DCT

1:17-cv-00944

XY LLC v. Trans Ova Genetics LC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00944, D. Colo., 10/18/2017
  • Venue Allegations: Venue is alleged to be proper because the Defendant is deemed to reside in the district and because a substantial part of the events giving rise to the claims occurred within the district.
  • Core Dispute: Plaintiffs allege that Defendant’s sperm sorting services and related products for animal breeding infringe seven patents related to flow cytometry, sperm sorting methods, cryopreservation, and embryo production.
  • Technical Context: The technology concerns the sex-selection of mammalian offspring, primarily in the livestock industry, by separating sperm carrying X (female) and Y (male) chromosomes based on their differential DNA content using high-speed flow cytometry.
  • Key Procedural History: The complaint details a significant history between the parties, noting that Defendant was a former licensee of Plaintiff XY’s technology. A prior lawsuit resulted in a jury verdict finding that the Defendant had materially breached its license agreement, which consequently expired on April 16, 2009, and had willfully infringed ten of Plaintiff XY’s patents. The complaint also notes that U.S. Patent No. 9,134,220 was reissued as RE46,559 during the course of litigation. An Inter Partes Review (IPR) proceeding resulted in the disclaimer of several asserted claims of U.S. Patent No. 7,208,265, including the lead independent claim asserted in this complaint.

Case Timeline

Date Event
1997-12-31 U.S. Patent No. 6,372,422 Priority Date
1998-01-29 U.S. Patent No. 9,365,822 Priority Date
1999-11-24 U.S. Patent No. 7,208,265 Priority Date
2000-11-29 U.S. Patent No. 8,652,769 Priority Date
2001-11-29 U.S. Patent No. 9,145,590 Priority Date
2002-04-16 U.S. Patent No. 6,372,422 Issued
2003-05-15 U.S. Patent No. 7,723,116 Priority Date
2004-04-16 License Agreement initiated between XY and TOG
2004-07-27 U.S. Patent No. RE46,559 Priority Date
2004-12-01 Lead Licensee Agreement initiated between XY and ST
2007-04-24 U.S. Patent No. 7,208,265 Issued
2009-04-16 License Agreement between XY and TOG expired
2010-05-25 U.S. Patent No. 7,723,116 Issued
2012-03-01 Prior lawsuit filed by XY against TOG
2014-02-18 U.S. Patent No. 8,652,769 Issued
2015-09-15 Alleged start of TOG's use of Summit software
2015-09-15 Original U.S. Patent No. 9,134,220 Issued
2015-09-29 U.S. Patent No. 9,145,590 Issued
2016-02-12 Jury verdict finds TOG materially breached agreement
2016-06-14 U.S. Patent No. 9,365,822 Issued
2017-02-21 Reissue application filed for U.S. Patent No. 9,134,220
2017-09-26 U.S. Patent No. RE46,559 Issued
2017-10-18 Plaintiffs’ Fourth Amended Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 9,145,590 - "Methods and Apparatus for High Purity X-Chromosome Bearing and Y-Chromosome Bearing Populations of Spermatozoa," issued September 29, 2015

The Invention Explained

  • Problem Addressed: The patent's background describes that prior art flow cytometry for sperm sorting faced challenges in achieving high levels of purity, noting that even small overlaps in the fluorescence signals between X- and Y-chromosome bearing sperm populations can significantly degrade the purity of the sorted samples (’590 Patent, col. 2:1-10).
  • The Patented Solution: The invention claims an apparatus, specifically a particle differentiation apparatus used for flow cytometry, with a modified electronic configuration. The solution involves operating a key component, the photomultiplier tube (which detects fluorescence), at a voltage below the conventional 400-volt minimum, thereby increasing the signal-to-noise ratio and allowing for better resolution between sperm populations with only slight differences in DNA content (’590 Patent, Abstract; col. 11:4-21).
  • Technical Importance: Achieving higher purity in sex-sorted sperm at commercially viable speeds is critical for the livestock breeding industry, as it enables more predictable and efficient production of animals with desired sex-linked traits (Compl. ¶8).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶25).
  • Essential elements of Claim 1 include:
    • a particle differentiation apparatus comprising:
    • at least one photomultiplier tube disposed to receive an amount of fluorescent light emitted by each of a plurality of particles...
    • a photomultiplier tube controller;
    • a plurality of electrical components for being placed in a circuit of the photomultiplier tube controller and capable of altering an operating voltage of the at least one photomultiplier tube throughout a range of nearly 0 volts to below 400 volts...
    • an analyzer configured to analyze said at least one signal of said at least one photomultiplier tube operated at a voltage in said voltage range of nearly 0 volts to below 400 volts to differentiate between particles...

