DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12, 14-20 have been presented for examination based on the amendment filed on 5/18/2026.
Claim(s) 1-12 are newly rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB No. 20210298909 A1 by Drew; Alex et al., in view of US 20220211444 A1 by Dassonville; Benjamin et al.
Claim(s) 14-20 is/are newly rejected under 35 U.S.C. 103 as being unpatentable over US 20140025181 A1 by Vanasse; Tom et al., in view of US PGPUB No. 20210298909 A1 by Drew; Alex et al. , further in view of in view of US 20220211444 A1 by Dassonville; Benjamin et al.
This action is made Final.
Response to Arguments
Applicant’s argument against Drew are considered. Drew does not explicitly teach bone model and implant model distance from the closest point, the trimming volume is the distance between the bone model and the implant model. The outer surface is the point of contact between the implant and bone. Hence examiner does not agree the applicant assertion made on Pg.8. Even if the trimming volume is not considered as the predefined distance from bone model of the patient, Dassonville (new prior art applied) teaches the uniform preset distance being measured between each region of the first and second selection sections and a closest point on the patient-specific bone model (Dassonville: Fig.31, [0222], [0223] "... [0223] MR system 212 may output a representation of the estimated distance (3010). As one example, MR system 212 may output an alert if the estimated distance (e.g., if any of the distances between the points on the virtual model of the implant or implant tool and the virtual model of the bone) is less than a threshold distance. As another example, MR system 212 may continuously output the estimated distance (or distances) between the implant and wall of the bone. The distances between the implant and the wall of the bone may be a remaining distance indicating how much space is present until the implant makes contact with the wall of the bone...."; [0231][0233]-[0240], [0312]. The uniform preset distance can be measured based on the threshold distance).
Arguments for claim 14 are addressed likewise.
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Claim Rejections - 35 USC § 103
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 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 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(s) 1-12 are newly rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB No. 20210298909 A1 by Drew; Alex et al., in view of US 20220211444 A1 by Dassonville; Benjamin et al.
Regarding Claim 1
Drew teaches 1. A method of preparing a computer-generated component file for fabricating an orthopedic implant (Drew : Fig.1 & 2A, 3B, [0040]-[0041] teaching orthopedic implant as joint implant) comprising steps of:
setting, via a computer processor (Drew: Fig.10 & [0056]) , first and second select sections of an initial implant model of a computer-aided design model to first and second model porous sections (Drew : Fig.1 & Fig.2B showing porous sections under 112a-112c; [0040]-[0042]; Figs.3-9 showing the CAD process of creating the plurality of porous sections 302/504/502) and leaving a remaining section of the initial implant model (Drew: Fig.4 shows one porous section and other section specifically a bone-facing side 110 of a patellar implant 102 not converted to porous section. Also of note the tops of the post 112a-112c are also left alone from meshing/making porous) , wherein all regions defining the first and the second select sections are spaced not more than a uniform preset distance from a patient- specific bone model of the computer-aided design model (Drew: Fig.4-7 and more specifically Fig.5 show "... a trimming volume may be defined that is partly or wholly on the interior of initial volume 402...". here the trimmed volume is inside where the porous section would contact the patient specific bone model. Any struts 502/lattices 500 that are outside are bent inwards/trimmed so as to remain inside the trimming volume, which is inside the initial volume 402. The initial volume 402 would be point of contact with the bone, which is shown in Fig.2A model and Fig.2B actual realization. Also look at post 112a-112c tops in Fig.2A-2B w.r.t to Fig.3 which are part of initial volume 402 in direct contact with the bone (model)) ,
merging, via the computer processor, the first and the second model porous sections with the remaining section of the initial implant model to form at least a portion of a final implant model of the computer-aided design model (Drew: [0052] "... FIG. 8 further illustrates bone-facing side 110 of patellar implant 102 as translucent for ease of visualization of the attraction step. FIG. 9 illustrates a CAD model of trimmed lattice 702 having the one or more attracted nodes and associated struts 902 merged with the solid substrate of patellar implant 102....", Fig.8 & 9 illustrates a CAD model of the trimmed lattice of FIG. 7 having one or more struts and/or nodes proximate to the implant substrate (the initial implant model), attracted to the implant substrate; ) ;
and storing, via the computer processor, the final implant model in a component file (Drew: Fig.10 & [0056]-[0058]) configured to be accessed by a computer-aided manufacturing machine for use in fabricating the orthopedic implant, at least a portion of the orthopedic implant corresponding to the final implant model (Drew: Fig.11 & [0059]-[0063]) .
