1:19-cv-00301
Cytonome St LLC v. NanoCellect Biomedical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cytonome/ST, LLC (Delaware)
- Defendant: NanoCellect Biomedical, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Akin Gump Strauss Hauer & Feld LLP
- Case Identification: 1:19-cv-00301, D. Del., 02/12/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and therefore "resides" in the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s WOLF Cell Sorter, a microfluidic device, infringes seven patents related to high-throughput particle and cell sorting technology.
- Technical Context: The technology concerns microfluidic systems for sorting microscopic particles, such as biological cells, a critical process in fields like flow cytometry, bioprocessing, and life sciences research.
- Key Procedural History: The complaint describes the 2009 formation of the Plaintiff entity, Cytonome/ST, LLC, through a combination of Cytonome, Inc. and STGenetics, a company involved in sex-sorting bull semen for artificial insemination. No prior litigation, licensing history with the defendant, or post-grant proceedings are mentioned in the complaint.
Case Timeline
| Date | Event |
|---|---|
| 2002-04-17 | Earliest Priority Date for ’528, ’295, ’797, ’850, ’263, and ’283 Patents |
| 2004-12-03 | Earliest Priority Date for ’188 Patent |
| 2005-04-12 | U.S. Patent No. 6,877,528 Issues |
| 2014-01-07 | U.S. Patent No. 8,623,295 Issues |
| 2015-04-21 | U.S. Patent No. 9,011,797 Issues |
| 2016-05-17 | U.S. Patent No. 9,339,850 Issues |
| 2016-06-15 | NanoCellect launches WOLF Cell Sorter product |
| 2018-07-24 | U.S. Patent No. 10,029,263 Issues |
| 2018-07-24 | U.S. Patent No. 10,029,283 Issues |
| 2018-09-04 | U.S. Patent No. 10,065,188 Issues |
| 2019-02-12 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,877,528 - “MICROFLUIDIC SYSTEM INCLUDING A BUBBLE VALVE FOR REGULATING FLUID FLOW THROUGH A MICROCHANNEL,” Issued April 12, 2005
The Invention Explained
- Problem Addressed: Conventional particle sorting devices can create shear stresses that damage delicate particles like biological cells during the sorting process, and their operational speed is limited (Compl. ¶15; ’528 Patent, col. 2:31-38).
- The Patented Solution: The invention is a microfluidic device that sorts particles flowing in a channel. Upon detection of a target particle, an actuator generates a "pressure pulse" to deflect it into a separate collection channel. A key component is a "buffer" positioned on the opposite side of the channel, which absorbs the pressure pulse, thereby reducing stress on the particle, preventing the pulse from reverberating and disrupting other particles, and enabling higher sorting speeds (Compl. ¶15; ’528 Patent, col. 3:5-30).
- Technical Importance: This approach allows for gentler and more efficient high-speed sorting of delicate biological materials compared to conventional methods (Compl. ¶15).
Key Claims at a Glance
- The complaint asserts at least independent claim 18 (Compl. ¶48).
- The essential elements of Claim 18 are:
- A microfluidic device, comprising:
- a channel for conveying a stream of particles in a carrier fluid;
- an actuator for selectively applying a pressure pulse to the stream to deflect a particle in the stream of particles from the stream of particles; and
- a buffer for absorbing the pressure pulse.
U.S. Patent No. 8,623,295 - “MICROFLUIDIC SYSTEM INCLUDING A BUBBLE VALVE FOR REGULATING FLUID FLOW THROUGH A MICROCHANNEL,” Issued January 7, 2014
The Invention Explained
- Problem Addressed: As with the ’528 Patent, the technology addresses the need to improve sorting efficiency and reduce shear stresses that can damage cells in conventional microfluidic systems (Compl. ¶19; ’295 Patent, col. 2:31-38).
- The Patented Solution: The invention is a microfluidic system featuring a flow channel connected to two opposing reservoirs via apertures. One reservoir is associated with an actuator and is adapted to generate a pressure pulse. The opposing "buffer" reservoir is adapted to absorb or dampen that pulse, enabling high-speed, low-stress particle sorting (Compl. ¶19; ’295 Patent, col. 3:36-50).
