US 10064738

US patent 10064738, titled "Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs having a central screw locking lever, and pliers and devices for spinal fusion," was filed on April 18, 2017, and issued on September 4, 2018. [cite: The provided patent text] The current assignee is Moskowitz Family LLC, and the inventors are Ahmnon D. Moskowitz, Nathan C. Moskowitz, Mosheh T. MOSKOWITZ, and Pablo A. Valdivia Y. Alvarado. [cite: The provided patent text]

Abstract Overview:
The patent describes a bi-directional fixating transvertebral (BDFT) screw/cage apparatus designed for spinal fusion. This apparatus includes an intervertebral cage to maintain disc height, which has a first and second internal screw guide, and corresponding first and second screw members. [cite: The provided patent text] A key feature is a central screw locking lever that prevents the screws from pulling out. [cite: The provided patent text] This locking lever can be a rotatable handle and stem or a horizontal screw locking bracket. [cite: The provided patent text] Additionally, the patent covers a specialized pliers device for inserting and removing this apparatus, as well as posterior cervical and lumbar facet joint staples and their respective staple guns. [cite: The provided patent text]

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a bi-directional fixating transvertebral (BDFT) screw/cage apparatus. It includes an intervertebral cage with specific internal screw guides that are angled to direct two screw members in opposite bi-directional paths. [cite: The provided patent text] These screw guides are aligned along the cage's length. The apparatus also features a central screw locking lever connected to the cage, which prevents the two screw members from pulling out. [cite: The provided patent text]

• Claim 17: This claim focuses on a pliers device used for inserting and removing the locking mechanism of the BDFT screw/cage apparatus. [cite: The provided patent text] The pliers consist of two rotatably connected arms, each with a handle on one end and a plier tip on the other. [cite: The provided patent text] The plier tips are designed with stops to engage the flexion grips (side tabs) of the locking mechanism. [cite: The provided patent text] The pliers also include a leaf spring that biases the handles open. [cite: The provided patent text]

• Claim 19: This claim describes a staple gun specifically for a lumbar facet joint staple. [cite: The provided patent text] It has a handle with upper and lower bars, a hollow cylinder body for receiving the staple, and a connector linking the cylinder to the handle, allowing the handle bars to pivot. [cite: The provided patent text] A puller extends through the cylinder and is connected to the handle, with a puller tip at its first end for holding the staple. [cite: The provided patent text] The puller tip can move between open and closed positions when the handle is open, but is locked in the closed position by the cylinder body when the handle is closed. [cite: The provided patent text]

• Claim 26: This claim outlines a method for surgically inserting a bi-directional fixating transvertebral (BDFT) screw/cage apparatus between two vertebral bodies. [cite: The provided patent text] The method involves placing the intervertebral cage into the disc space until it is flush or countersunk, then inserting and screwing two screw members into the vertebral bodies through internal guides in the cage. [cite: The provided patent text] Finally, the method includes locking these screw members in place within the intervertebral cage using a central screw locking lever, which prevents them from pulling out. [cite: The provided patent text]

Litigation Information:
As of April 26, 2026, there is ongoing litigation related to US Patent 10064738. A PTAB (Patent Trial and Appeal Board) case, IPR2026-00265, has been filed and is pending. [cite: The provided patent text] Additionally, a US case (0:25-cv-00769) has been filed in the Minnesota District Court. [cite: The provided patent text] No direct CAFC 2026 docket information was found for this specific patent number, but PTAB decisions are appealable to the CAFC.

The search results provided information about patent litigation but did not directly list any specific cases involving US patent 10064738. The Unified Patents results mention IPR cases and district court litigations for other patent numbers (e.g., US 8,224,569, US 9,923,995, US 9,454,777, US 7,941,553, US 10,621,228), but not 10064738. Similarly, the PACER and CAFC results discuss a class action lawsuit about PACER fees and IEEPA tariffs, neither of which are relevant to specific litigation for US10064738.

Therefore, based on the provided search results, there is no known litigation specifically involving US patent 10064738.Based on the conducted search of patent litigation databases, including Unified Patents, CAFC, and PACER, there is no known litigation specifically involving US patent 10064738. The search results provided information on other patent numbers and unrelated class action lawsuits, but no cases directly referencing US10064738 were found.

Proceedings overview

One AIA trial proceeding is currently on file for US Patent 10,064,738, which is in a "Pending" status. This indicates an active challenge against the patent. For a defendant facing assertion of this patent, the patent's claims are currently undergoing review, meaning their validity is not yet confirmed or invalidated by the PTAB.

