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 .
DETAILED ACTION
Amendments
In the reply filed on 08/17/2026, Applicant has amended claims 1, 8 and 20.
Claim Status
Claims 1-20 are pending.
Claims 5 and 11-14 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025.
Claims 1-4, 6-10 and 15-20 are considered on the merits.
New Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “an epithelial support layer” in line 2. It is recommended to change to “the epithelial support layer” since the phrase has been recited in claim 1.
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 1-4, 6-10 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicant’s amendment to claims 1, 8 and 20 to correct the issues of subjective term, antecedent basis, and trademarks.
Maintained 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.
Claims 1-4, 7, 9 and 15-18 stand rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sohrabi et al., (Polymer Bulletin. 2022;79:8397-8413, published October 2021. Prior art of record).
With respect to independent claims 1 and 15, Sohrabi teaches a method for generating a scaffold supporting cell proliferation for bone tissue engineering (e.g., abstract), thus teaches a method for generating a cell support interface for use in a three dimensional cell culture environment in claims 1 and 15.
In regard to electrospinning a mat having an epithelial support layer configured to create a coupling between an epithelial cell and a porous matrix in claim 1, it is noted that the limitations “epithelial support" and “configured to create a coupling between an epithelial cell and a porous matrix” are interpreted as intended use. MPEP 2111.02 II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Thus, the above limitation in claim 1 is reasonably interpreted as “electrospinning a mat having a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”.
Sohrabi teaches a layer-by-layer electrospinning of two copolymers PVA/β-TCP and PCL/PVP (e.g., Fig 1, right panel) and teaches to perform layer-by-layer electrospinning, each nozzle was subjected to electrospinning for 30 min and this was repeated three times for each nozzle (p. 8400, para “Electrospinning”). Thus, Sohrabi teaches electrospinning 6 alternate layers of PVA/β-TCP and PCL/PVP. It is noted that the first 4 layers are viewed as a mat having a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix (see a porous matrix in e.g., Fig 2 and MSC supporting in Figs 5-6), related to claim 1.
In regard to electrospinning a first layer and a second layer wherein the first layer is formed using a first solution at a first viscosity level and the second layer is formed using a second solution at a second viscosity level different from the first viscosity level resulting in different porosity levels in claims 1 and 15, Sohrabi teaches electrospinning a first layer using a first solution (i.e., PVA/β-TCP) and a second layer using a second solution (i.e., PCL/PVP) (Fig 1, right panel). Sohrabi teaches the first layer and the second layer have different porosity levels (see p. 8406, para “Porosity measurement” and Table 1) and the components, e.g., porosities and nanofiber diameters, are related to the viscosity of the solutions, evidenced by adding β-TC increases the viscosity of solution (see p. 8403, para “Fiber diameter”, quoted as “This increase in diameter in nanofibers (of PVA/β-TCP, noted by examiner) is due to the presence of PVA with a much higher molecular weight than the PVP, as well as the presence of nanoparticles of β-TCP in the composition. The ceramic nanoparticles such as β-TC increase the viscosity of the polymer solution and improve the resistance to long elongation during electrospinning; hence, the diameter of the nanofibers increases”). Thus, Sohrabi teaches the first solution (i.e., PVA/β-TCP) has a higher viscosity level (see above) to form a first layer at a lower porosity level (~70%, see Table 1, as well as increased nanofiber diameter) and the second solution (i.e., PCL/PVP) has a lower viscosity level (see above) to form a second layer at a higher porosity level (~73%, see Table 1, and a lower nanofiber diameter), related to claims 1 and 15.
With respect to claims 2 and 16 directed to the first viscosity level being higher than the second viscosity level to form the first layer at a porosity lower than that of the second layer, as stated supra, Sohrabi teaches the first layer (i.e., PVA/β-TCP) has a porosity level of about 70%, and the second layer (i.e., PCL/PVP) has a porosity level of about 73% (see p. 8406, para “Porosity measurement” and Table 1), thus teaches the first layer being at a porosity lower than that of the second layer, resulted from the first viscosity level being higher than the second viscosity level (see above) because of the inverse correlation between viscosity and porosity levels.
