DCT
1:22-cv-00789
Advance Medical Designs Inc v. Corbin Clinical Resources LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Advance Medical Designs, Inc. (Georgia)
- Defendant: Corbin Clinical Resources, LLC (Maryland)
- Plaintiff’s Counsel: Dunlap Bennett & Ludwig PLLC; Lee & Hayes, P.C.
- Case Identification: 1:22-cv-00789, D. Md., 07/20/2022
- Venue Allegations: Venue is asserted in the District of Maryland on the basis that Defendant Corbin Clinical Resources, LLC has its principal place of business in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its SureFire medical device does not infringe three of Defendant's patents related to transperineal prostate biopsy guides, and further that the patents-in-suit are invalid.
- Technical Context: The technology concerns guided systems for performing transperineal prostate biopsies, a procedure intended to reduce infection risk compared to the more common transrectal approach.
- Key Procedural History: The action follows a series of pre-suit communications initiated by the patentee, Corbin, beginning with a demand letter on August 12, 2020. The complaint notes that Corbin filed counterclaims for infringement of the ’762 and ’677 patents in response to an earlier version of the complaint. The complaint also raises invalidity challenges based on alleged prior art, including a commercial product and an earlier patent. Public records indicate that two of the asserted patents, the ’762 and ’677 patents, have been the subject of ex parte reexamination proceedings, resulting in the issuance of reexamination certificates.
Case Timeline
| Date | Event |
|---|---|
| 2010-01-01 | Alleged first sale of BK Medical UA1324 prior art product |
| 2014-04-03 | Earliest Priority Date for ’681, ’762, and ’677 Patents |
| 2018-09-04 | ’681 Patent Issued |
| 2020-08-12 | Corbin sends first demand letter to Advance Medical regarding ’681 Patent |
| 2021-08-24 | ’762 Patent Issued |
| 2022-02-15 | ’677 Patent Issued |
| 2022-04-15 | Corbin files counterclaims for infringement of ’762 and ’677 Patents |
| 2022-07-20 | Advance Medical files Second Amended Complaint for Declaratory Judgment |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,064,681 - "Method, System, and Device for Planning and Performing, Guided and Free-Handed Transperineal Prostate Biopsies," Issued Sep. 4, 2018
The Invention Explained
- Problem Addressed: The patent identifies drawbacks in conventional prostate biopsy methods. Transrectal (TRUS) biopsies carry a risk of infection from passing a needle through the rectal wall, while traditional transperineal (TPUS) systems often rely on fixed grids that limit the free-hand movement of the ultrasound probe and may require multiple skin punctures (’681 Patent, col. 1:36-61, col. 2:11-18).
- The Patented Solution: The invention is a guide apparatus that attaches to a standard transrectal ultrasound probe to enable a "free-handed" transperineal biopsy. The guide features a pair of stabilization bars upon which a platform slides (’681 Patent, col. 4:30-38). This platform holds an access needle, fixing its position and alignment relative to the real-time ultrasound image, which allows a clinician to guide the needle to a target with precision through a single skin entry point (’681 Patent, Abstract; Fig. 1).
- Technical Importance: The technology aims to provide the lower infection risk of a transperineal approach while offering the procedural flexibility and real-time sagittal plane guidance typically associated with free-hand transrectal methods (’681 Patent, col. 2:53-61).
Key Claims at a Glance
- The complaint asserts non-infringement of independent claims 1 and 19 (Compl. ¶¶34-36).
- Claim 1 elements include:
- An upper mount and a lower mount configured to couple to each other to secure a transrectal probe.
- The upper mount comprises a platform and a pair of stabilization bars.
- The platform is configured to support an access needle.
- The platform is "configured to slide on the pair of stabilization bars along at least a portion of the length so as to displace the access needle."
- Claim 19 elements include:
- An upper mount comprising a pair of stabilization bars and a platform.
- The platform is configured to support an access needle "in a central position between the pair of stabilization bars."
- The platform is "configured to slide along at least a portion of the length of the pair of stabilization bars."
- A lower mount configured to engage with the transrectal probe and couple to the upper mount.
- The complaint does not explicitly reserve the right to assert non-infringement of dependent claims.
U.S. Patent No. 11,096,762 - "Method, System, and Device for Planning and Performing, Guided and Free-Handed Transperineal Prostate Biopsies," Issued Aug. 24, 2021
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’681 Patent, this patent addresses the same technical problems regarding prostate biopsy procedures (’762 Patent, col. 1:30-58).
