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 .
Election/Restrictions
Claims 1-6 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/24/25. The traversal is based on Applicant’s belief that there would not be a serious burden on the Examiner if a restriction requirement was not made. Applicant requests reconsideration and withdrawal of the restriction requirement (See Remarks, page 6).
Applicant’s traversal and request have been fully considered but found unconvincing. The restriction is proper because the claims of Groups I and II are distinct from claims of Group II (claims 7-15) in that they are of a different statutory class of claims, contain different limitations and would require different search and considerations. For example, claim 1, 3 and 19 are directed to a material comprising a ferroelectric polymer, i.e. polylactic acid, while the method of preparation in claims 7 and 8 require specific process steps that not required for claims 1, 3 and 19, or any of claims belonging to Group I. Claims of Group III are directed to a method of regulating an antimicrobial activity comprising an antimicrobial material.
The no-elected claims may be considered for rejoinder at the time claims 7-15 may be found allowable.
The restriction is proper and made final. Claims 7-15 are under examination on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is indefinite for reciting “preparing a precursor material from a ferroelectric polymer and optionally and inorganic ferroelectric particle and/or an inorganic pore-forming agent. This is indefinite because according to the Specification and claim 15, zinc oxide and calcium carbonate are both inorganic particles and inorganic pore-forming agents. Thus, the claim scope is indefinite as it is not clear how the method step comprises adding two zinc oxides or two calcium carbonates.
Claim 7 is also indefinite fore reciting preparing a precursor material from a ferroelectric polymer. That is, in one embodiment of the claimed method there is no inorganic particle and inorganic pore-forming agent, as they are optional. Thus, in the embodiment that they are not present, the ferroelectric polymer is the only component in the precursor material and thus it is not clear how it is prepared.
Claim 8 is indefinite because it comprises two embodiments, one with and one without the addition of inorganic particle and inorganic pore-forming agent. In step (1), the polymer may be combined with the inorganic particle and inorganic pore-forming agent to form a polymer mixture. Thus, in the embodiment that there is no inorganic particle and inorganic pore-forming agent, it is not clear how a polymer mixture is transferred.
Claim 8 is also indefinite because in step (2), the polymer (mixture) is transferred to an electrospinning syringe (for electrospinning), but there is no actual step of electrospinning.
Claim 8 recites the limitation "subjecting a membrane formed after completion of spinning" in step (3). There is insufficient antecedent basis for this limitation in the claim. There is no step of spinning or forming a membrane in step (2). Thus, the said limitations in step (3) lack any support.
Claim 12 is indefinite for reciting that the acidic solution has a mass percent concentration of from 1% to 50%. This is indefinite because it is not recited or clear what the basis for this percentage range is. That is, is it the concentration of acid in the aqueous solution, or the concentration of acid solution in the medical material or else.
Claim 13 is indefinite for reciting the term “preferably” in lines 2 and 4. The term preferably renders the claim scope indianite as it is not clear if the recitation after “preferably” is required or optional.
Claim 14 recites the limitation "a ferroelectric ceramic particle" in the method of claim 7. There is insufficient antecedent basis for this limitation in the claim. Claim 7 does not recite a ferroelectric ceramic particle.
Remaining claims are rejected for depending on rejected claim 7.
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.
Claims 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over CN 112870391 (recitations from the English translation attached).
CN ‘391 teach a ferroelectric antibacterial material and a preparation method and application thereof.
Regarding claim 7, CN ‘391 teaches an antibacterial material comprising a base layer subjected to polarization treatment. The ferroelectric-based composite material is a composite material including the ferroelectric material as a matrix (See abstract and claim 1).
The said polymer matrix is subjected to polarization treatment, annealing treatment and acid treatment (second solvent) (See page 3, middle of the page and claim 10).
Regarding the 2nd embodiment of claim 7, the polymer matrix is combined with an inorganic material such as barium titanate, potassium niobate, lithium niobate, lithium tantalate, bismuth titanate, etc, (See page 2, last 5 paragraphs).
Regarding claims 7, 8 and 13, the said ferroelectric polymer is subjected to ultrasonic treatment, wherein the frequency of the ultrasonic wave is 20 kHz-200 MHz, and the power density is 1 W/cm2-1 kW/cm2 (See page 4, lines 1-7).