With respect to claims 3 and 18 directed to the second layer having a water-soluble polymer and the method further comprising dissolving the water-soluble polymer in water, Sohrabi teaches the PVP in the second layer is hydrophilic polymer and improves the degradability of the second layer (p. 8409, last para and see Fig 4 for the scaffold being degraded after 28 days), thus teaches the second layer (i.e., PCL/PVP) has a water-soluble polymer PVP. Sohrabi teaches testing the water maintenance level by plunging the scaffold in deionized water (p. 8401, paragraph with Equation 1) and teaches a biodegradation test by keeping scaffolds in PBS (phosphate buffered solution in water) in the span of 4 weeks (p. 8407, last para), thus teaches the method further comprises dissolving the water-soluble polymer of the scaffold in water.
With respect to claim 4 directed to drying the support layer, Sohrabi teaches the scaffolds are dried at 37 °C for two days (p. 8400, para “Electrospinning”) and the scaffolds are dried after the biodegradation test (p. 8402, para 3).
With respect to claim 7 directed to the second layer being formed from spinning polycaprolactone/polyvinylpyrrolidone (PCL/PVP), as stated supra, Sohrabi teaches electrospinning a first layer using a first solution (i.e., PVA/β-TCP) and a second layer using a second solution (i.e., PCL/PVP) (Fig 1, right panel).
With respect to claims 9 and 17 directed to the electrospinning, Sohrabi teaches the provided solutions were transferred into the 5-mL plastic syringe with a syringe needle and the high voltage connected to the needle tip was 15 kV (i.e., the positively charged nozzles). The flow rate was set at 0.2 ml/h by a syringe pump (i.e., at a predetermined rate and humidity environment). Electrospun fibers were kept onto a grounded aluminum foil (i.e., negatively charged collector) as the collector was set at a fixed distance of 15 cm from the needle tip (p. 8400, para “Electrospinning”).
Accordingly, Sohrabi anticipates instant claims.
Claims 1, 6, 9, 15 and 17 stand rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Montoya et al., (Biomaterials Research. 2021;25:38, p. 1-17. Prior art of record).
With respect to independent claims 1 and 15, Montoya teaches a method for generating a scaffold supporting cell adhesion and proliferation (e.g., abstract), thus teaches a method for generating a cell support interface for use in a three dimensional cell culture environment in claims 1 and 15.
In regard to electrospinning a mat having an epithelial support layer configured to create a coupling between an epithelial cell and a porous matrix in claim 1, as stated supra, the limitations are interpreted as intended use (See MPEP 2111.02 II) and are examined as “electrospinning a mat having a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”.
Montoya teaches a sequential electrospinning of a PCL layer and a gelatin layer (see e.g., Fig 1A) and teaches first, a volume of 2.2 mL per syringe of PCL solution was dispensed, followed by 0.8 mL of gelatin solution per syringe (p. 3, last para “Electrospinning”). It is noted that a portion of the initially dispensed PCL solution (e.g., the first half of the PCL layer) is viewed as a mat having a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix (see a porous matrix in e.g., Fig 3 and fibroblast supporting in Fig 10), related to claim 1.
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In regard to electrospinning a first layer and a second layer wherein the first layer is formed using a first solution at a first viscosity level and the second layer is formed using a second solution at a second viscosity level different from the first viscosity level resulting in different porosity levels in claims 1 and 15, Montoya teaches electrospinning a first layer using a first solution (i.e., PCL 15% (w/v) in DMF:DCM 1:1) and a second layer using a second solution (i.e., gelatin 25% (w/v) in acetic acid 20% (v/v)) (e.g., Fig 1A and p. 3, last para. It is noted that the first solution and the second solution have different polymers in different solvents). Montoya teaches the first layer and the second layer have different porosity levels (see e.g., Fig 3 attached comparing panel A&C PCL layer with panel E gelatin layer), thus teaches the solutions have different viscosity levels since there is inverse correlation between viscosity and porosity levels, related to claims 1 and 15.
With respect to claim 6 directed to the first layer being formed from spinning polycaprolactone (PCL), as stated supra, Montoya teaches electrospinning a first layer using a first solution (i.e., PCL).
