Obviousness

An analysis of obviousness under 35 U.S.C. § 103 for US Patent 12268428 requires identifying combinations of prior art references that would render the claims obvious and explaining the motivation a person having ordinary skill in the art (POSA) would have to combine them.

However, the provided patent text for US12268428, specifically the "Prior Art section" (which consists of "Prior art keywords" and a "Prior art date"), does not include specific prior art documents or references, other than a single reference for bone plates (US2016/0192970) that is distinct from the core method and fulcrum claims. While "metatarsal," "bone," "surgical technique," "instrument," and "fulcrum" are listed as prior art keywords, these are broad terms and not specific documents that can be combined. The listed related applications (e.g., US9622805B2, US10342590B2) are ancestral family members, and while they disclose related subject matter, their claims would need to be specifically examined to determine their relevance as §103 prior art against the current claims.

Therefore, without specific prior art references that teach or suggest the claimed elements of US12268428, it is not possible to confidently identify combinations of references or articulate the specific motivations a POSA would have had to combine them to achieve the claimed inventions. I cannot fabricate such combinations or motivations.

A proper obviousness analysis would typically proceed as follows for each independent claim:

Independent Claim 1: Method of Correcting a Bunion Deformity

Key features:

1. Inserting a fulcrum between the first and second metatarsals.
2. Preparing the end of the first metatarsal and the opposing end of the medial cuneiform.
3. Moving a distal portion of the first metatarsal toward the second metatarsal in a transverse plane, pivoting a proximal portion of the first metatarsal about the fulcrum, and reducing the intermetatarsal angle.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A surgical method for correcting bunion deformities, possibly involving osteotomy or fusion of the tarsal-metatarsal joint, and techniques for preparing bone ends. The patent mentions the Lapidus procedure as an example, which involves tarsal-metatarsal fusion.
• A second reference: The use of a fulcrum or spacer in foot surgery, specifically in the intermetatarsal space, to facilitate bone movement or maintain spacing during realignment. The prior art keywords explicitly mention "fulcrum".
• Motivation to Combine: A POSA might be motivated to combine these references to improve existing bunion correction techniques. For example, if a prior art method for bunion correction lacked precise control over the pivot point or resulted in undesirable bone impingement, a POSA would be motivated to introduce a fulcrum (from a second reference) to provide a controlled pivot, minimize base shift, or maintain intermetatarsal spacing during the repositioning and reduction of the intermetatarsal angle. This could be driven by known problems such as uncontrolled rotation or translation of the metatarsals during realignment procedures.

Independent Claim 12: Fulcrum Device

Key features:

1. A fulcrum for bone realignment.
2. Includes a body configured for insertion into an intermetatarsal space.
3. Includes a handle operatively connected to the body.
4. The handle projects at a non-zero degree angle from the body to define a tissue retraction space between the handle and the body.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A fulcrum or similar instrument designed for insertion into narrow anatomical spaces, such as between bones, for surgical manipulation or spacing.
• A second reference: A surgical instrument with a handle designed for tissue retraction. The patent describes the handle of fulcrum 356 as pushing skin away from the surgical incision line to provide access.
• Motivation to Combine: A POSA would be motivated to combine these elements to create a more versatile or user-friendly fulcrum. For instance, if existing fulcrums were difficult to manipulate or obscured the surgical field, a POSA would consider adding an angled handle (from a second reference) to provide both a mechanical advantage for manipulation and a tissue retraction function, thereby improving surgical access and efficiency. The ergonomic benefits of an angled handle are well-known in surgical instrument design.

Independent Claim 15: Multidimensional Fulcrum

Key features:

1. A fulcrum body with length, width, and thickness.
2. A first end with a first thickness for a first size intermetatarsal space.
3. A second end with a second thickness for a second size intermetatarsal space.
4. The second thickness is greater than the first thickness.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A fulcrum or spacer instrument used in orthopedic surgery that is designed for insertion between bones.
• A second reference: Surgical instruments or shims that are reversible or multi-ended, offering different dimensions (e.g., thicknesses) to accommodate varying anatomical sizes or surgical requirements. The patent explicitly states that different thicknesses can be useful for different sized intermetatarsal spaces and that a clinician might flip the instrument.
• Motivation to Combine: A POSA would be motivated to combine these features to create a single instrument capable of serving multiple functions or accommodating a range of patient anatomies, thereby reducing the need for multiple instruments and improving surgical workflow. The ability to select different thicknesses from a single instrument (e.g., by flipping it) for "different sized intermetatarsal spaces" would be an obvious design choice for a POSA seeking efficiency and adaptability, especially in procedures where anatomical variations are common.

In summary, while the conceptual framework for obviousness can be outlined based on the claim elements, specific conclusions regarding US12268428 cannot be drawn without the actual prior art documents that were considered during its prosecution, or those that would otherwise be relevant under 35 U.S.C. § 103.