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., 06/21/2022
- Venue Allegations: Venue is alleged to be proper in the District of Maryland because Defendant Corbin is a Maryland company with its principal place of business in the district, and a substantial part of the events giving rise to the claims occurred there.
- Core Dispute: Plaintiff seeks a declaratory judgment that its SureFire medical device does not infringe three of the Defendant's patents, that the patents are invalid, and that the Defendant engaged in a bad faith patent assertion under Maryland law.
- Technical Context: The technology involves mechanical guides used with transrectal ultrasound probes to assist clinicians in performing transperineal prostate biopsies, a procedure for diagnosing prostate cancer.
- Key Procedural History: The action was initiated after Plaintiff received demand letters from Defendant beginning in August 2020, alleging that Plaintiff's SureFire product infringes the patents-in-suit. Defendant subsequently filed counterclaims for infringement of two of the asserted patents.
Case Timeline
| Date | Event |
|---|---|
| 2010-01-01 | BK Medical UA1324, cited as prior art, allegedly on sale (at least as early as 2010) |
| 2014-04-03 | Earliest Priority Date for '681, '762, and '677 Patents |
| 2018-09-04 | U.S. Patent No. 10,064,681 ('681 Patent) Issued |
| 2020-08-12 | Defendant sends first demand letter to Plaintiff regarding '681 Patent |
| 2021-08-24 | U.S. Patent No. 11,096,762 ('762 Patent) Issued |
| 2022-02-15 | U.S. Patent No. 11,246,677 ('677 Patent) Issued |
| 2022-04-15 | Defendant files counterclaims for infringement of '762 and '677 Patents |
| 2022-06-21 | Plaintiff files First 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 describes drawbacks of existing prostate biopsy methods. Transrectal (TRUS) biopsies carry a risk of infection from coliform bacteria, while conventional transperineal (TPUS) systems are cumbersome, often requiring a fixed grid and not allowing for "free-hand movement of the ultrasound probe" (’681 Patent, col. 1:40-64).
- The Patented Solution: The invention is a guide apparatus that couples to a transrectal ultrasound probe to enable "free-handed, guided, transperineal" biopsies ('681 Patent, col. 4:6-8). The guide features a "sliding platform" mounted on "stabilization bars" which supports an access needle, allowing a user to position the needle along a sagittal plane for optimal targeting while using real-time ultrasound imaging ('681 Patent, col. 4:35-39; Fig. 1).
- Technical Importance: The technology purports to combine the lower infection risk of the transperineal approach with the procedural flexibility and real-time guidance more typical of the transrectal approach, thereby satisfying a demand for a less burdensome and more effective biopsy method ('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).
- Independent Claim 1 Elements:
- An apparatus configured to couple with a transrectal probe.
- An upper mount and a lower mount configured to couple to each other to engage and secure the probe.
- The upper mount comprising 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 "so as to displace the access needle."
- Independent Claim 19 Elements:
- An apparatus with an upper mount comprising stabilization bars and a platform.
- The platform is configured to support the access needle "in a central position between the pair of stabilization bars."
- The platform is configured to slide along the stabilization bars "so as to displace the access needle."
- A lower mount configured to engage the probe and couple to the upper mount.
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 '681 patent, the '762 patent addresses the same technical challenges: the infection risk and procedural limitations of prior art biopsy systems (’762 Patent, col. 1:40-44, col. 2:13-18).
- The Patented Solution: The invention provides a similar guide for free-handed transperineal biopsies using a transrectal ultrasound probe ('762 Patent, col. 2:25-34). It enables real-time visualization and guidance for an access needle, which is fixed relative to the probe, allowing for multiple samples to be taken through a single skin perforation ('762 Patent, col. 4:26-30, 4:51-58).
- Technical Importance: The disclosed methods and systems aim to "reduce or eliminate multiple skin perforations" and avoid burdensome patient preparation, thereby improving the efficacy and patient experience of prostate biopsies (’762 Patent, col. 4:47-55).
Key Claims at a Glance
- The complaint asserts non-infringement of claims 13 and 36 (Compl. ¶41). Independent claim 13 is an apparatus claim.
- Independent Claim 13 Elements:
- A method of performing a transperineal prostate biopsy.
- Inserting an access needle into a perineal access site.
- The access needle is engaged with a platform "that is 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 the prostate.
- The complaint does not explicitly reserve the right to assert dependent claims but seeks a declaration of non-infringement for "any valid claim" of the patent (Compl. ¶40).
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 continuation patent also describes a guide for performing free-handed transperineal prostate biopsies. The guide couples to a transrectal ultrasound probe and includes a platform that holds an access needle, allowing the needle's position to be fixed relative to the probe for guided, real-time procedures (’677 Patent, col. 2:25-34).
- Asserted Claims: The complaint asserts non-infringement of independent claims 1, 13, and 22 (Compl. ¶47).
- Accused Features: Plaintiff alleges its SureFire product does not meet limitations common to the asserted claims, specifically the requirement of a "platform configured to slide" relative to a base portion or stabilization members (Compl. ¶47).
III. The Accused Instrumentality
Product Identification
- The Advance Medical SureFire Product (Compl. ¶11).
