Prosecution Insights
Last updated: April 19, 2026
Application No. 18/573,671

TISSUE-ENGINEERED SCAFFOLDS AND METHODS OF MAKING

Non-Final OA §102§103§112
Filed
Dec 22, 2023
Examiner
DARNELL, BAILEIGH K
Art Unit
1743
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Georgia Tech Research Corporation
OA Round
1 (Non-Final)
70%
Grant Probability
Favorable
1-2
OA Rounds
2y 12m
To Grant
96%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allow Rate
259 granted / 372 resolved
+4.6% vs TC avg
Strong +26% interview lift
Without
With
+26.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 12m
Avg Prosecution
28 currently pending
Career history
400
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
49.4%
+9.4% vs TC avg
§102
20.1%
-19.9% vs TC avg
§112
25.6%
-14.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 372 resolved cases

Office Action

§102 §103 §112
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. 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 appl icant regards as his invention. center 93929 Claims 27 and 35 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. Regarding claim 27 : there is insufficient antecedent basis for the following recitations: a textile layer, a plurality of yarns, interlocking bundles of fibers, a first polymer, a first polymer mixture, one or more substrate layers, a second polymer, and a second polymer mixture, as claim 27 depends from claim 1 and claim 1 previously introduced each of the above elements making it unclear as to whether the recitations in claim 27 are equivalent to those already introduced in claim 1 or if claim 27 is attempting to introduce new recitations of each of the elements . Claim 35 is rejected due to its dependency on claim 27. 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. (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. center 117399 0 Claim s 1-2, 4, 10, 12, 27 and 35 are rejected under 35 U.S.C. 102 ( a )( 1 ) and 102(a)(2) as being anticipated by Hakimi et al. (US 2020/0155724; made of record in the IDS filed 12/23/2023, herein referred to as Hakimi ) . As to claim 1 : Hakimi discloses the claimed method of making a scaffold for tissue engineering (i.e., biodegradable scaffold for tissue repair and methods of making such scaffolds and uses thereof ) ( Hakimi at [0002]) comprising: providing a textile layer formed of a plurality of yarns (i.e., polymer fibre layer , consisting of electrospun polymer consisting of polymer fibres or yarns ) ( Hakimi at [ 0007 ] , [0009], [0017], [0027], [0034] , FIG. 1I ) , wherein the plurality of yarns are formed of interlocking bundles of fibers formed from a first polymer or a first polymer mixture (i.e., the polymer fibre layer is formed from fibres obtained via electrospinning, where the fibres comprise or consist of substantially non-uniform and/or non-regular interlaced or entagled fibres ) ( Hakimi at [0017], [ 0027 ]) ; and forming one or more substrate layers of a second polymer or a second polymer mixture onto the textile layer having a pre-defined thickness (i.e., material layer bonded to the polymer fibre layer, the material layer having a thickness between about 20 µm and about 1 cm ) ( Hakimi at [ 0007 ] , [0008], [0011], [0017], [0049] ) . As to claim 2 : Hakimi discloses the claimed method of making a scaffold for tissue engineering of claim 1. Hakimi further discloses the claimed wherein the textile layer is formed of the plurality of yarns by a weaving operation, a knitting operation, a crocheting operation, a knotting operation, a tatting operation, a felting operation, a bonding operation, or a braiding operation to have a pre- defined textile pattern for cell growth of a population of cells onto the scaffold ( Hakimi at [ 0017 ] , [0021], [0027], [0029], [0101] ) . As to claim 4 : Hakimi discloses the claimed method of making a scaffold for tissue engineering of claim 1. Hakimi further discloses the claimed wherein the one or more substrate layers is an electrospun mat ( Hakimi at [ 0017 ]) . As to claim 10 : Hakimi discloses the claimed method of making a scaffold for tissue engineering of claim 1. Hakimi further discloses the claimed method further comprising seeding a population of cells onto the scaffold ( Hakimi at [ 0054 ] , [0056], [0086] ) . As to claim 1 2 : Hakimi discloses the claimed method of making a scaffold for tissue engineering of claim 1. Hakimi further discloses the claimed method further comprising: electrospinning the one or more substrate layers; and varying the duration of the electrospinning step to achieve a desired substrate layer thickness ( Hakimi at [0017], [0049] ) . As to claim 27 : Hakimi discloses the claimed scaffold for