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 for amended claim 1 are found persuasive. The amendments to claim 1 overcome the prior art rejection and claims 1-2 and 12 are allowed.
Applicant's remaining arguments filed 8/3/2026 have been fully considered but they are not persuasive.
Regarding claim 9, applicant argues (pg. 9) that “Tavana states that the tips were designed to match the contour and dimensions of gel-loading tips for the purpose of studying the effect of cross-sectional diameter of printing tips on printed pattern resolution.” 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.
Examiner notes claim 9 recites “the at least one vessel accommodating the gel-like material,” while Tavana teaches the container 12 to be a dish [0052]. This teaching alone meets the claim which only requires a vessel to accommodate a gel. However, Tavana further teaches gel-loading tips [0099] and “printing tips and lowered into the container containing the polymer phase to begin dispensing,” [0079].
Applicant argues (pg. 10) that “Tavana's own disclosure defeats the Examiner's assertion. Tavana describes its dispensing mechanism as gravity-driven, dependent upon the interfacial tension between immiscible liquid phases (see Tavana at [0014], [0078]-[0079])” but this is not found persuasive. Firstly, the claim only recites an intended use of gel-like materials and the apparatus of Tavana is capable of use with gel-like materials. Secondly, the gravity-driven along with interfacial tension deposition described in paragraph [0078] appears to be compatible with the claimed gel-like materials. Tavana teaches depositing into a “aqueous polymer solution contains polyethylene glycol (PEG)”. Although not defined to be a hydrogel, PEG is a viscous material. Applicant has not defined a viscosity required of the gel-like material that renders it incompatible with the apparatus of Tavana.
Applicant argues (pg. 10) that “the reliance on Tavana for such a modification would have been unobvious because without inappropriate hindsight reliance on Applicant’s own disclosure” but this is not found persuasive. Tavana is the primary reference in the rejection of claim 9. Therefore, no modification of Tavana is required to achieve the claimed “printing device to print in a gel-like material”. That is, hindsight reasoning is not relevant to a primary reference in a combination.
Allowable Subject Matter
Claims 1-2 and 12 are allowed.
The following is an examiner’s statement of reasons for allowance: The closest prior art includes Maggiore (US 2017/0335271 A1), 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 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 fixed to the exterior of the mixing valve, the mixing valve housed in a repository region;
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].
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.
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]).
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]).
However, none of references alone or in combination achieve the claimed arrangement 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 fixed to the exterior of the mixing valve, the mixing valve housed in a repository region.
Claims 2 and 12 are allowed because each claim depends from claim 1 and requires all of the limitation of allowed claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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) 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]. Further this limitation is interpreted as the intended use of the apparatus, see MPEP 2114) 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 (container 12, [0052], Fig. 3) accommodating the gel-like material, (The apparatus of Tavana is capable of accommodating a gel-like material because the tips are the same dimensions as gel-loading tips, see [0099], and container 12 is taught to be a dish [0052])
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 MICHAEL M. ROBINSON whose telephone number is (571)270-0467. The examiner can normally be reached Monday-Friday 9:30AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Zhao can be reached on (571)270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL M. ROBINSON/Primary Examiner, Art Unit 1744
