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 .
Response to Amendment
According to the amendment filed August 20, 2026, independent claims 1, 12 and 22 have been amended. Claims 1-26 are currently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s):
Claims 1, 12 and 22 each recite “wherein each of the major branched lattice or the minor branched lattice, or both, are at least one of: a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprise two or more different types of lattices selected from the Gyroid lattice, the Schwartz lattice, or the Split P lattice”. Examiner notes that Fig. 8A shows “the major branched lattice, onto which a smaller gyroid lattice is generated” (para. 0019) and Fig. 8C shows “the major branched lattice, onto which a smaller Schwarz lattice is generated” (para. 0021). However, the following iterations of the claimed embodiment(s)/feature(s) must be shown or canceled from the claims:
wherein the major branched lattice is at least one of a gyroid lattice, a split P lattice, or a Schwarz lattice;
wherein the minor branched lattice is a split P lattice;
wherein both of the major branched lattice and the minor branched lattice are a gyroid lattice;
wherein both of the major branched lattice and the minor branched lattice are a Schwarz lattice;
wherein both of the major branched lattice and the minor branched lattice are a split P lattice;
wherein one or both of the major and minor branched lattices comprise a combination of two or more different types of lattices selected from the gyroid, Schwarz or split P lattices,
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4, 7, 12, 15, 18, 22 and 25 are objected to because of the following informalities (i.e., improper capitalization in the claims, and an error in the spelling of “Schwarz”):
In claim 1, line 8, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 1, line 10, “Split” should be deleted and replaced with ---split---
In claim 1, line 12, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 1, line 12, “Schwartz” should be deleted and replaced with ---Schwarz---
In claim 1, line 12, “Split” should be deleted and replaced with ---split---
In claim 4, line 3, “Hydroxyapatite” should be deleted and replaced with ---hydroxyapatite---
In claim 7, line 2, “Hydroxyapatite” should be deleted and replaced with ---hydroxyapatite---
In claim 12, line 11, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 12, line 13, “Split” should be deleted and replaced with ---split---
In claim 12, line 15, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 12, line 15, “Schwartz” should be deleted and replaced with ---Schwarz---
In claim 12, line 15, “Split” should be deleted and replaced with ---split---
In claim 15, line 2, “Hydroxyapatite” should be deleted and replaced with ---hydroxyapatite--
In claim 18, line 2, “Hydroxyapatite” should be deleted and replaced with ---hydroxyapatite--
In claim 22, line 8, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 22, line 10, “Split” should be deleted and replaced with ---split---
In claim 22, line 12, “Gyroid” should be deleted and replaced with ---gyroid---
In claim 22, line 12, “Schwartz” should be deleted and replaced with ---Schwarz---
In claim 22, line 12, “Split” should be deleted and replaced with ---split---
In claim 25, line 3, “Hydroxyapatite” should be deleted and replaced with ---hydroxyapatite--
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.
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.
Claims 1-6, 8-17 and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Unger (US 2019/0133783 A1), Steinmann (US 2015/0018956 A1) and Miller (US 10,772,732 B1).
Regarding claim 1, Unger teaches a spinal implant (100; Figs. 1A-D; para. 0027) comprising:
a major branched lattice (defined by upper and lower endplates 101, 102 identified in Figs. 1A-1D having “a microporous endplate structure 110” as recited in para. 0033, shown in Fig. 3 being formed of a network of struts 140; para. 0033) formed in at least a portion of a middle portion of the spinal implant (as shown formed in at least a portion of a middle section of the implant when, e.g. when viewed from above as depicted in Fig. 1D); and
a minor branched lattice (defined by the network of struts 140 of the central body 130 identified in Figs. 1A-1C, described in para. 0027 as having a microporous lattice structure body 120, which reference numeral is not included in the drawings) formed throughout the major branched lattice (as shown in Figs. 1A-1C, formed through the entire central body area between the endplates 101, 102 defining the major branched lattice).
