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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18852651, filed on 09/30/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/30/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-5, 7, 11-17 are objected to for including part numbers (i.e. 211-n, 201, 10, 16, etc.).
Claim 1 is objected to for reciting “location specific material properties” and “location-specific material properties”, one of which should be amended for consistency with the other.
Claims 7, 8, and 10 are objected to for reciting “is/are”, which should be changed to “is” or “are” dependent on of they are referencing a singular or plural element.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “computing device” in claims 15 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. NOTE THAT the claims contain an abundance of antecedence issues, rendering the claims indefinite. Applicant is required to carefully review each element of each limitation of each claim and make significant changes.
Claims 1-8, 12-14, and 16 recite various elements ending in “(s)”, such as vector(s), bone tissue(s), implant(s), etc. It is unclear if these elements are being claimed in the singular, plural, or as in ‘one or more’. Under BRI, and in line with the apparent meaning, these elements are all being interpreted as ‘one or more’ (i.e. ‘one or more vectors’). Further note that some elements are recited both with and without the (s) throughout the claims, such as ‘interconnection(s)’ and ‘interconnection’ in claim 1. These must be amended for consistency throughout the claims.
Claims 9-11, 15, and 17 are rejected as dependent on the above claims.
Claim 1 contains the following antecedence issues: “the following method steps” (being interpreted as ‘method steps’); “the orthopaedic implant” (being interpreted as referring to ‘the orthopaedic implant(s)’); “the one or more of the first finite elements” (being interpreted as ‘one or more of the first finite elements’); and “the interconnection” (being interpreted as referring to ‘the interconnection(s)’).
Claims 2-17 are rejected as dependent on claim 1.
Claim 2 contains the following antecedence issues: “an assessment” (being interpreted as ‘the assessment’); “the interconnection” (being interpreted as referring to ‘the interconnection(s)’).
Claim 3 is rejected as dependent on claim 2.
Claim 3 contains the following antecedence issues: “the orthopaedic implant” (being interpreted as referring to ‘the orthopaedic implant(s)’); “the second finite elements (FEII) adjacent to the orthopaedic implant” (being interpreted as a new element, i.e. a subset of second finite elements, out of the second finite elements, which are adjacent to the implant); “the first finite elements (FEI) adjacent to the second finite elements” (being interpreted as a new element, i.e. a subset of first finite elements, out of the first finite elements, which are adjacent to the second finite elements); “a loading factor” (interpreted as referring to “the loading factor(s)”); “the internal stresses (S) for each finite element” (interpreted as a new element, i.e. a new set of internal stresses corresponding to the finite elements, which are distinct from “the internal stresses (S) of the 3D-Finite Element Model”); “the assessment area” (being interpreted as referring to “the assessment area(s)”).
Claim 4 contains the following antecedence issues: “the orthopaedic implant” (being interpreted as referring to ‘the orthopaedic implant(s)’).
Claims 5 and 6 are rejected as dependent on claim 4.
Claim 5 contains the following antecedence issues: “the patient-specific musculoskeletal model” (being interpreted as “the partial patient-specific musculoskeletal model”)
Claim 7 contains the following antecedence issues: “the loading factor(s)” (being interpreted as a new element).
Claim 10, limitation a., appears to be incomplete, as it merely restates a limitation of claim 1 without any further limiting. For the purposes of examination, it is being interpreted as merely restating the analogous limitation of claim 1.
Claim 10, limitation b., is grammatically incorrect rendering the meaning unclear. This is being interpreted such that the loading factor(s) are determined for the cortical bone tissue area.
Claim 11 contains the following antecedence issues: “the group of the following orthopaedic implants” (being interpreted as new elements)
Claim 13 contains the following antecedence issues: “the orthopaedic implant” (being interpreted as referring to “the orthopaedic implant(s)”); “the same” (being interpreted as “a same”)
Claim 14 contains the following antecedence issues: “location-specific information about the material properties” (being interpreted as “the location-specific material properties”).
