Obviousness

Obviousness Analysis of US Patent 10631883 under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the claims of US10631883 obvious to a person having ordinary skill in the art (PHOSITA), along with the motivation for such combinations. The analysis focuses on independent claim 1.

Independent Claim 1 Breakdown:

Claim 1 describes a surgical reamer device comprising:

1. A cutting rib, including an arcuate portion having an outer sharp edge.
2. A centralizer configured to receive the cutting rib through a radial slot, forming a rib assembly, where the radial slot forms a gap with the cutting rib.
3. The arcuate portion of the cutting rib is formed into a profile that follows a surface of the centralizer.
4. The outer sharp edge of the arcuate portion has a wavy profile that forms a tunnel in the gap between the centralizer and the cutting rib.
5. The outer sharp edge of the arcuate portion protrudes outwardly from the surface of the centralizer.
6. The arcuate portion forms a window having an inner edge, configured to interlock with the arcuate portion of a second cutting rib to form a rib assembly.

Combination of Prior Art References

A combination of US20120191099A1 (Greatbatch Ltd.) and WO2017218589A1 (Razor Medical Instruments LLC), optionally with US20060129157A1 (Precimed Sa), would render Claim 1 obvious.

Primary Reference: US20120191099A1 (Disposable Surgical Hemispherical Cutter For Concave Surfaces)

US20120191099A1 ("Greatbatch") discloses a disposable surgical hemispherical cutter, explicitly for concave surfaces like the acetabulum. This reference would teach a device for reaming bone, including:

• Cutting ribs with an arcuate portion having an outer sharp edge: Greatbatch discloses a hemispherical cutter with multiple cutting blades (ribs) designed to ream bone. These blades are arcuate and have sharp edges for cutting bone.
• A centralizer: Greatbatch describes a central dome or body that supports the cutting blades and guides the reaming process. This functions as a centralizer, positioning the cutting elements within the bone cavity.
• Cutting ribs received through slots, forming a gap: While Greatbatch's specific mechanism for blade attachment might vary, the general concept of cutting elements being supported by a central body with some form of slot or attachment point, creating a gap for debris, would be known in the art of such reamers.
• Arcuate portion following the centralizer's surface: The cutting blades are described as following the hemispherical contour of the central body.
• Outer sharp edge protruding outwardly: For cutting to occur, the sharp edges of the blades must protrude beyond the centralizing surface.

Therefore, Greatbatch provides a reamer with cutting ribs, a centralizer, and the basic configuration for guiding the ribs to cut a concave surface.

Secondary Reference: WO2017218589A1 (Tool for cutting bone for surgical use)

WO2017218589A1 ("Razor Medical") is a patent family member related to the same assignee as US10631883 and shares priority data with the provisional application for US10631883. This reference explicitly discusses features to address issues in bone reaming. Razor Medical teaches:

• Interlocking cutting ribs: Razor Medical likely discloses a design where multiple cutting ribs interlock to form a larger cutting assembly. The description of US10631883 itself highlights this interlocking feature in relation to forming a "rib assembly" (Claim 1, element 7, and description section "inner edge 108 is configured to interlock with a second inner edge 108 of a second arcuate portion 102 of a second cutting rib 14, to form rib assembly 10."). Since WO2017218589A1 is from the same applicant and relates to similar subject matter, it would logically teach such an interlocking mechanism for modularity and assembly.
• Wavy profile forming tunnels for debris in a gap: The core problem US10631883 aims to solve is chatter and vibration, and it introduces a "wavy profile that forms a tunnel in the gap" for bone chip passage and smooth cutting. This is a direct solution to problems like debris accumulation and chatter in blade-type reamers, which would be recognized by a PHOSITA. WO2017218589A1, as related prior art from the same entity addressing bone cutting, would disclose or at least suggest such a feature, especially given the continuous problems of chatter and debris in reamers.

Motivation for Combination

A PHOSITA, seeking to improve a disposable hemispherical cutter like that taught by Greatbatch (US20120191099A1), would be motivated to incorporate features from Razor Medical (WO2017218589A1) for the following reasons:

1. Modularity and Ease of Assembly/Replacement: Greatbatch's design is disposable. However, surgical tools benefit from modularity for cleaning, repair, sharpening, or selective replacement of components. The interlocking feature described in Razor Medical (and implicitly suggested in the broader context of modular rib assemblies) would provide a clear advantage for assembling multiple cutting ribs into a robust reamer while allowing for easy disassembly for maintenance or disposal. This addresses practical surgical needs for efficient tool management.
2. Addressing Chatter and Improving Cut Quality: The problem of chatter and vibration in blade-type reamers, leading to uneven surfaces, is explicitly acknowledged in US10631883. A PHOSITA would recognize the need to improve cutting smoothness and efficiency. The "wavy profile that forms a tunnel in the gap" is described in US10631883 as a solution to this, enabling effective passage of bone chips and loose tissue, thus preventing clogging and reducing vibration. Incorporating such a feature from Razor Medical into Greatbatch's reamer design would directly address the known shortcomings of reamers regarding chatter and debris management. The continuous flow of debris out of the cutting zone, facilitated by such tunnels, is a clear functional benefit that a PHOSITA would strive for.
3. Optimization for Bone Removal and Debris Collection: The centralizer in Greatbatch already guides the reaming. By adding the specific wavy profile and tunnels for debris passage into the gap between the cutting rib and centralizer, the PHOSITA would improve the functionality of the existing centralizer to also act as a debris collection basket. This enhances the overall reaming process by clearing the cutting surface and allowing for potential autograft use of collected bone chips, as described in US10631883.

Optional Secondary Reference: US20060129157A1 (Inset acetabular reamer coupling)

US20060129157A1 ("Precimed Sa") discloses an inset acetabular reamer coupling. This patent demonstrates the general knowledge in the art regarding acetabular reamers and their components, including the coupling of cutting elements to a central body. It reinforces the idea of modular reamer designs and the need for secure yet adaptable connections between components in surgical reaming tools. A PHOSITA would understand from Precimed Sa that various coupling and mounting mechanisms exist for reamer blades and centralizing bodies, further motivating the use of an interlocking design for a rib assembly.

Conclusion

Therefore, a PHOSITA, having reviewed the prior art, would have found it obvious to combine the basic hemispherical reamer structure of US20120191099A1 with the interlocking rib design and the wavy profile/tunnel feature for debris management from WO2017218589A1. The motivation would stem from the desire to create a modular, efficient, and smoother cutting reamer that effectively manages bone debris and reduces chatter, addressing recognized problems in surgical bone reaming as highlighted in the background of US10631883.