DETAILED ACTION
Response to Amendment
The Amendment filed 3/12/26 has been entered. Claims 1-7 and 9-36 remain pending in the application. Claim(s) 37-42 have been canceled New claim(s) 43-44 have been added. Applicant's amendments to the claims have overcome the 112(d) rejections previously set forth in the Non-Final Rejection mailed 12/5/2025.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 43 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for ceramics metals and alloys having a printed hardness in a range from about 32 HRC to about 40 HRC, does not reasonably provide enablement for any known polymer to have a printed hardness in a range from about 32 HRC to about 40 HRC. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The broadest reasonable interpretation of claim 43 encompasses all known and to be discovered polymers. The specification discloses sufficient information for one of ordinary skill in the art to use powders of ceramics metals and alloys to print an implant having a printed hardness in a range from about 32 HRC to about 40 HRC. However, the specification does not provide direction on how to use any polymer powder to print an implant having a printed hardness in a range from about 32 HRC to about 40 HRC. At the time of filing, the state of the art was such that the hardness of polymers is not on the HRC scale, and many polymers are quite soft.
The instant specification states that “Polymer may herein refer to, but are not limited to photopolymers, thermoplastics and thermosetting polymers” (paragraph 0050]). Accordingly, any known or future discovered polymer is intended to be included in the scope of the claim as interpreted in light of the specification. The instant specification states that “the build implant can have a hardness in a range from about 32 HRC to about 40 HRC, as measured according to the Hardness Rockwell C (HRC) scale, and that it should be appreciated that the implant's printed density and/or hardness can be adapted, such as by adjusting the material composition, powder size, and infill volume, by way of non-limiting examples” (paragraph [0056]). No further guidance is provided as to how to adapt the hardness when working with soft polymers. The Hardness Rockwell C (HRC) is used to measure the hardness of steel, deep case hardened steel, stainless steel, hard cast irons, pearlitic malleable iron, titanium, titanium alloys, and other materials harder than 100 HRB, not polymers. There is no discussion of hardness in the two paragraphs that mention polymers and there is no discussion of polymers in the two paragraphs that mention hardness. Thus, the disclosed guidance provided in the specification does not bear a reasonable correlation to the full scope of the claim. Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of claim 43.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Language from the reference(s) is shown in quotations. Limitations from the claims are shown in quotations within parenthesis. Examiner explanations are shown in italics.
Claims 1-7, 9-12, 14-15, 17, 21-22, 29, 35-36, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1).
Regarding claims 1 and 4-5, Feldmann teaches “a method for additive manufacturing comprises exposing a layer of material on a build surface to a linear array of laser energy pixels” (which reads upon “a method of making a part, comprising directing a projection of laser energy on a build surface, thereby forming a layer”, as recited in the instant claim; paragraph [0005]). Feldmann teaches that “each laser energy pixel has a rectangular shape and a substantially uniform power density, and wherein there is no spacing between adjacent laser energy pixels” (which reads upon “wherein the projection of laser energy comprises adjacent energy pixels that share common boundaries on the build surface and each pixel has a respective power density that is substantially uniform on the build surface”, as recited in the instant claim; paragraph [0005]). Feldmann teaches that “a linear array 200 that may be projected onto a surface (e.g., onto a powder bed surface), and the linear array comprises a series of adjacent rectangular laser energy pixels 201-205” (which reads upon “directing a projection of laser energy on a build surface atop a bed of powder”, as recited in the instant claim; paragraph [0063]). Feldmann teaches that “once a layer is completed, the structure is indexed, a new layer of metal powder is laid down and the process is repeated” (which reads upon “repeating the directing step a plurality of times, in a layer-by-layer manner”, as recited in the instant claim; paragraph [0003]). Feldmann teaches that “this process can be repeated many times in order to build up a 3-dimensional shape of almost any form” (which reads upon “such that a totality of the formed layers define at least a portion of the part”, as recited in the instant claim; paragraph [0003]).
Feldmann teaches that “this process can be repeated many times in order to build up a 3-dimensional shape of almost any form” (paragraph [0003]). Feldmann is silent regarding the shape of the part produced, specifically, Feldmann is silent regarding an implantable device, forming a layer of an implantable device such that a totality of the formed layers define at least a portion of the implantable device.