Claim 16 contains the following bolded antecedence issues: “A system comprising: a. an imaging device (50), in particular a CT imaging device, communicatively connected to the computing device (10), the imaging device (50) being configured to capture pre- and/or post-operative image(s) of at least part of the bone tissue(s) (201, 201 1-n); and b. a computing device (10) according to claim 15.” Note that claim 16 is being interpreted as dependent on claim 15, as limitation b imports all limitations of claim 15 (and therefore claim 1 as well). Claim 16 should be rewritten accordingly to overcome these various antecedence issues. Limitation b should also be amended to precede limitation a to further clarify claim dependency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Limitation a of claim 10 restates the analogous limitation of claim 1, without providing any further limits. Since the claim recites limitation a and b in the alternative, if the claim were interpreted to only include limitation a, it would not further limit claim 1, which also recites limitation a. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter for reciting “a computer program product.” As the specification does not define the “computer program product” as having any physical structure, the BRI of the product is software. Software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). The MPEP provides a list of non-limiting examples of claims that are not directed to any of the statutory categories including products that do not have a physical or tangible form including information (often referred to as “data per se”) or a computer program per se (often referred to as “software per se”) when claimed as a product without any structural recitations. MPEP 2106.03, subsection I. Since claim 17 is a software per se claim, it is non-statutory for failing to be limited to one of the four statutory categories of invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 9, 10, and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yosibash (US20160242852A1).
Regarding claim 1, Yosibash teaches, “A computer implemented method for assessment of interconnection(s) between orthopaedic implant(s) (211-n) and bone tissue(s) (201, 2011-n) of a specific patient comprising the following method steps carried out by a computing device (10):” (Yosibash, Paragraph 13, “It is an object of the present invention to disclose a fully-automatic computer-implemented system that can accept an image of a bone, extract therefrom the bone's shape in three dimensions and the bone's density as a function of position in three dimensions, create and analyze strains/stresses on the physiologically-loaded bone, with or without implants or other surgical modifications and assess the numerical accuracy, while accepting input and displaying results on a hand-held device, and to provide a method of using the system.”)
“a. extracting location specific material properties of the bone tissue(s) (201, 2011-n) from pre- and/or post-operative images of the bone tissue(s) (201, 2011-n);” (Yosibash, Paragraph 12 and Figure 1, elements 110 and 130, “It is therefore a long felt need to provide a fully-automatic system that can accept an image of a bone, extract therefrom the bone's shape in three dimensions and the bone's density as a function of position in three dimensions, create and analyze strains/stresses on the physiologically-loaded bone, with or without implants or other surgical modifications, assuring the accuracy of the results while accepting input and displaying results on a hand-held device.” Note that an image of a bone with implant is inherently post-operative. Yosibash also describes pre-operative planning in which the bone images are pre-operative (see Paragraph 202).)
“b. generating a 3D-Finite Element Model (FE) comprising:
first finite elements (FEI) representing the orthopaedic implant (211-n) interconnected to the bone tissue(s) (201, 2011-n), and
ii. second finite elements (FEII) representing at least part of the bone tissue(s) (201, 2011-n) surrounding the orthopaedic implant (211-n);
c. applying the location-specific material properties to the second finite elements (FEII);
d. applying at least one external load (Lext) to the one or more of the first finite elements (FEI);”
(Yosibash, Paragraph 205 and Figures 1-2, “In reference to FIGS. 1 and 2, as described in more detail hereinbelow, the system executes the following steps: 1. A bone image or images is input into the system (110). 2. The image or images are analyzed to determine, in three dimensions (3D), the outer boundaries of the bone (120) and the bone density and other material properties, such as anisotropic Young's modulus (130) as a function of 3D position, within the bone. For example, the 3D bone density will show the boundary between cortical and trabecular bone. This generates a full 3D solid model (140) of the bone, including the shape of its surface and information about its interior. The full 3D solid model of the bone has a smooth (not jagged) surface. 3. From the full 3D solid model, a finite element (FE) model is generated (150) ab initio. Since the 3D model has a smooth surface, the FE model also has a smooth surface, simplifying the meshing of the FE model. 4. Either at the solid model stage or at the FE model stage, parts of the bone can be removed (160, 170), implants can be added (180, 190), or both. If the removals or additions are done at the solid model stage, the modified solid model will be meshed in its entirety. If additions are done at the FE model stage, the addition can be pre-meshed and this mesh appropriately connected to the bone FE mesh. 5. The FE model is meshed (210), using p-FEs. 6. Each FE is given material properties (220). The material properties, such as bone density, can be functions of 3D position within the bone. 7. The FE mesh is loaded (230)—physiological loads are applied to the p-FE mesh. 8. The loaded model is solved (240). 9. Results are presented to the user (250).” Note that applying the load to the FE model amounts to applying the load to both first and second finite elements (implants and bone).)