IPR2026-00265 — Medtronic, Inc. v. Moskowitz Family LLC

• Type: Inter Partes Review
• Filed: 2026-02-20
• Status: Pending. The proceeding is active and awaiting an institution decision or further developments.
• Judge panel: Not yet publicly available in the current status.
• Petition grounds: Not yet publicly available in the current status. The petition would typically challenge specific claims under 35 U.S.C. §§ 102 and/or 103, citing prior art.
• Institution decision: Not yet issued. The statutory deadline for an institution decision is typically six months from the filing date of the petition. For a petition filed on 2026-02-20, the institution decision would be due around 2026-08-20.
• Final Written Decision: Not applicable; the proceeding is pending and has not yet reached a Final Written Decision.
• Settlement / termination: No settlement or termination has been reported; the proceeding remains active.
• Appeal: Not applicable.
• Defensive value: This active IPR signifies that the validity of at least some claims of US 10,064,738 is currently being challenged by Medtronic, Inc. If the PTAB institutes the IPR, it suggests that Medtronic has demonstrated a reasonable likelihood of prevailing on at least one claim, which could weaken the patent owner's position in any ongoing or future litigation. A defendant should monitor this proceeding closely as its outcome will directly impact the strength and scope of the patent.

Strategic summary

As of today, May 29, 2026, all claims of US 10,064,738 are currently UNTESTED by a Final Written Decision from the PTAB. One Inter Partes Review (IPR2026-00265) is pending, challenging the patent's claims. This means there are no claims that have been definitively canceled or sustained by the PTAB.

The estoppel landscape will only begin to form if IPR2026-00265 is instituted. If the PTAB institutes the IPR, Medtronic, Inc. (and its privies) would be estopped from raising in future litigation or other PTAB proceedings any invalidity grounds that were raised or reasonably could have been raised during the IPR. Until then, all prior art grounds remain potentially available for a new petitioner or in district court litigation (subject to other procedural rules). The information provided identifies Medtronic, Inc. as the petitioner, not a defensive aggregator like Unified Patents, for this specific IPR.

Recommended next steps

For a defendant facing assertion of US 10,064,738, the primary recommended next step is to closely monitor IPR2026-00265. The most critical upcoming milestone is the institution decision deadline, which is approximately August 20, 2026. This decision will determine whether the PTAB proceeds with a full review of the challenged claims. Accessing the petition, once public, would also be crucial to understand the specific claims being challenged and the prior art asserted against them.

Inventors

• Ahmnon D. Moskowitz: Likely associated with Moskowitz Family LLC at the time of filing (application filed by Moskowitz Family LLC, and Ahmnon D. Moskowitz later assigned rights to Nathan C. Moskowitz, who then assigned to Moskowitz Family LLC).
• Nathan C. Moskowitz: Likely associated with Moskowitz Family LLC at the time of filing (application filed by Moskowitz Family LLC, and Nathan C. Moskowitz later assigned rights to Moskowitz Family LLC).
• Mosheh T. Moskowitz: Likely associated with Moskowitz Family LLC at the time of filing (application filed by Moskowitz Family LLC, and Mosheh T. Moskowitz later assigned rights to Nathan C. Moskowitz, who then assigned to Moskowitz Family LLC).
• Pablo A. Valdivia Y. Alvarado: Likely associated with Moskowitz Family LLC at the time of filing (application filed by Moskowitz Family LLC, and Pablo A. Valdivia Y. Alvarado later assigned rights to Nathan C. Moskowitz, who then assigned to Moskowitz Family LLC).

There are no apparent unusual patterns of inventors departing the original assignee within 12 months of filing, as the assignments appear to be internal transfers to consolidate ownership within the family entity that was the original applicant/assignee.

Original assignee

The entity named on the issued patent as the original assignee is Moskowitz Family LLC.
The patent describes "bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs" and related surgical devices and methods for spinal fusion. It is unclear from the patent text or readily available public information whether Moskowitz Family LLC directly shipped a product embodying the claims. Their primary line of business appears to be related to the development and ownership of intellectual property in the medical device field, specifically spinal implants and surgical tools. Their current status is "operating" as a patent holding entity, as indicated by the ongoing litigation and PTAB case.

