DCT

1:25-cv-00953

Shukla Medical Inc v. Mahe Medical USA LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00953, D. Colo., 03/25/2025
  • Venue Allegations: Venue is based on Defendant being a Colorado limited liability company with its principal place of business and other offices in Colorado, and having allegedly marketed, sold, and committed acts of infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s "Xtracta-Screw" orthopedic screw extractors infringe two patents related to the design of surgical tools for removing damaged bone screws.
  • Technical Context: The technology concerns specialized surgical instruments designed to grip and remove orthopedic screws that have been damaged (e.g., stripped), a common challenge in revision surgeries.
  • Key Procedural History: The complaint notes that Plaintiff filed a prior suit in the Middle District of Florida in December 2023, which was dismissed for lack of personal jurisdiction. Plaintiff also alleges sending a cease and desist letter to Defendant on December 22, 2023, putting Defendant on notice of its patent rights.

Case Timeline

Date Event
2016-05-02 '226 & '488 Patents Priority Date
2021-XX-XX Defendant allegedly begins marketing accused "Xtracta-Screw" product
2022-08-30 U.S. Patent No. 11,426,226 Issues
2023-12-XX Plaintiff files prior lawsuit in M.D. Florida
2023-12-22 Plaintiff sends cease and desist notice to Defendant
2024-07-23 U.S. Patent No. 12,043,488 Issues
2025-03-25 Complaint Filing Date

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

U.S. Patent No. 11,426,226 - "Orthopedic Screw Extractor"

  • Patent Identification: U.S. Patent No. 11,426,226 ("Orthopedic Screw Extractor"), issued August 30, 2022. (Compl. ¶35).

The Invention Explained

  • Problem Addressed: The patent identifies the difficulty surgeons face when removing orthopedic bone screws that have been damaged or stripped. Conventional extractors may not provide sufficient "bite," making removal difficult and potentially leading to excessive bone loss for the patient. (’226 Patent, col. 1:17-28).
  • The Patented Solution: The invention is a screw extractor with a precisely engineered tip designed to overcome this problem. It features a frustoconical (cone-like) shape with a specific taper angle, combined with multiple screw threads having defined dimensions for their lead, pitch, and depth. This geometry is intended to maximize the extractor's engagement with the interior of a damaged screw, allowing for a stronger grip and more efficient removal. (’226 Patent, Abstract; col. 1:36-50).
  • Technical Importance: The specified design aims to make a challenging revision surgery safer and more reliable by ensuring a secure lock onto damaged hardware, thereby minimizing trauma to surrounding bone. (’226 Patent, col. 1:29-33).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 4, 5, and 9. (Compl. ¶99).
  • Independent Claim 1 requires:
    • An orthopedic screw extractor with a shaft and a handle-attachment portion.
    • A "screw extracting tip" at the opposite end of the shaft.
    • The tip must have a "frustoconical shape" with a side at a taper angle "of about 5 to 15 degrees."
    • The tip must have "screw threads" with specific dimensional ranges: a "lead of about 0.04 to 0.14 inches," a "pitch of about 0.01 to 0.05 inches," and a "depth of about 0.004 to 0.03 inches." (’226 Patent, col. 11:9-22).
  • The complaint notes that its infringement allegations are preliminary. (Compl. ¶100).

U.S. Patent No. 12,043,488 - "Orthopedic Screw Extractor"

  • Patent Identification: U.S. Patent No. 12,043,488 ("Orthopedic Screw Extractor"), issued July 23, 2024. (Compl. ¶36).

The Invention Explained

  • Problem Addressed: As a continuation in the same patent family, the ’488 Patent addresses the same technical challenge of removing stripped or damaged orthopedic fasteners without sufficient grip, which can lead to difficult extractions and bone loss. (’488 Patent, col. 1:26-31).
  • The Patented Solution: The patent describes a similarly designed orthopedic screw extractor tip. The claims of the ’488 Patent, however, define the invention using a different combination of features. The focus of the independent claim is on the combination of the frustoconical shape, the presence of a screw thread, and a specific overall length of the tip, differing from the lead/pitch/depth requirements of the ’226 Patent's independent claim. (’488 Patent, Abstract; col. 11:1-8).
  • Technical Importance: The invention provides an alternative configuration for an extractor tip aimed at improving the safety and efficiency of removing compromised surgical screws. (’488 Patent, col. 1:32-36).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and numerous dependent claims. (Compl. ¶114).
  • Independent Claim 1 requires:
    • An orthopedic screw extractor with a shaft.
    • A "screw extracting tip" on the shaft.
    • The tip must have a "frustoconical shape" with a side at a taper angle "of about 5 to 15 degrees."
    • The tip must have "a screw thread."
    • The tip must have an "overall length of about 0.20 to 0.32 inches." (’488 Patent, col. 11:1-8).
  • The complaint characterizes its allegations as preliminary. (Compl. ¶115).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies the accused products as the "Xtracta-Screws," specifically the "Mahe Medical Xtracta-Screw brand stripped screw extractor." (Compl. ¶¶40, 99).

