DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment to the claims filed on May 21, 2026, has been entered. Applicant’s amendment have overcome the claim objections, as well as the rejections under 35 USC § 101 to claim 16. Therefore, said objections/rejections are hereby withdrawn. Claims 13 – 22 and 25 are currently amended. Claims 1 – 7 are withdrawn. Claims 8 – 12 and 23 – 24 are cancelled. Claim 26 is new. Claims 13 – 22 and 25 – 26 are pending and under examination. The amendment necessitated the new grounds of rejection.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
New Grounds of Rejection
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13 – 15, and 18 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over GAIGNON et al. (US 2017/0304056 A1, “GAIGNON”), in view of Watanabe (US 2015/0259247 A1; of record) and Beam et al. (US 2003/0065400 A1; of record).
Regarding claim 13, GAIGNON teaches a method for manufacturing an artificial bone (e.g., [0017] “ceramic material part 11”, see [0016 – 0040]), based on shape data representing a three-dimensional shape of the artificial bone ([0017] “from the scanner data from the patient (STL files)”):
wherein in a charged state (see e.g., FIGs. 5, 9, 14) where the artificial bone (11) is charged in a missing portion (defect 10) of a living bone (body 2) (see FIGs. 2 – 6), the artificial bone (11) forms a bone body together with the living bone (see FIGs. 2 – 13),
the artificial bone (11) includes an outer surface (11b in FIG. 13; 11C in FIG. 15) that serves as an outer-side surface of the bone body in the charged state ([0088] “a surface part 11b which is not provided with a revascularization network, thus without channels (with only the microporosity) for a better resistance”; [0093] “a surface part 11C surrounding the bores 25, which is not provided with a revascularization network, thus without channels (with only the microporosity) for a better resistance”), and
an end surface (11B in FIG. 15) that is located on an opposite side of the outer surface (11C) and that is to be adjacent to a bottom surface of the missing portion in the charged state (e.g., see FIGs. 5, 8, 9, 15 and [0092] “a part 11B intended to come into contact with the patient's bone, in which the three-dimensional network of vascularization channels is more dense or is composed of square-section channels with a section larger than the channels of the part 11A”),
the artificial bone (11) includes an outer-side portion forming the outer surface (11C), and an inner-side portion forming entirety of the end surface (11B) (e.g., see FIGs. 5, 8, 9, 15 and [0082] – [0094]),
the outer-side portion is connected to the inner-side portion directly or via an intermediate portion (e.g., 11A, FIG. 15 [0091] “a core part 11A in which the three-dimensional network of revascularization channels is composed of square-section channels”), and extends continuously to the outer surface from a position at which the outer-side portion is connected to the inner-side portion or the intermediate portion (e.g., see FIGs. 5, 8, 9, 15),
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the inner-side portion further forms a peripheral surface that extends in a peripheral direction of surrounding the artificial bone when viewed from the outer surface toward the end surface (see the annotated copy of GAIGNON FIG. 15 below),
and the peripheral surface (e.g., outer-side portion peripheral surface in the above annotated figure) also extends from the end surface toward the outer surface and is to be adjacent to an inner surface included in the missing portion and excluding the bottom surface in the charged state (e.g., see the above annotated figure),
the method comprises:
a layer forming step of forming a ceramic layer, using a powder ceramic material ([0046] – [0047], [0094]);
a curing liquid applying step of applying, to a target region (e.g., [00900] – [0094] discloses an embodiment wherein the formed part comprises three different regions regarding its “porosity”) in the layer ([0047] – [0048]), based on the shape data ([0042] “acquiring a three-dimensional image of a patient's bone having the bone defect to be filled in; [0043] designing, by computer-aided design, a computing model of the synthetic block which shape corresponds to the bone defect”); and
repeating the layer forming step and the curing liquid applying step so as to form the artificial bone by a reaction product of the ceramic material cured ([0051] “optionally repeating said steps for providing a green part”),
wherein a region included in the target region and becoming the outer-side portion is defined as an outer-side region, and a region included in the target region and becoming the inner-side portion is defined as an inner-side region (e.g., [00900] – [0094] discloses an embodiment wherein the formed part comprises three different regions regarding its “porosity”), and
