DCT
1:14-cv-00440
Alifax Holding Spa v. Alcor Scientific Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Alifax Holding SpA (Italy) and Sire Analytical Systems Srl (Italy)
- Defendant: Alcor Scientific Inc. (Rhode Island) and Francesco A. Frappa (Italy)
- Plaintiff’s Counsel: Manelli Selter PLLC; Pierce Atwood LLP
- Case Identification: 1:14-cv-00440, D.R.I., 03/17/2015
- Venue Allegations: Venue is asserted based on Defendant Alcor Scientific Inc. maintaining its principal place of business in Rhode Island.
- Core Dispute: Plaintiffs allege that Defendant’s erythrocyte sedimentation rate (ESR) analyzer infringes patents related to rapid blood analysis methods and apparatus, and further allege trade secret misappropriation by a former key employee who joined Defendant Alcor.
- Technical Context: The technology concerns automated clinical instruments for determining the erythrocyte sedimentation rate (ESR), a common blood test used to detect inflammation, with a focus on methods that reduce analysis time from an hour to seconds.
- Key Procedural History: The complaint alleges that Defendant Francesco Frappa, a former director at Plaintiff Sire, joined Defendant Alcor and, within a year, helped Alcor develop the accused competing product. Plaintiffs sent a cease and desist letter regarding patent infringement prior to filing suit, which Defendant Alcor allegedly refused. The complaint also alleges that an Alcor patent, listing Mr. Frappa as an inventor, misappropriates concepts developed at Sire.
Case Timeline
| Date | Event |
|---|---|
| 1999-11-08 | Priority Date for ’679 and ’107 Patents |
| 2002-10-07 | Defendant Frappa hired by Plaintiff Sire |
| 2003-10-14 | U.S. Patent No. 6,632,679 Issued |
| 2006-02-28 | U.S. Patent No. 7,005,107 Issued |
| 2011-09-01 | Defendant Frappa resigns from Plaintiff Sire |
| Late 2012 | Defendant Alcor allegedly introduces the iSED analyzer |
| 2014-03-07 | Plaintiffs send cease and desist letter to Defendant Alcor |
| 2015-03-17 | Amended Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,632,679 - Method to Determine the Speed of Sedimentation of Blood and Other Parameters Correlated Thereto, and Relative Apparatus, Issued October 14, 2003
The Invention Explained
- Problem Addressed: The patent’s background section identifies that prior methods for measuring ESR were slow, often taking an hour, required considerable volumes of blood, and relied on costly disposable containers or bulky, complex equipment with centrifugal means (Compl. ¶ 20; ’679 Patent, col. 1:21-48, col. 2:11-23).
- The Patented Solution: The invention claims a method for rapidly determining ESR by flowing a blood sample through a capillary container and then instantly interrupting that flow. This "stopped-flow" technique causes a rapid compaction and sedimentation of red blood cells, the optical density of which is measured "substantially simultaneously" with the stop to calculate the ESR, drastically reducing measurement time (’679 Patent, Abstract; col. 3:15-23).
- Technical Importance: This method enables the creation of compact, rapid ESR analyzers that can produce results in seconds rather than an hour, facilitating faster clinical diagnoses and integration with other blood analysis systems (’679 Patent, col. 2:46-53).
Key Claims at a Glance
- The complaint asserts "one or more claims," including at least independent claim 1 (Compl. ¶ 57).
- The essential elements of independent claim 1 include:
- A method for determining the speed of sedimentation of blood by detecting the optical density/absorbance of a sample.
- Sending the sample in a flow inside a capillary container.
- Instantly interrupting the flow of the blood sample inside the capillary.
- This interruption is for the purpose of determining a compaction and sedimentation of red cells.
- Making the optical detection substantially simultaneously with the instant interruption.
U.S. Patent No. 7,005,107 - Apparatus for Determining the Speed of Sedimentation of Blood and Other Parameters Correlated Thereto, Issued February 28, 2006
The Invention Explained
- Problem Addressed: As a divisional of the ’679 Patent, the ’107 Patent addresses the same problems of slow and cumbersome prior art ESR analysis devices (’107 Patent, col. 1:25-50).
- The Patented Solution: The invention is an apparatus that implements the "stopped-flow" method. It consists of a sample intake, a capillary container, a pump to circulate the blood, an optical sensor, a processing unit, and, critically, a "stop operatively coupled to the pump" that is configured to "instantly interrupt" the blood flow for measurement (’107 Patent, Abstract; Fig. 2).
- Technical Importance: The invention provides the physical framework for a compact and automated instrument capable of performing the rapid ESR analysis, making the technology practical for use in hospitals, labs, and mobile units (’107 Patent, col. 4:6-10).
Key Claims at a Glance
- The complaint asserts "one or more claims," including at least independent claim 1 (Compl. ¶ 57).
- The essential elements of independent claim 1 include:
- An apparatus with a blood sample-withdrawing organ, a capillary container, and a connecting circuit.
- A sensor in optical communication with the capillary.
- A processing unit to acquire and compare photometric data to determine ESR.
- A pump to circulate the blood sample.
- A "stop" operatively coupled to the pump, configured to "instantly interrupt the circulation" of the blood.
III. The Accused Instrumentality
- Product Identification: The accused product is the Alcor "iSED" ESR analyzer (Compl. ¶ 43).
