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 .
This Office action is in response to the amendment filed 06/24/2025. Claims 1-6, 40-49 and 51-54 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/24/2025 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.
Claims 1-2, 4, 41-46 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al. (U.S. 2007/0276501 A1).
Regarding claim 1, Mosnier teaches a method of manufacturing a spinal rod (Para. 0002, “The present invention relates to a method making it possible to produce the ideal curvature of a rod of vertebral osteosynthesis material designed to support a patient's vertebral column”; also see Para. 0053), comprising:
obtaining images of a patient’s spine (see par. 0018);
identifying a final geometric shape of the spinal rod (Para. 0017-0043 describe the method steps of identifying a final geometric shape of the spinal rod, steps a through j), the final geometric shape along a length of the spinal rod including at least one of a bend and a varying diameter (Fig 12, Para. 0029-0041, the final shape comprises a bend corresponding to the target vertebral curvature); and forming at least part of the spinal rod using a manufacturing process (see pars. 0044 and 0051, step K).
However, Mosnier fails to teach the step of uploading the images to a software suite to identify the final geometric rod shape, then forming a template that is used to form the rod by an additive manufacturing process, comprising selecting a material from which the at least part of the spinal rod will be formed and curing a plurality of layers of the selected material to form the spinal rod having the identified final geometric shape without the need for bending or other machining processes to conform to a patient's body.
Kottilingam teaches a method of manufacturing an item (Figs 1-4 & 10, Para. 0023, swirling device 102 “capable of being manufactured by selective laser melting”) comprising:
identifying a final geometric shape of the item (Para. 0026, “selective laser melting is achieved from a predetermined design file or two-dimensional slices of a three-dimensional file, for example, from a computer-aided design program”); and
forming at least part of the item using an additive manufacturing process (Para. 0025, selective laser melting is used to form the swirling device 102), comprising:
selecting a material from which the at least part of the item will be formed (Para. 0027-0041, the material for the atomized powder and the substrate are selected prior to the selective laser melting); and
curing a plurality of layers of the selected material to form the item having the identified final geometric shape without the need for bending or other machining processes to conform to a final end usage of the item (Para. 0025, “selective laser melting distributes an atomized powder onto a substrate plate … using a coating mechanism. … The atomized powder is melted … to form a portion or layer of a three-dimensional product, such as, a portion of the swirling device 102. The process is repeated to form the three-dimensional product”, such that the item is formed without the need for bending or other machining processes and is ready for use).
Betz et al. teach a method of producing patient-specific spinal implants by obtaining images of a patient’s spine (see par. 0078); uploading the images to a software suite (see pars. 0097 and 0106); and generating a spinal implant template to form the final implant (see pars. 0099 and 0105).
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 method of Mosnier to comprise the additive manufacturing process of Kottilingam and the planning steps of Betz et al. Such a modification would be advantageous in allowing for a more streamlined manufacturing process capable of producing a fully formed spinal rod that is immediately ready for implantation without additional manipulation or machining processes.
In view of such a modification, the combination of Mosnier in view of Kottilingam and Betz et al. teach a method of manufacturing a spinal rod, comprising:
obtaining images of a patient’s spine;
uploading the images to a software suite;
identifying a final geometric shape of the spinal rod using the software suite, the final geometric shape along a length of the spinal rod including at least one of a bend and a varying diameter; generating a template from the final geometric shape; and
forming at least part of the spinal rod using an additive manufacturing process using the template, comprising:
selecting a material from which the at least part of the spinal rod will be formed; and
curing a plurality of layers of the selected material to form the spinal rod having the identified final geometric shape without the need for bending or other machining processes to conform to a patient's body.
Regarding claim 2, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method according to claim 1, wherein selecting the material includes selecting a molybdenum rhenium alloy from which the at least part of the spinal rod will be formed (Kottilingam, Para. 0031, molybdenum forms “about 1.3% to about 1.7%” and rhenium forms “about 2.6% to about 3%” of the substrate, such that at least part of the spinal rod is formed of a molybdenum rhenium alloy).
