DETAILED ACTION
Applicant’s response filed 3/23/2026 has been received and entered into the application file. Applicant’s arguments and amendments to the claims have been fully considered.
Claims 1-20 from the claim set filed 3/23/2026 are pending. Claims 2-5 and 7-19 were previously withdrawn. After further thought and consideration and upon Applicant’s request, claim 5 has been rejoined. Thus, claims 2-4 and 7-19 are withdrawn.
As such, claims 1, 5-6, and 20 are being examined on the merits herein.
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 .
REJECTION(S) WITHDRAWN
Claim Rejections - 35 USC § 103
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.
RE: Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Milone (US 20150030619 A1, published January 29, 2015; PTO 892) in view of Blott (WO 9831783 A1, published July 23, 1998; PTO 892) and G-BioSciences (G-Biosciences, “Protein Cross-Linkers Handbook and Selection Guide” (updated June 8, 2018); PTO 892).
Applicant amended claim 1 to now state: “A substrate, for steering of cells into a predetermined direction of cell functionality, the steering of cells consisting of steering cells into a predetermined direction of cell differentiation, the substrate comprising:
a bulk-modified elastomer comprising an elastomer material and a plurality of fatty acid moieties, the elastomer material having one or more cell functionality- inducing stimuli coupled thereto via carboxylic acid groups of the fatty acid moieties, wherein the cell functionality-inducing stimuli comprise cell differentiation-inducing stimuli, wherein the elastomer material comprises a polymer.”
Examiner notes the previously cited references do not teach of the newly required limitations of claim 1. As such, the previously filed rejections are withdrawn. However, Applicant amendment has necessitated new grounds of rejection as set forth below.
New Ground(s) of Rejections, Necessitated by Amendment
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.
Claims 1, 5-6, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Koninklijke [hereinafter ‘988] (WO 2019/015988 A1, published 1/24/2019, EFD 7/18/2017; PTO 892), as evidenced by Singh (Singh et al, Journal of Cell Science (2012) 125: 3703-3712; PTO 892).
In regards to claims 1, 5-6, and 20, ‘988 teaches a material for binding to a cell culturing protein (i.e., a cell functionality-inducing stimuli), the material containing a bulk-modified elastomer comprising a plurality of fatty acid moieties bound to the elastomer bulk, wherein the carboxylic groups of said fatty acid moieties are available to provide binding of said cell culturing proteins (pp3, lines 23-26). ‘988 teaches a cell culturing scaffold comprising the inventive material and a cell culturing protein bound to at least some of said carboxylic acid groups (p4, lines 32-34). ‘988 teaches said cell culturing scaffold having a substantially homogenous distribution of cell culturing proteins across a surface of the inventive material (claim 20) (p5, lines 1-6). ‘988 teaches said cell culturing proteins may be fibronectin, collagen, or elastin (p9, lines 7-8). As a POSITA will appreciate, fibronectin, collagen and elastin are essential extracellular matrix components and act as cell differentiation stimuli by providing biochemical and mechanical cues. For example, and as is evidenced by Singh, fibronectin has an effect on the differentiation of chondrocytes and affects cartilage development (Abstract). Singh additionally evidences fibronectin induces differentiation of ES cells (p3704, end of 1st column – top of 2nd column). Thus, fibronectin is a cell functionality-inducing stimuli and further is a cell differentiation-inducing stimulus. ‘988 teaches said elastomer may be a polymer (p10, lines 14-15) and further teaches the elastomer comprises a polybutadiene (claim 5) (p4, lines 24-25).
In regards to claim 6, ‘988 teaches the carboxylic acid groups (compound I) may be reacted with 1-ethyl-3-(3-dimethyllaminopropyl) carbodiimide hydrochloride (EDC, compound II, i.e., a reactive group of a precursor elastomer material) followed by a reaction with N-hydroxysuccinimide (NHS, compound IV, i.e., a reactive group of a precursor elastomer material), which can react with the amine groups of fibronectin (compound VII) (i.e., the functional group of the cell culturing protein, i.e., the functional group of the one or more cell functionality-inducing stimuli) to covalently bind (i.e., a type of bioconjugation crosslinking reaction) the fibronectin to the carboxylic acid groups of the bulk-modified elastomer (p15, lines 23-26 – p16, lines 1-2).
This reads on the limitations of claim 6.
Thus, ‘988 anticipates claims 1, 5-6, and 20 and therefore said claims are properly rejected.
Conclusion
No claims are allowable. No claims are free of the prior art.
Examiner respectfully notes the applied prior art is the closest prior art for the instant invention, as defined by the current claim language. Thus, if Applicant were to file a joint research agreement, the claims as currently written, would be free of the prior art. Examiner notes there does not appear to be prior art, other than ‘988, making the instant invention, as defined by the claims as currently written, either anticipated or obvious.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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