DETAILED ACTION
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 .
Status of Claims
This office action is in response to the patent application 18/415,794 originally filed on January 18, 2024. Claims 1-56 were originally presented for examination.
In the Preliminary Amendment filed January 18, 2024, claims 5, 9, 11-16, 18, 21-24, 28, 32-34, 37-41, and 43-56 were canceled. Claims Inventor name search, Assignee search, PE2E-Search text search (see attached printout), Class/subclass search, Forward/Backward citation search, and Similarity Search remain pending examination. Claims 1, 25, and 29 are independent.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 1/18/2024, 5/6/2024, and 10/14/2025 have been considered. Initialed copies of the Form 1449 are enclosed herewith.
In the IDS filed 1/18/2024, non-patent literature documents Cite numbers 1 and 3 could not be considered because no date was provided. Cite number 6 could not be considered because no date was provided, and the document is illegible.
Priority
This application claims priority of US Provisional Application 63/480,361, filed January 18, 2023.
Claim Rejections - 35 USC § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 29-31, 35, 36, and 42 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 29 is directed to “a system” (i.e. a machine), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
However, the claims are drawn to an abstract idea of “rehearsing a surgical procedure” reasonably in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion) which are “performed on a computer” (per MPEP 2106(III)(C) “A Claim That Requires a Computer May Still Recite a Mental Process”).
Regardless, the claims are reasonably understood as “mental processes,” which require the following limitations:
“access a virtual anatomical model… the virtual anatomical model associated with an anatomy;
cause the virtual anatomical model to be displayed…
assign a fracture pattern to the virtual anatomical model based on one or more parameters; and
generate a configuration associated with a physical anatomical model representative of the virtual anatomical model, the configuration specifying a fracture path established according to the assigned fracture pattern.”
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “a system,” “a computing device,” “a processor,” “a memory,” and “a graphical user interface” are claimed, as these are merely claimed to add insignificant extra-solution activity to the judicial exception (e.g., data gathering) and/or do no more than generally link the use of a judicial exception to a particular technological environment or field of use. In other words, the claimed “rehearsing a surgical procedure” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a system,” “a computing device,” “a processor,” “a memory,” and “a graphical user interface” are claimed these are all generic, well-known, and conventional computing elements. As evidence that these are generic, well-known, and conventional computing elements, Applicant’s specification discloses them in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a), which satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
Specifically, the Applicant’s claimed “a system” comprises “a computing device,” “a processor,” “a memory,” and “a graphical user interface.” The “system” is described in instant specification paragraph [000374-000138], as follows: “The system 20 may include a host computer 21 and one or more client computers 22. The host computer 21 may be configured to execute one or more software programs… The host computer 21 and each client computer 22may include one or more of a computer processor, memory, storage means, network device and input and/or output devices and/or interfaces… The host computer 21 and each client computer 22 may be a desktop computer, laptop computer, smart phone, tablet, or any other computing device… Each client computer 22may be operable to access and locally and/or remotely execute a planning environment 26… The planning environment 26 may provide a display or visualization of one or more virtual anatomical models 29 and related images and/or one or more implant models 30 via one or more graphical user interfaces (GUI).” (emphasis added)
These elements are reasonably interpreted as a generic computer which provides no details of anything beyond ubiquitous standard equipment. As such, the claimed limitation of “a system” is reasonably understood as not providing anything significantly more. Therefore, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 30, 31, 35, 36, and 42 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 30, 31, 35, 36, and 42 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to independent claim 29.
Therefore, claims 29-31, 35, 36, and 42 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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 1-4, 6, 7, 10, 17, 19, 29-31, 35, 36, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neijhoft et al., “Visualization of complicated fractures by 3D-printed models for teaching and surgery: hands-on transitional fractures of the ankle” (hereinafter “Neijhoft,” Non-patent Literature, full citation in PTO-892).