Regarding claim 4, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method according to claim 1, wherein selecting the material includes selecting a titanium or a titanium alloy from which the at least part of the spinal rod will be formed (Kottilingam, Para. 0029, a titanium alloy comprising 3.5% titanium may be used for the substrate portion of the spinal rod).
Regarding claim 41, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method according to claim 1, wherein identifying the final geometric shape includes identifying a bend (Mosnier, Figs 6-12, Para. 0087-0089, the rod is configured such that it has a bend; see annotated Figures 10 and 12).
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Regarding claim 42, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method according to claim 41, wherein identifying the final geometric shape further comprises identifying a first bend radius for the bend in the spinal rod and identifying a second bend with a second bend radius different from the first bend radius, the bend and the second bend being located at different locations on the length of the spinal rod (Mosnier, see annotated Figures 10 and 12 and Para. 0087-0089, the rod has a first and second bend each at a different location and each with a different bend radius).
Regarding claim 43, Mosnier teaches a method of manufacturing a spinal rod (Para. 0002, “The present invention relates to a method making it possible to produce the ideal curvature of a rod of vertebral osteosynthesis material designed to support a patient's vertebral column”; also see Para. 0053), the method comprising:
obtaining images of a patient’s spine (see par. 0018);
identifying a final geometric shape of the spinal rod using an overlay on a plurality of anatomical landmarks in a patient (Para. 0017-0043 describe the method steps of identifying a final geometric shape of the spinal rod, steps a through j, based on a wire model of a patient’s spine comprising a plurality of anatomical landmarks); and
forming the spinal rod using a manufacturing process (Para. 0044, “k) from a straight rod producing the curvature of the rod according to [the method steps]”; Para. 0051, “Preferably, the curvature produced in step k) is done by cold bending”).
However, Mosnier fails to teach the step of uploading the images to a software suite and an imaging modality to identify the final geometric rod shape, and generating a template to form the final geometric shape using an additive manufacturing process comprising selecting a material that includes molybdenum and rhenium, the material being used to form at least part of the spinal rod and curing a plurality of layers to form the spinal rod directly into the final geometric shape, wherein the formed spinal rod in the final geometric shape does not require additional manipulation in order to conform to a patient's body.
Kottilingam does teach a method of manufacturing an item (Figs 1-4 & 10, Para. 0023, swirling device 102 “capable of being manufactured by selective laser melting”), the method comprising:
identifying a final geometric shape of the item (Para. 0026, “selective laser melting is achieved from a predetermined design file or two-dimensional slices of a three-dimensional file, for example, from a computer-aided design program”); and
forming the item using an additive manufacturing process (Para. 0025, selective laser melting is used to form the swirling device 102) comprising:
selecting a material that includes molybdenum and rhenium, the material being used to form at least part of the spinal rod (Para. 0027-0041, the material for the atomized powder and the substrate are selected prior to the selective laser melting, the substrate including molybdenum and rhenium); and
curing a plurality of layers to form the item directly into the final geometric shape, wherein the formed item in the final geometric shape does not require additional manipulation in order to conform to a final end usage of the item (Para. 0025, “selective laser melting distributes an atomized powder onto a substrate plate … using a coating mechanism. … The atomized powder is melted … to form a portion or layer of a three-dimensional product, such as, a portion of the swirling device 102. The process is repeated to form the three-dimensional product”, such that the item is formed without the need for bending or other machining processes and is ready to use).
Betz et al. teach a method of producing patient-specific spinal implants by obtaining images of a patient’s spine (see par. 0078); uploading the images to a software suite and an imaging modality (see pars. 0097 and 0106); and generating a spinal implant template to form the final implant (see pars. 0099 and 0105).
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 method of Mosnier to comprise the additive manufacturing process of Kottilingam and the planning steps of Betz et al. Such a modification would be advantageous in allowing for a more streamlined manufacturing process capable of producing a fully formed spinal rod that is immediately ready for implantation without additional manipulation or machining processes.
