DCT
1:19-cv-00881
Keramed Inc v. Andrei Iancu
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Yichieh Shiuey and KeraMed, Inc. (Delaware)
- Defendant: Andrei Iancu, in his official capacity as Director of the United States Patent and Trademark Office (USPTO)
- Plaintiff’s Counsel: Rothwell, Figg, Ernst & Manbeck, P.C.
- Case Identification: 1:19-cv-00881, E.D. Va., 07/02/2019
- Venue Allegations: Venue is asserted pursuant to 35 U.S.C. § 145, which provides for civil actions against the USPTO Director to be brought in the U.S. District Court for the Eastern District of Virginia.
- Core Dispute: Plaintiffs seek a judgment from the court that they are entitled to a patent for a corneal implant invention, appealing a final decision by the Patent Trial and Appeal Board (PTAB) which affirmed the USPTO's rejection of the application's claims as obvious over prior art.
- Technical Context: The technology concerns implantable medical devices, specifically biocompatible scaffolds designed to be surgically placed within the cornea to alter its shape and correct vision defects.
- Key Procedural History: During prosecution of U.S. Patent Application No. 13/189,337 ('337 Application), the USPTO Examiner rejected the pending claims as obvious under 35 U.S.C. § 103, primarily based on U.S. Patent No. 6,543,453 to Klima in combination with other references, including U.S. Patent No. 5,391,201 to Barrett. On May 7, 2019, the PTAB issued a final decision affirming the Examiner's rejection. This action represents a de novo appeal of that administrative decision to the district court.
Case Timeline
| Date | Event |
|---|---|
| 2010-07-23 | Earliest Priority Date ('337 Application) |
| 2016-08-09 | First Declaration of inventor Dr. Shiuey submitted |
| 2016-11-18 | USPTO Office Action issued |
| 2017-01-17 | Second Declaration of inventor Dr. Shiuey submitted |
| 2017-02-23 | USPTO Advisory Action issued |
| 2019-05-07 | PTAB issues final decision affirming rejection of claims |
| 2019-07-02 | Complaint filed in E.D. Va. |
II. Technology and Patent Application-in-Suit Analysis
- Patent Application Identification: U.S. Patent Application Serial No. 13/189,337 (the '337 Application). The complaint does not specify the application's title. The application was filed on July 23, 2011.
The Invention Explained
- Problem Addressed: The complaint does not explicitly state a technical problem, but the context of the invention implies a need for improved medical devices and implants for corneal surgery to correct vision (Compl. ¶ 3).
- The Patented Solution: The '337 Application describes a corneal implant constructed as a "reversibly deformable scaffold" (Compl. ¶ 12). In its relaxed state, the implant has the shape of a "truncate dome"—a dome with a flattened top (Compl. ¶ 12). The structure is formed by an upper ring and a lower ring joined by arcuate connecting elements (Compl. ¶ 13). The combination of two connecting elements with segments of the upper and lower rings is alleged to form a "quadrilateral comprising curved sides" (Compl. ¶ 14, ¶ 45). When implanted into a pocket in the cornea, this scaffold is designed to reshape the cornea, for instance by flattening a central region, thereby providing vision correction (Compl. ¶¶ 17-18). An example of the implant is depicted in Figure 17C of the application (Compl. ¶ 11).
- Technical Importance: The claimed invention purports to provide a specific scaffold geometry that achieves vision correction through a different principle of operation than prior art conical implants, which are alleged to rely on bulk properties and an "arc-shortening effect" (Compl. ¶ 41).
Key Claims at a Glance
- The complaint identifies independent claims 39 and 50 as being at issue (Compl. ¶ 1).
- Independent Claim 39 includes the following essential elements:
- A corneal implant comprising a reversibly deformable scaffold having a relaxed state and a deformed state.
- The relaxed state is in the shape of a truncate dome constructed from an upper ring and a lower ring joined by arcuate connecting elements.
- The connecting elements and ring segments form a quadrilateral comprising curved sides.
- The sides are curved from the top to the bottom of the dome and are curved outward from the center of the scaffold.
- Implantation results in a flattening of a central region of the cornea and a steepening of a central region of the cornea.
- Independent Claim 50 includes a similar structure, with the key difference being the functional result:
- Implantation results in a "change of shape of the cornea towards the peripheral shape of the truncate dome."
- The complaint notes that dependent claims 40, 43-49, and 51-64 are also part of the appeal (Compl. ¶ 1).
III. The Accused Instrumentality
This action is a 35 U.S.C. § 145 appeal against the USPTO Director and does not involve an accused product or service.
IV. Analysis of Patentability Allegations
The central dispute is whether the claims of the '337 Application are obvious in light of prior art cited by the USPTO, primarily U.S. Patent No. 6,543,453 ("Klima") and U.S. Patent No. 5,391,201 ("Barrett"). The complaint alleges that the PTAB and the Examiner erred by concluding the prior art teaches or suggests key limitations of the claims.
