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 Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive.
Applicant argues that “Maggiore’s ‘selection valve’ merely selects a feed source, it does not mix materials”. Examiner notes the previous and current rejection states that the mixing valve is met by the combination of Maggiore and Weinberg, where Weinberg teaches that Fig. 29C shows a top view of the mixing nozzle in which the four materials are to be mixed within the tip chamber, see [0350]. Examiner notes that the valves and mixing nozzle of Warren meets the claimed mixing valve.
Applicant argues that “Warren’s multi-feed mixing nozzle directly contradicts Maggiore’s hygiene, sterility, and isolation principals” but this is not found persuasive. Maggiore teaches a selection valve 678 located on the manifold 676 may be utilized to select the feed source to be connected to the interior tubing of the single-use biological material dispensing element during dispensing [0129]. That is, both Maggiore and Warren teach an apparatus that can use multiple sources of materials. The introduction of a mixing valve within the apparatus of Maggiore would be not contradict the hygiene, sterility, and isolation principals. Moreover, Maggiore teaches the benefits of mixing in para. [0116] “[a]n internal tubing for the biological material may contain a plurality of baffles 506 to aid in the mixing and dispensing of biological materials aseptically received from a feed source 508. The mixing device and baffles 506 may allow for proper mixing and uniformity of a heterogeneous material, for easier dispensing of a viscous material, and/or for promoting the dispensing of either denser or less dense materials such as dispensing cells while removing cell debris”.
Applicant argues that “Warren’s bi-directional piston is for pump control, no bi-directional material flow through a mixing valve” but this is not found persuasive. Firstly, the claim only recites “said mixing valve directing bi-directional flow” (claim 1) and “the delivery system exhibiting bi-directional material flow in the one or more cartridges” (claim 9). Thus, a pump capable of pushing and pulling material through the apparatus meets the claim.
Secondly, all of the pending claims are directed to an apparatus. The courts have held that the manner of operating a device does not differentiate an apparatus from the prior art, see MPEP 2114(II). Warren teaches control of piston 140 to displace material or retract to pull material in a reverse direction, see [0243]. Examiner notes that the apparatus of Warren is at least capable of bi-directional flow through a mixing valve or cartridge and meets the claim.
Applicant argues that the combination of Maggiore and Warren is improper hindsight because “Maggiore intentionally avoids mixing” but this is not found persuasive. Applicant has provided no citation in Maggiore that disparages mixing two materials before dispensing. In fact, Maggiore teaches in para. [0116] “[a]n internal tubing for the biological material may contain a plurality of baffles 506 to aid in the mixing and dispensing of biological materials aseptically received from a feed source 508. The mixing device and baffles 506 may allow for proper mixing and uniformity of a heterogeneous material, for easier dispensing of a viscous material, and/or for promoting the dispensing of either denser or less dense materials such as dispensing cells while removing cell debris”.
Applicant argues that Sun does not teach “conversion matched to the control-point-indexed enclosure interior” but this is not found persuasive. Firstly, this language is not found in the pending claims and thus not a required element as stated. Secondly, the concept is found obvious in view of the references cited. Sun teaches the construct pattern can be created in a CAD environment (in silico), converted to an STL file and then converted into a toolpath, see [0145]. Weinberg teaches the robotic arm 160 includes a control system 162 [0026] where the coordinates are relative to a fixed Cartesian grid for the build space, see [0043], and identify an insert location, object orientation, and an entry vector for insertion of the object [0065]. Thus the combination meets the claim.
Applicant argues that the teaching of Weinberg “are not control points inside an enclosure, are not posted markers, features, or indexing structures”. Examiner notes that a “posted markers” is not found in the claims and, as rejected in the previous office action, the instant specification does not have support for such an element. Weinberg teaches “identify an insert location, object orientation, and an entry vector for insertion of the object” [0065]. One of ordinary skill in the art would have understood that Weinberg’s step of identifying an insert location within software is synonymous with a step of indexing a location. That is, the claimed term “indexing” is simply another word for identifying a location.
Applicant argues that no single cited reference teaches the various features including “predetermined control points” (this language was removed from current claim set), a mixing valve, a computer system converting a tissue design, and printing in situ inside an enclosure. Examiner notes that these limitations are not a single inventive concept. That is, a mixing valve is separate inventive concept from an enclosure, each is designed and disclosed separately in the prior art. An enclosure is a separate inventive concept from a computer system for converting a tissue design. Thus, while each concept is known in the prior, simply combining disparate elements does not render the claims non-obvious. In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
Applicant argues that Tavana uses gel-loading tips to dispense liquid samples into wells, not print within a gel medium. Firstly, the term “gel-loading tips” is a term of the art meaning the tips are designed to be inserted into gels. Secondly, all of the pending claims are directed to an apparatus. The courts have held that the manner of operating a device does not differentiate an apparatus from the prior art, see MPEP 2114(II). Examiner notes that the apparatus of Tavana is at least capable of printing a gel medium.
