Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 02/02/2026. Presently, claims 1-23 are now pending.
Response to Arguments
Applicant's arguments filed on 02/02/2026 have been fully considered but they are not persuasive. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claims 1-23 is maintained as presented below.
Applicant’s representative alleges the following:
In regards to 35 U.S.C. 102(a)(1), Clifton's foam merely fills the housing unit and simulates visualization hindrance. Significantly, it does not constitute a separate positionable cover with surface structures simulating relevant anatomy.
Regarding point (1), the examiner respectfully disagrees.
Applicant’s representative argues that Clifton's Figure 2 shows polyurethane foam that is placed within the box, layered on top of the vertebral models to simulate soft tissue. This foam is internal padding material placed inside the housing unit-it is not a separate "box cover" that is "positionable over the open box." In contrast, the present invention's "box cover" is a distinct structural element that covers the open top of the box and includes surface structures simulating skin, bony landmarks, or other relevant anatomical features. As described in the specification at paragraph [0045], "the box cover includes surface structures that simulate anatomical structures found on the surface of a patient's body, such as skin, bony structures close to the skin, or combinations thereof."
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a separate box cover) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, the upholstery foam sheet placed on top of the SpineBox in Fig 1 is used as a separate cover because it is separate from the SpineBox and is positionable over the open box as shown in Fig 2.
Applicant’s representative argues that since Clifton does not disclose or suggest the suggested features of claim 1 and so, all other dependent claims are patentable. However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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.
Claims 1 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clifton et al. (The SpineBox: A Freely Available, Open-access, 3D-printed Simulator Design for Lumbar Pedicle Screw Placement; hereinafter Clifton).
Regarding claim 1, Clifton discloses a simulation device for simulating a surgical procedure (abstract) comprising: an open box (Fig 1, housing unit); a three-dimensional model of a bony or soft tissue anatomical structure that is positionable in the open box (lumbar vertebral model inside the box; Fig 1); and a box cover that is positionable over the open box (Cover over box in Fig 2), the box cover having surface structures that simulate anatomical structures relevant to the surgical procedure (replicating visualization hindrance of the bony posterior elements of the lumbar spine; Description under Fig 2).
Regarding claim 10, Clifton discloses wherein the three-dimensional model is created from a patient's imaging data (CT scan of adult patient; Page 2 - Materials and Methods - 2nd paragraph).
Regarding claim 11, Clifton discloses configured to simulate spinal surgical procedures (Page 2 - Introduction - 1st paragraph).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Piron et al. (US20160155364A1; hereinafter Piron).
Regarding claim 2, Clifton discloses wherein the surface structures include skin (Fig 2) but does not explicitly disclose bony structures close to the skin and combination thereof.
However, Piron teaches bony structures (Fig 2) close to the skin and combination thereof (implementation of training model 100 in Fig 2 may be covered in skin layer; ¶48).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Piron because having a surface that simulates both skin and bony structure provides a realistic anatomical human model. Furthermore, it allows the surgeons or trainees to visualize a better representation of a human model and improve their training efficacy.
Regarding claim 3, Clifton does not explicitly disclose wherein the surface structures include structures simulating a portion of a human skull.
However, Piron teaches wherein the surface structures include structures simulating a portion of a human skull (skull component 220 simulates a portion of a human skull; Fig 2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Piron because having a surface structure that simulates the correct portion of the anatomical structure with high fidelity. While Clifton simulates the skin portion before reaching the spine, Piron simulates a skin and bony structure for a human skull, which is beneficial to surgical training to provide a realistic anatomical human model without having to practice on a real patient.
Claim 21-22 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Masuda et al. (WO2020144806A1 see-translation; hereinafter Masuda).
Regarding claim 21, Clifton does not explicitly disclose simulating transsphenoidal hypophysectomy.
However, Masuda teaches simulating transsphenoidal hypophysectomy (3D model used to simulate a transsphenoidal hypophysectomy, which is a tumor around the pituitary gland being removed via the nasal cavity and sphenoid sinus; ¶15 and Fig 1-2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Masuda because a 3D model that simulates a transsphenoidal hypophysectomy provides a realistic environment for surgical training. This procedure is highly complex and a 3D model will provide surgeons with training and visualization on how to properly perform the procedure.
Regarding claim 22, Clifton does not disclose wherein the surface structures simulates a first portion of a human skull and the three-dimensional model simulates a second portion of the human skull.
