DCT
8:12-cv-02206
Masimo Corp v. Mindray DS USA Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Masimo Corporation (Delaware) and Masimo International SARL (Switzerland)
- Defendant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd (People's Republic of China)
- Plaintiff’s Counsel: Knobbe, Martens, Olson & Bear, LLP
- Case Identification: 8:12-cv-02206, C.D. Cal., 07/07/2014
- Venue Allegations: Venue is alleged to be proper based on an agreement between the parties consenting to jurisdiction in the Central District of California, as well as on Defendant's business activities within the district.
- Core Dispute: Plaintiff alleges that Defendant’s noninvasive patient monitoring devices, which incorporate "Mindray SpO2 Technology," infringe nine U.S. patents related to signal processing for physiological measurements and optical probe design.
- Technical Context: The technology at issue is pulse oximetry, which involves noninvasively measuring blood oxygen saturation and pulse rate by passing light through body tissue, and the signal processing methods used to extract accurate data from signals corrupted by noise, particularly from patient motion.
- Key Procedural History: The complaint details an extensive contractual history, beginning with a Purchasing and Licensing Agreement on November 13, 2002, under which Defendant was allegedly required to integrate and promote Plaintiff's patented Masimo SET® technology. Plaintiff alleges Defendant breached this agreement and subsequently developed and sold its own infringing technology. The complaint also states that Plaintiff provided pre-suit notice of infringement for six of the nine patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 1991-03-07 | Priority Date for ’222, ’060, ’986 Patents |
| 1997-04-14 | Priority Date for ’952, ’194, ’958, ’154 Patents |
| 1999-08-26 | Priority Date for ’086, ’533 Patents |
| 1999-12-14 | U.S. Patent No. 6,002,952 Issued |
| 2001-07-17 | U.S. Patent No. 6,263,222 Issued |
| 2002-11-13 | Masimo and Mindray enter Original Purchasing and Licensing Agreement |
| 2003-06-17 | U.S. Patent No. 6,580,086 Issued |
| 2004-03-02 | U.S. Patent No. 6,699,194 Issued |
| 2004-06-01 | U.S. Patent No. 6,745,060 Issued |
| 2007-05-08 | U.S. Patent No. 7,215,986 Issued |
| 2008-05-01 | Alleged Infringing Activity Begins (approx. date) |
| 2009-02-10 | U.S. Patent No. 7,489,958 Issued |
| 2009-03-24 | U.S. Patent No. 7,509,154 Issued |
| 2012-02-27 | Masimo notifies Mindray of a contractual dispute |
| 2012-07-24 | U.S. Patent No. 8,229,533 Issued |
| 2014-07-07 | Second Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,002,952 - "Signal Processing Apparatus and Method"
The Invention Explained
- Problem Addressed: The patent’s background section describes the difficulty of extracting a desired physiological signal, such as a plethysmographic wave used in pulse oximetry, from a composite measured signal that is corrupted by a secondary signal portion, such as noise from patient motion. Conventional filtering techniques are often ineffective when the noise and the desired signal overlap in the frequency spectrum (ʼ952 Patent, col. 1:11-24, col. 2:34-40).
- The Patented Solution: The invention proposes a method and apparatus to analyze two measured signals (e.g., from red and infrared light) by modeling them as containing both desired and undesired portions. The solution involves transforming the measured signals into a spectral domain (e.g., via Fourier transform) and using coefficients derived from the relationship between the signals to mathematically "scrub" the unwanted noise portions, thereby isolating the clean physiological signal. The patent also discloses a rule-based method for determining pulserate by analyzing the spectral peaks of the cleaned signal (ʼ952 Patent, Abstract; col. 6:15-28; FIG. 12).
- Technical Importance: This signal processing approach was designed to enable reliable physiological monitoring during periods of patient motion, a significant limitation for prior art pulse oximeters (Compl. ¶¶15-17).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying any particular claim (Compl. ¶60). Independent claim 1 is representative of the rule-based pulserate detection method.
- The essential elements of Claim 1 are:
- A physiological monitor with a detector producing a waveform related to heartbeats.
- A signal processor configured to transform the waveform into a spectral domain.
- The processor then identifies a series of spectral peaks and their corresponding frequencies.
- The processor applies a "plurality of rules" to these peaks and frequencies to determine a pulserate estimate.
- The complaint makes a general allegation of infringement against the patent as a whole.