It is further noted that Unger’s endplates forming the major branched lattice and the central body defining the minor branched lattice each comprise a plurality of irregularly shaped pores formed by a plurality of struts (as recited in the abstract)
Unger does not specifically disclose wherein each of the major branched lattice or the minor branched lattice, or both, are at least one of: a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
Steinmann, in analogous art, is directed towards a spinal implant (cage 10; Figs. 2-5; para. 0070) having upper and lower endplate surface structures having a porous structure formed via an additive manufacturing technique (see porous surfaces 12 depicted in Figs. 2-5; para. 0070). Steinmann further describes an exemplary porous structures, e.g. for forming the endplate surface structures, as cubic lattice structures (Figs. 9A-9L; para. 0033-0044, 0066).
Miller discloses a variety of spinal implants (see Figs. 4A-4B, 13-15), each having a lattice structure disposed within a frame of the implant (see at least frame 1307 in Fig. 13, described in column 8, lines 5-16), and teaches that these central lattice structures can be formed of exemplary lattice structures, including “gyroid lattice 100A (FIG. 1A), Schwarz-diamond lattice 100B (FIG. 1B), and Schwarz-primitive lattice 100C (FIG. 1C)” (see column 7, lines 9-11, and more generally, column 7, lines 58-67). In one exemplary spinal implant (400A shown in Fig. 4A), Miller teaches the central body structure having triply periodic minimal surface portions forming a central body of the implant (see portions 401A; Fig. 4A; column 11, lines 32-48), where these portions “are formed from one or more unit cells 200A (Fig. 2A) or other unit cells described herein, the unit cells 200A being formed from gyroid lattices 100A (or other lattices described herein)” as recited in column 11, lines 32-39, where the unit cells (e.g., the cubic unit cells depicted in Figs. 2A-2C) are understood to form types of cubic lattice structures, including the gyroid lattice architecture described above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unger’s minor branched lattice, defined by the lattice structure of Unger’s central body, to be of a gyroid lattice form as taught by Miller, because Miller recognizes that providing a spinal implant with such a gyroid architecture “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Further, in view of Steinmann’s teaching that microporous endplates may have a cubic lattice structure (as described above), it would have been obvious to one of ordinary skill in the art to have formed Unger’s microporous endplates (i.e., the major branched lattice) to have Steinmann’s cubic lattice structure, because Steinmann teaches that providing a porous cubic lattice as endplate structures on a spinal implant advantageously promotes bony fixation (see Steinmann, para. 0070).
Additionally, one of ordinary skill in the art would have found it obvious to select Miller’s gyroid unit cells to form the particular type of cubic lattice structure of the microporous endplates (i.e., the major branched lattice), so that both of the major and minor branched lattices are at least one of a gyroid, Schwarz, or split P lattice, as claimed, because the gyroid lattice is a known type of cubic lattice structure, and where Steinmann teaches that a cubic lattice structure can promote bony fixation as noted above, Miller also recognizes that a gyroid lattice architecture formed of cubic unit cells “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Regarding claims 2-6 and 8-11, the combined teachings of Unger, Steinmann and Miller disclose the spinal implant of claim 1, and Unger teaches:
[Claim 2] wherein the spinal implant is flat or wedge- shaped (implant 100 is wedge-shaped, as illustrated in Figs. 1A-1C);
[Claim 3] wherein a front face of the spinal implant is closed (via engagement feature 104; Figs. 1A-1C; para. 0033);
[Claim 4] wherein the spinal implant comprises a stainless steel, a titanium alloy, an aluminum alloy, a chromium alloy, a metal alloy, CoCrMo, Hydroxyapatite, a polyether ether ketone (PEEK) material, a polyether ketone (PEKK), a carbon fiber material, an ABS plastic, a polyurethane, a polyethylene, a photo-polymer, a resin, a fiber- encased resinous material, a latex, a synthetic rubber, a synthetic material, a polymer, or a natural material, or another biocompatible material (para. 0027 recites the “implant 100 may be constructed from one single biocompatible material or […] several biocompatible materials”, with para. 0031 providing a titanium alloy as an exemplary material);
