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 .
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.
Claim Status
Applicant’s amendment of 03/19/2026 is acknowledged. Claims 1, 8-10, and 13 are amended; claim 12 is cancelled; and claim 14 is new. Claims 1-11 and 13-14 are currently pending and are examined on the merits herein.
Priority
The instant application claims foreign priority to TW110136633 filed on 10/01/2021 as reflected in the filing receipt dated on 07/27/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 103 rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of objection and rejection presented herein. Applicant’s arguments insofar as they pertain to any revised grounds of rejection are addressed herein.
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 1-2, 5-7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action).
Lee, throughout the references, teaches a multi-layered anti-adhesion barrier comprising: (a) a nanofibrous structured base layer of a hydrophobic, biodegradable, biocompatible polymer; and (b) a polymer layer of a hydrophilic, bio-originated polymer [abstract; claims].
Regarding claim 1: Lee teaches an anti-adhesion barrier comprising a base layer of electrospun polylactide (same as polylactic acid or PLA) coated with electrospun collagen [0076, table 1; 0079, table 2, example 14]. Electrospinning prepares nanofibers [0047].
The collagen nanofibrous layer of Lee’s Example 14 reads on the instantly claimed hydrophilic material layer as evidenced by instant claim 2. The hydrophilic layer has a thickness of 50 µm [0079, table 2], which lies within and thus reads on the instantly claimed range.
The PLA nanofibrous layer of Lee’s Example 14 meets the instant limitation of a hydrophobic material layer that includes a hydrophobic polymer. The thickness of the hydrophobic layer is 60 µm [0079, table 2], which lies within and thus reads on the instantly claimed range.
Regarding the order of disposing each layer: Lee teaches that the collagen layer is coated on the PLA layer [0079]. However, because the electrospinning method of Lee does not require a mold or base surface as may be required by the disclosed casting or dip coating methods, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrospinning method of Lee by depositing the PLA nanofibers onto the collagen nanofibers. It would have been obvious and there is a reasonable expectation of success because Lee teaches the specific electrospinning conditions for each layer [0076, table 1; 0079, table 2] and depositing the layers in an alternative order would not be expected to change the resulting structure of the anti-adhesion barrier, given that the final structure comprises only two layers. Note: MPEP 2144.04(IV)(C).
Regarding the total thickness and thickness ratio between the hydrophobic and hydrophilic layers: The anti-adhesion barrier formed in Lee’s Example 14 has a total thickness of 110 µm, which closely approaches the instantly claimed range, and a thickness ratio between the hydrophobic and hydrophilic layers of 1.2:1 (calculated by Examiner). Lee further teaches that the thickness of the hydrophobic base layer can range from 5 to 500 µm in order to achieve sufficient strength and elongation while effectively blocking infiltration of blood and cells and preventing foreign body sensation and tissue granulation [0049]. Similarly, the thickness of the bio-originated polymer layer can range from 1 to 200 µm in order to ensure the anti-adhesion barrier has suitable adhesivity and biocompatibility while remaining flexible enough for folding or rolling [0060].
Therefore, it would have been prima facie obvious to manipulate the thickness of each layer within the prior art ranges, which in turn affects the total thickness and thickness ratio between the hydrophobic and hydrophilic layers, in order to achieve a desired balance of properties such as strength, flexibility, adhesivity, etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of the thicknesses of each layer have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness or thickness ratio via routine experimentation.
However, Lee is silent as to the content of poly-D-lactic acid and poly-L-lactic acid in the PLA layer.
Cristea teaches that the ratio of L- to D-enantiomers is known to impact the properties of polylactic acid (PLA) and that PLA comprising close 100% L-lactic acid is highly crystalline, whereas a ratio of L-lactic acid to D-lactic acid of 1:1 results in an amorphous structure [pg. 3, first para.].
Because anti-adhesion barrier of Lee is intended to have superior flexibility and ease of handling, e.g., folding and bending [0070], it would have been prima facie obvious to manipulate the weight ratio of D-lactic acid to L-lactic acid within the PLA layer of Lee using 1:1 (same as 5:5), which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization in order to achieve an anti-adhesion barrier with a desired strength and flexibility. An ordinarily skilled artisan would reasonably expect success because Cristea teaches that the ratio of L- to D-enantiomers in PLA is routinely manipulated to achieve a desired level of crystallinity.