Cryder is similarly concerned with forms of additive manufacturing, or 3D printing, [which] have been developed which allow structures to be formed layer by layer (paragraph [0046]). Cryder teaches that “layer-by-layer manufacturing allows for the direct fabrication of complex parts that would be cost-prohibitive, and often impossible, to produce through traditional manufacturing processes” (paragraph [0046]). Cryder teaches that “the implants of the disclosure may be manufactured from any of these or other additive manufacturing processes currently known or later developed” (which reads upon “an implantable device, forming a layer of an implantable device such that a totality of the formed layers define at least a portion of the implantable device”, as recited in the instant claim; paragraph [0048]; the process of Feldmann is later developed). Cryder teaches that “an intervertebral implant 100 (“implant 100”) according to a first exemplary embodiment is shown, and that implant 100 includes a superior endplate 110 and an inferior endplate 150 that is adjacent to and expandably connected to the superior endplate 110 such that the superior endplate 110 is expandable away from the inferior endplate 150” (which reads upon “an implantable device, forming a layer of an implantable device such that a totality of the formed layers define at least a portion of the implantable device”, as recited in the instant claim; which reads upon claims 4-5; paragraph [0049]). Cryder teaches that “endplates having geometries designed for enhanced bone fusion, intervertebral implants, such as expandable implants, utilizing such endplates, and methods of increasing bone graft packing are provided, and that the endplate geometries and improved packing methods may promote and enhance bone growth and fusion” (paragraph [0007]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the unspecified part shape of Feldmann with an intervertebral implant, such as an expandable implant, as taught by Cryder to provide a useful part, specifically an implant which promotes and enhances bone growth and fusion. Additionally, Cryder teaches that “the implants of the disclosure may be manufactured from any of these or other additive manufacturing processes currently known or later developed” (paragraph [0048]). The Examiner notes that the process of Feldmann is later developed, thus Cryder specifically teaches that such a production method is obvious.
Feldmann is silent regarding wherein the at least the portion of the implantable device comprises a macrostructure having a printed density in a range of about 99.5 percent to about 100 percent.
Cryder teaches “an implant, such as an expandable implant, includes a superior endplate and an inferior endplate, and that each of the endplates may include a first portion having a solid structure and a second portion having a porosity” (which reads upon “wherein the at least the portion of the implantable device comprises a macrostructure having a printed density in a range of about 99.5 percent to about 100 percent”, as recited in the instant claim; paragraph [0049]; if the portion is solid then the microstructures must also be solid, i.e., fully dense).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the unspecified part shape of Feldmann with an intervertebral implant, such as an expandable implant, including a superior endplate and an inferior endplate, such that each of the endplates includes a first portion having a solid structure and a second portion having a porosity as taught by Cryder to provide a useful part, specifically an implant which promotes and enhances bone growth and fusion. Additionally, Cryder teaches that “the implants of the disclosure may be manufactured from any of these or other additive manufacturing processes currently known or later developed” (paragraph [0048]). The Examiner notes that the process of Feldmann is later developed, thus Cryder specifically teaches that such a production method is obvious.
Additionally, or alternatively, Feldmann is silent regarding wherein the at least the portion of the implantable device comprises a macrostructure having a printed density in a range of about 99.5 percent to about 100 percent.
