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 .
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1,2,3,4,8,11,12,20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019/021325. WO2019/021325 teach the claimed process as evidenced at pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26.
1. An electrospinning method, comprising:
providing a composition to be electrospun (WO2019/021325: water solution; pg 8:6-pg 9:3);
providing an electrospinning device comprising an electrospinning head and a collector, between which there is applied an electric field (WO2019/021325: pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26); and
feeding said composition to be electrospun through said electrospinning head, so that the electric field applied induces the formation of an electrospun fiber to form a membrane substrate able to be absorbed by the skin (WO2019/021325: pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26; pg 11:2-5; pg 12:3-12; the continuous fiber can be formed into a membrane can be invaded and populated by cells, absorbs wound exudates, or releases antimicrobial agents to speed up healing of wounds);
wherein said composition to be electrospun comprises a first compound to be electrospun, an electrospinning promoter and an active ingredient, wherein said first compound to be electrospun comprises hyaluronic acid (WO2019/021325: hyaluronic acid is used as the glycosaminoglycan; pg 8:19-21); said electrospinning promoter is at least one selected from pullulan , a mixture of alginate and poly(oxyethylene) having a weight proportion equal to 1:1, and a mixture thereof (WO2019/021325: pullulan is used as the polysaccharide; pg 8:31-9:3), and said active ingredient is selected from cosmetic active ingredients, pharmaceutical active ingredients and/or nutritional active ingredients (WO2019/021325: chondroitin sulfate or antimicrobial agents; pg 2:1-11; pg 8:14-21; pg 12:3-12).
2. The method as in claim 1, wherein the electrospinning head comprises a delivery member which comprises at least one needle (WO2019/021325: pg 1:14-26).
3. The method as in claim1, wherein the electric field applied between the electrospinning head and the collector is equal to at least 5kV (WO2019/021325: pg 10:12-15).
4. The method as in claim1, wherein the electrospinning head and the collector are set in motion one relative to the other (WO2019/021325: pg 10:23-26).
8. The method as in claim1, wherein the first compound to be electrospun, the electrospinning promoter and the active ingredient are co-electrospun, that is, they are electrospun together (WO2019/021325: pg 8:6-18).
11. The method as in claim 2, wherein the electric field applied between the electrospinning head and the collector is equal to at least 5kV (WO2019/021325: pg 10:12-15).
12. The method as in claim 11, wherein the electrospinning head and the collector are set in motion one relative to the other (WO2019/021325: pg 10:23-26).
20. (Previously presented) The method as in claim 1, wherein the electrospinning promoter is pullulan (WO2019/021325: pg 8:31-pg 9:3).
22. (Previously presented) The method as in claim 1, wherein the composition to be electrospun comprises hyaluronic acid as first compound to be electrospun and pullulan as electrospinning promoter (WO2019/021325: pg 8:6-pg 9:3).
Claim(s) 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019/021325. WO2019/021325 teach the claimed process as evidenced at pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26.
Since the instant specification or claims do not clearly indicate what the basic and novel characteristics of the claimed invention are, the transition phrase “consisting essential of” has been construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). If an applicant contends that additional materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989).
25. (New) An electrospinning method, comprising:
providing a composition to be electrospun (WO2019/021325: water solution; pg 8:6-pg 9:3);
providing an electrospinning device comprising an electrospinning head and a collector, between which there is applied an electric field (WO2019/021325: pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26); and
feeding said composition to be electrospun through said electrospinning head, so that the electric field applied induces the formation of an electrospun fiber to form a membrane substrate able to be absorbed by the skin (WO2019/021325: pg 1:14-26; pg 8:6-pg 9:3; pg 10:12-14 and 23-26; pg 11:2-5; pg 12:3-12; the continuous fiber can be formed into a membrane can be invaded and populated by cells, absorbs wound exudates, or releases antimicrobial agents to speed up healing of wounds);
wherein said composition to be electrospun is an aqueous solution consisting essentially of water (WO2019/021325: water is used as the solvent; pg 8:5-18; examples using composition 1-7 recite dissolving all the components of the electrospun fiber in an aqueous solution), hyaluronic acid (WO2019/021325: hyaluronic acid is used as the glycosaminoglycan; pg 8:19-21), an electrospinning promoter (WO2019/021325: pullulan is used as the polysaccharide; pg 8:31-9:3), and, optionally, at least one active ingredient (WO2019/021325: chondroitin sulfate or antimicrobial agents; pg 2:1-11; pg 8:14-21; pg 12:3-12),
wherein said electrospinning promoter is pullulan (WO2019/021325: pullulan is used as the polysaccharide; pg 8:31-9:3), a mixture of alginate and poly(oxyethylene) having a weight proportion equal to 1:1, or a mixture thereof; andwherein said at least one active ingredient is selected from the group consisting of cosmetic active ingredients, pharmaceutical active ingredients and nutritional active ingredients (WO2019/021325: chondroitin sulfate or antimicrobial agents; pg 2:1-11; pg 8:14-21; pg 12:3-12).
