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
Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/04/2026.
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.
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(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kesti et al. (US20170348458), and further in view of Sakai et al. (“Extrusion-Based Bioprinting through Glucose-Mediated Enzymatic Hydrogelation” Int J Bioprint, 2020, 6(1):250, pg. 43-42- see attached).
Regarding claim 1, Kesti teaches a method for producing a three-dimensional object (Abstract: "a method… depositing said printing mix in a three-dimensional form"), comprising:
individually discharging (a) a model material ink containing a crosslinkable polymer ([0092], [0093]) and (b) a support material ink containing a support material ([0068], [0069], [0142] The printing mix material was printed onto a substrate and the support polymer Pluronic F127 was co-extruded to fill subsequent layer, [0145] HRP was mixed either to the bio-ink in 1 unit/ml concentration or to the pluronic F127 30% mixture together with the hydrogen peroxide in 0.0012% concentration); and
removing an object of the support material ink after the crosslinkable polymer is crosslinked ([0016] the sacrificial polymer is co-deposited with the printing mix and functions as a reservoir of crosslinking initiators to polymerize the printing mix and is removed after polymerization),
wherein one of the model material ink (a) and the support material ink (b) further contains a hydrogen peroxide decomposer and the other of the model material ink (a) and the support material ink (b) further contains hydrogen peroxide ([0083], [0084], [0145] This bio-ink composition was further bioprinted in the presence of HRP and hydrogen peroxide when HRP was mixed either to the bio-ink in 1 unit/ml concentration or to the pluronic F127 30% mixture). While Kesti teaches the presence of horseradish peroxidase and hydrogen peroxide generates an enzymatically crosslinkable hydrogel ([0145] Base polymer gellan 3% with additive hyaluronan conjugated with tyramine 3% were mixed together to generate enzymatically crosslinkable hydrogel in the presence of horseradisch peroxidase (HRP) and hydrogen peroxide), Kesti fails to explicitly teach the enzyme-mediated crosslinking occurs by the hydrogen peroxide decomposer decomposing the hydrogen peroxide.
In the same field of endeavor pertaining to methods for producing three-dimensional objects, Sakai teaches enzyme-mediated crosslinking proceeds by a hydrogen peroxide decomposer decomposing a hydrogen peroxide ("The cross-linking of Alg-Ph and CNF-based bioink through HRPcatalyzed reaction that consumes H2O2 generated by HRP and glucose enabled to print 3D cellladen construct with good shape fidelity"- see 4 Conclusions on pg. 50).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the discharged hydrogen peroxide decomposer of Kesti decompose the discharged hydrogen peroxide of Kesti, as taught by Sakai, to achieve the predictable result of crosslinking the crosslinkable polymer. There would have been a reasonable expectation of success for the hydrogen peroxide decomposer to decompose the hydrogen peroxide, since both Kesti and Sakai teach a hydrogen peroxide and hydrogen peroxide decomposer are used in an enzyme-mediated crosslinking, and Sakai teaches the mechanism occurs by the hydrogen peroxide decomposing the hydrogen peroxide.
Regarding claim 2, Kesti modified with Sakai teaches the method for producing a three-dimensional object according to claim 1. Further, Kesti teaches wherein the hydrogen peroxide decomposer is a crosslink-forming enzyme ([0145] Base polymer gellan 3% with additive hyaluronan conjugated with tyramine 3% were mixed together to generate enzymatically crosslinkable hydrogel in the presence of horseradisch peroxidase (HRP) and hydrogen peroxide).
Regarding claim 3, Kesti modified with Sakai teaches the method for producing a three-dimensional object according to claim 1. However, Kesti fails to teach wherein the hydrogen peroxide is formed by a hydrogen peroxide donor, and wherein the hydrogen peroxide donor is a hydrogen peroxide-producing enzyme.
In the same field of endeavor pertaining to methods for producing three-dimensional objects, Sakai teaches the hydrogen peroxide is formed by a hydrogen peroxide donor, and wherein the hydrogen peroxide donor is a hydrogen peroxide-producing enzyme ("we have developed a way to supply H2O2 indirectly to this enzymatic reaction in the presence of reducing sugars, such as glucose, galactose, and mannose[32,33]. In this system, the redox reactions between thiol groups in HRP and formed disulfide bond gradually generate H2O2 by consuming reducing sugar under aerobic conditions"- see pg. 44). Hydrogen peroxide-producing enzymes avoid the direct use of hydrogen peroxide and minimizes the exposure time or concentration of hydrogen peroxide to living cells within a 3D hydrogel construct ("a major consideration in this reaction system is a way of supplying H2O2. To print a 3D hydrogel construct with living cells, the exposure time or the concentration of H2O2 should be at non-cytotoxic level and harmless to the activity of the enzyme itself… Recently, we have developed a way to supply H2O2 indirectly to this enzymatic reaction in the presence of reducing sugars, such as glucose, galactose, and mannose"- see pg. 44).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the hydrogen peroxide of Kesti modified with Sakai with the hydrogen peroxide-producing enzyme of Sakai, for the benefit of minimizing the exposure time or concentration of hydrogen peroxide to living cells within a 3D hydrogel construct.
Regarding claim 4, Kesti modified with Sakai teaches the method for producing a three-dimensional object according to claim 1.
Further, Kesti teaches wherein the crosslinkable polymer contains a phenolic hydroxy group ([0145] Base polymer gellan 3% with additive hyaluronan conjugated with tyramine 3%).
Regarding claim 5, Kesti modified with Sakai teaches the method for producing a three-dimensional object according to claim 1. Further, Kesti teaches wherein the support material is a water-soluble polymer or a water-dispersible polymer ([0145] when HRP was mixed either to the bio-ink in 1 unit/ml concentration or to the pluronic F127 30% mixture).
Regarding claim 6, Kesti modified with Sakai teaches the method for producing a three-dimensional object according to claim 5. Further, Sakai teaches wherein the water-soluble polymer or water-dispersible polymer is capable of forming an aqueous gel ([0030] In certain embodiments, the particles and/or fibres are made of… gel forming poloxamers F108, F127, F68, F88) that can interact with an ionic compound to aggregate or decrease in viscosity, and the step of removing an object of the support material ink comprises removing the object of the support material ink (b) by interaction with the ionic compound ([0142] After layer-by-layer deposition of the material into desired form, the sacrificial support Pluronic was eluted in a 20 mM SrCl.sub.2 bath for few minutes before the construct was transferred to 37° C. cell culture medium; Applicant’s disclosure states in [0074]: “Examples of the ionic compound include multivalent metal salts such as salts of calcium, zinc, magnesium, barium, strontium, copper, iron, aluminum, and cobalt).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIELLA MACHNESS whose telephone number is (408)918-7587. The examiner can normally be reached Monday - Friday, 6:30-2:30 PT.
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/ARIELLA MACHNESS/Examiner, Art Unit 1743
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