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 .
The Amendment filed 10/6/2025 has been entered. The previous Double Patenting rejection is withdrawn because the reference application (Application No. 17/295,984) is abandoned and, therefore, no longer copending. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant's arguments filed 10/6/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Gordon in view of Gabbrielli does not teach the newly added limitations, the examiner disagrees. Annotated fig. 7 of Gabbrielli below shows curved cavities that are curved channels delimited at least partially by concave side walls defining cavity sections, as claimed. See rejection below for further explanation.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sheet TPMS that is generated by offsetting the minimal surface along its normal to form a double surface (a double-sided structure, referred to as “side walls”)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Response to Amendment
The Declaration under 37 CFR 1.132 filed 10/6/2025 is insufficient to overcome the rejection of claims 1-20 based upon Gordon in view of Gabbrielli as set forth in the last Office action because: It refer(s) only to the system described in the above referenced application and not to the individual claims of the application. As noted above, the claims do not recite sheet TPMS structurally defined by surfaces forming interconnected walls. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. Further, objective evidence to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. Applicants have not presented any experimental data showing that the objective evidence is of probative value. See MPEP § 716.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim Objections
Claims 1-5, 8-10, and 12 are objected to because of the following informalities:
Each of claims 1, 2, 8-10, and 12 recite the limitation “the/said cavities”, which appear to be referring to – the/said curved cavities – as recited earlier in claim 1.
Each of claims 1-5 recite “the/said [smooth] side walls”, which appear to be referring to – the/said [smooth] concave side walls – as recite earlier in claim 1.
Appropriate correction is required.
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 (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 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2010/0268337 A1 to Gordon et al. (Gordon) in view of US Patent Application Publication No. 2011/0125284 to Gabbrielli et al. (Gabbrielli).
Regarding claim 1
Gordon teaches a monolithic material including a first region having a first variability of strength and a second region joined to the first region, the second region having a second variability of strength (abstract). Gordon meets the limitations of an implant (50) made of a biocompatible ceramic of synthetic origin (paragraph 0106 discloses that the implant may be entirely made of ceramic, such as partially stabilized zirconia) obtained by additive manufacturing (paragraph 0032 discloses forming the implant layer by layer, which is construed to be a process of additive manufacturing and meets the limitation, as claimed; it is also noted that this limitation is a product by process limitation – see MPEP 2113), wherein said implant: has a material density by volume ranging from 20% to 100% (paragraph 0095 discloses a bulk porosity of the dense region that is 4% or less; therefore the density is 96% or more), and comprises cavities delimited at least partially by side walls defining cavity sections (the porous region is described in paragraph 0099 as having a three dimensional framework with interconnected structural members, which are construed to be side walls, with interstitial interconnected passages between the structure members, which are construed to be cavities delimited at least partially by the side walls defining cavity sections), said cavity sections each having an extension such that it is possible to fit each of said cavity sections in a circle having a diameter ranging from 0.3 mm to 1.2 mm (paragraph 0100 disclose dimensions between 200 and 1000 microns which overlaps the claimed range with sufficient specificity and therefore anticipates; see MPEP 2131.03), and wherein said implant has an average microporosity defined by a material density corresponding to the ratio of the volume of said cavities to the overall volume of the implant (paragraph 0091 discloses the proportions of porosity to density of the implant material, which can be calculated by dividing the total mass by the total volume), said material density ranging from 20% to 100% (paragraph 0095 discloses a dense region 54 having a porosity of 4% or less which is equal to a density of 96% or more and falls within the claimed range with sufficient specificity and therefore anticipates; see MPEP 2131.03).
However, Gordon does not teach that the cavities are curved cavities being curved channels delimited at least partially by concave side walls or that said side walls delimiting at least partially the cavities are being defined by a triply periodic minimal surface.
Gabbrielli clearly teaches a joint part, such as an acetabular cup, similar to Gordon, that includes a solid portion and a porous portion that are preferably made in one piece such that the joint part is formed via solid freeform fabrication to provide a one-piece integrated structure (paragraphs 0022 and 0045), and that the machines which provide for solid freeform fabrication use mathematical functions, which define periodic nodal surfaces that are triply periodic surfaces, namely gyroid (TPMS) (paragraphs 0015 and 0049). Figs. 1-3 of Gabbrielli show examples of the acetabular cup defined by gyroid surfaces such that porosity increases outwardly to facilitate natural incursion of material into the implant when in use to provide secure fixing of the implant (paragraph 0043). Fig. 7 of Gabbrielli shows a basic cubic shape generated from modelling a gyroid surface and includes cavities that are curved cavities being curved channels delimited at least partially by concave side walls defining cavity sections, wherein said side walls delimiting at least partially the cavities are being defined by a triply periodic minimal surface, as claimed (see annotated fig. 7 below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Gordon to specify that the cavities are curved cavities being curved channels delimited at least partially by concave side walls and that said side walls delimiting at least partially the cavities are being defined by a triply periodic minimal surface, in order to facilitate natural incursion of material into the implant when in use to provide secure fixing of the implant, as taught by Gabbrielli.