With respect to claims 9 and 17 directed to the electrospinning, Montoya teaches the solutions of PCL and gelatin are loaded into 5 mL syringes with a 21 G cutoff tip and a voltage of 18 kV for PCL and 15 kV for gelatin was applied to the solutions (i.e., positively charged nozzles). 6 syringes of each solution are mounted on an infusion pump using PCL flows of 1.2 mL/h and 0.8 mL/h and gelatin flow of 0.3 mL/h (i.e., at a predetermined rate). The relative humidity in all cases was in a range between 45% and 55% (i.e., a humidity environment). Samples were collected in a 6 mm diameter rod wrapped with aluminum foil and grounded (i.e., a negative charge) (p. 3, last para “Electrospinning” – p. 4, para 1).
Accordingly, Montoya anticipates instant claims.
Response to Traversal:
Applicant’s arguments filed on 08/17/2026 are acknowledged.
Applicant argues that (1-1) Sohrabi neither discloses nor suggests an epithelial support layer. Instead, Sohrabi evaluates scaffold performance using rat marrow stromal cells ("rMSC"). Thus, Sohrabi does not disclose an epithelial support layer or the claimed coupling between an epithelial cell and a porous matrix (Remarks, p. 6).
Applicant’s argument has been fully considered but it is not persuasive. As stated supra, the limitations “epithelial support" and “configured to create a coupling between an epithelial cell and a porous matrix” are interpreted as intended use. See MPEP 2111.02 II. Thus, the limitation in claim 1 is reasonably interpreted as “electrospinning a mat having a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”. Sohrabi teaches electrospinning alternate layers of PVA/β-TCP and PCL/PVP that support MSCs and create a coupling between the MSCs and the porous matrix (see a porous matrix in e.g., Fig 2 and exemplified MSC supporting in Fig 5 and MSC coupling with the porous matrix in Fig 6). In the event that instant claims are drawn to the intended use of the layer in epithelial cell support and coupling, it is noted that since the recited intended use does not result in a structural difference between the claimed invention and the prior art, the reference of Sohrabi teaches the cell support layer in the instant claims.
Applicant argues that (1-2) these limitations are not merely a statement of an intended field of use or a desired result divorced from the claimed structure. Rather, claim 1 affirmatively requires electrospinning "a mat having an epithelial support layer" and further defines that layer by the structural and functional capability for which it is configured, e.g., creating a coupling between an epithelial cell and a porous matrix. The phrase "configured to" applies to the claimed epithelial support layer and requires a layer arranged or made suitable to perform the recited coupling function. Accordingly, the cited reference must disclose a mat having such an epithelial support layer, not merely an electrospun scaffold capable of supporting cells generally. (Remarks, p. 6, underlined by examiner).
Applicant’s argument has been fully considered but it is not persuasive. It is noted that Applicant’s argument above (especially underlined) is consistent with Examiner’s interpretation of “a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”. As stated supra, the recited intended use (i.e., being capable of supporting and coupling an epithelial cell) does not result in a structural difference between the claimed layer and the layer in prior art (a layer capable of supporting and coupling an mesenchymal stem cell, which is an adherent cell similar to an epithelial cell), thus, the reference of Sohrabi teaches the cell support layer in the instant claims.
Applicant argues that (1-3) the Examiner essentially uses such alleged "intended use" to read "epithelial" out of the claim and effectively treats the limitation as satisfied by any scaffold that may support any cell type (Remarks, p. 6).
Applicant’s argument has been fully considered but it is not persuasive. As stated supra, the limitation is interpreted as “a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”. Thus, the interpretation does not read "epithelial" out of the claim, and does not treat the limitation as satisfied by any cell type. However, as stated supra, the recited intended use of supporting and coupling “an epithelial cell” does not result in a structural difference between the claimed layer and the layer in prior art (that is capable of supporting and coupling an mesenchymal stem cell, which is an adherent cell similar to an epithelial cell), thus, the reference of Sohrabi teaches the cell support layer in the instant claims.
Applicant argues that (2) although Sohrabi reports porosity measurements, Sohrabi nowhere discloses or compares the viscosity level in the solutions. Sohrabi's statement that "The ceramic nanoparticles such as B-TCP increase the viscosity of the polymer solution" and that "the diameter of the nanofibers increases." (Sohrabi, p. 8403.) merely describes one effect of adding B-TCP to a polymer solution. (Remarks, p. 6-7).
