Prosecution Insights
Last updated: October 21, 2026
Application No. 19/181,471

Bioink Compositions and Methods for 3D Printing Of Vascularized Tissue Constructs

Non-Final OA §102§103§112
Filed
Apr 17, 2025
Priority
Apr 19, 2024 — provisional 63/636,141
Examiner
LI, WENHAN
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Wake Forest University Health Sciences
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
Avg Prosecution
29 currently pending
Career history
26
Total Applications
across all art units
This examiner has no resolved cases yet (career too new); statute-level performance unavailable. The Grant Probability card shows Tech Center averages instead.

Office Action

§102 §103 §112
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 . Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claim Status Claims 1-14, 20-22, and 38-40 are rejected. No claims are allowed. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 01-Aug-2025 has been considered by the examiner. Claim Objections Claims 14, 22, and 39 objected to because of the following informalities: Claims 14, 22, and 39 recites “bladder cells epithelial cells, fibroblast cells…” and lacks either a conjunction or a comma between bladder cells and epithelial cells. It is unclear to a person of ordinary skill whether this limitation refers to a single hybrid cell type such as a bladder epithelial cell or two categories. 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 2 and claim 5 contain the trademark/trade name IRGACURE 2959, RIBOFLAVIN, OMNIRAD TPO-L, IRGACURE 2100, IRGACURE 819-DW, IRGACURE 184, IRGACURE 651, R1800 to describe MAXGUARD R1800, R1888 to describe MAXGUARD R1888, MAXGARD® 1888 . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe 2-Hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone, Riboflavin-5'- phosphate sodium salt dehydrate, Ethyl (2,4,6-trimethylbenzoyl)-phenyl phosphinate, Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate, Phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide, 1-Hydroxycyclohexyl phenyl ketone, 2,2-Dimethoxy-2-phenylacetophenone, 2,2'-Dihydroxy-4,4'-dimethoxybenzophenone-5,5'-bis (sodium sulfonate), Disodium-2,2'- dihydroxy-4,4'-dimethoxy-5,5'-disulfobenzo phenome, Benzophenone-9 and, accordingly, the identification/description is indefinite. Claim 20 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 20, step iii recites “mixing the components from a) and b)…” but no a) or b) is recited previously. 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) 1-4, 7, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al. (Photoinhibiting via simultaneous photoabsorption and free-radical reaction for high-fidelity light-based bioprinting, Published: 27-May-2023) (hereinafter He). He discloses a Sil-MA bioink composed of 15 wt% Sil-MA (EFL-Sil-MA-001, Yongqinquan Intelligent Equipment Co., Ltd., Suzhou, China) (i.e. silk methacrylate or Silk-MA) and 10mM LAP (i.e. a photoinitiator) was generated to verify the suitability of Cur-Na (i.e. a UV absorber) for other hydrogels (Page 12, Polymer and photoinitiator synthesis). This single embodiment discloses every element of claim 1, 7, and 10: silk methacrylate, a UV absorber, and a photoinitiator. The LAP of He is the specific photoinitiator of instant claims 2 and 3. With respect to claim 4, He’s 10 mM LAP (294.21 g/mol) converts to 0.29421% w/v. (0.010 mol/L x 294.21 g/mol = 2.9421 g/L. The specification does not define “about” nor provide a range, 0.294 w/v% falls within “about 0.2% w/v,” anticipating claim 4. 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). Claim(s) 1-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (Photoinhibiting via simultaneous photoabsorption and free-radical reaction for high-fidelity light-based bioprinting, Published: 27-May-2023) (hereinafter He) as applied to claims 1-4, 7, and 10 above, and further in view of Huh et al. (Combinations of photoinitiator and UV absorber for cell-based digital light processing (DLP) bioprinting, Published: 24-May-2021) (hereinafter Huh). He discloses a UV absorber of Cur-Na added to the Silk-MA and LAP bioink composition (Page 12, Polymer and photoinitiator synthesis) for the purposes of preventing over-curing beyond the focal layer. He does not disclose the specific UV absorber species recited in instant claim 5 nor the concentration of those species of instant claim 6. However, Huh discloses “2,2′-Dihydroxy-4,4′-dimethoxybenzophenone-5,5′-bis(sodium sulfonate) (Maxgard® R1800) and disodium-2,2′-dihydroxy-4,4′-dimethoxy-5,5′-disulfobenzophenone (Maxgard® R1888) were purchased from Lycus LTD (El Dorado, AR). 