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
Applicant’s election without traverse of claims 1-19 in the reply filed on 02/23/2026 is acknowledged.
Claims 20-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2026.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Solorzano (US 2018/0281280 A1) in view of Wuest (EP2679669A1).
Regarding claim 1, the field of bioprinting that allows for methods of biofabrication, Solorzano teaches a multi-headed auto-calibrating bioprinter capable of dispensing a hydrogel composition in a layer by layer fashion (device for the layerwise building-up of three-dimensional hydrogel structures) (¶0002, 0062,0115) comprising cartridge systems 120; wherein each cartridge is sized and configured to receive a delivery device; wherein the delivery device can contain, store, or otherwise hold the composition, such as a hydrogel; wherein the delivery device is configured to dispense the composition at any appropriate flow rate or volume for bioprinting; therein cartridge systems 120 extrude onto a printing stage or bed plate 125; wherein printing stage 125 is configured such that it can hold a receiving means; wherein the bed plate comprises a recessed area or cut outs sized and configured to hold and secure a receiving means such as a glass slide; wherein the bed plate comprises temperature control unit and the temperature control unit comprises a source to heat or cool via with thermal heating, thermo electric cooling, liquid heating, liquid cooling, and/or electrical heating, which can control the temperature of the construct being creating in the receiving device; wherein the bed one or more linear motion carriages control movement of one or more components of the bioprinter including, without limitation, a cartridge, a bed plate, or any combination thereof; and wherein the movement of the linear motion carriages may be performed using skill in the art including, without limitation, a motor (a print-head for metered release of a liquid hydrogel solution; a heat-insulating tray; a sample carrier; a support, disposed inside the heat-insulating tray, to accommodate the sample carrier; and a positioning device, which is configured to change a relative position of the print-head to the support in three spatial directions) (Fig. 1-9 and ¶0022,0063,0070-0073,0083-0089).
While Solorzano teaches a device comprising a heat-insulting tray, Solorzano does not explicitly disclose a device comprising a heat-insulting tray configured for a cold gas to be fed into.
However, in the same field of endeavor, bioprinting devices for bioprinting hydrogel compositions, Wuest teaches the known technique to achieve cooling of the cell suspension after printing by directing a stream of cold gas such as cold nitrogen gas at the cell suspension, wherein the cell suspension comprises hydrogel (¶0013,0018). In this manner, the cell suspension is automatically cooled once it reaches the substrate or the material which has been deposited on the substrate earlier (¶0018).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the device disclosed in Solorzano by applying the known technique of achieving cooling hydrogel after printing by directing a stream of cold gas such as cold nitrogen gas at the hydrogel as disclosed in Wuest to the bed plate comprising the temperature control unit disclosed in Solorzano with predictable results and resulting in an improved device comprising a heat-insulting tray configured for a cold gas to be fed into. MPEP 2143(D).
Regarding claim 2, as applied to claim 1, Solorzano in view of Wuest teach a device wherein the sample carrier comprises glass (Solorzano, ¶0021).
Regarding claim 3, as applied to claim 1, Solorzano in view of Wuest teach a device further comprising a control device configured to control the print-head and the positioning device to perform a layerwise application of the liquid hydrogel solution onto the sample carrier in a temperature environment, a temperature of which is below a freezing point of the liquid hydrogel solution, to produce a frozen 3D layered hydrogel structure (Solorzano, ¶0059,0074,0130-0143).
Regarding claims 17-18, as applied to claim 1, a claim is only limited by positively recited elements. MPEP 2115. Regarding the limitation(s) “wherein the liquid hydrogel solution contains at least one of the following additives: porogens to influence pore formation; bulking agents; surfactants; polyethylene glycol; a protein, cells, collagen; gelatin; an aqueous solution; and a gelling agent for chemical crosslinking by way of multivalent cations and wherein the liquid hydrogel solution contains a first additive, which gels by chemically induced crosslinking, and a second additive, which gels by thermally induced crosslinking,” the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.
Regarding claim 19, as applied to claim 3, Solorzano in view of Wuest teach a device further comprising the cold gas fed into the heat-insulating tray to adjust the temperature of the temperature environment (Wuest, 0018,0028,0032-0033).
