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Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2/11/26.
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 2/11/26 is acknowledged.
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.
Claims 2 and 5 are 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.
Claims 2 and 5 contain the trademark/trade name Matrigel (claim 2) and Ivocerin and Irgacure (claim 5). 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 polymers and photoinitiators and, accordingly, the identification/description is indefinite.
Further, with claim 5, it is unclear whether the tradename in parenthesis is exemplary or further defining chemical to that specific brand. Thus, there are at least two reasonable interpretations and it is unclear which is intended.
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.
Claim(s) 1-3 and 5-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. “Bioprinting-Based PDLSC-ECM Screening for in Vivo Repair of Alveolar Bone Defect Using Cell-Laden, Injectable and Photocrosslinkable Hydrogels” ACS Biomater. Sci. Eng. (2017) 10:1-43 (herein Ma).
As to claims 1-3 and 5-6, Ma discloses a method of preparing a bio-ink (comprising gelatin) composition for bio-printing (see abstract) comprising mixing a polymer with methacrylate (specifically GelMa, which is gelatin (GA) wherein methacrylate (MA) is introduced), a crosslinking agent having 2 acrylate groups (PEGDA, polyethylene glycol diacrylate) and a photoinitiator (2-hydroxy-2-methylpropionphenone). See section 2. Experimental, specifically under 2.2 and examples.
MPEP 2111.02 states that "if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction". Further, MPEP 2111.02 states that statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the purpose or intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the intended use is bio-ink composition for bioprinting, and further defining the type of bioprinting in claim 6. However, the composition and method of preparing a composition is identical and therefore, the bio (comprises gelatin) ink composition is identical and could be utilized for 3D printing.
As to claims 7-8, a method of prospering a biological structure (e.g. bone parts, see abstract and figure 1) is disclosed by allowing the bioink of claim 1 to be irradiated via photocrosslinking the polymer and crosslinking agent (see abstract and examples). See examples in section 2 that expose the bioink to UV light. The amount of light (crosslinking) controls the mechanical properties (thus adjusting properties). See examples and section 2.3.
As to claim 9, UV light has a wavelength of 100 to 400 nm, which is within the claimed range. See examples.
As to claim 10, the irradiation is performed for 30 seconds (30 s). See examples.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim Nuhui “Fabrication and Characterization of Artificial Ear Cartilages Containing ECM Powders using Bioprinting” (Master’s thesis, Graduate School of Sogang University), 2019 (herein Kim).
As to claims 1-5, Kim discloses a method of preparing a bio-ink composition for bio-printing (see abstract) comprising mixing a polymer with methacrylate (specifically GelMa, which is gelatin (GA) wherein methacrylate (MA) is introduced, see pages 3-4), a crosslinking agent having 2 acrylate groups (PEGDA, polyethylene glycol diacrylate, with a Mn of 700, thus a equivalent weight of about 350, see page 4) and a photoinitiator (LAP, Lithium phenyl-2,4,6-trimethyl benzoylphosphinate, see page 4). Described in examples in chapter 2. See pages 3-6 in general.
As to claim 6, MPEP 2111.02 states that "if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction". Further, MPEP 2111.02 states that statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the purpose or intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the intended use is bio-ink composition for bioprinting, and further defining the type of bioprinting in claim 6. However, the composition and method of preparing a composition is identical and therefore, the bio (comprises gelatin) ink composition is identical and could be utilized in the same 3d printing techniques.
As to claims 7-9, a biological structure (ear, pages 7-9 and examples) is prepared by allowing the bio-ink is irradiated by UV light at 365 nm (page 8 and examples), wherein the irradiation adjusts the physical properties (e.g. mechanical properties, see pages 2, 11, 13, and examples) via photocrosslinking the polymer and agent (see examples).
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by US 2020/0122140 (herein Zhang).
As to claims 1-6, Zhang discloses a bio-ink (paragraph 44) comprising a polymer with methacrylate (specifically GelMa, which is gelatin (GA)), a crosslinking agent having 2 acrylate groups (PEGDA, polyethylene glycol diacrylate, with a Mn of 700, thus a equivalent weight of about 350) and a photoinitiator (LAP, Lithium phenyl-2,4,6-trimethyl benzoylphosphinate). See paragraph 97 describing the biogel, which is disclosed as a bioink in paragraph 44. The bioink is utilized in 3D printing such a in a masked (paragraph 32-33) stereolithographic printer such as a digital light processing device (DLP). See paragraph 53.
As to claims 7-10, methods of preparing biological structures (e.g. biological tissues, see paragraph 83-84) from the bioink that is irradiated with a light source at 365 nm (paragraph 94 and examples), which were exposed between 1 to 20 seconds to crosslink the polymer and crosslinker. See paragraphs 94, 91 and examples.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK S KAUCHER whose telephone number is (571)270-7340. The examiner can normally be reached M-F 8-6 PM EST.
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/MARK S KAUCHER/Primary Examiner, Art Unit 1764