“e. determining internal stresses (S) of the 3D-Finite Element Model (FE);” (Yosibash, Figure 2 element 240 and Paragraph 48, “It is another object of the present invention to disclose the computer-implemented method, wherein said steps of analyzing said solved model comprises locating regions in said solved model in which a measure of strains/stresses or any function of these are greater than a predetermined self-determined maximum; locating regions in said solved model where fractures have occurred; locating regions in said solved model in which movement is greater than a predetermined maximum; and any combination thereof.”)
“f. outputting an assessment of the interconnection between the orthopaedic implant(s) (211-n) and the bone tissue(s) (201, 2011-n) based on the determined internal stresses (S).” (Yosibash, Figure 2 element 250 outputs the results of the FE analysis (i.e. internal stresses at a plurality of FE model regions). This amounts to an assessment of bone-implant interconnections because the stress calculations themselves are based on the bone-implant modeling. Paragraph 48 additionally describes multi-regional stress measurements, implicitly including bone-implant regions, which are subsequently output: “It is another object of the present invention to disclose the computer-implemented method, wherein said steps of analyzing said solved model comprises locating regions in said solved model in which a measure of strains/stresses or any function of these are greater than a predetermined self-determined maximum; locating regions in said solved model where fractures have occurred; locating regions in said solved model in which movement is greater than a predetermined maximum; and any combination thereof.”)
Regarding claim 9, Yosibash teaches, “The computer implemented method according to claim 1,”
“wherein the second finite elements (FEII) comprise finite elements representing a cortical bone tissue area and finite elements representing trabecular bone tissue area.” (Yosibash, Paragraph 141-142 and 205, “It is another object of the present invention to disclose the computer-implemented system, additionally adapted to identify the cortical-trabecular boundary of said bone. It is another object of the present invention to disclose the computer-implemented system, wherein voxel values of HU>475 (ρash>0.486 g/cm3) identify said bone as said cortical bone and voxel values of HU<475 identify said bone as said trabecular bone.”; “In reference to FIGS. 1 and 2, as described in more detail hereinbelow, the system executes the following steps: 1. A bone image or images is input into the system (110). 2. The image or images are analyzed to determine, in three dimensions (3D), the outer boundaries of the bone (120) and the bone density and other material properties, such as anisotropic Young's modulus (130) as a function of 3D position, within the bone. For example, the 3D bone density will show the boundary between cortical and trabecular bone. This generates a full 3D solid model (140) of the bone, including the shape of its surface and information about its interior. The full 3D solid model of the bone has a smooth (not jagged) surface. 3. From the full 3D solid model, a finite element (FE) model is generated (150) ab initio. Since the 3D model has a smooth surface, the FE model also has a smooth surface, simplifying the meshing of the FE model. 4. Either at the solid model stage or at the FE model stage, parts of the bone can be removed (160, 170), implants can be added (180, 190), or both. If the removals or additions are done at the solid model stage, the modified solid model will be meshed in its entirety. If additions are done at the FE model stage, the addition can be pre-meshed and this mesh appropriately connected to the bone FE mesh. 5. The FE model is meshed (210), using p-FEs. 6. Each FE is given material properties (220). The material properties, such as bone density, can be functions of 3D position within the bone. 7. The FE mesh is loaded (230)—physiological loads are applied to the p-FE mesh. 8. The loaded model is solved (240). 9. Results are presented to the user (250).”)
Regarding claim 10, Yosibash teaches, “The computer implemented method according to claim 1,”
“wherein a. determining internal stresses (S) of the 3D-Finite Element Model (FE); and/or b. determining a loading factor is/are limited to cortical bone tissue area.” (Option ‘a.’ of this claim is fully embodied in limitation ‘e.’ of claim 1, therefore claim 10 is disclosed by Yosibash.)
