Office Action 2: Notice of Allowance (2025-08-12)

CLAIMS:
Having described the invention, we claim:

1\. A method of forming a substrate comprising:mapping a three dimensional spatial distribution of at least one structural protein fiber and/or natural or synthetic analogs thereof of extracellular matrix of biological material of interest;
designing a fiber assembly pattern based on an intrinsic pattern of the at least one structural protein fiber and/or natural or synthetic analogs thereof of the extracellular matrix of the biological material; and
assembling fibers based on the fiber assembly pattern to form the substrate.
2\. The method of claim 1, wherein the substrate is a biomedical material, tissue implant, or mechanically functional textile.
3\. The method of claim 1, wherein the at least one structural protein fiber (and/or natural or synthetic analogs thereof) comprises collagen fibers and elastin fibers of the extracellular matrix of the biological material.
4\. The method of claim 3, wherein the three dimensional spatial distribution of the collagen fibers and elastin fiber are mapped using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers.
5\. The method of claim 1 claim, wherein the fiber assembly pattern comprises a weaving algorithm based on the intrinsic pattern.
6\. The method of claim 5, wherein the assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.
7\. The method of claim 1, wherein the biological material comprises tissue of a plant or animal.

8\. The method of claim 7, wherein the tissue comprises at least one periosteum, pericardium, perimycium, or tissue bounding an organ or tissue compartment of animal or plant or other natural origin.

9\. A method of forming a textile, the method comprising:mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest;
designing a fiber assembly pattern based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material; and
assembling fibers based on the fiber assembly pattern to form the textile.

10\. The method of claim 9, wherein the textile is a tissue implant or mechanically functional textile.

11\. The method of claim 9, wherein the at least one structural protein fiber comprises collagen fibers and elastin fibers and/or natural or synthetic analogs thereof of the extracellular matrix of the biological material.

12\. The method of claim 9, wherein the three dimensional spatial distribution of the collagen fibers and elastin fiber are mapped using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers of the tissue.

13\. The method of claim 9 claim, wherein the fiber assembly pattern comprises a weaving algorithm based on the intrinsic pattern.

14\. The method of claim 13, wherein the assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.

15\. The method of claim 9, wherein the biological material comprises tissue of a plant or animal.

16\. The method of claim 15, wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue bounding an organ or tissue compartment of animal or plant or other natural origin.

17\. A method of forming an engineered tissue construct, the method comprising:mapping a three dimensional spatial distribution of collagen fibers and elastin fibers of the extracellular matrix of a tissue of interest;designing a fiber weaving motif based on an intrinsic pattern of the collagen fibers and elastin fibers of the extracellular matrix of the tissue; and
weaving fibers based on the fiber weaving motif to define the weave pattern and fiber orientation and form the engineered tissue construct.

18\. The method of claim 17, wherein the three dimensional spatial distribution of the structural proteins such as collagen fibers and elastin fibers are mapped using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers of the tissue.

19\. The method of claim 9 claim, wherein the fiber assembly pattern comprises a weaving algorithm based on the intrinsic pattern.

20\. The method of claim 19, wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue bounding an organ or tissue compartment.

OFFICE 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 .
EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Richard Sutkus on 8/8/2025.
The application has been amended as follows:
In claim 5, line 1, delete the second occurrence of the term “claim”;
In In claim 13, line 1, delete the second occurrence of the term “claim”;  and
claim 19, line 1, delete the second occurrence of the term “claim”.

APPLICANT REBUTTAL: REMARKS/ARGUMENTSReconsideration of the above-identified application is respectfully requested.Below is a discussion of the outstanding rejections of the claims.1.   Nonstatutory double patenting rejection of claims 1-20 Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,814,757. Although the claims at issue are not identical, they are not patentably distinct from each other.In response to the double patenting rejection, a Terminal Disclaimer is submitted herewith to overcome the rejection of claims 1-20 over claims 1-15 of U.S. Patent No. 11,814,757.In view of the foregoing, it is respectfully submitted that the present application is in a condition of allowance and allowance of the present application is respectfully requested.Please charge any deficiency or credit any overpayment in the fees for this matter to our Deposit Account No. 20-0090.Respectfully submitted, /Richard A. Sutkus/ Richard A. Sutkus Reg. No. 43,941 TAROLLI, SUNDHEIM, COVELL,& TUMMINO L.L.P.950 Main Avenue, Suite 710 Cleveland, Ohio 44113 Phone: (216) 621-2234 Fax: (216) 621-4072 Customer No.: 26,294