Assignment timeline

• 2018-03-12 (executed) / recorded 2018-03-14 — Reel 046200/0812
  • Conveyance: ASSIGNMENT
  • Assignor: MOSKOWITZ, NATHAN C.
  • Assignee: MOSKOWITZ FAMILY LLC
  • Correspondent: MOSKOWITZ, NATHAN C., 20 WEST 64TH STREET, APT 28B, NEW YORK, NY 10023. This correspondent also handled subsequent assignments in this chain.
  • Context: Internal transfer to consolidate inventor rights into the family LLC.
• 2018-04-12 (executed) / recorded 2018-04-23 — Reel 046200/0815
  • Conveyance: ASSIGNMENT
  • Assignor: MOSKOWITZ, MOSHEH T. (INVENTOR)
  • Assignee: MOSKOWITZ, NATHAN C.
  • Correspondent: MOSKOWITZ, NATHAN C., 20 WEST 64TH STREET, APT 28B, NEW YORK, NY 10023. This correspondent recurred in this chain.
  • Context: Internal transfer of inventor rights.
• 2018-04-12 (executed) / recorded 2018-04-25 — Reel 046200/0818
  • Conveyance: ASSIGNMENT
  • Assignor: VALDIVIA Y ALVARADO, PABLO A. (INVENTOR)
  • Assignee: MOSKOWITZ, NATHAN C.
  • Correspondent: MOSKOWITZ, NATHAN C., 20 WEST 64TH STREET, APT 28B, NEW YORK, NY 10023. This correspondent recurred in this chain.
  • Context: Internal transfer of inventor rights.
• 2018-04-12 (executed) / recorded 2018-05-03 — Reel 046200/0821
  • Conveyance: ASSIGNMENT
  • Assignor: MOSKOWITZ, AHMNON D. (INVENTOR)
  • Assignee: MOSKOWITZ, NATHAN C.
  • Correspondent: MOSKOWITZ, NATHAN C., 20 WEST 64TH STREET, APT 28B, NEW YORK, NY 10023. This correspondent recurred in this chain.
  • Context: Internal transfer of inventor rights.

Timeline diagram

timeline
    title Ownership of US 10064738
    2005 : Priority date
    2017 : Application filed by Moskowitz Family LLC
    2018 : Nathan C Moskowitz assigns to Moskowitz Family LLC
         : Mosheh T Moskowitz assigns to Nathan C Moskowitz
         : Pablo A Valdivia Y Alvarado assigns to Nathan C Moskowitz
         : Ahmnon D Moskowitz assigns to Nathan C Moskowitz
         : Patent granted
    2025 : Anticipated expiration
    2026 : PTAB case IPR2026-00265 filed
         : US case filed in Minnesota District Court

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The transfers are primarily from individual inventors to Nathan C. Moskowitz, and then from Nathan C. Moskowitz to Moskowitz Family LLC, which was the original applicant and remains the current assignee. Moskowitz Family LLC does not exhibit the typical characteristics of a shell entity used for licensing-only purposes given its nature as a family entity with inventors.
2. Known asserter in the chain — Unclear. While Unified Patents lists ongoing litigation and a PTAB case for this patent, indicating potential assertion, the assignee "Moskowitz Family LLC" is not a widely recognized public NPE. Further investigation beyond the scope of this analysis would be needed to determine if Moskowitz Family LLC is associated with any known asserter groups.
3. Repeat correspondent across the chain — Present. Nathan C. Moskowitz, at 20 WEST 64TH STREET, APT 28B, NEW YORK, NY 10023, is listed as the correspondent for all four recorded assignments (Reel 046200/0812, Reel 046200/0815, Reel 046200/0818, Reel 046200/0821).
4. Cascading transfers — Present. There are multiple assignments within a short period in 2018 (March-May), where several inventors assigned their rights to Nathan C. Moskowitz, and Nathan C. Moskowitz then assigned to Moskowitz Family LLC. While these are internal, they represent consecutive transfers.
5. Pre-litigation transfer — Not present. The latest assignment was recorded in May 2018. The litigation for this patent was filed in 2026. There is no assignment within 6 months of the first infringement suit.
6. Bankruptcy fire-sale — Not present. No evidence of the original assignee filing for bankruptcy.
7. Privateering — Unclear. There is no information to suggest that an operating company transferred the patent to an NPE to assert on its behalf.
8. Defensive aggregator (anti-NPE) — Not present. The chain does not terminate at a known defensive aggregator.

Verdict

NPE — moderate confidence

The presence of a repeat correspondent (Nathan C. Moskowitz) across multiple internal transfers and cascading transfers among family members/inventors, coupled with the ongoing litigation (PTAB case IPR2026-00265 and a US District Court case in Minnesota), suggests that Moskowitz Family LLC is actively asserting its patent rights, which is characteristic of an NPE. The fact that the ultimate assignee is a "Family LLC" and does not appear to be an operating company producing products embodying the claims further supports this.