Claims 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over Solorzano (US 2018/0281280 A1) in view of Wuest (EP2679669A1), as applied to claim 3, and in further view of Rubinsky (WO-2017066727-A1).
Regarding claims 4-11, as applied to claim 3, Solorzano in view of Wuest do not teach a device further comprising a dryer configured to dry off the frozen 3D layered hydrogel structure to produce a porous 3D hydrogel structure; wherein the dryer is configured to: perform freeze-drying and/or sublimating of at least a part of frozen water from the frozen 3D layered hydrogel structure at reduced pressure; and/or perform infrared (IR) drying or a critical-point drying method; wherein the control device is further configured to adjust, in the layerwise application, a first pore property of the 3D hydrogel structure by at least one first operating parameter; wherein the first pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; wherein the at least one first operating parameter comprises at least one of: the temperature of the temperature environment; a temperature distribution and/or temperature gradient of the temperature environment; a composition of an atmosphere, in which the liquid hydrogel solution is applied onto the sample carrier; a concentration of the liquid hydrogel solution; a viscosity of the liquid hydrogel solution; and a speed of the layerwise application; wherein the dryer is further configured to adjust, in the drying, a second pore property of the 3D hydrogel structure by at least one second operating parameter; wherein the second pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; nor wherein the at least second operating parameter comprises at least one of: an ambient temperature; an ambient pressure; and a duration of the drying procedure.
However, in the same field of endeavor, apparatus and methods for producing freeze-dried or frozen material structures using 3D printing, Rubinsky teaches the known technique of a device comprising a dryer configured to dry off the frozen 3D layered hydrogel structure to produce a porous 3D hydrogel structure; wherein the dryer is configured to: perform freeze-drying and/or sublimating of at least a part of frozen water from the frozen 3D layered hydrogel structure at reduced pressure; and/or perform infrared (IR) drying or a critical-point drying method; wherein the control device is further configured to adjust, in the layerwise application, a first pore property of the 3D hydrogel structure by at least one first operating parameter; wherein the first pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; wherein the at least one first operating parameter comprises at least one of: the temperature of the temperature environment; a temperature distribution and/or temperature gradient of the temperature environment; a composition of an atmosphere, in which the liquid hydrogel solution is applied onto the sample carrier; a concentration of the liquid hydrogel solution; a viscosity of the liquid hydrogel solution; and a speed of the layerwise application; wherein the dryer is further configured to adjust, in the drying, a second pore property of the 3D hydrogel structure by at least one second operating parameter; wherein the second pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; and wherein the at least second operating parameter comprises at least one of: an ambient temperature; an ambient pressure; and a duration of the drying procedure (Fig 1, 2, 4 and ¶0005,0008-0009,0042,0057-0060,0089-0090,0099,0101-0102,0104,0106,0112-0114).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the device disclosed in Solorzano in view of Wuest by applying the known technique of a device comprising a dryer configured to dry off the frozen 3D layered hydrogel structure to produce a porous 3D hydrogel structure; wherein the dryer is configured to: perform freeze-drying and/or sublimating of at least a part of frozen water from the frozen 3D layered hydrogel structure at reduced pressure; and/or perform infrared (IR) drying or a critical-point drying method; wherein the control device is further configured to adjust, in the layerwise application, a first pore property of the 3D hydrogel structure by at least one first operating parameter; wherein the first pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; wherein the at least one first operating parameter comprises at least one of: the temperature of the temperature environment; a temperature distribution and/or temperature gradient of the temperature environment; a composition of an atmosphere, in which the liquid hydrogel solution is applied onto the sample carrier; a concentration of the liquid hydrogel solution; a viscosity of the liquid hydrogel solution; and a speed of the layerwise application; wherein the dryer is further configured to adjust, in the drying, a second pore property of the 3D hydrogel structure by at least one second operating parameter; wherein the second pore property of the 3D hydrogel structure is at least one of: a pore distribution; a porosity; a mean pore size; a mean pore orientation; a mean pore shape; and a mean pore volume; and wherein the at least second operating parameter comprises at least one of: an ambient temperature; an ambient pressure; and a duration of the drying procedure as disclosed in Rubinsky to the device disclosed in Solorzano in view of Wuest with predictable results and resulting in an improved device. MPEP 2143(D).