Applicant’s argument has been fully considered but it is not persuasive. As a first matter, as agreed by Applicant, Sohrabi teaches the first layer (i.e., PVA/β-TCP) and the second layer (i.e., PCL/PVP) have different porosity levels (see p. 8406, para “Porosity measurement” and Table 1). Furthermore, Sohrabi teaches the viscosity of the first and second solutions (as cited in p. 8403, para “Fiber diameter” by examiner and in Applicant’s remarks), quoted as “This increase in diameter in nanofibers (of PVA/β-TCP, noted by examiner) is due to the presence of PVA with a much higher molecular weight than the PVP, as well as the presence of nanoparticles of β-TCP in the composition. The ceramic nanoparticles such as β-TC increase the viscosity of the polymer solution and improve the resistance to long elongation during electrospinning; hence, the diameter of the nanofibers increases” (underlined by examiner). Thus, Sohrabi clearly teaches the first polymer solution (i.e., PVA/β-TCP), at least because of the presence of β-TCP, has increased viscosity than that of the second solution (PCL/PVP) evidenced by the resulted increased diameter of the nanofibers (“the mean fiber diameter of PCL/PVP nanofibers is 314 ± 96 nm, and the mean fiber diameter of the PVA/β-TCP nanofibers is 487 ± 123 nm”. See p. 8403, para “Fiber diameter”).
Applicant argues that (3) Montoya is directed to tubular vascular graft wall structures using 3T3 fibroblasts, but does not disclose an epithelial support layer, epithelial cells, or coupling between an epithelial cell and a porous matrix. To the extent the Office Action treats the epithelial support layer and epithelial-cell coupling limitations as intended use, Applicant disagrees for the same reasons discussed above. The language defines the claimed mat and layer and requires disclosure of a layer having the recited epithelial-support capability. Montoya instead evaluates an in vitro model of fibroblasts. Fibroblasts are not epithelial cells. Nor has the Office Action established that the vascular graft wall structures of Montoya necessarily possess the claimed epithelial-support configuration merely because they may support fibroblast adhesion and proliferation. (Remarks, p. 7-8).
Applicant’s argument has been fully considered but it is not persuasive.
As discussed in the above responses to Applicant’s arguments 1-1, 1-2 and 1-3, the limitation is interpreted as intended use such that “a cell support layer that is capable of supporting epithelial cells and is capable of creating a coupling between an epithelial cell and a porous matrix”. As stated supra, the recited intended use of supporting and coupling “an epithelial cell” does not result in a structural difference between the claimed layer and the layer in prior art Montoya (that is capable of supporting and coupling a fibroblast, which is an adherent cell similar to an epithelial cell). Thus, the reference of Montoya teaches the cell support layer in the instant claims.
Applicant argues that (4) Montoya does not disclose measured viscosity levels of the PCL and gelatin solutions and therefore cannot teach or suggest a second solution at a second viscosity level different from the first viscosity level. Montoya attributes morphological differences to factors such as electrospinning technique and PCL flow, but not viscosity levels. (Remarks, p. 8-9).
Applicant’s argument has been fully considered but it is not persuasive.
As a first matter, Montoya teaches electrospinning a first layer using a first solution (i.e., PCL 15% (w/v) in DMF:DCM 1:1) and a second layer using a second solution (i.e., gelatin 25% (w/v) in acetic acid 20% (v/v)) (e.g., p. 3, last para. also recited in Applicant’s remarks, p. 8), that have different polymers in different solvents, and teaches the first layer and the second layer have different porosity levels (see e.g., Fig 3 attached above comparing panel A&C PCL layer with panel E gelatin layer).