Regarding claim 8, CN ‘391 discloses a method for preparing the ferroelectric antibacterial material, when the ferroelectric antibacterial material contains a ferroelectric polymer, the method includes the following steps: dispersing and/or dissolving a ferroelectric material or a ferroelectric-based composite material in a first solvent, coating the first solvent on a substrate, drying to obtain a ferroelectric material or a ferroelectric-based composite material layer, and carrying out polarization treatment on the ferroelectric material or the ferroelectric-based composite material layer to obtain a base layer of the ferroelectric material or the ferroelectric-based composite material; when the ferroelectric antibacterial material contains at least one of an inorganic ferroelectric material or a non-ferroelectric material, the method further comprises adding a second solvent into the ferroelectric material or the ferroelectric-based composite material for wet grinding, then carrying out hot-pressing treatment, finally annealing to obtain the ferroelectric material or the ferroelectric-based composite material layer, and carrying out polarization treatment on the ferroelectric material or the ferroelectric-based composite material layer to obtain the base layer of the ferroelectric material or the ferroelectric-based composite material (See page 2).
The said ferroelectric polymer includes polyvinylidene fluoride and its copolymers, polyvinylidene fluoride-trifluoroethylene copolymer, polyvinylidene fluoride Ethylene-tetrafluoroethylene copolymer, etc, (See page 2).
Regarding claim 14, CN ‘391 discloses a method of preparation comprising the steps recited in claim 7 and wherein a ferroelectric ceramic plate is used and subjected to corona polarization, annealing and wherein the ferroelectric polymer may be combined with a second solvent (acid treatment) (See Examples 3 and 6).
Regarding claims 7-8 and 10, CN ‘391 discloses that the said ferroelectric antibacterial material, wherein the ferroelectric-based composite material further comprises a non-ferroelectric material, and the non-ferroelectric material comprises a photothermal material; Preferably, the ultrasonically dispersing 1% by mass of 100nm barium titanate particles in dimethyl sulfoxide, dissolving 10% by mass of polyvinylidene fluoride-trifluoroethylene (PVDF-TrFE) copolymer in the dispersion liquid, taking 5mL of mixed solution to cast on a clean 2-inch silicon wafer, drying at 80 ℃ for 12h, and then taking down the PVDF-TrFE composite membrane from the silicon wafer. Placing on a metal base plate, adopting 26kV high-voltage corona polarization, and polarizing the PVDF-TrFE composite film to obtain a piezoelectric coefficient d33Is 24 pC/N (See Example 4).
CN ‘262 teaches a preparation method of a chemically strengthened pore-forming high-flux polyvinylidene fluoride hollow fiber ultrafiltration membrane. The method includes the steps of: stirring and mixing polyvinylidene fluoride (Pvdf), solvents, additives, and chemical porogens to prepare a homogeneous casting solution; extruding the casting solution and core solution from the spinneret, and gel membrane formation in a bath; gel phase inversion and chemical post-treatment on the membrane to prepare a high-flux polyvinylidene fluoride hollow fiber ultrafiltration membrane. The said method results in preparing the polyvinylidene fluoride ultrafiltration membrane with high flux, high strength, high rejection rate and good hydrophilicity (See abstract).
Regarding 2nd embodiment in claims 7-8, 9, 14 and 15, CN ‘262 teaches that said pore-forming agent is calcium carbonate (See page 2 and page 3, 6th para).
Regarding acid treatment in claims 7-8, 12, 14 and 15, CN ‘262 teaches that
the inorganic carbonate calcium particulate is added, in post processing to hydrochloric acid. Acid and CaCO3 can part stripping, and be controlled according to the acid-treated time, and result in improved film strength (See middle of page 3).