Summary of Patentability Dispute (per Plaintiff's Allegations)
| Claim Element (from Independent Claims 39/50) | Alleged Deficiency in Prior Art | Complaint Citation | Prior Art Cited by USPTO |
|---|---|---|---|
| a truncate dome with sides that are curved from top to bottom | Klima teaches a "frusto-conical implant with straight sides," not a dome with curved sides, a point the Examiner allegedly conceded. Barrett teaches a device with a fully curved dome top and a flat bottom, not a "truncated" dome. | ¶¶ 22-23, 30-31 | Klima, Barrett |
| connecting elements that are curved outward from the center | Klima’s connecting elements are allegedly bent "left and right" in a frontal plane, not "outward from the center" in a sagittal plane as claimed. Plaintiff illustrates this distinction with a simple drawing showing the claimed outward curvature is not taught (Compl. p. 12). | ¶¶ 25, 27, 48 | Klima |
| a quadrilateral comprising curved sides | The structure in Klima's Figure 21, relied upon by the Examiner, allegedly shows a circular element touching the upper and lower rings at a single point each. Plaintiff argues a point is not a "segment" and a circle is not a "quadrilateral." | ¶¶ 46-47, 49 | Klima |
| implantation results in a [specific] change of shape of the cornea | Plaintiff argues that Klima and Barrett disclose frustoconical implants that operate on a different principle (arc-shortening based on bulk/thickness) and do not teach or suggest the claimed corneal reshaping effects. | ¶¶ 35-38, 41 | Klima, Barrett |
| a relaxed state in the shape of a truncate dome before implantation | Klima's disclosure of bending elements via in-situ treatment with radiation occurs after implantation, which contradicts the claim requirement of the structure having a defined shape in its "relaxed state" before implantation. | ¶¶ 27-28 | Klima |
- Identified Points of Contention:
- Factual Scope of Prior Art: A central question is whether the structures disclosed in the Klima and Barrett patents are factually equivalent to the structures claimed in the '337 Application. This involves comparing Klima's "frusto-conical" shape to the claimed "truncate dome" and Klima's circular connectors to the claimed "quadrilateral."
- Interpretation of Prior Art Operation: The parties may dispute the principle of operation of the prior art devices. Plaintiff contends the prior art operates via an "arc-shortening effect" proportional to implant thickness, which is fundamentally different from the principle of the claimed invention (Compl. ¶ 41).
- Propriety of Obviousness Combination: A legal and factual question is whether a person of ordinary skill would have been motivated to combine the teachings of Klima and Barrett to arrive at the claimed invention, particularly in light of Plaintiff's arguments that the references teach away from each other and operate on different principles (Compl. ¶¶ 34, 55).
V. Key Claim Terms for Construction
The dispute over patentability raises questions about the proper interpretation of key claim terms, which will define the scope of the claims relative to the prior art.
The Term: "truncate dome"
- Context and Importance: This term is central to distinguishing the invention from the prior art. Plaintiff characterizes Klima as "frusto-conical" with "straight sides" (Compl. ¶ 23) and Barrett as having a "fully curved" top (Compl. ¶ 30). The patentability of the claims may depend on whether "truncate dome" is interpreted as a distinct structure not taught or suggested by these prior art shapes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not offer language supporting a broad interpretation; rather, it seeks to define the term specifically to distinguish it from the art.
- Evidence for a Narrower Interpretation: The complaint describes the shape as "a dome which has been truncated on top" and explicitly links it to the illustration in Figure 17C (Compl. ¶ 12). A court may be asked to limit the term's meaning to the specific geometry shown and described.
The Term: "quadrilateral comprising curved sides"
- Context and Importance: Plaintiff's argument against the Klima reference hinges on this term. Plaintiff alleges Klima shows circular elements that touch rings at single tangent points, which cannot form a "quadrilateral" made of "segments" (Compl. ¶¶ 47, 49). Practitioners may focus on this term because the patentability determination could turn on whether a point of tangency can be considered a "side" or part of a "segment" that forms a quadrilateral.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be argued to encompass any four-sided shape with curved boundaries, regardless of how those boundaries are formed.
- Evidence for a Narrower Interpretation: The complaint defines the structure with high specificity as being "formed by connecting element 400, segment 401 of the lower ring, connecting element 402, and segment 403 of the upper ring" as depicted in Figure 17C (Compl. ¶ 15). This suggests the term requires four distinct sides, including actual, finite-length segments of the upper and lower rings, not just points of tangency.
VI. Other Allegations
No other allegations, such as indirect or willful infringement, are made in the complaint.
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents a de novo review of a USPTO patentability decision. The court will not be bound by the PTAB's factual findings. The key questions for resolution appear to be:
- A core issue will be one of prior art interpretation: Does the "frusto-conical" structure with "straight sides" disclosed in the Klima reference, or the "fully domed" device in Barrett, teach or render obvious the claimed "truncate dome with curved sides"?
- A second key issue is one of definitional scope: Can the claimed "quadrilateral" structure—defined in the application as being formed by two connecting elements and two ring "segments"—be read upon the prior art Klima device, which Plaintiffs allege uses circular elements touching the rings at single tangent "points"?
- A dispositive legal question will be the application of the obviousness standard: Did the PTAB err in finding a motivation to combine the prior art references, particularly given Plaintiffs’ allegations that the references operate on different technical principles and that modifying them to arrive at the invention would change their principle of operation?