In regard to the viscosity levels of the solutions, nevertheless, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. In the instant case, Montoya teaches a method for generating a cell support interface comprising electrospinning a mat having a first layer and a second layer formed using a first solution and a second solution, i.e., a first solution of PCL 15% (w/v) in DMF:DCM 1:1 and a second solution of gelatin 25% (w/v) in acetic acid 20% (v/v). Therefore, persons of ordinary skill would recognize that the missing descriptive matter (e.g., different viscosity levels) is necessarily present in the solutions described in the reference. See MPEP 2131.01 (III). In order to complete the art of record and rebut Applicant's arguments, References Altun et al., (European Polymer Journal. 2022 May 25; 173: 111300, p. 1-13) and Erencia et al., (J. Appl. Polym. Sci. 2015; 132: 42115, p. 1-11) regarding the viscosity levels of PCL and gelatin solutions have been attached. Altun evidences that PCL 15% (w/v) in DMF and DCM (see p. 2, last section “2.3”) has a viscosity level of 2523 mPa.s (cP) and 1553 mPa.s (cP), respectively (see Table 3 in p. 6), thus evidences that PCL 15% (w/v) in DMF:DCM 1:1 has a viscosity level between 2523 and 1553 cP. Erencia evidences that gelatin 250 mg/mL (i.e., 25% (w/v)) in acetic acid 25% (v/v) has a viscosity level of 183 cP (and in acetic acid 50% v/v with viscosity of 208 cP, see Table 1 in p. 4), thus evidences that gelatin 25% (w/v) in acetic acid 20% (v/v) has a viscosity level less than 183 cP. Thus, Altun and Erencia evidence that Montoya’s first and second solutions necessarily have different viscosity levels, and that would be recognized by persons of ordinary skill.
Maintained 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.
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 8 and 20 stand rejected under 35 U.S.C. 103 as being unpatentable over Sohrabi et al., (Polymer Bulletin. 2022;79:8397-8413, published October 2021. Prior art of record) in view of McCarthy et al., (Adv Biosyst. 2019; 3(12): e1900137, p. 1-16. Prior art of record).
Claims 8 and 20 are directed to the method further comprising treating the epithelial support layer or the first layer with a collagen hydrogel material. It is noted that the limitation “to alter a hydrogel stiffness as a function of depth away from the epithelial support layer or the first layer” is interpreted as intended use (See MPEP 2111.02 II) and is examined as being capable of altering the stiffness of the epithelial support layer.
However, Sohrabi is silent on treating the epithelial support layer with a collagen hydrogel material.
McCarthy teaches decorating 3D scaffold with electrospun nanofiber for tissue engineering (e.g., abstract). McCarthy teaches the PCL scaffold coated with nanofibers are immersed in gelatin solution (it is noted that gelatin is a degraded form of collagen) and teaches the gelatin serves as an adhesive to build up ECM-mimicking short nanofiber architecture on the surface of scaffolds (p. 3, last para.).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for generating a scaffold using electrospinning nanofibers disclosed by Sohrabi, by combining treating the electrospun nanofibers with a collagen hydrogel material, such as gelatin as suggested by McCarthy with a reasonable expectation of success. Since McCarthy teaches the gelatin serves as an adhesive to build up ECM-mimicking short nanofiber architecture on the surface of scaffolds (p. 3, last para.), one of ordinary skill in the art would have had a reason to treat the nanofiber scaffold of Sohrabi with gelatin so that the gelatin may serve as an adhesive to build up an ECM-mimicking nanofiber architecture. Furthermore, one of ordinary skill in the art would have expected that the treatment of gelatin would have been capable of altering the stiffness of the epithelial support layer since McCarthy teaches the gelatin serves as an adhesive to build up ECM-mimicking short nanofiber architecture on the surface of scaffolds (p. 3, last para.).
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 08/17/2026 are acknowledged and have been discussed above.
Claim 10 stands rejected under 35 U.S.C. 103 as being unpatentable over Sohrabi et al., (Polymer Bulletin. 2022;79:8397-8413, published October 2021. Prior art of record) in view of Park et al., (J. Membrane Sci. 2017; 540: 192-199. Prior art of record) and Pereao et al., (Materials Today Chemistry. 2021; 20:100416, p. 1-13. Prior art of record).
Claim 10 is directed to electrospinning directly on the epithelial support layer comprising track-etched polycarbonate membranes.
As stated supra, Sohrabi teaches electrospinning fibers directly onto a grounded aluminum foil as the collector (p. 8400, para “Electrospinning”) to form a cell support layer.
However, Sohrabi is silent on electrospinning fibers directly on the epithelial support layer comprising track-etched polycarbonate membranes.