tissue engineering formed by the method of claim 1 (see the rejection of claim 1 above) , the scaffold comprising: a textile layer formed of a plurality of yarns, wherein the plurality of yarns are formed of interlocking bundles of fibers formed from a first polymer or a first polymer mixture (i.e., polymer fibre layer , consisting of electrospun polymer consisting of polymer fibres or yarns ) ( Hakimi at [0007], [0009], [0017], [0027], [0034], FIG. 1I) ; and one or more substrate layers comprising a second polymer or a second polymer mixture formed onto or attached to the textile layer (i.e., material layer bonded to the polymer fibre layer, the material layer having a thickness between about 20 µm and about 1 cm ) ( Hakimi at [0007], [0008], [0011], [0017], [0049]) . As to claim 35 : Hakimi discloses the claimed therapeutic method (i.e., scaffold for use as a medicament ) ( Hakimi at [0058], [0059]) comprising: providing the scaffold of claim 27 (i.e., biodegradable scaffold for tissue repair – see the rejection of claim 27 above) ; and implanting the scaffold into or onto a subject (i.e., implementation of the layered scaffold in a rat ) ( Hakimi at [0119]) . 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. center 2350389 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 3, 5-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hakimi as applied to claim 1 above, and further in view of W u et al. ( “Interwoven Aligned Conductive Nanofiber Yarn/Hydrogel Composite Scaffolds for Engineered 3D Cardiac Anisotropy” ACS Nano, Vol. 11, Issue 6, pp. 5646-5659, 2017; made of record in the IDS filed 11/20/2024, herein referred to as Wu ) . As to claim 3 : Hakimi discloses the claimed method of making a scaffold for tissue engineering of claim 1. Hakimi discloses the claimed method further comprising: forming a yarn of the plurality of fibers by electrospinning the first polymer or the first polymer mixture into the plurality of fibers ( Hakimi at [0017], [ 0027 ]). Though, Hakimi fails to explicitly disclose the claimed drawing the plurality of fibers out of an electrospinning bath to form the bundles; and forming the yarn from the bundles. However, Wu teaches a 3D hybrid scaffold by encapsulating conductive nanofiber yarns network (NFYs-NET) within hydrogel shell to engineer anisotropic and endothelialized cardiac constructs by controlling cellular orientation and organization of cardiomyocyte within a 3D multilayer environment ; and t o mimic the complex interwoven structure of native cardiac tissue and control cellular alignment and elongation, the interwoven conductive aligned NFYs-NET structures via a weaving technique were prepared ( Wu at page 5648, paragraph 2) . Wu further teaches t he aligned PCL/SF/CNT nanofiber yarns were prepared by an enhanced wet−dry electro spinning process , where t he nanofibrous random web was first received on the surface of a distilled water/ethanol bath, and then drawn with a rotating receptor and lifted off the surface of solution to obtain the continuous nanofiber yarns ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b ) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the electrospinning bath to form the bundles and forming the yarn from the bundles as such is known in the art of scaffold formation for tissue engineering given the discussion of Wu above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results . As to claim 5 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Wu further reads on the claimed wherein electrospinning of the fiber comprises wet electrospinning ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b ), for similar motivation discussed in the rejection of claim 3. As to claim 6 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Wu further reads on the claimed wherein the step of drawing the plurality of fibers out of the electrospinning bath to form the bundles further comprises winding the plurality of drawn fibers around a roller ( Wu at Figure 1b ), for similar motivation discussed in the rejection of claim 3 . As to claim 7 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Wu further reads on the claimed method further comprising varying a drawing speed to generate (i) a desired fiber alignment of the plurality of fibers, (ii) a desired bundle diameter of the plurality of fibers, or a combination thereof ( Wu at Results and Discussion, Paragraph 1 ), for similar motivation discussed in the rejection of claim 3 . As to claim 8 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Hakimi further discloses the claimed wherein the first polymer or the first polymer mixture comprises polyester, polylactic acid (PLA), polyglycolic