- Technical Importance: The use of opposing, connected reservoirs provides a specific structural configuration for generating and absorbing pressure pulses to achieve gentle, high-throughput cell sorting (Compl. ¶19).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶57).
- The essential elements of Claim 1 are:
- A microfluidic system comprising:
- a microfluidic flow channel formed in a substrate adapted to facilitate analysis or processing of a sample;
- a first reservoir operatively associated with the flow channel and adapted for dampening or absorbing a pressure pulse propagated across the flow channel;
- a second reservoir operatively associated with the flow channel and adapted for generating the pressure pulse;
- wherein the flow channel defines a first aperture for connecting to the first reservoir and a second aperture for connecting to the second reservoir, and wherein the first aperture is substantially opposite the second aperture.
U.S. Patent No. 9,011,797 - “MICROFLUIDIC SYSTEM INCLUDING A BUBBLE VALVE FOR REGULATING FLUID FLOW THROUGH,” Issued April 21, 2015
Technology Synopsis
This patent relates to a microfluidic device for sorting particles that uses a pressure pulse and a reservoir that absorbs the pulse (Compl. ¶23). A key feature is that the absorbing reservoir is sealed from the exterior environment to facilitate high-speed operation and reduce shear stress on sorted particles (Compl. ¶23; ’797 Patent, col. 3:51-64, Claim 5).
Asserted Claims
At least claim 5 (Compl. ¶68).
Accused Features
The complaint alleges that the WOLF Cell Sorter’s microfluidic chip includes a flow channel and a first reservoir that is in fluid communication with the channel, adapted for absorbing a pressure pulse, and sealed from the exterior environment (Compl. ¶69, ¶72).
U.S. Patent No. 9,339,850 - “METHOD AND APPARATUS FOR SORTING PARTICLES,” Issued May 17, 2016
Technology Synopsis
This patent describes a particle sorting system comprising a duct with an inlet and multiple outlets, an actuator, and a buffer (Compl. ¶27). The system is configured so that particles normally flow to a first outlet, but a selected particle is deflected into a second outlet by a pressure pulse from the actuator, while the buffer absorbs the pulse to allow other particles to continue to the first outlet undisturbed (’850 Patent, Abstract).
Asserted Claims
At least claim 1 (Compl. ¶77).
Accused Features
The complaint alleges the WOLF Cell Sorter is a particle sorting system with a duct, multiple outlets, a piezoelectric actuator, and an opposing buffer reservoir that cooperate to sort particles as described in the patent (Compl. ¶79-82).
U.S. Patent No. 10,029,263 - “METHOD AND APPARATUS FOR SORTING PARTICLES,” Issued July 24, 2018
Technology Synopsis
This patent describes a microfluidic sorting system with a flow channel, a downstream detection region, and a switching device that delivers a transient pressure pulse perpendicular to the fluid flow to separate a single sensed particle (Compl. ¶31). The system also includes a reservoir for absorbing the pulse, and the switching device is specified not to block or partially block fluid flow when activated (’263 Patent, Abstract).
Asserted Claims
At least claim 1 (Compl. ¶86).
Accused Features
The complaint alleges the WOLF Cell Sorter contains all elements of the claimed system, including the flow channel, detection region (laser), switching device (piezoelectric actuator), and absorbing reservoir (buffer) (Compl. ¶88-94).
U.S. Patent No. 10,029,283 - “METHOD AND APPARATUS FOR SORTING PARTICLES,” Issued July 24, 2018
Technology Synopsis
This patent relates to a particle sorting chip with a duct, a sealed first chamber in fluid communication with the duct via a side opening, and an actuator associated with the first chamber (Compl. ¶35). The actuator increases pressure in the chamber to discharge fluid into the duct, thereby deflecting a selected particle into a separate outlet (’283 Patent, Abstract).
Asserted Claims
At least claim 1 (Compl. ¶99).
Accused Features
The complaint alleges the WOLF Cell Sorter is a particle sorting "chip" with a duct, a sealed chamber connected via a side opening, and a piezoelectric actuator configured to increase pressure in that chamber to sort particles (Compl. ¶101-104).