Regarding claim 2
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gabbrielli also teaches wherein the side walls delimiting at least partially the cavities are defined by a triply periodic minimal surface of the gyroid type (paragraph 0015 discloses using functions that define a periodic nodal surface that are triply periodic surfaces, including gyroid, and figs. 1-3 of Gabbrielli show examples of the acetabular cup defined by gyroid surfaces such that porosity increases outwardly to facilitate natural incursion of material into the implant when in use to provide secure fixing of the implant; paragraphs 0038 and 0043 – it is noted that the term “gyroid type” has been interpreted in accordance with paragraph 0182 of applicant’s specification which provides a standard for ascertaining the requisite degree to which the cavities are defined by the claimed gyroid type such that one of ordinary skill in the art would be reasonably apprised of the scope of the invention).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the side walls delimiting at least partially the cavities are defined by a triply periodic minimal surface of the gyroid type, in order to facilitate natural incursion of material into the implant when in use to provide secure fixing of the implant, as taught by Gabbrielli, particularly so that the implant is suitable to surgically treat skeletal joint conditions such as arthritis and cartilage lesions, as intended by Gordon.
Regarding claim 3
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein said side walls are smooth (in accordance with applicant’s disclosure at paragraph 0048, the term smooth has been interpreted to mean not intersected by another surface – since the side walls/framework of Gordon is not intersected by another surface it meets this limitation as claimed).
Regarding claim 4
Gordon in view of Gabbrielli teaches the implant according to claim 3. Gabbrielli also teaches wherein said smooth side walls are defined by a mathematical function in three dimensions so that they are all non-self-intersecting (paragraph 0015 teaches that one or more mathematical functions in three dimensions that are used to define a triply periodic nodal surface, which include non-self-intersecting side walls), for the purpose of facilitating natural incursion of material into the implant when in use to provide secure fixing of the implant (paragraph 0043).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the side walls of the implant of Gordon, which has improved strength value reliability, to be defined by a mathematical function in three dimensions so that they are all non-self-intersecting, in order to facilitate natural incursion of material into the implant when in use to provide secure fixing of the implant, as taught by Gabbrielli, particularly so that the implant is suitable to surgically treat skeletal joint conditions such as arthritis and cartilage lesions, as intended by Gordon.
Regarding claim 5
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein said side walls comprise a single non-intersecting surface (fig. 3, for example, shows that the interconnecting framework/side walls include a single non-intersecting surface, at least to the same extent as applicant’s).
Regarding claim 6
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches that the interconnected pore passageways (cavities) each have a dimension less than 1000 micrometers, or between 200 and 600 micrometers, for the purpose of promoting bone ingrowth (paragraph 0100). However, Gordon does not explicitly teach wherein the curved cavities are defined by a radius of curvature ranging from 300 µm to 1000 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimension of Gordon from between 200 micrometers and 1000 micrometers to between 300 µm to 1000 µm as applicant appears to have placed no criticality on the claimed range (see paragraph 0050 indicating the cavities are “preferably” curved such that the preferred radius of curvature is within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 7
Gordon in view of Gabbrielli teaches the implant according to claim 6. Gordon also teaches that the interconnected pore passageways (cavities) each have a dimension less than 1000 micrometers, or between 200 and 600 micrometers, for the purpose of promoting bone ingrowth (paragraph 0100). However, Gordon does not explicitly teach wherein the radius of curvature ranges from 500 µm to 750 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimension of Gordon from between 200 micrometers and 1000 micrometers to between 500 µm to 750 µm as applicant appears to have placed no criticality on the claimed range (see paragraph 0050 indicating the cavities are “preferably” curved such that the preferred radius of curvature is within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein the cavities open onto an external surface through openings (the outer/upper surface 60 and perimeters of the dense and porous portions together define an external surface onto which the cavities open as shown in fig. 3, for example).
Regarding claim 9
Gordon in view of Gabbrielli teaches the implant according to claim 8. Gordon also teaches wherein the cavities all communicate with said external surface (the outer/upper surface 60 and perimeters of the dense and porous portions together define an external surface onto which the cavities open, therefore communicating with said external surface, as shown in fig. 3, for example, to allow bone growth as disclosed in paragraph 0099).
Regarding claim 10
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein the diameters of the cavities are distributed periodically within the implant (it is construed that the cavities/passages of Gordon meet the limitation of a periodic distribution as disclosed in paragraphs 0099-0101 to match the surrounding tissues).