Regarding claim 2: Collagen reads on the same as instantly claimed.
Regarding claim 5: While the combination of Lee and Cristea is silent as to the diameter of the PLA nanofibers, the Lee teaches that the base layer has a nanofiber in the range of 50 to 2,000 nm [0048], which substantially overlaps the instantly claimed range. It would have been prima facie obvious to manipulate the diameter of the PLA nanofibers within the prior art range and according to known methods because Lee expressly teaches that specific nanofiber diameters can be achieve in a predictable manner by adjusting polymer concentration, spinning voltage, spinning distance, and flow rate [0077].
Regarding claim 6: Lee teaches that the PLA layer is formed by electrospinning and thus meets the claim limitation.
Regarding claim 7: While the combination of Lee and Cristea is silent as to the tensile strength of the anti-adhesion barrier, Lee teaches that the multilayered anti-adhesion barrier should have a tensile strength of at least 2 N/mm2 (equivalent to 2 MPa) [claim 15]. It would have been prima facie obvious to manipulate the tensile strength of the anti-adhesion barrier using 2 MPa, which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization to ensure the material has adequate strength to endure folding and bending when handled using surgical instruments [0087].
Regarding claim 14: Absent any limiting definition of the term “solid” provided in Applicant’s instant disclosure, the claim is interpreted broadly to mean that the layer is not liquid or fluid. Therefore, the PLA nanofibrous layer taught by the combination of Lee and Cristea, which physically blocks the infiltration or migration of blood and cells, meets the instant claim limitation.
Claims 1-2, 5-8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action), as applied to claims 1-2, 5-7, and 14 above, and further in view of Casasola et al. (Polymer, vol. 55, p. 4728-4737; published: 06/16/2014; PTO-892 of 12/23/2025).
The combination of Lee and Cristea teaches the invention(s) of claims 1-2, 5-7, and 14 as discussed in detail above and further incorporated herein.
Regarding the step of “using a first electrospinning solution…” as recited in claim 8: Lee teaches that the bio-originated polymer, i.e., collagen, was dissolved in a spinning solution, and that electrospinning was carried out to form the layer [0079].
Regarding the step of “using a second electrospinning solution…” as recited in claim 8: Lee teaches that the hydrophobic polymer, i.e., PLA, was prepared in a solution of 2, 5, or 10 wt% polymer, and that an electrospinning apparatus was used to attain the layer [0076-0078, table 1].
Regarding the order of disposing each layer as recited in claim 8: As discussed above in relation to instant claim 1, it would have been prima facie obvious to deposit the PLA nanofibers onto the collagen nanofibers instead of depositing the collagen nanofibers onto the PLA nanofibers. It would have been obvious and there is a reasonable expectation of success because Lee teaches the specific electrospinning conditions for each layer [0076, table 1; 0079, table 2] and depositing the layers in an alternative order would not be expected to change the resulting structure of the anti-adhesion barrier, given that the final structure comprises only two layers. Note: MPEP 2144.04(IV)(C).
Regarding the weight ratio between poly-D-lactic acid and poly-L-lactic acid recited in claim 8: As discussed above in relation to instant claim 1, the combination of Lee and Cristea teaches a PLA polymer including poly-D-lactic acid and poly-L-lactic acid at a weight ratio that reads on the instantly claimed range.
Regarding the total thickness and thickness ratio recited in claim 8: As discussed in relation to instant claim 1, it would have been prima facie obvious to manipulate the thickness of each layer within the prior art ranges, which in turn affects the total thickness and thickness ratio between the hydrophobic and hydrophilic layers, in order to achieve a desired balance of properties such as strength, flexibility, adhesivity, etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of the thicknesses of each layer have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness or thickness ratio via routine experimentation.
However, the method taught by the combination of Lee and Cristea does not expressly teach that the PLA electrospinning solution includes a mixture of acetone and dimethylacetamide as recited in claim 8.
Casasola, throughout the reference, teaches preparation of poly lactic acid (PLA) solutions in various pure solvents and binary-solvent systems and investigates the effect of different solution properties on nanofiber morphology and diameter [abstract].