Regarding claim 12, as applied to claim 6, Solorzano in view of Wuest and Rubinsky teach a device wherein the at least one first operating parameter comprises a spacing between the print-head and the sample carrier and/or a spacing between the print-head and a last applied layer of hydrogel solution (Solorzano, ¶0059,0070-0073).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Solorzano (US 2018/0281280 A1) in view of Wuest (EP2679669A1), as applied to claim 3, and in further view of Warlo (EP-3500807-B1).
Regarding claims 13-14, as applied to claim 3, Solorzano in view of Wuest do not teach a device further configured to mechanically structure the porous 3D hydrogel structure nor wherein the device is configured to: drill and/or melt channels into the porous 3D hydrogel structure; and/or rough and/or ground the surface of the porous 3D hydrogel structure; and/or press defined shapes into the porous 3D hydrogel structure by a stamp.
However, reasonably pertinent to the particular problem with which the applicant was concerned (mechanical structuring of porous materials; see MPEP 2141.01(a)), Warlo discloses a known technique wherein if a surface structuring of a porous layer by mechanical structuring in the form of grooves, pins, etc., for selectively generated roughnesses (¶0028).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the device disclosed in Solorzano in view of Wuest by applying the known technique of a surface structuring of a porous layer by mechanical structuring in the form of grooves, pins as disclosed in Warlo to the device disclosed in Solorzano in view of Wuest with predictable results and resulting in an improved device. MPEP 2143(D).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano (US 2018/0281280 A1) in view of Wuest (EP2679669A1), as applied to claim 3, and in further view of Fuhr (US 2015/0289500 A1).
Regarding claim 15, as applied to claim 3, Solorzano in view of Wuest do not teach a device further comprising a device further configured to store of the porous 3D hydrogel structure in a cryogenic environment.
However, reasonably pertinent to the particular problem with which the applicant was concerned (storage in cryogenic environment; see MPEP 2141.01(a)), Fuhr discloses a known technique of providing a cryogenic storage device 100 for storing biological samples 1 in the cryopreserved state (fig 1 and abstract).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the device disclosed in Solorzano in view of Wuest by applying the known technique of providing a cryogenic storage device for storing biological samples in the cryopreserved state as disclosed in Furh to the device disclosed in Solorzano in view of Wuest with predictable results and resulting in an improved device. MPEP 2143(D).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Solorzano (US 2018/0281280 A1) in view of Wuest (EP2679669A1), as applied to claim 3, and in further view of Maggiore (US 2016/0068793 A1).
Regarding claim 16, as applied to claim 3, Solorzano in view of Wuest do not teach a device further configured to coat the porous 3D hydrogel structure with proteins and/or cells.
However, reasonably pertinent to the particular problem with which the applicant was concerned (device to coat a structure with proteins; see MPEP 2141.01(a)), Maggiore discloses a known technique of providing a spray deposition printing head 36 for coating the three-dimensional printed object with proteins (¶0132).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the device disclosed in Solorzano in view of Wuest by applying the known technique of providing a spray deposition printing head 36 for coating the three-dimensional printed object with proteins as disclosed in Maggiore to the device disclosed in Solorzano in view of Wuest with predictable results and resulting in an improved device. MPEP 2143(D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Erb (US 2018/0243980 A1) teaches an augmented three-dimensional (3D) printing systems and methods for constructing and mineralizing a hydrogel structure with defined geometry (abstract).
Jeon (US 2018/0238780 A1) teaches a method and apparatus of preparing an alginate hydrogel having a pattern (Fig 1A and ¶0049).
Staal (US 2020/0238615 A1) teaches a device wherein the build platform and/or the modular build platform units comprises one or more channels ending in one or more cavities and/or openings, wherein the channels are adapted to receive, during use, one or more fluid heating or cooling agents (i.e. liquid or gaseous (e.g. carbon dioxide, air, nitrogen gas, etc.) heating or cooling agents) thereby heating or cooling, respectively, one or more additively manufactured products or products being additively manufactured (e.g. an injection moulding part) being supported by the build platform and/or the modular build platform units (¶0058).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JaMel M Nelson whose telephone number is (571)272-8174. The examiner can normally be reached 9:00 a.m. to 5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached on (571) 270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMEL M NELSON/Primary Examiner, Art Unit 1743