Dean is similarly concerned with the design and fabrication of an implant that is restorative in the immediate and long term (paragraph [0019]). Dean teaches “a system and method for optimizing part orientation when manufacturing the part using 3D printing, e.g., selective laser melting techniques” (paragraph [0033]). Dean teaches that “FIG. 39 illustrates relative density of laser-based and powder-bed-based AM NiTi parts as a function of scan velocity for different laser powers” (paragraph [0077]). Dean teaches that “FIG. 40 illustrates relative density of laser-based and powder-bed-based AM nitinol parts as a function of energy density” (paragraph [0078]). Dean teaches that “the effects of SLM process parameters on part density, impurity pickup, transformation characteristics, and shape memory behavior are presented” (paragraph [0238]). Dean teaches that “this sample has a measured relative density of 98% and the micrograph confirms that it is free of any visible pores” (which reads upon “wherein the at least the portion of the implantable device comprises a macrostructure having a printed density in a range of about 99.5 percent to about 100 percent”, as recited in the instant claim; paragraph [0256]; if the portion of the part has a measured relative density of 98% then the microstructures that make up the portion must also have measured relative density of 98%). Dean teaches that “the optimal build parameters for SLM rendering of maximally dense NiTi parts on a Phenix-PXM machine are determined to result from an energy density of ωv=55.5 J/mm3” (paragraph [0272]; maximally dense parts are optimal for implants). Dean teaches that “using the optimized parameter setup, it is shown that impurity pickup can be relatively minimized while maintaining high density in the SLM part” (paragraph [0262]; again teaching the importance of maintaining high density when printing implants). Dean teaches “the effect of varying hatch spacing while using the optimal parameter setup on relative density, and it is shown that with these process parameters, hatch spacing between 60 μm and 145 μm can be used to produce fully dense parts (>98% relative density)” (which reads upon “wherein the at least the portion of the implantable device comprises a macrostructure having a printed density in a range of about 99.5 percent to about 100 percent”, as recited in the instant claim; paragraph [0259]; fully dense parts (>98% relative density) are optimal).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the parameters of Feldmann to produce fully dense parts (>98% relative density), as taught by Dean, see FIGs. 39-40 and related text, because fully dense parts are optimal for at least a portion of an implant.
Feldmann is silent regarding the physical attributes of the finished implant, specifically, Feldmann is silent regarding a printed hardness in a range from about 32 HRC to about 40 HRC. Regarding the subject limitations, in order to carry out the invention of Feldmann, it would have been necessary and obvious to look to the prior art for exemplary values of hardness used in medical implants prepared by laser additive manufacturing. Yan provides this teaching. Yan is similarly concerned with medical implants (paragraph [0003]). Yan teaches laser additive manufacturing technology (paragraph [0023]). Yan teaches that the SLM prepared samples basically compose of completely dense and fine equiaxed grains, and there are only a small amount of columnar crystals existing at the junction of the melt channel (paragraph [0071]; SLM is selective laser melting). Yan teaches to use a microhardness tester (model Leitz Wetzlar, Germany) to measure the Vickers microhardness of the sample (paragraph [0072]). Yan teaches to polish the surface of the test surface of the SLM samples to reach a roughness of less than 0.15 μm, measure the microhardness values at different positions on the surface of the SLM sample, and take an average value after 10 measurements (paragraph [0072]). Yan teaches that the average microhardness obtained by the testing was 356±6.2 HV0.2 (which reads upon claim 8; paragraph [0072]; about 32 HRC is about 303 Vickers; about 40 HRC is about 388 Vickers). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the medical implant of the prior art combination, and adjusting and varying the value of hardness, such as within the claimed ranges, as taught by Yan, motivated to form a conventional medical implant using known and tested values of hardness predictably suitable for medical implant applications.
Regarding claims 2-3, modified Feldmann teaches the method of claim 1 as stated above. One of ordinary skill in the art would understand that the profile of any part made by powder bed fusion has an irregular profile. Such a profile would be observable in a reference plane under 50x magnification using light optical microscopy.
Regarding claims 6, 10-11, and 14-15, modified Feldmann teaches the method of claim 5 as stated above. Cryder teaches that “an expander 190 is adjustably located between the superior endplate 110 and the inferior endplate 150” (paragraph [0050]). Cryder teaches that “the expander 190 is used to adjust the vertical height of the superior endplate 110 with respect to the inferior endplate 150” (paragraph [0050]). Cryder teaches that “the expander 190 may include one or more ramped surfaces 194 configured to engage one or more ramped surfaces 196 on the superior and inferior endplates 110, 150, respectively” (paragraph [0050]).
Regarding claim 7, modified Feldmann teaches the method of claim 1 as stated above. Cryder teaches “an implant, such as an expandable implant, includes a superior endplate and an inferior endplate, and that each of the endplates may include a first portion having a solid structure and a second portion having a porosity” (paragraph [0049]). Dean teaches that “this sample has a measured relative density of 98% and the micrograph confirms that it is free of any visible pores” (paragraph [0256]).