U.S. Patent No. 7,723,116 - "Apparatus, Methods and Processes for Sorting Particles and for Providing Sex-Sorted Animal Sperm," issued May 25, 2010

The Invention Explained

  • Problem Addressed: The patent background discusses the need to improve the speed and efficiency of flow cytometry, particularly for delicate biological samples like sperm cells, and notes the potential for damage from the continuous wave lasers traditionally used (’116 Patent, col. 2:1-20).
  • The Patented Solution: The invention proposes two main improvements: first, the use of a pulsed laser instead of a continuous wave laser to reduce potential damage to the cells, and second, a system for splitting a single radiation source (e.g., a laser beam) to supply multiple sorting nozzles simultaneously. This parallel processing architecture is designed to increase overall throughput (’116 Patent, Abstract; col. 8:1-10).
  • Technical Importance: Increasing the throughput of high-purity sperm sorting is a key factor for commercial-scale artificial insemination programs, and using a single laser for multiple sorting streams can reduce system cost and complexity (Compl. ¶8, ¶9).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (a method claim) and independent claim 42 (an apparatus claim) (Compl. ¶31).
  • Essential elements of Claim 1 include:
    • A method of flow cytometry sperm processing comprising the steps of: establishing at least one sheath fluid; flowing said at least one sheath fluid into at least two nozzles; ...utilizing one radiation source; splitting said radiation into at least two beams; and directing each of said beams to said nozzle...
  • Essential elements of Claim 42 include:
    • A flow cytometry system for sperm comprising: at least one sheath fluid port...; a sample injection element...; at least two nozzles...; a radiation emitter; a beam splitter...

Multi-Patent Capsule: U.S. Patent No. 9,365,822

  • Patent Identification: U.S. Patent No. 9365822, "System and Method for Sorting Cells," issued June 14, 2016 (Compl. ¶36).
  • Technology Synopsis: The patent is directed to methods for producing sexed embryos. The methods involve using sperm that has been sorted by sex and then fertilizing eggs either in-vitro or in-vivo (Compl. ¶37). This technology represents a downstream application of the core sperm-sorting process.
  • Asserted Claims: At least independent claim 11 (Compl. ¶37).
  • Accused Features: Defendant’s services for producing sexed embryos through in-vitro or in-vivo fertilization of eggs using sex-sorted semen that was allegedly processed on infringing MoFlo SX instruments using Plaintiffs' proprietary fluid media (Compl. ¶37).

Multi-Patent Capsule: U.S. Patent No. 7,208,265

  • Patent Identification: U.S. Patent No. 7208265, "Method of Cryopreserving Selected Sperm Cells," issued April 24, 2007 (Compl. ¶42).
  • Technology Synopsis: The patent describes methods for the cryopreservation (freezing) of sperm cells that have already been selected for a specific characteristic, such as sex. This process is crucial for enabling the long-term storage and global distribution of valuable sex-sorted semen samples (’265 Patent, Abstract; Compl. ¶43).
  • Asserted Claims: At least independent claim 1 (Compl. ¶43).
  • Accused Features: Defendant’s alleged process of producing and freezing sex-selected sperm cells using its MoFlo SX instruments according to Plaintiffs' proprietary protocols (Compl. ¶43).

Multi-Patent Capsule: U.S. Patent No. 6,372,422

  • Patent Identification: U.S. Patent No. 6372422, "Multiple Sexed Embryo Production System for Mammals," issued April 16, 2002 (Compl. ¶48).
  • Technology Synopsis: The patent claims a system for producing multiple embryos of a desired sex from a single female mammal. The system involves inducing superovulation in the female to produce multiple eggs, followed by insemination with sex-sorted sperm (’422 Patent, Abstract). This combines hormonal treatments with sperm sorting technology to increase reproductive efficiency.
  • Asserted Claims: At least independent claim 1 (Compl. ¶49).
  • Accused Features: Defendant’s in-vivo embryo transfer services, which allegedly include making a cow superovulate to produce multiple eggs and then inseminating it with sex-sorted sperm produced using Plaintiffs' technology (Compl. ¶49).

Multi-Patent Capsule: U.S. Patent No. 8,652,769

  • Patent Identification: U.S. Patent No. 8652769, "Methods for Separating Frozen-Thawed Spermatozoa into X-Chromosome Bearing and Y-Chromosome Bearing Populations," issued February 18, 2014 (Compl. ¶54).
  • Technology Synopsis: This patent addresses "reverse sorting," which is the process of sex-sorting sperm that has been previously frozen and then thawed. This allows for the sex selection of valuable genetic material that was stored before sorting technology was available or practical (’769 Patent, Abstract; Compl. ¶55).
  • Asserted Claims: At least independent claim 16 (Compl. ¶55).
  • Accused Features: Defendant’s "reverse sorting" services, which allegedly use MoFlo SX machines and protocols derived from Plaintiffs' technology to sort previously frozen sperm cells (Compl. ¶55).

