Catalyst OrthoScience Inc v. Shoulder Innovations Inc

1. Case Identification

• Case #: PGR2025-00001
• Patent #: 12,023,254
• Filed: October 11, 2024
• Petitioner(s): Catalyst Orthoscience Inc.
• Patent Owner(s): Shoulder Innovations, Inc.
• Challenged Claims: 1-22

2. Patent Overview

• Title: Total Reverse Shoulder Systems and Methods
• Brief Description: The ’254 patent discloses a reverse total shoulder replacement implant system. The system comprises a baseplate secured to the glenoid (shoulder socket), a central post passing through the baseplate for fixation, a glenosphere (ball component), a separate locking nut, and a glenosphere screw to assemble the components.

3. Grounds for Unpatentability

Ground 1: Obviousness over Orphanos Combination - Claims 1-7, 9-18, and 20-22 are obvious over Orphanos in view of Hopkins, Perego, and Roche.

• Prior Art Relied Upon: Orphanos (Patent 10,813,769), Hopkins (Application # 2018/0193074), Perego (Patent 11,596,520), and Roche (Patent 9,233,003).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Orphanos taught a reverse shoulder implant with nearly all claimed components, including a baseplate, a glenosphere, a glenosphere screw, and a collet-style locking nut. However, Orphanos disclosed using a central bone screw for fixation rather than a central post, and its collet used a snap-fit mechanism rather than an external thread to engage the baseplate.
  • Motivation to Combine: A POSITA would combine the teachings of Hopkins and Perego, which established that posts and screws were well-known, interchangeable options for anchoring baseplates, to modify Orphanos's central screw into the claimed central post. This was presented as a simple substitution of one known element for another to achieve a predictable result. Furthermore, a POSITA would replace Orphanos's snap-fit collet with an externally threaded locking nut, as snap-fit and threaded couplings were known to be interchangeable. This modification would utilize a known threaded "reducing bushing" design to solve the same problem addressed by Orphanos's collet. Roche was cited for its teaching of using locking cap screws to prevent anchoring elements from backing out, a known problem in the art.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because the proposed modifications involved substituting known, interchangeable elements to perform their established functions.

Ground 2: Obviousness over Orphanos Combination with Gargac - Claims 8 and 19 are obvious over Orphanos in view of Hopkins, Perego, Roche, and further in view of Gargac.

• Prior Art Relied Upon: Orphanos, Hopkins, Perego, Roche, and Gargac (Application # 2015/0305877).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon Ground 1 to address the specific central post lengths recited in claims 8 and 19 (e.g., 5 mm to 15 mm). Petitioner asserted that the primary Orphanos combination taught all limitations except for these specific dimensions.
  • Motivation to Combine: Gargac was introduced because it explicitly disclosed anchor members for shoulder implants in various lengths, including a 15mm-40mm range, which overlaps with and teaches the claimed 15 mm length. Petitioner argued that selecting a specific, suitable length for a central post from a known range of options taught by the prior art would have been a matter of routine optimization and design choice for a POSITA.
  • Expectation of Success: Combining these teachings would be predictable, as it amounted to applying a known dimension to a component for a known purpose.

Ground 3: Obviousness over Lefebvre Combination - Claims 1-7, 9-18, and 20-22 are obvious over Lefebvre in view of Orphanos, Hopkins, Perego, and Roche.

• Prior Art Relied Upon: Lefebvre (Patent 11,439,513), Orphanos, Hopkins, Perego, and Roche.

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner asserted Lefebvre as an alternative primary reference that disclosed a reverse shoulder implant with a baseplate, a central anchoring element, and a glenosphere. In Lefebvre, the locking nut and central post were taught as an integrated, single-piece component (the main anchoring screw).
  • Motivation to Combine: A POSITA would have been motivated to modify Lefebvre’s integrated design by separating the locking nut from the central post, citing Orphanos, which taught both integral and separate component designs. The motivation for this separation was to implement a "free spinning" central post, which was a known technique to provide better compression against the bone without the locking nut binding during insertion. This modification was argued to be an obvious design choice to improve a known implant configuration.
  • Expectation of Success: A POSITA would expect success in separating the components, as this was a known design modification taught by Orphanos to solve a known problem.

• Additional Grounds: Petitioner asserted an additional obviousness challenge against claims 8 and 19 based on the Lefebvre combination further in view of Gargac, relying on a similar dimensional teaching and design choice theory as in Ground 2.

4. Key Technical Contentions (Beyond Claim Construction)

• Indefiniteness of "baseplate central channel": Petitioner argued that all challenged claims are unpatentable under §112 for indefiniteness. The term "baseplate central channel" was argued to be fatally ambiguous, as the claims require it to be both an empty passageway through which the central post can pass, and simultaneously a physical structure with which the locking nut’s external threads can "couple" or "engage." This contradictory description, Petitioner contended, would prevent a POSITA from ascertaining the scope of the claims with reasonable certainty.
• Indefiniteness of "interface": Petitioner also argued the claims are indefinite due to the phrase "glenosphere central channel...configured to interface with the baseplate." Petitioner asserted that the term "interface" is not defined in the specification, is not a term of art with a clear meaning in this context, and has multiple ordinary meanings that would lead to different claim scopes, rendering the limitation ambiguous.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §314(a) based on Fintiv factors would be inappropriate. It was asserted that the co-pending district court litigation is in a very early stage, with discovery having just begun, no trial date set, and minimal investment by the court and parties. Petitioner also noted that the presiding judge has a history of staying cases pending PTAB review.
• Petitioner further argued that discretionary denial under §325(d) is not warranted. The prosecution history of the ’254 patent shows that the examiner issued a notice of allowance without any office actions or substantive review of prior art. Therefore, the art and arguments presented in the petition were not previously considered by the USPTO, weighing strongly in favor of institution.

6. Relief Requested

• Petitioner requests institution of post-grant review and cancellation of claims 1-22 of the ’254 patent as unpatentable.