Regarding claim 1, Neijhoft discloses a physical anatomical model comprising:
a main body including an external surface associated with an anatomical profile of a bone, and the main body including a fracture path that establishes one or more localized regions (see Neijhoft Figs. 5 and 6, showing physical models of fractured bones; also Neijhoft page 3924, Results, “the fracture line in the case of the twoplane fracture follows the growth plate to the lateral side in one plane. The fragment often can be seen in the x-ray on the a.p. image as seen in Figs. 3 and 4 in the CT scan. The life-sized printed models as well as the digital reconstruction is shown in Fig. 5. In most cases closed reposition is possible followed by fixation with an Kirschner’s wire or screw as seen in Fig. 6.”); and
wherein the main body is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions (see Neijhoft Figs. 5 and 6, showing physical models of fractured bones that can be physically pulled apart; also Neijhoft page 3925, Discussion, “Printing life-sized fracture models gives the advantage of holding and feeling the model with one's hand, instead of just looking at it. Especially in case of complicated fractures, comprehension of the fracture line is essential to the patient's outcome. A 3d printed model can help to understand, classify and plan surgical procedure. So there are multiple advantages, not only in education but, as shown in other studies with different fracture types, also in the potential reduction of time of the surgical procedure or intra operative blood loss… Taking the fracture fragments apart allows having a look from every side and understand therapy options, surgical approaches and screw placement. Afterward, the fracture can be puzzled together again.”).
Regarding claim 2, Neijhoft discloses wherein the fracture path includes one or more segments, and each of the one or more segments establishes a loop about the respective localized region (see Neijhoft Figs. 5 and 6, showing bone sections with fragments broken off, the fracture path of each segment forming a “loop” shape).
Regarding claim 3, Neijhoft discloses wherein the fracture path is established according to a predetermined fracture pattern (see Neijhoft Fig. 5, showing computer models of fractured bones in predetermined fracture patterns “Twoplane,” “Triplane I,” and “Triplane II Fracture”).
Regarding claim 4, Neijhoft does not explicitly teach wherein: the main body includes a first volume and a second volume; the first volume establishes the external surface of the main body and is representative of cortical bone; and the second volume is representative of cancellous bone (Neijhoft page 3925, Discussion, “We used transitional fractures as an example to show the potential use of modern teaching techniques. It is even possible to try screw placement or cutting with these models, but in this case cooling of the drill/saw is essential as the plastic can melt when reaching higher temperatures on the tip of the drill. One downside is that PLA as the material used for this study, does not entirely reel like hone or artificial hone in the case of drilling, which not only is caused by the material but also the missing microstructure of cancellous and cortical bone,” Neijhoft takes into account the different structures of the bones when forming the models).
Regarding claim 6, Neijhoft discloses wherein: the fracture path extends along a boundary region between the first volume and the second volume; and the main body includes a fracture volume established along the fracture path such that the fracture volume is at least partially embedded in the first volume, and the main body is severable along the fracture volume to establish the one or more fragments (see Neijhoft Fig. 5, showing a “Triplane II Fracture” on the bottom right, which is separated into three pieces).
Regarding claim 7, Neijhoft discloses wherein the first volume has a first property, and the fracture volume has a second property that differs from the first property (see Neijhoft Fig. 5, showing a “Triplane II Fracture” on the bottom right, which is separated into three pieces. The “first property” and “second property” are not elaborated upon, and therefore under broadest reasonable interpretation they can be any property).
Regarding claim 10, Neijhoft discloses wherein: the main body includes one or more indicators associated with the fracture path (see Neijhoft Fig. 5, showing that the fracture path is visible).
Regarding claim 17, Neijhoft discloses a fracture volume associated with the fracture path, wherein the fracture volume extends substantially through the main body such that the main body is severable along the fracture volume to establish the one or more fragments (see Neijhoft Fig. 5, showing main body severable along the fracture volume).
Regarding claim 19, Neijhoft discloses wherein the fracture volume includes at least one indicator adapted to selectively communicate a state of the physical anatomical model in response to an external force (see Neijhoft Fig. 5, showing physical model of fractured bones that will visibly react when acted upon).
