DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 01/30/2026.
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 Objection
Following claims are objected to because of the following informalities:
Claim 19 lines 1-5 “wherein the 2D nanofiber membrane is larger than the 3D expanded nanofiber membrane such that when viewed from the 3D expanded nanofiber membrane side, a margin of the 2D nanofiber membrane is seen around the 3D expanded nanofiber membrane” needs to be corrected. A suggested correction is – wherein the 2D nanofiber membrane is larger than the 3D expanded nanofiber membrane in a manner that as viewed from the 3D expanded nanofiber membrane side, a margin of the 2D nanofiber membrane is seen around the 3D expanded nanofiber membrane—[a] to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that”, is even required or not required and [b] to avoid conditional limitation recitation which would raise question as to what occurs when the “when” encompassing condition is not met.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 16-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention for the following reasons:
Each of claim 16 and 17 recites “about” which renders the claim unclear. The term " about" here in claims is a relative range term which renders the claim indefinite. The term " about" is not defined by the claim with respect to the boundary i.e. unclear as to whether the term “about” refers herein to a value of +/-0.25% of the defined measure; or the term “about” refers herein to a value of +/-0.10% of the defined measure or some other value or percentage. Additionally, the specification does not provide a standard for ascertaining the requisite degree/range, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed page 17 lines 17-24, page 20 lines 11-28, page 21 lines 16-26.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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 of this title, 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.
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 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Boey et al. (Pub. No.: US 20140044861 A1, hereinafter referred to as “Boey) in view of Xie Jingwei et al. (Pub. No.: WO 2018227078 A1, hereinafter referred to as “Xie”).
As per independent Claim 1, Boey discloses a hernia mesh (Boey in at least abstract, fig. 1, fig. 3-5, fig. 8, [0002], [0012-0014], [0017], [0031-0032], [0034], [0041], [0047], [0050-0052], [0064], [0071], [0074], [0084-0090] for example disclose relevant subject-matter. More specifically, fig. 1, fig. 3-4, Boey abstract, [0002], [0012], [0014], [0017], [0031-0032], [0084] for example discloses hernia mesh See at least Boey [0002] “prostheses having a multi-layered sheet structure and their use in hernia repair”; [0017] “hernia defect and a hernia repair by using a mesh-like prosthesis” [0084]; “a mesh-like film structure”) comprising
a 2D nanofiber membrane and a 3D nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane and 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh i.e. 3D expanded nanofiber for use as hernia mesh as well-known prior art. Boey in at least fig. 3-4, [0032], [0047] for example discloses hernia mesh comprising 2D nanofiber membranes, 3D nanofiber membranes or strengthening or support membranes. See at least Boey [0032] “"prosthesis" as used … means any sheet-like structure which can … made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other …sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis… the three-dimensional sub-structure can …made of the same or any different material”; [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer… layer 10 is the above-described porous layer on which the second layer 20… is provided”).
Boey does not explicitly disclose 3D nanofiber membrane that is expanded.
However, in an analogous surgical implant field of endeavor, Xie discloses surgical mesh implant (Xie in at least fig. 1, fig. 7, abstract, page 1 lines 15-17, page 2 lines 8-25, lines 31-34, page 5 lines 27-29, page 6 lines 12-13, lines 29-30, page 8 lines 7-30, page 10 lines 4-10, lines 20-33, page 11 lines 1-25, page 13 lines 19-29, page 14 lines 11-29, page 14-18, page 21 lines 19-30 for example discloses relevant subject-matter. More specifically, Xie in at least fig. 7D-7F, page 2 line 34, page 21 line 19, page 21 lines 28-29 for example discloses surgical mesh implant. See at least Xie page 2 line 34 “nanofiber skin grafts ready for implantation”; page 21 line 19 “to form square arrayed holes throughout nanofiber membranes”; page 21 lines 28-29 “SEM image of cross-sections indicated a layered and highly porous structure (Figures 7D-7F)”) comprising
a 2D nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit nanofiber mesh for use as hernia mesh as well-known prior art. Xie in at least page 5 lines 20-21, page 6 line 14 for example discloses mesh comprises a 2D nanofiber membrane. See at least Xie page 5 lines 20-21 “nanofiber membranes used were two dimensional (2D)”; page 6 line 14 “2D nanofiber membranes were fabricated using electrospinning”) and
a 3D expanded nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh i.e. 3D expanded nanofiber for use as hernia mesh as well-known prior art. Lastly, Xie in at least page 5 lines 27-29, page 6 lines 29-30, page 10 lines 20-33 for example discloses a 3D expanded nanofiber membrane. See at least Xie page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify 3D membrane of the multilayered hernia mesh as taught by Boey, such that the 3D nanofiber membrane is expanded, as taught by Xie. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of enhancing the efficiency of the treatment of the patients in need and provide faster and better healing of the surgery wounds (Xie, page 14 line 24-page 15 line 25).
As per dependent Claim 2, the combination of Boey and Xie as a whole further discloses hernia mesh wherein said 2D nanofiber membrane is bonded to said 3D expanded nanofiber membrane (Boey’s in at least disclosure in at least fig. 3-5, [0013-0014], [0032], [0047], [0064], [0085], [0087] for example discloses wherein said 2D nanofiber membrane is bonded to said 3D nanofiber membrane while Xie discloses the 3D nanofiber membrane can be an gas expanded nanofiber membrane. Thus, combination of applied art as a whole discloses subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Boey [0085] “thus obtained film structure was then further processed by adhering a top coating made of carboxymethylcellulose … containing pharmaceutically active agents thereon. In order to enhance the adhesive properties, biocompatible polymers like PLGA were used as adhesive-promoting agents in the form of an additional film or as adjective to the carboxymethylcellulose. Thus, a multi-layered film prosthesis was prepared comprising a porous PVDF film layer.”).
