DETAILED ACTION
Claims 1-10 are presented for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings received on 15 December 2022 are accepted.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
The abstract includes phrases which can be implied. Examiner suggests amending the abstract as follows:
A method for designing an implant for finger bones, the method including a finger bone image collection step of collecting 3D images of several human finger bones, a finger bone measurement step of measuring the length, cross-sectional width, and thickness of each of the finger bones from the 3D images of the finger bones, and an implant shape derivation step of calculating average values of the lengths, cross-sectional widths, and thicknesses of the finger bones and deriving and storing the shapes of implants for finger bones into a database on the basis of the calculated average values of the cross-sectional widths and thicknesses and shapes of cut surfaces.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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:
Claim 9:
a finger bone image input unit that receives 3D images … (Specification ¶30 “implemented by a common computer”)
a finger bone data measurer that measures … (Specification ¶30 “implemented by a common computer”)
an implant shape deriver that calculates average values of … (Specification ¶30 “implemented by a common computer”)
Claim 10:
a product output unit that manufactures implants … (Specification ¶31 “a common 3D (3 Dimensions) printer”)
Each unit, measurer, and deriver is specifically excluded from being interpreted as software per se. See MPEP §2181(II)(B) fourth to last paragraph.
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.
Streamlined Subject Matter Eligibility §101
Claims 1 and 9 recite a “shape deriver” calculation of lengths, widths, and thicknesses. If taken out of context, this shape derivation could be interpreted as potentially capable of being performed mentally in the form of evaluation, judgment, or opinion. However, considering the claim overall as a whole, the claim is directed towards significant measurement data collection. While mere data gathering does not integrate an otherwise abstract idea into a practical application (see MPEP §2106.05(g)), the instant claims are more than nominally or tangentially related to the invention. Accordingly, Examiner finds the instant claims are more likely than not eligible subject matter under 35 U.S.C. §101.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9, and 10
Claims 1-3, 9, and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US patent 11,229,519 B2 Radermacher, et al. [herein “Radermacher”].
Claim 1 recites “[Claim 1] A method for designing an implant for a finger bone that is implemented by a system including a medical imaging device, a finger bone image input unit, a finger bone data measurer, and an implant shape deriver.” Radermacher column 1 lines 29-30 discloses “designing and selecting patient-adapted (e.g., patient-specific and/or patient-engineered) implant designs.”
Radermacher column 3 line 37 discloses “Imaging, Computer Modeling and Software.” Radermacher column 23 disclose “Computer software programs to generate models of patient-specific renderings of implant assembly.” Computer software and computer modeling indicates implementation by a computer.
Claim 1 further recites “the method comprising: finger bone image collection step of collecting 3D images of finger bones of several people by storing 3D images of finger bones created by imaging finger bones of at least two or more people through the medical imaging device in a database through the finger bone image input unit.” Radermacher column 4 discloses:
Image data can be obtained 910 from near or within the patient's biological structure(s) of interest. For example, pixel or voxel data from one or more radiographic or tomographic images of a patient's joint can be obtained, for example, using computed or magnetic resonance tomography. A wide variety of imaging modalities known in the art can be used, including X-ray, ultrasound, laser imaging, MRI, PET, SPECT, radiography including digital radiography, digital tomosynthesis, cone beam CT, and contrast enhanced imaging.
Obtaining image data from the patient’s biological structure of interest corresponds with collecting images.
Radermacher column 26 lines 4-5 disclose “anatomical information from specific patients and/or from general population groups and/or averages.” Radermacher column 15 line 63 to column 16 line 11 disclose:
Moreover, the patient-specific measurements may be compared, analyzed or otherwise modified based on one or more "normalized" patient model or models, or by reference to a desired database of anatomical features of interest. For example, a series of patient-specific femoral measurements may be compiled and compared to one or more exemplary femoral or tibial measurements from a library or other database of "normal" ( or other reference population) femur measurements. Comparisons and analysis thereof may concern, but is not limited to, one or more or any combination of the following dimensions: femoral shape, length, width, height, of one or both condyles, intercondylar shapes and dimensions, trochlea shape and dimensions, coronal curvature, sagittal curvature, cortical/cancellous bone volume and/or quality, etc., and a series of recommendations and/or modifications may be accomplished.