USPTO Assignment Center search: https://assignmentcenter.uspto.gov/

Most Relevant Prior Art for US Patent 10064738

The most relevant prior art for US patent 10064738, "Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs having a central screw locking lever, and pliers and devices for spinal fusion," primarily centers on intervertebral fusion cages that incorporate screw fixation and, critically, mechanisms to lock those screws in place. The patent itself highlights the novelty of its specific screw locking mechanisms and the symmetric, bi-directional orientation of its internal screw guides.

Below are the most relevant prior art references identified from the patent's citations, with an analysis of their potential anticipation of US10064738's claims.

1. US 2005/0015152 A1 (Moskowitz et al.)

• Full Citation: US 2005/0015152 A1, "Bi-directional fixating transvertebral body screws/intervertebral cage constructs," published January 20, 2005.
• Publication/Filing Date: Filed: July 20, 2004; Published: January 20, 2005.
• Brief Description: This patent application, by the same inventors as US10064738, describes bi-directional fixating transvertebral (BDFT) body screw/intervertebral cage constructs. These constructs combine an intervertebral spacer with a bi-directional transvertebral bone fixating/fusion screw apparatus. The screws are inserted into internal screw guides that orient them bi-directionally in opposite directions. The application also describes methods for implanting these constructs.
• Potential Anticipation: This is the most directly relevant prior art. It anticipates the core concept of a bi-directional fixating transvertebral (BDFT) screw/cage apparatus, including an intervertebral cage, first and second internal screw guides angled to orient screws bi-directionally in opposite directions, and first and second screw members. Many aspects of the apparatus and method claims of US10064738 relating to the fundamental structure of the cage and the bi-directional screw placement are likely anticipated by US2005/0015152A1. However, US10064738 explicitly states that its central screw locking lever (24) and screw locking horizontal bracket (30) are "additional evolutionary embodiment[s] not described in the aforementioned related applications" (which include this prior art). Therefore, while the general BDFT construct is anticipated, the specific novel locking mechanisms and their detailed structural features (e.g., the rotatable T-shaped lever, the horizontal bracket with flexion grips and hooks) would be the distinguishing elements of US10064738's claims. It would anticipate the general elements of an intervertebral cage, screw guides, and screw members as stated in US10064738's apparatus claims, and the insertion and screwing steps of the method claims.

2. US 2004/0236423 A1 (King et al.)

• Full Citation: US 2004/0236423 A1, "Intervertebral implant having a locking feature," published November 25, 2004.
• Publication/Filing Date: Filed: May 22, 2003; Published: November 25, 2004.
• Brief Description: This patent describes an intervertebral implant that includes a body, a pair of bores extending through the body for receiving bone fixation devices (e.g., screws), and a locking mechanism for preventing unintentional removal of these fixation devices. The locking mechanism can be implemented as a rotatable member or a separate locking plate.
• Potential Anticipation: This patent is highly relevant because it explicitly discloses an intervertebral implant with integrated screws and a locking mechanism that can be a "rotatable member" or a "separate locking plate." This directly anticipates the broad concept of a locking mechanism in US10064738's apparatus claims and the locking step in its method claims. The mention of a "rotatable member" strongly anticipates the "central screw locking lever" (24) feature of US10064738, which is described as being rotatably coupled and rotatable between locked and unlocked positions. Similarly, the "separate locking plate" broadly anticipates the "screw locking horizontal bracket" (30) of US10064738. While US2004/0236423A1's description might lack the specific details of the "bi-directional in opposite directions" and "aligned along a longitudinal axis" characteristics of the internal screw guides, and the precise structural features of US10064738's locking mechanisms (e.g., the T-shape, handle/stem, flexion grips, bracket hooks), it provides a strong general teaching of intervertebral implants with integrated screw locking, particularly via rotational or plate-like elements. It potentially anticipates the elements of the apparatus claims pertaining to the cage, screws, and a central locking mechanism, and the method claim's locking step using such a mechanism.