- Functionality and Market Context: The complaint alleges the iSED is an automated ESR analyzer capable of producing blood test results in 20 seconds (Compl. ¶ 9, ¶ 44). This performance is alleged to be "just like Plaintiffs' ESR analyzers" and a significant improvement over traditional, hour-long methods (Compl. ¶ 9). The complaint asserts that, other than Plaintiffs’ own products, the iSED is the only ESR analyzer on the market with such rapid analysis capabilities (Compl. ¶ 9). Alcor is alleged to be in direct competition with Plaintiffs and to have sold the iSED to Plaintiffs' former customers (Compl. ¶¶ 9, 48). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the iSED analyzer practices the inventions of the ’679 and ’107 patents (Compl. ¶ 56). The following tables summarize the infringement theory for the lead independent claim of each patent based on the complaint's description of the accused product.
U.S. Patent No. 6,632,679 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| wherein the method instantly interrupts the flow of the blood sample flowing inside said capillary container | The complaint alleges that the iSED analyzer "practice[s] the claimed invention" which produces results in 20 seconds, thereby implying that its method of operation includes the claimed "instant interruption" of flow to enable rapid measurement. | ¶9, ¶56, ¶57 | col. 6:7-10 |
| and makes said detection substantially simultaneously with said instant interruption | The complaint does not describe the specific timing of the iSED's internal operations but alleges infringement of claim 1, which requires this step. The allegation is supported by the assertion that the iSED achieves the same rapid result as Plaintiffs' devices that embody the patented method. | ¶9, ¶56, ¶57 | col. 6:11-14 |
U.S. Patent No. 7,005,107 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a capillary container inside which the sample of blood is flowable | The complaint identifies the iSED as an "ESR analyzer" that analyzes blood samples, which suggests the presence of internal tubing or a capillary through which blood flows for analysis. | ¶9, ¶43 | col. 5:42-45 |
| a stop operatively coupled to the pump, the stop configured...to instantly interrupt the circulation of the sample of blood | The complaint broadly alleges that the iSED analyzer as a whole infringes, which implies that the apparatus contains components, including a "stop," that perform the functions recited in the claim. | ¶56, ¶57 | col. 6:7-10 |
- Identified Points of Contention:
- Technical Questions: A central evidentiary question will be whether the accused iSED analyzer actually operates using the "instant interruption" of flow claimed in the patents. The complaint does not provide technical details on the iSED's mechanism. Discovery will likely focus on the iSED's internal components and control software to determine if its function matches the claim limitations.
- Scope Questions: The complaint notes that Defendant Alcor filed its own patent ('886 patent) for determining blood aggregation rates using "ultrasound waves" (Compl. ¶ 46). This raises the question of whether the iSED operates via a different, potentially non-infringing technology (e.g., ultrasound-based agitation and measurement) rather than the "stopped-flow" mechanical principle of the patents-in-suit.
V. Key Claim Terms for Construction
The Term: "instantly interrupts" / "instant interruption"
Context and Importance: This phrase appears in the independent claims of both asserted patents and captures the core of the claimed invention. The outcome of the infringement analysis will heavily depend on whether the operation of the iSED analyzer, once fully understood, falls within the court's construction of this term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses phrases like "suddenly interrupt" and describes the effect as a "strong deceleration (stopped-flow)" (’679 Patent, col. 3:16-18). Plaintiffs may argue that "instantly" does not require a zero-time event but encompasses any rapid cessation of flow sufficient to cause the claimed cell compaction.
- Evidence for a Narrower Interpretation: The specification discloses an "instant stoppage pump" and alternatively "valve means" to achieve the interruption (’679 Patent, col. 5:48; col. 6:49-52). Defendants may argue these disclosures limit the term to a specific type of mechanical or electro-mechanical action, as opposed to a more gradual process like a pump motor spinning down.
The Term: "substantially simultaneously with said instant interruption"
Context and Importance: This term from the ’679 Patent method claim defines the critical timing between the flow stoppage and the optical measurement. Practitioners may focus on this term because if the iSED employs a waiting period between stopping flow and measuring, it may not infringe.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: "Substantially" is a term of approximation. The patent states that "at the same time as the pump 14 stops, the control and processing unit 20 commands the detector 17 to acquire the photometric data" (’679 Patent, col. 6:11-14), suggesting a direct cause-and-effect relationship rather than a literal same-femtosecond event.
- Evidence for a Narrower Interpretation: A defendant could argue that the phrase requires the measurement to commence at the moment of interruption. The description of the detection period taking between 1 and 30 seconds could be used to argue that if a measurement happens later in that window, it is not "substantially simultaneous" with the initial interruption event (’679 Patent, col. 6:15-16).
VI. Other Allegations
- Indirect Infringement: The complaint's first cause of action focuses on direct infringement under 35 U.S.C. § 271(a) and does not contain specific factual allegations to support claims for induced or contributory infringement (Compl. ¶ 57).
- Willful Infringement: The complaint alleges that Defendant Alcor had knowledge of the patents-in-suit at least as of 2011 or 2012, when it hired Plaintiffs' former employee, Mr. Frappa (Compl. ¶ 55). It further alleges post-suit knowledge based on a cease-and-desist letter sent in March 2014 (Compl. ¶ 50). The complaint requests a finding that the case is "exceptional," supported by the overarching allegations of trade secret misappropriation and the hiring of a key employee to create a directly competing product (Compl. ¶ 59).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of operative fact: does the accused iSED analyzer function by "instantly interrupting" blood flow to measure sedimentation, as claimed in the patents, or does it employ a different, non-infringing mechanism, such as the use of ultrasound waves as suggested by Defendant's own patent filings?
- The case will also turn on claim construction: the interpretation of the phrase "instantly interrupts" will be critical in determining whether the iSED's operational process, once revealed in discovery, falls within the scope of the asserted claims.
- Finally, a key theme will be the interplay between the patent and trade secret claims. The allegations that a former key employee of Plaintiffs developed the accused product for a direct competitor will likely heavily influence the judicial narrative concerning willfulness and potential damages, creating significant risk for the defendants beyond the technical infringement analysis.