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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 10/06/2025 is acknowledged.
Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/28/2022.
Information Disclosure Statement
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
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.
Claims 1, 3-5, 9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Solorzano et al. (US 20180281280 A).
Regarding claim 1, Solorzano teaches a three-dimensional (3D) bioprinter (abstract; Figs. 1-16) comprising:
a base unit comprising a support member (Fig. 1, frame of bioprinter 100 comprising x bar rail 110 that supports y bar 155) adapted for mounting at least one bioprinter toolhead (Figs. 1-2 teaches the x bar rail 110 and y bar 155 are structurally capable of mounting at least one cartridge system 120 with a cartridge 230 with a syringe and needle 235, i.e. bioprinter toolhead);
a bioprinter toolhead (Figs. 1-3 teaches at least one cartridge system 120 with a cartridge 230 with a syringe and needle 235, i.e. bioprinter toolhead) secured to the support member (Figs. 1-2 teach the cartridge system 120 secured to the x bar rail 110 and y bar 155 via rotating extruder system 165) and capable of dispensing a biomaterial (paragraph [0013]);
a print bed (Fig. 1, printing stage or bed plate 125), the print bed and the bioprinter toolhead movable in relation to one another along an X-axis, a Y-axis, and a Z-axis (paragraphs [0024],[0060] teaches the multi-headed mechanism moves in X,Y, and Z directions; paragraphs [0060],[0085]-[0086] teach the printing stage is movable in the Z direction);
a light source (paragraph [0062], source of electromagnetic radiation, e.g. LED; paragraphs [0101]-[0102] teach a “light”; paragraph [0104], LEDs) capable of outputting visible light directed toward the print bed (paragraphs [0101]-[0102] teach a light to control materials that require cross linking at desired wavelengths; paragraph [0104] teaches LEDs of wavelengths greater than 405 nm, i.e. visible light; paragraph [0160] teaches visible light and a photo-initiator that is a visible light photo-initiator; therefore, the light is capable of outputting visible light towards the print bead); and
a drive mechanism arranged to control movement of the bioprinter toolhead (paragraph [0024] teaches the multi-headed mechanism sits on a 3 axis gantry system, i.e. drive mechanism, that moves in X and Y directions; therefore, the gantry system controls movement of the bioprinter toolhead).
Regarding claim 3, Solorzano further teaches wherein the print bed is configured to hold one or more of a Petri dish, a tissue culture dish, a multiwell plate, a microtiter plate, or a glass slide (interpreted as a functional limitation of the print bed, see MPEP 2114; paragraph [0021]).
Regarding claim 4, Solorzano further teaches wherein the print bed is configured to move in one or more of X, Y, and Z direction (paragraphs [0060],[0085]-[0086] teach the printing stage is movable in the Z direction).
Regarding claim 5, Solorzano further teaches wherein the bioprinter toolhead is configured to move in one or more of X, Y, and Z direction (paragraph [0024] teaches the multi-headed mechanism sits on a 3 axis gantry system, i.e. drive mechanism, that moves in X and Y directions; therefore, the bioprinter toolhead is configured to move in the X and Y directions).
Regarding claim 9, Solorzano further teaches the 3D bioprinter of claim 1, further comprising a bioprinter toolhead holder configured to hold and secure the bioprinter toolhead (Fig. 3 and paragraph [0079] teaches a plate or rail 375, i.e. bioprinter toolhead holder, that holds and secures the cartridges 385).
Regarding claim 11, Solorzano further teaches the 3D bioprinter of claim 1, further comprising a visible light-curable biomaterial (paragraphs [0062]-[0063] teaches the delivery device comprising a combination of biomaterial, biological material, and curable extrusion agent; paragraphs [0156]-[0157] teaches the extrusion agent is a support material that is curable at a wavelength of about 405 nm or greater, i.e. visible-light curable biomaterial; paragraph [0160] teaches a visible light photo-initiator).
Regarding claim 12, Solorzano teaches a 3D bioprinter system (abstract; Figs. 1-16), comprising:
a 3D bioprinter according to claim 1 (see above claim 1);
a visible light-curable biomaterial provided in a non-cured state (paragraphs [0062]-[0063] teaches the delivery device comprising a combination of biomaterial, biological material, and curable extrusion agent; paragraphs [0156]-[0157] teaches the extrusion agent is a support material that is curable at a wavelength of about 405 nm or greater, i.e. visible-light curable biomaterial; paragraph [0160] teaches a visible light photo-initiator) and capable of being dispensed by the bioprinter toolhead (paragraph [0063] teaches the delivery device can dispense the composition); and
a source of viable cells (paragraphs [0024],[0028],[0062],[0146],[0148],[0149],[0189] teaches cells; paragraph [0148] teaches the biomaterial and/or the biological material is viably maintained in a composition; therefore, the cells are interpreted as a source of viable cells).