Regarding claim 14, Yosibash teaches, “The computer implemented method according to claim 1,”
“further comprising: a. controlling an imaging device to capture the pre- and/or post-operative images of the bone tissue(s) (201, 2011-n) comprising location-specific information about the material properties of the bone tissue(s) (201, 2011-n); b. receiving the images of the bone tissue(s) (201, 2011-n) from the imaging device.” (Yosibash, Paragraph 243 and Figure 3, “In reference to FIG. 3, in the method used herein, bone image (310) files preferably in the DICoM format, preferably CT images, are imported into the system from the CT scanner or from a database. Each file represents a section of the bone having a specific thickness. Each image (110) undergoes an automatic boundary detection process (320), based on apparent density. Areas where the density is greater than a user-specified value (325, white) are deemed to be bone. Typically, the user-specified value will be a Hounsfield unit (HU) value.”)
Regarding claim 15, Claim 15 recites a computing device with processing unit and memory unit used for the performance of the steps recited in Claim 1. Therefore, the rejection of claim 1 is applied here. Yosibash additionally teaches a computing device with processing unit and memory unit (Yosibash, Paragraph 143, “It is another object of the present invention to disclose a computer-implemented system for providing FEA analysis of at least a portion of at least one bone in a patient, said system comprising: a. at least one processor adapted to: i. input an image of at least a portion of at least one bone in a patient; ii. calculate material properties of said bone as a function of 3D position within said bone from density of said bone as a function of 3D position within said bone via empirically-determined inhomogeneous isotropic material properties correlated to density, said density determined from at least one property of said image of said bone; iii. generate an analyzable model, said generation comprising: 1. generation by an automatic algorithm, from said image, of a solid model of said at least a portion of said at least one bone by identifying the boundaries of said bone in said image, said boundary identification via edge detection software; smoothing said boundaries; creating a point cloud model of said boundaries; generating spline curves through points in said point cloud; and generating a solid model through said spline curves; 2. automatic generation, from said solid model, of a FE mesh of said at least a portion of said at least one bone, said FEs being p FEs (p-FE); 3. for each said FE in said p-FE mesh, setting of said material properties of said FE according to said material properties of said bone at said 3D position; and 4. application of at least one member of a group consisting of loads and constraints to at least one said FE in said FE mesh; iv. solve said analyzable model, thereby generating a solved model; and b. a means of providing to a user at least one result from said solved model wherein said bone image enables said solved model to be patient-specific; further wherein said point cloud and spline curves enable the surface of said solid model to be smooth, and further wherein said use of said p-FEs enables said FEs to have heterogeneous material properties and reduce the number of FEs in said FE mesh.” One skilled in the art would understand that a memory unit is necessarily embodied in the above computer-implemented system in order for the processor to perform the described steps.)
Regarding claim 16, Yosibash teaches “A system comprising: a. an imaging device (50), in particular a CT imaging device, communicatively connected to the computing device (10), the imaging device (50) being configured to capture pre- and/or post-operative image(s) of at least part of the bone tissue(s) (201, 2011-n)” (Yobisash, Figure 3 and Paragraph 243, “In reference to FIG. 3, in the method used herein, bone image (310) files preferably in the DICoM format, preferably CT images, are imported into the system from the CT scanner or from a database. Each file represents a section of the bone having a specific thickness. Each image (110) undergoes an automatic boundary detection process (320), based on apparent density. Areas where the density is greater than a user-specified value (325, white) are deemed to be bone. Typically, the user-specified value will be a Hounsfield unit (HU) value.”)
“and b. a computing device (10) according to claim 15.” (The rejection of claim 15 is applied here.)