As per dependent Claim 3, the combination of Boey and Xie as a whole further discloses hernia mesh wherein said hernia mesh further comprises a strengthening or support membrane (Boey in at least [0047] for example discloses further comprises a strengthening or support membrane. Here, applied art supporting/reinforcing layer is representative of support membrane as recited. Boey in at least [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer…The layer 10 is the above-described porous layer on which the second layer 20, also called reinforcing layer, is provided. The reinforcing layer 20 generally provides a respective reinforcing action to the prosthesis and, thus, allowing a reinforcement of a tissue or closing a tissue or wall defect”).
As per dependent Claim 4, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane and the 3D expanded nanofiber membrane comprise a polymer selected from the group consisting of polymethacrylate, poly vinyl phenol, polyvinylchloride, cellulose, polyvinyl alcohol, polyacrylamide, poly(lactic-co-glycolic) acid (PLGA), collagen, polycaprolactone (PCL), polyurethanes, polyvinyl fluoride, polyamide, silk, nylon, polybennzimidazole, polycarbonate, polyacrylonitrile, polyvinyl alcohol, polylactic acid, polyethylene-co-vinyl acetate, polyethylene oxide, polyaniline, polystyrene, polyvinylcarbazole, polyethylene terephthalate, polyacrylic acid-polypyrene methanol, poly(2-hydroxyethyl methacrylate), polyether imide, polyethylene glycol, poly(ethylene-co- vinyl alcohol), polyacrylnitrile, polyvinyl pyrrolidone, polymetha-phenylene isophthalamide, gelatin, alginate, chitosan, starch, pectin, cellulose, methylcellulose, sodium polyacrylate, starch-acrylonitrile co-polymers, and combinations of two or more polymers (Xie in at least page 8 line 7-10 “hydrophobic polymers include, without limitation: polyvinyl alcohol (PVA), poly(hydroxyethyl methacrylate), poly(N-isopropyl acrylamide), poly(lactic acid) (PLA (or PDLA)), poly(lactide-co-glycolide) (PLG), poly(lactic-co-glycolic acid) (PLGA), polyglycolide or polyglycolic acid (PGA), polycaprolactone (PCL)”; page 8 lines 18 “(PEUU), cellulose acetate, polypropylene (PP), polyethylene terephthalate (PET)”; page 8 lines 26-30 “Amphiphilic copolymers may comprise a hydrophilic polymer (e.g., segment) and a hydrophobic polymer (e.g., segment) from those listed above (e.g., gelatin/PVA, PCL/collagen, chitosan/PVA, gelatin/elastin/PLGA, PDO/elastin, PHBV/collagen, PLA/hyaluronic acid, PLGA/hyaluronic acid, PCL/hyaluronic acid,PCL/collagen/hyaluronic acid, gelatin/siloxane, PLLA/MWNTs/hyaluronic acid).”).
As per dependent Claim 5, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane and the 3D expanded nanofiber membrane comprise polycaprolactone (PCL) and polylactide (PLA) (Xie in at least page 8 line 10 “polyglycolide or polyglycolic acid (PGA), polycaprolactone (PCL)”).
As per dependent Claim 6, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane and/or the 3D expanded nanofiber membrane comprise electrospun nanofibers (Xie at least page 2 lines 17-18 “nanofiber structure may comprise a plurality of nanofibers … electrospun fibers”; page 2 lines 30-31 “Nanofiber membrane generated by electrospinning”; page 7 lines 8-9 “the nanofiber structures comprise electrospun nanofibers.”; page 10 lines 21-22 “Electrospun nanofibers are usually deposited on a substrate to form a nanofiber mat.”).
As per dependent Claim 7, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 3D expanded nanofiber membrane is manufactured using a gas expansion method (Xie in at least page 2 lines 8-18 “nanofiber/nanofibrous structures comprise an expanded, nanofiber structure comprising a plurality of nanofibers… … nanofiber structure has been expanded by exposure to gas bubbles. The gas bubbles may be generated by a chemical reaction and/or physical means… gas bubbles are generated as a product of a chemical reaction (e.g., the hydrolysis of sodium borohydride)”; page 6 lines 29-30 “2D membranes were transformed into 3D nanofiber scaffolds using a modified gas-foaming technique”; page 10 lines 20-33 “nanofiber structures of the instant invention are expanded. Electrospun nanofibers are usually deposited on a substrate to form a nanofiber mat… nanofiber mats can be expanded by making use of bubbles (e.g., generated by chemical reactions in an aqueous solution (e.g., a gas foaming technique)). The gas bubbles may be formed by any chemical reaction and/or physical mean… nanofiber structure is submerged or immersed in a bubble/gas producing chemical reaction or physical manipulation”).
As per dependent Claim 8, the combination of Boey and Xie as a whole further discloses hernia mesh wherein said hernia mesh further comprises a strengthening or support membrane, and a second 3D expanded nanofiber membrane (Boey in [0032], [0047], [0064] for example discloses mesh comprising three or more layers including strengthening or support membrane, and a 3D nanofiber membrane while Xie in at least page 5 lines 20-21, page 6 line 14 discloses mesh comprises a 3D expanded nanofiber membranes and in page 5 lines 27-29, page 6 lines 29-30, page 10 lines 20-33 discloses a 3D expanded nanofiber membranes. Thus, combination of applied art as a whole makes obvious the subject-matter as now explicitly, positively and specifically recited by the Applicants as a matter a mere duplication or rearrangement of prior art discloses elements (see MPEP 2144.04) in order to enhance the efficiency of the treatment of the patients in need and provide faster and better healing of the surgery wounds (Xie, page 14 line 24-page 15 line 25). See at least Boey [0032] “"prosthesis" as used … means any sheet-like structure which can … made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other …sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis… the three-dimensional sub-structure can comprise a plug on a multi-layered sheet made of the same or any different material”; [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer…The layer 10 is the above-described porous layer on which the second layer 20, also called reinforcing layer, is provided”; [0064] “multi-layered structures such as prosthesis with three, four or more different layers”; See at ;least Xie page 5 lines 20-21 “nanofiber membranes used were two dimensional (2D)”; page 6 line 14 “2D nanofiber membranes were fabricated using electrospinning”; page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”).