U.S. Patent No. 6,263,222 - "Signal Processing Apparatus"
The Invention Explained
- Problem Addressed: The patent addresses the problem of separating a primary signal portion (e.g., arterial blood signal) from a secondary signal portion (e.g., motion-induced noise) in a measured physiological signal, particularly when little is known about either component and conventional filtering is ineffective ('222 Patent, col. 1:11-18, col. 2:48-56).
- The Patented Solution: The invention describes a signal processor that acquires two correlated signals, each containing primary and secondary portions. The processor generates a "secondary reference signal" by mathematically combining the two measured signals in a way that cancels out the primary signal portions, leaving a signal that is correlated only with the secondary (noise) portions. This reference signal is then fed into a correlation canceler to remove the noise from one of the original measured signals, yielding an approximation of the clean primary signal ('222 Patent, Abstract; FIG. 4a).
- Technical Importance: This method provides an adaptive system for noise cancellation in physiological monitoring, which can improve accuracy in challenging clinical environments where patient motion is common (Compl. ¶¶15-17).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying any particular claim (Compl. ¶65). Independent claim 1 is representative of the apparatus for generating and using a reference signal.
- The essential elements of Claim 1 are:
- A signal processor for receiving first and second signals, each with primary and secondary portions.
- The processor generates a "secondary reference signal" that is correlated with the secondary signal portions of both input signals.
- The processor has an input for this reference signal and an input for one of the original signals.
- The processor is configured to "substantially remove" a secondary signal portion from one of the original signals.
- The complaint makes a general allegation of infringement against the patent as a whole.
U.S. Patent No. 6,580,086 - "Shielded Optical Probe and Method"
- Technology Synopsis: This patent describes the physical design of an optical probe for physiological measurements. The invention focuses on using light shields and light-absorbent materials within the probe housing to reduce noise caused by ambient light and internal light reflections, thereby increasing measurement accuracy.
- Asserted Claims: The complaint does not specify claims; independent claims 1 and 12 are representative.
- Accused Features: The complaint alleges that "Mindray Reusable Sensors" infringe one or more claims of the ’086 Patent (Compl. ¶70).
U.S. Patent No. 6,699,194 - "Signal Processing Apparatus and Method"
- Technology Synopsis: This patent describes methods for determining a pulserate from a physiological signal. The invention involves transforming a signal into a spectral domain, identifying spectral peaks, and applying a set of rules to these peaks (such as analyzing harmonics and relative magnitudes) to derive a reliable pulserate estimate, particularly in the presence of noise.
- Asserted Claims: The complaint does not specify claims; independent claims 1, 3, 5, 8, 10, 14, and 15 are representative.
- Accused Features: The complaint alleges that "Mindray SpO2 Products and Systems" infringe one or more claims of the ’194 Patent (Compl. ¶76).
U.S. Patent No. 6,745,060 - "Signal Processing Apparatus"
- Technology Synopsis: This patent describes a signal processor that generates and uses a reference signal for noise cancellation. It acquires first and second correlated signals and combines them to create a secondary reference signal correlated with the noise portions. This reference is then used in a correlation canceler to remove noise from the original signals.
- Asserted Claims: The complaint does not specify claims; independent claims 1 and 23 are representative.
- Accused Features: The complaint alleges that "Mindray SpO2 Products and Systems" infringe one or more claims of the ’060 Patent (Compl. ¶81).
U.S. Patent No. 7,215,986 - "Signal Processing Apparatus"
- Technology Synopsis: This patent describes a signal processor for analyzing measured signals containing both primary (desired) and secondary (noise) components. It generates a reference signal correlated to the noise and uses a correlation canceler to remove that noise, thereby isolating the desired physiological information.
- Asserted Claims: The complaint does not specify claims; independent claims 1 and 41 are representative.
- Accused Features: The complaint alleges that "Mindray SpO2 Products and Systems" infringe one or more claims of the ’986 Patent (Compl. ¶86).
U.S. Patent No. 7,489,958 - "Signal Processing Apparatus and Method"
- Technology Synopsis: This patent discloses methods for determining pulserate from a physiological signal corrupted by noise. The invention involves transforming the signal into a spectral domain and applying rules to the resulting spectral peaks to identify the true pulserate frequency, distinguishing it from noise artifacts.
- Asserted Claims: The complaint does not specify claims; independent claims 1 and 16 are representative.
- Accused Features: The complaint alleges that "Mindray SpO2 Products and Systems" infringe one or more claims of the ’958 Patent (Compl. ¶91).
U.S. Patent No. 7,509,154 - "Signal Processing Apparatus"
- Technology Synopsis: This patent describes a signal processing system for physiological monitors. The system uses a processor to analyze measured signals, identify desired and undesired components, and apply signal processing techniques to remove the undesired components, improving the accuracy of physiological measurements.