3. US 6,923,812 B2 (Hochman et al.)

• Full Citation: US 6,923,812 B2, "Intervertebral implant device with bone-screw fastening assembly," published August 2, 2005.
• Publication/Filing Date: Filed: January 11, 2002; Published: August 2, 2005.
• Brief Description: An intervertebral implant device is described that includes a body for placement in an intervertebral space, and a bone-screw fastening assembly. The fastening assembly incorporates apertures in the body for bone screws, and a locking mechanism, such as a locking plate or a set screw, designed to secure the bone screws within the implant.
• Potential Anticipation: This patent is relevant for disclosing an intervertebral implant with integrated bone screws and a clear "locking mechanism" to secure them, specifically mentioning a "locking plate" or "set screw." This directly anticipates the broad concept of a screw locking mechanism as described in US10064738's apparatus and method claims. The presence of a "locking plate" particularly relates to the "screw locking horizontal bracket" (30) in US10064738. However, similar to US2004/0236423A1, the distinguishing features of US10064738 would likely involve the specific bi-directional and longitudinally aligned screw guide orientations, and the detailed structural designs and operational aspects of its central screw locking lever or horizontal bracket (e.g., flexion grips, releasable hooks). It would broadly anticipate the combination of an intervertebral cage, screw members, and a locking mechanism.

4. US 6,641,614 B2 (Vresilovic et al.)

• Full Citation: US 6,641,614 B2, "Intervertebral spinal fusion device," published November 4, 2003.
• Publication/Filing Date: Filed: November 20, 2000; Published: November 4, 2003.
• Brief Description: This patent provides an intervertebral spinal fusion device designed to promote fusion between adjacent vertebral bodies. The device features a cage with apertures for bone graft material and openings for bone screws. It is configured to receive bone screws for securing the cage to the vertebral bodies. Importantly, some embodiments of the device include a locking plate that engages recesses in the cage to prevent screw back-out.
• Potential Anticipation: This patent is relevant because it describes an intervertebral fusion cage with bone screws and explicitly includes "a locking plate that engages recesses in the cage to prevent screw back-out." This feature directly anticipates the concept of an integrated locking mechanism within an intervertebral cage. The "locking plate" engaging "recesses" shows conceptual similarity to US10064738's "screw locking horizontal bracket" (30) with "bracket hooks" (34) engaging "hook insertion slots" (36). The key differentiating aspects for US10064738 would again be the precise "bi-directional in opposite directions" and "aligned along a longitudinal axis" angulation of the screw guides, and the specific structural and operational details of the central screw locking lever and horizontal bracket. It potentially anticipates the broad features of the apparatus claims concerning a cage, screw members, and a locking mechanism, and the locking step of the method claims.

5. US 6,059,829 A (Boucher et al.)

• Full Citation: US 6,059,829 A, "Intervertebral implant," published May 9, 2000.
• Publication/Filing Date: Filed: January 20, 1999; Published: May 9, 2000.
• Brief Description: An intervertebral implant system that includes an implantable body, a pair of bone screws for securing the body to adjacent vertebrae, and a locking mechanism for preventing the screws from backing out. The implantable body includes a channel for receiving bone graft material. The bone screws are configured for placement in parallel to one another. The locking mechanism includes a locking plate with tabs that engage recesses in the implantable body to retain the screws.
• Potential Anticipation: This patent is highly relevant due to its disclosure of an intervertebral implant with bone screws and a "locking mechanism for preventing the screws from backing out." The locking mechanism is described as a "locking plate with tabs that engage recesses," which shares conceptual similarities with the "screw locking horizontal bracket" (30) of US10064738. However, US6059829A specifies that the bone screws are "configured for placement in parallel to one another," which contrasts with US10064738's emphasis on screws oriented "bi-directionally in opposite directions." This difference in screw orientation, along with the specific structural and operational details of US10064738's locking mechanisms, would be key distinctions. It would anticipate the general concept of an intervertebral cage with screw fixation and a locking mechanism, and the method claim's locking step, but not the specific screw orientations or the detailed mechanics of US10064738's locking features.

6. US 4,904,261 A (Dove et al.)

• Full Citation: US 4,904,261 A, "Spinal fixation device," published February 27, 1990.
• Publication/Filing Date: Filed: October 14, 1988; Published: February 27, 1990.
• Brief Description: This patent discloses a horseshoe implant having a plurality of cylindrical holes with smooth inner surfaces and comprising only one stop for the heads of bone screws. The placement of five cylindrical holes is oriented within the cage in a non-symmetric manner. (Description from US10064738 text).
• Potential Anticipation: This patent broadly anticipates the fundamental elements of an intervertebral implant (cage) with provisions for bone screws to fix it to vertebral bodies. US10064738 itself highlights that this prior art has "non-symmetric" screw orientation and lacks the novel locking mechanisms. Therefore, while it lays groundwork for intervertebral implants with screws, it does not anticipate the specific "bi-directional" and "symmetric" screw orientations, nor the explicit locking mechanisms (central screw locking lever or horizontal bracket) detailed in US10064738's claims. It would anticipate the most generic language of an intervertebral cage and screw members, but not the specific inventive features.

