving the beam from the cell in a mass-to-charge ratio analyzer.
  • The complaint reserves the right to assert additional claims (Compl. ¶69, 97).

U.S. Reissue Patent No. RE45,553 - “Mass Spectrometer and Mass Filters Therefor”

  • Technology Synopsis: This patent addresses the degradation of high-resolution mass filters caused by the deposition of rejected ion material on their surfaces. It proposes a solution using two mass filter stages in series: a first, lower-resolution "coarse" filter removes the majority of the ion beam, passing only a narrow sub-range of mass-to-charge ratios. The second, high-resolution "primary resolving filter" then analyzes this pre-cleaned beam, and because it has to reject far fewer ions, it suffers from less material deposition, thereby extending its operational lifetime and accuracy ('553 Patent, col. 2:19-28, col. 4:6-15).
  • Asserted Claims: Independent method claim 32 is asserted (Compl. ¶121, 135).
  • Accused Features: The complaint alleges that the "single-quad" mode of the Agilent 8800 and 8900 products infringes. In this mode, the first quadrupole (Q1) allegedly operates as a "first mass filter stage" by acting as an adjustable bandpass filter, while the second quadrupole (Q2) acts as the "second mass filter stage" to perform the final analysis (Compl. ¶126, 127, 140-141).

III. The Accused Instrumentality

Product Identification

  • The complaint accuses the Agilent 8800 and 8900 ICP-QQQ Mass Spectrometers, as well as the Agilent 7700, 7800, and 7900 ICP-MS Mass Spectrometer Series (Compl. ¶19-20, 24-26).

Functionality and Market Context

  • The accused Agilent 8800 and 8900 products are described as triple quadrupole (QQQ) mass spectrometers. They comprise an inductively coupled plasma (ICP) ion source, a first quadrupole mass filter (Q1), an octopole collision/reaction cell, and a second quadrupole mass filter (Q2) (Compl. ¶21). The complaint alleges that in certain user-selectable modes, such as "MS/MS mode," Q1 is driven as a mass filter to pre-select ions before they enter the collision cell (Compl. ¶45). The image provided in the complaint from Agilent's marketing materials illustrates this principle of pre-selecting desired ions (¹⁰³Rh⁺) while rejecting others before the collision cell. (Compl. ¶46, p. 14).
  • The Agilent 7700, 7800, and 7900 series are single-quadrupole ICP-MS instruments which are also alleged to infringe the '232 patent. The complaint alleges these systems incorporate an "off-axis Omega Lens" that acts as a "double deflector" to guide ions and reject neutral particles, as well as a collision/reaction cell to remove interferences (Compl. ¶83, 84, 86). The image of the "Omega Lens" from an Agilent poster explicitly labels "First Deflection" and "Second Deflection" points, which the complaint uses to support its infringement theory (Compl. ¶84, p. 29). Another image shows a component labeled "Deflector" in the 7800 and 7900 models (Compl. ¶90, p. 34).
  • The complaint alleges the product families are structurally and operationally similar for the purposes of infringement, with the 8900 being the "2nd generation" of the 8800 (Compl. ¶22, 23, 27).