2,2,6,6-Tetramethyl-1-piperidinyloxy (TEMPO), 5-benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid (HMBS), and 1,4-benzenediol (Hydroquinone)” (Page 2, 2.2. UV absorbers (UAs)) as UV absorbers for digital light processing (DLP) bioprinting, the same additive manufacturing process relied upon by He, in which a typically Gaussian light beam is projected by a single micromirror (Page 4, Photoinhibiting mechanism) for the purposes of building a three dimensional construct layer by layer (Page 6, Printing resolution and fidelity) , and evaluated each in the overlapping ranges of the table below (Page 6, Table 2): PNG media_image1.png 776 1073 media_image1.png Greyscale Further, Huh discloses as seen in Table 2 above, that the UV absorbers were evaluated at 0.1, 0.3, 0.5, 0.7, 1.0 w/v% with the optimized print using 0.2 w/v% LAP and 0.5 w/v% of R1800 (Page 6, 2.9. DLP printing of a perfusable heart-shaped construct). He relies on Huh as the source reference for its discussion on the conventional UV absorbers as the art recognized alternative to the photoabsorber approach He presents as an improvement, and therefore establishes as a direct equivalence between He’s Cur-Na and Huh’s R1800/R1888/TEMPO/HMBS/Hydroquinone class of UV absorbers for the identical overcuring prevention function in DLP bioprinting. It would have been obvious to substitute Huh’s named UV absorber, at Huh’s disclosed concentrations, for He’s Cur-Na in Sil-Ma/LAP bioink to arrive at the bioink composition of instant claims 5 and 6. One would have been motivated to do since He cites Huh as the source of the conventional UV absorber class that He’s own novel photoabsorber approach is presented as an improvement upon. Because He already identifies Huh’s UV absorbers as art recognized alternatives for performing the same overcuring prevention function that He’s Cur-Na performs, a person of ordinary skill would have looked to Huh’s specific and well characterized absorbers as a substitute. Substituting Huh’s named absorbers for He’s Cur-Na would produce a Silk-MA bioink with a known better characterized curing inhibitor. This represents a simple substitution of one known prior art element for another performing the identical function. A known or obvious invention does not become patentable simply because it has been described as somewhat inferior to some alternative for the same use. In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994). Indeed, “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine. Medichem, SA v. Rolabo, SL, 437 F.3d 1157, 1165 (Fed. Cir. 2006). Even to the extent that He characterized their own Cur-Na system as an improvement over the conventional UV absorber class exemplified by Huh, this does not defeat the motivation to substitute Huh’s UV absorbers, since He’s own disclosure confirms Huh’s UV absorbers are art recognized as functional for the identical purpose. A skilled artisan would have had a reasonable expectation of success because both He and Huh both address the technical problem of how to prevent overcuring beyond the focal layer in a DLP bioprinting scenario, using the identical fabrication modality of DLP printing of a methacrylate based, LAP initiated bioink. Huh’s UV absorbers were already demonstrated to function in exactly the identified role of preventing overcuring while maintaining cell viability, in a DLP bioink, so substituting them into He’s analogous Sil-MA/LAP system would have predicably performed the same function with predictable results. