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 Group I, claims 1-12, in the reply filed on 13 May 2026 is acknowledged. It is noted that even though claim 16 is amended to depend from elected claim 1, claims 16-20 are still withdrawn as they lack the same or corresponding special technical feature in view of the prior art.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 13 May 2026.
Claim Rejections - 35 USC § 112
Claims 3-4 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 3-4 contain parenthesis. Parenthesis and/or brackets in claims should only be used with labels/number from the specification or drawings. It is unclear whether the applicant intends these limitations to be a part of the claim.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chao et al. (“Preparation and Characterization of pH Sensitive Semi-interpenetrating Network Hydrogel Based on Methacrylic Acid, Bovine Serum Albumin (BSA), and PEG”, Journal of Polymer Research (2006), 13: 349-355).
Regarding claims 1 and 5-10; Chao et al. teaches, in a preferred embodiment, the synthesis of P(MAA-EG)-BSA SIPN hydrogel prepared by UV-initiated free radical polymerization of a mixture of 0.4g MMA (methyl methacrylate), 0.25g BSA (bovine serum albumin, non-acrylated globular protein), 0.6g PEGDMA (polyethylene glycol dimethacrylate, diacrylate-containing compound), 0.03g BIS (crosslinker), and 1% w/w DMPA (2,2-dimethoxy-2-pheyl acetophenone, photoinitiating component) in a co-solvent of water/ethanol (60/40 V/V, solvent) [p350, col1, para3].
Regarding claim 2; Chao et al. does not explicitly disclose a viscosity that ranges from greater than 0 to less than 10 Pa·s. The Office realizes that all the claimed effects or physical properties are not positively stated by the reference. However, the reference teaches all of the claimed reagents, claimed amounts, and substantially similar processes. According to the original specification, the globular protein is used at an amount sufficient to retain a viscosity of 10 Pas or less, particularly at concentrations 15% to 40% by weight [062]. Chao et al. teaches the BSA is employed in an amount of 19.5% by weight (0.25g/1.28g total MMA+BSA+PEGDMA+BIS+DMPA, as calculated by Examiner). Therefore, the claimed effects and physical properties, i.e. viscosity, would necessarily be present in a composition with all the claimed ingredients. If it is the applicants' position that this wouldn’t be the case: (1) evidence would need to be presented to support applicants' position; and (2) it would be the Offices' position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties and effects with only the claimed ingredients, claimed amounts, and substantially similar processes. See In re Spada, MPEP §2112.01, I-II.
Regarding claims 3-4; Chao et al. teaches 0.25g BSA and 0.6g PEGDMA, thus a ratio of 1 BSA: 2.4 PEGDMA, as calculated by Examiner [p350, col1, para3].
Regarding claim 11; Chao et al. does not explicitly disclose wherein the non-acrylated globular protein is covalently bound to the diacrylate-containing compound through a covalent bond formed between an amine group or the non-acrylated globular protein and a carbon atom of the diacrylate-containing compound. The Office realizes that all the claimed effects or physical properties are not positively stated by the reference. However, the reference teaches all of the claimed reagents, claimed amounts, and substantially similar processes. Therefore, the claimed effects and physical properties, i.e. the non-acrylated globular protein is covalently bound to the diacrylate-containing compound through a covalent bond, would necessarily be present in a composition with all the claimed ingredients. If it is the applicants' position that this wouldn’t be the case: (1) evidence would need to be presented to support applicants' position; and (2) it would be the Offices' position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties and effects with only the claimed ingredients, claimed amounts, and substantially similar processes. See In re Spada, MPEP §2112.01, I-II.
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.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chao et al. (“Preparation and Characterization of pH Sensitive Semi-interpenetrating Network Hydrogel Based on Methacrylic Acid, Bovine Serum Albumin (BSA), and PEG”, Journal of Polymer Research (2006), 13: 349-355), as applied to claim 1 above, and further in view of Smith et al. (“Additive Manufacturing of Bovine Serum Albumin-Based Hydrogels and Bioplastics”, Biomacromolecules 2020, 21, 484-492 (published 19 Nov 2020)), as cited on the IDS.
Chao et al. teaches the basic claimed protein-based composition, as set forth above, with respect to claim 1.
Regarding claim 12; Chao et al. teaches a composition comprising bovine serum albumin, poly(ethylene glycol) dimethacrylate, and water, however fails to teach the photoinitiating component comprises sodium persulfate and ruthenium tris(bipyridyl) chloride. Smith et al. teaches bovine serum albumin-based hydrogels prepared by reacting PEG-DA (polyethylene glycol diacrylate) dissolved in water with MA-BSA (methacrylated bovine serum albumin), ruthenium tris(bipyridyl) chloride and sodium persulfate. Chao et al. and Smith et al. are analogous art because they are both concerned with the same field of endeavor, namely hydrogels prepared from acrylated compounds and bovine serum albumin. At the time of filing, a person of ordinary skill in the art would have found it obvious add ruthenium tris(bipyridyl) chloride and sodium persulfate, as taught by Smith et al., to the composition of Chao et al., and would have been motivated to do so because ruthenium tris(bipyridyl) chloride and sodium persulfate have excellent solubility in water, thus make for more efficient curing.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA ROSWELL whose telephone number is (571)270-5453. The examiner can normally be reached M-F 8:00 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached at 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA M ROSWELL/ Primary Examiner, Art Unit 1767
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