A reference population is several people including two or more people. A database of normalized measurements derived from a reference population corresponds to collected imaging in a database.
Claim 1 further recites “a finger bone measurement step in which the finger bone data measurer measures the length, cross-sectional width, and thickness of each finger bone from the 3D images of the finger bones stored in the database.” Radermacher column 15 lines 24-30 of table 1 show “exemplary measurement” of “anatomical feature” of a “finger” including: 3D shape, height, length, width, depth, thickness, curvature, and slope.
Claim 1 further recites “and an implant shape derivation step in which the implant shape deriver calculates average values of the measured lengths, cross-sectional widths, and thicknesses of the finger bones, and derives and stores shapes of implants for the finger bones in the database on the basis of the calculated average values of the lengths, cross-sectional widths, and thicknesses, and the shapes of cut surfaces.” Radermacher column 16 lines 20-27 disclose:
modified data may then be utilized to select and/or design an appropriate implant and/or tool to match the modified features, and a final verification operation may be accomplished to ensure the selected and/or designed implant and/or tool is acceptable and appropriate to the original unmodified patient-specific measurements (i.e., the selected and/or designed implant and/or tool will ultimately "fit" the original patient anatomy).
Designing an implant to match the modified features corresponds with a shape derivation derives a shape of implant on the basis of the respective measurements discussed above including both the patient-specific measurements and the reference population measurement comparison(s).
Claim 2 further recites “[Claim 2] The method of claim 1, wherein the finger bone measurement step measures a length from a head point at an upper portion and a bottom point at a lower portion of a bone that are visually observed from the 3D image of a finger bone, and determines the measured length as the entire length of the finger bone, and measures a cross-sectional width in a Medio-Lateral direction of a cut surface and a thickness in an Antero-Posterior direction of the cut surface at a point of the finger bone that corresponds to an intermediate value of the entire length measured on the 3D image of the finger bone.” Radermacher column 15 lines 24-30 of table 1 show “exemplary measurement” of “anatomical feature” of a “finger” including: 3D shape, height, length, width, depth, thickness, curvature, and slope. Radermacher column 22 lines 22-25 disclose “formed or selected from a library or database of systems of various sizes, including various medio-lateral (ML), antero-posterior (AP), and supero-inferior (SI) dimensions, curvatures, and thicknesses.” Radermacher column 15 lines 32-34 disclose “Portions or all of cortical bone perimeter at an intended resection level” and “Resection surface at an intended resection level.” The resection surface corresponds with a cut surface point. The intended resection level corresponds with an intermediate value somewhere along the entire length of the finger bone.
Claim 3 further recites “[Claim 3] The method of claim 1, wherein the implant shape derivation step includes: a process of setting an outline shape in which the implant shape deriver creates a standardization model having the average values of the measured lengths, cross-sectional widths of cut surfaces, and thicknesses of finger bones, thereby setting shapes of outlines of the cut surfaces of the finger bones; and a process of setting a curvature in a sagittal direction that sets a curvature in a sagittal direction of the standardization model of the finger bones.” Radermacher column 15 lines 24-30 of table 1 show “exemplary measurement” of “anatomical feature” of a “finger” including: 3D shape, height, length, width, depth, thickness, curvature, and slope.
Radermacher column 26 lines 4-5 disclose “anatomical information from specific patients and/or from general population groups and/or averages.” A population average corresponds with average values of the respective measurements.
Radermacher column 15 line 63 to column 16 line 11 disclose:
Moreover, the patient-specific measurements may be compared, analyzed or otherwise modified based on one or more "normalized" patient model or models, or by reference to a desired database of anatomical features of interest. For example, a series of patient-specific femoral measurements may be compiled and compared to one or more exemplary femoral or tibial measurements from a library or other database of "normal" ( or other reference population) femur measurements. Comparisons and analysis thereof may concern, but is not limited to, one or more or any combination of the following dimensions: femoral shape, length, width, height, of one or both condyles, intercondylar shapes and dimensions, trochlea shape and dimensions, coronal curvature, sagittal curvature, cortical/cancellous bone volume and/or quality, etc., and a series of recommendations and/or modifications may be accomplished.