Multi-Patent Capsule: U.S. Patent No. RE46,559

  • Patent Identification: U.S. Patent No. RE46,559, "Enhanced Flow Cytometry Discrimination with Geometric Transformation," issued September 26, 2017 (Compl. ¶101).
  • Technology Synopsis: The patent describes a data processing method for use in flow cytometry. It involves applying a "geometric transformation," such as a rotational alteration, to the multi-dimensional data generated from particles to enhance the separation and discrimination between closely related populations, such as X- and Y-bearing sperm (’559 Patent, Abstract; Compl. ¶105).
  • Asserted Claims: At least independent claim 1 (Compl. ¶105).
  • Accused Features: Defendant’s use of "Summit software" on its MoFlo SX instruments, which the complaint alleges is capable of "rotationally altering data" to sort sperm cells in an infringing manner (Compl. ¶105).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant’s processes and systems for providing sex-selected mammalian sperm and embryos, primarily for cattle breeding (Compl. ¶11). This includes: (1) the manufacture and use of "MoFlo SX sperm sorting flow cytometers" allegedly converted from general-purpose machines using Plaintiffs' trade secrets (Compl. ¶14, ¶16); (2) the use of Plaintiffs' proprietary methods, or "XY Protocols," for sorting, processing, and cryopreserving sperm (Compl. ¶17); and (3) the use of "Summit software" for operating the sorting instruments (Compl. ¶22).
  • Functionality and Market Context: The complaint alleges that Defendant, a former licensee, continued to use Plaintiffs’ entire proprietary technology ecosystem after its license expired in 2009 (Compl. ¶13, ¶15). The core accused functionality is the unauthorized replication and commercial use of Plaintiffs' integrated system for high-purity, high-throughput sperm sex selection (Compl. ¶8, ¶10). Defendant provides reproductive services to cattle breeders, placing it in direct competition with Plaintiffs and their authorized licensees (Compl. ¶11, ¶28).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,145,590 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a particle differentiation apparatus comprising: at least one photomultiplier tube... Defendant makes and uses MoFlo SX sperm sorters, a type of flow cytometer which uses photomultiplier tubes to detect fluorescence from stained sperm cells. ¶25 col. 11:4-6
a photomultiplier tube controller; Defendant’s MoFlo SX sperm sorters include electronic control systems for their components, including the photomultiplier tubes. ¶25 col. 11:13-14
a plurality of electrical components for being placed in a circuit of the photomultiplier tube controller and capable of altering an operating voltage of the at least one photomultiplier tube throughout a range of nearly 0 volts to below 400 volts... The complaint alleges that the accused MoFlo SX sperm sorter "meets all of the limitations of at least claim 1," but does not provide specific facts regarding the operating voltage of the photomultiplier tubes in Defendant's machines. ¶25 col. 11:15-21
an analyzer configured to analyze said at least one signal of said at least one photomultiplier tube operated at a voltage in said voltage range of nearly 0 volts to below 400 volts to differentiate between particles based upon said at least one particle differentiation characteristic. The MoFlo SX system includes software (allegedly the "Summit software") that analyzes signals from the detectors to differentiate and sort sperm cells based on DNA content. The complaint does not specify the voltage at which the analysis is configured to operate. ¶25, ¶22 col. 11:22-28
  • Identified Points of Contention:
    • Evidentiary Question: The complaint provides a conclusory allegation that Defendant's apparatus "includes every limitation of at least claim 1" (Compl. ¶25). A primary point of contention will be an evidentiary one: what proof will be offered to show that Defendant’s converted MoFlo SX machines actually contain the specific electronic configuration claimed, particularly the capability to operate the photomultiplier tubes in a voltage range "below 400 volts"?
    • Scope Question: The analysis may raise the question of whether simply having the latent capability to operate below 400 volts is sufficient for infringement, or if the claim requires active operation in that range during the sorting process.