In view of such a modification, the combination of Mosnier in view of Kottilingam and Betz et al. teaches a method of manufacturing a spinal rod, the method comprising:
obtaining images of a patient’s spine;
uploading the images to a software and an imaging modality;
identifying a final geometric shape of the spinal rod using an overlay on a plurality of anatomical landmarks in a patient; and
generating a template from the final geometric shape; and
forming the spinal rod using an additive manufacturing process using the template comprising:
selecting a material that includes molybdenum and rhenium, the material being used to form at least part of the spinal rod; and
curing a plurality of layers to form the spinal rod directly into the final geometric shape,
wherein the formed spinal rod in the final geometric shape does not require additional manipulation in order to conform to a patient's body.
Regarding claim 44, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method of claim 43, wherein the method is for manufacturing the spinal rod and the final geometric shape includes at least one bend (Mosnier, Figs 6-12, Para. 0087-0089, the rod is configured such that it has at least a first bend; see annotated Figures 10 and 12).
Regarding claim 45, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method of claim 44, wherein the at least one bend has a predetermined radius (Mosnier, Figs 6-12, Para. 0087-0089, the first bend is specifically configured with a predetermined radius in order to match a desired curvature of the spine).
Regarding claim 46, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method of claim 43, further comprising using software and an imaging modality to identify the plurality of anatomical landmarks in the patient (Mosnier, Para. 0018-0029, step a) involves taking an x-ray of the vertebral column of a patient, identifying anatomical landmarks in step b), and in step d) performing a software modeling of the patient’s spine).
Regarding claim 51, the combination of Mosnier in view of Kottilingam and Betz et al. teaches the method of claim 43, wherein selecting the material includes selecting from the group consisting of molybdenum and rhenium, titanium and cobalt chrome alloy (Kottilingam, Para. 0031, the materials used for the substate include molybdenum and rhenium, and titanium and cobalt chrome alloy).
Claims 3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al. (U.S. 2007/0276501 A1) as applied to claims 1 and 43 above, and further in view of Roth (US Patent No. 2017/0216494 A1).
Regarding claim 3, the combination of Mosnier, Kottilingam and Betz et al. teaches the method according to claim 1, wherein selecting the material includes selecting a molybdenum rhenium alloy from which the at least part of the spinal rod will be formed (Kottilingam, Para. 0031, molybdenum forms “about 1.3% to about 1.7%” and rhenium forms “about 2.6% to about 3%” of the substrate, such that at least part of the spinal rod is formed of a molybdenum rhenium alloy).
The combination of Mosnier in view of Kottilingam and Betz et al. fails to teach that the molybdenum rhenium alloy contains between 40 and 51% molybdenum and rhenium.
However, Roth does teach a method of manufacturing a spinal rod (Para. 0011, “the novel metal alloy can be used to form a core of a portion or all of a medical device. For example, a medical device can be in the form of a rod”; also see Para. 0056 & Para. 0065), comprising identifying a final geometric shape of the spinal rod (Para. 0026, “the raw starting material can be first annealed to soften and then machined into the metal into a desired shape”, with the desired shape being identified prior to the machining step), and forming at least part of the spinal rod using an additive manufacturing process (Para. 0011, “the core of the rod can be formed of the metal alloy and then the outside of the core can then be coated with one or more other materials”), comprising:
selecting a material from which the at least part of the spinal rod will be formed (Para. 0010, “the core of the rod is formed of a metal (e.g., iron, CoCr alloy, titanium alloy, SS steel, MoHfC, MoY.sub.2O.sub.3, MoCs.sub.2O, MoW, MoTa, MoZrO.sub.2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.) … and the other layer of the clad rod is formed of the metal alloy”, with the material selected prior to formation of the rod); and
curing a plurality of layers of the selected material to form the spinal rod according to the identified final geometric shape (Para. 0011, the inner and outer layers are annealed, which is followed by curing and forming the rod in the final shape); and
wherein selecting the material includes selecting a molybdenum rhenium alloy from which the at least part of the spinal rod will be formed, the molybdenum rhenium alloy containing between 40 and 51% molybdenum and rhenium (Roth, table 1, molybdenum may be between 51-54% of the weight and rhenium may be 46-49% of the weight).