As per dependent Claim 9, the combination of Boey and Xie as a whole further discloses hernia mesh wherein said 2D nanofiber membrane and/or 3D expanded nanofiber membrane comprises one or more active agents(Xie in at least page 13 lines 19-page 14 line 10 “nanofiber structures … may comprise or encapsulate at least one agent, particularly a bioactive agent such as a drug or therapeutic agent … Small molecules include, without limitation, simvastatin, kartogenin, retinoic acid, paclitaxel, vitamin D3, etc.”;).
As per dependent Claim 10, the combination of Boey and Xie as a whole further discloses hernia mesh wherein said active agents are selected from the group consisting of antimicrobial agents, chemokines, cytokines, and growth factors(Xie in at least page 13 line 19-34 “nanofiber structures …may comprise or encapsulate at least one agent, particularly a bioactive agent such as a drug or therapeutic agent (e.g., analgesic, growth factor, anti-inflammatory, signaling molecule, cytokine, antimicrobial (e.g., antibacterial, antibiotic, antiviral, and/or antifungal), blood clotting agent, factor, or protein, etc.)… agent treats/prevents infections (e.g., antimicrobials such as antibacterials, antivirals and/or antifungals… agent is an antimicrobial, particularly an antibacterial.”).
As per dependent Claim 11, the combination of Boey and Xie as a whole further discloses hernia mesh wherein a surface of the 3D expanded nanofiber membrane comprises extra cellular matrix mimetic materials, a hydrogel, antimicrobial agents and/or growth factors(Xie in at least page 10 lines 4-10 “material is a hydrogel (e.g., a polymer matrix able to retain water, particularly large amounts of water, in a swollen state).”; page 14 lines 27-29 “nanofiber structures can also be combined with a variety of hydrogels or biological matrices/cues to form 3D hybrid scaffolds that can release biologically functional molecules.”; page 13 lines 19-34 “nanofiber structures …may comprise or encapsulate at least one agent, particularly a bioactive agent such as a drug or therapeutic agent (e.g., analgesic, growth factor, anti-inflammatory, signaling molecule, cytokine, antimicrobial (e.g., antibacterial, antibiotic, antiviral, and/or antifungal), blood clotting agent, factor, or protein, etc.)… agent treats/prevents infections (e.g., antimicrobials such as antibacterials, antivirals and/or antifungals… agent is an antimicrobial”).
As per dependent Claim 12, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 3D expanded nanofiber membrane is coated with gelatin and crosslinked(Xie page 10 lines 6-10 “material is a hydrogel (e.g., a polymer matrix able to retain water, particularly large amounts of water, in a swollen state… the material is gelatin…expanded nanofiber structures are coated with about 0.05% to about 10% coating material (e.g., gelatin), …the material (e.g., hydrogel) is crosslinked.”).
As per dependent Claim 13, Boey further discloses a method of treating, preventing, and/or inhibiting a hernia in a subject in need thereof, said method comprising administering to said subject the hernia mesh (Boey in at least fig. 1, [0014], [0034], [0086-0087] for example discloses method of treating, preventing, and/or inhibiting a hernia in a subject in need thereof, said method comprising administering to said subject the hernia mesh. See at least Boey [0014] “a method of treating a patient in need of a sheet-like surgical prosthesis or a patient in need of hernia repair…method includes the implantation of the prosthesis of the invention into the patient in need thereof”) of claim 1 (see claim 1 above).
As per independent Claim 14, Boey discloses a method for producing a hernia mesh (Examiner notes that this claim is being interpreted as a product-by-process claim (also cross reference MPEP 2113) and thus, even if the product-by-process claim is limited by and defined by the process, determination of patentability is based on the product itself as the patentability of a product does not depend on its method of production and consequently, if the product in the product-by-process claim is the same as or obvious from a product of the prior art as detailed below, the claim is unpatentable even if the prior product was potentially made by a different process. Boey in at least abstract, fig. 1, fig. 3-5, fig. 8, [0002], [0012-0014], [0017], [0031-0032], [0034], [0041], [0047], [0050-0052], [0064], [0071], [0074], [0084-0090] for example disclose relevant subject-matter. More specifically, abstract, [0002], [0013], [0031-0032], [0085] for example discloses method for producing a hernia mesh. See at least Boey [0002] “prostheses for surgical applications, to methods of their manufacturing …prostheses having a multi-layered sheet structure and their use in hernia repair”; [0013] “a method of manufacturing a prosthesis having a multi-layered sheet structure…method comprises forming at least two continuous film layers to produce the multi-layered structure”; [0085] “a multi-layered film prosthesis was prepared comprising a porous PVDF film layer”), said method comprising
a) synthesizing a first 2D nanofiber membrane (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Consequently, Boey’s disclosure in at least fig. 3-4, [0032], [0047] for example of a first 2D nanofiber membrane makes obvious subject-matter as now recited. See at least Boey [0032] “"prosthesis" as used … means any sheet-like structure which can … made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other …sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis… the three-dimensional sub-structure can comprise a plug on a multi-layered sheet made of the same or any different material”; [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer… layer 10 is the above-described porous layer on which the second layer 20, also called reinforcing layer, is provided”);
b) synthesizing a second 3D nanofiber membrane (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Consequently, Boey’s disclosure in [0032] [0064] for example discloses a 3D nanofiber membrane makes obvious subject-matter as now recited.. See at least Boey [0032] “"prosthesis" as used … means any sheet-like structure which can … made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other …sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis… the three-dimensional sub-structure can comprise a plug on a multi-layered sheet made of the same or any different material”; [0064] “multi-layered structures such as prosthesis with three, four or more different layers”), and
c) bonding said 2D nanofiber membrane and said 3D nanofiber membrane thereby producing said hernia mesh (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Consequently, Boey’s disclosure in at least fig. 3-5, [0013-0014], [0032], [0047], [0064], [0085], [0087] for example of a multi-layered film prosthesis was prepared comprising a porous PVDF film layer makes obvious hernia mesh comprising in which 2D nanofiber membrane is bonded to said 3D nanofiber membrane. See at least Boey [0085] “thus obtained film structure was then further processed by adhering a top coating made of carboxymethylcellulose … containing pharmaceutically active agents thereon. In order to enhance the adhesive properties, biocompatible polymers like PLGA were used as adhesive-promoting agents in the form of an additional film or as adjective to the carboxymethylcellulose. Thus, a multi-layered film prosthesis was prepared comprising a porous PVDF film layer.”).