U.S. Patent No. 7,723,116 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of flow cytometry sperm processing comprising the steps of: establishing at least one sheath fluid; flowing said at least one sheath fluid into at least two nozzles; Defendant allegedly uses modified MoFlo SX instruments, which are flow cytometers that operate using sheath fluid and nozzles. The complaint alleges modification of at least two instruments. ¶31 col. 37:55-58
...utilizing one radiation source; splitting said radiation into at least two beams; and directing each of said beams to said nozzle and said sperm cells... The complaint alleges, "Upon information and belief, TOG modified at least two MoFlo SX instruments to share a single interrogation laser through the use of beam splitters and mirrors." ¶31 col. 38:1-3
[other method steps such as staining, injecting, sorting, etc.] The complaint alleges that Defendant uses the modified instruments to sort sperm cells "in accordance with the XY Protocols," which allegedly meets all limitations of the claim. ¶31 col. 37:55-67
  • Identified Points of Contention:
    • Evidentiary Question: The infringement theory hinges on the allegation, made "Upon information and belief," that Defendant physically modified its instruments to share a single laser via beam splitters. A key question will be what evidence supports this specific hardware modification claim.
    • Scope Question: A potential point of contention may be whether using mirrors to direct a laser to two separate, standalone cytometer instruments constitutes "splitting a radiation source into at least two beams" and directing them to "at least two nozzles" within the meaning of the patent, which may be construed as describing a single, integrated multi-nozzle apparatus.

V. Key Claim Terms for Construction

  • For the ’590 Patent:
    • The Term: "altering an operating voltage of the at least one photomultiplier tube... to below 400 volts"
    • Context and Importance: This phrase is the central technical novelty recited in independent claim 1. The infringement analysis for the ’590 Patent will likely depend entirely on whether Defendant's accused machines are found to practice this specific electronic operation. Practitioners may focus on whether "altering" requires a dynamic change in voltage during operation or if it can be read to cover a static configuration that sets the operating voltage below the 400-volt threshold.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification's general discussion of the benefits of lower-voltage operation for reducing electronic noise and improving signal resolution could support an interpretation that any configuration enabling operation below 400 volts meets the claim’s purpose (’590 Patent, Abstract).
      • Evidence for a Narrower Interpretation: The patent may describe specific circuits or control methods for achieving the voltage alteration. A defendant could argue that these specific embodiments limit the term to those particular implementations, potentially excluding the configuration of the accused devices (’590 Patent, Fig. 11, Fig. 12).
  • For the ’116 Patent:
    • The Term: "splitting a radiation source into at least two beams"
    • Context and Importance: This term defines the core parallel-processing architecture of the invention. The infringement case rests on the allegation that Defendant’s use of "beam splitters and mirrors" to make two cytometers "share a single interrogation laser" falls within the scope of this term (Compl. ¶31). The construction will determine if the claim reads on a setup involving two physically separate instruments or is limited to a single, integrated multi-nozzle device.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself does not explicitly require the "at least two nozzles" to be part of a single apparatus. A plaintiff may argue that any system using one laser and a splitter to power two sorting streams infringes, regardless of whether those streams are in one or two boxes.
      • Evidence for a Narrower Interpretation: Figures in the patent depict a single radiation source being split to serve multiple nozzles arranged in a compact array, seemingly within a single instrument housing (’116 Patent, Fig. 1, Fig. 9). This could support an argument that the invention is limited to such an integrated apparatus, not a workshop setup where a laser is routed to separate machines.

VI. Other Allegations

  • Indirect Infringement: For each asserted patent, the complaint alleges contributory and induced infringement, stating that Defendant provides the infringing apparatuses and protocols to its employees and customers, thereby causing them to directly infringe (Compl. ¶25, ¶31, ¶37).
  • Willful Infringement: The complaint alleges that Defendant’s infringement has been willful and deliberate for all asserted patents. The basis for this allegation is Defendant’s status as a former licensee of the technology, its alleged knowledge of the patents since their issuance, and a prior jury verdict that found Defendant had willfully infringed other patents in the same family (Compl. ¶13, ¶26, ¶32).

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

  • A central issue will be one of evidentiary proof: The complaint premises key infringement allegations, such as the specific hardware modifications for the ’116 Patent and the electronic operating parameters for the ’590 Patent, on "information and belief." Given the contentious history between the parties, a core question for the court will be what factual evidence, beyond conclusory statements, will be produced during discovery to substantiate these highly specific technical claims.
  • A second key issue will be one of definitional scope: The case may turn on claim construction, particularly whether the ’116 Patent’s claim to "splitting a radiation source" to serve "at least two nozzles" can be construed to cover the alleged practice of using mirrors to route a single laser to two physically separate cytometer instruments.
  • Finally, the extensive history of prior litigation, including a jury verdict of willful infringement on related patents, raises a threshold question of preclusion and intent: To what extent will the findings from the previous litigation, particularly regarding willfulness and the date the Defendant's license terminated, influence the court’s analysis of knowledge and intent for the infringement alleged in this new action?