Applicant argues that Tavana does not teach bi-directional flow. This is met by the combination of Tavana and Warren. Warren teaches control of piston 140 to displace material or retract to pull material in a reverse direction, see [0243]. As discussed above, the apparatus of Warren is at least capable of bi-directional flow.
Applicant argues that Tavana does not teach accommodating vessels are varying dimensions and would require “replacing it with a novel mechanical structure enabling multi-size compatibility”. Examiner notes that the claims do not recite a novel mechanical structure and only recite generic apparatus capable of “accommodating vessels of varying dimensions”. Examiner notes that if a novel design is claimed, Applicant should clarify the novel nature of the mechanism in the claims and drawings.
Applicant argues that “Warren’s bi-directional piston is for pump control, no bi-directional material flow through a mixing valve” but this is not found persuasive. Firstly, the claim only recites “said mixing valve directing bi-directional flow” (claim 1) and “the delivery system exhibiting bi-directional material flow in the one or more cartridges” (claim 9). Thus, a pump capable of pushing and pulling material through the apparatus meets the claim.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maggiore (US 2017/0335271 A1) in view of Sun et al. (US 2011/0136162 A1), Weinberg et al. (US 2014/0277679), and Warren (US 2004/0253365 A1).
Regarding claim 1, Maggiore meets the claimed bioprinting system for multi-dimensional printing of tissue into a tissue enclosure, (supply both a structural material and a biological material for additive manufacturing [0023] in order to create e.g. cell patterns and living tissues [0002]) the bioprinting system comprising: a multi-axis, multi-dimensional (MAMD) printer (at least two articulating axis joints 922 and 924 on the printer head 926 allow for the positioning of a printer head dispenser 928 at a plurality of angles in relation to the printing tray 920, [0166], Fig. 11) including a robot controller controlling motion of the MAMD printer, (memory storage device 888 may store programs local to the automated control assembly 880 to control the movements of the robotic arm assembly 854 [0158]) and a delivery device operably coupled with the MAMD printer, (a dispensing device 806, Fig. 10) the delivery device delivering the tissue a delivery device locating subsystem (controller 894 may utilize positional information to send instructions to the automated control assembly 880 to control the movements of the robotic arm assembly 854 [0160] proximity sensors, GPS devices, IMUs and internal or external positioning sensor, [0163]) the tissue enclosure including a space for the delivered tissue, the tissue enclosure receiving the delivered tissue, (small printing tray or multi-well plate 858, Fig. 11) the tissue enclosure including a plurality of control points enabling the delivery device locating subsystem to return the delivery device to selected locations within the delivered tissue, (Examiner notes the apparatus of Maggiore is capable of identifying “control points” and returning to “selected locations” because Maggiore teaches positional sensors [0163] and controller 894 may utilize positional information to send instructions to the automated control assembly 880 to control the movements of the robotic arm assembly 854 [0160]) the tissue enclosure including production line mounting features; (connect to additional sterilized chambers to form a more complex assembly [0165]) a computer executing instructions including: (automated control assembly 880 for executing a printing of an object within the sterile chamber 852 using the robotic arm assembly 854, Fig. 11, [0158]) accessing a design of the tissue; (stored positional file of the recorded movements of the dispensing device may be utilized to replicate a qualified printed design [0039]) transferring the robot coordinates from the computer to the MAMD printer; (send the data to the internal dispensing device 856 through the data cable 864 [0159]) and printing the tissue into the tissue enclosure by commanding the MAMD printer based on the robot coordinates. (executing a printing of an object within the sterile chamber 852 using the robotic arm assembly 854, Fig. 11, [0158])
Maggiore does not teach in a single embodiment a mixing valve coupled to the MAMD printer, said mixing valve directing bi-directional material flow from one or more cartridges to at least one outlet of the mixing valve.
Maggiore teaches a selection valve 678 located on the manifold 676 may be utilized to select the feed source to be connected to the interior tubing of the single-use biological material dispensing element during dispensing [0129]. Maggiore teaches an internal tubing for the biological material may contain a plurality of baffles 506 to aid in the mixing and dispensing of biological materials aseptically received from a feed source 508. The mixing device and baffles 506 may allow for proper mixing and uniformity of a heterogeneous material, for easier dispensing of a viscous material, and/or for promoting the dispensing of either denser or less dense materials such as dispensing cells while removing cell debris, see [0116].