Regarding claim 29, Neijhoft discloses a system for rehearsing a surgical procedure comprising:
a computing device including a processor coupled to memory (Neijhoft page 3924, Methods, “For building a 3D printable model, a 3-dimensional dataset of fractures as CT scans, in case of children low dose CT scans or MRI-datasets, are necessary,” computing device with processor and memory are required to do this), wherein the processor is configured to:
access a virtual anatomical model from the memory, the virtual anatomical model associated with an anatomy (Neijhoft page 3923, Introduction, “Understanding of the orientation of fracture lines and mechanism is the essential key to sufficient surgical therapy… Using 3D-printed models in the learning process will fill this gap, which could help students not only to see but also to feel the fracture. The fused filament fabrication (FFF) 3D printing technology offers a promising possibility to cost-efficiently build and reproduce fracture models for teaching purposes from daily CT (computer tomography) data”);
cause the virtual anatomical model to be displayed in a graphical user interface (see Neijhoft Fig. 5, showing virtual anatomical model animated on a graphical user interface);
assign a fracture pattern to the virtual anatomical model based on one or more parameters (Neijhoft page 3924, Methods, “For building a 3D printable model, a 3-dimensional dataset of fractures as CT scans, in case of children low dose CT scans or MRI-datasets, are necessary. The 3D printer needs a coordinate-based filesystem, so the Digital Imaging and Communications in Medicine (DICOM) data must be segmented into its parts of interest and then translated into a coordinate-based language, readable by the 3D printer.”); and
generate a configuration associated with a physical anatomical model representative of the virtual anatomical model, the configuration specifying a fracture path established according to the assigned fracture pattern (Neijhoft page 3924, Methods, “Then segmented bone can be exported as a standard tessellation language (STL) file, which is broadly used for a lot of printers and slicing software. The tile then is processed by another software for further adjustments in terms of printability like adding manual support structures, such as Meshmixer (Autodesk, Version 3.5.474). After that, the file is machined by a slicer. This software works as the last step before printing and is translating the STL file into a coordinate-based file format. which is called GCODE.”).
Regarding claim 30, Neijhoft discloses wherein: the processor is configured to generate the configuration such that the physical anatomical model is severable along the fracture path to establish one or more fragments (see Neijhoft Figs. 5 and 6, showing physical models of fractured bones that can be physically pulled apart; also Neijhoft page 3925, Discussion, “Printing life-sized fracture models gives the advantage of holding and feeling the model with one's hand, instead of just looking at it. Especially in case of complicated fractures, comprehension of the fracture line is essential to the patient's outcome. A 3d printed model can help to understand, classify and plan surgical procedure. So there are multiple advantages, not only in education but, as shown in other studies with different fracture types, also in the potential reduction of time of the surgical procedure or intra operative blood loss… Taking the fracture fragments apart allows having a look from every side and understand therapy options, surgical approaches and screw placement. Afterward, the fracture can be puzzled together again.”).
Regarding claim 31, Neijhoft discloses wherein: the processor is configured to generate a fracture volume that follows a length of the fracture pattern, and the configuration is established according to the fracture volume (see Neijhoft Fig. 5, showing bones with different fracture patterns).
Regarding claim 35, Neijhoft discloses wherein: the one or more parameters are associated with a predefined fracture classification scheme; and the processor is configured to assign the fracture pattern to the virtual anatomical model in response to setting the one or more parameters associated with the predefined fracture classification scheme (see Neijhoft Fig. 5, showing computer models of fractured bones in predetermined fracture patterns “Twoplane,” “Triplane I,” and “Triplane II Fracture”).
Regarding claim 36, Neijhoft discloses wherein: the virtual anatomical model includes a first volume and a second volume; the first volume is representative of cortical bone; and the second volume is representative of cancellous bone (Neijhoft page 3925, Discussion, “We used transitional fractures as an example to show the potential use of modern teaching techniques. It is even possible to try screw placement or cutting with these models, but in this case cooling of the drill/saw is essential as the plastic can melt when reaching higher temperatures on the tip of the drill. One downside is that PLA as the material used for this study, does not entirely reel like hone or artificial hone in the case of drilling, which not only is caused by the material but also the missing microstructure of cancellous and cortical bone,” Neijhoft takes into account the different structures of the bones when forming the models).
Regarding claim 42, Neijhoft discloses wherein: the processor is configured to generate a fracture volume based on the fracture pattern such that the fracture volume extends substantially through a main body of the physical anatomical model such that the main body is severable along the fracture volume to establish one or more fragments (see Neijhoft Figs. 5 and 6, showing physical models of fractured bones that can be physically pulled apart; also Neijhoft page 3925, Discussion, “Printing life-sized fracture models gives the advantage of holding and feeling the model with one's hand, instead of just looking at it. Especially in case of complicated fractures, comprehension of the fracture line is essential to the patient's outcome. A 3d printed model can help to understand, classify and plan surgical procedure. So there are multiple advantages, not only in education but, as shown in other studies with different fracture types, also in the potential reduction of time of the surgical procedure or intra operative blood loss… Taking the fracture fragments apart allows having a look from every side and understand therapy options, surgical approaches and screw placement. Afterward, the fracture can be puzzled together again.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Neijhoft in view of Blair-Pattison et al. (hereinafter “Blair,” US 2018/0005548).
