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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 11, 2026, has been entered.
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) in view of Rucker (US 2022/0117753 A1).
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).
Unger also discloses wherein each of the major and minor branched lattices are formed of struts, as noted above, the struts defining a system of non-uniformly shaped and sized pores (see para. 0033), and wherein the scale of the network of struts and corresponding pores of the microporous structure of the end plates defining the major branched lattice is smaller than that of the microporous body lattice structure defining the minor branched lattice (see para. 0033).
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 Voronoi lattice; a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Voronoi lattice, a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed each of Unger’s major and minor branched lattices so that the struts form a Voronoi lattice, as taught by Rucker, where the scale of the major branched lattice is smaller than that of the minor branched lattice as required by Unger, because Rucker recognizes that providing such a lattice structure in a spinal implant provides “superior elasticity, bony ingrowth and purchase, and structural integrity and strength properties” (see para. 0018).
Regarding claims 2-6 and 8-11, the combined teachings of Unger and Rucker 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).
Unger also discloses wherein each of the major and minor branched lattices are formed of struts, as noted above, the struts defining a system of non-uniformly shaped and sized pores (see para. 0033), and wherein the scale of the network of struts and corresponding pores of the microporous structure of the end plates defining the major branched lattice is smaller than that of the microporous body lattice structure defining the minor branched lattice (see para. 0033).
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 Voronoi lattice; a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Voronoi lattice, a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
Rucker, in analogous art, is directed towards a spinal implant (10; Fig. 1) comprising a branched lattice structure (lattice volume 14; Figs. 1-2, 6-7; para. 0019) formed by a plurality of struts that may be formed of different sizes and define various pore sizes (see struts 14a-d; Figs. 1, 7; para. 0020-0021), and Rucker teaches wherein the branched lattice is a Voronoi lattice (as described in para. 0023, lattice volume 14 is formed as a Voronoi volume lattice 26; Figs. 1-2, 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed each of Unger’s major and minor branched lattices so that the struts form a Voronoi lattice, as taught by Rucker, where the scale of the major branched lattice is smaller than that of the minor branched lattice as required by Unger, because Rucker recognizes that providing such a lattice structure in a spinal implant provides “superior elasticity, bony ingrowth and purchase, and structural integrity and strength properties” (see para. 0018).
Regarding claims 13-17 and 19-21, the combined teachings of Unger and Rucker 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).
Unger also discloses wherein each of the major and minor branched lattices are formed of struts, as noted above, the struts defining a system of non-uniformly shaped and sized pores (see para. 0033), and wherein the scale of the network of struts and corresponding pores of the microporous structure of the end plates defining the major branched lattice is smaller than that of the microporous body lattice structure defining the minor branched lattice (see para. 0033).
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 Voronoi lattice; a Gyroid lattice; a Schwarz lattice; or a Split P lattice; or comprises two or more different types of lattices selected from a Voronoi lattice, a Gyroid lattice, a Schwartz lattice, or a Split P lattice.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed each of Unger’s major and minor branched lattices so that the struts form a Voronoi lattice, as taught by Rucker, where the scale of the major branched lattice is smaller than that of the minor branched lattice as required by Unger, because Rucker recognizes that providing such a lattice structure in a spinal implant provides “superior elasticity, bony ingrowth and purchase, and structural integrity and strength properties” (see para. 0018).
Regarding claims 23-26, the combined teachings of Unger and Rucker 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) and Rucker (US 2022/0117753 A1), 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.
Neither Unger nor Rucker 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892.
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 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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