Warren teaches a mixing valve coupled to the MAMD printer, (Warren teaches a device for depositing biological materials [0003] where each feed channel may be provided with an independent valve controlling egress of material from the feed channel. A combination of independent pumps and independent valves may be provided to refine further control of individual feed channels, see [0267], Fig. 29A. Further Fig. 29C shows a top view of the mixing nozzle in which the four materials are to be mixed within the tip chamber, see [0350]. Examiner notes that the valves and mixing nozzle of Warren meets the claimed mixing valve) said mixing valve directing bi-directional material flow from one or more cartridges to at least one outlet of the mixing valve. (Warren teaches control of piston 140 to displace material or retract to pull material in a reverse direction, see [0243]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the valves, mixing nozzle, and bi-directional flow of Warren with the selection valve of Maggiore because it improves mixing of the multiple materials before dispensing, see Warren [0350].
Maggiore does not teach converting the design to robot coordinates that the MAMD printer can use to print the tissue into the tissue enclosure.
Sun teaches converting the design to robot coordinates that the MAMD printer can use to print the tissue into the tissue enclosure. (Sun teaches the construct pattern can be created in a CAD environment (in silico), converted to an STL file and then converted into a toolpath. This toolpath can be used by the motion control software to direct the printhead and create the desired part [0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the model conversion step of Sun with the 3D printing apparatus of Maggiore because the it allows for the ability to vary the geometry within the tissue chamber design, see Sun [0145].
Maggiore as modified does not explicitly teach the tissue enclosure including a plurality of control points positioned at fixed location within said tissue enclosure for indexing the delivery device to enter the tissue enclosure.
Weinberg meets the claimed the tissue enclosure including a plurality of control points positioned at fixed location within said tissue enclosure for indexing the delivery device to enter the tissue enclosure. (Weinberg teaches the robotic arm 160 includes a control system 162 [0026] where the coordinates are relative to a fixed Cartesian grid for the build space, see [0043], and identify an insert location, object orientation, and an entry vector for insertion of the object [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the fixed Cartesian grid and identification of insert locations to control for robot arms taught by Weinberg with the robot arm of Maggiore because it allows for the movements of the arm to be precisely controlled [0068].
Regarding claim 2, Maggiore meets the claimed wherein the instructions comprise: accessing parameters associated with the design; pathing of the design based on the parameters, the pathing producing the robot coordinates of the design; (Sun teaches the construct pattern can be created in a CAD environment (in silico), converted to an STL file and then converted into a toolpath. This toolpath can be used by the motion control software to direct the printhead and create the desired part [0145])
Maggiore does not meet the claimed processing the robot coordinates including: converting the robot coordinates to robot points, an approach vector, an orientation vector, and at least one path; choosing a robot figure for each of the at least one path based on a desired robot position and a range of motion of the robot; determining a translation data type based on the approach vector, the orientation vector, and the robot figure; creating at least one motion command based on the translation data type and the robot points; and providing the at least one motion command to the MAMD printer.
Weinberg meets the claimed processing the robot coordinates including: converting the robot coordinates to robot points, (Weinberg teaches the robotic arm 160 includes a control system 162 [0026] where the coordinates are relative to a fixed Cartesian grid for the build space, see [0043]) an approach vector, an orientation vector, (identify an insert location, object orientation, and an entry vector for insertion of the object [0065]) and at least one path; (Examiner notes the path is inherently determined by the entry vector and approach vector, see [0068]) choosing a robot figure for each of the at least one path based on a desired robot position and a range of motion of the robot; determining a translation data type based on the approach vector, the orientation vector, and the robot figure; (Fig. 6, step 620) creating at least one motion command based on the translation data type and the robot points; and providing the at least one motion command to the MAMD printer. (Fig. 6, step 630).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the entry vector and approach vector control for robot arms taught by Weinberg with the robot arm of Maggiore because it allows for the movements of the arm to be precisely controlled [0068].
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tavana (US 2016/0083681 A1) in view of Weinberg et al. (US 2014/0277679) and Warren (US 20040253365 A1).