- The Patented Solution: This patent claims the method of using the biopsy guide system. The claimed process involves positioning the guide's stabilization members against the patient's perineal skin, inserting an access needle engaged with the sliding platform, and then passing a biopsy needle through the access needle to obtain tissue samples from one or more locations within the prostate, all while the guide is secured to a movable ultrasound probe (’762 Patent, Abstract; col. 15:10-27).
- Technical Importance: By claiming the method of use, the patent provides a scope of protection that complements the apparatus claims of the parent ’681 Patent.
Key Claims at a Glance
- The complaint asserts non-infringement of independent claims 13 and 36 (Compl. ¶¶41-42).
- Claim 13 is a method comprising:
- Inserting an access needle into a perineal access site, where the needle is engaged with a platform "configured to slide on a pair of stabilization members of a biopsy guide."
- The access needle is "centrally positioned between the pair of stabilization members."
- Inserting a biopsy needle through the access needle into a first location within the prostate.
- Claim 36 is a method comprising:
- Inserting an access needle into a perineal access site, where the needle is engaged with a platform that slides on stabilization members of a guide secured to an ultrasound probe.
- The access needle is "positioned within the sagittal plane" when engaged with the platform and imaged by the probe.
- Inserting a biopsy needle through the access needle into a first location within the prostate.
- The complaint does not explicitly reserve the right to assert non-infringement of dependent claims.
U.S. Patent No. 11,246,677 - "Method, System, and Device for Planning and Performing, Guided and Free-Handed Transperineal Prostate Biopsies," Issued Feb. 15, 2022
Technology Synopsis
This patent, also in the same family, claims a biopsy guide apparatus. Its claims focus on the structural relationship between a "base portion" (which includes stabilization members or a channel) and a "platform" that is "slidably engageable" with it, emphasizing the "frictional engagement" between the platform's lateral surfaces and the base portion's inner surfaces (’677 Patent, col. 15:10-26).
Asserted Claims
The complaint asserts non-infringement of independent claims 1, 13, and 22 (Compl. ¶47).
Accused Features
The complaint alleges that the SureFire product does not meet the "platform configured to slide" limitations of the asserted claims (Compl. ¶47).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the "SureFire Product" manufactured and sold by Plaintiff Advance Medical Designs, Inc. (Compl. ¶11).
Functionality and Market Context
The SureFire Product is a "transperineal needle guide for a transrectal ultrasound probe" (Compl. ¶11). It includes a clamp for mounting the device to an ultrasound probe and a "needle plate with a plurality of channels for receiving a needle at different heights" (Compl. ¶11). The complaint states that the position of this needle plate is adjustable and describes its use: after the guide is secured to the probe and the probe is inserted, the needle plate is "adjusted horizontally to the correct position and then locked in place" before a needle is inserted through one of its channels (Compl. ¶12). An image in the complaint shows the SureFire Product featuring a "Clear vertical indicator with 9 settings" and "Flexible length adjustment" (Compl. p. 4). A six-step diagram illustrates the product's use, showing that the needle plate is adjusted horizontally before the biopsy instrument is inserted (Compl. p. 5). The complaint does not contain allegations regarding the product's specific market positioning.
IV. Analysis of Infringement Allegations
'681 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an upper mount and a lower mount configured to couple to each other, the lower mount configured to engage the transrectal probe and secure the upper mount relative to the transrectal probe | The complaint alleges the SureFire Product does not meet this limitation, but provides no specific factual basis for the denial. | ¶34 | col. 15:15-22 |
| the platform configured to slide on the pair of stabilization bars along at least a portion of the length so as to displace the access needle | The complaint alleges the SureFire Product's needle plate is not configured to slide while a needle is being inserted, but is instead adjusted and then locked into a fixed position prior to needle insertion. | ¶13, ¶35 | col. 15:30-34 |
- Identified Points of Contention:
- Scope Questions: The primary dispute appears to be over the term "configured to slide." The complaint suggests this requires the ability to slide during the biopsy procedure, not merely be adjustable beforehand (Compl. ¶13, ¶18). The question for the court will be whether a "lock-then-use" mechanism like that described for the SureFire Product (Compl. ¶12) falls outside the scope of a platform "configured to slide."
