DETAILED ACTION
Claims 18-26 (filed 03/28/2023) have been considered in this action. Claims 1-17 have been canceled. Claims 18-26 are newly filed.
Priority
This application discloses and claims only subject matter disclosed in prior Application No. 16/902,234, filed 06/15/2020, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a continuation or divisional. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
The examiner notes that Application Data Sheet filed 11/07/2022 (Form AIA /14) for instant application does not include complete domestic priority information, including that the instant application is a divisional filing of application 16/902,234. It is further noted that restricted claims 6-10 from Application No. 16/902,234 have been canceled, and thus does not afford any priority to the new claims. Accordingly, the priority date in the instant application is the filing date. In the spirit of compact prosecution, the examiner has provided references with priority dates before the alleged parent applications.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-23 and 25-26 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yoo et al. (US 20140065194, hereinafter Yoo).
In regards to Claim 18, Yoo teaches “A method for producing layered tissue constructs, comprising a controller, a set of platforms, and a set of stations;” (Fig. 1 shows three dimensional printing system with controller; [0004] Three-dimensional powder-liquid printing technology has been used to prepare articles such as pharmaceutical dosage forms, mechanical prototypes and concept models, molds for casting mechanical parts, bone growth promoting implants, electronic circuit boards, scaffolds for tissue engineering, responsive biomedical composites, tissue growth promoting implants, dental restorations, jewelry, fluid filters and other such articles; wherein scaffolds for tissue engineering are tissue constructs [0032] the equipment assembly further comprises a control system comprising one or more computerized controllers, one or more computers, and one or more user interfaces for one or more computers. In some embodiments, one or more components of the equipment assembly are computer controlled. In some embodiments, one or more components of the three-dimensional printing build system are computer controlled. In some embodiments, the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system and the at least one printing system are computer controlled. In some embodiments, the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels) “the controller generating a first control signal to result in platforms indexing between stations” ([0037] a conveyor system adapted to conduct plural build modules and comprising positioning-controller and plural build module engagements; [0038] plural build modules engaged with the conveyor system, wherein the build modules are adapted to receive and temporarily retain powder from a powder layering system, and wherein a build module comprises an incrementally height adjustable platform, an optional build plate disposed above the platform, and one or more sidewalls defining a cavity within which the platform the optional build plate can be disposed; wherein the conveyers is controlled by the computer controller that moves height adjustable platforms on build modules; [0040] wherein the conveyor system is adapted to repeatedly transport the plural build modules from the at least one powder layering system to the at least one printing system) “generating additional control signals to position each platform relative to each station” ([0089] In some embodiments, operation of each of the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system, and the at least one printing system are controlled by the control system. In some embodiments, operation of one or more of the build plate loading system (9), optional powder recovery system (11) and bed transfer system is controlled by the control system; [0105] The size of a vertical increment can be relative to a prior initial position of the build platform or the height adjuster of the powder fill head or both. For example, the platform is lowered within the cavity by a first increment to a first position relative to upper surface of the build module. A printed incremental layer is formed on the platform at the first position during a first build lap. The platform is then lowered by a second increment to a second position but relative to where it was at the first position. Another printed incremental layer is formed on the platform while at the second position during a second build lap. This process is repeated until completion of a build cycle; [0117] The print head of FIG. 3B directs a stream of droplets of liquid into a printing region (29) through which build modules pass. The exemplary system (4) comprises a frame or gantry (tracks 27a, 27b) by way of which the print head (28) can translate/move in the direction of Arrow D, which is transverse to the direction of motion of a build module during printing. Translation of the print head can be performed manually or via computer controlled operation.) “generating additional control signals to result in material dispensed at one or more stations in defined patterns simultaneously” ([0020] . A build cycle comprises one or more build laps or plural build laps and is defined as the sum total of build laps required to form a 3DP article. A build lap is defined as the process of forming a printed incremental layer, i.e. placing an incremental layer of powdered build material and depositing (printing) liquid upon it. Accordingly, a build cycle results in the formation of plural stacked printed incremental layers that adhere to one another to together form a three-dimensionally printed article. [0032] the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels. In some embodiments, the two-dimensional image files are structured such that certain pixels indicate dispensing of droplets, and other pixels represent no dispensing of droplets. In some embodiments, the two-dimensional image files include different colors of pixels to indicate dispensing of different liquids, or no dispensing of liquid; wherein when there is just one station it is done simultaneously with itself) “until all platforms have sequenced through all stations for all layers as required, forming complete tissue constructs on each platform” ([0088] Build module (6a) includes six 3-D articles in a printed bed of powder. As the build modules (6, 6a-6L) are conducted along the predetermined course, they pass through the bed transfer system (8), which transfers build plates containing completed three-dimensionally printed beds, one or more at a time, away from the three-dimensional printing build system. [0097] b) at least one bed transfer system adapted to transfer completed three-dimensionally printed beds, one or more at a time, away from the build region of the three-dimensional printing build system; wherein the bed transfer system transfers the completed objects that have been formed after passing through the various stations).
