DCT
1:24-cv-00990
Applied Science Inc v. Uneklo USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Applied Science, Inc. (California)
- Defendant: Uneklo USA, Inc. d/b/a Macopharma USA (Delaware)
- Plaintiff’s Counsel: Shaw Keller LLP; Robins Kaplan LLP
- Case Identification: 1:24-cv-00990, D. Del., 08/29/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is incorporated in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s blood collection mixer infringes a patent related to methods for ensuring proper skin disinfection by using timed scrub and dry periods prior to venipuncture.
- Technical Context: The technology relates to automated systems in the field of blood collection, designed to reduce human error and increase safety by standardizing procedural steps.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of infringement via a letter on August 24, 2023. It further states that subsequent communications, including an offer for a "mutually beneficial resolution" on June 7, 2024, failed to resolve the dispute.
Case Timeline
| Date | Event |
|---|---|
| 2014-05-30 | '498 Patent Priority Date |
| 2015-06-01 | '498 Patent Application Filing Date |
| 2015-10-19 | Maco enters agreement with Blood Bank Computer Systems, Inc. |
| 2016-09-26 | Maco submits 510(k) application to FDA for MACOMIX |
| 2017-11-15 | FDA authorizes Maco to market the MACOMIX in the U.S. |
| 2022-08-30 | '498 Patent Issue Date |
| 2023-08-24 | Applied Science sends notice letter to Maco |
| 2024-06-07 | Applied Science again contacts Maco to resolve infringement issue |
| 2024-08-29 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 11,426,498, "Systems and Methods for Managing Blood Donations," issued August 30, 2022.
- The Invention Explained:
- Problem Addressed: The patent background describes the "variability and simple human error" associated with phlebotomists preparing a patient's skin for a blood draw, noting that non-standardized scrub and dry times can lead to contamination of the collected blood (’498 Patent, col. 1:41-53).
- The Patented Solution: The invention is a blood collection apparatus with an integrated timer system that guides the user through distinct, pre-configured scrub and dry time periods using visual and/or audible cues (’498 Patent, Abstract). This automates the timing of the skin preparation process to reduce procedural variability and the risk of contamination (’498 Patent, col. 2:9-24).
- Technical Importance: The technology aims to standardize a critical procedural step in blood donation to enhance the safety and quality of the blood supply by preventing bacterial contamination at the point of collection (’498 Patent, col. 1:31-40).
- Key Claims at a Glance:
- The complaint asserts independent method claim 21 (’498 Patent, col. 10:30-49).
- The essential elements of independent claim 21 are:
- initiating, in a blood collection device, a scrub timer having a scrub time period;
- visibly and/or audibly counting down the scrub timer during the scrub time period with a graphical user interface and/or an audible output of the blood collection device;
- automatically initiating, in the blood collection device after the scrub time period has elapsed, a dry timer having a dry time period;
- visibly and/or audibly counting down the dry timer during the dry time period with the graphical user interface and/or the audible output of the blood collection device; and
- beginning a blood draw process with the blood collection device after the dry time period has elapsed.
- The complaint notes infringement of "exemplary claim 21, among other claims" but does not specify any dependent claims (Compl. ¶30).
III. The Accused Instrumentality
- Product Identification: The MACOMIX HM20 Whole Blood Collection Mixer ("MACOMIX") (Compl. ¶3).
- Functionality and Market Context:
- The complaint alleges the MACOMIX is a blood collection device that includes a "scrub and dry timer function" (Compl. ¶36). The purpose of this function is "to inform the user of the disinfection time and dry time before the venipuncture" (Compl. ¶36). The device allegedly displays a message for a first timer (the scrub timer) and, after it concludes, displays a second timer (the dry timer) (Compl. ¶¶37-38). A screenshot from the device's operating manual illustrates instructions for this two-timer process (Compl. p. 7).
- The complaint alleges that the MACOMIX was authorized for marketing in the United States by the FDA on or around November 15, 2017, and that Defendant entered into an agreement with Blood Bank Computer Systems, Inc. to certify the device for use with certain software applications in the U.S. (Compl. ¶¶18, 20).