Drew does not specifically teach the uniform preset distance being measured between each region of the first and second selection sections and a closest point on the patient-specific bone model.
Dassonville teaches the uniform preset distance being measured between each region of the first and second selection sections and a closest point on the patient-specific bone model (Dassonville: Fig.31, [0222], [0223] "... [0223] MR system 212 may output a representation of the estimated distance (3010). As one example, MR system 212 may output an alert if the estimated distance (e.g., if any of the distances between the points on the virtual model of the implant or implant tool and the virtual model of the bone) is less than a threshold distance. As another example, MR system 212 may continuously output the estimated distance (or distances) between the implant and wall of the bone. The distances between the implant and the wall of the bone may be a remaining distance indicating how much space is present until the implant makes contact with the wall of the bone...."; [0231][0233]-[0240], [0312]. The uniform preset distance can be measured based on the threshold distance).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Dassonville to Drew to complement the implant model with bone model so that use of virtual 3-dimensional models may eliminate the need for expending hospital resources on such cameras and mounting systems. (Dassonville: [0311]) and provide both the implant and bone models in same view (Dassonville: Figs. 32A-32E [0222]). Further motivation to combine would have been that Dassonville and Drew are analogous art to the instant claim in the field of CAD based implant design (Dassonville: [0222]; Drew: Figs.3-9 & flow Fig.12).
Regarding Claim 2
Drew teaches the method of claim 1, further comprising a step of removing, before the setting step and via the computer processor, the first and second select sections from the initial implant model, wherein the remaining section of the initial implant model remains following the removing step (Drew: [0044]-[0049] & Fig.3-4 show removing the first/second sections for each of the 112a-112c post while the post tops and bone-facing side 110 of a patellar implant 102 remains as is) .
Regarding Claim 3
Drew teaches the method of claim 1, wherein the first and the second model porous sections have a first model porous thickness, further comprising a step of: setting, via the computer processor, a third select section of the initial implant model to a third model porous section, wherein all regions defining the third select section are spaced not more than the preset distance from the patient-specific bone model as measured uniformly (Drew: Fig.4-7 and more specifically Fig.5 show "... a trimming volume may be defined that is partly or wholly on the interior of initial volume 402...". here the trimmed volume is inside where the porous section would contact the patient specific bone model. Any struts 502/lattices 500 that are outside are bent inwards/trimmed so as to remain inside the trimming volume, which is inside the initial volume 402. The initial volume 402 would be point of contact with the bone, which is shown in Fig.2A model and Fig.2B actual realization. Also look at post 112a-112c tops in Fig.2A-2B w.r.t to Fig.3 which are part of initial volume 402 in direct contact with the bone (model) – In re Harza, Drew showing first section specific to 112c, while second and third sections under 112a and 112b would be similarly made porous and at a specific distance determined by the trimming volume inside the initial volume) , wherein first and second model implant thicknesses of the initial implant model taken along respective first and second lines through the first and the second select sections include at least a preset minimum model continuous solid thickness and a third model implant thickness of the initial implant model taken along a third line through the third select section includes less than the preset minimum model continuous solid thickness (Drew: Looking at Fig.4 the lines through the model form the stems of 112a-112c with a certain thickness) , the third model porous section having a second model porous thickness equal to a difference between the third model implant thickness and the preset minimum model continuous solid thickness when the third model implant thickness is greater than the preset minimum model continuous solid thickness or is otherwise zero, wherein the merging step comprises merging, via the computer processor, the third model porous section with the remaining section of the initial implant model to form at least the portion of the final implant model (
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Drew: Fig.4 & Fig.7-8 showing merging of the porous section, implant stem with preset thickness) .