- Asserted Claims: The complaint does not specify claims; independent claim 1 is representative.
- Accused Features: The complaint alleges that "Mindray SpO2 Products and Systems" infringe one or more claims of the ’154 Patent (Compl. ¶96).
U.S. Patent No. 8,229,533 - "Low-Noise Optical Probes For Reducing Ambient Noise"
- Technology Synopsis: This patent relates to the physical construction of optical probes, such as those used for pulse oximetry. The design focuses on features that reduce noise from ambient light, including the use of specific materials, shielding, and structural configurations that stabilize the probe on a patient's tissue.
- Asserted Claims: The complaint does not specify claims; independent claims 1, 11, and 16 are representative.
- Accused Features: The complaint alleges that "Mindray Disposable Sensors" infringe one or more claims of the ’533 Patent (Compl. ¶¶101, 28).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are identified as "Mindray SpO2 Products and Systems" (Compl. ¶26). This category includes, but is not limited to, the PM-50 Pulse Oximeter, PM-60 Pulse Oximeter, PM-7000, PM-8000, and PM-9000 series Patient Monitors, the VS-800 Vital Signs Monitor, and the BeneView T Series Patient Monitors (Models T5, T6, and T8) (Compl. ¶26). The complaint also accuses "Mindray Reusable Sensors" and "Mindray Disposable Sensors" (Compl. ¶¶27-28).
Functionality and Market Context
- The accused products are described as noninvasive patient monitoring devices that incorporate "Mindray SpO2 Technology," which is distinct from Plaintiff's licensed Masimo SET® technology (Compl. ¶24, ¶26). The complaint alleges these products are used for noninvasive patient monitoring and that Defendant has imported, marketed, sold, and distributed them in the United States (Compl. ¶¶24, 26). Defendant is also alleged to have provided user manuals instructing customers in the U.S. on how to use these devices (Compl. ¶29). The complaint does not provide specific technical details on the internal operation or algorithms of the "Mindray SpO2 Technology."
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain specific claim charts or a detailed, element-by-element mapping of asserted claims to accused functionality. The following tables summarize the infringement theory based on the language of representative independent claims and the general allegations in the complaint.
'952 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a detector responsive to physiological properties relating to heartbeats, said detector producing a detector output waveform | The accused products are pulse oximeters that necessarily include a detector for sensing light attenuated by pulsing blood flow. | ¶26 | col. 25:29-32 |
| a signal processor... configured to... transform said detector output waveform into a spectral domain waveform | The accused products are alleged to incorporate "Mindray SpO2 Technology," which performs signal processing on the detector waveform, allegedly including a transformation to a spectral domain. | ¶26, ¶60 | col. 23:49-53 |
| identify a series of spectral peaks and peak frequencies corresponding to said spectral peaks in said spectral domain waveform | The accused products' signal processing technology is alleged to identify spectral peaks and frequencies in the processed signal to determine physiological parameters. | ¶26, ¶60 | col. 23:54-58 |
| apply a plurality of rules to said spectral peaks and said peak frequencies in order to determine an estimate for said pulserate | The accused products' signal processing is alleged to apply a set of rules or algorithms to the identified spectral peaks to calculate a pulserate. | ¶26, ¶60 | col. 24:11-15 |
- Identified Points of Contention:
- Scope Questions: A central issue may be the scope of the term "plurality of rules." The question for the court will be whether this term is limited to the specific rule-based categories disclosed in the patent's specification or if it can be construed more broadly to cover any algorithm that uses logical steps to analyze spectral data to find a pulserate.
- Technical Questions: The complaint does not provide any evidence describing the actual algorithms used in the "Mindray SpO2 Technology." A key factual question will be what evidence demonstrates that the accused products' signal processing method performs the specific steps of transforming the signal to a spectral domain and applying a "plurality of rules" as required by the claim.