Regarding claim 13, Solorzano further teaches wherein the viable cells comprise microorganisms (paragraphs [0148],[0178] teaches the cell is a bacterial cell, i.e. microorganism).
Regarding claim 14, Solorzano further teaches wherein the cells are viable in the biomaterial (paragraph [0148] teaches the biomaterial and/or the biological material is viably maintained in a composition).
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano as applied to claim 1 above, and further in view of Ouyang et al. (US 20220324163 A1; effectively filed 06/04/2019).
Regarding claim 2, while Solorzano teaches the system is configured to control the light through an electronics board (paragraphs [0101]-[0102]), Solorzano fails to teach the 3D bioprinter of claim 1, further comprising a light intensity controller configured to control the light intensity of the light source.
Ouyang teaches a 3D bio-printing system configured to project light into bio-ink that can be cured by light (abstract). Ouyang teaches the change or conversion of light can be reflected as the change of the light focus position and the change of intensity, so as to realize the printing or processing of different structures in different parts, or more complex structures (paragraph [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Solorzano to incorporate the teachings of change of intensity of light affecting 3D bioprinting of Ouyang (paragraph [0021]) to provide: the 3D bioprinter of claim 1, further comprising a light intensity controller configured to control the light intensity of the light source. Doing so would have a reasonable expectation of successfully improving control of the characteristics of the light from the light source, therefore allowing for printing of desired complex structures as taught by Ouyang (paragraph [0021]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano as applied to claim 1 above.
Regarding claim 6, Solorzano fails to explicitly teach wherein the light source provides a center wavelength (CWL) of about 405 nm.
Solorzano teaches curable materials at a wavelength of about 405 nm or greater (paragraphs [0156]-[0157],[0174],[0183]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source of Solorzano to incorporate the teachings of the use of curable materials at a wavelength of about 405 nm (paragraphs [0156]-[0157],[0174],[0183]) to provide: wherein the light source provides a center wavelength (CWL) of about 405 nm. Doing so would have a reasonable expectation of successfully improving and optimizing the wavelength of the light source for improved curing of a desired material of Solorzano.
In an alternative interpretation of claim 6, claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano as applied to claim 1 above, and further in view of Boisen et al. (US 20240227290 A1; effectively filed 03/04/2021).
Regarding claim 6, while Solorzano teaches curable materials at a wavelength of about 405 nm or greater (paragraphs [0156]-[0157],[0174],[0183]), Solorzano fails to explicitly teach wherein the light source provides a center wavelength (CWL) of about 405 nm.
Boisen teaches a method of 3D-printing a polymer-based structure including depositing a photocurable resin (abstract). Boisen teaches the photocurable resin chosen for specific tasks is selected with consideration for parameters such as the wavelength and power of the laser, the spot size established by the optical system etc (paragraph [0025]). Boisen teaches the system 10 further comprises a light source 4 which in this embodiment of the invention comprises a laser which emits light at a center wavelength of 405 nanometres (paragraph [0147]), wherein the power provided by the laser light is used to cure the photocurable resin (paragraph [0147]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source of Solorzano to incorporate the teachings of a 3D printer with a light source emitting a center wavelength of 405 nm of Boisen (paragraph [0147]) and the teachings of the use of curable materials at a wavelength of about 405 nm (paragraphs [0156]-[0157],[0174],[0183]) to provide: wherein the light source provides a center wavelength (CWL) of about 405 nm. Doing so would have a reasonable expectation of successfully improving and optimizing the wavelength of the light source for improved curing of a desired material of Solorzano and as taught by Boisen (paragraph [0147]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Solorzano as applied to claim 1 above, and further in view of Yun (KR 20170005209 A; see machine translation).
Regarding claim 7, Solorzano fails to teach wherein the angle of the light source is adjustable in relation to the print bed.
