DCT
0:21-cv-01275
DoseLogix LLC v. Reflex Medical Corp
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: DoseLogix, LLC (Georgia)
- Defendant: Reflex Medical Corp. (Minnesota)
- Plaintiff’s Counsel: Dicke, Billig & Czaja, PLLC
- Case Identification: 0:21-cv-01275, D. Minn., 05/24/2021
- Venue Allegations: Venue is alleged to be proper in the District of Minnesota because Defendant is incorporated in Minnesota, maintains a regular and established place of business within the district, and has allegedly committed acts of patent infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s metered-dose topical applicator infringes patents related to mechanical dosing dispenser systems that provide auditory and tactile feedback for accurate dosing.
- Technical Context: The technology concerns mechanical dispensers designed for the precise, repeatable application of topical medications, such as creams, a field where accuracy is important for therapeutic efficacy and patient safety.
- Key Procedural History: The patents-in-suit share a common specification and priority claim, stemming from the same provisional application, which suggests a coordinated patent strategy covering various features of a single dispenser system.
Case Timeline
| Date | Event |
|---|---|
| 2016-12-27 | Priority Date for ’027 and ’685 Patents |
| 2021-02-16 | U.S. Patent No. 10,919,685 Issued |
| 2021-03-16 | U.S. Patent No. 10,947,027 Issued |
| 2021-05-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,947,027, "Dosing Dispenser System," Issued March 16, 2021
- The Invention Explained:
- Problem Addressed: The patent addresses the difficulty of accurately administering measured doses of cream-based medicines, particularly for patients who may have dexterity or vision impairments that make traditional syringes with side markings challenging to use precisely (’685 Patent, col. 1:29-44).
- The Patented Solution: The invention is a dispenser where rotating a base at one end causes a threaded driver to advance a plunger, expelling a controlled amount of a flowable composition. The core innovation is an "anti-back rotation assembly" which uses flexible arms that engage with notches in the dispenser's base support; this interaction produces a distinct tactile and/or audible "click" at set intervals, preventing reverse rotation and signaling to the user that a precise, predetermined dose has been dispensed (’685 Patent, Abstract; col. 9:46-62; Fig. 1).
- Technical Importance: This mechanical feedback mechanism aims to replace reliance on visual markings with a more intuitive and reliable system, potentially improving patient compliance and the accuracy of self-administered topical treatments (’685 Patent, col. 1:29-44).
- Key Claims at a Glance:
- The complaint asserts independent claims 1 and 12 (Compl. ¶¶18, 22).
- Independent Claim 1 requires:
- A housing defining a chamber.
- A traveler retained within the chamber.
- An anti-back rotation assembly with an elongated driver and at least one rotatable flexible arm, where rotation of the driver positions the traveler.
- The flexible arm extends circumferentially opposite the driver's rotation direction and has an outer surface that is the outermost extent of the assembly.
- A base that is rotatable relative to the housing and causes rotation of the driver.
- A plunger engageable with the traveler.
- The plunger is "unidirectionally movable" by the traveler to dispense a predetermined quantity.
- Independent Claim 12 requires:
- A housing with a first dispensing end, a second end, and a sidewall.
- A traveler with two ends, retained within the chamber.
- A driver engaged with the traveler, where rotation of the driver movably positions the traveler.
- A plunger engageable with the traveler, movable between a "filled position" (maximum distance from dispensing end) and a "dispensed position" (minimum distance).
- In the dispensed position, at least a portion of the driver is "uncovered" within the chamber relative to the sidewall.
- The complaint also asserts dependent claims 3-8, which add further limitations regarding the plunger's structure and the dispenser's ability to dispense multiple predetermined quantities (Compl. ¶¶27-39).
U.S. Patent No. 10,919,685, "Dosing Dispenser System," Issued February 16, 2021
- The Invention Explained:
- Problem Addressed: As with the ’027 patent, the invention seeks to solve the problem of inaccurate dosing of cream-based medicines from manual dispensers (’685 Patent, col. 1:29-44).
- The Patented Solution: This patent describes the same general dispenser but focuses its claims on more specific features of the clicking mechanism. The claims detail the properties of the flexible arms responsible for the feedback, requiring that they have a "non-uniform profile" or a "clicking profile" and are "bendable" to provide "auditory feedback" as they engage with the dispenser housing (’685 Patent, col. 23:10-26).
- Technical Importance: By claiming specific structural features that produce the audible click, this patent seeks to protect the particular implementation of the user feedback system, which is central to the product's function of ensuring accurate dosing (’685 Patent, col. 9:56-62).