Boey does not explicitly disclose expanding the second 2D nanofiber membrane to generate a 3D expanded nanofiber membrane.
However, in an analogous surgical implant field of endeavor, Xie discloses a method for producing a mesh (Examiner notes that this claim is being interpreted as a product-by-process claim (also cross reference MPEP 2113) and thus, even if the product-by-process claim is limited by and defined by the process, determination of patentability is based on the product itself as the patentability of a product does not depend on its method of production and consequently, if the product in the product-by-process claim is the same as or obvious from a product of the prior art as detailed below, the claim is unpatentable even if the prior product was potentially made by a different process. Xie in at least fig. 1, fig. 7m abstract, page 1 lines 15-17, page 2 lines 8-25, lines 31-34, page 5 lines 27-29, page 6 lines 12-13, lines 29-30, page 8 lines 7-30, page 10 lines 4-10, lines 20-33, page 11 lines 1-25, page 13 lines 19-29, page 14 lines 11-29, page 14-18, page 21 lines 19-30 for example discloses relevant subject-matter. More specifically, Xie in at least page 2 lines 22-25 and line 34, page 14 lines 11-16, page 21 lines 19-29 for example discloses method for producing a mesh. See at least page 2 line 34 “nanofiber skin grafts ready for implantation to the chronic wound”; page 14 lines 11-16 “methods of synthesizing the nanofiber structures …comprises electrospinning a nanofiber structure or mat … expanding the nanofiber structure or mat with gas”; page 21 lines 19-29 “Nanofiber membranes were expanded …using a modified gas foaming technique … …SEM image of cross-sections indicated a layered and highly porous structure (Figures 7D-7F)”), said method comprising
a) synthesizing a first 2D nanofiber membrane (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Xie in at least page 5 lines 20-21, page 6 line 14 for example discloses synthesizing a first 2D nanofiber membrane. See at least Xie page 5 lines 20-21 “nanofiber membranes used were two dimensional (2D)”; page 6 line 14 “2D nanofiber membranes were fabricated using electrospinning”);
b) synthesizing a second 2D nanofiber membrane and expanding the second 2D nanofiber membrane to generate a 3D expanded nanofiber membrane (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113).Xie in at least page 5 lines 27-29, page 6 lines 29-30, page 10 lines 20-33 for example discloses synthesizing a second 2D nanofiber membrane/nanofiber mat and expanding the second 2D nanofiber membrane to generate a 3D expanded nanofiber membrane by making use of bubbles. See at least Xie page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”; page 10 lines 22-25 “nanofiber structures … are expanded. Electrospun nanofibers are usually deposited on a substrate to form a nanofiber mat… nanofiber mats can be expanded by making use of bubbles (e.g., generated by chemical reactions in an aqueous solution (e.g., a gas foaming technique)). The gas bubbles may be formed by any chemical reaction and/or physical mean.”), and
c) bonding said 2D nanofiber membrane and said 3D expanded nanofiber membrane thereby producing said mesh (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Xie in at least page 10 lines 6-10, page 21 lines 19-29 for example discloses bonding said 2D nanofiber membrane and said 3D expanded nanofiber membrane. See Xie page 10 lines 6-10 “material is a hydrogel (e.g., a polymer matrix able to retain water, particularly large amounts of water, in a swollen state… the material is gelatin…expanded nanofiber structures are coated with about 0.05% to about 10% coating material (e.g., gelatin), …the material (e.g., hydrogel) is crosslinked.”; page 21 lines 19-29 “Nanofiber membranes were expanded …using a modified gas foaming technique … …SEM image of cross-sections indicated a layered and highly porous structure (Figures 7D-7F).”).
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 hernia mesh comprising multiple layers as taught by Boey, by further including a 3D expanded nanofiber membrane, as taught by Xie. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of enhancing the efficiency of the treatment of the patients in need and provide faster and better healing of the surgery wounds (Xie, page 14 line 24-page 15 line 25).
As per dependent Claim 15, the combination of Boey and Xie as a whole further discloses hernia mesh method further comprising adding a strengthening or support membrane to said hernia mesh (Here, the limitation is being interpreted as a product-by-process limitation (also cross reference MPEP 2113). Boey in at least [0047] for example discloses end product which further comprises a strengthening or support membrane which reads on subject-matter as now explicitly, positively and specifically recited by the Applicants. Here, applied art supporting/reinforcing layer is representative of support membrane as recited. Boey in at least [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer…The layer 10 is the above-described porous layer on which the second layer 20, also called reinforcing layer, is provided. The reinforcing layer 20 generally provides a respective reinforcing action to the prosthesis and, thus, allowing a reinforcement of a tissue or closing a tissue or wall defect”).
As per dependent Claim 16, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 3D expanded nanofiber membrane is about 1.5 to about 5 times as thick as the 2D nanofiber membrane (Examiner notes that the specification as-filed is silent as to the criticality of recited membrane thickness ranges as evidenced in at least instant application specification as-filed page 15 lines 6-13. Boey in at least fig. 3-4, [0032], [0047] for example discloses hernia mesh comprising 2D nanofiber membranes of a therapeutically effective thickness and 3D nanofiber membranes a therapeutically effective thickness while Xie in at least at least page 5 lines 20-21, lines 27-29, page 6 line 14, page 6 lines 29-30, page 10 lines 20-33 discloses implant comprising 2D nanofiber membranes of a therapeutically effective thickness and 3D nanofiber membranes of a therapeutically effective thickness which make subject-matter as now explicitly, positively and specifically recited by the Applicants obvious as a matter of design choice. See at least Xie in at least page 7 lines 21-27 “nanofiber scaffolds … can be formed and manufactured into a variety of … thicknesses… the expanded nanofiber scaffold is from about 1 to about 20 mm thick. In another embodiment, the expanded nanofiber scaffold is from about 1 to about 10 mm thick. In another embodiment, the expanded nanofiber scaffold is from about 1 to about 5 mm thick”; “page 21 lines 24-25 “nanofiber membrane was initially 0.4 mm thick and became about 4 mm thick after expansion.”).
