DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to claims in application 18/532,536 filed on 12/7/2023.
The Pre-Grant publication # 2025/0191499 A1 is published on 6/12/2025.
Claims 1-16 are pending.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication Number 20210330468 A1 Mimnaugh et al. (Mimnaugh)..
Claim 1. Mimnaugh teaches a method for producing an articulating anatomical model using flexible fill material (Fig.6; Para 0040 filled-in between fibers elements 50A, 50B in Fig.3), comprising:
separately printing individual anatomical components with gaps between the component (Para 0033 three-dimensional (3D) printing techniques, such as electron beam or laser additive manufacturing while flexible spacer can be made of a polymeric material including fibers to facilitate flexing. ; Fig.1 elements 18,20 first metatarsophalangeal joint includes distal phalange bone, proximal phalange bone 18 and metatarsal phalange 20.);
assembling by the use of supporting structure the individual components in their proper anatomical arrangement (Fig.7 assembling supporting structures 18 and 20 by proper anatomic joint can be resected to form planar anterior surface 82. Proximal end 84 of proximal phalange bone 18 can he resected to form planar posterior surface 86);
injecting a flexible paste or sealant material into the gaps between the components (Fig.6, Para 0029 he cartilage along with joint fluid provides a cushion between each bone that also facilitates flexion of the joint); and
curing the flexible material to form flexible joints between the components, where the flexible joints maintain the spatial positioning of the components while enabling articulation (Para 0034 prosthetic joint device 40 of the present disclosure including flexible spacer 42 and anchor components 44A and 44B coupled between proximal phalange bone 18 and metatarsal phalange bone 20 of Fig.3).
Claim 2. Mimnaugh teaches the method according to claim 1, wherein the supporting structure comprises inserting a wire or needle temporarily through holes in the components to maintain their spatial positioning while injecting the flexible material ((Para 0053 cancellous bones within bones maintains spatial positions similar to inserting wire or needle).
Claim 3. Mimnaugh teaches the method according to claim 2, wherein a wire path may be developed before the printing, disposed on the support between the talus the fibula and the tibia on the correct mechanical axis to allow fill motion of the ankle after the flexible material is placed and the wire is removed (Para 0053 joint connection between the metatarsal bones in the foot and the phalanges like toes bones ; Para 0040 guiding axis for example disposed to support bone graft).
Claim 4. Mimnaugh teaches the method according to claim 1, further comprising printing the individual components onto a support structure or frame matching the shape of the assembled structure, to hold the components in proper anatomical arrangement during printing and assembly (Para 0058 3D during printing process).
Claim 5. Mimnaugh teaches a method for producing an articulating anatomical model using breakaway supports, comprising:
printing individual anatomical components with small breakable supports connecting the components; assembling the individual components together such that the supports hold the components in their proper anatomical arrangement; applying a tissue layer over the assembled components; and breaking the small supports between components with light force to allow articulation while retaining the anatomical alignment (Para 0028-0030 cartilage along with joint fluid provides a cushion between each bone that also facilitates flexion of the joint proper anatomical arrangement alignment and movements) .
Claim 6. Mimnaugh teaches the method according to claim 5, wherein applying a tissue layer comprises encapsulating the assembled components with a polymer foam or other flexible material to simulate soft tissue (Para 0045 soft tissue).
Claim 7. Mimnaugh teaches the method according to claim 5, further comprising tuning the properties of the flexible fill material to achieve desired joint stiffness for mimicking cartilage, tendons, or ligaments (Para 0052 filled material for joint properties).
Claim 8. Mimnaugh teaches the method according to claim 5, further comprising using CT, MRI, or other scan data to print components modeled on a subject's specific anatomy ( CT and MRI images).
Claim 9. Mimnaugh teaches the method according to claim 5, wherein the anatomical components comprise bones of the foot and ankle for surgical simulation and training (Para 0053 joint connection between the metatarsal bones in the foot and the phalanges, toes).
Claim 10. Mimnaugh teaches an articulating anatomical model (Fig.3) comprising:
a plurality of separately printed anatomical components assembled together in their correct anatomical arrangement on a structure (Para 0041 Fibers 46 can be separated from each other to provide space for matrix) ; and
a flexible fill material between the components bonding them together while allowing articulation (para 0050 bonding strength to survive implantation and operation of anchor component, while permitting infusion of bone and polymer material).
Claim 11. Mimnaugh teaches the anatomical model of claim 10, wherein the flexible fill material comprises a paste, glue, or sealant that adheres to the components(para 0052 fill materials with synovial fluid).
Claim 12. Mimnaugh teaches the anatomical model of claim 10, further comprising a layer of polymer foam or flexible material encapsulating the components to simulate soft tissue (Para 0041 compressing could be encapsulating; A ratio can provide adequate stiffness to flexible spacer for the purposes of compression, tension and torsion, but facilitates bending of flexible spacer in a manner that realistically reproduces operation of a natural joint).
Claim 13. Mimnaugh teaches the anatomical model of claim 12, wherein the flexible fill material has tunable mechanical properties to mimic joint stiffness and mechanics(Para 0044 bones in close mimic to interconnecting struts mechanics).
Claim 14. Mimnaugh teaches the anatomical model of claim 10, wherein the components are based on CT, MRI, or scan data from a subject (Para 0058 CT,MRI images) .
Claim 15. Mimnaugh teaches the anatomical model of claim 10, wherein the components comprise foot and ankle bones (Para 0053 joint connection between the metatarsal bones in the foot and the phalanges, toes).
Claim 16. Mimnaugh teaches the anatomical model of claim 10, wherein the components are printed with small breakable supports connecting the components (Fig.7 breakable connections).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11657287 B2 Poltaretskyi; Sergii et al.
Virtual guidance for ankle surgery procedures
US 9318032 B2 Samosky; Joseph T. et al.
Hybrid physical-virtual reality simulation for clinical training capable of providing feedback to a physical anatomic model .
US 20210330468 A1 McAlpine; Michael C. et al.
METARSOPHALANGEAL JOINT REPLACEMENT DEVICE AND METHODS
US 11875704 B2 Dixon; Angela R. et al.
Nose simulator with multisampling modes for airstream evaluation
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/S.Z/Examiner, Art Unit 3715
September 6, 2025
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715