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Huh’s UV absorber into He’s Sil-MA bioink to arrive at instant claims 5 and 6. For the forgoing reasons, claims 1 and 5-6 are rendered obvious by the teachings of the prior art. 2. Claim(s) 1-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (Photoinhibiting via simultaneous photoabsorption and free-radical reaction for high-fidelity light-based bioprinting, Published: 27-May-2023) (hereinafter He) as applied to claims 1-7 and 10 above. The teachings of He are discussed supra. He discloses a bioink composition suitable for use with living cells comprising Sil-Ma, at least one UV absorber such as Cur-Na, and a photoinitiator such as LAP, disclosed in a single combined DLP printable formulation. He does not disclose that the Sil-MA embodiment is combined with gelatin methacrylate in a single formulation. However, He separately discloses a second bioink composition of “PEG-GelMA bioink composed of 6wt% PEGDA (6 kDa), 4wt% GelMA and 17mMLAP was developed for DLP-based printing” (Page 12, Polymer and photoinitiator synthesis). Thus, disclosing Gel-MA at 4 wt%, within the range recited in instant claim 8 of “about 1% to about 5% w/v”. He discloses “Bioink for DLP printing typically consists of a photo-cross-linkable hydrogel (e.g., gelatin methacryloyl (GelMA)20, poly(ethylene glycol) diacrylate (PEGDA)21 and silk fibroin modified by glycidylmethacrylate (Sil-MA)7), a photoinitiator (e.g., lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP)) and cells. GelMA, a natural protein biopolymer, is commonly used in 3D bioprinting due to its exceptional biocompatibility and cell-adhesive capability. However, it possesses poor mechanical performance and low viscosity, and a mixture of other materials (e.g., alginate/methylcellulose22 and PEGDA23) is usually implemented to enhance the printability of the bioink and the mechanical performance of printed objects” (Page 1-2, Introduction). Thus, He expressly groups GelMA and Sil-MA together as members of the class of photo-crosslinkable DLP hydrogels, and further identifies GelMA’s known mechanical shortcoming as a reason for why a skilled artisan would routinely combine it with other hydrogel materials to improve printability and mechanical performance. It would have been obvious to combine He’s second embodiment of Gel-MA with He’s first embodiment of Sil-MA to arrive at a Sil-MA/Gel-MA bioink composition falling within instant claim 8’s recited range, because He discloses that both materials as compatible and interchangeable photo-crosslinkable components use LAP photoinitiator and photoabsorber systems. A person having ordinary skill in the art would have recognized that He treats Sil-MA and Gel-MA as functionally interchangeable hydrogels within the DLP fabrication process, and would have been motivated to combine the two materials into a single formulation to drawn on known mechanical and biological properties that each material provides. Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). He’s own disclosure supplies this teaching directly: He identifies GelMA and Sil-Ma as members of the same class of DLP-compatible photo crosslinkable hydrogels, each independently useful in the same DLP bioprinting process, and further identifies GelMA’s known low viscosity and poor mechanical performance as a specific reason to combine it with a mechanically robust material, such as Sil-MA, which is shown elsewhere in He. One of ordinary skill would have had a reasonable expectation of success because both embodiments are disclosed in the same reference, using the same photoinitiator, the same UV/photoabsorber system, and the same DLP printing platform. Since He already demonstrates that each material independently photo crosslinks and prints successfully under identical conditions, combining them would predictably yield a composite hydrogel without modification of the underlying chemistry. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine He’s Gel-MA with He’s Sil-MA embodiment to arrive at instant claim 8. For the foregoing reasons, claims 1 and 8 are rendered obvious by the teachings of the prior art. 3. Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (Photoinhibiting via simultaneous photoabsorption and free-radical reaction for high-fidelity light-based bioprinting, Published: 27-May-2023) (hereinafter He) as applied to claim 1-8 and 10 above, and further in view of Li et al. (A heparin-functionalized bioink with sustained delivery of vascular endothelial growth factor for 3D bioprinting of prevascularized dermal constructs, Published: 08-Feb-2024) (hereinafter Li). The teachings of He are discussed supra. He discloses a bioink composition of Sil-MA, and optional Gel-MA component, a UV absorber, and a photoinitiator, and further discloses living cells such as PC-12 and HepG2 cells encapsulated within the bioink and printed with DLP bioprinting. He does not disclose heparin methacrylate as recited in instant claim 9. For