Regarding claim 9, modified Feldmann teaches the method of claim 1 as stated above. Feldmann teaches that “each rectangular laser energy pixel has a substantially uniform power density, the rectangular laser energy pixels are arranged to form a linear array of laser energy pixels on the build surface with no spacing between adjacent laser energy pixels, and exposure of a layer of material on the build surface to the linear array of laser energy pixels melts at least a portion of the layer of material (i.e., a line array) may have a uniform power density along the long length of the line array” (paragraph [0004]).
Regarding claim 12, modified Feldmann teaches the method of claim 11 as stated above.
Modified Feldmann is silent regarding wherein the interconnected components have spatial resolution and accuracy at scales less than about 10 micrometers (pm).
It is reasonable to conclude that wherein the interconnected components have spatial resolution and accuracy at scales less than about 10 micrometers (µm) is inherent to the implant of modified Feldmann. Support for said conclusion is found in the use of like materials, manufactured in a like manner, which would result in the claimed property. For example modified Feldmann teaches using pixelated laser energy based additive manufacturing to create a medical implant, as stated above.
Applicant teaches that the methods described herein (pixelated laser energy based additive manufacturing) allow in-layer interconnection of components that have macrostructure (e.g., dimensions from 1 mm to 200 mm or greater), microstructure (e.g., dimensions from 1 micrometer (µm) to 1000 micrometers (µm)), and nanostructure (e.g., dimensions under 100 µm), and that in some embodiments, the interconnected components have spatial resolution and accuracy at scales less than about 10 µm).
The burden is upon the Applicant to prove otherwise. In addition, the presently claimed property would obviously have been present once the implant of modified Feldmann is provided. In re Best, Bolton, and Shaw, 195 USPQ 430 (CCPA 1977).
Regarding claim 17, modified Feldmann teaches the method of claim 1 as stated above. Feldmann teaches that “a recoater head 570 is arranged to add a layer of material (e.g., a powdered metal) on to the build surface after the vertical slide is indexed down” (paragraph [0087]).
Regarding claims 21-22, modified Feldmann teaches the method of claim 1 as stated above. Feldmann teaches that one of the issues the present invention addresses is that “if the incident laser spot energy is too high and the scan speed is increased to compensate in order reduce the resulting metal vaporization issues noted above, the thermal energy may not be able to propagate sufficiently fast into the powder layer to fully melt and fuse all the metal powder; accordingly, the final part will then contain voids of unmelted metal powder, which may compromise the properties of the final part” (paragraph [0037]). The method of Feldmann addresses this issue resulting in a part which is substantially devoid of defect at or adjacent to a surface of the implant. Feldmann is silent regarding allowing defects at or adjacent to a surface of the implant. Cryder is silent regarding allowing defects at or adjacent to a surface of the implant.
Regarding claim 29, modified Feldmann teaches the method of claim 1 as stated above. Feldmann teaches “intervertebral implants configured to promote intervertebral fusion and associated methods thereof” (paragraph [0003]).
Regarding claim 35, modified Feldmann teaches the method of claim 1 as stated above. Cryder teaches that “the implant 100 may combine solid and porous portions to enhance structural stability and bone growth” (paragraph [0052]). Cryder teaches that “endplates having geometries designed for enhanced bone fusion, intervertebral implants, such as expandable implants, utilizing such endplates, and methods of increasing bone graft packing are provided” (paragraph [0007]).
Regarding claim 36, modified Feldmann teaches the method of claim 1 as stated above. Cryder teaches that “the expander 190 also provides a connecting point at a threaded connection 192 for an inserter” (paragraph [0050]).
Regarding claims 43-44, modified Feldmann teaches the method of claim 1 as stated above. Cryder teaches that “the parts may be 3D printed with materials, such as biocompatible materials, including metals, polymers, ceramics or combinations thereof” (paragraph [0045]). Cryder teaches that “biocompatible metals may include titanium, titanium alloys, cobalt-chrome, stainless steel, or the like and biocompatible plastics, such as PEEK may be suitable” (paragraph [0045]).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1), as applied to claims 11 and 14 above, and further in view of Wang et al. (US 20180200066 A1).
Regarding claim 13, modified Feldmann teaches the method of claim 11 as stated above.