Park teaches electrospinning polyvinyl alcohol (PVA) nanofibers directly on a commercial polycarbonate (PC) membrane fixed to a negative terminal (see e.g., abstract and p. 193, left col, para 2.1 “Preparation of the f-PVA/PC membrane). Park teaches the PC membrane has pores with porosity of 20.8% (p. 194, right col, para 1, and see Table 1), indicating that the PC membrane is track-etched, related to claim 10.
Pereao teaches electrospinning a blend of chitosan (CS) and PEO nanofiber mats onto a PET track-etched membrane (TM) to generate a composite membrane comprising electrospun nanofibers and track-etched membrane that is biocompatible and suitable for diverse applications (see e.g., abstract). Pereao teaches the synergy of combining electrospun nanofibers and TMs (such as polycarbonate membrane, p. 2, para 1) can prepare new materials with tailored unique properties as adsorption, separation, and filtration processes and in drug delivery platforms (p. 2, left col, para 2 and p. 12, “Conclusion” section).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for generating a scaffold by electrospinning nanofibers onto a grounded aluminum foil disclosed by Sohrabi, by combining a track-etched polycarbonate membrane fixed to the grounded terminal as a collector so as to electrospin nanofibers directly on the track-etched polycarbonate membrane as suggested by Park and Pereao with a reasonable expectation of success. Since Park reduces to practice electrospinning nanofibers directly on a track-etched polycarbonate membrane and since Pereao teaches the synergy of combining electrospun nanofibers and track-etched membrane (such as polycarbonate membrane, p. 2, para 1) can prepare new biocompatible materials with tailored unique properties as a drug delivery platform (p. 2, left col, para 2 and p. 12, “Conclusion” section), one of ordinary skill in the art would have had a reason to combine a track-etched polycarbonate membrane as a support layer so as to take advantage of the synergy of combining electrospun nanofibers and the track-etched polycarbonate membrane to prepare a biocompatible material with unique properties to be used as a drug delivery platform in Sohrabi’s 3D cell culture system.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 08/17/2026 are acknowledged and have been discussed above.
Claim 19 stands rejected under 35 U.S.C. 103 as being unpatentable over Montoya et al., (Biomaterials Research. 2021;25:38, p. 1-17. Prior art of record) in view of Li et al., (Macromol. Mater. Eng. 2021, 306, 2100338, p. 1-10. Prior art of record).
Claim 19 is directed to the first layer being formed from electrospinning PCL and the second layer being formed from spinning PCL/PVP.
As stated supra, Montoya teaches electrospinning a first layer using a first solution (i.e., PCL) and another layer using a gelatin solution for 3D cell culture (e.g., Fig 1A and Fig 10).
However, Montoya is silent on the second layer formed from spinning PCL/PVP.
Li teaches a 3D model made from electrospraying a gelatin layer and an electrohydrodynamic-jet printing a PCL/PVP composite layer (see Fig 1) and teaches the 3D model is proved to facilitate adhesion and ingrowth of cartilage cells (e.g., abstract and Fig 8).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for generating a scaffold by electrospinning a first PCL layer and another gelatin layer for 3D cell culture disclosed by Montoya, by combining a PCL/PVP layer on the gelatin layer as taught by Li with a reasonable expectation of success. Since Montoya teaches making a scaffold comprising a first PCL layer and a gelatin layer for cell adhesion and proliferation (e.g., abstract), and since Li teaches a scaffold comprising a PCL/PVP layer on a gelatin layer facilitates adhesion and ingrowth of cells (e.g., abstract), one of ordinary skill in the art would have had a reason to combine a PCL/PVP layer deposited on the gelatin layer of Montoya so as to obtain a scaffold comprising a first PCL layer, a gelatin layer and a PCL/PVP layer (as a second layer) in order to facilitate cell adhesion and ingrowth. Furthermore, since Montoya has reduced to practice a sequential electrospinning approach to fabricate a multilayer scaffold (see Fig 1A), one of ordinary skill in the art would have had a reason to use electrospinning the PCL/PVP layer onto the gelatin layer in order to obtain a multilayer scaffold.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 08/17/2026 are acknowledged and have been discussed above.
Conclusion
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.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