the curing liquid applying step includes applying the curing liquid to the target region, based on a position range of each of the outer-side region and the inner-side region expressed by the shape data (e.g., [0047] “forming, on a rigid support or on a part being manufactured, a first thermosetting composition layer comprising at least one ceramic material and a photocurable monomer; [0048] curing the first photocurable composition layer, by irradiation according to the pattern defined for said layer, forming a first stage; [0049] forming, on the first stage, a second photocurable composition layer; [0050] curing the second photocurable composition layer, by irradiation according to the pattern defined for said layer, forming a second stage”), thereby forming a single continuous porous portion that is entirety of the inner-side portion, and forming a dense portion that is entirety of the outer-side portion, wherein the dense portion has a dense degree higher than that of the porous portion (see [0090]), and
the dense degree indicates a ratio of a space occupied by the reaction product in the artificial bone (see [0034] “Advantageously, the channels forming the revascularization system have a greater section within the region of the part intended to contact the bone delimiting the bone defect, namely being square-section channels with a 400-600 μm side with a 200 μm tolerance, the core channels of the part being square-section channels with a smaller side; alternatively, the density of the channels forming the revascularization system can be higher within the one or more regions of the part intended to contact the bone defect.”, [0035] “The ceramic material constituting the part has in particular an intergranular microporosity, measured by mercury porosimetry, of 5-30% in volume, the micropores having a size of 0.1-10 μm.”, [0038] “the outer periphery of the part (considered in its position placed within the bone defect) has a structure as close as possible to the characteristics of the cortical bone: dense and rigid; and [0039] the portion of the part intended to come into contact with the patient's bone is very “porous” for allowing the fastest possible revascularization.”
GAIGNON does not disclose,
wherein the curing liquid includes a chelating agent, the artificial bone been formed by a reaction product of the ceramic material cured as a result of chelating reaction with the chelating agent in the target regions of the layers superimposed on each other,
applying the curing liquid such that an amount of the curing liquid applied to each unit area in the outer-side region is larger than an amount of the curing liquid applied to each unit area in the inner-side region, and
the dense degree indicates a ratio of a space occupied by the reaction product in the artificial bone, the dense degree of the porous portion is lower than a threshold value, and the threshold value is value within a range equal to or higher than 30% and equal to or lower than 65%.
Like GAIGNON, Watanabe teaches a layer stack object formation method that can form with a high strength and a good precision, a layer stack object that scarcely transforms to unabsorbable hydroxyapatite when transplanted into a living body, and has a high hardening speed, a high bone inducing ability, and a complex three-dimensional shape [0007-0013, 0135], the method comprising, inter alia, a layer forming step of forming a ceramic layer [0004, 0097-0112], using a powder ceramic material [0004, 0172] (see FIGs. 1 – 2); a curing liquid applying step of applying (see FIGs. 1-2, “powder layer stack formation hardening liquid” [0113-0120, 0173]), to a target region in the layer (e.g., “predetermined region” [0016], see FIGs. 1-2 [0117-0119]), a curing liquid including a chelating agent [0026-0037, 0120], based on the shape data [0117-0119, 0135]; and repeating the layer forming step and the curing liquid applying step so as to form the three-dimensional shaped object by a reaction product of the ceramic material with the chelating agent in the target regions of the layers superimposed on each other (see [0015-0017, 0135], and FIGs. 1-2 and [0179]).
Watanabe [0032] discloses that “It is preferable that the organic compound having carboxyl group be a chelate material [i.e., a chelating agent] that has an ability to capture a calcium ion contained in calcium phosphate, is non-toxic to a human body, and can be egested easily”, [0033] “Examples of the organic compound having carboxyl group include malic acid, succinic acid, citric acid, and edetic acid. Among these, citric acid that has 3 or more carboxyl groups per molecule and is water-soluble is more preferable because more carboxyl groups per molecule is preferable in order to improve the calcium ion capture ability.” [0026] – [0037]. [0120] "The organic compound having phosphate group or carboxyl group used in the powder layer stack formation hardening liquid tends to exhibit a strong acidity. Typically, a preferably pH is from 5 (weakly acidic) to 12 (basic) in terms of preventing corrosion or clogging of the nozzle head portion of the nozzle used. When a phytic acid is used as the organic compound having phosphate group, corrosion does not occur to the contrary, because phytic acid forms an anticorrosive coating over the surface of a metal such as SUS. Hence, a phytic acid is used favorably as the organic compound having phosphate group.”