Modified Feldmann is silent regarding wherein the interconnected components collectively define conduits through the implantable device.
Wang is similarly concerned with forming implants by additive manufacturing (paragraph [0029]). Wang teaches that “the method can be performed so that the structure is either porous or solid and, if porous, the pores can be interconnecting to provide an interconnected porosity” (which reads upon “wherein the interconnected components collectively define conduits through the implantable device”, as recited in the instant claim; paragraph [0076]). Wang teaches that “the preferred pore structure is interconnected, with a minimum pore size between about 80 μm and 100 μm and a maximum pore size between 80 μm and 800 μm” (paragraph [0081]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the implant of Feldmann including interconnected porosity, as taught by Wang because it is the preferred pore structure.
Regarding claim 16, modified Feldmann teaches the method of claim 14 as stated above.
Modified Feldmann is silent regarding wherein the interconnected components comprise deployable securing spikes for securing the implantable device to one or more vertebrae.
Wang is similarly concerned with forming implants by additive manufacturing (paragraph [0029]). Wang teaches that “the tibial component 300 of FIGS. 9 and 10 include two or more spikes 330, which have a porous portion 332 and a solid tip portion 334” (which reads upon “deployable securing spikes for securing the implantable device”, as recited in the instant claim; paragraph [0068]). Wang teaches that “the porous portions 332 of the spikes 330 can have a solid core 336 to reinforce the connection of the spikes 330 to baseplate 312” (paragraph [0068]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Feldmann to include spikes, as taught by Wang to increase bone adhesion.
Claims 18-20 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1), as applied to claim 1 above, and further in view of Cowan et al. (US 20190254836 A1).
Regarding claims 18-20, modified Feldmann teaches the method of claim 1 as stated above. Cryder teaches that “the parts may be 3D printed with materials, such as biocompatible materials, including metals, polymers, ceramics or combinations thereof” (paragraph [0045]).
Modified Feldmann is silent regarding wherein, after conclusion of the repeating steps, the at least one ceramic component is a ceramic coating that coats at least a portion of the at least one metallic component, wherein the ceramic coating is resorbable, or wherein the ceramic coating comprises hydroxyapatite (HA).
Cowan is similarly concerned with and expandable spinal implant system (title). Cowan teaches that “the components of expandable spinal implant system may be formed using a variety of subtractive and additive manufacturing techniques, including, but not limited to machining, milling, extruding, molding, 3D-printing, sintering, coating, vapor deposition, and laser/beam melting” (paragraph [0067]). Cowan teaches that “various components of the expandable spinal implant system may be coated or treated with a variety of additives or coatings to improve biocompatibility, bone growth promotion or other features” (which reads upon “wherein, after conclusion of the repeating steps, the at least one ceramic component is a ceramic coating that coats at least a portion of the at least one metallic component”, as recited in instant claim 18; paragraph [0067]). Cowan teaches that “the endplates 110, 120, 210, 220, 310, 320, 410, 420 may be selectively coated with bone growth promoting or bone ongrowth promoting surface treatments that may include, but are not limited to: titanium coatings (solid, porous or textured), hydroxyapatite coatings, or titanium plates (solid, porous or textured)” (which reads upon “wherein the ceramic coating is resorbable”, as recited in instant claim 19; which reads upon “wherein the ceramic coating comprises hydroxyapatite (HA)”, as recited in instant claim 20; paragraph [0067]; hydroxyapatite (HA) is a resorbable ceramic). Cowan teaches that “the components of the expandable spinal implant and system described herein can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites” (which reads upon “wherein the powder bed further contains ceramic powder”, as recited in the instant claim; paragraph [0066]). Cowan teaches that “the components of expandable spinal implant system, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations” (which reads upon “wherein the powder bed further contains ceramic powder, such that, during at least some of the repeating steps, the energy pixels form at least one metallic component of the implantable device and concurrently form at least one ceramic component of the implantable device”, as recited in the instant claim; paragraph [0066]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the hydroxyapatite to the powder bed of Feldmann, as taught by Cowan to provide a coating which promotes bone growth or bone ongrowth to the implant.