- Key Claims at a Glance:
- The complaint asserts independent claim 6 and dependent claims 8 and 12 (Compl. ¶¶40, 42, 44). The dependent claims implicitly rely on independent claim 7.
- Independent Claim 6 requires:
- A housing, plunger, traveler, and rotatable driver.
- A first and second arm rotatable with the driver.
- The first arm has a "non-uniform profile" and provides "auditory feedback."
- Both arms are "bendable with rotation of the driver."
- At least one arm comprises a "projection extending from the at least one arm."
- Independent Claim 7 (base for asserted dependent claims 8 and 12) requires:
- A housing, plunger, traveler, and rotatable driver.
- At least one arm rotatable with the driver, extending radially outwards.
- The arm has an inner surface, an outer surface, and an end face.
- The end face is "circumferentially offset" from the arm's base when the arm is in bent and un-bent configurations.
- The complaint also asserts dependent claims 8 and 12, which add limitations requiring the traveler to be retained within the chamber and for the arm to have a "clicking profile" that provides auditory feedback (Compl. ¶¶40-41, 44-45).
III. The Accused Instrumentality
- Product Identification: The accused product is the "UnoDose™ Metered-Dose Topical Applicator" (Compl. ¶6).
- Functionality and Market Context:
- The UnoDose applicator is a medical dispenser for topical creams that functions by rotating a base "dosing knob" (Compl. ¶16, Exhibit C; Compl. ¶31). The complaint alleges that each quarter turn, or "click," dispenses a predetermined quantity (0.25ml) of a flowable composition, with the device allowing for up to 160 such clicks (Compl. ¶¶31, 33).
- The complaint includes a photograph of the disassembled product, identifying its core internal components as a "Plunger," "Traveler," and "Driver," which interact to push the composition out of the housing (Compl. ¶20, image). A key alleged feature is the presence of "Flexible Arms" on an internal component that rotate with the driver to produce the clicking action (Compl. ¶25, image).
- The product is marketed as having an "innovative mechanical drive system" for "precise dispensing" and an "easy-to-read scale label for pharmacists, compounders and patients," suggesting its target market is compounding pharmacies and patients requiring accurate self-dosing (Compl. ¶16, image).
IV. Analysis of Infringement Allegations
’027 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an anti-back rotation assembly comprising an elongated driver and at least one flexible arm rotatable with the elongated driver | The UnoDose applicator includes an anti-back rotation assembly with at least one flexible arm that is rotatable with the driver. | ¶25 | col. 9:4-12 |
| wherein the at least one flexible arm extends circumferentially in a direction opposite a direction of rotation of the driver | The complaint provides a photograph alleging that the flexible arms extend circumferentially opposite to the direction of rotation, which is illustrated with a yellow arrow. | ¶25 | col. 9:4-12 |
| a base that is rotatable relative to the housing, and wherein the rotation of the driver is caused by rotation of the base | The product has a base, outlined in orange in a provided image, that is rotatable relative to the housing and causes rotation of the driver. | ¶24 | col. 10:59-62 |
| a plunger within the chamber and engageable with the traveler, wherein... the plunger is unidirectionally movable by the traveler within the chamber along the axis | The product has a plunger that is engaged by the traveler. The complaint alleges the traveler "unidirectionally moves the plunger along an axis." | ¶¶23, 31 | col. 7:15-21 |
| wherein the traveler is configured to selectively position the plunger at a predetermined location... so as to dispense a predetermined quantity of a flowable composition | The traveler is alleged to be configured to selectively position the plunger to dispense a predetermined quantity of 0.25ml per quarter turn "click." | ¶¶26, 31 | col. 7:7-14 |
- Identified Points of Contention:
- Scope Questions: A central question will be whether the accused product's internal mechanism constitutes an "anti-back rotation assembly" as that term is understood from the patent's specification.
- Technical Questions: What evidence supports the allegation that the plunger is "unidirectionally movable"? While the clicking mechanism may prevent reverse rotation of the base during normal operation, the defense may question whether this equates to the plunger itself being strictly unidirectional under all conditions.