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 method of the combination of Mosnier in view of Kottilingam and Betz to comprise the additional method step of selecting a molybdenum rhenium alloy from which the at least part of the spinal rod will be formed, the molybdenum rhenium alloy containing between 40 and 51% molybdenum and rhenium, in the manner of Roth. Such a modification may be advantageous in simplifying the manufacturing process of Kottilingam by only utilizing two metals, with molybdenum rhenium alloys being a well known biomaterial in the art.
Regarding claim 5, the combination of Mosnier, Kottilingam and Betz et al. fails to teach the method step of forming a portion of the spinal rod using a process other than additive manufacturing.
However, Roth does teach a method of manufacturing a spinal rod (Para. 0011, “the novel metal alloy can be used to form a core of a portion or all of a medical device. For example, a medical device can be in the form of a rod”; also see Para. 0056 & Para. 0065), comprising identifying a final geometric shape of the spinal rod (Para. 0026, “the raw starting material can be first annealed to soften and then machined into the metal into a desired shape”, with the desired shape being identified prior to the machining step), and forming at least part of the spinal rod using an additive manufacturing process (Para. 0011, “the core of the rod can be formed of the metal alloy and then the outside of the core can then be coated with one or more other materials”), comprising:
selecting a material from which the at least part of the spinal rod will be formed (Para. 0010, “the core of the rod is formed of a metal (e.g., iron, CoCr alloy, titanium alloy, SS steel, MoHfC, MoY.sub.2O.sub.3, MoCs.sub.2O, MoW, MoTa, MoZrO.sub.2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.) … and the other layer of the clad rod is formed of the metal alloy”, with the material selected prior to formation of the rod); and
curing a plurality of layers of the selected material to form the spinal rod according to the identified final geometric shape (Para. 0011, the inner and outer layers are annealed, which is followed by curing and forming the rod in the final shape); and
forming a portion of the spinal rod using a process other than additive manufacturing (Roth, Para. 0057, “when a solid rod of the metal alloy is formed, the rod is then formed into a tube … by a variety of processes such as, but not limited to, cutting or drilling (e.g., gun drilling, etc.) or by cutting (e.g., EDM, etc.). The cavity or passageway formed in the rod typically is formed fully through the rod; however, this is not required”, such that the cavity may be a portion formed in and limited to one edge or both edges of the rod).
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 method of the combination of Mosnier in view of Kottilingam and Betz et al. to comprise the additional method step of forming a portion of the spinal rod using a process other than additive manufacturing in the manner of Roth. Such a modification would be advantageous in allowing for a wider variety of potential applications of the method of the combination, allowing for secondary manufacturing steps to provide a wider variety of spinal rods used for different applications and with different structural characteristics.
Regarding claim 6, the combination of Mosnier in view of Kottilingam and Betz et al. fails to teach the method step of forming a portion of the spinal rod separate from the at least part of the spinal rod, the portion formed through the selection of a second material different than the material.
However, Roth does teach a method of manufacturing a spinal rod (Para. 0011, “the novel metal alloy can be used to form a core of a portion or all of a medical device. For example, a medical device can be in the form of a rod”; also see Para. 0056 & Para. 0065), comprising identifying a final geometric shape of the spinal rod (Para. 0026, “the raw starting material can be first annealed to soften and then machined into the metal into a desired shape”, with the desired shape being identified prior to the machining step), and forming at least part of the spinal rod using an additive manufacturing process (Para. 0011, “the core of the rod can be formed of the metal alloy and then the outside of the core can then be coated with one or more other materials”), comprising:
selecting a material from which the at least part of the spinal rod will be formed (Para. 0010, “the core of the rod is formed of a metal (e.g., iron, CoCr alloy, titanium alloy, SS steel, MoHfC, MoY.sub.2O.sub.3, MoCs.sub.2O, MoW, MoTa, MoZrO.sub.2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.) … and the other layer of the clad rod is formed of the metal alloy”, with the material selected prior to formation of the rod); and
curing a plurality of layers of the selected material to form the spinal rod according to the identified final geometric shape (Para. 0011, the inner and outer layers are annealed, which is followed by curing and forming the rod in the final shape); and
forming a portion of the spinal rod separate from the at least part of the spinal rod, the portion formed through the selection of a second material different than the material (Roth, Para. 0011, “the core of the rod can be formed of the metal alloy and then the outside of the core can then be coated with one or more other materials (e.g., another type of metal or metal alloy, polymer coating, ceramic coating, composite material coating, etc.)”)