IV. Analysis of Infringement Allegations

RE45,386 Infringement Allegations

Claim Element (from Independent Claim 28) Alleged Infringing Functionality Complaint Citation Patent Citation
an inductively coupled plasma ion source for generating ions from a sample, the generated ions including first atomic ions having a first mass-to-charge ratio and artefact ions... that interferes... The Agilent 8800 and 8900 products include an ICP ion source that generates both desired analyte ions and interfering "artefact ions," which Agilent marketing materials refer to as causing "spectral interference." ¶43-44 col. 10:29-36
an ion optical device... configured to mass select at least a portion of the ion beam... at the first mass-to-charge ratio, thereby removing, from the ion beam, ions not having the first mass-to-charge ratio In "MS/MS mode," the first quadrupole (Q1) is allegedly driven as a mass filter with unit mass resolving power, allowing only ions with the selected mass-to-charge ratio to pass through to the collision cell. ¶45 col. 10:37-44
a collision cell disposed to receive... a mass selected ion beam from the ion optical device and configured to remove... artefact ions... The instruments contain a collision/reaction cell (octopole) located after Q1, which is pressurized with gas to remove interfering ions from the beam that was pre-selected by Q1. ¶46 col. 10:45-51
the ion optical device being configured substantially to minimize the formation in the collision cell of interfering artefact ions... By pre-selecting ions with Q1 before the collision cell, the accused products allegedly prevent other ions from entering the cell and reacting with the cell gas (e.g., NH₃) to form new interfering products, as depicted in a diagram from an Agilent poster. This diagram shows the principle of operation. (Compl. p. 14, Fig. 9). ¶46 col. 10:51-55
a mass analyzer disposed to receive... the mass selected ion beam from the collision cell... being configured to mass analyze the received ion beam at the same mass-to-charge ratio... The second quadrupole (Q2) is a mass analyzer positioned after the collision cell. It is allegedly configured to mass analyze the ion beam at the same mass-to-charge ratio set on Q1 to detect the target atomic ions. ¶47 col. 10:56-67

Identified Points of Contention

  • Scope Questions: A likely point of dispute will be the meaning of "configured substantially to minimize the formation... of interfering artefact ions." Defendant may argue that its Q1 is primarily configured as a general bandpass filter and that any minimization of new artefact formation is an inherent, but not explicitly configured, result of that primary function. The complaint cites Defendant's alleged admission in an IPR petition regarding the meaning of "configured to" in an attempt to counter this (Compl. ¶45).
  • Technical Questions: The central technical question is whether the operation of Q1 in the accused MS/MS mode meets the specific functional requirement of minimizing the formation of new interferences in the collision cell, as opposed to simply removing existing interferences from the beam.

7,230,232 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an ion source for generating an ion beam from a sample introduced into a plasma, the beam containing unwanted gas components and artifact ions All accused products (7700, 7800, 7900, 8800, 8900) use an ICP source that generates an ion beam containing desired ions as well as unwanted components, which the complaint equates with "contamination and spectral interference" described in Defendant's literature. ¶77-78, 85-86 col. 8:36-39
a collision cell within an evacuation chamber... arranged to be pressurized with a target gas for removing unwanted artifact ions... All accused products allegedly contain a collision/reaction cell within a vacuum chamber that can be pressurized with a gas (e.g., helium) to remove interfering artifact ions from the ion beam. ¶79, 87 col. 8:39-43
an ion optical device configured upstream of the collision cell to reduce gas loading from the ion source on the collision cell The complaint alleges that the accused products contain an "ion optical device" upstream of the collision cell to reduce gas loading. For the 8800/8900, this is identified as Q1. For the 7000-series, it is identified as an "off-axis Omega Lens" or "double deflector" that rejects neutral gas components. The complaint includes images of a "Deflector" in the 7800/7900 models to support this. (Compl. p. 34). ¶80, 88 col. 8:43-47
a mass-to-charge ratio analyzer... arranged to receive... the ion beam from the collision cell and to mass analyze the received ion beam... All accused products use a quadrupole mass analyzer (identified as Q2 in the 8800/8900) located after the collision cell to receive the filtered ion beam and produce a mass spectrum. ¶81, 89 col. 8:48-53

Identified Points of Contention

  • Scope Questions: The construction of "ion optical device configured... to reduce gas loading" will be critical. The dispute may focus on whether this requires a dedicated component or if a standard component (like a mass filter or a lens) that has the effect of reducing gas load meets the limitation.
  • Technical Questions: For dependent claims asserting a "double deflector," a key question will be whether the accused "Omega Lens" in the 7000-series products structurally and functionally meets the patent's definition. The complaint's reliance on a diagram from Defendant's own poster showing a "double-deflects" path (Compl. ¶84, p.29) and an alleged admission from an IPR (Compl. ¶84) suggests this will be a significant point of evidence.