U.S. Patent No. 10,065,188 - “ACTUATION OF PARALLEL MICROFLUIDIC ARRAYS,” Issued September 4, 2018
Technology Synopsis
This patent describes a particle processing assembly for sorting individual particles, comprising a microfluidic chip with a switching region that interfaces with an actuator external to the chip (Compl. ¶39). The external actuator directs a pressure pulse across the channel to deflect a selected particle upon detection of a specific characteristic (’188 Patent, Abstract).
Asserted Claims
At least claim 1 (Compl. ¶107).
Accused Features
The complaint alleges the WOLF Cell Sorter is a particle processing assembly with a microfluidic chip and an external piezoelectric actuator that interfaces with a switching region on the chip to direct a pressure pulse and sort particles (Compl. ¶109-111).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the NanoCellect “WOLF Cell Sorter” and its associated disposable microfluidic chips (Compl. ¶7, ¶42).
Functionality and Market Context
The WOLF Cell Sorter is a system for microfluidic cell analysis and sorting (Compl. ¶41). According to Defendant's materials cited in the complaint, it "uses an on-chip piezoacoustic actuator that gently directs cells into collection channels" within a disposable chip (Compl. ¶42). The complaint alleges, based on inspection and marketing materials, that the system includes microchannels, an actuator, and a "buffer" reservoir used to sort cells (Compl. ¶43, ¶44). An animation screenshot provided in the complaint depicts the microfluidic chip's operation, showing a laser for detection, a piezoelectric actuator ("PZT"), and sorting channels (Compl. ¶43, p. 14). A photograph of the device's chip shows a central channel where particles flow, flanked by structures alleged to be the actuator and buffer reservoirs (Compl. ¶44, p. 14). The complaint further alleges that a flexible membrane covers the chip, including the buffer reservoir, to facilitate absorption of the pressure pulse generated by the actuator (Compl. ¶44, ¶45). The product was launched in the U.S. in June 2016 (Compl. ¶41).
IV. Analysis of Infringement Allegations
’528 Patent Infringement Allegations
| Claim Element (from Independent Claim 18) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A microfluidic device, comprising: a channel for conveying a stream of particles in a carrier fluid; | The WOLF Cell Sorter includes a channel in a disposable chip where particles, such as cells, flow downstream in a carrier fluid ("sheath buffer") (Compl. ¶51). | ¶51 | col. 8:1-20 |
| an actuator for selectively applying a pressure pulse to the stream to deflect a particle in the stream of particles from the stream of particles; | The device uses a Piezoelectric actuator ("PZT") that applies a pressure pulse to deflect a selected particle after it is detected by a laser (Compl. ¶52). | ¶52 | col. 8:15-20 |
| and a buffer for absorbing the pressure pulse. | A "buffer reservoir" is positioned opposite the actuator, and a flexible membrane is applied over the buffer to facilitate absorption of the pressure pulse (Compl. ¶53, ¶54). A screenshot from a product video is provided as evidence of this membrane (Compl. ¶45, p. 15). | ¶53-54 | col. 8:21-25 |
- Identified Points of Contention:
- Scope Questions: A central question will be whether the accused product's structure, described as a "buffer reservoir" combined with a "flexible membrane" (Compl. ¶53-54), falls within the scope of the term "buffer" as used in the patent. The defense may argue that "buffer" is limited to the specific "bubble valve" embodiment described in the patent's specification (e.g., ’528 Patent, col. 8:21-22).
- Technical Questions: The complaint's theory relies on the accused "buffer reservoir" and membrane performing the function of "absorbing the pressure pulse." A technical question for the court will be what evidence supports this functional allegation and whether the accused product operates in the manner claimed.