acid (PGA), polyethylene oxide (PEO), poly lactic-co- glycolide (PLGA), polycaprolactone (PCL), polydioxanone (PDS), a polyhydroxyalkanoate (PHA), polyurethane (PU), a poly( phosphazine ), a poly(phosphate ester), a gelatin, a collagen, alginate, chitosan, agarose, fibrin, hyaluronic acid, a polyethylene glycol (PEG), elastin, silk fibroin, copolymers thereof, and blends thereof ( Hakimi at [0030], [0031] ) . As to claim 9 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Hakimi further discloses wherein the second polymer or the second polymer mixture comprises polyester, polylactic acid (PLA), polyglycolic acid (PGA), polyethylene oxide (PEO), poly lactic-co- glycolide (PLGA), polycaprolactone (PCL), polydioxanone (PDS), a polyhydroxyalkanoate (PHA), polyurethane (PU), a poly( phosphazine ), a poly(phosphate ester), a gelatin, a collagen, alginate, chitosan, agarose, fibrin, hyaluronic acid, a polyethylene glycol (PEG), elastin, silk fibroin, or copolymers thereof, and blends thereof ( Hakimi at [00 22 ], [00 23 ] ) . As to claim 1 3 : Hakimi and Wu disclose the method of making a scaffold for tissue engineering of claim 3. Wu further reads on the claimed wherein the electrospinning bath comprises a liquid having a concentration in the electrospinning bath to form the plurality of fibers having a pre-defined mechanical property with the one or more substrate layers, wherein the pre-defined mechanical property is selected from the group consisting of a pre-defined resilience or range, a pre-defined elastic modulus or range, a pre- defined maximum strain or range, and a pre-defined maximum stress or range, or any combination thereof ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b ), for similar motivation discussed in the rejection of claim 3 . center 261950 0 Claim s 36, 44 , 51 and 58- 59 are rejected under 35 U.S.C. 103 as being unpatentable over W u et al. (“Interwoven Aligned Conductive Nanofiber Yarn/Hydrogel Composite Scaffolds for Engineered 3D Cardiac Anisotropy” ACS Nano, Vol. 11, Issue 6, pp. 5646-5659, 2017; made of record in the IDS filed 11/20/2024, herein referred to as Wu ) in view of Zh e ng et al. ( “Uniform nanoparticle coating of cellulose fibers during wet electrospinning” Journal of Materials Chemistry A, Issue 36, 2014; made of record in the IDS filed 11/20/2024; herein referred to as Zheng ) . As to claim 36 : Wu discloses the claimed method of fabricating composite yarns (i.e., nanofiber yarns , NFYs ) ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b) , the method comprising: forming fibers of one or more polymers in a bath ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b) ; extracting the fibers from the bath ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b) ; and interlocking bundles of fibers to form composite yarns, the composite yarns can include the one or more polymers and carbon nanomaterial ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b) . Wu discloses the CNT’s were embedded within the nanofiber ( Wu at Results and Discussion, paragraph 1); though, Wu fails to explicitly disclose the claimed carbon nanomaterial bath, the carbon nanomaterial bath can include a carbon nanomaterial suspended in a liquid ; and coating the fibers with the carbon nanomaterial to form fibers . However, Zheng teaches uniform nanoparticle coating of fibers during wet electrospinning ( Zheng at Title), where the synthesis of nanofiber composites includes functional nanoparticles being embedded into the surface of wet electrospun fibers by having an aqueous coagulation bath that contains a suspension of two types of nanoparticles ( Zheng at Introduction, paragraph 2). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the carbon nanomaterial bath, the carbon nanomaterial bath can include a carbon nanomaterial suspended in a liquid ; and coating the fibers with the carbon nanomaterial to form fibers given the discussion of Zheng above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results. As to claim 44 : Wu discloses the claimed method of fabricating a scaffold for tissue engineering ( Wu at Methods – Fabrication of NFYs-NET Scaffold & Fabrication of NFYs-NET/Gel 3D Scaffold; Figure 2a) , the method comprising: fabricating composite yarns according to the method of claim 36 ( see Wu and Zheng as applied in the rejection of claim 36 ) ; and forming a scaffold comprising the composite yarns ( Wu at Methods – Fabrication of NFYs-NET Scaffold & Fabrication of NFYs-NET/Gel 3D Scaffold; Figure 2a ) . As to claim 5 1 : Wu discloses the claimed composite yarn (i.e., nanofiber yarns , NFYs ) ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b) comprising: a yarn core