As per dependent Claim 17, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 3D expanded nanofiber membrane is about 3 times as thick as the 2D nanofiber membrane (Examiner notes that the specification as-filed is silent as to the criticality of recited membrane thickness ranges as evidenced in at least instant application specification as-filed page 15 lines 6-13. Boey in at least fig. 3-4, [0032], [0047] for example discloses hernia mesh comprising 2D nanofiber membranes of a therapeutically effective thickness and 3D nanofiber membranes a therapeutically effective thickness while Xie in at least at least page 5 lines 20-21, lines 27-29, page 6 line 14, page 6 lines 29-30, page 10 lines 20-33 discloses implant comprising 2D nanofiber membranes of a therapeutically effective thickness and 3D nanofiber membranes of a therapeutically effective thickness which make subject-matter as now explicitly, positively and specifically recited by the Applicants obvious as a matter of design choice. See at least Xie in at least page 7 lines 21-27 “nanofiber scaffolds … can be formed and manufactured into a variety of … thicknesses… the expanded nanofiber scaffold is from about 1 to about 20 mm thick. In another embodiment, the expanded nanofiber scaffold is from about 1 to about 10 mm thick. In another embodiment, the expanded nanofiber scaffold is from about 1 to about 5 mm thick”; “page 21 lines 24-25 “nanofiber membrane was initially 0.4 mm thick and became about 4 mm thick after expansion.”).
As per dependent Claim 18, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 3D expanded nanofiber membrane comprises the same polymer(s) as the 2D nanofiber membrane (Examiner notes that the specification as-filed is silent as to the criticality of recited membrane material used as evidenced in at least instant application specification as-filed page 15 lines 14-19. Xie in at least page 5 lines 27-29, page 6 lines 29-30, page 10 lines 20-33 for example discloses synthesizing a second 2D nanofiber membrane/nanofiber mat and expanding the second 2D nanofiber membrane to generate a 3D expanded nanofiber membrane by making use of bubbles which reads on subject-matter as now explicitly, positively and specifically recited by the Applicants since 2D expanded nanofiber membrane is expanded to create the 3D nanofiber membrane. See at least Xie page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”; page 10 lines 22-25 “nanofiber structures … are expanded. Electrospun nanofibers are usually deposited on a substrate to form a nanofiber mat… nanofiber mats can be expanded by making use of bubbles (e.g., generated by chemical reactions in an aqueous solution (e.g., a gas foaming technique)). The gas bubbles may be formed by any chemical reaction and/or physical mean.”).
As per dependent Claim 19, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane is larger than the 3D expanded nanofiber membrane such that when viewed from the 3D expanded nanofiber membrane side, a margin of the 2D nanofiber membrane is seen around the 3D expanded nanofiber membrane (Examiner notes that the specification as-filed is silent as to the criticality of recited membrane shaped as evidenced in at least instant application specification as-filed page 14 lines 27-page 15 line 33. Boey in at least [0033] discloses the hernia mesh/implant outline and size can be shaped as needed which makes subject-matter as now explicitly, positively and specifically recited by the Applicant obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attempt in order to ensure the implant/mesh conform to the surgical anatomical site of interest. see at least Boey [0033] “prosthesis may be configured to have any suitable shape … and sufficiently pliable to allow a surgeon to manipulate the shape of the surgical prosthesis to conform to the anatomical site of interest and to be sutured or stapled thereto. …the outline and the size of the prosthesis may vary according to the surgical application as would be apparent to one of skill in the art. The prosthesis can be pre-shaped or shaped by the surgeon during the surgical procedure. To be sufficiently moldable during implantation”. Also see Xie page 7 lines 21-24 “nanofiber scaffolds of the present invention can be formed and manufactured into a variety of shapes (ex. round, square, rectangular), sizes, and thicknesses… nanofiber structure may be cut or shaped prior to expansion.” Thus, combination of applied art as a whole discloses all the limitations as now explicitly, positively and specifically recited by the Applicants. ).
As per dependent Claim 20, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane comprises nanofibers comprising biodegradable polymers, and wherein the 3D expanded nanofiber membrane comprises nanofibers comprising biodegradable polymers (Boey in at least fig. 3-4, [0032], [0040], [0047] for example discloses the 2D nanofiber membrane comprises nanofibers comprising biodegradable polymers, and wherein the 3D nanofiber membrane comprises nanofibers comprising biodegradable polymers while Xie in page 6 line 25-page 7 line 5, page 7 lines 28-31 discloses 3D expanded nanofiber membrane comprising biodegradable polymers. Thus, applied art as a whole discloses all the limitations as now explicitly, positively and specifically recited by the Applicants. See at least Boey [0040] “Various examples of bioresorbable polymer materials are known in the art, any one of which is generally suitable for use in a polymer coating described herein…biodegradable polyethers… naturally-occurring biodegradable polymers such as chitosan, starch, gelatin, collagen, fibrinogen, fibrin, cellulose, alginate, polysaccharides, amylase, or any polymer blends, copolymers, or derivatives thereof. …a biodegradable polyamide, a biodegradable aliphatic polyester, and/or copolymers thereof. Illustrative examples of biodegradable polymers include, but are not limited to a polylactide, such as poly(L-lactide) (PLLA), a polycaprolactone (PCL), a copolymer of polycaprolactone (PCL) and polylactic acid (PLA), or a copolymer of poly(lactide) and poly(glycolide) (PLGA). … Each of the above-mentioned bioresorbable polymer materials has a characteristic degradation rate in the body…Thus, one skilled in the art will be able to choose an appropriate bioresorbable material with a desired degradation rate that is suitable for the desired application of the prosthesis”; See Xie page 7 lines 28-31 “The nanofibers of the instant invention may comprise any polymer… the polymer is biocompatible. The polymer may be biodegradable … polymer is a biodegradable polymer.”).