Regarding claim 17, Claim 17 recites a computer program product carrying out the method of claim 1 via a processing unit and computing device. Therefore, the rejection of claim 1 is applied here. Yosibash additionally teaches a computer program product implemented by a processing unit and computing device, (Yosibash, Paragraph 143, “It is another object of the present invention to disclose a computer-implemented system for providing FEA analysis of at least a portion of at least one bone in a patient, said system comprising: a. at least one processor adapted to: i. input an image of at least a portion of at least one bone in a patient; ii. calculate material properties of said bone as a function of 3D position within said bone from density of said bone as a function of 3D position within said bone via empirically-determined inhomogeneous isotropic material properties correlated to density, said density determined from at least one property of said image of said bone; iii. generate an analyzable model, said generation comprising: 1. generation by an automatic algorithm, from said image, of a solid model of said at least a portion of said at least one bone by identifying the boundaries of said bone in said image, said boundary identification via edge detection software; smoothing said boundaries; creating a point cloud model of said boundaries; generating spline curves through points in said point cloud; and generating a solid model through said spline curves; 2. automatic generation, from said solid model, of a FE mesh of said at least a portion of said at least one bone, said FEs being p FEs (p-FE); 3. for each said FE in said p-FE mesh, setting of said material properties of said FE according to said material properties of said bone at said 3D position; and 4. application of at least one member of a group consisting of loads and constraints to at least one said FE in said FE mesh; iv. solve said analyzable model, thereby generating a solved model; and b. a means of providing to a user at least one result from said solved model wherein said bone image enables said solved model to be patient-specific; further wherein said point cloud and spline curves enable the surface of said solid model to be smooth, and further wherein said use of said p-FEs enables said FEs to have heterogeneous material properties and reduce the number of FEs in said FE mesh.” One skilled in the art would understand that a computer program product is necessarily embodied in the above computer-implemented system in order to carry instructions for the processor perform the described steps.)
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yosibash in view of Yemineni (Evaluation of Maximum Principal Stress, Von Mises Stress, and Deformation on Surrounding Mandibular Bone During Insertion of an Implant: A Three-Dimensional Finite Element Study).
Regarding claim 2, Yosibash teaches, “The computer implemented method according to claim 1,”
While Yosibash teaches determining internal stresses of the 3D-Finite Element Model (FE) (see claim 1 rejection), and outputting the assessment as a score based on comparing the stresses to a threshold (Yosibash, Paragraph 48, “It is another object of the present invention to disclose the computer-implemented method, wherein said steps of analyzing said solved model comprises locating regions in said solved model in which a measure of strains/stresses or any function of these are greater than a predetermined self-determined maximum; locating regions in said solved model where fractures have occurred; locating regions in said solved model in which movement is greater than a predetermined maximum; and any combination thereof.” Note that the determination and output of regions in which stress exceeds the threshold (maximum) amounts to a semantic scoring (i.e. “above threshold”)), Yosibash does not expressly disclose determining a loading factor based on the determined internal stresses, and using the loading factor for the subsequent threshold-based score determination/outputting.
Yemineni teaches calculating loading factors based on internal stress and 3D FE modeling, then comparing the loading factors to a threshold for assessing bone-implant interconnection, (Yemineni, Figure 3 shows von Mises stresses at bone-implant interfaces; Figure 4 compares maximum von Mises stress at different regions; Discussion: “Distribution of stress and deformation on the bone during implant placement plays a pivotal role in the longevity of the implant. Excessive stress or deformation beyond the threshold might result in implant-related complications during and post-surgery. Hence, it is essential to consider these parameters during implant placement. The gold standard for evaluating stress distributed on the bone is the maximum principal stress, as well as the von Mises stress. Maximum principal stresses are the components of stresses when the basis of other stress tensors are zero and define the stress concentrated in a specific region. Von Mises stress, on the other hand, is a scalar quantity obtained from the stresses acting on any structure. It helps us to evaluate the yielding (or failure) of a ductile material. The idea of evaluating both stresses hold a critical point that von Mises stress is a measure of overall stress distributed on the mandible in all the axial planes. In contrast, maximum principal stress, as the definition says, is confined to stress exerted at a particular area during uniaxial loading. Maximum principal stress and von Mises stress are measured in units of megapascal (MPa).”)
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to replace the stress-based thresholding of Yosibash with the loading factor (von Mises) calculation and thresholding of Yemineni, for the subsequent determination of the assessment score.
The motivation for doing so, as described above by Yemineni, would have been to better “evaluate the yielding (or failure) of a ductile material” (i.e. anticipate implant failure) for better surgical outcomes. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching of Yemineni to fully disclose, “further comprising determining loading factor(s) based on the determined internal stresses (S) of the 3D-Finite Element Model (FE), wherein outputting an assessment of the interconnection between the orthopaedic implant(s) (211-n) and the bone tissue(s) (201, 2011-n) comprises outputting an assessment score based on a comparison of the loading factor(s) with loading factor threshold(s).”