- Technical Questions: A question exists whether the SureFire Product's clamping mechanism, depicted as a single integrated component, constitutes the structurally distinct "upper mount and a lower mount" required by the claims (Compl. p. 4; Compl. ¶34).
'762 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| inserting an access needle into a perineal access site leading to the prostate, the access needle engaged with a platform that is configured to slide on a pair of stabilization members of a biopsy guide | The complaint alleges the SureFire Product does not have a platform "configured to slide" in the manner required by the claim. | ¶41 | col. 16:11-15 |
| the access needle being centrally positioned between the pair of stabilization members | The complaint makes a conclusory denial that the SureFire Product meets this limitation, without providing specific facts. | ¶42 | col. 16:15-18 |
- Identified Points of Contention:
- Scope Questions: As with the ’681 Patent, the central issue is the interpretation of "configured to slide" in the context of a method claim. The dispute will focus on whether the claimed method steps require a platform that can be repositioned dynamically during the procedure or if pre-procedure adjustment suffices.
- Technical Questions: The complaint's denial regarding the "centrally positioned" limitation raises a factual question about the geometry of the SureFire Product's needle plate and guide channels relative to its mounting structure (Compl. ¶42).
V. Key Claim Terms for Construction
The Term: "platform configured to slide"
- Context and Importance: This term appears in the independent claims of all three asserted patents and is the primary basis for Advance Medical's non-infringement argument (Compl. ¶35, ¶41, ¶47). Practitioners may focus on this term because its interpretation—whether it means merely adjustable or requires movement during the procedure—is likely dispositive of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language states the platform slides "so as to displace the access needle" (’681 Patent, col. 15:33-34). This could be interpreted to cover any sliding that results in displacement, including pre-use adjustment. The specification notes the guide allows "multiple extractions of tissue or cell specimens from the prostate" from a "single access location," which could be accomplished by adjusting, locking, and then sampling in series (’681 Patent, col. 4:51-54).
- Evidence for a Narrower Interpretation: The patent describes a "sliding platform that allows a user... to place the access needle along a sagittal transducer plane at optimal positions for obtaining prostate biopsies" (’681 Patent, col. 4:35-39). The complaint highlights that the product is locked before needle insertion, arguing this is functionally different from a platform that slides while in use (Compl. ¶12-13).
The Term: "an upper mount and a lower mount"
- Context and Importance: This two-component structure is recited in claims of the ’681 Patent, and Advance Medical denies that its product meets this limitation (Compl. ¶34). The visual evidence suggests the SureFire Product may use a unitary clamp (Compl. p. 4).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's purpose is to secure a probe between two components. A defendant could argue that any clamp necessarily has an "upper" and "lower" portion that performs this function, even if manufactured as a single piece. The claims require they are "configured to couple to each other" (’681 Patent, col. 15:16), which could describe the action of a single-piece clamp closing.
- Evidence for a Narrower Interpretation: The claims recite two distinct structural elements. The patent figures consistently depict two separate components, an upper mount (105) and a lower mount (104), that are fastened together (’681 Patent, Figs. 1, 4, 7). This provides strong evidence that the inventor contemplated two physically separate pieces.
VI. Other Allegations
- Indirect Infringement: The provided complaint, being a declaratory judgment action by the accused infringer, does not contain allegations of indirect infringement. Such allegations would be expected in the patentee's counterclaims.
- Willful Infringement: The complaint does not allege willfulness. However, it establishes a basis for a potential willfulness claim by the patentee, Corbin, by documenting pre-suit knowledge of the patents. The complaint details a demand letter concerning the ’681 Patent sent on August 12, 2020, and subsequent correspondence (Compl. ¶14, ¶18, ¶20). This timeline establishes pre-suit notice, which is a prerequisite for enhanced damages under 35 U.S.C. § 284.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: does the limitation "platform configured to slide," as used across the asserted patents, require that the platform be movable during the biopsy to reposition the needle, or is it broad enough to cover a device where the platform is adjusted and then locked into a fixed position before the procedure begins?
- A key evidentiary question will be one of invalidity: can Advance Medical prove by clear and convincing evidence that the asserted claims are anticipated or rendered obvious by prior art, such as the BK Medical UA1324 product, which it alleges was on sale before the patents' priority date and contains similar features?
- A secondary infringement question will be one of structural identity: does the SureFire product’s clamping mechanism, which appears to be a unitary structure, meet the "upper mount and a lower mount" limitation of the ’681 Patent, or is there a definitive structural difference that avoids literal infringement?