Regarding Claim 4
Drew teaches method of claim 3, further comprising a step of removing, before the third select section setting step and via the computer processor, the third select section from the initial implant model (Drew: Fig.4-8 showing one section for 112a and the third section would be e,g. under 112b with similar process to remove the solid initial volume and replacing with porous section) .
Regarding Claim 5
Drew teaches the method of claim 2, further comprising a step of receiving, via the computer processor, an input instruction, wherein each of the removing, setting, and merging steps occur automatically in response to the input instruction (Drew: Fig.10-11 showing the instructions run by respective processors and Fig.12 showing the process [0064]-[0074]) .
Regarding Claim 6
Drew teaches the method of claim 1, wherein the first and the second select sections include first and second digital surfaces contacting the patient-specific bone model (Drew teaches the: [0040]-[0041], Fig.2A, 1 and 3-9 & shown in model form and Fig.2B actually showing the contact the bone) .
Regarding Claim 7
Drew teaches the method of claim 1, further comprising a step of removing from the select sections, before the setting step and via the computer processor, any regions of the initial implant model that are not within a porous thickness distance of any point on any surface of the initial implant model that is within an interface proximity of a bone model (Drew: Process disclosed in Fig.13 [0064]-[0074] explained in Figs.3-9 of the removal process of structs and nodes which outside of the trimming volume [0050]-[0052]) .
Regarding Claim 8
Drew teaches the method of claim 1, further comprising a step of extending, via the computer processor, the model porous sections beyond the initial implant model (Drew: [0051]"... For example, a group of free strut ends may be extended further outward from the trimming volume boundary than the remaining free strut ends...." ) .
Regarding Claim 9
Drew teaches the method of claim 1, further comprising a step of setting, via the computer processor, a boundary region of the initial implant model, the boundary region being contiguous with one or more of the model porous sections as a region of gradient porosity (Drew: Fig.3 element 402 & 112c show the initial boundary region of the initial implant 110, these boundaries, e.g. 112c remain contiguous with the porous region (Fig.9 element 702 trimmed lattice/porous volume) after the process) .
Regarding Claim 10
Drew teaches the method of claim 1, further comprising a step of extending, via the computer processor, a model added thickness layer having a predetermined model thickness to a side of the initial implant model facing away from the bone model (Drew: [0040] "...While not illustrated in FIG. 1, patellar implant 102 also comprises a joint-facing, or articulating, side opposite bone-facing side 110 that is substantially contoured appropriately for abutting the knee joint of a patient...."; [0052] showing in view of Fig.8 struts facing away and opposite from the bone side with thickness assigned in [0053]
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Regarding Claim 11
Drew teaches the method of claim 10, further comprising steps of: fabricating a component according to the final implant model; and removing at least some material from the component corresponding to the model added thickness layer to define at least a portion of the orthopedic implant (Drew: Fig.11-12 [0059]-[0074], removing the material is shown in process of Fig.12 & Figs.3-9) .
Regarding Claim 12
Drew teaches the method of claim 1, wherein the first and the second select section setting step includes sending instructions, via the computer processor, to a computer-aided design model to associate a porosity with the first and the second model porous sections of the initial implant model (Drew: the porosity is defined by the pattern of the seeding methodology/number of node & struts and finally the thickness of the struts 302 (See Fig. 2A) – see [0045]-[0049] and [0053] ) .
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Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140025181 A1 by Vanasse; Tom et al., in view of US PGPUB No. 20210298909 A1 by Drew; Alex et al. , further in view of in view of US 20220211444 A1 by Dassonville; Benjamin et al.