In regards to Claim 19, Yoo further teaches “Method of claim 18, where the controller acquires inspection information from one or more stations related to the partially formed or finished tissue constructs” ([0044] 7) the equipment assembly further comprises an inspection system; 8) an inspection system is a printed powder inspection system that determines the integrity of printing in one or more printed incremental layers and/or one or more printed articles and/or determines whether or not powder was properly applied in one or more incremental layers; 9) determining the integrity of printing comprises at least one of determining whether or not liquid has been correctly applied to one or more incremental layers according to one or more predetermined patterns and/or determining whether or not liquid has been correctly applied to one or more incremental layers according to a predetermined amount; 10) the inspection system is a printed article inspection system that determines whether or not one or more printed articles have the correct size, shape, weight, appearance, density, content and/or color; 11) the inspection system is a liquid application inspection system that monitors droplets of liquid applied by the print head to powder; 12) the inspection system comprises one or more cameras; and/or 13) a camera is independently selected at each occurrence from the group consisting of a visible wavelength camera, an UV wavelength camera, a near infrared wavelength camera, an x-ray camera and an infrared wavelength camera).
In regards to Claim 20, Yoo teaches “A method of producing layered tissue constructs, carried out by a computer, comprising steps” (Fig. 1 shows three dimensional printing system with controller; [0004] Three-dimensional powder-liquid printing technology has been used to prepare articles such as pharmaceutical dosage forms, mechanical prototypes and concept models, molds for casting mechanical parts, bone growth promoting implants, electronic circuit boards, scaffolds for tissue engineering, responsive biomedical composites, tissue growth promoting implants, dental restorations, jewelry, fluid filters and other such articles; wherein scaffolds for tissue engineering are tissue constructs [0032] the equipment assembly further comprises a control system comprising one or more computerized controllers, one or more computers, and one or more user interfaces for one or more computers. In some embodiments, one or more components of the equipment assembly are computer controlled. In some embodiments, one or more components of the three-dimensional printing build system are computer controlled. In some embodiments, the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system and the at least one printing system are computer controlled. In some embodiments, the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels) “positioning platforms in relation to stations” ([0089] In some embodiments, operation of each of the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system, and the at least one printing system are controlled by the control system. In some embodiments, operation of one or more of the build plate loading system (9), optional powder recovery system (11) and bed transfer system is controlled by the control system; [0105] The size of a vertical increment can be relative to a prior initial position of the build platform or the height adjuster of the powder fill head or both. For example, the platform is lowered within the cavity by a first increment to a first position relative to upper surface of the build module. A printed incremental layer is formed on the platform at the first position during a first build lap. The platform is then lowered by a second increment to a second position but relative to where it was at the first position. Another printed incremental layer is formed on the platform while at the second position during a second build lap. This process is repeated until completion of a build cycle; [0117] The print head of FIG. 3B directs a stream of droplets of liquid into a printing region (29) through which build modules pass. The exemplary system (4) comprises a frame or gantry (tracks 27a, 27b) by way of which the print head (28) can translate/move in the direction of Arrow D, which is transverse to the direction of motion of a build module during printing. Translation of the print head can be performed manually or via computer controlled operation.) “directing one or more stations to perform material dispensing operations for a layer of a tissue construct on each platform;” ([0032] the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels. In some embodiments, the two-dimensional image files are structured such that certain pixels indicate dispensing of droplets, and other pixels represent no dispensing of droplets. In some embodiments, the two-dimensional image files include different colors of pixels to indicate dispensing of different liquids, or no dispensing of liquid) “and sequencing the platforms and stations to successively form all layers of all tissue constructs, patterns and sequences for depositing layers computed or recalled from computer memory” ([0087] In the cyclic system depicted, the conveyor system is a continuous loop system that repeatedly transports/cycles the build modules from the at least one powder layering system to the at least one printing system to form a three-dimensionally printed bed comprising one or more three-dimensionally