this reason, Li is added Li discloses “a heparin-functionalized bioink, GH/HepMA, composed of 10 % (w/v) GelMA, 0.3 % (w/v) HA, and 0.5 % (w/v) HepMA, was developed and used to construct prevascularized dermal constructs with a bilayer network using extrusion 3D printing” (Page 2, Introduction). This 0.5% w/v HepMA concentration falls within the range recited in instant claim 9 of “about 0.1% to about 3% w/v”, and Li’s use of HepMA together with GelMA, a hydrogel material He identifies as a member of the photo crosslinkable DLP bioprinting compatible hydrogels as Sil-MA, directly connects Li’s HepMA teachings to the purpose of He, which is to provide a functional photo crosslinkable additive that is in the same class of bioink materials that He used. Further, Li discloses “VEGF was incorporated to enhance the ability of the bioink to stimulate endothelial cell angiogenesis. The release profiles of VEGF from the GH/Hep + VEGF and GH/HepMA+VEGF hydrogels are shown in Fig. 3F. The GH/Hep + VEGF hydrogel released over 50 % of the loaded VEGF within 3 d, and almost 80 % was released within 6 d. In contrast, the GH/HepMA+VEGF hydrogel showed a slow release effect, with sustained release lasting for 21 d” (Page 7, 3.2. Synthesis and characterization of bioinks). It would have been obvious to add Li’s HepMA and VEGF teachings to He’s Sil/MA bioink, arriving at a bioink comprising Hep-MA within instant claim 9’s recited range, because Li teaches that heparin methacrylate as a known functional additive for “sequestering molecules for signaling or adhesion proteins” (Page 2, Introduction) as an “effective strategy for inducing angiogenesis” (Page 2, Introduction). A person having ordinary skill in the art seeking to impart growth factor delivery capabilities to He’s Sil-MA bioink such as to promote vascularization within a printed construct, a goal directly relevant to He’s own stated purpose in manufacturing a perfusable (200-800 nm) vascular network containing constructs (Page 9, Figure 6), would have been motivated to incorporate Li’s HepMA+VEGF system because doing so would supply He’s vascular network capable bioink with the means to actively promote vascularization of the printed construct over a time course rather than solely relying on passive channel geometries that He discloses. A skilled artisan would have had reasonable expectation of success because Li’s HepMA is a methacrylate biopolymer that crosslinks using the same LAP photoinitiator already used in He’s Sil-MA bioink, and Li demonstrates that HepMA can successfully crosslink with GelMA without disruptions to the underlying chemistry. Because the crosslinking mechanism is shared across both references, incorporating HepMA of Li into He’s Sil-MA would predictably function to bind and sequester the growth factor in the same manner that Li demonstrates. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Li’s HepMA and VEGF teachings to He’s Sil-MA bioink to arrive at instant claims 9. For the foregoing reasons, claims 1 and 9 are rendered obvious by the teachings of the prior art. 4. Claim(s) 1-10, 11-14, 20-22, and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (Photoinhibiting via simultaneous photoabsorption and free-radical reaction for high-fidelity light-based bioprinting, Published: 27-May-2023) (hereinafter He) as applied to claims 1-10 above, and further in view of Kim et al. (Precisely printable and biocompatible silk fibroin bioink for digital light processing 3D printing, Published: 2018) (hereinafter Kim) and Hwang et al. (A 3D bioprinted hybrid encapsulation system for delivery of human pluripotent stem cell-derived pancreatic islet-like aggregates, Published: 07-Oct-2021) (hereinafter Hwang) As set forth in greater detail above, He discloses PC-12 and HepG2 cells and that “[t]he PC-12 or HepG2 cells were added to the PEG-GelMA/Cur-Na bioink, and the cell density of the solution was 1–2×107mL-1” (Page 13, Characterisation of cytocompatibility of 3D cell-laden scaffolds). He does not disclose or suggest any therapeutic application for the PC-12 and HepG2 cell. He’s disclosure confirms that PC-12 and HepG2 cells are used only to characterize the cytotoxicity of the bioink formulation, with no other specific therapeutic end use for the printed construct. He does not disclose pancreatic β-cells, a cell density range of instant claim 13, or that