Regarding the organic solvent recited in claim 8: Casasola teaches that a binary-solvent system comprising acetone and dimethylacetamide [see fig. 2f] produces smooth defect-free nanofibers with a narrow diameter distribution [pg. 4730-4732]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PLA electrospinning solution taught by the combination of Lee and Cristea by including a mixture of acetone and dimethylacetamide as the solvent, which is an art-recognized solvent for electrospinning PLA fibers, because Casasola teaches that this binary-solvent system produces nanofibers with improved morphology and uniform distribution.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the prior art as proposed because Casasola teaches that solvent systems are routinely optimized to produce desired nanofiber properties and morphologies, and Lee does not limit the solvent in the electrospinning solution.
Claims 1-8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action) and Casasola et al. (Polymer, vol. 55, p. 4728-4737; published: 06/16/2014; PTO-892 of 12/23/2025), as applied to claims 1-2, 5-8, and 14 above, and further in view of Fu et al. (Int. J. of Nanomedicine, vol. 9, pg. 2335-2344; published: 05/13/2014; PTO-892 of instant action) and as evidenced by Barrera et al. (Materials Today Bio, vol. 7, pg. 1-15; published: 07/31/2020; PTO-892 of instant action).
The combination of Lee, Cristea, and Casasola teaches the invention(s) of claims 1-2, 5-8, and 14 as discussed in detail above and further incorporated herein.
However, the prior art combination does not expressly teach that the molecular weight of the collagen is within the range recited in claim 3, that the collagen nanofibers further include an excipient in the weight ratio recited in claim 4.
Fu, also drawn to electrospun membranes for biomedical applications, teaches the use of an electrospinning solution comprising 8% w/v of collagen/polycaprolactone (PCL) in a weight ratio of 50:50 (also written as 1:1) in hexafluoroisopropanol to generate hydrophilic hybrid nanofibers with excellent mechanical properties and biocompatibility compared to pure collagen, which is unable to retain its structural integrity in aqueous environments [pg. 2336; pg. 2342-2343, “Discussion”]. The collagen used by Fu is type I collagen from Sichuan Mingrang Biotechnology Co., which is known to have a molecular weight of ~100 kDa as evidenced by Barrera [pg. 3, sec. 2.4].
Regarding claims 3-4: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by the combination of Lee, Cristea, and Casasola by substituting the collagen electrospinning solution with one comprising 8% w/v type I collagen having a molecular weight of ~100 kDa and biologically-derived PCL in a 1:1 weight ratio of collagen:PCL in hexafluoroisopropanol because Fu teaches that this combination achieves hydrophilic nanofibers with improved structural integrity and biocompatibility. Absent any limiting definition provided in Applicant’s instant disclosure and in alignment with Applicant’s specification, which states that the excipient enhances structural characteristics of the hydrophilic layer [0037], PCL reads on the instantly claimed “excipient”. The molecular weight of collagen and the weight ratio of collagen:PCL each lie within and thus read on the instantly claimed ranges. An ordinarily skilled artisan would reasonably expect success because Lee expressly teaches that the bio-originated polymer layer can include polycaprolactone [0079], and Fu teaches that the hybrid nanofibers retain their hydrophilicity.
Claims 1-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action), Casasola et al. (Polymer, vol. 55, p. 4728-4737; published: 06/16/2014; PTO-892 of 12/23/2025), and Fu et al. (Int. J. of Nanomedicine, vol. 9, pg. 2335-2344; published: 05/13/2014; PTO-892 of instant action), as applied to claims 1-8 and 14 above, and further in view of Zhou et al. (Int. J. of Nanomedicine; vol 10, pg. 3203-3215; published: 04/29/2015; PTO-892 of instant action) and as evidenced by Barrera et al. (Materials Today Bio, vol. 7, pg. 1-15; published: 07/31/2020; PTO-892 of instant action).
The combination of Lee, Cristea, Casasola, and Fu as evidenced by Barrera teaches the invention(s) of claims 1-8 and 14 as discussed in detail above and further incorporated herein.
However, the prior art combination does not expressly teach that the collagen electrospinning solution comprises 5 wt% to 75 wt% alcohol, 25 wt% to 95 wt% water, 0.5 wt% to 5 wt% hydrophilic polymer, and 2 wt.% to 15 wt.% of the excipient as recited in claim 9.