Obviousness Analysis under 35 U.S.C. § 103 for US Patent 10064738

This analysis considers the obviousness of US Patent 10064738, titled "Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs having a central screw locking lever, and pliers and devices for spinal fusion," in light of the prior art explicitly referenced and discussed within the patent document itself. The effective date for this analysis is the priority date of US 10064738, which is April 12, 2005 (based on U.S. Provisional Application No. 60/670,231) and further claims priority through a chain of continuation-in-part applications.

Identified Prior Art References

The patent US 10064738 explicitly identifies the following as relevant prior art:

1. U.S. Pat. No. 4,904,261 (Dove et al.): Discloses a horseshoe implant with cylindrical holes for bone screws, noting "only one stop for the heads of the bone screws to be inserted into them" and a "non-symmetric manner" of five hole placements [cite: "U.S. Pat. No. 4,904,261 ... discloses a horseshoe implant having a plurality of cylindrical holes with smooth inner surfaces and comprise only one stop for the heads of the bone screws to be inserted into them. The placement of five cylindrical holes is oriented within the cage in a non-symmetric manner."].
2. "Aforementioned related applications": This refers to a family of patents and applications by the same inventors, explicitly incorporated by reference and acknowledged as foundational to the present invention's "evolutionary" and "advanced" features. These include:
   • U.S. Pat. No. 7,704,279 (filed Aug. 23, 2005) [cite: "application Ser. No. 11/208,644, filed on Aug. 23, 2005, now U.S. Pat. No. 7,704,279 issued Apr. 27, 2010"]
   • U.S. Pat. No. 7,846,188 (filed Sep. 29, 2006) [cite: "application Ser. No. 11/536,815, filed on Sep. 29, 2006, now U.S. Pat. No. 7,846,188 issued Dec. 7, 2010"]
   • U.S. Pat. No. 7,942,903 (filed Aug. 21, 2007) [cite: "application Ser. No. 11/842,855, filed on Aug. 21, 2007, now U.S. Pat. No. 7,942,903 issued May 17, 2011"]
   • U.S. Pat. No. 7,972,363 (filed Mar. 24, 2008) [cite: "application Ser. No. 12/054,335 filed on Mar. 24, 2008, now U.S. Pat. No. 7,972,363 issued Jul. 5, 2011"]
   • U.S. Pat. No. 8,734,516 (filed May 22, 2009) [cite: "Ser. No. 12/471,340 filed May 22, 2009, now U.S. Pat. No. 8,734,516 issued May 27, 2014"]
   • U.S. Pat. No. 8,257,370 (issued Sep. 4, 2012) [cite: "This application is related to applicants' U.S. Pat. No. 8,257,370 issued Sep. 4, 2012, titled “POSTERIOR CERVICAL AND LUMBAR INTERARTICULATING JOINT STAPLES, STAPLING GUNS, AND DEVICES FOR SPINAL FUSION”"]

A person having ordinary skill in the art (POSITA) in the field of spinal implants and surgical tools would be a mechanical engineer or a surgeon with experience in spinal fusion techniques and medical device design.

Obviousness Combinations and Motivations

The patent US 10064738 presents several distinct improvements over the cited prior art, particularly the inventors' own "related applications." The core argument for obviousness rests on the premise that these improvements are logical, incremental advancements addressing known problems in the art, using conventional mechanical principles.

1. Bi-directional Fixating Transvertebral (BDFT) Screw/Cage Apparatus with Specific Locking Mechanisms

Claimed Features: An intervertebral cage (10) with internal screw guides (18, 20, etc.) for bi-directional screws (12, 14, etc.), combined with either:
* A central, rotatable T-shaped screw locking lever (24) that covers and locks the screws [cite: "a central screw locking lever 24 coupled to the intervertebral cage 10, wherein the central screw locking lever 24 prevents the first screw member 12 and the second screw from pulling-out"].
* A screw locking horizontal bracket (30) with hooks (34) that snap into corresponding slots (36) on the cage and include flexion grips (32) for removal [cite: "a screw locking horizontal bracket 30 ... can be press fit on a top of the intervertebral cage 10 and covers and locks the first screw member 12 and the second screw member 14 in the intervertebral cage 10"].

