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 1-20 have been presented for examination based on the application filed on 10/21/2022.
An election was made by applicant for Group I (Claim 1-12, and 14-20) and claims 1-12 and 14-20 are therefore examined below.
Group II (Claim 13) is withdrawn from consideration.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US PGPUB No. 20210298909 A1 by Drew; Alex et al.
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.
This action is made Non-Final.
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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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is 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.
Claim 20 recites the limitation :
20. The orthopedic implant of claim 19, wherein all regions of the final implant model are within the preset distance from the bone model with the exceptions of i) regions surrounding digital holes corresponding to holes configured for receiving shafts of separate objects separate from the first implant structure and ii) regions within a minimum continuous solid thickness zone of the final implant model, 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.
It is unclear if the exception is limitation that is included or prior art teaching the limitation of “wherein all regions of the final implant model are within the preset distance from the bone model” and not teaching the exception is sufficient to teach the limitation. Positive recitation all three regions clearly indicated whether they are all required/at least one of them is required would cure this deficiency.
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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 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.
(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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PGPUB No. 20210298909 A1 by Drew; Alex et al.
In Alternate: A single reference rejection under 35 USC 103 is made also:
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US PGPUB No. 20210298909 A1 by Drew; Alex et al. The rationale for this alternate rejection is that the reference teaches a small genus (single region – (112c in Drew) to perform meshing/porous region creation, but would be obvious to perform such meshing for second or third region – (region 112a and 112b in Drew) ) which places a claimed species in the possession of the public as in In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), and the species would have been obvious even if the genus were not sufficiently small to justify a rejection under 35 U.S.C. 102. See MPEP §§ 2131.02 and 2144.08 for more information on anticipation and obviousness of species by a disclosure of a genus.
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]) .
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 (Or Alternately, a single reference 103 with Duplication of parts/process for third porous section in view of In re Harza)
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] ) .
Regarding Claim 13 (Withdrawn/Non-Elected claim)
13. A method of replacing a portion of a bone comprising steps of: removing one or more bone portions from one or more bones to leave, respectively, a remaining first bone portion or a remaining first plurality of bone portions; and placing an implant having a plurality of irregularly shaped porous portions and a plurality of irregularly shaped solid portions each separating at least portions of respective pairs of the plurality of irregularly shaped porous portions against only the respective remaining first bone portion or first plurality of bone portions such that none of the plurality of irregularly shaped porous portions includes a region located more than a preset distance from at least one bone portion of the respective remaining first bone portion or first plurality of bone portions, the irregularly shaped porous portions and the irregularly shaped solid portions defining all bone-facing surface portions of the implant.
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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) 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.
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.
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)).
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]).
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 teaches the orthopedic implant of claim 19, wherein all regions of the final implant model are within the 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)) with the exceptions of (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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Conclusion
All claims are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Examiner’s Note: Examiner has cited particular columns and line numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
In the case of amending the claimed invention, Applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for proper interpretation and also to verify and ascertain the metes and bounds of the claimed invention.
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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 Friday, February 6, 2026