A normalized patient model from a reference population corresponds with a standardized model. A sagittal curvature of the exemplary comparison for the normalized model corresponds with a curvature in a sagittal direction that sets a curvature in a sagittal direction.
Claim 9 recites “[Claim 9] A system for designing an implant for a finger bone.” Radermacher column 1 lines 29-30 discloses “designing and selecting patient-adapted (e.g., patient-specific and/or patient-engineered) implant designs.”
Claim 9 further recites “comprising: a finger bone image input unit that receives 3D images of the finger bones of several people taken by a medical imaging device and stores the 3D images in an interlocked database.” Radermacher column 4 discloses:
Image data can be obtained 910 from near or within the patient's biological structure(s) of interest. For example, pixel or voxel data from one or more radiographic or tomographic images of a patient's joint can be obtained, for example, using computed or magnetic resonance tomography. A wide variety of imaging modalities known in the art can be used, including X-ray, ultrasound, laser imaging, MRI, PET, SPECT, radiography including digital radiography, digital tomosynthesis, cone beam CT, and contrast enhanced imaging.
Obtaining image data from the patient’s biological structure of interest corresponds with collecting images.
Radermacher column 26 lines 4-5 disclose “anatomical information from specific patients and/or from general population groups and/or averages.” Radermacher column 15 line 63 to column 16 line 11 disclose:
Moreover, the patient-specific measurements may be compared, analyzed or otherwise modified based on one or more "normalized" patient model or models, or by reference to a desired database of anatomical features of interest. For example, a series of patient-specific femoral measurements may be compiled and compared to one or more exemplary femoral or tibial measurements from a library or other database of "normal" ( or other reference population) femur measurements. Comparisons and analysis thereof may concern, but is not limited to, one or more or any combination of the following dimensions: femoral shape, length, width, height, of one or both condyles, intercondylar shapes and dimensions, trochlea shape and dimensions, coronal curvature, sagittal curvature, cortical/cancellous bone volume and/or quality, etc., and a series of recommendations and/or modifications may be accomplished.
A reference population is several people including two or more people. A database of normalized measurements derived from a reference population corresponds to collected imaging in a database.
Claim 9 further recites “a finger bone data measurer that measures a length, a width, and a thickness of each of finger bones from the input 3D images of the finger bones.” Radermacher column 15 lines 24-30 of table 1 show “exemplary measurement” of “anatomical feature” of a “finger” including: 3D shape, height, length, width, depth, thickness, curvature, and slope.
Claim 9 further recites “and an implant shape deriver that calculates average values of the measured lengths, cross-sectional widths, and thicknesses of the finger bones, and derives and stores shapes of implants for the finger bones in the database on the basis of the calculated average values of the lengths, cross-sectional widths, and thicknesses, and the shapes of cut surfaces.” Radermacher column 16 lines 20-27 disclose:
modified data may then be utilized to select and/or design an appropriate implant and/or tool to match the modified features, and a final verification operation may be accomplished to ensure the selected and/or designed implant and/or tool is acceptable and appropriate to the original unmodified patient-specific measurements (i.e., the selected and/or designed implant and/or tool will ultimately "fit" the original patient anatomy).
Designing an implant to match the modified features corresponds with a shape derivation derives a shape of implant on the basis of the respective measurements discussed above including both the patient-specific measurements and the reference population measurement comparison(s).
Claim 10 further recites “[Claim 10] The system of claim 9, further comprising a product output unit that manufactures implants in accordance with the derived shapes of implants.” Radermacher column 27 line 67 to column 28 line 1 discloses “actual manufacture of the implant.”
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.
Dependent Claims 4-6
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Radermacher as applied to claim 3 above, and further in view of US patent 8,775,133 B2 Schroeder [herein “Schroeder”].
Claim 4 further recites “[Claim 4] The method of claim 3, wherein the process of setting an outline shape calculates a closed curve spaced a predetermined distance inward along an outermost line of a distal direction of the cut surface of the standardization model.” The claim language “cut surface” is interpreted in light of figures 7A and 7B which shows cross-section.
