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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 March 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 6 March 2026 have been entered. Claims 23-24 are new. Claims 1, 3-11, and 16-24 are pending.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1, 8-9, 11, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe” and further in view of Globerman et al. (US 2013/0079829 A1), “Globerman”.
Bauer teaches a bone implant (Fig. 9, tibial augment cone 8), comprising a main body (Fig. 9, first portion 81) with an open-cell metallic porous lattice structure in its outer region (Fig. 9, second portion 82 may be formed using additive methods such as SLM or EBM to make products of metal material and may comprise titanium alloys, pure titanium, cobalt chromium, stainless steel, tantalum, zirconium, or other biocompatible materials [0004-0005]), said lattice structure comprising a plurality of regularly arranged unit cells (Fig. 1, porous structure 3 comprises regularly arranged elementary cells 4 [0054]), wherein the unit cells are arranged in layers (Fig. 1, elementary cells are regularly arranged in layers [0054]), wherein the unit cells are an assembled structure and are constructed from an interior space (Fig. 1, elementary cells 4 feature an internal free space 40 that is inter-connected with internal free-space of neighboring cells [0054]) and a plurality of interconnected bars surrounding the interior space (Fig. 2, elementary cells 4 comprise legs 51, 52, 53, and 54), wherein the porous lattice structure is covered with a coating which promotes bone growth (Fig. 1, coating 30 of bone growth promoting material [0028]), comprising calcium phosphate (Fig. 1, coating 30 comprises CaP [0063]), but fails to teach characterized in that the calcium phosphate coating has a hydroxyapatite content of less than or equal to 1 wt.%, and penetrates throughout all layers of the porous lattice structure, wherein the calcium phosphate coating has a crystal phase which comprises at least 90 wt.% brushite and monetite, and wherein the brushite fraction is not less than 65 wt.%.
Erbe teaches bone matrix materials characterized in that the calcium phosphate coating has a hydroxyapatite content of less than or equal to 1 wt.%, (Fig. 11, Sample R8 White comprises 1.69% hydroxyapatite) and wherein the calcium phosphate coating has a crystal phase which comprises at least 90 wt.% brushite and monetite (Fig. 11, Sample R8 White comprises 74% brushite and 17% monetite (i.e., combined 91%)), and wherein the brushite fraction is not less than 65 wt.% (Fig. 11, Sample R8 White comprises 74% brushite). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation. However, Bauer in view of Erbe fails to teach the coating penetrates throughout all layers of the porous lattice structure.
Globerman teaches an implant comprising a coating which penetrates throughout all layers of the porous lattice structure (implant may be configured to comprise a hydroxyapatite coating wherein the particles of the coating are incorporated into the entire implant, rather than just an outer layer [0323-0325]). Globerman discloses that the coating improves the ability of the implant to integrate in the bone and enhances bone ingrowth [0323]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating taught by Bauer in view of Erbe with its ability to penetrate throughout the implant as taught by Globerman in order to increase the implant’s integration abilities.
Regarding claim 8, Bauer teaches an implant and lattice structure wherein the open-cell porous lattice structure (Fig. 1, porous structure 3) is a 3D printed structure, printed by means of electron beam melting (EBM) or selective laser melting (SLM) (porous structure is formed using manufacturing methods such as EBM or SLM [0024]).
Regarding claim 9, Bauer teaches an implant and lattice structure wherein the main body (Fig. 9, first portion 81) is made of the same material as the open-cell porous lattice structure (Fig. 9, first portion 81 comprises porous structure).
Regarding claim 11, Bauer teaches an implant and lattice structure wherein the interior spaces (Fig. 1, internal free space 40) of the unit cells (Fig. 1, elementary cells 4) form macropores, the width of which is at least ten times the thickness of the coating (this limitation is non-limiting due to the “or” statement), or the width of the pores is in the range between 0.4 and 2 mm (average pore width ranges between 0.1 and 1.55 mm [0034]) and the coating has a thickness between 10 and 20 microns (thickness of the coating is between 1µm and 10 µm [0028]).
Regarding claim 16, Bauer teaches an implant and lattice structure wherein the main body (Fig. 9, first portion 81) comprises a solid portion (Fig. 10, intermediate wall 80), wherein the solid portion and the open-cell porous lattice structure (Fig. 1, porous structure 3) are a single unit (Fig. 9, tibial augment cone 8 comprises all preciously mentioned elements in one single unit).
Regarding claim 17, Bauer teaches the calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]), but fails to teach a crystal phase which comprises at least 95 wt.% brushite and monetite.
