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 .
Response to Amendment
The amendment filed 06/22/2026 has been entered. Claims 1 and 27 have been amended. Claims 14-26, 37-43, 45-50, 52-57 and 60-64 remain canceled. No claims have been newly submitted. Accordingly, claims 1-13, 27, 35-36, 44, 51 and 58-59 remain pending and are the claims addressed and examined below.
The non-final action mailed on 03/19/2026 will be vacated with the instant non-final office action replacing the previously mailed non-final action in view of Applicant’s persuasive arguments against previously applied reference(s) to claims 36 and 51.
Response to Arguments
Applicant’s arguments, filed 06/22/2026, with respect to the rejection(s) of amended claim(s) 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new reference found in an updated search necessitated by the amendments made to the claim (see Lelkes et al. (US 2013/0131830) as applied in the rejections below).
Applicant’s arguments, filed 06/22/2026, with respect to the rejection(s) of claim(s) 36 and 51 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new reference found in an updated search (see Lee et al. (US 2017/0130194) as applied in the rejections below).
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 applicant regards as his invention.
Claims 3, 5-8, 13 and 27 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 3: there is insufficient antecedent basis for the recitation “the plurality of fibers” in line 2. Claim 3 depends from claim 1 which does not include a plurality of fibers; therefore, the claim contains no earlier recitation or limitation of a plurality of fibers making it unclear as to what element the limitation is making reference. See MPEP § 2173.05(e). Claims 5-8 and 13 depend from claim 3 and are therefore rejected due to their dependency.
Regarding claim 5: there is insufficient antecedent basis for the recitation “the fiber” in line 1. Claim 5 depends form claim 3 which includes a plurality of fibers, and therefore it is not clear if the recitation “the fiber” is referring to a specific fiber of the plurality of fibers or if the recitation is referring to a different and/or additional fiber.
Regarding claim 27: there is insufficient antecedent basis for the following recitations: “a first polymer” in line 4, “a first polymer mixture” in lines 4-5, “a second polymer” in line 6, and “a second polymer mixture” in lines 6-7. Claim 27 depends from claim 1, and claim 1 previously introduced each of the above recitations 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 a different and/or additional first polymer, first polymer mixture, second polymer, and second polymer mixture. Claim 35 is rejected due to its dependency on claim 27.
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.
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.
Claims 1-2, 4, 9-10, 12, 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hakimi et al. (US 2020/0155724; made of record in the IDS filed 12/23/2023) in view of Lelkes et al. (US 2013/0131830).
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]).
Though, Hakimi discloses electrospinning the material layer onto the polymer fibre layer and an adhesive component between the material layer and the polymer fibre (Hakimi at Abstract) and therefore fails to disclose the claimed wherein forming one or more substrate layers comprises electrospinning the one or more substrate layers directly on the textile layer.
However, Lelkes teaches preparing a scaffold by electrospinning a solution of matrix material in a solvent upon a textile template, where the textile template is a knitted/woven fabric (Lelkes at [0007], [0011], [0013], [0015]).
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 electrospinning the one or more substrate layers directly on the textile layer as such is known in the art of preparing scaffolds given the discussion of Lelkes above presenting a reasonable expectation of success; and doing so is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
As to claim 2: Hakimi and Lelkes disclose 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 and Lelkes disclose 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 9: Hakimi and Lelkes disclose the method of making a scaffold for tissue engineering of claim 4. 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 [0022], [0023]).
As to claim 10: Hakimi and Lelkes disclose 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 12: Hakimi and Lelkes disclose 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 and Lelkes disclose the claimed scaffold for tissue engineering formed by the method of claim 1 (see the rejection of claim 1 above), the scaffold comprising:
the textile layer comprising 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
the one or more substrate layers comprising a second polymer or a second polymer mixture on 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 and Lelkes disclose 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]).
Claims 3, 5-8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hakimi and Lelkes as applied to claim 1 above, and further in view of Wu 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).
As to claim 3: Hakimi and Lelkes disclose 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 modified thus far 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 to 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 the aligned PCL/SF/CNT nanofiber yarns were prepared by an enhanced wet−dry electro spinning process, where the 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, Lelkes 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, Lelkes 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, Lelkes 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, Lelkes 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 13: Hakimi, Lelkes 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.
Claims 36, 44, 51 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Wu 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) in view of Lee et al. (US 2017/0130194).
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, Lee teaches a scaffold for tissue engineering containing a nanomaterial, or nanofiber, coated with graphene oxide (i.e., carbon nanomaterial) (Lee at [0033], [0059]). Lee specifically teaches the nanofibers being contacted with a solution of graphene oxide (i.e., 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) (Lee at claim 19).
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 as such is known in the art of scaffold formation for tissue engineering given the discussion of Lee 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 Lee 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 51: 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, Lee teaches a scaffold for tissue engineering containing a nanomaterial, or nanofiber, coated with graphene oxide (i.e., carbon nanomaterial) (Lee at [0033], [0059]). Lee specifically teaches the nanofibers being contacted with a solution of graphene oxide (i.e., 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) (Lee at claim 19).
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 as such is known in the art of scaffold formation for tissue engineering given the discussion of Lee 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 Lee 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 Lee as applied in the rejection of claim 36);
fabricating a tissue engineered scaffold according to the method of claim 44 (see Wu and Lee 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 BAILEIGH K. DARNELL whose telephone number is (469)295-9287. The examiner can normally be reached M-F, 9am-5pm, MST.
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/BAILEIGH KATE DARNELL/ Examiner, Art Unit 1743
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