Radermacher column 15 line 63 to column 16 line 11 disclose:
Moreover, the patient-specific measurements may be compared, analyzed or otherwise modified based on one or more "normalized" patient model or models, or by reference to a desired database of anatomical features of interest. For example, a series of patient-specific femoral measurements may be compiled and compared to one or more exemplary femoral or tibial measurements from a library or other database of "normal" ( or other reference population) femur measurements. Comparisons and analysis thereof may concern, but is not limited to, one or more or any combination of the following dimensions: femoral shape, length, width, height, of one or both condyles, intercondylar shapes and dimensions, trochlea shape and dimensions, coronal curvature, sagittal curvature, cortical/cancellous bone volume and/or quality, etc., and a series of recommendations and/or modifications may be accomplished.
A normalized patient model from a reference population corresponds with a standardized model. The shape and dimensions includes outline shape with respective closed curvatures.
Radermacher column 15 lines 32-34 disclose “Portions or all of cortical bone perimeter at an intended resection level” and “Resection surface at an intended resection level.” The resection surface corresponds with a cut surface. The bone perimeter corresponds with an outermost line of the resection.
Radermacher does not explicitly disclose a predetermined distance inward of a cut surface; however, in analogous art of personalized orthopedic implants, Schroeder column 11 lines 17-23 teaches:
the surgeon or clinician is able to uniformly offset the recommended resection profile (RRP) by a constant amount (e.g. 1 mm, ... , 5 mm, ... , 10 mm, ... , 20 mm, ... , 50 mm, etc.) through a haptics graphical user interface, or draw on the model using a haptics joystick (e.g. to create a variable offset of the RRP based on his/her discretion).
An offset from the resection profile corresponds with a predetermined distance inward along an outermost line of the cut surface.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Radermacher and Schroeder. One having ordinary skill in the art would have found motivation to use an offset from a resection profile into the system of patient-adapted implants for the advantageous purpose of “the variety of sizes of current orthopedic devices are to accommodate different ranges of anatomical features.” See Schroeder column 1 lines 61-64 and column 2 lines 30-31.
Claim 4 further recites “and sets the calculated shape of the closed curve as an outline shape of a cut surface of an implant.” Schroeder column 11 lines 17-23 teaches:
the surgeon or clinician is able to uniformly offset the recommended resection profile (RRP) by a constant amount (e.g. 1 mm, ... , 5 mm, ... , 10 mm, ... , 20 mm, ... , 50 mm, etc.) through a haptics graphical user interface, or draw on the model using a haptics joystick (e.g. to create a variable offset of the RRP based on his/her discretion).
An offsetting the resection profile corresponds with setting the outline shape of a cut surface for the implant.
Claim 5 further recites “[Claim 5] The method of claim 4, wherein the process of setting an outline shape is configured to, when the outline shape of the implant is set as described above, be able to adjust the values of the cross-sectional width and the thickness of the cut surface are made into variables such that the values of the cross-sectional width and the thickness while having a constant outline shape in order to manufacture the shape of the implant into a patient-fit type.” Radermacher column 15 lines 32-34 disclose “Portions or all of cortical bone perimeter at an intended resection level” and “Resection surface at an intended resection level.” The resection surface corresponds with a cut surface. The bone perimeter corresponds with an outermost line of the resection.
Radermacher does not explicitly disclose a predetermined distance inward of a cut surface; however, in analogous art of personalized orthopedic implants, Schroeder column 11 lines 17-23 teaches:
the surgeon or clinician is able to uniformly offset the recommended resection profile (RRP) by a constant amount (e.g. 1 mm, ... , 5 mm, ... , 10 mm, ... , 20 mm, ... , 50 mm, etc.) through a haptics graphical user interface, or draw on the model using a haptics joystick (e.g. to create a variable offset of the RRP based on his/her discretion).
Creating a variable offset of the resection profile correspond with adjusting the values of the cross-sectional width of the cut surface with variables while otherwise having a constant outline shape.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Radermacher and Schroeder. One having ordinary skill in the art would have found motivation to use an offset from a resection profile into the system of patient-adapted implants for the advantageous purpose of “the variety of sizes of current orthopedic devices are to accommodate different ranges of anatomical features.” See Schroeder column 1 lines 61-64 and column 2 lines 30-31.