However, Masuda teaches wherein the surface structures simulates a first portion of a human skull (surface structure in Fig 4 simulates a first portion of a human skull) and the three-dimensional model simulates a second portion of the human skull (the 3D model in Fig 2 simulates a second portion of the human skull).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Masuda because simulating different portions of the skull allows surgeons or trainees to visually practice and understand the external and internal anatomy of the skull and the surrounding parts.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Takasu et al. (US 9129535 B2; hereinafter Takasu).
Regarding claim 4, Clifton does not disclose wherein the three-dimensional model is divided into multiple sections held together by magnetic technology.
However, Takasu teaches wherein the three-dimensional model is divided into multiple sections held together by magnetic technology (sections of a humerus member held together by magnetic force; col 11 lines 64-67 and col 12 lines 21-25).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Takasu because it provides a way to hold different sections of the 3D model together while allowing for a modular, repeatable, and replaceable design. With this type of model you can assembly and disassemble the model repeatedly for training of multiple users or multiple scenarios.
Regarding claim 5, Clifton does not disclose wherein the magnetic technology that designed to withstand a force a surgeon applies when performing a procedure.
However, Takasu teaches wherein the magnetic technology that designed to withstand a force a surgeon applies when performing a procedure (magnetic technology reproduces the same amount of resistance as muscle or tendon of human body in col 12 lines 31-36 which simulates how the magnetic technology will hold the sections together or not, depending on how much force is used).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Takasu because it provides a realistic scenario for training by having realistic resistance for the parts of the 3D model. If too much force is used, the surgeon or trainee will visualize it during the training and adjust it based on that feedback.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Willobee et al. (US7780451B2; hereinafter Willobee).
Regarding claim 6, Clifton does not disclose wherein the three-dimensional model is divided into multiple sections held together by protrusions and opens that receive the protrusions.
However, back of invention of Willobee teaches wherein the three-dimensional model is divided into multiple sections held together by protrusions and opens that receive the protrusions (model of a human shoulder can be divided into sections and be held together by a ball and socket mechanism; Background of the Invention col 1 lines 18-24).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Willobee because ball and socket mimics natural articulation of the human body. Ball and socket joints also allows parts to be held together while also allowing full range of motion.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Hoke et al. (US 20130101973 A1; hereinafter Hoke).
Regarding claim 7, Clifton does not disclose wherein the three-dimensional model includes a replaceable component that simulates material altered or removed by the surgical procedure.
However, Hoke teaches wherein the three-dimensional model includes a replaceable component that simulates material altered or removed by the surgical procedure (simulated tissue structure is modular and interchangeable and includes an artificial tumor as a replaceable component; abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Hoke because a replaceable part that simulates a component being removed or altered is realistic to what surgeons will do during a surgical procedure. Having this part be replaceable allows for training of multiple users or multiple scenarios.
Regarding claim 8, Clifton does not disclose wherein the replaceable component simulates a tumor.
However, Hoke teaches wherein the replaceable component simulates a tumor (abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Hoke because a replaceable part that simulates a component being removed or altered, like a tumor, is realistic to what surgeons will do during a surgical procedure. Having this part be replaceable allows for training of multiple users or multiple scenarios.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Hoke in view of Wu et al. (US 10529255 B2; hereinafter Wu).
Regarding claim 9, Clifton does not disclose wherein the replaceable component simulates a spinal dura rupture.
However, Wu teaches wherein the replaceable component simulates a spinal dura rupture (modular unit 300 may be modeled to mimic fractured bone and tears col 6 lines 11-15 which can include a dural tear col 3 lines 48-50).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Wu because a spinal dura rupture can cause a cerebrospinal fluid (CSF) leak, which is one of the most common and serious complications. Having a replaceable component will help surgeons and trainees to train for a more efficient and safer procedure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Wu.
Regarding claim 12, Clifton does not disclose wherein the spinal surgical procedures include spinal dura repair or microdiscectomy.
However, Wu teaches wherein the spinal surgical procedures include spinal dura repair or microdiscectomy (surgical training to fix multiple conditions such as spinal dural tear; col 3 lines 48-57).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Wu because a spinal dura rupture can cause a cerebrospinal fluid (CSF) leak, which is one of the most common and serious complications. Having spinal surgical procedures to practice multiple conditions or injuries in the spine will help surgeons and trainees to train for a more efficient and safer procedure.
Claims 13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Jeffrey S. Dove (US 6579940 B1; hereinafter Dove).
Regarding claim 13, Clifton discloses latex tubing to mimic a patient’s spinal canal, but it does not disclose the tube to be made of plastic.