As per dependent Claim 21, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane comprises electrospun nanofibers and the 3D expanded nanofiber membrane comprises electrospun nanofibers expanded using a gas expansion method (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane and 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh expanded using the gas-foaming technique as well-known prior art. Xie in at least page 5 lines 20-21, lines 27-29, page 6 line 14, lines 29-30, page 10 lines 20-33 for example discloses 2D nanofiber membrane comprises electrospun nanofibers and the 3D expanded nanofiber membrane comprises electrospun nanofibers expanded using a gas expansion method. See at least Xie page 5 lines 20-21 “nanofiber membranes used were two dimensional (2D)”; page 6 line 14 “2D nanofiber membranes were fabricated using electrospinning”. See at least Xie page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”).
As per dependent Claim 22, the combination of Boey and Xie as a whole further discloses hernia mesh wherein the 2D nanofiber membrane and the 3D expanded nanofiber membrane are bonded together with a biocompatible glue (Examiner notes that the specification as-filed is silent as to the criticality of recited membrane thickness ranges as evidenced in at least instant application specification as-filed page 15 lines 20-33. Boey’s in at least disclosure in at least fig. 3-5, [0013-0014], [0032], [0047], [0064], [0085], [0087] for example discloses the 2D nanofiber membrane and the 3D nanofiber membrane are bonded together with a biocompatible glue represented by prior art biocompatible polymers like PLGA which confers adhesive property while Xie discloses the 3D expanded nanofiber membrane. Thus, combination of applied art as a whole discloses subject-matter as now explicitly, positively and specifically recited by the Applicants. see Boey [0085] “In order to enhance the adhesive properties, biocompatible polymers like PLGA were used as adhesive-promoting agents in the form of an additional film or as adjective to the carboxymethylcellulose. Thus, a multi-layered film prosthesis was prepared comprising a porous PVDF film layer.”).
Response to Amendment
According to the Amendment, filed 01/30/2026, the status of the claims is as follows:
Claims 1-6, 8, 11, 13, 14 are currently amended;
Claims 7, 9, 10, 12 are as originally filed; and
Claims 15-22 are new.
The Specification/Drawings has been amended in view of the Amendment, filed 01/30/2026. No new matter was introduced.
By the current amendment, as a result, claims 1-22 are now pending in this application and are being examined on the merits.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Pages 7-10 of Applicant’s Amendment dated 01/30/2026
The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 11/04/2025: [1] The objection to Specification/Drawings is withdrawn in view of the amendment and arguments, filed 01/30/2026; [2] The objection to claims is withdrawn in view of the amendment and arguments, filed 01/30/2026; [3] The 35 U.S.C. 112(a), rejections to claims as raised in Office Action dated 11/04/2025 are withdrawn in view of the amendment, filed 01/30/2026;[4] The 35 U.S.C. 112(b), rejections to claims as raised in Office Action dated 11/04/2025 are withdrawn in view of the amendment, filed 01/30/2026; The 35 U.S.C. 112(d), rejections to claims as raised in Office Action dated 11/04/2025 are withdrawn in view of the amendment, filed 01/30/2026.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 10-14 of Applicant’s Amendment dated 01/30/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 102/103 Rejection of the Amended Independent Claim 1 and Amended Independent Claim 14
[A] Boey et al. neither teach nor suggest a 3D nanofiber membrane nor a 3D expanded nanofiber membrane. At paragraph [0032], Boey et al. states that the prosthesis is a "substantially flat sheet" wherein "the thickness of the sheet is usually small and is generally not considered as a third dimension" (emphasis added). The only reference to anything being three-dimensional in Boey et al. is in reference to a "three-dimensional sub-structure." A sub-structure clearly is NOT a membrane or layer or sheet. Rather, Boey et al. teach that the three- dimensional "sub-structure" is a plug, "artificial opening", or a "projecting guiding cone" (paragraph [0032]). These sub-structures clearly cannot be considered a membrane or layer or sheet of the prosthesis
[B]In addition to all of the above, Boey et al. also clearly fail to teach or suggest a nanofiber membrane - either 2D or 3D.
[C]In light of the above, it is clear that Boey et al. fail to teach or suggest hernia meshes with nanofiber membranes and fail to teach or suggest hernia meshes with a 3D nanofiber membrane or 3D expanded nanofiber membrane.
[D] The other reference cited by the Examiner - Xie et al. - fails to overcome the many deficiencies in the teachings of Boey et al. Indeed, Xie et al. does not specifically recite hernia meshes.
[E]As such, the skilled artisan would have neither the motivation nor expectation of success to modify the prostheses of Boey et al., particularly in a manner that conflicts with the express teachings of Boey et al.
[F] Claim 14 has been rejected under 35 U.S.C.
§103 as allegedly unpatentable over Boey et al. in view of Xie et al. Applicant respectfully disagrees with the Examiner's position for at least the following reasons. As explained hereinabove, Applicant has amended claim 1 to recite the features of previous claim 2. Inasmuch as the references cited by the Examiner fail to teach or suggest each and every element of the instantly claimed invention, the rejection under 35 U.S.C. §103 cannot be reasonably maintained. Withdrawal of the rejection is respectfully requested.
[G] In view of the amendments and evidence presented herewith and the foregoing remarks, it is respectfully urged that the objections and rejections set forth in the November 4, 2025 Official Action be withdrawn and that this application be passed to issue.
Applicant’s arguments [A-G] above, with respect to the above claim limitation in Claim 1 have been considered and are persuasive. Therefore, claim 1 rejection under 35 U.S.C 102 as anticipated by Boey is withdraw. Upon further consideration, new grounds of rejection are raised with respect to claim 1 under 35 U.S.C 103 over the combination of Boey and Xie as a whole. The new grounds of rejection were necessitated by Applicant’s amendments to the claims.