Regarding claim 8, Neijhoft does not explicitly teach wherein the first property includes a first material strength, and the second property includes a second material strength that is less than the first material strength.
However, Blair discloses wherein the first property includes a first material strength, and the second property includes a second material strength that is less than the first material strength (Blair [0004], “Current simulated bones are designed to look like bone but do not reproduce the tactile and structural properties of bone. These simulated bone materials are suitable for demonstrating the spatial relationships between bones and also for the spatial relationship between bones and various devices such as tools, implants, and screws but not for simulations of procedures and processes that act upon the bone through sawing, screwing, cutting, scraping, drilling, hammering, etc. that require specific bone-related material properties such as the strength, elastic modulus, bone density (e.g., cancellous/cortical bone), heterogeneity, variability and weight etc. Current synthetic bone models use a plastic exterior and foam interior construction that, while allowing for an accurate exterior look of real bone, does not accurately simulate the feel of real bone when acted upon.”).
Blair is analogous to Neijhoft, as both are drawn to the art of orthopaedic surgery. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Neijhoft, to include wherein the first property includes a first material strength, and the second property includes a second material strength that is less than the first material strength, as taught by Blair, so that the constructed bones will have realistic properties when acted upon (Blair [0004]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Neijhoft in view of Willobee et al. (hereinafter “Willobee,” US 7,780,451).
Regarding claim 20, Neijhoft does not explicitly teach wherein the fracture volume includes a compressible material.
However, Willobee discloses wherein the fracture volume includes a compressible material (Willobee Abstract, “The bones of the shoulder assembly are made of foam-cortical shell, the shoulder musculature is made of foam, the soft tissue components are made of thermoplastic elastomers, and the skin is made of vinyl.”).
Willobee is analogous to Neijhoft, as both are drawn to the art of orthopaedic surgery. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Neijhoft, to include wherein the fracture volume includes a compressible material, as taught by Willobee, in order to create a more realistic feel (Willobee col. 5 lines 35-43). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Samara State Medical University (hereinafter “Samara,” RU-197305-U1, machine translation) in view of Lalonde (US 6,315,780).
Regarding claim 25, Samara discloses an orthopaedic system comprising:
a physical anatomical model including a main body having a fracture path (Samara Fig. 1 and [0012-0013], “A template for modeling bone plates is made and used as follows. The patient performs computed tomography of a damaged and similar intact bone of the opposite limb; in the computer program "Autoplan" process data, creating three-dimensional models of intact bone and fragments of damaged bone; using Meshlab software create a mirror model of the intact bone and combine it sequentially with models of fragments of the damaged bone, comparing them with each other and drawing a contour line of the fracture on the mirror model of the intact bone; On the basis of the obtained model, a full-size stereolithographic template is made on a 3D printer corresponding to the damaged bone, with a fracture line drawn in it in the form of a furrow. Before the operation, the plate is modeled according to the stereolithographic template and the surgical access is planned, taking into account the location of the fracture line and the plate… A template for modeling bone plates is shown in FIG. 1 and 2. In FIG. 1A, B, a stereolithographic model of the humerus with a fracture line plotted in it in the form of a furrow (shown by an arrow) is shown. In FIG. 2A, B shows the modeling process of the plate on the template.”).
Samara does not explicitly teach a fracture tool adapted to cause the main body to sever along the fracture path to establish one or more fragments.
While Samara does not disclose any tool for separating the bone segments, the claims do not elaborate on any structural elements of the “fracture tool.” Therefore, any tool capable of severing fragments from the main body can be interpreted as being a “fracture tool” under the broadest reasonable interpretation in light of the specification.