Regarding claim 11
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein the implant has a uniform porosity characterized by a single shape and evenly distributed throughout the volume (it is construed that the cavities/passages of Gordon have a given cavity section that is distributed regularly and that cavity section is controlled in terms of their size, as disclosed in paragraphs 0099-0101 to match the surrounding tissues, and therefore meets the limitations claimed, in view of the term “uniform” as disclosed in applicant’s specification at paragraph 0014).
Regarding claim 12
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein said cavities that have a given cavity section are distributed regularly throughout the implant and that said cavity sections are controlled in terms of their size (it is construed that the cavities/passages of Gordon meet the limitation of having a cavity section that has a regular distribution with controlled sizes, as disclosed in paragraphs 0099-0101 to match the surrounding tissues).
Regarding claim 13
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein the biocompatible ceramic comprises a composition of calcium phosphate ranging from 0 to 100% (paragraph 0103 discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, which necessarily has a composition at least above 0%).
Regarding claim 14
Gordon in view of Gabbrielli teaches the implant according to claim 1, wherein the biocompatible ceramic comprises a hydroxyapatite composition ranging from 0 to 100% (paragraph 0103 discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, which would necessarily have a composition above 0%).
Regarding claim 15
Gordon in view of Gabbrielli teaches the implant according to claim 14. Gordon also discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, for the purpose of promoting bone ingrowth for bone fixation (paragraph 0103). However, Gordon does not explicitly teach wherein the biocompatible ceramic comprises the hydroxyapatite composition ranging from 50% to 100%.
Gordon teaches that the purpose of including the hydroxyapatite composition is to promote bone ingrowth for bone fixation and one of ordinary skill in the art would understand that the composition must be significant enough to perform this intended function. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the hydroxyapatite of Gordon to have a composition within the claimed range, as it involves only adjusting the amount of material disclosed to promote bone ingrowth. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of hydroxyapatite of Gordon to be ranging from 50% to 100% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 16
Gordon in view of Gabbrielli teaches the implant according to claim 15. Gordon also discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, for the purpose of promoting bone ingrowth for bone fixation (paragraph 0103). However, Gordon does not explicitly teach wherein the biocompatible ceramic comprises the hydroxyapatite composition ranging from 55% to 97%.
Gordon teaches that the purpose of including the hydroxyapatite composition is to promote bone ingrowth for bone fixation and one of ordinary skill in the art would understand that the composition must be significant enough to perform this intended function. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the hydroxyapatite of Gordon to have a composition within the claimed range, as it involves only adjusting the amount of material disclosed to promote bone ingrowth. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of hydroxyapatite of Gordon to be ranging from 55% to 97% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches wherein the biocompatible ceramic comprises a tricalcium phosphate composition ranging from 0 to 100% (paragraph 0103 discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, such as TCP, which would necessarily have a composition above 0%).
Regarding claim 18
Gordon in view of Gabbrielli teaches the implant according to claim 17. Gordon also teaches wherein the biocompatible ceramic comprises the tricalcium phosphate composition ranging from 0 to 50% (paragraph 0103 discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, such as TCP, which would necessarily have a composition above 0%).
Regarding claim 19
Gordon in view of Gabbrielli teaches the implant according to claim 18. Gordon also discloses that a region of the implant comprises hydroxyapatite, or a form of calcium phosphate, such as TCP, for the purpose of promoting bone ingrowth for bone fixation (paragraph 0103). However, Gordon does not explicitly teach wherein the biocompatible ceramic comprises the tricalcium phosphate composition ranging from 3% to 45%.
Gordon teaches that the purpose of including the tricalcium phosphate composition is to promote bone ingrowth for bone fixation and one of ordinary skill in the art would understand that the composition must be significant enough to perform this intended function. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the tricalcium phosphate of Gordon to have a composition within the claimed range, as it involves only adjusting the amount of material disclosed to promote bone ingrowth. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of tricalcium phosphate of Gordon to be ranging from 3% to 45% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20
Gordon in view of Gabbrielli teaches the implant according to claim 1. Gordon also teaches that the reconstructive procedure replaces one bone end of two or more bone ends comprising a skeletal joint, for the purpose of preventing or delaying global progression of arthritis to the entire joint (paragraph 0020), such as a dental implant (paragraph 0031). However, Gordon does not explicitly teach wherein the implant is a cranial-maxillofacial implant selected from cranial implant, upper jaw bone implant, or facial implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the skeletal joint being repaired by Gordon is a cranial-maxillofacial implant selected from cranial implant, upper jaw bone implant, or facial implant, in order to prevent or delay global progression of arthritis to the entire joint, as taught by Gordon.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/
Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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