[Claim 5] wherein the spinal implant is made at least in part by rapid prototyping, 3D printing, stereolithography (STL), selective laser sintering (SLS), fused deposition modeling (FDM), direct metal laser sintering (DMLS), electron beam melting (EBM), multi-jet fusion (MJF), or an additive manufacturing machine (para. 0034 teaches additive manufacturing techniques including 3D printing for producing implant 100);
[Claim 6] wherein surfaces of the minor branched lattice are coated with a bone growth-promoting agent (implant 100 may include a textured surface coating 160, shown in Figs. 4A-4E for encouraging bone growth onto the implant, such that surfaces of the minor branched lattice defining central body 130 are coated; para. 0044);
[Claim 8] wherein the each of the major branched lattice or the minor branched lattice, or both, are configured to reduce or prevent leakage of the bone growth-promoting agent from the spinal implant (endplates 101, 102 defining the major branched lattice are understood to reduce leakage of bone growth promoting agent from the central body 130 of the implant 100; Figs. 1A-1D);
[Claim 9] wherein there are no supporting structures surrounding the major, the minor, or both the major and minor lattices (as shown in Figs. 1A-1D, similar to the analogous implant in Figs. 15-19 that does not include a frame 190 provided with an alternative implant shown in Figs. 5-14; para. 0046, 0048);
[Claim 10] wherein a roughness is applied to surfaces of the minor branched lattice (where minor branched lattice of central body 130, defined by a microporous lattice body 120 described above, not labeled in the drawings, para. 0043 teaches that the microporous lattice body has a surface roughness comprising a surface texture; Figs. 1A-1D); and
[Claim 11] further comprising at least one of: one or more openings in the spinal implant for fasteners to secure the spinal implant to one or more vertebrae; one or more openings for fasteners comprising a locking tab to secure a fastener; or one or more instrument ports (tool receiving aperture 105; Figs. 1A-1C; para. 0027).
Regarding claim 12, Unger teaches a method of using a spinal implant comprising:
providing a patient in need of the spinal implant (where implant 100 is implanted in a patient, the patient is understood to be in need of the implant; Figs. 1A-1D; para. 0028);
providing the spinal implant (100; Figs. 1A-D; para. 0027) comprising:
a major branched lattice (defined by upper and lower endplates 101, 102 identified in Figs. 1A-1D having “a microporous endplate structure 110” as recited in para. 0033, shown in Fig. 3 being formed of a network of struts 140; para. 0033) formed in at least a portion of a middle portion of the spinal implant (as shown formed in at least a portion of a middle section of the implant when, e.g. when viewed from above as depicted in Fig. 1D); and
a minor branched lattice (defined by the network of struts 140 of the central body 130 identified in Figs. 1A-1C, described in para. 0027 as having a microporous lattice structure body 120, which reference numeral is not included in the drawings) formed throughout the major branched lattice (as shown in Figs. 1A-1C, formed through the entire central body area between the endplates 101, 102 defining the major branched lattice); and
implanting the spinal implant into a spine of the patient (as recited in para. 0028).
It is further noted that Unger’s endplates forming the major branched lattice and the central body defining the minor branched lattice each comprise a plurality of irregularly shaped pores formed by a plurality of struts (as recited in the abstract)
Unger does not specifically disclose wherein each of the major branched lattice or the minor branched lattice, or both, are at least one of: a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
Steinmann, in analogous art, is directed towards a spinal implant (cage 10; Figs. 2-5; para. 0070) having upper and lower endplate surface structures having a porous structure formed via an additive manufacturing technique (see porous surfaces 12 depicted in Figs. 2-5; para. 0070). Steinmann further describes an exemplary porous structures, e.g. for forming the endplate surface structures, as cubic lattice structures (Figs. 9A-9L; para. 0033-0044, 0066).