Lalonde discloses a fracture tool adapted to cause the main body to sever along the fracture path to establish one or more fragments (Lalonde Abstract, “A bone clamp permits temporary securement of adjacent bone segments of an involved bone separated by a fracture following open reduction thereof”; also see Lalonde Fig. 1, showing a clamp that can be used to grip a bone segment in order to separate it from the main body along a fracture path).
Lalonde is analogous to Samara, as both are drawn to the art of orthopaedic surgery. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Samara, to include a fracture tool adapted to cause the main body to sever along the fracture path to establish one or more fragments, as taught by Lalonde, because it would have combined prior art elements of bone clamp tools according to known methods to yield predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 27, Samara does not teach wherein: the fracture tool includes a clamp having a first clamp element and a second clamp element; the first clamp element includes a plurality of configurable engagement elements dimensioned to engage selectable contact points along the main body; and each of the engagement elements is adapted to cooperate with the second clamp element to apply a compressive force at the respective contact point to cause the main body to sever along the fracture path to establish the one or more fragments.
However, Lalonde discloses wherein: the fracture tool includes a clamp having a first clamp element and a second clamp element; the first clamp element includes a plurality of configurable engagement elements dimensioned to engage selectable contact points along the main body; and each of the engagement elements is adapted to cooperate with the second clamp element to apply a compressive force at the respective contact point to cause the main body to sever along the fracture path to establish the one or more fragments (Lalonde col. 3 lines 9-30, “there is provided a bone clamp which permits temporary securement of adjacent bone segments of an involved bone separated by a fracture following open reduction thereof. A pair of jaw members opposed to one another are mutually urgeable together, each of the pair of jaw members including gripping structure carried on a support for fixedly engaging the abutted segments of the involved bone, the fracture being oriented within an intermediate region located between said opposed ends of the support. In an embodiment directed to non-dynamic compression of the fracture, the gripping structure either frictionally engages the surface of the bone, or penetrates perpendicular to a longitudinal bone axis. An alternative embodiment is directed to a dynamic compression clamp, in which the gripping structure includes piercing structure which enters respective bone segments at an opposed angle to the fracture, and in which penetrating movement of the piercing structure thereby effects an urging together of the bone segments in a direction of the fracture line.”; also see Lalonde Fig. 1, showing a clamp that can be used to grip a bone segment in order to separate it from the main body along a fracture path).
Lalonde is analogous to Samara, as both are drawn to the art of orthopaedic surgery. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Samara, to include wherein: the fracture tool includes a clamp having a first clamp element and a second clamp element; the first clamp element includes a plurality of configurable engagement elements dimensioned to engage selectable contact points along the main body; and each of the engagement elements is adapted to cooperate with the second clamp element to apply a compressive force at the respective contact point to cause the main body to sever along the fracture path to establish the one or more fragments, as taught by Lalonde, because it would have combined prior art elements of bone clamp tools according to known methods to yield predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Samara in view of Lalonde, and in further view of Neijhoft.
Regarding claim 26, Samara in view of Lalonde does not explicitly teach wherein: the main body includes a first volume and a second volume; the first volume establishes an external surface of the main body and is representative of cortical bone; and the second volume is representative of cancellous bone.
However, Neijhoft discloses wherein: the main body includes a first volume and a second volume; the first volume establishes an external surface of the main body and is representative of cortical bone; and the second volume is representative of cancellous bone (Neijhoft page 3925, Discussion, “We used transitional fractures as an example to show the potential use of modern teaching techniques. It is even possible to try screw placement or cutting with these models, but in this case cooling of the drill/saw is essential as the plastic can melt when reaching higher temperatures on the tip of the drill. One downside is that PLA as the material used for this study, does not entirely reel like hone or artificial hone in the case of drilling, which not only is caused by the material but also the missing microstructure of cancellous and cortical bone,” Neijhoft takes into account the different structures of the bones when forming the models).
Neijhoft is analogous to Samara in view of Lalonde, as both are drawn to the art of orthopaedic surgery. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Samara in view of Lalonde, to include wherein: the main body includes a first volume and a second volume; the first volume establishes an external surface of the main body and is representative of cortical bone; and the second volume is representative of cancellous bone, as taught by Neijhoft, since it would have applied a known technique of mimicking real bone structures to a known system of modelling bones, ready for improvement, to yield predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Conclusion
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/STEPHEN ALVESTEFFER/Examiner, Art Unit 3715