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the curing liquid in the method of GAIGNON by selecting a curing liquid including a chelating agent, so that the artificial bone is formed by a reaction product of the ceramic material cured as a result of chelating reaction with the chelating agent in the target regions of the layers superimposed on each other, for the purpose of, as suggested by the prior art, providing a curing liquid having the ability to capture a calcium ion contained in calcium phosphate of the ceramic material, which is non-toxic to a human body, since Watanabe [0032] teaches that “It is preferable that the organic compound having carboxyl group be a chelate material [i.e., a chelating agent] that has an ability to capture a calcium ion contained in calcium phosphate, is non-toxic to a human body, and can be egested easily”. See MPEP 2143 (I) (G).
As to the limitation, “applying the curing liquid such that an amount of the curing liquid applied to each unit area in the outer-side region is larger than an amount of the curing liquid applied to each unit area in the inner-side region”.
Beam et al., teaches forming a macrostructure in an engineered regenerative biostructure in materials which are sinterable (e.g., ceramics [0097-0098]), by any 3DP process (three-dimensional printing process) ([0084], FIGs. 7A-7D), and discloses at [0089], inter alia, a “method involves double-printing, i.e., printing on a layer of powder, allowing the volatile part of the binder liquid to evaporate essentially completely, and printing more binder liquid onto the same place such that the binder substance which remains after the last printing is built up above the actual powder particles in the bed. The next layer of powder which is spread or deposited cannot occupy the region which is occupied by the built-up binder substance from the "puddle" formed by the repeat printing(s) at the same location. Eventually, when the binder material in the puddle decomposes and exits as gaseous decomposition products, the absence of particles in the region formerly occupied by the puddle yields a macrostructure of empty space.” – analogous to the claimed “an amount of the curing liquid applied to each unit area in the one-side region is larger than an amount of the curing liquid applied to each unit area in the opposite-side region, thereby forming a dense portion in the one-side portion, and forming a porous portion in the opposite-side portion.”
[0103] discloses “It may be desired that some portions of the biostructure be made so as to contain mesostructures (porous, see Beam et al. [0045]) and also to contain other regions which may have a more uniform packing density of powder particles, i.e., a more thorough joining of primitives so as not to exhibit mesostructures.” – Hence a dense portion and a porous portion. Beam et al. discloses the purpose could be for applications where the biostructure may require more strength than what is available from a biostructure containing only mesostructures everywhere.
[0104] One method of producing and eliminating mesostructures is by adjusting the saturation parameter during printing in different regions. “A sufficiently large saturation parameter may result in an essentially uniform distribution of powder particles in the final biostructure and primitives that are essentially fully bound to one another. A sufficiently small saturation parameter may result in the creation of mesostructures.”
[0105] Adjustment of the saturation parameter from one region of a biostructure to another, using a given dispenser, may be achieved by adjusting any of the variables which together make up the saturation parameter. This may be achieved by adjusting the amount of dispensed liquid per unit distance traveled along the principal direction of motion. – Hence, applying a larger amount of curing liquid to a one-side region of the target region).
[0124] “Further, the porosity of the biostructure may vary from region to region of the biostructure. For example, appropriate porosity might be used to imitate the structure of cortical bone (the dense hard outer portion of bone) or of cancellous bone (the softer inner portion of bone) or of both types of bone within a single biostructure.”
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the curing liquid applying step to the target region (GAIGNON [00900] – [0094], Watanabe [0024]), in the method for manufacturing a 3D shaped object of GAIGNON/Watanabe, such that an amount of the curing liquid applied to each unit area in the outer-side region is larger than an amount of the curing liquid applied to each unit area in the inner-side region, as suggested by the prior art of Beam et al., thereby forming a dense portion in the outer-side portion, and forming a porous portion in the inner-side portion, as taught and suggested by the prior art of Beam et al., for the purpose of, as suggested by Beam et al. [0124], having the porosity of the biostructure vary from region to region of the biostructure, to imitate the structure of cortical bone (the dense hard outer portion of bone) or of cancellous bone (the softer inner portion of bone) or of both types of bone within a single biostructure, and/or to, as suggested by Watanabe [0006], combining a porous texture portion and a dense texture portion that would lead to expression of a desired biocompatibility. See MPEP 2143 (I)(G).