Miller discloses a variety of spinal implants (see Figs. 4A-4B, 13-15), each having a lattice structure disposed within a frame of the implant (see at least frame 1307 in Fig. 13, described in column 8, lines 5-16), and teaches that these central lattice structures can be formed of exemplary lattice structures, including “gyroid lattice 100A (FIG. 1A), Schwarz-diamond lattice 100B (FIG. 1B), and Schwarz-primitive lattice 100C (FIG. 1C)” (see column 7, lines 9-11, and more generally, column 7, lines 58-67). In one exemplary spinal implant (400A shown in Fig. 4A), Miller teaches the central body structure having triply periodic minimal surface portions forming a central body of the implant (see portions 401A; Fig. 4A; column 11, lines 32-48), where these portions “are formed from one or more unit cells 200A (Fig. 2A) or other unit cells described herein, the unit cells 200A being formed from gyroid lattices 100A (or other lattices described herein)” as recited in column 11, lines 32-39, where the unit cells (e.g., the cubic unit cells depicted in Figs. 2A-2C) are understood to form types of cubic lattice structures, including the gyroid lattice architecture described above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unger’s minor branched lattice, defined by the lattice structure of Unger’s central body, to be of a gyroid lattice form as taught by Miller, because Miller recognizes that providing a spinal implant with such a gyroid architecture “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Further, in view of Steinmann’s teaching that microporous endplates may have a cubic lattice structure (as described above), it would have been obvious to one of ordinary skill in the art to have formed Unger’s microporous endplates (i.e., the major branched lattice) to have Steinmann’s cubic lattice structure, because Steinmann teaches that providing a porous cubic lattice as endplate structures on a spinal implant advantageously promotes bony fixation (see Steinmann, para. 0070).
Additionally, one of ordinary skill in the art would have found it obvious to select Miller’s gyroid unit cells to form the particular type of cubic lattice structure of the microporous endplates (i.e., the major branched lattice), so that both of the major and minor branched lattices are at least one of a gyroid, Schwarz, or split P lattice, as claimed, because the gyroid lattice is a known type of cubic lattice structure, and where Steinmann teaches that a cubic lattice structure can promote bony fixation as noted above, Miller also recognizes that a gyroid lattice architecture formed of cubic unit cells “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Regarding claims 13-17 and 19-21, the combined teachings of Unger, Steinmann and Miller disclose the spinal implant of claim 1, and Unger teaches:
[Claim 13] wherein the spinal implant is flat or wedge- shaped (implant 100 is wedge-shaped, as illustrated in Figs. 1A-1C);
[Claim 14] wherein a front face of the spinal implant is closed (via engagement feature 104; Figs. 1A-1C; para. 0033);
[Claim 15] wherein the spinal implant comprises a stainless steel, a titanium alloy, an aluminum alloy, a chromium alloy, a metal alloy, CoCrMo, Hydroxyapatite, a polyether ether ketone (PEEK) material, a polyether ketone (PEKK), a carbon fiber material, an ABS plastic, a polyurethane, a polyethylene, a photo-polymer, a resin, a fiber- encased resinous material, a latex, a synthetic rubber, a synthetic material, a polymer, or a natural material, or another biocompatible material (para. 0027 recites the “implant 100 may be constructed from one single biocompatible material or […] several biocompatible materials”, with para. 0031 providing a titanium alloy as an exemplary material);
[Claim 16] wherein the spinal implant is made at least in part by rapid prototyping, 3D printing, stereolithography (STL), selective laser sintering (SLS), fused deposition modeling (FDM), direct metal laser sintering (DMLS), electron beam melting (EBM), multi-jet fusion (MJF), or an additive manufacturing machine (para. 0034 teaches additive manufacturing techniques including 3D printing for producing implant 100);
[Claim 17] wherein surfaces of the minor branched lattice are coated with a bone growth-promoting agent (implant 100 may include a textured surface coating 160, shown in Figs. 4A-4E for encouraging bone growth onto the implant, such that surfaces of the minor branched lattice defining central body 130 are coated; para. 0044);
[Claim 19] wherein the each of the major branched lattice or the minor branched lattice, or both, are configured to reduce or prevent leakage of the bone growth-promoting agent from the spinal implant (endplates 101, 102 defining the major branched lattice are understood to reduce leakage of bone growth promoting agent from the central body 130 of the implant 100; Figs. 1A-1D);
[Claim 20] wherein at least one of: a roughness is applied to surfaces of the minor branched lattice (where minor branched lattice of central body 130, defined by a microporous lattice body 120 described above, not labeled in the drawings, para. 0043 teaches that the microporous lattice body has a surface roughness comprising a surface texture; Figs. 1A-1D); the spinal implant comprises one or more openings for fasteners to secure the spinal implant to one or more vertebrae; or each of the one or more openings comprises a locking tab to secure a fastener; and
[Claim 21] further comprising or more instrument ports (tool receiving aperture 105 and aperture 103; Figs. 1A-1C; para. 0027).