printed articles in the build modules. The exemplary conveyor system (2) comprises at least one drive (12) and plural conveyor modules (2a), thereby forming a segmented or modular conveyor system. A conveyor module is engaged with a corresponding build module and conducted along a predetermined pathway in the direction of Arrow A. [0088] The equipment assembly in FIG. 1 is depicted finishing three-dimensional printing of a first batch of 3-D (three dimensional) articles and starting the 3-D printing of a second batch of 3-D articles. A three-dimensionally printed bed from the end of a first build cycle is in build module (6a), and the beginning of the second batch starts with a printed incremental layer in build module (6L). Build module (6a) includes six 3-D articles in a printed bed of powder. As the build modules (6, 6a-6L) are conducted along the predetermined course, they pass through the bed transfer system (8), which transfers build plates containing completed three-dimensionally printed beds, one or more at a time, away from the three-dimensional printing build system. A build module comprises a body (7a), and upper surface (7c) having a cavity with in which a height adjustable build platform (7b) is disposed. An empty build module (6g) optionally receives a build plate (10) as it passes through the build plate loading region of an optional build plate loading system (9). The build module (6h) is now ready to receive powder. Build modules will pass through at least one build station comprising at least one powder layering system (3) and at least one printing system (4)).
In regards to Claim 21, Yoo further teaches “Method of claim 20, with the computer acquiring inspection information from one or more stations related to the partially formed or finished tissue constructs” ([0044] 7) the equipment assembly further comprises an inspection system; 8) an inspection system is a printed powder inspection system that determines the integrity of printing in one or more printed incremental layers and/or one or more printed articles and/or determines whether or not powder was properly applied in one or more incremental layers; 9) determining the integrity of printing comprises at least one of determining whether or not liquid has been correctly applied to one or more incremental layers according to one or more predetermined patterns and/or determining whether or not liquid has been correctly applied to one or more incremental layers according to a predetermined amount; 10) the inspection system is a printed article inspection system that determines whether or not one or more printed articles have the correct size, shape, weight, appearance, density, content and/or color; 11) the inspection system is a liquid application inspection system that monitors droplets of liquid applied by the print head to powder; 12) the inspection system comprises one or more cameras; and/or 13) a camera is independently selected at each occurrence from the group consisting of a visible wavelength camera, an UV wavelength camera, a near infrared wavelength camera, an x-ray camera and an infrared wavelength camera).
In regards to Claim 22, Yoo teaches “A method for producing tissue constructs formed of one or more materials, dispensed or applied in patterned layers on build plates or print surfaces on each of two or more platforms, sequenced or indexed through two or more stations, the method comprising” (Fig. 1 shows three dimensional printing system with controller; [0004] Three-dimensional powder-liquid printing technology has been used to prepare articles such as pharmaceutical dosage forms, mechanical prototypes and concept models, molds for casting mechanical parts, bone growth promoting implants, electronic circuit boards, scaffolds for tissue engineering, responsive biomedical composites, tissue growth promoting implants, dental restorations, jewelry, fluid filters and other such articles; wherein scaffolds for tissue engineering are tissue constructs [0032] the equipment assembly further comprises a control system comprising one or more computerized controllers, one or more computers, and one or more user interfaces for one or more computers. In some embodiments, one or more components of the equipment assembly are computer controlled. In some embodiments, one or more components of the three-dimensional printing build system are computer controlled. In some embodiments, the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system and the at least one printing system are computer controlled. In some embodiments, the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels) “performing dispensing, mechanical modification, chemical modification, biological modification, or inspection operations;” ([0032] the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels. In some embodiments, the two-dimensional image files are structured such that certain pixels indicate dispensing of droplets, and other pixels represent no dispensing of droplets. In some embodiments, the two-dimensional image files include different colors of pixels to indicate dispensing of different liquids, or no dispensing of liquid; wherein the spreading of powder and dispensing of liquid are dispensing and mechanical modification) “operations of stations and relative positioning of platforms and stations directed by signals from a controller” ([0032] In some embodiments, the equipment assembly further comprises a control system comprising one or more