Zhou, also drawn to electrospun collagen for biomedical applications, teaches that a 3:2 v/v ratio of water-based PBS buffer to ethanol is a suitable alternative to hexafluoroisopropanol and trifluoroethanol electrospinning solvents, which are known to induce loss of collagen helical structure and are also expensive, highly volatile, and corrosive solvents that pose health risks to humans [pg. 3204].
Regarding claim 9: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collagen electrospinning solution taught by the combination of Lee, Cristea, Casasola, and Fu by substituting the hexafluoroisoproanol solvent with the mixture of PBS and ethanol in a ratio of 3:2 v/v, as taught by Zhou, in order to prepare a more cost-effective and less cytotoxic electrospinning solution. An ordinarily skilled artisan would reasonably expect success because PBS/ethanol solvent is an art-recognized and safer alternative to hexafluoroisopropanol solvent for preparing electrospun collagen for biomedical uses.
Together, the prior art teaches an electrospinning solution comprising: 4% w/v collagen and 4% w/v PCL in a solvent comprising a 3:2 v/v mixture of water-based PBS to ethanol. Because an ordinarily skilled artisan would recognize that the density of water is ~1 g/mL, which is the basis of PBS buffer, and the density of ethanol is 0.789 g/mL, the dilute prior art electrospinning solution would have a density of approximately 0.9 g/mL (calculated by Examiner: [0.6 * 1] + [0.4 * 0.789]). Therefore, the concentrations of each component in the electrospinning solution are approximately: 4.4% w/w collagen (calculated by Examiner: 4 / 0.9), 4.4% w/w PCL (calculated by Examiner: 4 / 0.9), 54.7% w/w water (calculated by Examiner: [100 – 4.4 – 4.4] * 0.6), and 36.5% w/w ethanol, which each lie within and thus read on the instantly claimed ranges.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of the concentrations within the electrospinning solutions of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of conditions is the optimum concentration. NOTE: MPEP 2144.05.
Claims 1-2, 5-7, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action), as applied to claims 1-2, 5-7, and 14 above, and further in view of Sankar et al. (Biotechnol. J., vol. 12, p. 1-11; published: 10/30/2017; PTO-892 of 12/23/2025) and as evidenced by Pabst et al. (ICT Prague, p. 1-123; published: 2007; PTO-892 of 12/23/2025).
The combination of Lee and Cristea teaches the invention(s) of claims 1-2, 5-7, and 14 as discussed in detail above and further incorporated herein.
Regarding the step of “using a hydrophilic electrospinning solution…” as recited in claim 10: Lee teaches that the bio-originated polymer, i.e., collagen, was dissolved in a spinning solution, and that electrospinning was carried out to form the layer [0079].
Regarding the step of “producing the double-layered medical membrane…” as recited in claim 10: Lee teaches that the hydrophobic polymer, i.e., PLA, was prepared in a solution of 2, 5, or 10 wt% polymer, and that an electrospinning apparatus was used to attain the layer [0076-0078, table 1]. As discussed above in relation to instant claim 1, it would have been prima facie obvious to deposit the PLA nanofibers onto the collagen nanofibers instead of depositing the collagen nanofibers onto the PLA nanofibers. It would have been obvious and there is a reasonable expectation of success because Lee teaches the specific electrospinning conditions for each layer [0076, table 1; 0079, table 2] and depositing the layers in an alternative order would not be expected to change the resulting structure of the anti-adhesion barrier, given that the final structure comprises only two layers. Note: MPEP 2144.04(IV)(C).
Regarding the weight ratio between poly-D-lactic acid and poly-L-lactic acid recited in claim 10: As discussed above in relation to instant claim 1, the combination of Lee and Cristea teaches a PLA polymer including poly-D-lactic acid and poly-L-lactic acid at a weight ratio that reads on the instantly claimed range.
Regarding the total thickness and thickness ratio recited in claim 10: As discussed in relation to instant claim 1, it would have been prima facie obvious to manipulate the thickness of each layer within the prior art ranges, which in turn affects the total thickness and thickness ratio between the hydrophobic and hydrophilic layers, in order to achieve a desired balance of properties such as strength, flexibility, adhesivity, etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of the thicknesses of each layer have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness or thickness ratio via routine experimentation.