Regarding claims 27-28, modified Feldmann teaches the method of claim 1 as stated above. Cowan teaches that “various components of spinal implant system may be formed or constructed material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference” (paragraph [0067]; various components having various desired elasticity reads on a first discrete region of the at least a portion of the implantable implant has a first modulus of elasticity, and a second discrete region of the at least a portion of the implantable implant has a second modulus of elasticity that differs from the first discrete region).
25. Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1), as applied to claim 22 above, and further in view of Kurlo et al. Novel Development of Implant Elements Manufactured through Selective Laser Melting 3D Printing, Advanced Engineering Materials Volume 23, Issue 7 2001488, First published: 15 April 2021.
26. Regarding claims 23-24, modified Feldmann teaches the method of claim 22 as stated above. Cryder teaches that “the material for both the solid structure and the lattice structure can be Ti-6Al-4V” (which reads upon “a titanium-aluminum-vanadium (TAV) alloy”, as recited in instant claim 24; paragraph [0045]).
Modified Feldmann is silent regarding wherein the one or more microstructures is alpha martensitic after conclusion of the repeating steps.
Kurlo is similarly concerned with novel bone fracture fixation implants made of titanium alloy (Ti–6Al–4V) manufactured through selective laser melting (SLM) 3D printing technology (3DPT) (which reads upon “a titanium-aluminum-vanadium (TAV) alloy”, as recited in the instant claim; abstract). Kurlo teaches that “not only are implant chemical composition and shape being modified, but implant surface is also undergoing various modifications; the aim of these modifications is to facilitate and accelerate the healing process and implant osseointegration in the human body” (page 1). Kurlo teaches that “standard technological parameters given by the printer software were applied for accurate printing using Ti–6Al–4V and to obtain the desired geometry based on the automatic selection on the printer's software” (pages 2-3). Kurlo teaches that “the parameters determining the temperature range and process time of the heat treatment were suggested by the printer manufacturer” (page 3). Kurlo teaches that “the microstructure of the as-built samples is mostly α′ martensite” (which reads upon “wherein the one or more microstructures is alpha martensitic after conclusion of the repeating steps”, as recited in the instant claim; page 9).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the implant of Feldmann using standard technological parameters given by the printer software, as taught by Kurlo to ensure accurate printing using Ti–6Al–4V and to obtain the desired geometry based on the automatic selection on the printer's software. Kurlo teaches that using standard technological parameters to print Ti–6Al–4V results in the as-built samples being mostly α′ martensite.
Regarding claim 25, modified Feldmann teaches the method of claim 23 as stated above. Cryder teaches that “the implants may be further processed during and/or after manufacture utilizing various techniques, for example, abrasion, machining, polishing, or chemical treatment” (paragraph [0048]; abrasion reads on a surface finish roughness configured to promote osteogenesis).
Regarding claim 26, modified Feldmann teaches the method of claim 23 as stated above. Kurlo teaches that “metallographic examination of the star connector and long plate samples was performed after heat treatment (hyperquenching and aging) in a gas-cooled vacuum furnace” (page 3).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1), as applied to claim 29 above, and further in view of Eleraky et al., Cervical corpectomy: report of 185 cases and review of the literature, J Neurosurg (Spine 1) 90:35–41, 1999.
Regarding claim 30, modified Feldmann teaches the method of claim 29 as stated above. Eleraky teaches that “between 1987 and 1998 at our institution, 185 patients (126 men and 59 women) underwent anterior decompressive cervical corpectomy (performed by the senior author)” (which reads upon “after a vertebral corpectomy”, as recited in the instant claim; page 35). Accordingly, all instances of the method of modified Feldmann performed after 1987 are after a vertebral corpectomy.
Claims 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Feldmann et al. (US 20190299286 A1), in view of Cryder et al. (US 20180338838 A1), Dean et al. (US 20170014169 A1), and Yan et al. (US 20230023628 A1), as applied to claim 1 above, and further in view of Dani, Smart components by additive technologies, IOP Conf. Series: Materials Science and Engineering 480 (2019) 012016 IOP Publishing doi:10.1088/1757-899X/480/1/012016.
Regarding claims 31-34, modified Feldmann teaches the method of claim 1 as stated above.
Modified Feldmann is silent regarding electronic circuitry and smart electronics.