computerized controllers, one or more computers, and one or more user interfaces for one or more computers. In some embodiments, one or more components of the equipment assembly are computer controlled. In some embodiments, one or more components of the three-dimensional printing build system are computer controlled. In some embodiments, the conveyor system, the height adjustable platforms of the build modules, the at least one powder layering system and the at least one printing system are computer controlled. In some embodiments, the equipment assembly is adapted to spread layers of powder and deposit (print) droplets of liquid in a predetermined pattern on to the layers according to instructions provided by a computerized controller. In some embodiments, the predetermined pattern is based on one or more two-dimensional image files comprising pixels. In some embodiments, the two-dimensional image files are structured such that certain pixels indicate dispensing of droplets, and other pixels represent no dispensing of droplets. In some embodiments, the two-dimensional image files include different colors of pixels to indicate dispensing of different liquids, or no dispensing of liquid; [0117] The print head of FIG. 3B directs a stream of droplets of liquid into a printing region (29) through which build modules pass. The exemplary system (4) comprises a frame or gantry (tracks 27a, 27b) by way of which the print head (28) can translate/move in the direction of Arrow D, which is transverse to the direction of motion of a build module during printing. Translation of the print head can be performed manually or via computer controlled operation.) “and causing station operations on platforms to be performed simultaneously, for each patterned layer until all layers have been applied in sequence to all tissue constructs on all platforms” ([0022] In some embodiments, the invention excludes an equipment assembly or a method wherein the powder fill head moves laterally or transversely or is not stationary, with respect to a build module, while depositing an incremental powder layer. In some embodiments, the invention excludes an equipment assembly or a method wherein the print head moves laterally or transversely or is not stationary, with respect to a build module, while applying liquid to an incremental powder layer; [0105] A printed incremental layer is formed on the platform at the first position during a first build lap. The platform is then lowered by a second increment to a second position but relative to where it was at the first position. Another printed incremental layer is formed on the platform while at the second position during a second build lap. This process is repeated until completion of a build cycle).
In regards to Claim 23, Yoo further teaches “Method of claim 22, where the sequencing of platforms through stations is performed synchronously” ([0131] The control system comprises a synchronizer that facilitates synchronization of operation of the various components of the equipment assembly. By taking into consideration the track (linear) speed of the conveyor and the target thickness and width of an incremental layer, a computer is able to instruct the powder layering system to charge powder onto the build modules at a certain feed rate. After part of a lap or after one or two calibration laps, the powder feed rate can be continuous. Once a proper incremental powder layer is formed, deposition of liquid onto the incremental layer can begin. A proximity sensor senses the leading edge of a build module and then sends instruction to the print system. A computer controlling the print system takes into consideration a set of printing instructions (which can include among other things the target print resolution (density), the image(s) (pattern(s)) to be printed on the incremental layer, the target rate of liquid deposition, the number of liquids to be deposited, the dimension of the print head and print modules, track speed, the set of images (patterns) that are to be printed to form a target 3D printed article, target article porosity or density, or other such parameters) and the signal generated by a wheel encoder, for example, to provide a pulse that sets the print rate at which to consume the image files in the printing instructions and the resolution at which to print the image file(s). Following completion of layering and printing per the printing instructions, a build cycle is completed).
In regards to Claim 25, Yoo further teaches “Method of claim 22, where the stations are held in stable positions, while the platforms are positioned relative to stations” ([0025] In some embodiments, both the print head and the powder fill head are stationary during formation of a printed incremental layer or are stationary as otherwise described herein. [0117] In some embodiments, the print head is stationary when applying liquid onto an incremental layer of powder, meaning that as liquid is being applied to a powder layer during a print lap, the print head (in particular the print modules) does not move in a direction which is transverse, with respect to the build plane, to the direction of motion of a build module during printing, i.e. during the application of liquid. Such a means of printing is different than prior systems wherein the print head (in particular the print module(s)) moves back and forth, in a direction which is transverse to the direction of motion of a build module, during printing).