Regarding claims 8 and 15, CN ‘262 teaches a preparation method for the polyvinylidene fluoride hollow fiber ultrafiltration porous membrane comprising the following steps: 1) preparation of casting solution: by Kynoar, chemical pore-foaming agent, solvent and additive blended under agitation for 12-36 h at the temperature of 20-80 ℃, standing and defoaming for 12-24 h under 20-80 ℃ of constant temperature to obtain a homogeneous casting solution; 2) spinning hollow fiber film thread: utilize dry-jet wet-spinning silk equipment under the spinning speed of setting, core liquid is injected to spinning head according to the core liquid measure of setting together with homogeneous casting solution, and extrude from spinning head together, make Pvdf microporous hollow fiber membrane silk; 3) phase-splitting processing: by step 2) the Pvdf microporous hollow fiber membrane silk is gained after the dry journey of 1-30 cm, enter successively the first coagulation bath and the second coagulation bath carries out gel phase conversion, film surface skin stratification pore-foaming agent is carried out to chemical pretreatment, form the polyvinylidene fluoride hollow fiber ultrafiltration membrane with micropore canals; 4) post processing: by the polyvinylidene fluoride hollow fiber ultrafiltration membrane with micropore canals after wire wrapping wheel is received silk; in chemical pretreatment solution at a certain temperature, complete chemical enhanced pore; after chemistry pore, to thering is polyvinylidene fluoride hollow fiber ultrafiltration membrane soaking and washing in water of micropore canals, to complete phase-splitting, obtain high-throughout polyvinylidene fluoride hollow fiber ultrafiltration membrane, and be immersed in the glycerine and the dodecyl sodium sulfate of 0.1-0.5wt% and the protection liquid of water composition that contains 10-30 wt% (See Page 2, last line to page 3, 4th para).
Regarding claim 12, it is disclosed that chemical pretreatment solution is the hydrochloric acid solution of 0.1-1 mol/L, and its temperature is 20-40 °C, and the soak time of film silk in chemical pretreatment solution is 1-12 h (See page 3, 5th para and claim 5).
CN ‘205 teach a powered tissue repair film and preparation method thereof containing the compound of the inclined fluorine trifluoro-ethylene of ferroelectricity polyphosphazene polymer vinylidene, ferroelectricity polyphosphazene polymer or both, which can be applied to surgical operation repair materials field (See Abstract).
Ferroelectric polymers include polyvinylidene fluoride, PVDF), poly- partially fluoro- trifluoro-ethylene (P (VDF-TrFE)), etc, (See Page 2, 4th para).
Regarding claims 7-8, 10 and 11, CN ‘205 teaches that the said preparation method comprises the following steps(1) polymer is added to the solvent, stirred for 3h~8h until completely dissolved wherein the polymer solution is obtained, (2) step (1) resulting solution is dried at a temperature of 40 ˚C~100 ˚C, solvent is volatilized completely, the tissue repair membrane material is obtained with a thickness is 1 μm~200 μm, (3) membrane material obtained by the step (2) is passed through into polarization process, polarization parameter includes polarizing voltage is 1kV~30kV, and polarization distance is 0 mm~50 mm, and poling temperature is 25 ˚C ~150 ˚C, and the polarization time is 1 min ~60 min (See page 2, 12th para).
Regarding claim 15, CN ‘205 teach es that “piezoelectric activity bone-repairing composite material as obtained by above step contains polymer P (VDF-TrFE) and polymer PLLA, it is film-like material, and thickness is 70 μm, and polymer P (VDF-TrFE) and polymer P LLA are in composite film material mass content is respectively 50%”. (Piezoelectric activity is the same as electroactivity) (See Page 3, Embodiments 3 and 4).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of CN ‘205 and CN 262 with that of CN ‘391 to arrive at the instant invention. It would have been obvious to do so because all three references disclose methods of preparing a medical membrane/material from a ferroelectric polymer with or without an inorganic particle/agent and/or an inorganic pore-forming agent. Thus, it would have been obvious to one of ordinary skill in the art to evaluate the process steps disclosed by the references and determine the steps and features that may prepare the optimum product. CN ‘262 teach the addition of a pore-forming agent to the ferroelectric polymer to make a porous, high-flux and strong membrane with good hydrophilicity. Thus, one of ordinary skill in the art would have been motivated to include the pore-forming agent of CN ‘262 into the process and polymer material taught by CN ‘391. CN ‘391 teaches the method of making the said medical material by polarization. CN ‘205 teach the advantages of the polarization method features. Thus, it would have been obvious to one of ordinary skill in the art to have incorporated the said features into the method of Cn ‘391 with a reasonable expectation of success.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Regarding the ranges such as temperature ranges or concentration ranges, it is noted that one of ordinary skill in the art is capable of optimizing ranges to arrive at the desired product or method. The courts have held that “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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lukiev et al (Antibacterial ferroelectric hybrid membranes fabricated via electrospinning for wound healing).
Lukiev et al teach a wound healing ferroelectric membrane doped with zinc oxide nanoparticles fabricated from vinylidene fluride-tetrafluoroethylene copolymer and polyvinlylpyrrolidone using electrospinning technique (See abstract).
Claims 7-15 are rejected. Claims 1-6 and 16-20 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616