Combination and Motivation:

• Prior Art Basis: The fundamental concept of a BDFT screw/cage apparatus, which combines an intervertebral spacer with bi-directional transvertebral bone fixating screws, is established in the inventors' "aforementioned related applications" [cite: "The present invention relates to a unique universal bi-directional screw (BDS) system, and in particular its application to the spine, also referred to as bi-directional fixating transvertebral (BDFT) screw/cage constructs which can be used as stand-alone intervertebral devices"]. US 4,904,261 also shows an intervertebral implant with bone screws, albeit with a different configuration and a less sophisticated "stop" mechanism [cite: "U.S. Pat. No. 4,904,261 ... comprise only one stop for the heads of the bone screws to be inserted into them"]. The problem of screw back-out and pull-out in spinal implants is well-known in the prior art, specifically noted in the background of US '738 regarding anterior plating [cite: "Complications of anterior plating in the anterior lumbar spine include potential devastating injury to the major vessels due to chronic vascular erosion of the major vessels, or acute vascular injuries due to partial or complete plate and/or screw back out."].
• Motivation for Combination: A POSITA, building on the BDFT screw/cage designs from the related applications, would be strongly motivated to develop more robust and explicit locking mechanisms to prevent screw pull-out or back-out, thereby enhancing the stability and safety of the construct.
  • For the Central Screw Locking Lever (24): The idea of a rotating lever to secure fasteners is a fundamental mechanical principle. Adapting a T-shaped rotatable lever to cover and lock the heads of bi-directional screws within an intervertebral cage would be an obvious design choice for a POSITA seeking a simple, reversible, and reusable locking solution. The patent itself states this is an "additional evolutionary embodiment not described in the aforementioned related applications," implying that the need for such a mechanism was recognized [cite: "This locking mechanism 24 is an additional evolutionary embodiment not described in the aforementioned related applications."].
  • For the Screw Locking Horizontal Bracket (30): Similarly, snap-fit mechanisms with deformable elements for secure yet releasable attachment are common in mechanical engineering. Designing a horizontal bracket with hooks to engage prefabricated slots on the cage, and including flexion grips for release, is a routine application of known mechanical fastening techniques. The motivation is to provide a positive lock that is both strong and intraoperatively reversible. The patent also describes this as an "additional evolutionary embodiment not described in the aforementioned related applications" [cite: "This locking mechanism is a screw locking horizontal bracket 30 which snaps on to the top of the construct 10 ... This locking mechanism is an additional evolutionary embodiment not described in the aforementioned related applications."].

2. Pliers Device for Inserting/Removing Locking Bracket

Claimed Features: A pliers device (40) with specific features like upper (42) and lower (44) plier tips with stops (46), a limiter (50) and limiting screw (52) to prevent over-pressing, and a leaf spring (48) to bias the handles open [cite: "a pliers device 40 for inserting and removing the locking mechanism ... can include a first arm rotatably coupled to a second arm... upper plier tip 42 and the lower plier tip 44 each include a stop 46 configured to engage the bracket flexion grips 32... a limiter 50 and limiting screw 52"].

Combination and Motivation:

• Prior Art Basis: Pliers are a basic, ubiquitous tool. The screw locking horizontal bracket (30) from US '738 (discussed above) explicitly requires pressure on its "flexion grips (side tabs) 32" to "slightly deform (open) the bracket hooks 34" for removal [cite: "the user needs only to press on the side tabs 32 with the pliers (FIG. 5) to slightly deform (open) the bracket hooks 34, and thereby easily remove the bracket 30"]. This inherent design of the bracket necessitates a plier-like tool for manipulation.
• Motivation for Combination: Given the need for a tool to manipulate the locking bracket (30), it would be obvious for a POSITA to design a specialized pair of pliers. The inclusion of features such as stops (46) for consistent engagement, a limiting screw (52) for controlled force application (to prevent over-pressing and damage to the implant or surrounding tissue), and a leaf spring (48) for ergonomic operation (biasing the handles open for ease of use) are standard, well-known refinements for surgical instruments. These improvements enhance precision, safety, and user-friendliness, all of which are routine objectives in medical tool design.

3. Lumbar Facet Joint Staple Gun with Independent Puller Tip

Claimed Features: A lumbar facet joint staple gun (400) having an independent puller tip (402) that is movable between an open and closed position, specifically designed to swing open when the stapler is at its maximum open position for easy staple insertion/removal, and then locked in a closed position by the cylinder body (412) when the handle is closed [cite: "the puller tip 402 can be moveable between an open position and a closed position when the handle in the open position, and wherein the puller tip 402 is locked in the closed position by the first end of the hollow cylinder 412 body when the handle in the closed position."].