In regards to Claim 26, Yoo further teaches “Method of claim 22, where the platforms are held in stable positions, while the stations are positioned relative to platforms” ([0117] The print head of FIG. 3B directs a stream of droplets of liquid into a printing region (29) through which build modules pass. The exemplary system (4) comprises a frame or gantry (tracks 27a, 27b) by way of which the print head (28) can translate/move in the direction of Arrow D, which is transverse to the direction of motion of a build module during printing. Translation of the print head can be performed manually or via computer controlled operation; [0121] The print module remains transversely, longitudinally and vertically stationary with respect to the plane defining the upper surface of the build module. The print module applies liquid onto the incremental layer of powder according to a predetermined pattern, thereby forming an incremental printed layer (180) comprising article(s) 181. The exemplary print head comprises a single print module (179; depicted in dashed line) that spans the width of a cavity of the build module).
Claim Rejections - 35 USC § 103
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo as applied to claim 22 above, and further in view of Rubinsky et al. (US 20210137153, hereinafter Rubinsky).
In regards to Claim 24, Yoo teaches the method of forming a tissue construct using additive manufacturing as incorporated by claim 22 above.
Yoo teaches that a loop is formed so that singular stations exist to perform a synchronous control at each station which is performed is series from powder applied to printed layer, and continuously performed in a loop.
Yoo fails to teach “where the sequencing of platforms through stations is performed asynchronously”.
Rubinsky teaches “where the sequencing of platforms through stations is performed asynchronously” ([0043] systems and methods may further perform the manufacture of 3D objects of aqueous solutions and organic materials in a parallel form, such that all the steps of the additive manufacturing are not performed sequentially at one station (as in conventional additive manufacturing) but rather in at least two stations where the steps can be performed in parallel. These systems and methods can facilitate large scale additive manufacturing of 3D objects made of aqueous solutions and/or organic materials by operating in parallel, thereby reducing the time of the manufacturing of the 3D object; wherein the parallel arrangement allows for asynchronous sequencing to the different printing stations; [0088] In general, cross linking is required to provide rigidity to the object. Regardless of the method of cross linking in parallel manufacturing the cross linking can be done before the assembly of the object or after the assembly of the object. In contrast, in conventional 3D printing the cross linking must be made the latest during the assembly because the assembly is element by element rather than complete layer by complete layer; wherein the crosslinking performed before or after assembly would be asynchronous; [0104] To speed up the printing process while maintaining the same resolution, in accordance with certain embodiments disclosed herein, the method may involve separating the additive manufacturing device into separate steps, with methods to transport the products of each step to an assembly location. Thus, a system as disclosed herein may comprise one or more, for example, two or more, manufacturing or printing stations and a transport device; wherein according to the applicant’s disclosure, the parallel arrangement affords asynchronous sequencing because plural layers are built for the same product in different stations).
It would have been obvious to a person having ordinary skill in the art before the effective file date of the claimed invention to have modified the system for producing 3D printed tissue constructs with a station for printing, to include the use of parallel stations and a build station so that multiple layers can be produced at the same time and finally assembled at a build station as taught by Rubinksy because it would gain the stated benefit of Rubinsky, namely the increased speed of production by forming plural layers at the same time in parallel ([0043]). By combining these elements, it can be considered taking the known methods of Yoo, and modify them with the configuration of Rubinsky that allows parallel printing at multiple stations so that layers and products can be indexed asynchronously in a known way that achieves predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kremer et al. (US 20200147685) – teaches a modular additive manufacturing plant with pre and post processing
Horn et al. (US 20200070421) – teaches an arrangement of a plurality of additive manufacturing machines arranged around a central robotic arm for providing build platforms
Guillemot et al. (US 20200046520) – teaches a bioprinting process whereby different layers are formed with different mixes of materials
Pourcher et al. (US 20210197477) – teaches an assembly line with plural additive manufacturing stations
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M SKRZYCKI whose telephone number is (571)272-0933. The examiner can normally be reached M-Th 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KAMINI SHAH can be reached at 571-272-2279. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN MICHAEL SKRZYCKI/ Examiner, Art Unit 2116