Claim 6 further recites “[Claim 6] The method of claim 4, wherein the implant shape deriver, in order to apply a shape according to diameter variation from a head point to a bottom point of a finger bone, sets the diameter of the bottom point shorter inwardly by an offset distance than the diameter of the head point in the process of setting an outline shape.” Radermacher column
Radermacher column 15 lines 32-34 disclose “Portions or all of cortical bone perimeter at an intended resection level” and “Resection surface at an intended resection level.” The resection surface corresponds with a cut surface. The bone perimeter corresponds with an outermost line of the resection.
Radermacher does not explicitly disclose a predetermined distance inward of a cut surface; however, in analogous art of personalized orthopedic implants, Schroeder column 11 lines 17-23 teaches:
the surgeon or clinician is able to uniformly offset the recommended resection profile (RRP) by a constant amount (e.g. 1 mm, ... , 5 mm, ... , 10 mm, ... , 20 mm, ... , 50 mm, etc.) through a haptics graphical user interface, or draw on the model using a haptics joystick (e.g. to create a variable offset of the RRP based on his/her discretion).
An offset from the resection profile corresponds with setting a diameter inwardly by an offset distance.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Radermacher and Schroeder. One having ordinary skill in the art would have found motivation to use an offset from a resection profile into the system of patient-adapted implants for the advantageous purpose of “the variety of sizes of current orthopedic devices are to accommodate different ranges of anatomical features.” See Schroeder column 1 lines 61-64 and column 2 lines 30-31.
Allowable Subject Matter
Claims 7 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
US patent 11,229,519 B2 Radermacher, et al. [herein “Radermacher”] teaches designing patient-adapted implants of various anatomical features. Radermacher column 10 line 25 discloses a medullary cavity. Radermacher column 33 lines 23-31 teaches a “resection dimension, an implant component thickness, and an implant component surface curvature.” Radermacher column 15 line 33 table 1 continued teaches “portions or all of cortical bone perimeter at an intended resection level.” A resection level corresponds with and offset distance from an outline perimeter. Radermacher fails to teach preventing an empty space in a medullary cavity by setting a curvature of the posterior of the implant.
US patent 8,775,133 B2 Schroeder [herein “Schroeder”] column 10 lines 63-66 teaches “calculating a recommended resection profile (e.g. two data sources). In some embodiments, CAD is used to determine the geometric variance between the healthy bone and the diseased bone.” Schroeder column 12 line 38 teaches “intramedullary rods.” Schroeder fails to teach preventing an empty space in a medullary cavity by setting a curvature of the posterior of the implant.
Gibson, I. et al. “Chapter 9: The Development of an Artificial Finger Joint” Bio-Materials & Prototyping Applications in Medicine, pp. 157-190 (2008) [herein “Gibson”] teaches “stable anchoring at the bone-implant interface by press-fit mechanical interlocking and long-term fixation to bone by osseointegration.” Gibson fails to teach preventing an empty space in a medullary cavity by setting a curvature of the posterior of the implant.
None of the references taken either alone or in combination with the prior art of record disclose “in order to prevent an empty space in a medullary cavity when an implant is perpendicularly inserted, sets a curvature of a curved surface of the anterior and a curvature of a curved surface of a posterior in an axial direction of the implant in accordance with the entire length of the implant to be inserted into a medullary cavity in the process of setting a curvature in a sagittal direction” in combination with the remaining elements and features of the claimed invention.
Conclusion
Prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20100217270 A1 Polinski; Martin J. et al.
teaches
Integrated Production of Patient-Specific Implants and Instrumentation
US 20140228860 A1 Steines; Daniel et al.
Automated Design, Selection, Manufacturing and Implantation of Patient-Adapted and Improved Articular Implants, Designs
US 20200163703 A1 Sperling; John W.
Optimization of Orthopedic Component Design
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jay B Hann whose telephone number is (571)272-3330. The examiner can normally be reached M-F 10am-7pm EDT.
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/Jay Hann/Primary Examiner, Art Unit 2186 4 February 2026