As to the limitation, “the dense degree indicates a ratio of a space occupied by the reaction product in the artificial bone, the dense degree of the porous portion is lower than a threshold value, and the threshold value is value within a range equal to or higher than 30% and equal to or lower than 65%.”
GAIGNON/Watanabe/Beam teaches the method of manufacturing an artificial bone comprising a gradient (i.e., a “dense degree”) in the porosity of the different regions, but the reference does not explicitly disclose the dense degree of the porous portion being lower than a threshold value, and the threshold value is value within a range equal to or higher than 30% and equal to or lower than 65%.
GAIGNON, however, discloses that [0034] “the density of the channels forming the revascularization system can be higher within the one or more regions of the part intended to contact the bone defect”, [0038] “the outer periphery of the part has a structure as close as possible to the characteristics of the cortical bone: dense and rigid”, and [0039] “the portion of the part intended to come into contact with the patient's bone is very “porous” for allowing the fastest possible revascularization,” [0093] “a surface part 11C surrounding the bores 25, which is not provided with a revascularization network, thus without channels (with only the microporosity) for a better resistance.”
As the revascularizing speed and the artificial bone’s rigidity and resistance are variables that can be modified, among others, by adjusting said dense degree, with said revascularizing speed increasing as the dense degree is increased, the precise dense degree of the porous portion would have been considered a result effective variable by one having ordinary skill in the art before the time the invention was effectively filed. As such, without showing unexpected results, the claimed dense degree threshold value cannot be considered critical. Accordingly, one of ordinary skill in the art at time the invention was effectively filed would have optimized, by routine experimentation, the dense degree of the porous region in the method of GAIGNON/Watanabe/Beam to obtain the desired balance between revascularizing speed in the porous region of the artificial bone and the outer surface rigidity and resistance of the artificial bone (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (A).
Regarding claim 14, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 13, wherein the outer-side portion is connected to the inner-side portion via the intermediate portion (GAIGNON 11A, FIG. 15), a region included in the target region and becoming the intermediate portion is defined as an intermediate region (GAIGNON 11A, FIG. 15), and
the curing liquid applying step includes applying the curing liquid to the target region, based on a position range of each of the outer-side region, the inner-side region, and the intermediate region expressed by the shape data (e.g., GAIGNON [0017], [0041] – [0054]), such that an amount of the curing liquid applied to each unit area in the intermediate region is smaller than the amount of the curing liquid applied to each unit area in the outer-side region, and is larger than the amount of the curing liquid applied to each unit area in the inner-side region, thereby forming the intermediate portion having a dense degree higher than the dense degree of the porous portion and lower than the dense degree of the dense portion – e.g., Beam et al. at [0278] discloses, “One embodiment of the biostructure of the present invention comprises a matrix-material network such that the space not occupied by the matrix material forms a non-matrix-material network that interlocks with the matrix-material network. The matrix material, forming a first interconnected network, may have exposed internal surfaces of that network at least some of which may receive essentially a coating of the interpenetrating material. The matrix material together with its coating may form a second network, which may be designated the second interconnected network or the interpenetrant network. The interpenetrant network may be such that the spaces not occupied by it also form a network, which may be designated the third interconnected network. All of these networks may be three dimensionally interconnected, although they do not have to be. Additionally there may be other regions of the biostructure in which the interpenetrant network may be completely or almost completely filled with interpenetrating material. Gradual variation of the extent of filling by the interpenetrating material may be provided. The matrix-material or first network may be deterministically designed including features such as macrostructure (a porous portion with a lower dense degree), mesostructured (an intermediate portion with a higher dense degree than the macrostructure), microstructure (a dense portion having a dense degree higher than both the macrostructure and mesoestructure), channels (which may be curved), internal void spaces, and other features that may be complicated.”
