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 .
Election/Restrictions
Claim 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 November 5, 2025.
Applicant’s election without traverse of Invention I (claims 1-11) in the reply filed on November 5, 2025 is acknowledged.
Regarding the species restriction requirement of species A-D, applicant’s arguments that the instant application discloses simultaneous operation of different types of stimulators (paragraph 83 of the instant specification) has been considered and is persuasive; therefore, the election requirement is withdrawn.
Status of Claims
Claims 1-11 are examined.
Claims 12-20 are withdrawn.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The instant specification cites PCT published patent application WO2019180749 and 13 non-patent literature references, but no IDS is filed.
Claim Objections
Claim 1 and 4 is objected to because of the following informalities:
claim 1, line 4 - “an upper surface” should read “the upper surface” for clarity
claim 4, line 2 - “spaced apparat” should read “spaced apart” for spelling.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7-8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7-8 recites the limitation “the thermal stimulator” in line 1. The claim depends on claim 5, but claim 5 does not recite “thermal stimulator”. Claim 6 recites “a thermal stimulator”; therefore, for examination purposes, the claims will be read as depending on claim 6.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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) 1 and 3-4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Neill (US 2022/0219402 A1).
Regarding claim 1, Neill discloses an adjustable platform (¶ [0180] – multi-dimensional build platform #3000) for a bioprinter (¶ [0107] – used in additive manufacturing, referred as “bioprinting”), wherein the adjustable platform comprises:
a housing (#3000) having an upper surface (¶ [0180] – surface of layer of build volume section, layer #3102) with a support region having a base plate at an upper surface thereof (¶ [0182] – build volume section #3100 of #3102, includes lattice structure #3104) for receiving biomaterial (¶ [0104] – material deposited or added to build platform), the base plate being conductive to transmit one or more stimuli to the biomaterial for 4D printing of the biomaterial (¶ [0182] – activation of elements #3106 microcoils produces either compressive or tension forces for modulating #3104); and
at least one stimulator that is mounted within the housing and coupled to the base plate (¶ [0180] – #3002 include microcoils #3106), the at least one stimulator being configured to provide one or more stimuli to the biomaterial during printing and/or after printing for effecting a change in characteristic of the biomaterial including structure and/or morphology (¶ [0180] – for geometrically reconfiguring #3000; ¶ [0183] – variable build volume section geometry that is dynamic and fully programmable), wherein the at least one stimulator comprises an electromagnetic stimulator (¶ [0180] – generate electromagnetic field distribution).
Regarding claim 3, Neill discloses the platform of claim 1, wherein the electromagnetic stimulator comprises at least one electromagnetic coil (¶ [0182] – elements #3106 microcoils) that is laterally offset from a center of the base plate (FIG. 21A-21B depict #3106 laterally offset from the center of #3102) and is electrically coupled to a controller for receiving a control signal therefrom (¶ [0181] – surface deformations and geometry manipulations of the build volume section are performed under the control of the microcontroller) to generate one or more electromagnetic stimuli with a controllable amplitude, frequency and/or duration (¶ [0181] – through microcoil current magnitude and direction control, and activation and deactivation instructions), the one or more electromagnetic stimuli being transmitted to the biomaterial during and/or after printing of the biomaterial (as material is deposited on the build platform, the surface deformations and geometry manipulations would to transmitted to the material).
Regarding claim 4, Neill discloses the platform of claim 3, wherein the electromagnetic stimulator comprises two or more electromagnetics coils that are spaced apart from one another and at and opposite sides of the base plate (FIG. 21A- 21B depicts #3106 spaced apart and at opposite sides of the base plate) to provide different electromagnetic stimuli to different regions of the support region of the platform (the microcoils #3106 at the different locations would provide different electromagnetic stimulation at different regions).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1, 3, and 4.
Regarding claim 5, Neill discloses the platform of claim 4. Neill discloses a second set of the electromagnetic coils are arranged to generate additional EM fields in the Z plane (¶ [0180] – generate electromagnetic field distribution; as depicted in FIG. 22A-22C #3102 is affected in the Z plane).
Neill does not disclose wherein a first set of the electromagnetic coils are arranged to generate EM fields in the XY plane. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a set of electromagnetic coils generate electromagnetic fields in the XY plane based on the structure and design of the final product.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1 and 12 in view of Steele (US 2022/0339859 A1).
Regarding claim 2, Neill discloses the platform of claim 1, Neill does not disclose wherein the mechanical stimulator comprises at least one piezoelectric transducer that is located underneath the base plate and is electrically coupled to a controller for receiving a control signal therefrom to generate one or more mechanical stimuli with a controllable amplitude, frequency, and/or duration, the one or more mechanical stimuli being transmitted to the biomaterial during and/or after printing of the biomaterial.