Yun teaches a multi-photopolymerization extrusion type composite 3D printer (paragraph [0001]) that uses a photocurable material (paragraph [0001]). Yun teaches a system (Figs. 1-6) comprising a first and second nozzle section (11, 12; paragraph [0045]) and a rail part (60) is formed on one side of the workbench to guide the movement of the light source moving part (50) (paragraph [0045]). Yun teaches a point curing unit that includes light sources whose intensity and wavelength can be adjusted (paragraph [0058]). Yun teaches the point curing unit that includes a fixing jig that supports a light source module that can be rotated at an angle to adjust the amount and angle of irradiation of light (paragraph [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source of Solorzano to incorporate the teachings of a 3D printer with a fixing jig that supports a light source module that can be rotated at an angle of Yun (paragraphs [0058]-[0059]) to provide: wherein the angle of the light source is adjustable in relation to the print bed. Doing so would have a reasonable expectation of successfully improving control of light irradiation angle of the light source and therefore improve control of bioprinting.
Regarding claim 8, Solorzano fails to teach the 3D bioprinter of claim 1, further comprising an adjustable light source holder configured to adjust the position and angle of the light source in relation to the print bed.
Yun teaches a multi-photopolymerization extrusion type composite 3D printer (paragraph [0001]) that uses a photocurable material (paragraph [0001]). Yun teaches a system (Figs. 1-6) comprising a first and second nozzle section (11, 12; paragraph [0045]) and a rail part (60) is formed on one side of the workbench to guide the movement of the light source moving part (50) (paragraph [0045]). Yun teaches a point curing unit that includes light sources whose intensity and wavelength can be adjusted (paragraph [0058]). Yun teaches the point curing unit that includes a fixing jig that supports a light source module that can be rotated at an angle to adjust the amount and angle of irradiation of light (paragraph [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source of Solorzano to incorporate the teachings of a 3D printer with a fixing jig that supports a light source module that can be rotated at an angle of Yun (paragraphs [0058]-[0059]) to provide: further comprising an adjustable light source holder configured to adjust the position and angle of the light source in relation to the print bed. Doing so would have a reasonable expectation of successfully improving control of light irradiation angle of the light source and therefore improve control of bioprinting.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano as applied to claim 1 above, and further in view of Armani et al. (US 20160236409 A1).
Regarding claim 10, while Solorzano teaches wires or cables running to the bioprinter toolhead (Fig. 6), Solorzano fails to teach the 3D bioprinter of claim 1, further comprising a cable management piece configured to hold and secure one or more wire or cable running to the bioprinter toolhead.
Armani teaches a 3D printer (abstract). Armani teaches base frame 101 provides internal supports for holding motors, electronics, lights, wires, and cables (paragraph [0072]). Armani teaches a multitude of supports in the base frame 101 and/or the internal body frame 6 may provide pathways for anchoring electronic wires, tubes, cables, and similar parts as is known in the art of making injection molded product enclosures (paragraph [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the 3D bioprinter of Solorzano to incorporate the teachings of a 3D printer with supports for anchoring wires and cables of Armani (paragraphs [0072],[0080]) to provide: the 3D bioprinter of claim 1, further comprising a cable management piece configured to hold and secure one or more wire or cable running to the bioprinter toolhead. Doing so would have a reasonable expectation of successfully anchoring and securing wires or cables to the device to improve organization of the wires or cables as taught by Armani (paragraphs [0072],[0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ahn et al. (Ahn et al., “Rapid High-Resolution Visible Light 3D Printing”, ACS Cent. Sci. 2020, 6, 1555−1563) teaches visible light-driven 3D printing by curing a photopolymer resin (abstract). Ahn teaches optimizing printing by changing the angles of light (page 1560, right column, second full paragraph).
Ng et al. (US 20180257301 A1) teaches an additive manufacturing apparatus including a platform and dispenser (abstract). Ng teaches curing feed material by an anergy delivery system (paragraph [0064]). Ng teaches energy delivery systems where the angles of the light beam paths can be adjusted through both or either of rotation of the support and independent rotation of the energy delivery systems (paragraph [0099]).
Lian et al. (CN 106003715 B; see machine translation) teaches an angle-adjustable dual-light source inkjet printing nozzle for photocuring 3D bioprinting (paragraph [0002]). Lian teaches existing inkjet light curing method uses a single light source for irradiation, not only will the curing speed be slow, but the problem of uneven energy of the light spot will occur; and furthermore, the light source with a fixed position is not easily adjustable during the actual printing process (paragraph [0005]). Lian teaches a light source angle can be adjusted via a light source fixture (paragraph [0016]).
He et al. (CN 112917891 A; see machine translation) teaches biological 3D printing method for large tissues (paragraph [0001]). He teaches a light irradiating visible light, where the wavelength may be blue light of 405 nm (paragraph [0053]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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