Regarding Claim 14
Vanasse teaches A method of preparing a computer-generated component file for fabricating an orthopedic implant (Vanasse: Abstract; Fig.1 [0023]-[0029]) (Drew: generation of CAD files Fig.10 [0056]-[0058] use of file in fabrication Fig.11, process of generation of file for fabrication Fig.12) comprising steps of:
forming, via a computer processor, a bone model of a first bone portion or a first plurality of bone portions (Vanasse: Fig.1 [0023]-[0026]) ;
forming, via the computer processor, a first implant model with only porous regions and solid regions (Vanasse: [0028]) ,
storing, via the computer processor, the first implant model in a component file configured to be accessed by a computer-aided manufacturing machine for use in fabricating the orthopedic implant, at least a portion of the orthopedic implant corresponding to the first implant model (Vanasse: Fig.1; [0004][0028]) .
Vanasse does not specifically teach all of the porous regions being formed only at locations of the first implant model within a preset distance from the bone model & the preset distance being measured between each of the locations and a closest point on the bone model.
Drew teaches all of the porous regions being formed only at locations of the first implant model within a preset distance from the bone model (Drew: Fig.4-7 and more specifically Fig.5 show "... a trimming volume may be defined that is partly or wholly on the interior of initial volume 402...". here the trimmed volume is inside where the porous section would contact the patient specific bone model. Any struts 502/lattices 500 that are outside are bent inwards/trimmed so as to remain inside the trimming volume, which is inside the initial volume 402. The initial volume 402 would be point of contact with the bone, which is shown in Fig.2A model and Fig.2B actual realization. Also look at post 112a-112c tops in Fig.2A-2B w.r.t to Fig.3 which are part of initial volume 402 in direct contact with the bone (model)).
Drew does not specifically teach the uniform preset distance being measured between each region of the first and second selection sections and a closest point on the patient-specific bone model (Emphasis on bolded).
Dassonville teaches the uniform preset distance being measured between each region of the first and second selection sections and a closest point on the patient-specific bone model (Dassonville: Fig.31, [0222], [0223] "... [0223] MR system 212 may output a representation of the estimated distance (3010). As one example, MR system 212 may output an alert if the estimated distance (e.g., if any of the distances between the points on the virtual model of the implant or implant tool and the virtual model of the bone) is less than a threshold distance. As another example, MR system 212 may continuously output the estimated distance (or distances) between the implant and wall of the bone. The distances between the implant and the wall of the bone may be a remaining distance indicating how much space is present until the implant makes contact with the wall of the bone...."; [0231][0233]-[0240], [0312).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Drew to Vanasse to complement how the mesh as taught in Vanasse is actually placed in the implant (Vanasse: [0027][0028] Fig.1; Drew: Figs.3-9 & flow Fig.12) . Further motivation to combine would have been that Vanasse and Drew are analogous art to the instant claim in the field of CAD based implant design with specific porous/mesh region design (Vanasse: [0027]-[0028]; Drew: Figs.3-9 & flow Fig.12) where drew herein improve upon existing additive manufacturing techniques for generating porous structures (Drew: [0004]).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Dassonville to Drew to complement the implant model with bone model so that use of virtual 3-dimensional models may eliminate the need for expending hospital resources on such cameras and mounting systems. (Dassonville: [0311]) and provide both the implant and bone models in same view (Dassonville: Figs. 32A-32E [0222]). Further motivation to combine would have been that Dassonville and Drew are analogous art to the instant claim in the field of CAD based implant design (Dassonville: [0222]; Drew: Figs.3-9 & flow Fig.12).