Regarding claim 22, Unger teaches a method of making a spinal implant (100; Figs. 1A-1D; para. 0027) comprising:
forming a major branched lattice (defined by upper and lower endplates 101, 102 identified in Figs. 1A-1D having “a microporous endplate structure 110” as recited in para. 0033, shown in Fig. 3 being formed of a network of struts 140; para. 0033) in at least a portion of a middle portion of the spinal implant (as shown formed in at least a portion of a middle section of the implant when, e.g. when viewed from above as depicted in Fig. 1D); and
forming a minor branched lattice (defined by the network of struts 140 of the central body 130 identified in Figs. 1A-1C, described in para. 0027 as having a microporous lattice structure body 120, which reference numeral is not included in the drawings) throughout the major branched lattice (as shown in Figs. 1A-1C, formed through the entire central body area between the endplates 101, 102 defining the major branched lattice).
It is further noted that Unger’s endplates forming the major branched lattice and the central body defining the minor branched lattice each comprise a plurality of irregularly shaped pores formed by a plurality of struts (as recited in the abstract)
Unger does not specifically disclose wherein each of the major branched lattice or the minor branched lattice, or both, are at least one of: a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
Steinmann, in analogous art, is directed towards a spinal implant (cage 10; Figs. 2-5; para. 0070) having upper and lower endplate surface structures having a porous structure formed via an additive manufacturing technique (see porous surfaces 12 depicted in Figs. 2-5; para. 0070). Steinmann further describes an exemplary porous structures, e.g. for forming the endplate surface structures, as cubic lattice structures (Figs. 9A-9L; para. 0033-0044, 0066).
Miller discloses a variety of spinal implants (see Figs. 4A-4B, 13-15), each having a lattice structure disposed within a frame of the implant (see at least frame 1307 in Fig. 13, described in column 8, lines 5-16), and teaches that these central lattice structures can be formed of exemplary lattice structures, including “gyroid lattice 100A (FIG. 1A), Schwarz-diamond lattice 100B (FIG. 1B), and Schwarz-primitive lattice 100C (FIG. 1C)” (see column 7, lines 9-11, and more generally, column 7, lines 58-67). In one exemplary spinal implant (400A shown in Fig. 4A), Miller teaches the central body structure having triply periodic minimal surface portions forming a central body of the implant (see portions 401A; Fig. 4A; column 11, lines 32-48), where these portions “are formed from one or more unit cells 200A (Fig. 2A) or other unit cells described herein, the unit cells 200A being formed from gyroid lattices 100A (or other lattices described herein)” as recited in column 11, lines 32-39, where the unit cells (e.g., the cubic unit cells depicted in Figs. 2A-2C) are understood to form types of cubic lattice structures, including the gyroid lattice architecture described above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unger’s minor branched lattice, defined by the lattice structure of Unger’s central body, to be of a gyroid lattice form as taught by Miller, because Miller recognizes that providing a spinal implant with such a gyroid architecture “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Further, in view of Steinmann’s teaching that microporous endplates may have a cubic lattice structure (as described above), it would have been obvious to one of ordinary skill in the art to have formed Unger’s microporous endplates (i.e., the major branched lattice) to have Steinmann’s cubic lattice structure, because Steinmann teaches that providing a porous cubic lattice as endplate structures on a spinal implant advantageously promotes bony fixation (see Steinmann, para. 0070).