Functionality and Market Context

  • The complaint alleges the accused products are orthopedic screw extractors sold for the purpose of removing stripped screws. (Compl. ¶108). The allegations are based on Plaintiff's evaluation and physical measurement of a sample Mahe product, part number U-ESR-KS5. (Compl. ¶¶101-107, 116-122). Based on this evaluation, the complaint alleges specific dimensions for the accused product's taper angle, thread lead, pitch, depth, and overall length. (Compl. ¶¶101-107). Plaintiff alleges that Defendant is a direct competitor in the orthopedic industry. (Compl. ¶108). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits 11 and 12) that were not included with the provided filing. The following summary is based on the narrative infringement allegations in the body of the complaint.

'226 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a frustoconical shape having a side at a taper angle α of about 5 to 15 degrees... The accused product's extracting tip allegedly has a frustoconical shape with a taper angle measured to be 15 degrees. ¶101 col. 11:15-18
screw threads including: a lead of about 0.04 to 0.14 inches... The accused product's extracting tip allegedly has a lead measured to be 0.054 inches. ¶102 col. 11:19-20
a pitch of about 0.01 to 0.05 inches... The accused product's extracting tip allegedly has a thread pitch measured to be 0.018 inches. ¶103 col. 11:21
a depth of about 0.004 to 0.03 inches. The accused product's extracting tip allegedly has a thread depth measured to be 0.004 inches. ¶104 col. 11:22

'488 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a frustoconical shape having a side at a taper angle α of about 5 to 15 degrees... The accused product's extracting tip allegedly has a frustoconical shape with a taper angle measured to be 15 degrees. ¶116 col. 11:3-6
a screw thread... The accused product's tip is alleged to have screw threads, with specific measurements for lead and pitch provided as evidence. ¶¶117-118 col. 11:7
an overall length of about 0.20 to 0.32 inches. The accused product's extracting tip allegedly has an overall length measured to be 0.32 inches. ¶120 col. 11:8
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the interpretation of the word "about," which precedes every numerical limitation in the asserted independent claims. The complaint alleges several measurements for the accused product that fall at the exact boundaries of the claimed ranges (e.g., a "15 degree" taper angle for a claimed range of "about 5 to 15 degrees"). The construction of "about" could be determinative of literal infringement.
    • Technical Questions: The infringement allegations rest on Plaintiff's "physical measurements" of a sample product. (Compl. ¶101). A key technical question for the court will be the verification of these measurements. The dispute may focus on whether the measurements are accurate and repeatable across a representative sample of Defendant’s products, particularly when accounting for standard manufacturing tolerances.

V. Key Claim Terms for Construction

  • The Term: "about"
  • Context and Importance: This term is used to qualify every numerical range in the asserted independent claims of both patents. The infringement allegations frequently place the accused product's measured dimensions at the precise edges of these ranges. Therefore, the scope afforded to "about" is critical to the infringement analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Practitioners may note that the '226 Patent specification provides an explicit definition: "About as used herein when referring to a measurable value... is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate." (’226 Patent, col. 4:63-66). Plaintiff will likely argue this definition is controlling and provides a clear, expansive scope.
    • Evidence for a Narrower Interpretation: Defendant may argue that the term renders the claims indefinite when applied to a range. Alternatively, Defendant could argue that even under the patent's definition, the measured values of its products, when considering manufacturing tolerances, do not fall within the scope of the claims.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead a separate count for indirect infringement. It notes that "various independent sales organizations sell the Mahe Medical Xtracta-Screw product on behalf of Defendant," but does not allege the specific elements of knowledge and intent required for a claim of induced infringement. (Compl. ¶40).
  • Willful Infringement: The complaint makes explicit allegations of willful infringement. The stated basis is Defendant’s alleged continued infringement after receiving a cease and desist letter on December 22, 2023, and after being a party to a prior lawsuit filed by Plaintiff in December 2023. (Compl. ¶¶27-29, 109, 126). The complaint alleges Defendant has "actual knowledge" of the patents. (Compl. ¶¶109, 126).

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

  • A central issue will be one of claim construction: how will the court construe the term "about," which modifies every numerical limitation in the asserted claims? The patent specification contains an explicit definition for the term, and the application of this definition to the complaint's allegations—which often place the accused product at the boundaries of the claimed ranges—will be a primary focus of the dispute.
  • The case will also present a key evidentiary question of measurement: will discovery and expert analysis validate the specific physical dimensions of the accused extractor tip as alleged by the Plaintiff? The outcome will depend on whether Plaintiff’s measurements are proven to be accurate and representative of the accused products as sold, especially when considering manufacturing tolerances.