Office Action 1: Non-Final Rejection (2025-04-10)
Rejection types: Double Patenting

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:
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11814757. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the patent is drawn to a method of forming a substrate comprising mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to form individual tiles in a transverse x-y plane of an x-y-z coordinate system; stacking the individual tiles in the z-direction to form a three-dimensional
model; designing a fiber assembly pattern comprising a weaving algorithm based
on an intrinsic pattern of the at least one structural protein fiber of the extracellular
matrix of the biological material in the three-dimensional model; and assembling fibers based on the fiber assembly pattern to form the substrate  and as such the instant intendent claim 1 differs only in that it is broader than the patented claim and as such the patented claim would anticipate the instant claim therefor the instant claim is not patentably distinct from the patented claim. The dependent claim are all drawn to limitations verbatim or non distinct (anticipated by) the patented claims in question.

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

NEXT 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”.

CITED REFERENCE SUMMARIES: Ref US11814757B2: Claims:
A method of forming a substrate comprising: mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to form individual tiles in a transverse x-y plane of an x-y-z coordinate system; stacking the individual tiles in the z-direction to form a three-dimensional model; designing a fiber assembly pattern comprising a weaving algorithm based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material in the three-dimensional model; and assembling fibers based on the fiber assembly pattern to form the substrate.
mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to form individual tiles in a transverse x-y plane of an x-y-z coordinate system;
stacking the individual tiles in the z-direction to form a three-dimensional model;
designing a fiber assembly pattern comprising a weaving algorithm based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material in the three-dimensional model; and
assembling fibers based on the fiber assembly pattern to form the substrate.
The method of claim 1 , wherein the substrate is a biomedical material, tissue implant, or mechanically functional textile.
The method of claim 1 , wherein the assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.
The method of claim 1 , wherein the biological material comprises tissue of a plant or animal.
The method of claim 4 , wherein the tissue comprises at least one periosteum, pericardium, perimycium, or tissue spanning an organ or tissue compartment of animal or plant or other natural origin.
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 comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system; stacking the individual tiles in the z-direction to form a three-dimensional model; designing a fiber assembly pattern comprising a weaving algorithm based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material in the three-dimensional model; and assembling fibers based on the fiber assembly pattern to form the textile.
mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system;
assembling fibers based on the fiber assembly pattern to form the textile.
The method of claim 6 , wherein the textile is a tissue implant or mechanically functional textile.
The method of claim 6 , wherein the assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.
The method of claim 6 , wherein the biological material comprises tissue of a plant or animal.
The method of claim 9 , wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue binding an organ or tissue compartment of animal or plant or other natural origin.
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, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system; stacking the individual tiles in the z-direction to form a three-dimensional model; designing a fiber weaving motif based on an intrinsic pattern of the collagen fibers and elastin fibers of the extracellular matrix of the tissue in the three-dimensional model; and weaving fibers based on the fiber weaving motif to define the weave pattern and fiber orientation and form the engineered tissue construct.
mapping a three dimensional spatial distribution of collagen fibers and elastin fibers of the extracellular matrix of a tissue of interest, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system;
designing a fiber weaving motif based on an intrinsic pattern of the collagen fibers and elastin fibers of the extracellular matrix of the tissue in the three-dimensional model; and
weaving fibers based on the fiber weaving motif to define the weave pattern and fiber orientation and form the engineered tissue construct.
The method of claim 11 , wherein the fiber assembly pattern comprises a weaving algorithm based on the intrinsic pattern.
The method of claim 12 , wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue binding spanning an organ or tissue compartment.
The method of claim 1 , wherein each tile has a thickness in the z-direction of 0.5 Î¼m.
The method of claim 1 , wherein the second harmonic imaging microscopy and the two photon excitation imaging microscopy are both performed at about 830 nm.
Ref US11814757: Claims:
1. A method of forming a substrate comprising:
mapping a three dimensional spatial distribution of at least one structural protein fiber of extracellular matrix of biological material of interest comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to form individual tiles in a transverse x-y plane of an x-y-z coordinate system;
stacking the individual tiles in the z-direction to form a three-dimensional model;
designing a fiber assembly pattern comprising a weaving algorithm based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material in the three-dimensional model; 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 assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.
4. The method of claim 1, wherein the biological material comprises tissue of a plant or animal.
5. The method of claim 4, wherein the tissue comprises at least one periosteum, pericardium, perimycium, or tissue spanning an organ or tissue compartment of animal or plant or other natural origin.
6. 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 comprising collagen fibers and elastin fibers, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system;
stacking the individual tiles in the z-direction to form a three-dimensional model;
designing a fiber assembly pattern comprising a weaving algorithm based on an intrinsic pattern of the at least one structural protein fiber of the extracellular matrix of the biological material in the three-dimensional model; and
assembling fibers based on the fiber assembly pattern to form the textile.
7. The method of claim 6, wherein the textile is a tissue implant or mechanically functional textile.
8. The method of claim 6, wherein the assembled fibers are woven using the weaving algorithm to define the weave pattern and fiber orientation.
9. The method of claim 6, wherein the biological material comprises tissue of a plant or animal.
10. The method of claim 9, wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue binding an organ or tissue compartment of animal or plant or other natural origin.
11. 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, the three dimensional spatial distribution using second harmonic imaging microscopy imaging of the collagen fibers and two photon excitation imaging microscopy of the elastin fibers to generate individual tiles in a transverse x-y plane of an x-y-z coordinate system;
stacking the individual tiles in the z-direction to form a three-dimensional model;
designing a fiber weaving motif based on an intrinsic pattern of the collagen fibers and elastin fibers of the extracellular matrix of the tissue in the three-dimensional model; and
weaving fibers based on the fiber weaving motif to define the weave pattern and fiber orientation and form the engineered tissue construct.
12. The method of claim 11, wherein the fiber assembly pattern comprises a weaving algorithm based on the intrinsic pattern.
13. The method of claim 12, wherein the tissue comprises at least one of periosteum, pericardium, perimycium, or tissue binding spanning an organ or tissue compartment.
14. The method of claim 1, wherein each tile has a thickness in the z-direction of 0.5 μm.
15. The method of claim 1, wherein the second harmonic imaging microscopy and the two photon excitation imaging microscopy are both performed at about 830 nm.