Regarding claim 15, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 13, further comprising: a washing step of washing the artificial bone after forming the artificial bone (see GAIGNON [0052] – [0054], [0100], Beam et al. [0088]).
Regarding claim 18, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 13, except for, wherein the dense portion has the dense degree equal to or higher than 80%, and the porous portion has the dense degree lower than 60%.
As the revascularizing speed and the artificial bone’s rigidity and resistance are variables that can be modified, among others, by adjusting said dense degree, with said revascularizing speed increasing as the dense degree is increased, the precise dense degree of the porous portion would have been considered a result effective variable by one having ordinary skill in the art before the time the invention was effectively filed. As such, without showing unexpected results, the claimed dense degree threshold value cannot be considered critical. Accordingly, one of ordinary skill in the art at time the invention was effectively filed would have optimized, by routine experimentation, the dense degree of the porous region in the method of GAIGNON/Watanabe/Beam to obtain the desired balance between revascularizing speed in the porous region of the artificial bone and the outer surface rigidity and resistance of the artificial bone (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (A).
Regarding claim 19, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 13, wherein the ceramic material is calcium phosphate (GAIGNON Abstract, [0006], [0010], [0012], [0015], [0032], [0065] – [0069]).
Regarding claim 20, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 19, wherein the calcium phosphate is any one of a-tricalcium phosphate (α-TCP), 6-tricalcium phosphate (β-TCP), octacalcium phosphate (OCP), and carbonate apatite (see GAIGNON [0065] – [0069]).
Regarding claim 21, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 19, wherein the chelating agent is an organic compound having three or more phosphate groups or carboxyl groups per one molecule (see GAIGNON [0032] – [0037]).
Regarding claim 22, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 21, wherein the organic compound is any one of etidronic acid, phytic acid, and citric acid (see GAIGNON [0074]).
Regarding claim 25, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 13, wherein the curing liquid applying processing includes: dropping or ejecting a cell inclusion liquid or a growth factor inclusion liquid to entirety or a predetermined region of the target region in each of the layers, wherein the cell inclusion liquid includes cells or includes both of cells and growth factors, and the growth factor inclusion liquid includes growth factors (e.g., see GAIGNON [0017], [0025] – [0029], Watanabe [0187] “cell culture liquid”, and Beam et al. [0192, 0292, 0351, 0449]).
Regarding claim 26, GAIGNON/Watanabe/Beam teaches the method for manufacturing the artificial bone according to claim 14, except for explicitly disclosing, wherein the curing liquid applying step includes, as a position in the intermediate region is more shifted from a side of the outer-side region to a side of the inner-side region, gradually reducing an amount of the curing liquid applied to a unit area at the position in the intermediate region, thereby forming the intermediate portion so as to have the dense degree that gradually decreases as the position is more shifted from a side of the dense portion to a side of the porous portion.
GAIGNON, however, discloses an artificial 3D printed bone having an intermediate portion (11A) having the dense degree that gradually decreases as the position is more shifted from a side of the dense portion to a side of the porous portion (see GAIGNON FIG. 15).
Furthermore, Beam [0105] discloses that “Adjustment of the saturation parameter from one region of a biostructure to another, using a given dispenser, may be achieved by adjusting any of the variables which together make up the saturation parameter. This may be achieved by adjusting the amount of dispensed liquid per unit distance traveled along the principal direction of motion.”, and [0278] discloses that “Gradual variation of the extent of filling by the interpenetrating material may be provided.”
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of GAIGNON/Watanabe/Beam so that the curing liquid applying step includes, as a position in the intermediate region is more shifted from a side of the outer-side region to a side of the inner-side region, gradually reducing an amount of the curing liquid applied to a unit area at the position in the intermediate region (e.g., by adjustment of the saturation parameter, as suggested by Beam), thereby forming the intermediate portion so as to have the dense degree that gradually decreases as the position is more shifted from a side of the dense portion to a side of the porous portion, for the purpose of manufacturing the artificial bone with optimal revascularizing speed in the porous region and rigidity and resistance of the outer surface of the artificial bone, since "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
As the revascularizing speed and the artificial bone’s rigidity and resistance are variables that can be modified, among others, by adjusting said dense degree, with said revascularizing speed increasing as the dense degree is increased, the precise dense degree of the porous portion would have been considered a result effective variable by one having ordinary skill in the art before the time the invention was effectively filed. As such, without showing unexpected results, the claimed dense degree threshold value cannot be considered critical. Accordingly, one of ordinary skill in the art at time the invention was effectively filed would have optimized, by routine experimentation, the dense degree gradient in the method of GAIGNON/Watanabe/Beam to obtain the desired balance between revascularizing speed in the porous region of the artificial bone and the outer surface rigidity and resistance of the artificial bone (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). See MPEP § 2144.05 (II) (A).