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.
Claim(s) 5,9,10,13,16,17,18,21,23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/021325 as applied to claim 1 above. The above teachings of WO2019/021325 are incorporated hereinafter.
Regarding claim 5, WO2019/021325 does not teach an electric field oriented vertically from top to bottom. The specific orientation of an apparatus is a mere obvious matter of choice dependent on apparatus availability. Since vertical electric fields are well-known in the electrospinning art for its effectiveness, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to impart a vertical electric field in the electrospun apparatus of WO2019/021325 in order to efficiently form the nanofiber of WO2019/021325.
Regarding claim 9, WO2019/021325 do not teach subsequently adding the active ingredient to the co-electrospun first compound and promoter. Since it is well-known in the electrospinning art to add components subsequently in order to add the component to target areas of the fiber, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the active ingredient of WO2019/021325 subsequently to the co-electrospun first component and promoter of WO2019/021325 in order to add the active ingredient of WO2019/021325 at desired locations on the fiber.
Regarding claim 10, WO2019/021325 does not teach the claimed type of active ingredients. Since the use of a specific material is a mere obvious matter of choice dependent on material availability and desired final product, and the claimed active ingredients are well-known in the cutaneous wound healing art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the claimed active ingredient as part of the electrospun composition of WO2019/021325 in order to form a diverse fiber.
Regarding claim 13, WO2019/021325 does not teach an electric field oriented vertically from top to bottom. The specific orientation of an apparatus is a mere obvious matter of choice dependent on apparatus availability. Since vertical electric fields are well-known in the electrospinning art for its effectiveness, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to impart a vertical electric field in the electrospun apparatus of WO2019/021325 in order to efficiently form the nanofiber of WO2019/021325.
Regarding claim 16, such is taught by WO2019/021325 (WO2019/021325: pg 8:6-18)
Regarding claim 17, WO2019/021325 do not teach subsequently adding the active ingredient to the co-electrospun first compound and promoter. Since it is well-known in the electrospinning art to add components subsequently in order to add the component to target areas of the fiber, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the active ingredient of WO2019/021325 subsequently to the co-electrospun first component and promoter of WO2019/021325 in order to add the active ingredient of WO2019/021325 at desired locations on the fiber.
Regarding claim 18, WO2019/021325 does not teach the claimed type of active ingredients. Since the use of a specific material is a mere obvious matter of choice dependent on material availability and desired final product, and the claimed active ingredients are well-known in the cutaneous wound healing art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the claimed active ingredient as part of the electrospun composition of WO2019/021325 in order to form a diverse fiber.
Regarding claims 21 and 23-24, WO2019/021325 do not teach the claimed proportion between the first component and the promoter. Since the claimed proportion is a mere matter of choice dependent on the desired combination of the components and the desired proportion would have been obviously and readily determined through routine experimentation by one of ordinary skill in the art before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the first component and promoter of WO2019/021325 within the claimed proportion in order to achieve a fiber having desired combinability and properties.
Applicant’s arguments with respect to claim(s) 1-5,8-13,16-18,20-24 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues the instant claims require the “active ingredients” to be separate and distinct from the fiber-forming material. This argument is misplaced since the instant claim do not recite the argued limitation. Since the instant claims are open-ended, the use of a single component that can perform multiple functions is appropriate. However, it should be noted that WO2019/021325 also teaches using antimicrobial agents as “active ingredients” (pg 12:3-12).
Applicant argues WO2019/021325 does not teach a membrane substrate able to be absorbed by the skin since the membrane of WO2019/021325 is water-insoluble. This argument is misplaced since the continuous fiber of WO2019/021325 can be formed into a membrane that can be invaded and populated by cells, absorbs wound exudates, or releases antimicrobial agents to speed up healing of wounds. The fact that the membrane of WO2019/021325 is water-insoluble does not negate the fact that the membrane, as a whole, can be invaded/populated by the cells of a wound or the antimicrobial agents of the membrane can be absorbed by the wounds.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USP20100129656 and CA2396640 teach electrospinning using first compound, a promoter, and an active ingredient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDMUND H LEE whose telephone number is (571)272-1204. The examiner can normally be reached M-Th 9AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao (Sam) Zhao can be reached on 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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EHL
/EDMUND H LEE/Primary Examiner, Art Unit 1744