With respect to Applicant’s arguments [A-C] above, Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane and 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh i.e. 3D expanded nanofiber for use as hernia mesh as well-known prior art. See instant specification as-filed:
page 17 lines 17-24 “Forms of electrospun nanofibers include, … production of electrospun fibers is described, for example, in Gibson et al. (1999) AlChE J., 45:190-195.”
page 20 lines 11-28 “Expanded synthetic nanofiber matrices for use as a hernia mesh were synthesized (PCT/US2015/052858; Jiang, et al. (2015) ACS Biomater. Sci. Engineering, 1(10):991-1001; Jiang, et al. (2016) Adv. Healthcare Mater., 5(23):2993-3003). …Nanofiber mesh was electrospun from 20% (w/v) polycaprolactone/polylactide, PCL/PLA (50:50 blend) in 4:1 dichloromethane:dimethylformamide as described (Xie, et al. (2012) Adv. Healthcare Mater. 1(5):674-678; Xie, et al. (2012) Macromol. Biosci., 12(10):1336-1341; Xie, et al. (2013) Acta Biomater., 9(3):5698-5707). The nanofiber mesh was then trimmed to the desired size (10×10 cm). The thickness of the electrospun PCL/PLA nanofiber sheets was expanded several-fold using a gas-foaming technique—either a sodium borohydride solution or a CO.sub.2 subcritical fluid and reduced pressure—to a final thickness of 2-3 mm (Jiang, et al. (2015) ACS Biomater. Sci. Engineering, 1(10):991-1001; Jiang, et al. (2016) Adv. Healthcare Mater., 5(23):2993-3003). The expanded mesh was then coated with gelatin and crosslinked with glutaraldehyde.”
page 21 lines 18-26 “since the 2D non-porous layer will minimize adhesion formation and tissue ingrowth (Aydemir Sezer, et al. (2019) Mater. Sci. Eng. C Mater. Biol. Appl., 99:1141-1152; Balique, et al. (2005) Hernia 9(1):68-74). The 3D expanded layer is in contact with the abdominal wall to encourage tissue ingrowth (Jiang, et al. (2016) Adv. Healthcare Mater., 5(23):2993-3003; Chen, et al. (2018) Biomaterials 179:46-59; Chen, et al. (2020) Appl. Phys. Rev., 7(2):021406; Chen, et al. (2020) J. Mater. Chem. B, 8(17):3733-3746; Chen, et al. (2017) Nanomedicine (Lond) 12(11):1335-1352; Chen, et al. (2020) Adv. Mater., 2020:e2003754; Chen, et al. (2020) Acta Biomater., 108:153-167; Jiang, et al. (2018) Acta Biomater., 68:237-248).”
With respect to Applicant’s arguments [A] and [C] above, stating Boey et al. does not disclose or suggest a 3D expanded nanofiber membrane, Examiner notes the Office Action dated 11/04/2025 does not state that Boey discloses 3D nanofiber membrane that has been expanded as incorrectly characterized by the Applicants. On the same note, Applicant’s arguments [D] above, stating Xie does not disclose hernia meshes, Examiner notes the Office Action dated 11/04/2025 does not state that Xie discloses hernia meshes as incorrectly characterized by the Applicants. In response to these applicant's arguments against the references individually, Examiner notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Further, with respect to Applicant’s arguments [A] above regarding Boey’s teaching in [0032], stating Boey et al. states that the prosthesis is a "substantially flat sheet" wherein "the thickness of the sheet is usually small and is generally not considered as a third dimension", Examiner notes that substantially flat sheet is not equivalent to a flat sheet and since it is "substantially flat sheet" (emphasis added), Boey’s disclosure does not completely exclude a 3D form/structure. Additionally, Examiner notes that "the thickness of the sheet is usually small and is generally not considered as a third dimension" does not completely exclude a 3D form/structure as argued by the Applicants. In response to Applicant’s arguments stating Boey et al. teaches that the three- dimensional "sub-structure" is a plug, "artificial opening", or a "projecting guiding cone", Examiner notes that Boey exemplarily discloses “the three-dimensional sub-structure can comprise a plug… may be an artificial opening(s)… can be a projecting guiding cone” (emphasis added) and does not state necessarily that sub-structure" is a plug, "artificial opening", or a "projecting guiding cone" as narrowly mischaracterized by the Applicants. Further, since the substructure is part of the main body, the prosthesis which includes the substructure and main body would necessarily form a layer/membrane/sheet having some percentage of the area which includes the 3D structure and thus, Boey’s disclosure does not completely exclude a 3D form/structure as evidenced below:
Boey [0032] discloses the following:
[0032] “The term "prosthesis" as used in the present invention means any sheet-like structure which can be a substantially flat sheet made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other…Nevertheless, the sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis, if at least the main body (more than about 50% such as 55%, 60%, 65%, 70%, 75, 80% or more of the total body) of the prosthesis has a sheet-like structure” (emphasis added)
With respect to Applicant’s arguments [E] above, it is unclear as to why Xie’s implant cannot be used for hernia repair. Xie in at least fig. 7D-7F, page 2 line 34, page 21 line 19, page 21 lines 28-29 for example discloses surgical mesh implant that can be used for hernia repair as also evidenced in at least Xie page 2 line 34 “nanofiber skin grafts ready for implantation”; page 21 line 19 “to form square arrayed holes throughout nanofiber membranes”; page 21 lines 28-29 “SEM image of cross-sections indicated a layered and highly porous structure (Figures 7D-7F)”.
With respect to Applicant’s arguments [E] above, stating that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify 3D membrane of the multilayered hernia mesh as taught by Boey, such that the 3D nanofiber membrane is expanded, as taught by Xie. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of enhancing the efficiency of the treatment of the patients in need and provide faster and better healing of the surgery wounds as evidenced in Xie, page 14 line 24-page 15 line 25.
