Obviousness

The obviousness analysis of US patent 11376136 under 35 U.S.C. § 103 requires identifying combinations of prior art references that would render the claims obvious, along with the motivation for a person having ordinary skill in the art (POSA) to combine them. For this analysis, the patent's own disclosures regarding its lineage and "previous designs" or "co-pending patents" will be treated as the primary prior art, as explicitly stated within the provided patent text. The priority date for this patent is April 12, 2005.

The patent US11376136 is a continuation of a chain of applications, including U.S. application Ser. No. 11/208,644 (now U.S. Pat. No. 7,704,279), U.S. application Ser. No. 11/536,815 (now U.S. Pat. No. 7,846,188), and U.S. application Ser. No. 11/842,855 (now U.S. Pat. No. 7,942,903), among others, all of which are incorporated by reference and disclose earlier aspects of the same inventive concept. The "Description of the Relevant Art" section of US11376136 also explicitly refers to "our two prior copending application Ser. No. 14/536,815, filed on Sep. 29, 2006, and Ser. No. 11/208,644, filed on Aug. 23, 2005" as relevant prior art.

A POSA in the field of spinal implants and surgical tools would have an understanding of existing intervertebral fusion devices, bone screws, expandable cages, facet staples, and associated surgical instrumentation.

Obviousness Analysis of Independent Claims:

Claim 1: Self-drilling bone fusion screw apparatus (expandable)

• Elements of Claim 1: A self-drilling bone fusion screw apparatus including a first sliding box, a second sliding box positioned relative to the first, a first screw member with a tapered end and threaded body within the first box, a second screw member with a tapered end and threaded body within the second box, and an adjuster for adjusting the height of the sliding boxes.
• Prior Art Basis (from US11376136 itself): The patent states that the expansion features "represent a continued evolution of our concept of expandable fusion cages described in our previous co-pending patents". It also indicates that "previous designs" employed "wormed driving screws and gears". This implies that earlier versions of their own intervertebral devices (e.g., disclosed in U.S. Pat. No. 7,704,279, U.S. Pat. No. 7,846,188, or U.S. Pat. No. 7,942,903) incorporated the general concept of expandable fusion cages and bi-directional screws.
• Motivation for Combination/Modification: A POSA would be motivated to improve existing expandable fusion cages to better fit the individual disc space height and depth, as explicitly stated in the patent. Given the existence of "expandable fusion cages" in their own "previous co-pending patents" by the same inventors, the specific implementation of "sliding triangular bases" and a "built-in screw adjuster" for height adjustment, as claimed, would have been an obvious design choice for a POSA seeking to achieve adjustable expansion. Sliding mechanisms and screw adjusters are well-known mechanical elements for achieving controlled expansion and custom fitting in various devices, including medical implants. The patent further explains that this embodiment "may eliminate the intervening wormed driving screws and gears required by previous designs," suggesting a motivation to simplify the mechanism.

Claim 11: Self-drilling bone fusion screw apparatus (single box, two lateral screws)

• Elements of Claim 11: A self-drilling bone fusion screw apparatus comprising a box, a first screw member and a second screw member (each with tapered end and threaded body) disposed at least partially within the box and laterally aligned with the box, and a plurality of ridges disposed along the sides of the box.
• Prior Art Basis (from US11376136 itself): The patent states, "We have designed a screw box to be placed inter-vertebrally... The housing screw box incorporates built-in screw and/or drill guides which allow the direct placement and insertion of two self drilling screws which are driven in two opposing directions into superior and inferior vertebral bodies, respectively". This is presented as an alternative to "intervening wormed driving screws and gears required by previous designs". The patent also describes ridges on the external edges of the bases (e.g., ridges 107 in FIGS. 1A-E and ridges 207 in FIGS. 2A-C) to facilitate integration and fusion with vertebral bodies.
• Motivation for Combination/Modification: A POSA, aware of the inventors' "previous designs" that utilized bi-directional screws with wormed gears, would be motivated to simplify the design, reduce complexity, and potentially ease production by eliminating the gears. Designing a "gearless screw box" with "built-in screw and/or drill guides" to directly place two self-drilling screws, as described, represents an obvious modification to achieve the same function of transvertebral fixation while improving surgical handling and potentially reducing component count. The inclusion of ridges for bone integration is a standard feature in interbody fusion devices to enhance stability and fusion. The choice of "laterally aligned" screws is an obvious design variation for screw trajectory.

Claim 13: Self-drilling bone fusion screw apparatus (two boxes, attachment member)

• Elements of Claim 13: A self-drilling bone fusion screw apparatus including a first box with a first screw member (tapered end, threaded body, laterally aligned), a second box with a second screw member (tapered end, threaded body, laterally aligned), and an attachment member for engaging the first and second boxes.
• Prior Art Basis (from US11376136 itself): The patent describes an embodiment where "a screw box which houses only one, instead of two screws" is used, with "two separate single screw boxes fuse the superior and inferior vertebrae". It further explicitly discloses that these screw boxes "can be capped with a horizontal mini-plate which will prevent bony growth into the thecal sac and nerves," referring to it as a "two-in-one device". Alternatively, "two BDFT screw boxes can be combined with a circumferential cage (also 2 in 1) to be placed anteriorly into the lumbar spine".
• Motivation for Combination/Modification: The patent explicitly articulates the motivation: to diminish the width of the screw box "in cases where it might be favorable to have less nerve root retraction with a smaller width device". Combining two such single-screw boxes with an attachment member (plate or circumferential cage) would be an obvious way to achieve broader intervertebral support, enhance fusion stability, and act as a physical barrier to prevent bone graft intrusion, as clearly stated in the patent. The use of plates or cages to connect or supplement intervertebral implants is common in spinal fusion surgery.