'222 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a signal processor for receiving a first signal... and a second signal... wherein said first and second secondary signal portions are correlated | The accused products receive signals from red and infrared light, with the noise components (secondary portions) being correlated due to their common origin (e.g., patient motion). | ¶26, ¶65 | col. 23:4-10 |
| said signal processor generating a secondary reference signal which is correlated with said first secondary signal portion and said second secondary signal portion | The accused products' signal processing technology is alleged to generate an internal reference signal that is correlated with the noise present in the detector signals. | ¶26, ¶65 | col. 23:11-14 |
| said signal processor having an input for said secondary reference signal and an input for one of said first and second signals | The accused products are alleged to use this generated reference signal internally within their signal processing architecture to perform noise cancellation on a measured signal. | ¶26, ¶65 | col. 23:15-18 |
| said signal processor being configured to substantially remove one of said first and second secondary signal portions from one of said first and second signals | The accused products' technology is alleged to use the reference signal to remove motion artifact noise from the measured physiological signals. | ¶26, ¶65 | col. 23:19-22 |
- Identified Points of Contention:
- Scope Questions: A potential dispute may arise over the definition of a "secondary reference signal." The question will be whether this term requires the specific mathematical generation method disclosed in the patent, or if it can read on any internally generated signal used for noise cancellation that is correlated with the noise in the measured signals.
- Technical Questions: The complaint provides no technical detail on whether the accused "Mindray SpO2 Technology" actually generates a reference signal by combining two measured signals for the purpose of adaptive noise cancellation. The central factual dispute will likely be whether the accused method operates in a manner consistent with the claimed generation and use of such a reference signal.
V. Key Claim Terms for Construction
- The Term: "plurality of rules" ('952 Patent, Claim 1)
- Context and Importance: This term is the functional core of the asserted method. The case may turn on whether the specific algorithms within the accused "Mindray SpO2 Technology" can be characterized as applying a "plurality of rules" to spectral data. Practitioners may focus on this term because its scope will determine whether infringement is found, as the complaint lacks specific allegations about what rules are used.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not restrict the "rules" to any particular type, suggesting that any set of logical or algorithmic steps applied to spectral peaks to derive a pulserate could fall within its scope.
- Evidence for a Narrower Interpretation: The specification provides a detailed embodiment of specific rules, including sorting peaks by magnitude, checking for harmonics, and applying different calculations based on the relationships between peak magnitudes and frequencies ('952 Patent, FIG. 18; col. 18:6–col. 20:30). A party could argue that "plurality of rules" should be construed as being limited to this disclosed class of spectral-analytic rules.
- The Term: "secondary reference signal" ('222 Patent, Claim 1)
- Context and Importance: The generation and use of this specific signal is a required step of the claimed noise cancellation method. Infringement will depend on whether the accused technology creates and uses a signal that meets this definition. Practitioners may focus on this term as it defines the novel mechanism for adaptive noise cancellation taught by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim defines the term functionally as a signal that is "correlated with said first secondary signal portion and said second secondary signal portion." A party might argue that any signal generated internally for noise cancellation that meets this functional correlation requirement falls within the scope, regardless of the precise mathematical method of its generation.
- Evidence for a Narrower Interpretation: The specification provides a specific mathematical basis for generating the reference signal, for example, by multiplying one measured signal by a coefficient and subtracting it from the other (
n'(t) = nλa(t)-ra*nλb(t)) ('222 Patent, col. 13:21-27). A party could argue that the term should be limited to signals generated in this manner or an equivalent thereof.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant induced infringement by U.S. customers by providing user manuals and demonstrations that instruct on the use of the accused products (Compl. ¶29). It also alleges inducement of its U.S. affiliate, Mindray USA, to directly infringe by selling and importing the accused products in the U.S. market (Compl. ¶30).
- Willful Infringement: Willfulness is alleged for all nine asserted patents (e.g., Compl. ¶61, ¶66). The complaint alleges pre-suit notice of infringement for the '952, '222, '086, '194, '060, and '986 patents, which may support a finding of pre-suit knowledge (Compl. ¶31). The extensive prior contractual relationship between the parties concerning Plaintiff's patented technology may also be presented as evidence of Defendant's knowledge of the patents.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of technical evidence: given the complaint's lack of specific, factual allegations about the inner workings of the "Mindray SpO2 Technology," what evidence will Plaintiff produce to demonstrate that the accused devices perform the specific signal processing steps required by the asserted claims, such as applying a "plurality of rules" to spectral data or generating a "secondary reference signal" for noise cancellation?
- A key legal question will be one of claim scope: can claim terms like "plurality of rules" be construed broadly to encompass any algorithm that analyzes spectral data to find a pulse rate, or will the court limit the term's scope to the specific types of harmonic and magnitude-based analyses disclosed in the patent's embodiments?
- The analysis of willfulness and intent will likely be influenced by the extensive prior contractual history between the parties. A core question for the fact-finder will be how this prior licensing relationship, where Defendant had access to and was allegedly obligated to use Plaintiff's patented technology, informs the assessment of Defendant's knowledge and intent regarding the asserted patents.