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 method of the combination of Mosnier in view of Kottilingam and Betz et al. to comprise the additional method step of forming a portion of the spinal rod separate from the at least part of the spinal rod, the portion formed through the selection of a second material different than the material in the manner of Roth. Such a modification would be advantageous in allowing for a wider variety of potential applications of the method of the combination, allowing for secondary manufacturing steps to provide a wider variety of spinal rods used for different applications and with different structural characteristics.
Claims 40 and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al. as applied to claims 1 and 43 above, and further in view of Barrus (US Patent No. 2016/0120575 A1).
Regarding claim 40, the combination of Mosnier in view of Kottilingam and Betz et al. fails to teach the method step of identifying the final geometric shape including identifying a varying diameter.
However, Barrus does teach a spinal rod formed in a final geometric shape (Fig 2, Para. 0033, spinal fixation member 10 including core member 40), the final geometric shape including a varying diameter (Fig 22, Para. 0035, first portion 40a of core member 40 has a fixed outer diameter 41, and the second portion 40b has a second diameter that “varies along at least a portion of the second portion 40b and is smaller than the fixed outer diameter 41”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a portion of the spinal rod produced by the method of the combination of Mosnier in view of Kottilingam and Betz et al. in order to comprise a varying diameter in the manner of Barrus. Such a modification may be advantageous in allowing for a wider variety of applications and uses of the resulting device, and may for instance allow the spinal rod to possess a portion with a reduced diameter capable of connecting to a separate device (see Barrus Figs 2-3).
Regarding claim 47, the combination of Mosnier in view of Kottilingam and Betz et al. fails to teach the method step of identifying a first stiffness for a first part of the spinal rod and a second stiffness for a second part of the spinal rod, the first stiffness being different from the second stiffness, the spinal rod being formed to include the first stiffness in the first part and the second stiffness in the second part.
However, Barrus does teach a spinal rod (Fig 2, Para. 0033, spinal fixation member 10 including core member 40), the spinal rod having a first part with a first stiffness (Para. 0039, core member 40 has a specific stiffness; Para. 0040, first portion 40a of the core member 40 has a greater stiffness than the second portion 40b) and a second part with a second stiffness (Para. 0040, “the stiffness of the material of the core member 40 at the second portion 40b … may be less than that of the first portion 40a”), the first stiffness being different from the second stiffness (first portion 40a has greater stiffness), the spinal rod being formed to include the first stiffness in the first part and the second stiffness in the second part (as the core member 40 is a unitary part, it is formed to include the first and second parts with their respective first and second stiffness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a portion of the spinal rod produced by the method of the combination of Mosnier in view of Kottilingam and Betz et al. to comprise a different stiffness in the manner taught by Barrus. Such a modification may be advantageous in allowing for the spinal rod to have more resilience to potential bending during use in certain areas where such bending may be permissible, while positioning the area with greater stiffness in regions where bending would be undesirable.
Regarding claim 48, the combination of Mosnier in view of Kottilingam, Betz et al., and Barrus fails to teach the method step of manufacturing the spinal rod such that the first part of the spinal rod has a first diameter and the second part of the spinal rod has a second diameter different from the first diameter.
However, Barrus does teach a spinal rod (Fig 2, Para. 0033, spinal fixation member 10 including core member 40), the final geometric shape including a varying diameter (Fig 22, Para. 0035, first portion 40a of core member 40 has a fixed outer diameter 41, and the second portion 40b has a second diameter that “varies along at least a portion of the second portion 40b and is smaller than the fixed outer diameter 41”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of the combination of Mosnier in view of Kottilingam, Betz et al., and Barrus in order for the spinal rod to comprise the first and second diameters of Barrus. Such a modification may be advantageous in allowing for a wider variety of applications and uses of the resulting device, and may for instance allow the spinal rod to possess a portion with a reduced diameter capable of connecting to a separate device (see Barrus Figs 2-3).