V. Key Claim Terms for Construction

From the '386 Patent

  • The Term: "configured substantially to minimize the formation in the collision cell of interfering artefact ions" (Claim 28)
  • Context and Importance: This functional language is the core of the asserted invention. The infringement case hinges on whether the accused Q1, when operated in MS/MS mode, is "configured" for this specific purpose. Practitioners may focus on this term because its interpretation will determine whether simply having the effect of minimizing new interferences is sufficient, or if the device must be specifically designed or programmed for that primary purpose.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's disclosure repeatedly emphasizes the goal of solving the problem of new artefact formation, stating the invention provides "a means whereby the formation, or re-formation, of unwanted artefact ions in a collision cell... may be minimised" (RE45,386 Patent, col. 3:13-17). This purpose-driven language may support a construction that covers any structure that achieves this stated function.
    • Evidence for a Narrower Interpretation: The specific embodiment describes using a quadrupole as a mass-selective "auxiliary mass filter" (RE45,386 Patent, col. 5:4-7). Defendant could argue this ties the term to a specific type of mass-selective operation, rather than any general filtering that might coincidentally reduce reactions.

From the '232 Patent

  • The Term: "deflector" / "double deflector" (Claims 12-13)
  • Context and Importance: Infringement by the 7000-series and 8000-series products depends on their "Omega Lens" being classified as a "double deflector." The definition of this structural term is therefore dispositive for these claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the deflector functionally as deflecting the "ion beam away from the original instrument axis" ('232 Patent, col. 8:12-14). This could support a broad interpretation covering any component that changes the beam's trajectory twice.
    • Evidence for a Narrower Interpretation: The specification provides a specific example, stating the deflector is "advantageously in the form of two small cylindrical electrostatic sectors, cross-coupled and in series" ('232 Patent, col. 8:15-18). A defendant could argue this language limits the term "deflector" to this specific structure or its direct equivalent, potentially creating a dispute if the "Omega Lens" has a different design.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all three patents. It asserts that Defendant intentionally encourages infringement by providing customers with publications, such as the "Agilent 8800 Posters," and instructions that teach them how to operate the accused products in an infringing manner (e.g., using the MS/MS mode) (Compl. ¶53-54, 97-98, 134-135).
  • Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. Pre-suit knowledge is alleged to date back to a November 9, 2012 notice letter for the '232 patent and the predecessors to the '386 and '553 patents (Compl. ¶63, 94, 117, 129, 143). The complaint emphasizes that the '386 and '553 patents reissued after the USPTO considered prior art cited by Defendant, allegedly strengthening the basis for objective recklessness (Compl. ¶32-33, 49). Post-suit knowledge is based on the service of the original complaint in August 2017 (Compl. ¶49).

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

  • A central issue will be one of claim construction and function: can the functional language "configured substantially to minimize the formation [of new] artefact ions" in the '386 patent be met by a user-selectable mode on the accused products, or will the court require evidence that the device's primary design purpose, rather than just its capability, matches the claim? This question extends to the "configured... to reduce gas loading" limitation in the '232 patent.
  • A key evidentiary question will concern structural identity and admissions: does Agilent's "Omega Lens" meet the definition of a "double deflector" as required by the '232 patent? The resolution of this issue may depend heavily on the weight the court gives to alleged admissions and diagrams from Agilent's own technical marketing materials and related IPR filings.
  • The case will present a focused inquiry on willfulness and the impact of reissue: given the extensive pre-suit notice and the fact that two asserted patents successfully emerged from reissue proceedings that considered Defendant's invalidity arguments, a critical question will be whether Defendant's continued sales of the accused products constituted objective recklessness sufficient to support a finding of willful infringement.