However, Dove teaches that tubing can also be made of plastic (thermoplastic elastomers can replace latex; col 2 lines 24-31).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Dove to replace latex tubing with plastic tubing because plastic tubing provides less allergenic (less allergic reactions for surgeons or trainees) and increased elastomeric resistance (improved ability to withstand stress and external factors without permanent degradation or deformation).
Regarding claim 15, Clifton discloses wherein a portion of the plastic tube is surrounded by a dura substitute material to simulate spinal dura (methods to reproduce dura and/or cerebrospinal fluid; Page 6 - 2nd paragraph - Last sentence).
Regarding claim 16, Clifton discloses wherein the dura substitute material includes a component selected from the group consisting of bovine pericardium was used as a dura substitute, leather, oriented polypropylene wrapping, chicken skin, and latex (latex tubing or Penrose drain; Page 6 - 2nd paragraph - Last sentence).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Bohl et al. (US 20200360090 A1; hereinafter Bohl).
Regarding claim 14, Clifton does not disclose wherein water is pumped through plastic tube to simulate cerebrospinal fluid (CSF) pressure and flow.
However, Bohl teaches wherein water is pumped through plastic tube to simulate cerebrospinal fluid (CSF) pressure and flow (water passing through the simulated thecal sac which is the structure that holds cerebrospinal fluid inside the spinal canal; ¶99).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Bohl because water has similar physical properties as cerebrospinal fluid, low cost, and readily available for use.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Dove in view of Bohl.
Regarding claim 17, Clifton does not disclose wherein a small incision is made on the dura substitute material to simulate an incidental durotomy.
However, Bohl teaches wherein a small incision is made (surgeon's tool can be a scalpel and scalpel is the tool used for incisions; ¶100) on the dura substitute material to simulate an incidental durotomy (tracking surgeon's movement to avoid a durotomy caused by the scalpel; ¶100).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Bohl because it provides a more realistic experience for the surgeon or trainee to react and recognize a sudden complication during surgery. Furthermore, an incision is the primary ways to simulate an incidental durotomy used in a 3D model.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Hart et al. (US 9514658 B1; hereinafter Hart).
Regarding claim 18, Clifton discloses providing a narrow surgical viewing plane (Fig 2), but does not explicitly disclose a synthetic covering that mimics skin.
However, Hart teaches the surface structures includes a synthetic covering that mimics skin (synthetic skin simulating animal tissue model; abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Hart because having synthetic skin mimic skin provides a more realistic scenario when performing surgery. Synthetic skin that mimics skin also allows trainees or surgeons to enhance their practice of realistic incisions, sutures, and any other type of wounds on the skin.
Regarding claim 19, Clifton does not disclose wherein materials for the synthetic covering include foam insulation, silicone, or ballistics gel.
However, Hart teaches wherein materials for the synthetic covering include foam insulation, silicone, or ballistics gel (synthetic skin can be made of silicone; abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Hart because having a synthetic covering made up of silicone allows it to have similar properties of elasticity and deformity like real skin. Furthermore, silicone is also highly resistant to heat, chemicals, and UV radiation. This durability is perfect for training models that will be used multiple times over long periods of time.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Frey et al. (US 20140350614 A1; hereinafter Frey).
Regarding claim 20, Clifton discloses an incision placed on the box cover of a patient's spine from a patient's back, but does not disclose a tubular retractor that is placed on the box cover to simulate an endoscopic approach to a patient's spine from a patient's back.
However, Frey teaches further comprising a tubular retractor used to simulate an endoscopic approach to a patient's spine (spinal surgeries may be performed by a retractor ¶10 and ¶194 provides an example of how a retractor can be tubular - a tube retractor 160).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Frey because a tubular retractor facilitates a minimally invasive surgical approach. Instead of making a large cut and stripping muscles away from bone, a tubular retractor can be inserted over a very small incision.
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Masuda in view of Gillet et al. (Methods of 3D printing models of pituitary tumors; hereinafter Gillet).
Regarding claim 23, Clifton does not disclose wherein the three-dimensional model includes a plastic structure simulating a pituitary gland.
However, Gillet teaches wherein the three-dimensional model includes a plastic structure (3D printing is done using Nylon PA2200, which is a type of plastic; Page 5 - 3D printing techniques - 1st paragraph) simulating a pituitary gland (3D model includes pituitary gland; abstract - Methods).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clifton to implement the teachings of Gillet because by the pituitary gland model made from plastic will be more durable, reusable, and customizable for training surgeons and trainees.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSE ANGELES/Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715