’685 Patent Infringement Allegations
| Claim Element (from Independent Claim 6) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first arm and a second arm, wherein the first arm and the second arm are rotatable with the driver | The accused applicator is alleged to have "multiple arm rotatable with the driver." A photograph shows the arms attached to the driver component. | ¶43, ¶41 (image) | col. 23:19-21 |
| wherein the first arm comprises a non-uniform profile along a length of the first arm | The complaint alleges that the arms have a "non-uniform profile along their length," and provides a side-view photograph purporting to show this feature. | ¶43, ¶43 (image) | col. 23:21-23 |
| and such that at least the first arm provides auditory feedback | The complaint alleges that the arms produce an "audible 'click'" when their projections engage with slots in the housing. | ¶43 | col. 23:23-24 |
| wherein the first arm and the second arm are each bendable with rotation of the driver | It is alleged that the arms are "bendable" with rotation. | ¶43 | col. 23:25-26 |
| wherein the at least one arm further comprises a projection extending from the at least one arm | The complaint alleges the arms have "projections at their ends which engage with slots in the housing." | ¶43 | col. 23:27-29 |
- Identified Points of Contention:
- Scope Questions: The meaning of "non-uniform profile" may be a key point of dispute. Does any variation in shape suffice, or does the specification require a specific profile functionally tied to producing the audible feedback?
- Technical Questions: What is the precise mechanical interaction that causes the "audible 'click'"? The complaint asserts it is the projection engaging a slot, but the defense may challenge whether this interaction is the sole source of the sound or if it meets the functional requirements of the claim.
V. Key Claim Terms for Construction
For the ’027 Patent:
- The Term: "unidirectionally movable"
- Context and Importance: This term is critical for defining the plunger's required behavior. Practitioners may focus on this term because the infringement analysis depends on whether the accused product's plunger, under normal operation, is prevented from moving backward. The plaintiff's theory of precise dosing relies on this one-way movement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's focus is on dispensing, implying the term applies during the act of dispensing. Language stating the traveler is configured to "selectively position the plunger... so as to dispense a predetermined quantity" may support an interpretation that "unidirectional" refers to this functional context, not an absolute physical constraint (’027 Patent, col. 24:42-47).
- Evidence for a Narrower Interpretation: The term itself implies movement in only one direction. A defendant could argue that if the plunger can be moved backward for any reason (e.g., disassembly), it is not "unidirectionally movable." The patent describes the anti-back rotation feature preventing the driver from reversing, which is the cause of the plunger's unidirectional movement, suggesting the effect should be just as constrained as the cause (’027 Patent, col. 23:36-40).
For the ’685 Patent:
- The Term: "non-uniform profile"
- Context and Importance: This term is central to Claim 6 and describes the physical characteristic of the arm that allegedly results in auditory feedback. The dispute will likely center on whether the shape of the accused device's arms constitutes a "non-uniform profile" within the patent's meaning, and if that profile is functionally responsible for the click.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not explicitly defined, which may support an argument that any profile that is not perfectly uniform along its length qualifies. The specification describes a "clicking profile (614)" as one example, but does not state it is the only possibility, potentially leaving the door open for other shapes that achieve the same result (’685 Patent, col. 9:60-62).
- Evidence for a Narrower Interpretation: The patent consistently links the "auditory feedback" to the interaction between a specific "clicking profile" on a projection and a slot. For example, Figure 11 shows a distinct shape (614) on the arm's engagement end (608). A defendant may argue that the term must be limited to a profile that is specifically shaped to create a click upon engaging a slot, not just any general non-uniformity (’685 Patent, col. 9:56-62).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. The allegations are based on Defendant's knowledge of the patents combined with its continued advertising, promotion, and sale of the Accused Products. The complaint asserts that the products are "specially made for use in a manner infringing" and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶¶50-51, 58-59).
- Willful Infringement: The complaint alleges that Defendant "has had knowledge of the '027 and '685 Patents prior to the filing of this Complaint" and that its infringement "has been and continues to be egregious and willful" (Compl. ¶¶46, 54, 62). This alleges pre-suit knowledge as the basis for willfulness.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope and construction: can functionally-oriented terms like "anti-back rotation assembly" (’027 Patent) and descriptive terms like "non-uniform profile" that provides "auditory feedback" (’685 Patent) be construed to read on the specific mechanical structures of the accused UnoDose applicator as depicted in the complaint’s photographs? The resolution of these terms will likely determine the outcome of the infringement analysis.
- A second central question will be evidentiary and functional: does the physical operation of the accused device's components match the functions required by the claims? Specifically, does the interaction between the flexible arms and the base in the UnoDose product create the claimed "auditory feedback" because of a "non-uniform profile," or does it arise from other mechanical interactions? Likewise, is the resulting movement of the plunger "unidirectional" in the manner required by the patent?