Regarding claim 49, the combination of Mosnier in view of Kottilingam, Betz et al., and Barrus teaches the method of claim 47, wherein selecting the material includes selecting titanium for the first part of the spinal rod and selecting molybdenum rhenium alloy for the second part of the spinal rod or implant (Kottilingam, the atomized powder may be titanium while the substrate may be a molybdenum rhenium alloy, such that the first part of the spinal rod may be titanium and the second part may be the molybdenum rhenium alloy, see Para. 0027 & Para. 0031).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al. as applied to claim 1 above, further in view of Williams (U.S. 10,194,953 B2).
Mosnier in view of Kottilingam and Betz et al. disclose the invention substantially as described above. However, Mosnier in view of Kottilingam and Betz et al. do not disclose an extension portion extending from the at least part of the spinal rod, the extension portion being made from a second metallic material.
Williams teaches a spinal rod extension which can be formed from titanium, titanium alloy, cobalt-chrome, stainless steel, or PEEK (see Fig. 1, element 105, and col. 10, lines 27-31) in the same field of endeavor for the purpose of attaching to an implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mosnier in view of Kottilingam and Betz et al. to include the step of forming an extension portion made from a second metallic material, the concept of which is disclosed by Williams, in order to provide a rod that can be attached to an existing spinal structure to enhance the stability of a patient’s spine.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al., further in view of Williams (U.S. 10,194,953 B2), as applied to claim 52 above, further in view of Biedermann et al. (U.S. 2006/0129147 A1).
Mosnier in view of Kittilingam, Betz et al. and Williams discloses the invention substantially as described above. However, Mosnier in view of Kittilingam, Betz et al. and Williams do not explicitly disclose a varying diameter spinal rod that ranges between 4 mm and 6 mm (spinal rod implant diameters commonly range from 4.5 mm to 6.35 mm).
Biedermann et al. disclose a spinal rod including a varying diameter (see Fig. 7b) in the same field of endeavor for the purpose of providing varying stiffness along the rod.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rod of Mosnier in view of Kottilingam, Betz et al., and Williams to include a varying diameter between 4 mm and 6 mm, in order to address the specific spinal support needs of the receiving patient.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Mosnier (US Patent No. 2016/0210374 A1) in view of Kottilingam (US Patent No. 2015/0068629 A1) and Betz et al., further in view of Williams (U.S. 10,194,953 B2), further in view of Biedermann et al. (U.S. 2006/0129147 A1) as applied to claim 53 above, further in view of Trieu et al. (U.S. 2014/0257393 A1).
Mosnier in view of Kittilingam, Betz et al, Williams, and Biedermann disclose the invention substantially as described above except for an oval cross-sectional profile of the rod.
Trieu et al. teach a spinal rod with an end having an oval cross-sectional profile in the same field of endeavor for the purpose of providing “a higher stiffness for fusion to resist flexion in the sagittal plane.” It would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to incorporate an oval rod section, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of shaping a spinal rod. In re Dailey and Eilers, 149 USPQ 47 (1966). Futhermore, the oval section has the advantage of providing heightened stiffness in a particular plane.
Response to Arguments
Applicant’s arguments filed 06/24/2025 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.
It is noted that the added method steps of uploading images of a patient’s spine to a software and an imaging modality, generating a template from a final geometric shape of a spinal implant, and using the template to form the spinal implant is a concept disclosed by Betz et al. Additionally, the prior art discloses a spinal rod having a bend and a varying diameter - round and oval combination, with an extension. The concept of using 3-D printing to form the required and final geometric shape is obvious to those of ordinary skill in the art. The claimed 3-D printing method is disclosed in the prior art, and one of ordinary skill would look to the specific method to form the claimed rod.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773