Functionality and Market Context
- The SureFire Product is a transperineal needle guide designed for use with a transrectal ultrasound probe (Compl. ¶11). It features a clamp for mounting to the probe and a "needle plate with a plurality of channels" for receiving a needle at various heights (Compl. ¶11). The complaint alleges that in use, the needle plate is adjusted to the correct position and then "locked in place" before a needle is inserted through one of the fixed channels (Compl. ¶12). An annotated photograph in the complaint shows the product mounted on an ultrasound probe, highlighting features such as a "Locker Button," "Flexible length adjustment," and a "Clear vertical indicator with 9 settings" (Compl. p. 3). The complaint does not contain allegations regarding the product's specific commercial importance.
IV. Analysis of Infringement Allegations
’681 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged 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 | Plaintiff alleges the SureFire product does not have this two-part mount structure. | ¶34 | col. 2:24-27 |
| a platform configured to slide on the pair of stabilization bars...so as to displace the access needle | The SureFire Product has a needle plate that is adjusted and then locked; Plaintiff alleges it is not configured to slide while a needle is being inserted. | ¶13, ¶35 | col. 4:35-39 |
| the platform configured to support the access needle be “in a central position between the pair of stabilization bars” (from Claim 19) | Plaintiff alleges the SureFire Product's platform is not in a central position between stabilization bars. | ¶36 | col. 16:35-37 |
’762 Patent Infringement Allegations
| Claim Element (from Independent Claim 13) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a platform that is configured to slide on a pair of stabilization members of a biopsy guide | The SureFire Product has a needle plate that is adjusted and then locked; Plaintiff alleges it is not configured to slide during use. | ¶13, ¶41 | col. 16:11-13 |
| the access needle be[] centrally positioned between the pair of stabilization members | Plaintiff alleges the access needle in the SureFire Product is not centrally positioned between the stabilization members. | ¶42 | col. 16:13-15 |
Identified Points of Contention
- Technical Questions: The primary technical dispute centers on the operation of the "platform." The complaint alleges the SureFire product's needle plate is adjusted and then locked, and is "not configured to slide while the needle is being inserted" (Compl. ¶13). The patents, however, describe a "sliding platform" that "allows a user... to place the access needle" ('681 Patent, col. 4:35-39). The case may turn on whether the claimed "sliding" refers to the initial adjustment and positioning of the platform, or to dynamic movement during the biopsy procedure itself.
- Scope Questions: A central legal question will be the construction of the term "platform configured to slide." A related question is the meaning of "centrally positioned between" the stabilization bars, which Plaintiff alleges its product does not meet (Compl. ¶36, ¶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 Plaintiff's non-infringement argument. Its construction is dispositive. Practitioners may focus on this term because the Plaintiff alleges a fundamental operational difference: its platform is locked before use, whereas the claim requires it to be "configured to slide" to displace the needle.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A defendant may argue that "configured to slide" simply means the platform is capable of sliding movement for adjustment, not necessarily during the entire procedure. The specification states the sliding platform "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), which could be interpreted as describing an adjustment function rather than continuous movement.
- Evidence for a Narrower Interpretation: A plaintiff may argue that the claim language "so as to displace the access needle" requires that the sliding action itself is the means of displacement during the procedure. The complaint alleges that during prosecution of the '681 Patent, the patentee distinguished prior art by emphasizing this sliding capability, which could create a record supporting a narrower construction (Compl. ¶17-18).
VI. Other Allegations
- Violation of Maryland's Bad Faith Patent Assertion Act: Plaintiff alleges Defendant violated Maryland law by making bad faith assertions of infringement (Compl. ¶62). The complaint alleges this is based on Defendant's failure to conduct an adequate pre-suit infringement analysis, particularly regarding whether the SureFire product's platform is "configured to slide" (Compl. ¶63). Plaintiff also alleges Defendant knew or should have known the '681 Patent was invalid in view of prior art and its own prosecution history arguments (Compl. ¶64).
- Invalidity Allegations: Plaintiff alleges the patents are invalid under 35 U.S.C. §§ 102 and 103 based on prior art, including the BK Medical UA1324 product (Compl. ¶51, ¶55, ¶59). The complaint alleges this product was on sale as early as 2010, pre-dating the patents' 2014 priority date, and has a "similar mount, platform configured to support an access needle, and stabilization bar" (Compl. ¶26-27). The complaint includes a photograph of the BK Medical UA1324 device to support this allegation (Compl. p. 7).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: Does the term "platform configured to slide," as used across the asserted patents, require that the platform be movable during the biopsy to displace the needle, or does it merely describe a platform that is adjustable via sliding before being locked into a fixed position for the procedure?
- A central evidentiary question will be one of anticipation and obviousness: Does the BK Medical UA1324 prior art device, allegedly on sale since 2010, disclose all elements of the asserted claims, as Plaintiff contends? The court will need to compare the structure and function of this prior art device to the patent claims.
- A further question relates to bad faith assertion: Did Defendant's pre-suit investigation and demand letters meet the required diligence standards under Maryland law, or did it, as Plaintiff alleges, proceed with infringement assertions despite evidence of non-infringement or invalidity?