Erbe teaches bone matrix materials comprising a crystal phase which comprises at least 95 wt.% brushite and monetite (Fig. 11, Sample R8 White comprises 74% brushite and 17% monetite (i.e., combined 91%)). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation.
Regarding claim 18, Bauer teaches the calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]), but fails to teach a crystal phase which comprises at least 99 wt.% brushite and monetite.
Erbe teaches bone matrix materials comprising a crystal phase which comprises at least 99 wt.% brushite and monetite (Fig. 11, Sample R8 White comprises 74% brushite and 17% monetite (i.e., combined 91%)). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation.
Regarding claim 19, Bauer fails to teach the limitations of claim 19. Erbe teaches a bone matrix wherein the brushite fraction is not less than is 90 wt.% (Fig. 11, Sample R8 White comprises 74% brushite). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation.
Regarding claim 20, Bauer fails to teach the limitations of claim 20. Erbe teaches a bone matrix wherein the brushite fraction is not less than is 95 wt.%. (Fig. 11, Sample R8 White comprises 74% brushite). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation.
Regarding claim 21, Bauer teaches the calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]) but fails to teach it is practically free of hydroxyapatite.
Erbe teaches bone matrix materials characterized in that the calcium phosphate coating that is practically free of hydroxyapatite, (Fig. 11, Sample R8 White comprises 1.69% hydroxyapatite). It is noted that Applicant’s specification defines “practically free” as “maximum 1 wt.%, and preferably even less than 1 wt.%” (par. 2, pg. 3). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I. Erbe further discloses that brushite and monetite possess osteoconductive and osteoinductive properties. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the brushite fraction of the coating taught by Bauer to include a ratio to reflect the teachings of Erbe in order to promote bone formation.
Regarding claim 22, Bauer teaches wherein the interior spaces (Fig. 1, internal free space 40) of the unit cells (Fig. 1, elementary cells 4) form macropores, the width of which is between 30 times and 200 times the thickness of the coating (average pore width ranges between 0.1 and 1.55 mm [0034] and the thickness of the coating is between 1µm and 10 µm [0028] (i.e., 100-1500µm pore width is 100-150 times the thickness of the coating)).
Regarding claim 23, Bauer teaches wherein the open-cell metallic porous lattice structure comprises titanium or a titanium alloy (Fig. 9, second portion 82 may be formed using additive methods such as SLM or EBM to make products of metal material and may comprise titanium alloys, pure titanium, cobalt chromium, stainless steel, tantalum, zirconium, or other biocompatible materials [0004-0005]), and surfaces of the bars within the interior spaces of the unit cells (Fig. 1, elementary cells 4 feature an internal free space 40 that is inter-connected with internal free-space of neighboring cells [0054]), and the calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]), but Bauer in view of Erbe fails to teach the coating is applied as an inner pore coating.
Globerman teaches an implant comprising a coating that is applied as an inner pore coating (implant may be configured to comprise a hydroxyapatite coating wherein the particles of the coating are incorporated into the entire implant, rather than just an outer layer [0323-0325]). Globerman discloses that the coating improves the ability of the implant to integrate in the bone and enhances bone ingrowth [0323]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating taught by Bauer in view of Erbe with its ability to penetrate throughout the implant as taught by Globerman in order to increase the implant’s integration abilities.
Regrading claim 24, Bauer teaches wherein the porous lattice structure comprises at least five layers of unit cells (Fig. 3a, porous structure 3 comprises regularly arranged elementary cells 4 [0054] having more than 5 layers), and the calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]), and the outermost layer and innermost layer of the porous lattice structure (Fig. 3a, porous structure 3 comprises inner and outer layers [0059]), but fails to teach the coating uniformly covers bar surfaces throughout all five layers from an outermost layer to an innermost layer of the porous lattice structure.
Globerman teaches an implant comprising a coating that uniformly covers bar surfaces throughout all five layers from an outermost layer to an innermost layer of the porous lattice structure (implant may be configured to comprise a hydroxyapatite coating wherein the particles of the coating are incorporated into the entire implant, rather than just an outer layer [0323-0325]). Globerman discloses that the coating improves the ability of the implant to integrate in the bone and enhances bone ingrowth [0323]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating taught by Bauer in view of Erbe with its ability to penetrate throughout the implant as taught by Globerman in order to increase the implant’s integration abilities.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Guzeev et al. (RU 22684617 C1), “Guzeev”.