Analogous art Steele discloses an additive manufacturing apparatus includes a support plate, a window, and a resin support configured to support an uncured layer of resin (¶ [0039]).
Steele discloses wherein the mechanical stimulator (¶ [0065] – a viscosity modification assembly integrated within the support plate) comprises at least one piezoelectric transducer (¶ [0066] – includes a movement device (transducer) coupled with support plate and may be a piezoelectric transducer) that is located underneath the base plate (FIG. 2A depicts movement device #78 under resin support #26) and is electrically coupled to a controller (¶ [0067] – movement device operably coupled with computing system) for receiving a control signal therefrom (¶ [0067] – signal generator) to generate one or more mechanical stimuli (¶ [0066] – to vibrate at least a portion of the support plate that is transferred) with a controllable amplitude, frequency, and/or duration (¶ [0067] – electric impulse to movement device, voltage varied at different frequencies and with different waveshapes, may transmit a constant amplitude signal at constant frequency), the one or more mechanical stimuli being transmitted to the biomaterial during and/or after printing of the biomaterial (¶ [0066] – vibrate is transferred to the resin). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the viscosity modification assembly with a piezoelectric transducer in Steele to the platform in Neill to apply a shearing stress to the resin to alter (reduce) a viscosity of the resin (¶ [0065]).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1, in view of Sterna (US 2018/0361667 A1).
Regarding claim 6, Neill discloses the platform of claim 1, wherein the platform further comprises a thermal stimulator (¶ [0184] - #3106 includes heating elements that allow for selective heating of the reconfigured #3102) that is located under the base plate (FIG. 21A-21B depicts #3106 are located under #3102) and is electrically coupled to a controller for receiving a control signal therefrom to generate one or more thermal stimuli with a controllable amplitude and duration (as microcontroller controls microcoils ¶ [0181], the selective heating of the heating elements would also be controlled).
Neill does not disclose the thermal stimulator comprises at least one thermoelectric cell.
Analogous art Sterna discloses a print bed #1 (¶ [0025]) for a 3D-printer particularly suitable for printing of organic materials, i.e. to function as 3D-bioprinter (¶ [0030]).
Sterna further discloses the platform #1 further comprises the thermal stimulator comprises at least one thermoelectric cell (¶ [0025] – Peltier element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the Peltier element in the platform in Sterna to the heating element in Neill to regulate the temperature up and down about a desired temperature, thereby enabling a temperature control which is both more accurate and more responsive compared to conventional print beds (¶ [0025]).
Regarding claim 7, modified Neill discloses the platform of claim 6. Neill does not disclose the thermal stimulator comprises two thermoelectric cells that are spaced apart from one another to provide different thermal stimuli to different regions of the base plate.
Sterna discloses wherein the thermal stimulator comprises two thermoelectric cells (¶ [0027] – at least two of Peltier elements are arranged to be controlled) that are spaced apart from one another (FIG. 3 depicts the Peltier elements, 2a and 2e are spaced apart) to provide different thermal stimuli to different regions of the base plate (¶ [0041] – two Peltier elements by applying respective voltages to each of the at least two Peltier elements; thereby assume different temperatures in different regions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the application of respective voltages to two Peltier elements in Sterna to the heating element in modified Neill to regulate the temperature up and down about a desired temperature, thereby enabling a temperature control which is both more accurate and more responsive compared to conventional print beds (¶ [0025]).
Regarding claim 8, modified Neill discloses the platform of claim 6. Neill does not disclose wherein the thermal stimulator also comprises a heat sink and/or a fan that are thermally coupled to the support region of the platform for conducting heat away from the support region during use depending on a temperature differential between a temperature at the support region and another temperature at the heat sink.
Sterna further discloses wherein the thermal stimulator also comprises a heat sink (¶ [0025] – heatsink thermal connected to the Peltier element) and/or a fan (¶ [0026] – at least one fan to such in air towards the heatsink) that are thermally coupled to the support region of the platform for conducting heat away from the support region (¶ [0025] – arranged to transfer heat generated by the at least one Peltier element and dissipate the transferred heat away from the at least one Peltier element; ¶ [0026] – transport of hot gas, typically hot air, away from the heat sink, thereby preventing a buildup of unwanted heat in the vicinity of the print bed) during use depending on a temperature differential between a temperature at the support region and another temperature at the heat sink (¶ [0025] – regulating temperature about a desired temperature).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the heatsink and fan in Sterna to the heating element in modified Neill to regulate the temperature up and down about a desired temperature, thereby enabling a temperature control which is both more accurate and more responsive compared to conventional print beds (¶ [0025]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1, in view of Bennet (US 2020/0406542 A1).