Lee further teaches that besides the use as an anti-adhesion barrier during or after surgery, the multi-layered adhesion barrier may also be used as a wound dressing, tissue engineering scaffold, cell carrier, etc. [0064].
However, the combination of Lee and Cristea does not expressly teach that the collagen layer includes hydrophilic particles having the particle size recited in claims 10 and 11.
Sankar, throughout the reference, teaches advances in electrospun fiber applications and focuses on the novel strategies applied for tissue regeneration and repair [abstract].
Regarding the hydrophilic particles recited in claims 10-11: The Examiner notes that Applicant’s instant disclosure provides no limiting definition of “particle”, and thus the term is interpreted under broadest reasonable interpretation and in light of the plain meaning of the term, as per MPEP 2173.01(I). Sankar teaches that a combination of micro- and nanofibers, which are classified as anisometric particles as evidenced by Pabst [pg. 5], in electrospinning produces greater pore interconnectivity and larger pore size, which leads to better cell penetration and infiltration [pg. 3]. Lee teaches that fiber diameter can be controlled by adjusting parameters such as spinning voltage, distance, and flow rate [0077]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by the combination of Lee and Cristea by adjusting electrospinning parameters through routine optimization to produce at least some collagen fibers within the micrometer range, which results in greater pore size/interconnectivity of the collagen layer and thus improved cell infiltration when the material is intended to be used as a tissue scaffold or cell carrier.
Regarding the limitation “further includes” recited in claim 11: Because the electrospinning parameters can be optimized to achieve a hydrophilic material layer having both nano- and microfibrous collagen particles, the incorporation of microfibrous collagen particles, which are separate structures from the existing nanofibrous particles, meet the limitation of further including hydrophilic particles.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the prior art method as proposed because Lee and Sankar teach that fiber sizes are routinely optimized to achieve desired properties. While Lee teaches that the hydrophobic layer should sufficiently block cell infiltration, the reference explicitly teaches that the material can also be used as a tissue scaffold or cell carrier and, thus, would reasonably expect success in modifying the properties of the bio-originated polymer layer.
Claims 1-2, 5-7, 10-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20080254091A1; published: 10/16/2008; PTO-892 of instant action) in view of Cristea et al. (Materials, vol. 13, pg. 1-21; published: 11/23/2020; PTO-892 of instant action) and Sankar et al. (Biotechnol. J., vol. 12, p. 1-11; published: 10/30/2017; PTO-892 of 12/23/2025), as applied to claims 1-2, 5-7, 10-11, and 14 above, and further in view of Dohse (US20160331873A1; published: 11/17/2016; PTO-892 of 12/23/2025) and as evidenced by Pabst et al. (ICT Prague, p. 1-123; published: 2007; PTO-892 of 12/23/2025).
The combination of Lee, Cristea, and Sankar as evidenced by Pabst teaches the invention(s) of claims 1-2, 5-7, 10-11, and 14 as discussed in detail above and further incorporated herein.
However, the prior art combination does not expressly teach that the electrospinning solution used to form the hydrophobic PLA layer includes 99 wt% butanone as recited in claim 13.
Dohse, throughout the reference, teaches fabrication of pore-free polymer filaments prepared by solution spinning, electrospinning, or melt spinning [claims].
Regarding claim 13: Dohse teaches butanone as a suitable organic solvent to chloroform for the electrospinning of bio-resorbable polymers such as polylactide [0054]. While the prior art combination is silent as to the solvent of the PLA electrospinning solution, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrospinning solution by substituting the solvent with butanone, which is an art-recognized solvent for electrospinning polylactide fibers, according to known methods to yield the predictable result of electrospun PLA nanofibers.
Regarding the claimed concentration of butanone, it would have been prima facie obvious to modify the relative concentrations of PLA and butanone within the hydrophobic electrospinning solution with a reasonable expectation of success because Lee teaches that polymer concentration is routinely optimized to achieve desired physical properties and fiber diameter [0077].
Response to Arguments
Applicant’s arguments submitted on 03/19/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action. However, these arguments are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights