DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicants amendments filed 6/22/2026 overcome the previous rejections under 112(a) and 112(b) but necessitate new rejections under 112(a).
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive.
Applicant argues that Melikoğlu does not describe a post-treatment of step of applying ionized air to the spun nanofibers. Applicant also notes that magnetic fields are incapable of direct ionization of air molecules. These arguments are not found to be persuasive. The claims do not specify that the exposure to the ionized air is a post-treatment step. Even so, as noted by Applicant, the electric field is a part of the electrospinning process meaning that the fibers being spun are exposed after they are spun from the nozzle and are still being exposed while on the collection plate, see Gul Section 2 and Figure 2. If the ionized air step is supposed to be an additional step performed after the fibers have already been spun and collected, this should be specified in the claims. Additionally, while Examiner agrees that Melikoğlu alone does not describe producing the ionized air using electrodes 10-50 mm apart at a voltage of 50-100 kV, this is taught by Gul. Since Gul is placing electrodes a distance apart and applying a field in the same manner as claimed, Gul is also producing the ionized air that is being produced in the claimed manner. Dependent claims 2-3 and 6-12 also remain rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 is amended to recite “the hydration level of the nanofiber is 50%-60^ higher than non-ionic nanofibers.” The range “50%-60%” is not adequately supported by the specification. The instant specification recites one singular example of the hydration level at [0064] which is 54.5%. The specification does not have support for any other number within the claimed range.
Claim 11 is amended to recite “the total antioxidant capacity of the nanofiber is 350% to 400% higher.” The range “350% to 400%” is not adequately supported by the specification. The instant specification has only one number for antioxidant capacity disclosed which is 374% in [0064]. The specification does not provide adequate support for the claimed range.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Melikoğlu modified by Melikoğlu (WO 2022225477, see copy previously provided) modified by Gul (“Electrospun Antibacterial Nanomaterials for Wound Dressings Applications,” 2021, see NPL copy previously provided.)
Regarding claim 1, Melikoğlu meets the claimed, A method of forming quasi-permanent charge-bearing nanofibers, comprising: preparing an aqueous fabrication solution comprising at least one water-soluble polymer, one charge-bearing polymer or α-Tocopherol, and a solvent, wherein the solvent is water or acetic acid; (Melikoğlu page 6 lines 14-16 describes combining solutions A-D which include water-soluble polymers including chitosan, collagen, and polyvinyl alcohol, charged polymers including polyhexanide, water, and acetic acid) electrospinning the aqueous solution to obtain nanofibers; and subjecting the nanofibers to ionized air to obtain quasi-permanent charge-bearing nanofibers (Melikoğlu page 4 lines 14-16 describes electrospinning the solutions A-D together and page 7 lines 20-25 describes how the fibers are exposed to ionized air via a magnetic field during the electrospinning process.)
Melikoğlu does not meet the claimed, wherein the ionized air is produced by electrodes placed at a distance of 10-50 mm apart applying a voltage of 50 – 100 kV.
Analogous in the field of electrospinning fibers for wound dressings, Gul does not explicitly meet the claimed, wherein the ionized air is produced by electrodes placed at a distance of 10-50 mm apart applying a voltage of 50 – 100 kV, however, Gul Section 2 from page 3 onwards and Table 1 explain that the Taylor cone produced during electrospinning is due to two electrodes, one at the spinneret/needle and one at the collector and that both the distance between the needle and collector and the applied voltage are result-effective variables. Table 1 describes the distance between the needle and the collector affects the traveling time of the fibers which affects the length of time available to complete evaporating the solvent in the solution. Table 1 also discloses that the applied voltage affects the size of the fibers and the stability of the jet.
It would have been obvious to a person of ordinary skill in the art before the filing date to modify the distance between the electrodes through routine optimization and arrive at the claimed range in order to optimize the distance and thereby the time the solvent has to evaporate, see Gul Table 1. It also would have been obvious to a person of ordinary skill in the art before the filing date to modify the amount of voltage applied through routine optimization in order to optimize the diameter of the fiber and the stability of the jet, see Gul Table 1.
Regarding claim 2, Melikoğlu meets the claimed, The method of claim 1, wherein the at least one water-soluble polymer is selected from polyvinyl alcohol, polyethylene oxide, gelatin, chitosan, polycaprolactone, polylactic acid, collagen and hyaluronic acid (Melikoğlu page 6 lines 14-16 describes combining solutions A-D which include several claimed water-soluble polymers such as chitosan, collagen, and polyvinyl alcohol.)
Regarding claim 3, Melikoğlu meets the claimed, The method of claim 1, wherein the at least one charge-bearing polymer is selected from polyacrylic acid, polyethyleneimine, polylysine or polyhexanide (Melikoğlu page 6 lines 14-16 describe combining solutions A-D, solution D includes polyhexanide, see page 6 lines 3-5.)
Regarding claim 5, Melikoğlu meets the claimed, A quasi-permanent charge-bearing nanofiber fabricated using the method of claim 1 (Melikoğlu page 7 lines 14-26 describe the fiber formed.)
Regarding claim 6, Melikoğlu does not explicitly meet the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the magnitude of the surface charge of the nanofiber is at least 10 mV, however, Melikoğlu page 7 lines 14-26 as modified by Gul describe a fiber formed which is identical to the claimed fiber in claims 5 and 1. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the surface charge being at least 10mV.
Regarding claim 7, Melikoğlu does not explicitly meet the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the surface charge retention of the nanofiber 12 months after fabrication under room temperature is at least 60% however, Melikoğlu page 7 lines 14-26 as modified by Gul describe a fiber formed which is identical to the claimed fiber in claims 5 and 1. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the same charge retention.
Regarding claim 8, Melikoğlu does not explicitly meet the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the surface charge retention of the nanofiber 72 hours after fabrication under a temperature of 50°C is at least 55% however, Melikoğlu page 7 lines 14-26 as modified by Gul describe a fiber formed which is identical to the claimed fiber in claims 5 and 1. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the same charge retention.
Regarding claim 9, Melikoğlu does not explicitly meet the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the surface charge retention of the nanofiber 72 hours after fabrication under a temperature of -20°C is at least 60%. however, Melikoğlu page 7 lines 14-26 as modified by Gul describe a fiber formed which is identical to the claimed fiber in claims 5 and 1. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the same charge retention.
Regarding claim 12, Melikoğlu meets the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the nanofiber bears positive charge (Melikoğlu page 6 lines 14-16 describe combining solutions A-D which have positively charged polymers such as chitosan and polyhexanide) and the charge-bearing polymer in the aqueous fabrication solution comprises polyhexanide (Melikoğlu page 6 lines 14-16 describe combining solutions A-D, solution D includes polyhexanide, see page 6 lines 3-5.)
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Melikoğlu modified by Gul as applied to claim 5 above, and further in view of Zahid (“Bi-layered α-tocopherol acetate loaded membranes for potential wound healing and skin regeneration”, 2019, see NPL copy provided.)
Regarding claim 10, Melikoğlu meets the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the aqueous fabrication solution comprises water, (Melikoğlu page 6 lines 14-16 describe the solutions include water).
Melikoğlu claim 7 describes polyethyelene oxide but does not disclose it in the cited embodiment and does not meet the claimed, wherein the aqueous fabrication solution comprises polyethyelene oxide.
Gul meets the claimed, wherein the aqueous fabrication solution comprises polyethyelene oxide (Gul Table 4 discloses polyethylene oxide in the fiber composition.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the solutions for producing the nano-fiber wound dressings as disclosed in Melikoğlu with the polyethylene oxide wound dressing as disclosed in Melikoğlu because polyethylene oxide is a known material for use in wound dressings and treating bacterial species such as S. aureus and E. coli, see Gul Table 4.
Neither Melikoğlu nor Gul describe α-Tocopherol and wherein the hydration level of the nanofiber is 50% to 60% higher than non-ionic nanofibers. Analogous in the field of electrospinning wound dressings, Zahid meets the claimed, wherein the aqueous fabrication solution comprises α-Tocopherol (Zahid page 439 second column describes vitamin E in the form of α-tocopherol is used in an electrospinning composition for producing wound dressings). It would have been obvious to a person of ordinary skill in the art before the filing date to combine he composition of the fibers in Melikoğlu with the α-tocopherol described in Zahid in order to promote healing via protecting the membrane from peroxidation, see Zahid page 439 column 2.
Zahid does not explicitly meet the claimed, and wherein the hydration level of the nanofiber is 50% to 60% higher than non-ionic nanofibers, however, Melikoğlu as modified by Gul and Zahid meet all the limitations of the structural and compositional elements of the claimed nanofiber. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu as modified by Gul and Zahid are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the same hydration level in comparison to other non-ionic nanofibers.
Regarding claim 11, Melikoğlu meets the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the aqueous fabrication solution comprises water, (Melikoğlu page 6 lines 14-16 describe the solutions include water).
Melikoğlu claim 7 describes polyethyelene oxide but does not disclose it in the cited embodiment and does not meet the claimed, wherein the aqueous fabrication solution comprises polyethyelene oxide.
Gul meets the claimed, wherein the aqueous fabrication solution comprises polyethyelene oxide (Gul Table 4 discloses polyethylene oxide in the fiber composition.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the solutions for producing the nano-fiber wound dressings as disclosed in Melikoğlu with the polyethylene oxide wound dressing as disclosed in Melikoğlu because polyethylene oxide is a known material for use in wound dressings and treating bacterial species such as S. aureus and E. coli, see Gul Table 4.
Neither Melikoğlu nor Gul describe α-Tocopherol and wherein the total antioxidant capacity of the nanofiber is 350% to 400% higher than non-ionic nanofibers Analogous in the field of electrospinning wound dressings, Zahid meets the claimed, wherein the aqueous fabrication solution comprises α-Tocopherol (Zahid page 439 second column describes vitamin E in the form of α-tocopherol is used in an electrospinning composition for producing wound dressings). It would have been obvious to a person of ordinary skill in the art before the filing date to combine he composition of the fibers in Melikoğlu with the α-tocopherol described in Zahid in order to promote healing via protecting the membrane from peroxidation, see Zahid page 439 column 2.
Zahid does not explicitly meet the claimed, and wherein the total antioxidant capacity of the nanofiber is 350% to 400% higher than non-ionic nanofibers, however, Melikoğlu as modified by Gul and Zahid meet all the limitations of the structural and compositional elements of the claimed nanofiber. As per MPEP §2112.01(I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation has been established. The nanofibers described in Melikoğlu as modified by Gul and Zahid are both the same composition and made by the same method as claimed, therefore, they are presumed to have the same properties including the same hydration level in comparison to other non-ionic nanofibers.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Melikoğlu as modified by Gul as applied to claim 5 above and in further view of Santiago-Morales (“Antimicrobial activity of poly(vinyl alcohol)-poly(acrylic acid) electrospun nanofibers”, 2016, see NPL copy provided.)
Regarding claim 13, Melikoğlu does not meet the claimed, The quasi-permanent charge-bearing nanofiber of claim 5, wherein the nanofiber bears negative charge and the charge-bearing polymer in the aqueous fabrication solution comprises polyacrylic acid.
Analogous in the field of electrospinning fibers, Santiago-Morales also discloses electrospinning nanofibers for the purposes of producing antibacterial purposes such as wound dressings. Santiago-Morales meets the claimed, The quasi-permanent charge-bearing nanofiber of claim 4, wherein the nanofiber bears negative charge (Santiago-Morales page 145 Section 2.1 and page 146 section 3.1 describe the electrospun fibers as being negative) and the charge-bearing polymer in the aqueous fabrication solution comprises polyacrylic acid (Santiago-Morales page 145 Section 2.1 discloses the fibers are made from poly(acrylic acid).)
It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the charged polymers in Melikoğlu with the polyacrylic acid (which is anionic) and negatively charged fibers as described in Santiago-Morales because the it is generally accepted that negatively charged fibers reduce bio-adhesion and prevent bio-fouling from negatively charged bacteria, see Santiago-Morales page 148, third full paragraph. Separately, it is also obvious that negatively charged polymers are also capable of producing anti-fouling effects irrespective of the charge, see Santiago Morales page 149.
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 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.
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/V.B./ Examiner, Art Unit 1744
/EMMANUEL S LUK/ Primary Examiner, Art Unit 1744
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