Regarding claim 3, Yosibash in view of Yemineni teaches, “The computer implemented method according to claim 2,”
“further comprising determining assessment area(s) (FEeval 1-n) of the 3D-Finite Element Model (FE) as a geometrical envelope of the orthopaedic implant (211-n), comprising at least the second finite elements (FEII) adjacent to the orthopaedic implant (211-n) and the first finite elements (FEI) adjacent to the second finite elements (FEII), wherein: a. determining the internal stresses (S) of the 3D-Finite Element Model (FE) comprises determining the internal stresses (S) for each finite element within the assessment area(s) (FEeval 1-n); and/ or b. determining a loading factor comprises determining location-specific loading factor(s) for each finite element within the assessment area (FEeval 1-n).”(The assessment area is mapped to the entire FE model of Yosibash in view of Yemineni, as the entire model embodies a geometrical region with adjacent finite elements representing both the bone and implants. Additionally, as shown in Figure 3 of Yemineni (incorporated with rationale and motivation in the rejection of claim 2), von Mises stresses (location-specific loading factors) are calculated for each finite element of the assessment area (FE model). The underlined limitation (option b) represents to elected alternative being rejected. However, the references inherently also disclose option a, because calculating von Mises stresses at each finite element requires calculating the internal stresses at each finite element.)
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yosibash in view of Phillips (Femoral bone mesoscale structural architecture prediction using musculoskeletal and finite element modelling).
Regarding claim 4, Yosibash teaches, “The computer implemented method according to claim 1,”
While Yosibach teaches applying the external load to the 3D FE model, Yosibash does not expressly disclose, “further comprising determining one or more critical loading vector(s) corresponding to the bone tissue(s) (201, 2011-n)- and/or corresponding to the orthopaedic implant (211-n), wherein the external load (Lext) is applied onto the 3D-Finite Element Model (FE) according to the critical loading vector(s).”
Phillips discloses determining a critical loading vector corresponding to bone tissues, and applying an external load to a 3D bone model according to the critical loading vector (Phillips, Section 2.1 Paragraph 4, “The body segments of the musculoskeletal model were scaled to the anatomical dimensions of the volunteer by calculating ratios from lengths between sets of virtual and experimental markers; the inertial properties of the body segments were updated according to the regression equations of Dumas et al. (2007). Joint angles describing the motion for each of the investigated daily living activities were calculated from the experimental markers using an inverse kinematics approach (Lu & O’Connor 1999). Muscle forces were estimated by minimising the sum of muscle activations squared for each frame of the kinematics under the constraints of joint moment equilibrium and physiological limits for the muscle forces (Modenese et al. 2011; Modenese & Phillips 2012). Finally, JCFs were calculated at the hip, knee and patellofemoral joint. All musculoskeletal simulations were performed in OpenSim (Version 3.0.1) (Delp et al. 2007).” Note that the JCF (joint contact force) is a vectoral quantity, and is mapped to the critical loading vector corresponding to bone tissues. Figure 6 further shows that the JCF is applied as a load on a 3D model, see caption: “Selected 5 mm slices for the converged mesoscale structural model subjected to a single load case taken at maximum hip JCF during walking. Shell elements representing cortical bone are shown in grey, truss elements representing trabecular bone with a radius mm are shown in red and truss elements with a radius mm are shown in the background in blue. Truss elements with a radius m are omitted for clarity.”)
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to determine the critical loading vector (JCF) of Phillips corresponding to bone tissues of Yosibash, and apply the external load to the 3D FE model of Yosibash according to the determined critical loading vector.
The motivation for doing so would have been to implement physiologically relevant loads. Yosibash describes implementing “expected physiological loading” for stress analysis (Paragraph 202), but does not disclose any method for actually obtaining these relevant load values. Phillips closes this gap. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching of Phillips to fully disclose, “further comprising determining one or more critical loading vector(s) corresponding to the bone tissue(s) (201, 2011-n)- and/or corresponding to the orthopaedic implant (211-n), wherein the external load (Lext) is applied onto the 3D-Finite Element Model (FE) according to the critical loading vector(s).”