Regarding claim 3, Bauer in view of Erbe and Globerman does not disclose a bioactive coating with a specific a calcium/phosphate ratio, however Guzeev further discloses a bioactive coating for implants wherein the calcium phosphate coating has a calcium/phosphate ratio in the range from 1.0 to 1.2 (hydroxyapatite: phosphate binder = 1-1.5: 1.5-2.0 [5]). It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the ratio of calcium/phosphate of the bioactive coating taught by Bauer to range from 1.0 to 1.2 as taught by Guzeev in order to optimize the implant coating.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Landon et al. (WO 2011/060312 A2), “Landon”.
Regarding claim 4, Bauer teaches an implant and lattice structure having interior spaces (Fig. 1, internal free space 40) of the unit cells (Fig. 1, elementary cells 4), but Bauer in view of Erbe fails to teach the interior spaces of the unit cells are between 10 and 25 µm.
Landon teaches porous structures comprising interior spaces of unit cells that are between 10 and 25 µm (average diameter of the pores ranges from 0.01 to 2000 microns [00108]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the width of the unit cells taught by Bauer in view of Guzeev and Nie to reflect the porous structure taught by Landon in order to increase bone ingrowth.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Mizutani et al. (JP 2003320017 A), “Mizutani”.
Regarding claim 5, Bauer teaches an implant and lattice structure having a calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]), but Bauer in view of Erbe fails to teach that it is unannealed.
Mizutani teaches a porous body having a calcium phosphate coating (calcium phosphate porous body [0033]) that is unannealed (calcium phosphate-based granules contain unhardened calcium phosphate [0033]). Mizutani discloses that the calcium phosphate porous body is easily absorbed by the living body [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implant and lattice structure taught by Bauer in view of Guzeev and Nie with the coating taught by Mizutani in order to promote biocompatibility.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Bhaduri et al. (US 2018/0289858 A1), “Bhaduri”.
Regarding claim 6, Bauer teaches an implant and lattice structure having a calcium phosphate coating (Fig. 1, coating 30 comprises CaP [0063]) and unit cells (Fig. 1, elementary cells 4), but Bauer in view of Guzeev, Nie, Engstrand, and Erbe fails to teach that the coating covers all sides of the assembled structure.
Bhaduri teaches a bioactive antibacterial coating that covers all sides of the assembled structure (Figs. 5A-D, Ca-P globules grow and cover the whole implant surface [0102]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implant and lattice structure taught by Bauer in view of Guzeev and Nie with the coating taught by Bhaduri in order to promote osseointegration of the implant.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Witold et al. (PL 221445 B1), “Witold”.
Regarding claim 7, Bauer teaches an implant and lattice structure wherein the layers (Figs. 3a-c, elementary cells 4 are regularly arranged in layers [0054]) form an open-cell trabecular structure (Fig. 1, porous structure 3 is trabecular), but Bauer in view of Guzeev, Nie, Engstrand, and Erbe fails to teach that the unit cells are in a wurtzite structure.
Witold teaches a bone implant having a wurtzite structure (synthetic hydroxyapatite with a hexagonal (i.e., wurtzite) structure is used to make the implant (pg. 4, par. 1)). Witold teaches that hydroxyapatite in a hexagonal structure supports the high strength demands of the bone implant (pg. 3, par. 9). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the unit cell arrangement taught by Bauer in view of Guzeev and Nie to reflect the unit cell arrangement taught by Witold in order to provide a bone implant that withstands high mechanical loads.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer (US 2018/0193152 A1), “Bauer” in view of Erbe et al. (2018/0085491 A1), “Erbe”, and Globerman et al. (US 2013/0079829 A1), “Globerman”, and further in view of Jones et al. (US Pat. No. 9456901 B2), “Jones”.
Regarding claim 10, Bauer teaches an implant and lattice structure wherein the main body (Fig. 9, first portion 81) has a supporting region (Fig. 10, intermediate wall 80), but Bauer in view of Erbe fails to teach wherein said supporting region has a lower porosity than the porosity of the open-cell porous lattice structure.
Jones teaches a porous structure having a lower porosity than the porosity of the open-cell porous lattice structure (powder layers differ in porosity (i.e., different regions may have different porosity (col. 7, lines 21-28)). Jones discloses that the porosity promotes bone in-growth and provides the medical implant with soft tissue characteristics (col. 4, lines 10-13). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implant and lattice structure taught by Bauer in view of Guzeev and Nie with the porous structure taught by Jones in order to promote bone in growth throughout the implant.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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