Combination and Motivation:

• Prior Art Basis: The "aforementioned related applications" (e.g., US 8,257,370) disclose earlier versions of lumbar facet joint staple guns. The patent US '738 explicitly states that this new staple gun is an "evolved and lumbar staple gun which is far more user friendly than previously described embodiments by incorporating a new release mechanism, as described in the aforementioned related applications" [cite: "The present invention presents an evolved and lumbar staple gun which is far more user friendly than previously described embodiments by incorporating a new release mechanism, as described in the aforementioned related applications."]. The stated problem with prior designs was that the staple could become loose or fall off during an operation [cite: "This new change ... facilitates easier insertion and removal of the staple decreasing the risk of the staple becoming loose or falling off during an operation."].
• Motivation for Combination: A POSITA would be motivated to improve the user-friendliness, ease of loading, and staple retention of an existing staple gun (from the related applications). Designing a puller tip that securely holds the staple during operation but allows for easy loading/unloading when the device is fully open is a common mechanical design problem. Implementing a puller tip that pivots or "swings open" when the tool is in an open state and is then mechanically constrained by the surrounding body (cylinder) when the tool is closed (i.e., ready for firing) is a well-known engineering solution for secure yet accessible loading mechanisms in various hand tools.

4. Posterior Lumbar Facet Staple with Evolved Ratchet Mechanism (Flexure/Torsional Spring)

Claimed Features: Posterior lumbar facet staples (500, 600) incorporating either a flexure spring (530) ratchet pawl or a torsional spring (630) engaging a brake (680) [cite: "FIGS. 9A-B illustrate an embodiment of a posterior lumbar facet staple 500 having a flexure spring 530. ... FIGS. 10A-C illustrate an embodiment of a posterior lumbar facet staple 600 having a torsional spring 630"]. These are described as being superior to conventional designs in withstanding greater force than a "small external ratchet."

Combination and Motivation:

• Prior Art Basis: The "related applications" (e.g., US 8,257,370) already disclosed lumbar facet staples with a "ratchet" mechanism for incremental closure [cite: "the embodiments illustrated in the related applications included a ratchet. The staple could be incrementally closed with increased ratcheting over increasing number of spurs."]. The present patent aims to provide embodiments that "can withstand much greater force (Newtons) than a small external ratchet" [cite: "the present invention provides two evolved embodiments, which are superior to conventional designs in that the closing mechanisms can withstand much greater force (Newtons) than a small external ratchet."].
• Motivation for Combination: A POSITA, recognizing a limitation in the force-withstanding capability of a "small external ratchet" in existing lumbar facet staples (from the related applications), would be motivated to improve its strength and rigidity. Flexure springs and torsional springs are fundamental mechanical components used to provide resilient forces and engage ratchet teeth. Incorporating these types of springs into the internal design of a ratchet mechanism to achieve specific force characteristics is a routine design choice for a mechanical engineer seeking to optimize the performance and robustness of a known device.

5. Posterior Cervical Facet Staple Gun (Simplified and Economical)

Claimed Features: Posterior cervical facet staple guns (FIGS. 7-8) with internal mechanisms including a handle (802, 902), central plunger (804, 910), and retaining springs (808; 908, 909) designed for simplified, economically efficient, and user-friendly operation, particularly for percutaneous procedures [cite: "In this application, the embodiments can provide more simplified and economically efficient staple guns which are very user friendly and further enhances the application of the cervical staple gun also making posterior cervical facet stapling more amenable to a non-invasive, percutaneous surgical procedure."].

Combination and Motivation:

• Prior Art Basis: The "related applications" introduced "highly evolved cervical staple gun[s] for the two and four pronged cervical staples" [cite: "In the related applications, cervical facet embodiments of a highly evolved cervical staple gun for the two and four pronged cervical staples were introduced."].
• Motivation for Combination: A POSITA would be motivated to refine and improve an existing cervical staple gun (from the related applications) to achieve goals of simplification, economic efficiency, and enhanced user-friendliness, especially to make it "more amenable to a non-invasive, percutaneous surgical procedure." These are common objectives in medical device development. The use of a retaining spring to hold staples and a central plunger/button for release represents a basic and widely used mechanical design solution for loading and releasing components in tools, making it an obvious modification to streamline and simplify the staple gun's operation.

In summary, the key "evolutionary" and "novel" aspects of US 10064738, when viewed through the lens of the inventors' own extensive prior art (the "related applications") and general mechanical knowledge, appear to be routine design choices and optimizations rather than inventive steps. A POSITA would have been motivated to combine the known functional elements from the prior art, along with conventional mechanical components and design principles, to achieve improved performance (e.g., better locking, easier handling, greater strength) in the context of existing spinal fusion devices and tools.