the living cells are pancreatic β-cells of instant claims 12-13 and 21. For this reason, Hwang and Kim are added. Hwang discloses a 3D bioprinted hybrid encapsulating system for delivering β-cell: “Based on the 3D bioprinting technology, the hydrogel-based cell-laden bioink can be placed into the islet encapsulation system in a single step procedure. Kim et al prepared a tissue-specific decellularized ECM (dECM)-based bioink to provide biochemical niches of native pancreatic tissue by mixing with β-cell aggregates and showed its printability by fabricating the cell-laden grid structure” (Page 2, Introduction). Hwang further discloses polymer and process compatibility relevant to He’s own Sil-MA/LAP/DLP platform in that Hwang’s pancreatic islet like aggregates are encapsulated within a GelMA based bioink and fabricated using the DLP bioprinting process, the same class of DLP printed hydrogel system as disclosed in He, and the same class of hydrogel He discloses. Kim discloses Sil-MA at 10-20% w/v combined with cell densities of 1-2x107 cells per mL or ~10-20x106 cells per mL, stating that the cell concentration “did not affect the integrity of the final construct” (Page 10, Discussion). The cell density of Kim falls within the range recited in instant claim 13. It would have been obvious to substitute Hwang’s pancreatic β-cell for He’s PC-12/HepG2 cells, at Kim’s disclosed higher cell density, in He’s Sil-MA bioink and DLP printing method to arrive at the bioink and method of instant claims 12-13 and 21 because Hwang demonstrates that pancreatic β-cell aggregates survive encapsulation (Page 8, Figure 3) and still retain insulin secretory function when printed (Page 11, Figure 6). A person having ordinary skill in the art seeking to produce a therapeutically relevant printed tissue construct such as for diabetes treatment such as Hwang, would have been motivated to substitute Hwang’s pancreatic cells for He’s generic cells, which He discloses as confirming to demonstrate general cell viability of the bioink rather than to serve a therapeutic purpose, meaning a skilled artisan seeking a therapeutic application would have necessarily had looked beyond He’s generic PC-12/HepG2 cells to an art relevant and therapeutically relevant cell type such as those pancreatic β-cells of Hwang, and would have look to Kim’s demonstrated higher density loading in the Sil-MA matrix and functional cell payload of the printed construct. One of ordinary skill would have had a reasonable expectation of success because both He and Hwang encapsulate living cells in a printable polymer. Hwang independently confirms that its pancreatic β-cells tolerates encapsulation and retains viability and function. Both the Sil-MA/LAP system of He and the GelMA system of Hwang are reliant on the same LAP photoinitiator to perform the cross linking chemistry, and the same general hydrogel class for cell encapsulation, and the same DLP bioprinting process, such that a skilled artisan would have expected Hwang’s β-cell to tolerate He’s Sil-MA based system in the same fashion that they have tolerated Hwang’s GelMA system. Kim’s demonstrated 10-20x106 cells/mL density in the identical Sil-MA matrix and concentration range further supports a reasonable expectation that higher cell-loading density would not compromise the integrity of the construct when combined with the pancreatic β-cell of Hwang. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Hwang’s pancreatic β-cells for He’s cells in He’s Sil-MA bioink and DLP printing method to arrive at instant claims 12-13 and 21, because doing so would predicably result in a viable, insulin-secreting, DLP printed pancreatic tissue construct suitable for a therapeutic application that He’s generic cytotoxicity disclosure does not address itself. For the foregoing reasons, claims 1, 11-14, 20-22, and 38-40 are rendered obvious by the teachings of the prior art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST. 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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /W.L./Examiner, Art Unit 1614 /SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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Prosecution Timeline

Apr 17, 2025
Application Filed
Oct 02, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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