Dani is similarly concerned with medical implants formed by additive manufacturing (abstract). Dani teaches that “additive manufacturing is especially suited for the production of smart structures with structurally integrated components due to its layer-by-layer fabrication process” (page 1). Dani teaches that “applications for sensor or actuator integrated smart parts include sophisticated biomechanical devices monitoring the interface between implant and bone and smart tools to monitor the process conditions or to predict maintenance” (which reads upon “wherein the electronic circuitry comprises smart electronics configured to execute one or more computer programs”, as recited in instant claim 33; page 1). Dani teaches that “LBM enables a materially bonded embedding of functional components to obtain a maximum sensitivity of the adaptronic system” (page 1). FIG. 2 of Dani shows during at least one of the repeated directing steps, printing electronic circuitry onto the respective layer wherein the step of printing electronic circuitry comprises depositing a substrate onto the layer and further depositing semiconductor material and conductive traces over the substrate (page 3). Dani teaches that “sensors to be exploited include thermocouples, resistance strain gauges and capacitive differential pressure sensor” (which reads upon “wherein the electronic circuitry comprises one or more of an accelerometer, a strain gauge, a proximity sensor, a PH sensor, a thermal sensor, and a thermal conductor”, as recited in instant claim 34; page 3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Feldmann to incorporate smart electronics and sensors, as taught by Dani because sensor or actuator integrated smart parts include sophisticated biomechanical devices monitoring the interface between implant and bone.
Response to Arguments
Applicant's arguments filed 3/12/26 have been fully considered but they are not persuasive. Applicant argues that the office does not meet its burden to establish that a person of ordinary skill in the art would have any motivation to modify Yan to arrive at Applicant's claimed technology or that such a modification would be successful (remarks, page 9). This is not found convincing because the office action does not modify Yan.
Applicant argues that Applicant's claim 1 recites an approach that includes "projection of laser energy comprises adjacent energy pixels that share common boundaries on the build surface, and each pixel has a respective power density that is substantially uniform on the build surface" so as to ultimately form an implantable device "having a printed hardness in a range from about 32 HRC to about 40 HRC" (remarks, page 9). Applicant argues that Yan teaches an approach that utilizes only a single "laser spot," Yan at [0063] (remarks, page 9). This is not found convincing because Yan is not relied upon to teach “projection of laser energy comprises adjacent energy pixels that share common boundaries on the build surface, and each pixel has a respective power density that is substantially uniform on the build surface,” rather Feldmann provides this teaching as stated above. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Yan's approach of using a single laser spot of unknown power density and then arrive at the multi-pixel, power density- control approach of Applicant's claims represent a fundamental change to the way in which Yan operates - and it is well-settled that "[i]f the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious." MPEP 2143.01.VI (remarks, page 9). This is not found convincing because the rejection is not based on modifying Yan with Feldmann. Feldmann is silent regarding the physical attributes of the finished implant, specifically, Feldmann is silent regarding a printed hardness in a range from about 32 HRC to about 40 HRC. The rejection is based upon one of ordinary skill in the art before the effective filing date of the claimed invention looking to the existing prior art, such as Yan, to determine a known and tested HRC hardness when printing medical implants.
Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01 I. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP § 2112.01 II. Therefore, it is expected that the implant of the prior art possesses the properties as claimed in the instant claims since a) the claimed and prior art products are identical or substantially identical in composition (see overlap of materials in the prior art and new claims 43-44), b) the claimed and prior art products are identical or substantially identical in structure (same materials processed in the same way), and c) the claimed and prior art products are produced by identical or substantially identical processes (as claimed in claim 1). Since the Office does not have a laboratory to test the reference alloy, it is applicant’s burden to show that the prior art implant does not possess the properties as claimed in the instant claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA JANSSEN whose telephone number is (571)272-5434. The examiner can normally be reached on Mon-Thurs 10-7 and alternating Fri 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. The Examiner requests that interviews not be scheduled during the last week of each fiscal quarter or the last half of September, which is the end of the fiscal year. Q3: 6/22-6/26/26; Q4: 9/21-9/30/26.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached on (571)272-1401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA JANSSEN/Primary Examiner, Art Unit 1733
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