Regarding claim 9, Neill discloses the platform of claim 1. Neill does not disclose wherein the platform further comprises at least one electrical stimulator that comprises an electrode for providing an electrical stimulus to the biomaterial.
Analogous art Bennet discloses a device performing bioprinting (Abstract) comprising a printing surface platform and printing surface (¶ [0071]).
Bennet further discloses the platform further comprises at least one electrical stimulator that comprises an electrode (¶ [0051, 0060] – printing surface has built-in features like special temperature control abilities or electrical terminals or built-in electrode arrays) for providing an electrical stimulus (¶ [0051] – voltage can be controlled independently of each other) to the biomaterial (¶ [0051, 0069] – control the shape of the electric field and material deposition guided by electrodes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the built-in electrode array in the printing surface in Bennet to the platform in Neill to control the shape of the electric field and to guide the deposition of the extruded material to help control depositing of material (¶ [0051]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1, in view of You (US 2022/0105686 A1).
Regarding claim 10, Neill discloses a bioprinter system for 4D printing of biomaterials (¶ [0104] – additive manufacturing system 300; ¶ [0107] – system for “bioprinting”), wherein the bioprinter system comprises:
a housing (¶ [0104] – a enclosure #310);
a frame (¶ [0104] – a frame #310) mounted to the housing
a printing head (¶ [0107] – fabrication assembly #304, such as an extruder) that is movably coupled to the frame (¶ [0110] – drive assembly #306 is an articulated robotic arm that moves #304; #306 and #304 would be coupled to #310) for printing the biomaterials (¶ [0107] - organic materials such as biomolecular or biomaterials); and
an adjustable platform (¶ [0180] – multi-dimensional build platform #3000) that is moveably coupled to the frame (FIG. 3A build plate #302 would be coupled to #310), wherein the
adjustable platform is defined according to claim 1 (see analysis of claim 1 in view of Neill).
Neill does not explicitly disclose a frame defining an incubator chamber.
Analogous art You discloses a three-dimensional (3D) bioprinter comprising a case, a printing chamber, and a bed (¶ [0041]).
You further discloses a frame defining an incubator chamber (¶ [0062] – printing chamber is formed so that CO2 incubation is allowed in a non-stop manner). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the printing chamber formed for CO2 incubation in You to the enclosure/frame in Neill so CO2 incubation may be performed without changing a place after the living tissue is printed (¶ [0062]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neill (US 2022/0219402 A1), as applied to claim 1, in view of You (US 2022/0105686 A1), as applied to claim 10, in further view of McKiel, Jr., henceforth Mckiel (US 2017/0165917 A1).
Regarding claim 11, modified Neill discloses the bioprinter system of claim 10. Modified Neill does not disclose wherein the frame comprises at least one guide rail and a lead screw and the adjustable platform is moveably coupled to the at least one guide rail via a slide bushing and the adjustable platform is moveably coupled to the lead screw via a worm gear sleeve.
Analogous art McKiel discloses a 3D printing system, an extruder (¶ [0038]), and a build plate (¶ [0040]).
McKiel further discloses the frame comprises at least one guide rail (¶ [0117] – thrust bearing) and a lead screw (¶ [0117] – lead screws) and the adjustable platform is moveably coupled to the at least one guide rail via a slide bushing (¶ [0117] – shaft may be free to slide vertically) and the adjustable platform is moveably coupled to the lead screw (¶ [0117] – lead screws to elevate build plate platform) via a worm gear sleeve (¶ [0117] – worm gear assembly comprising worm and worm wheel). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the build plate platform with a motor, worm gear assembly, common shaft, and a thrust bearing to the platform in Neill to allow the motor to drive the shaft vertically but allow the shaft to freely rotate under the control of the worm wheel and a wide variety of designs are well known (¶ [0117]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2022/0111579 A1 discloses a inkjet printer configured to dispense an electromagnetic energy curable material, bioink, and a material curable by directing electromagnetic energy therein, onto carrier mounted on a movable stage
US 2023/0399597 A1 discloses a 3D printing process with a sequence of applying bio-ink to a reaction plane and bringing electromagnetic waves into contact with the crosslinking molecules and activation of the crosslinking molecules, as a result of which crosslinked structures are formed and vascular structures are thus obtained
US 2014/0072777 A1 discloses a fabricating apparatus comprising a three-dimensional inkjet printing unit and a substrate on a print bed where a heat source is a resistive coil heating element capable of heating so that cross-linking agent deposited by inkjet heads copolymerizes with the hydrophobic polymer
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/JONATHAN B WOO/Examiner, Art Unit 1754
/SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754