’295 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a microfluidic flow channel formed in a substrate... | The WOLF Cell Sorter has a microfluidic flow channel on a disposable chip where particles suspended in a medium flow (Compl. ¶60-61). | ¶60-61 | col. 8:1-14 |
| a first reservoir operatively associated with the flow channel and adapted for dampening or absorbing a pressure pulse... | A reservoir is located on one side of the channel, opposite the actuator, and is alleged to absorb or dampen the pressure pulse propagated across the channel (Compl. ¶62). | ¶62 | col. 8:26-34 |
| a second reservoir operatively associated with the flow channel and adapted for generating the pressure pulse... | The device has an actuator that, when energized, creates a change in volume and pressure in an associated reservoir to generate the pressure pulse (Compl. ¶64). | ¶64 | col. 8:22-25 |
| wherein the flow channel defines a first aperture for connecting the flow channel relative to the first reservoir and a second aperture... wherein the first aperture is substantially opposite the second aperture. | Screenshots from an animation allegedly show that the two reservoirs are connected to the channel via apertures on substantially opposite sides (Compl. ¶65). A micrograph image is also provided as evidence of this structure (Compl. ¶66, p. 23). | ¶65-66 | col. 8:10-14 |
- Identified Points of Contention:
- Scope Questions: Claim 1 requires two distinct "reservoirs", one for generating a pulse and one for absorbing it. A key question will be whether the accused product's piezoelectric actuator assembly constitutes a "reservoir" as that term is understood in the patent. The defense may contend that a PZT actuator is an active component, distinct from the passive "reservoir" structures depicted in the patent's figures.
- Technical Questions: The claim requires the first and second apertures to be "substantially opposite." The analysis will depend on the geometric configuration of the accused device and how the court construes this spatial limitation.
V. Key Claim Terms for Construction
For the ’528 Patent:
- The Term: "buffer"
- Context and Importance: This term defines a core functional element of the claimed invention. The infringement case hinges on mapping this term to the accused product's "buffer reservoir" and "flexible membrane" structure. Practitioners may focus on this term because its construction could be dispositive of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is functional: "a buffer for absorbing the pressure pulse." The specification supports a functional definition, describing the buffer as serving "for absorbing pressure transients" (’528 Patent, col. 8:21-24) and having "resilient properties" (col. 9:28-32).
- Evidence for a Narrower Interpretation: The specification's primary embodiment describes the buffer as a "second bubble valve" (’528 Patent, col. 8:21-22). The abstract also frames the invention around a "bubble valve." A party could argue the term should be limited to structures related to this disclosed embodiment.
For the ’295 Patent:
- The Term: "reservoir"
- Context and Importance: Claim 1 requires two distinct reservoirs, one for generating the pulse and one for absorbing it. Plaintiff’s infringement theory requires the structure associated with the piezoelectric actuator to be a "reservoir." The case may turn on whether an active actuator assembly can be considered a "reservoir" under the patent's definition.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses the term in a general sense, for example, referring to "two opposing reservoirs adapted to generate and absorb a pressure pulse" (Compl. ¶19), which could suggest any contained volume capable of performing the function. The specification refers to a "compression chamber" and a "buffer chamber," which may support a broader reading of "reservoir" as a type of chamber (’295 Patent, col. 8:22-29).
- Evidence for a Narrower Interpretation: The figures in the patent (e.g., Fig. 1) depict the reservoirs as distinct, somewhat passive, bulbous structures. A party may argue that the term "reservoir" should be construed as being limited to these depicted passive structures, and not an active component like a piezoelectric actuator assembly.
VI. Other Allegations
- Indirect Infringement: Each count alleges that NanoCellect "induces the infringement" of the asserted patent (e.g., Compl. ¶48, ¶57). The complaint does not, however, plead specific facts to support the element of intent, such as alleging that Defendant's user manuals or marketing materials instruct customers to operate the WOLF Cell Sorter in an infringing manner.
- Willful Infringement: The prayer for relief requests a finding of willful infringement and an award of enhanced damages (Compl. p. 39, ¶B). The complaint does not contain allegations of pre-suit knowledge, suggesting the willfulness claim is based on alleged continued infringement after the filing of the complaint.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can key claim terms like "buffer" and "reservoir", which are rooted in the patents’ descriptions of "bubble valve" technology, be construed broadly enough to cover the distinct "piezoacoustic actuator" and "flexible membrane" structures of the accused WOLF Cell Sorter? The outcome of claim construction for these terms may be central to the dispute.
- A second key issue will be one of technical and factual proof: assuming a favorable claim construction, the case will turn on whether the accused device's components actually function as claimed. Does the accused product's "buffer reservoir" demonstrably perform the function of "absorbing" or "dampening" a pressure pulse in the manner required by the asserted claims, or is there a fundamental mismatch in technical operation? The complaint relies heavily on visual representations from marketing materials, raising the question of what discovery and expert testing will reveal about the device's actual mechanics.