Regarding claim 5, Yosibash in view of Phillips teaches, “The computer implemented method according to claim 4,”
“further comprising: a. creating at least a partial patient-specific musculoskeletal model (MMusc) comprising the bone tissue(s) (201, 2011-n); and b. determining the critical loading vector(s) using the patient-specific musculoskeletal model (MMusc).” (Phillips, Section 2.1 Paragraph 4, “The body segments of the musculoskeletal model were scaled to the anatomical dimensions of the volunteer by calculating ratios from lengths between sets of virtual and experimental markers; the inertial properties of the body segments were updated according to the regression equations of Dumas et al. (2007). Joint angles describing the motion for each of the investigated daily living activities were calculated from the experimental markers using an inverse kinematics approach (Lu & O’Connor 1999). Muscle forces were estimated by minimising the sum of muscle activations squared for each frame of the kinematics under the constraints of joint moment equilibrium and physiological limits for the muscle forces (Modenese et al. 2011; Modenese & Phillips 2012). Finally, JCFs were calculated at the hip, knee and patellofemoral joint. All musculoskeletal simulations were performed in OpenSim (Version 3.0.1) (Delp et al. 2007).” Note that this passage was incorporated with rationale and motivation in the rejection of claim 4.)
Regarding claim 6, Yosibash in view of Phillips teaches, “The computer implemented method according to claim 4,”
“wherein the critical loading vector(s) comprise a caudo-cranial direction (C-C) and/or a torsional direction.” (The JCF, taught by Phillips and incorporated in the rejection of claim 4, is mapped to the critical loading vector. This is a three-dimensional vector and therefore inherently has at least one directional component that is at least partially in a caudo-cranial direction.)
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yosibash in view of McGinty (“Von Mises Stress”).
Regarding claim 7, Yosibash teaches, “The computer implemented method according to claim 1,”
Yosibash does not expressly disclose, “wherein the loading factor(s) is/are calculated as a function of a location-specific stress on the bone tissue(s) (201, 2011-n) and a location-specific failure resistance of the bone tissue(s) (201, 2011-n).”
McGinty teaches calculation of loading factors (von Mises Yield Criterion) as a function of location-specific stress (von Mises stress) and location-specific failure resistance (yield), (McGinty, Introduction, “The von Mises stress is often used in determining whether an isotropic and ductile metal will yield when subjected to a complex loading condition. This is accomplished by calculating the von Mises stress and comparing it to the material's yield stress, which constitutes the von Mises Yield Criterion. The objective is to develop a yield criterion for ductile metals that works for any complex 3-D loading condition, regardless of the mix of normal and shear stresses. The von Mises stress does this by boiling the complex stress state down into a single scalar number that is compared to a metal's yield strength, also a single scalar numerical value determined from a uniaxial tension test (because that's the easiest) on the material in a lab. It should be noted that this is not an exact science like, say \(F = m\,a\). It is an empirical process, with inherent error and deviations. In fact, there is no hard & fast rule saying that metals must yield according to von Mises yield criteria. It is as much a coincidence as anything. Nevertheless, it does work very well and remains the method of choice a full century after it was first proposed.” Note that evaluation of stress and yield in a 3D model is inherently “location-specific”.)
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to calculate loading factors as a function of location-specific stress and location-specific failure resistance, as taught by McGinty, with respect to the bone tissues of Yosibash.
The motivation for doing so would have been to understand yielding conditions for the bone under loading, in order to improve pre-surgical planning for better surgical outcomes. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching of McGinty to fully disclose, “wherein the loading factor(s) is/are calculated as a function of a location-specific stress on the bone tissue(s) (201, 2011-n) and a location-specific failure resistance of the bone tissue(s) (201, 2011-n).”
Regarding claim 8, Yosibash in view of McGinty teaches, “The computer implemented method according to claim 7,”
“wherein the loading factor(s) is/are calculated as a function of a Von Mises stress and a location-specific yield criterion.” (McGinty, Introduction, “The von Mises stress is often used in determining whether an isotropic and ductile metal will yield when subjected to a complex loading condition. This is accomplished by calculating the von Mises stress and comparing it to the material's yield stress, which constitutes the von Mises Yield Criterion. The objective is to develop a yield criterion for ductile metals that works for any complex 3-D loading condition, regardless of the mix of normal and shear stresses. The von Mises stress does this by boiling the complex stress state down into a single scalar number that is compared to a metal's yield strength, also a single scalar numerical value determined from a uniaxial tension test (because that's the easiest) on the material in a lab. It should be noted that this is not an exact science like, say \(F = m\,a\). It is an empirical process, with inherent error and deviations. In fact, there is no hard & fast rule saying that metals must yield according to von Mises yield criteria. It is as much a coincidence as anything. Nevertheless, it does work very well and remains the method of choice a full century after it was first proposed.” Note that evaluation of yield in a 3D model is inherently “location-specific”. Further, note that the above passage was incorporated with motivation and rationale in the rejection of claim 7.)