Additionally, one of ordinary skill in the art would have found it obvious to select Miller’s gyroid unit cells to form the particular type of cubic lattice structure of the microporous endplates (i.e., the major branched lattice), so that both of the major and minor branched lattices are at least one of a gyroid, Schwarz, or split P lattice, as claimed, because the gyroid lattice is a known type of cubic lattice structure, and where Steinmann teaches that a cubic lattice structure can promote bony fixation as noted above, Miller also recognizes that a gyroid lattice architecture formed of cubic unit cells “provides for improved osseointegration and mechanical performance over previous implants due to novel ratios of porosity to compressive strength” (see Miller, abstract).
Regarding claims 23-26, the combined teachings of Unger, Steinmann and Miller disclose the method of claim 22, and Unger teaches:
[Claim 23] further comprising coating surfaces of the minor branched lattice with a bone growth-promoting agent (implant 100 may include a textured surface coating 160, shown in Figs. 4A-4E for encouraging bone growth onto the implant, such that surfaces of the minor branched lattice defining central body 130 are coated; para. 0044);
[Claim 24] wherein a front face of the spinal implant is closed (via engagement feature 104; Figs. 1A-1C; para. 0033);
[Claim 25] wherein the spinal implant comprises a stainless steel, a titanium alloy, an aluminum alloy, a chromium alloy, a metal alloy, CoCrMo, Hydroxyapatite, a polyether ether ketone (PEEK) material, a polyether ketone (PEKK), a carbon fiber material, an ABS plastic, a polyurethane, a polyethylene, a photo-polymer, a resin, a fiber- encased resinous material, a latex, a synthetic rubber, a synthetic material, a polymer, or a natural material, or another biocompatible material (para. 0027 recites the “implant 100 may be constructed from one single biocompatible material or […] several biocompatible materials”, with para. 0031 providing a titanium alloy as an exemplary material); and
[Claim 26] wherein the spinal implant is made at least in part by rapid prototyping, 3D printing, stereolithography (STL), selective laser sintering (SLS), fused deposition modeling (FDM), direct metal laser sintering (DMLS), electron beam melting (EBM), multi-jet fusion (MJF), or an additive manufacturing machine (para. 0034 teaches additive manufacturing techniques including 3D printing for producing implant 100).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Unger (US 2019/0133783 A1), Steinmann (US 2015/0018956 A1) and Miller (US 10,772,732 B1), as applied to claims 6 and 17 above, respectively, further in view of Reith (US 2022/0327679 A1).
Regarding claims 7 and 18, the combined teachings of Unger and Rucker disclose the spinal implant of claim 6 and the method of claim 17, respectively.
The above-cited references do not specifically disclose wherein the bone growth-promoting agent comprises Hydroxyapatite (HA).
Reith, in analogous art, teaches a spinal implant (1000; Figs. 8D-8E; para. 0151) having a minor branched lattice (framework 1004; Figs. 8D-8E; para. 0151) wherein surfaces thereof are coated with a bone growth promoting agent that comprises Hydroxyapatite (para. 0181 recites that implant 1000 may include a hydroxyapatite coating that extends into the pores of the implant, thus coating the minor branched lattice 1004 in Figs. 8D-8E, to promote faster osseointegration, i.e. bone growth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used hydroxyapatite, as taught by Reith, in Unger’s bone-growth promoting agent coating surfaces of the minor branched lattice, as claimed, because Reith teaches that coating such a porous, lattice structure of a spinal implant with hydroxyapatite creates a hydrophilic surface and promotes faster osseointegration, promoting bone on-growth and in-growth of the implant leading to greater integration strength of the implant within the patient (see Reith, para. 0181).
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 ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/Examiner, Art Unit 3773
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