With respect to Applicant’s arguments [E] above stating “modify the prostheses of Boey et al., particularly in a manner that conflicts with the express teachings of Boey et al.”, i.e. primary reference teaches away from modification, please note it has been held that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). In order for a reference to teach away from the invention (i) prior art must criticize, discredit or otherwise discourage" the combination of the references;(ii) one or more references expressly exclude combining the references; and (iii) secondary reference destroys the functionality of the primary reference. Here, neither Boey nor Xie, criticize, discredit or otherwise discourage the combination of the references, neither reference, Boey or Xie criticize, expressly exclude combining the references; and (iii) secondary reference, Xie, does NOT destroys the functionality of the primary reference.
With respect to Applicant’s arguments [F] above, with respect to independent method claim 14, Applicant’s arguments have been considered but are not persuasive as Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claim 14 defines a patentable invention based on new limitations that were added to claim 1 without specifically pointing out how the language of the claim 14 patentably distinguishes them from the references.
With respect Applicant’s arguments [A-D] above, the combination of Boey and Xie as a whole discloses a hernia mesh comprising a 2D nanofiber membrane and a 3D expanded nanofiber membrane as now explicitly, positively and specifically recited by the Applicants. More specifically, Boey in fig. 1, fig. 3-4, abstract, [0002], [0012], [0014], [0017], [0031-0032], [0084] hernia mesh (See at least Boey [0002] “prostheses having a multi-layered sheet structure and their use in hernia repair”; [0017] “hernia defect and a hernia repair by using a mesh-like prosthesis” [0084]; “a mesh-like film structure”) comprising a 2D nanofiber membrane and a 3D nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane and 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh i.e. 3D expanded nanofiber for use as hernia mesh as well-known prior art. Boey in at least fig. 3-4, [0032], [0047] for example discloses hernia mesh comprising 2D nanofiber membranes, 3D nanofiber membranes or strengthening or support membranes. See at least Boey [0032] “"prosthesis" as used … means any sheet-like structure which can … made of at least two layers, i.e., two, three, four, five or more consecutive layers of sheet-like format, layered or arranged on each other …sheet structure is not limited to a two-dimensionally one, and bodies having a three-dimensional sub-structure with a complex shape also fall within the definition of the term prosthesis… the three-dimensional sub-structure can …made of the same or any different material”; [0047] “prosthesis having a multi-layered structure has an additional continuous polymer film layer supporting the porous layer… layer 10 is the above-described porous layer on which the second layer 20… is provided”). Boey does not explicitly disclose 3D nanofiber membrane that is expanded. However, in an analogous surgical implant field of endeavor, Xie in at least fig. 7D-7F, page 2 line 34, page 21 line 19, page 21 lines 28-29 for example discloses surgical mesh implant( See at least Xie page 2 line 34 “nanofiber skin grafts ready for implantation”; page 21 line 19 “to form square arrayed holes throughout nanofiber membranes”; page 21 lines 28-29 “SEM image of cross-sections indicated a layered and highly porous structure (Figures 7D-7F)”) comprising a 2D nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 2D nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit nanofiber mesh for use as hernia mesh as well-known prior art. Xie in at least page 5 lines 20-21, page 6 line 14 for example discloses mesh comprises a 2D nanofiber membrane. See at least Xie page 5 lines 20-21 “nanofiber membranes used were two dimensional (2D)”; page 6 line 14 “2D nanofiber membranes were fabricated using electrospinning”) and a 3D expanded nanofiber membrane (Examiner notes that the Applicants in at least page 21 lines 18-26 disclose and admit 3D expanded nanofiber membrane as well-known prior art. Additionally, Applicant’s in at least page 17 lines 17-24 admit electrospun nanofiber as well-known prior art. Furthermore, Applicant’s in at least page 20 lines 11-28 admit expanded nanofiber mesh i.e. 3D expanded nanofiber for use as hernia mesh as well-known prior art. Lastly, Xie in at least page 5 lines 27-29, page 6 lines 29-30, page 10 lines 20-33 for example discloses a 3D expanded nanofiber membrane. See at least Xie page 5 lines 27-29 “three-dimensional (3D) scaffolds composed of PCL and gelatin nanofibers were fabricated by a combination of electrospinning and modified gas-foaming”). Thus, the combination of Boey and Xie as a whole discloses a hernia mesh comprising a 2D nanofiber membrane and a 3D expanded nanofiber membrane as now explicitly, positively and specifically recited by the Applicants.
With respect Applicant’s arguments [A-G] above, since, device claim 1 is still rejectable under 35 U.S. C 103 over the combination of applied art, Boey and Xie, as a whole and method claim 14 still remains rejectable under 35 U.S. C 103 over the combination of applied art, Boey and Xie, as a whole, these claims as now explicitly, positively and specifically presented are not allowable at this time. Please also cross-reference detailed claim 1 and 14 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 10-14 of Applicant’s Amendment dated 01/30/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 102/103 Rejection of Dependent Claims 2-13.
[a] Claims 2-12 have been rejected under 35 U.S.C.
§103 as allegedly unpatentable over Boey et al. in view of Xie et al. Applicant respectfully disagrees with the Examiner's position for at least the following reasons. As explained hereinabove, Applicant has amended claim 1 to recite the features of previous claim 2.
[b]Boey et al. fail to teach or suggest the claimed hernia mesh. Applicant has amended claim 1, from which claim 13 depends, to recite that the hernia mesh comprises a 2D nanofiber membrane and a 3D expanded nanofiber membrane, as previously recited in claim 2. Boey et al. clearly fail to teach a hernia mesh comprising a 2D nanofiber membrane and a 3D expanded nanofiber membrane.
[c]In view of the amendments and evidence presented herewith and the foregoing remarks, it is respectfully urged that the objections and rejections set forth in the November 4, 2025 Official Action be withdrawn and that this application be passed to issue.
Applicant’s arguments [a-c] above, with respect to dependent claims 2-13 been considered but are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 3 and 11 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
For the above reasons, since clams 2-13 are still rejectable under 35 U.S.C 103 over the combination of applied art, Boey and Xie as a whole, claims as now explicitly, positively and specifically recited are not allowable at this time . Please also cross-reference detailed claims 2-13 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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