Regarding Claim 15
Drew teaches the method of claim 14, further comprising a step of extending a model added thickness layer of a predetermined thickness to a side of the initial implant model facing away from the bone model (Drew: [0040] "...While not illustrated in FIG. 1, patellar implant 102 also comprises a joint-facing, or articulating, side opposite bone-facing side 110 that is substantially contoured appropriately for abutting the knee joint of a patient...."; [0052] showing in view of Fig.8 struts facing away and opposite from the bone side with thickness assigned in [0053]
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Regarding Claim 16
Drew & Vanasse teach the method of claim 15, further comprising steps of fabricating a component according to the first implant model (Drew : Fig.12 flow) and machining away a first portion of the component corresponding to at least part of the model added thickness layer to expose a second portion of the component corresponding to at least one of the solid regions (Drew: [0059] machining as various sintering techniques; Vanasse: [0030] "... [0030] While not required herein, it should be understood and appreciated that traditional manufacturing techniques (e.g., casting, molding, forming, machining, joining/welding, polishing, blasting, etc.) can also be used in conjunction with the additive manufacturing processes of the present invention if desired....") , the one or more of the solid regions corresponding to the second portion of the component being on the side of the initial implant model facing away from the bone model (Drew: [0040] "... While not illustrated in FIG. 1, patellar implant 102 also comprises a joint-facing, or articulating, side opposite bone-facing side 110 that is substantially contoured appropriately for abutting the knee joint of a patient...."); Fig.8 shows the side opposite to the bone side facing away from bone
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Regarding Claim 17
Drew teaches method of claim 14, wherein the initial implant model forming step comprises steps of defining an axis extending through a surface facing the bone model and through the bone model and excluding the porous regions from any region a predefined distance away from the axis (Drew: Fig.8 shows no porous region on the joint side of implant 102 – only on the bone side) .
Regarding Claim 18
Drew teaches the method of claim 14, wherein the initial implant model forming step comprises a step of excluding the porous regions from any region at least a predefined distance away from the side of the initial implant model facing away from the bone model (Drew: Fig.8 shows no porous region on the joint side of implant 102 – only on the bone side where the post 112a-112c are located there is porous region which is predefined distance).
Regarding Claim 19
Drew teaches A orthopedic implant comprising: a first implant structure fabricated by an additive manufacturing machine using the computer-generated component file prepared using the method of claim 1, wherein the first implant structure corresponds to the final implant model and comprises porous portions corresponding to the model porous sections and a solid region corresponding to the remaining section of the initial implant model (Drew: See Fig.1 and 2B pictures of actual orthopedic/joint implant made by method of claim 1 – as mapped in claim 1) .
Regarding Claim 20
Drew & Dassonville teaches the orthopedic implant of claim 19, wherein all regions of the final implant model (Drew: Fig.4-7 and more specifically Fig.5 show "... a trimming volume may be defined that is partly or wholly on the interior of initial volume 402...". here the trimmed volume is inside where the porous section would contact the patient specific bone model. Any struts 502/lattices 500 that are outside are bent inwards/trimmed so as to remain inside the trimming volume, which is inside the initial volume 402. The initial volume 402 would be point of contact with the bone, which is shown in Fig.2A model and Fig.2B actual realization. Also look at post 112a-112c tops in Fig.2A-2B w.r.t to Fig.3 which are part of initial volume 402 in direct contact with the bone (model))
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continuous solid thickness zone of the final implant model are within the preset distance from the bone model (Dassonville: Fig.32E
[0232]-[0233])
, the minimum continuous solid thickness zone having a boundary on a digital opposing surface of the final implant model opposite a digital bone-facing surface of the final implant model facing the bone model and having a thickness corresponding to a minimum continuous solid thickness preset within final implant model model (Drew: [0040] "...While not illustrated in FIG. 1, patellar implant 102 also comprises a joint-facing, or articulating, side opposite bone-facing side 110 that is substantially contoured appropriately for abutting the knee joint of a patient...."; [0052] showing in view of Fig.8 struts facing away and opposite from the bone side with thickness assigned in [0053]
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Dassonville: Fig.32A-32E & [0237]-[0238] teaching at least minimum distance between the implant and bone model).
Motivation to combine is same as the parent claim 14 above and is incorporated herein.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKASH SAXENA whose telephone number is (571)272-8351. The examiner can normally be reached Mon-Fri, 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RYAN PITARO can be reached on (571) 272-4071. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AKASH SAXENA
Primary Examiner
Art Unit 2188
/AKASH SAXENA/Primary Examiner, Art Unit 2188 Tuesday, August 11, 2026
Prosecution Insights