Claim(s) 16 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over GAIGNON et al. (US 2017/0304056 A1, “GAIGNON”), in view of Watanabe (US 2015/0259247 A1; of record) and Beam et al. (US 2003/0065400 A1; of record), as applied to claim 13 above, and further in view of SARUTA (US 2020/0247043 A1).
Regarding claim 16, for the sake of brevity of the Office action, only those limitations not shared by claim 16 and claim 13 will be discussed below. Those limitations shared between claim 16 and claim 13 are hereby omitted (see the discussion of claim 13 above). GAIGNON/Watanabe/Beam teaches the method according to claim 13 is implemented from computer-aided design data/parameters to manufacture the desired synthetic block by stereolithography or 3D printing or technique of additive methods by controlling a three-dimensional shaping apparatus to cause the three-dimensional shaping apparatus to execute: layer forming processing; curing liquid applying processing of, based on the shape data, causing the three-dimensional shaping apparatus to apply, to a target region in the layer, a curing liquid including a chelating agent; and processing of repeating the layer forming processing and the curing liquid applying processing (see GAIGNON [0041] – [0045], [0098], and the discussion of claim 13 above).
GAIGNON/Watanabe/Beam does not explicitly disclose, a storage device readable by a computer storing a control program for controlling a three-dimensional shaping apparatus.
SARUTA teaches a three-dimensional shaping device comprising, inter alia, a discharge unit which discharges a liquid from the nozzles toward a stage (comprising a later of ceramic material [0029]); a main moving unit; and a control unit that, “while controlling the discharge unit and the main moving unit to change the relative position between the discharge unit and the stage along the second direction, repeats executing processing of forming a shaping layer by discharging the liquid from the nozzle, to shape a laminated body in which the shaping layers are laminated.” [0005]. ([0024] – [0026], [0040], [0046], [0049] – [0052], [0062], [0076] – [0084]).
[0025] “The control unit 500 is implemented by a computer that includes one or more processors, a main storage device (analogous to the claimed “a storage device readable by a computer”), and an input/output interface for inputting and outputting signals from and to the outside. …the control unit 500 executes a shaping processing for shaping the three-dimensional shaped object OB1, …by the processor executing a program or a command read on the main storage device (analogous to the claimed “a storage device readable by a computer storing a control program for controlling a three-dimensional shaping apparatus”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the three-dimensional shaping apparatus in the method of GAIGNON/Watanabe/Beam with a storage device readable by a computer storing a control program for controlling a three-dimensional shaping apparatus, as suggested by the prior art, since it have held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP § 2144.07.
Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claim 17, for the sake of brevity of the Office action, only those limitations not shared by claim 17 and claim 13 will be discussed below. Those limitations shared between claim 17 and claim 13 are hereby omitted (see the discussion of claim 13 and claim 16 above). GAIGNON/Watanabe/Beam/SARUTA teaches a control device that controls a three-dimensional shaping apparatus to implement the method according to claim 13, the control device (SARUTA control unit 500 [0024] – [0026], [0040], [0046], [0049] – [0052], [0062], [0076] – [0084]) causing the three-dimensional shaping apparatus to perform (see the discussion of claim 13 and claim 16 above).
Response to Arguments
Applicant’s arguments with respect to claim(s) 13 – 15 and 17 – 15 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.
Applicant’s arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDGAREDMANUEL TROCHE whose telephone number is (571)272-9766. The examiner can normally be reached M-F 7:30-5:30.
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/EDGAREDMANUEL TROCHE/Examiner, Art Unit 1744
/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742