comprising one or more polymers ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b ) , wherein the yarn core is used to form a textile layer of a scaffold for tissue engineering ( Wu at Abstract; Methods – Fabrication of NFYs-NET Scaffold & Fabrication of NFYs-NET/Gel 3D Scaffold; Figure 2a ) , and wherein the yarns are formed of interlocking bundles of fibers comprising the one or more polymers and the carbon nanomaterial ( Wu at Methods – Preparation of Aligned PCL/SF/CNT Nanofiber Yarns; Figure 1b ) . Wu discloses the CNT’s were embedded within the nanofiber ( Wu at Results and Discussion, paragraph 1); though, Wu fails to explicitly disclose the claimed carbon nanomaterial being on the surface of the yarn core. However, Zheng teaches uniform nanoparticle coating of fibers during wet electrospinning ( Zheng at Title), where the synthesis of nanofiber composites includes functional nanoparticles being embedded into the surface of wet electrospun fibers by having an aqueous coagulation bath that contains a suspension of two types of nanoparticles ( Zheng at Introduction, paragraph 2) . It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the carbon nanomaterial being on the surface of the yarn core as such is known in the art of composite yarns given the discussion of Zheng above presenting a reasonable expectation of success; and doing so is combining prior art elements according to known methods to yield predictable results. As to claim 58 : Wu and Zheng disclose the composite yarns of claim 51 and therefore also read on the claimed tissue engineering scaffold comprising the composite yarns of claim 51 ( Wu at Results and Discussion, Paragraph 2) . As to claim 59 : Wu discloses the claimed method of promoting cell adhesion to a tissue engineered scaffold ( Wu at Abstract; Results and Discussion, paragraphs 6-9) , the method comprising: fabricating composite yarns according to the method of claim 36 (see Wu and Zheng as applied in the rejection of claim 36) ; fabricating a tissue engineered scaffold according to the method of claim 44 (see Wu and Zheng as applied in the rejection of claim 36) ; and contacting the tissue engineered scaffold with cells in an environment that promotes cell viability ( Wu at Results and Discussion, paragraphs 6-9) . Allowable Subject Matter Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to teach or reasonably suggest a method of making a scaffold for tissue engineering meeting every limitation of claim 11; specifically, wherein forming the textile layer comprises crocheting the plurality of yarns with a pre-defined crochet hook size to provide the scaffold with a pre-defined mechanical property selected from the group consisting of a pre-defined resilience or range, a pre-defined elastic modulus or range, a pre-defined maximum strain or range, and a pre-defined maximum stress or range, or any combination thereof. Williams et al. (US 2019/0269817; herein referred to as Williams ) discloses a surgical mesh which is a crocheted mesh ( Williams at claim 1) and Malcuit et al. (US 2013/0095078; herein referred to as Malcuit ) discloses an engineered construct in the form of a braided collagen microthread scaffold and manipulating the braiding angle to alter the space between the individual threads depending on whether high mechanical strength is or is not needed ( Malcuit at [0078]). Though, neither of the references teach or reasonably suggest claim 11, wherein forming the textile layer comprises crocheting the plurality of yarns with a pre-defined crochet hook size to provide the scaffold with a pre-defined mechanical property selected from the group consisting of a pre-defined resilience or range, a pre-defined elastic modulus or range, a pre-defined maximum strain or range, and a pre-defined maximum stress or range, or any combination thereof. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BAILEIGH K. DARNELL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (469)295-9287 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F, 9am-5pm, MST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Galen H. Hauth can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)270-5516 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BAILEIGH KATE DARNELL/ Examiner, Art Unit 1743
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Prosecution Timeline

Dec 22, 2023
Application Filed
Mar 17, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
70%
Grant Probability
96%
With Interview (+26.4%)
2y 12m
Median Time to Grant
Low
PTA Risk
Based on 372 resolved cases by this examiner. Grant probability derived from career allow rate.

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