Regarding claim 9, Tavana meets the clamed printing device to print in a gel-like material, (The apparatus of Tavana is capable of printing in a gel material because the tips are the same dimensions as gel-loading tips, see [0099]) the printing device comprising: at least one chassis composed of a base structure (platform 26, Fig. 3) and a chassis upright (z-axis linear slide 42c, Fig. 4) and further comprising a first region and a second region, the first region partitioned from the second region through a barrier on the base structure; (first and second plate 30, 32 separate two regions of platform 26, Fig. 3) at least one primary carriage (carriage 48c, Fig. 4) operatively coupled with the chassis upright, (slide 42c, Fig. 4) the at least one primary carriage performing a first set of at least one guided motion along at least one fixed path on a plane of the chassis upright; (carriage 48c moves in the vertical direction on a fixed path of slide 42c, [0056]) at least one first sub-carriage (48b, Fig. 4) providing an engaging feature and a pathway operatively coupled with the at least one primary carriage (carriage 48b is coupled to slide 42c, see Fig. 4) to perform a second set of at least one guided motion; (positioned in horizontal (x) 42a, orthogonal directions (y) 42b, and vertical (z) 42c, [0055]) at least one second sub-carriage (carriage 48a is couple to slide 42a, Fig. 4) traveling along the pathway of the at least one first sub- carriage to perform a third set (carriage 48a moves in a third direction, Fig. 4) of at least one guided motion; at least one delivery system (printing tips 22) engaged with one of the at least one primary carriages through a common base plate, (piece 58, Fig. 3) the at least one delivery system performing a resultant motion from combination of first, second and third sets of at least one guided motion, (positioned in horizontal (x) 42a, orthogonal directions (y) 42b, and vertical (z) 42c, [0055]) the delivery system engaging one or more printing cartridges at more than one engaging point, (a printer cartridge 18 configured to securely hold one or more printing tips 22, Fig. 3)
the delivery system exhibiting bi-directional material flow in the one or more cartridges; (Examiner notes the flow direction is considered the intended use of the apparatus, see MPEP 2114. Tavana teaches an apparatus capable of bi-directional flow if it were to be applied to the printing tips 22) and at least one vessel (container 12, Fig. 3) wherein the printing device prints, the at least one vessel arrested by a vessel adaptor (holder 34 was made of a rectangular piece of Plexiglas containing a negative relief of a 60-mm polystyrene petri dish, [0053]) the at least one vessel accommodating the gel-like material, (The apparatus of Tavana is capable of printing in a gel material because the tips are the same dimensions as gel-loading tips, see [0099])
Tavana does not teach vessel adaptor configured to accommodate vessels of varying dimensions.
Tavana teaches holder 34 may be designed in SolidWorks and fabricated using high-powered machining tools and placed on the surface 36 with screws, bolt, brackets, see [0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to create an additional holder 34 of Tavana with screws to be smaller to accommodate smaller containers 12 to allow for varying dimensions of vessels in order to improve the size of the 3D printer to fit inside a standard sterile culture hood, see [0047].
Tavana does not teach in a single embodiment a mixing valve coupled to the MAMD printer, said mixing valve directing bi-directional material flow from one or more cartridges to at least one outlet of the mixing valve.
Warren teaches a mixing valve coupled to the MAMD printer, (Warren teaches a device for depositing biological materials [0003] where each feed channel may be provided with an independent valve controlling egress of material from the feed channel. A combination of independent pumps and independent valves may be provided to refine further control of individual feed channels, see [0267], Fig. 29A. Further Fig. 29C shows a top view of the mixing nozzle in which the four materials are to be mixed within the tip chamber, see [0350]. Examiner notes that the valves and mixing nozzle of Warren meets the claimed mixing valve) said mixing valve directing bi-directional material flow from one or more cartridges to at least one outlet of the mixing valve. (Warren teaches control of piston 140 to displace material or retract to pull material in a reverse direction, see [0243]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the valves, mixing nozzle, and bi-directional flow of Warren with the apparatus of Tavana because it improves mixing of the multiple materials before dispensing, see Warren [0350].
Tavana as modified does not explicitly teach the tissue enclosure including a plurality of control points positioned at fixed locations within said tissue enclosure for indexing the delivery device to enter the tissue enclosure, and including control points wherein the delivery device locating subsystem positions the outlet of the mixing valve relative to the vessel.
Weinberg meets the claimed the tissue enclosure including a plurality of control points positioned at fixed locations within said tissue enclosure for indexing the delivery device to enter the tissue enclosure, and including control points wherein the delivery device locating subsystem positions the outlet of the mixing valve relative to the vessel. (Weinberg teaches the robotic arm 160 includes a control system 162 [0026] where the coordinates are relative to a fixed Cartesian grid for the build space, see [0043], and identify an insert location, object orientation, and an entry vector for insertion of the object [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the fixed Cartesian grid and identification of insert locations to control for robot arms taught by Weinberg with the robot arm of Maggiore because it allows for the movements of the arm to be precisely controlled [0068].
Regarding claim 11, Tavana as modified by Weinberg meets the claimed further comprising at least one monitoring system operating in conjunction with the control points. (Weinberg teaches the robotic arm 160 includes a control system 162 [0026] where the coordinates are relative to a fixed Cartesian grid for the build space, see [0043], and identify an insert location, object orientation, and an entry vector for insertion of the object [0065]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL M. ROBINSON whose telephone number is (571)270-0467. The examiner can normally be reached Monday-Friday 9:30AM-6PM.
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/MICHAEL M. ROBINSON/Primary Examiner, Art Unit 1744