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yosibash in view of OFFICIAL NOTICE.
Regarding claim 11, Yosibash teaches, “The computer implemented method according to claim 1,”
Yosibash does not expressly disclose “wherein the first finite elements (FEI) represent at least one out of the group of the following orthopaedic implants (211-n): a fixation element, a load transfer element, a reinforcing screw, a pedicle screw, a reinforcing rod or a combination thereof.”
The Examiner takes OFFICIAL NOTICE that the above claimed alternatives for the implants are well-known implements in orthopaedic surgery applications. One skilled in the art would understand that these implants exist and have utility. For example, see Kim (Orthopedic implants and devices for bone fractures and defects: Past, present and perspective).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to use a fixation element, a load transfer element, a reinforcing screw, a pedicle screw, a reinforcing rod or a combination thereof, as taught by OFFICIAL NOTICE, as the first finite elements of Yosibash.
The motivation for doing so would have been to improve pre-operative planning in cases where these types of implants are being used, thereby improving surgical outcomes. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching from OFFICIAL NOTICE to fully disclose, “wherein the first finite elements (FEI) represent at least one out of the group of the following orthopaedic implants (211-n): a fixation element, a load transfer element, a reinforcing screw, a pedicle screw, a reinforcing rod or a combination thereof.”
Regarding claim 12, Yosibash teaches, “The computer implemented method according to claim 1,”
Yosibash does not expressly disclose “wherein the second finite elements (FEI) represent one or more vertebrae (2001-n) or pedicle(s) of vertebrae and wherein the first finite elements (FEI) represent pedicle screw(s) (201-n) arranged within the vertebrae (2001-n).”
The Examiner takes OFFICIAL NOTICE that pedicle screw implants in vertebrae is a well-known surgical scenario. For example, see Shea (Designs and Techniques That Improve the Pullout Strength of Pedicle Screws in Osteoporotic Vertebrae: Current Status).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to use a vertebrae and pedicle screws, taught by OFFICIAL NOTICE, as the second and first finite elements, respectively, of Yosibash.
The motivation for doing so would have been to enable pre-operative planning in this common surgical scenario, thereby improving surgical outcomes. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching from OFFICIAL NOTICE to fully disclose, “wherein the second finite elements (FEI) represent one or more vertebrae (2001-n) or pedicle(s) of vertebrae and wherein the first finite elements (FEI) represent pedicle screw(s) (201-n) arranged within the vertebrae (2001-n).”
Regarding claim 13, Yosibash teaches, “The computer implemented method according to claim 1,”
Yosibash does not expressly disclose “wherein the first finite elements (FEI) represent a combination of the orthopaedic implant (211-n), a reinforcing rod and a least one further orthopaedic implant (211-n) arranged in the same or a different bone tissue(s) (201, 2011-n).”
The Examiner takes OFFICIAL NOTICE that the use of implants and reinforcing rods in combination is well-known and routine in orthopaedic surgical applications. For example, see Kim (Orthopedic implants and devices for bone fractures and defects: Past, present and perspective).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to use a combination of implants and a reinforcing rod, taught by OFFICIAL NOTICE, as the first finite elements of Yosibash.
The motivation for doing so would have been to improve pre-operative planning in cases where these types of implants are being used, thereby improving surgical outcomes. Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Yosibash with the above teaching from OFFICIAL NOTICE to fully disclose, “wherein the first finite elements (FEI) represent a combination of the orthopaedic implant (211-n), a reinforcing rod and a least one further orthopaedic implant (211-n) arranged in the same or a different bone tissue(s) (201, 2011-n).”
Conclusion
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/AARON JOSEPH SORRIN/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
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