IV. Analysis of Infringement Allegations
- '498 Patent Infringement Allegations
| Claim Element (from Independent Claim 21) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| initiating, in a blood collection device, a scrub timer having a scrub time period; | The MACOMIX contains a "scrub . . . timer function" which is initiated when a user presses a key to start the count for the "first timer." | ¶36 | col. 10:32-33 |
| visibly and/or audibly counting down the scrub timer during the scrub time period with a graphical user interface and/or an audible output of the blood collection device; | The MACOMIX operation manual allegedly instructs that a "message is displayed on the screen" and "When the time arrives to 0, a beep is emitted." | ¶37 | col. 10:34-37 |
| automatically initiating, in the blood collection device after the scrub time period has elapsed, a dry timer having a dry time period; | After the scrub time "arrives to 0 . . . the second timer is displayed." The complaint alleges this constitutes "automatically initiating" the dry timer. | ¶38 | col. 10:38-40 |
| visibly and/or audibly counting down the dry timer during the dry time period with the graphical user interface and/or the audible output of the blood collection device; | The MACOMIX manual allegedly instructs that the "second timer is displayed," the user presses a key to "start the count," and "the time arrives to 0, a beep ism [sic] emitted." | ¶39 | col. 10:41-44 |
| beginning a blood draw process with the blood collection device after the dry time period has elapsed. | The operation manual allegedly instructs that after the dry timer reaches 0, "the collection start can be continued." | ¶40 | col. 10:45-48 |
- Identified Points of Contention:
- Scope Questions: A central question will be the proper construction of the term "automatically initiating." The complaint alleges this limitation is met because the "second timer is displayed" after the first timer elapses (Compl. ¶38). However, the evidence provided in the complaint's visual exhibit indicates a user must "Press key '►' for start the count" for this second timer (Compl. p. 8). This raises the question of whether "automatically initiating" a timer requires the countdown to begin without user intervention, or if merely displaying the timer prompt for user activation is sufficient.
- Technical Questions: What evidence will be presented to demonstrate how the accused MACOMIX device actually operates? The dispute may turn on whether the device's software, in its ordinary course, begins the dry timer countdown without requiring the key press referenced in the user manual, or if that manual step is required for the timer to function as claimed.
V. Key Claim Terms for Construction
- The Term: "automatically initiating"
- Context and Importance: This term is critical because the infringement allegation hinges on whether the accused device's transition from the scrub timer to the dry timer meets this limitation. Defendant will likely argue that the user's required key press to start the dry timer's countdown means the initiation is manual, not automatic. Practitioners may focus on this term because the evidence presented in the complaint itself appears to create a factual dispute on this element.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the overall process is automated and the key press is a mere confirmation step within a larger automated sequence. The patent describes that "additional time cycles may be triggered automatically" ('498 Patent, col. 2:21-22), which could be interpreted to mean the system sets up the next cycle for the user, fulfilling the "initiation" step.
- Evidence for a Narrower Interpretation: A party could argue that the plain meaning of "automatically initiating" requires the timer to start without any intervening user action. The patent's flowchart (FIG. 2) depicts "START SCRUB TIMER" (206) and "START DRY TIMER" (210) as distinct "START" events ('498 Patent, Fig. 2). Furthermore, dependent claim 20 recites "automatically restarting the scrub timer," suggesting the patentee knew how to explicitly claim a fully automated start action when intended, and chose the potentially different term "initiating" in claim 21.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), stating that Defendant knowingly encourages and instructs end users (e.g., phlebotomists) to perform the patented method by providing "detailed instructions, user manuals, marketing materials, demonstrations, and/or other technical support" (Compl. ¶¶32-33).
- Willful Infringement: The complaint alleges pre-suit knowledge of the '498 Patent, citing a notice letter sent to Defendant on August 24, 2023, which allegedly explained that the MACOMIX infringed specific claims (Compl. ¶14). The allegation of ongoing infringement after this date forms the basis for willfulness.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: does the term "automatically initiating," in the context of the '498 patent, require a timer's countdown to begin without any user action, or can it be construed to cover the automatic display of a timer prompt that a user must then manually activate?
- A key evidentiary question will be one of technical operation: does the MACOMIX device's functionality, as evidenced by its software and user manuals, align with the "automatically initiating" limitation as it is ultimately construed by the court? The resolution of this factual question, in light of the court's claim construction, will likely be dispositive of the infringement claim.