Claim 16: Tool assembly for manipulating a self-drilling bone fusion screw apparatus

• Elements of Claim 16: A tool assembly comprising a handle, a gripper cooperating with the handle and having a plurality of prongs, and a screw guide held in place by the plurality of prongs for controlling the direction of self-drilling screws.
• Prior Art Basis (from US11376136 itself): The patent explicitly describes this tool: "The key components of this device include an Allen key 501, a spring 502, a handle 503, a griper 504 and a screw guide 505". It states that "The griper 504 has griper prongs 506 which insert into grooves of the screw guide 505 and the screw box 200 (FIGS. 5A-D) thus perfectly aligning them". The tool's purpose is to assist in screw trajectory and box expansion.
• Motivation for Combination/Modification: Surgical tools for implant placement are essential companions to implants. A POSA would be motivated to develop a tool that ensures accurate placement, alignment, and screw trajectory for the described screw box apparatuses. The components (handle, gripper with prongs, and screw guide) are standard elements in surgical instrument design, and their combination to achieve precise control during implant insertion and screw placement would be an obvious engineering task for a POSA.

Claim 20: Cervical facet staple

• Elements of Claim 20: A cervical facet staple including a curved staple base, at least two prongs attached to the bottom surface of the curved staple base, and an insertion member disposed on the top surface of the curved staple base.
• Prior Art Basis (from US11376136 itself): The patent clearly states, "In this patent application we also introduce a novel posterior cervical facet stapling device". However, it also refers to "Previous improvements included a novel calibrated lumbar/thoracic facet stapling device" from its "previous co-pending patent application Ser. No. 14/536,815, filed on Sep. 29, 2006, and Ser. No. 11/208,644, filed on Aug. 23, 2005".
• Motivation for Combination/Modification: A POSA, already aware of the inventors' lumbar/thoracic facet stapling devices, would be motivated to apply similar principles to the cervical spine to address the need for cervical fusion. The patent itself highlights the "advantage of cervical facet staples is speed and safety" and that they "obviate" risks associated with cervical pedicle screw fixation. Adapting a known facet stapling concept from one spinal region (lumbar/thoracic) to another (cervical) would involve adjusting the staple base to be "contoured to align with the curved surface of the cervical facet joints", which is a routine design adaptation for a POSA understanding spinal anatomy. The prongs and an insertion member are fundamental features of a staple for attachment and insertion.

Claim 23: Impaction tool for a cervical facet staple

• Elements of Claim 23: An impaction tool for a cervical facet staple, comprising a handle, a stem attached to the handle, a plurality of wings for contacting the cervical facet staple, and an insertion member for coupling the cervical facet staple to the impaction tool.
• Prior Art Basis (from US11376136 itself): The patent describes the "two-pronged cervical staple impactor 900" and "four-pronged cervical staple impactor 1000" (FIGS. 9A-B, 10A-C) for use with the cervical facet staples. These tools include a handle, stem, wings, and a screw insert for coupling.
• Motivation for Combination/Modification: Once the cervical facet staple (Claim 20) is considered obvious, the development of a suitable impaction tool to facilitate its precise and safe insertion would be obvious to a POSA. The described features—a handle for gripping, a stem to provide length, wings to stabilize the staple during impaction, and an insertion member for coupling—are all well-known elements in the design of surgical impaction tools. The handle being "broad in order to allow impaction by a mallet" is a logical design choice for such a tool.

Claim 25: Lumbar facet staple with calibrated ratcheting mechanism

• Elements of Claim 25: A lumbar facet staple comprising a pair of rotating arms, at least two prongs attached to the inner surfaces of the rotating arms, a plurality of spurs attached to one of the rotating arms, and a ratchet attached to one of the rotating arms, wherein the rotating arms and prongs are rotated to a closed position to staple a lumbar facet joint.
• Prior Art Basis (from US11376136 itself): The patent explicitly states that "This lumbar facet staple has been thoroughly described in our previous co-pending patent application Ser. No. 14/536,815, filed on Sep. 29, 2006, and Ser. No. 11/208,644, filed on Aug. 23, 2005, the relevant portion of each of which is hereby incorporated by reference hereinafter". It then specifies that "the new improvement of this device includes a ratchet 1201".
• Motivation for Combination/Modification: The core lumbar facet staple with rotating arms and prongs is admitted to be prior art by the inventors themselves. The "new improvement" is the addition of a ratchet mechanism to provide "calibrated levels of lumbar facet joint fusion, and conversely diminishing joint flexibility". Ratcheting mechanisms are common mechanical devices used across various industries, including medical devices, for incremental adjustment, controlled closure, and locking. A POSA, desiring to enhance the "calibrating capability" and achieve varying degrees of "flexible fusions" as stated in the patent, would find it obvious to integrate a known ratcheting mechanism with an existing lumbar facet staple design to achieve this adjustability and calibration.