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 .
Information Disclosure Statement
The information disclosure statement filed September 6, 2024 has been received. Note the acknowledged PTO-1449 form enclosed herewith.
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.
Claim(s) 1-4, 7, 11, 13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009022761 A1 (“Yoo”) in view of JP 2012057275 A (“Hiroshi”).
Regarding claim 1, Yoo discloses a dissolvable nano web porous film and a method of preparing the same that substantially discloses Applicant’s claimed invention. More specifically, Yoo discloses a composition to be electrospun (see para. [0049]-[0050] which discloses a composition for nano web porous film and para. [0108] which discloses formation of nano web porous film by electrospinning), comprising a first compound to be electrospun selected from xanthan gum, pectins, chitin, chitosan, dextran, carrageenan, guar gum, agar, cellulose derivatives, albumin, starch, gelatin, collagen, elastin, 3-glucans, glycosaminoglycans, mucopolysaccharides, water-soluble polysaccharides and their derivatives (see para. [0053], which at least discloses xanthan gum and a mixture of two or more materials identified in para. [0053]); and an electrospinning promoter selected from alginate, pullulan and a mixture thereof (note the disclosure of alginate and pullulan in para. [0053]); wherein the composition also comprises a surfactant (see para. 0071)]).
Yoo fails to disclose the surfactant is of biological and organic origin obtained by fermentation of gram positive microorganisms. However, Hiroshi in the disclosure of an analogous electrospun web teaches it is known to use surfactants having lipopeptide structure, typified by surfactin, in the formation of fibers in order to improve processibility (see the abstract and the second paragraph of page 2). Further disclosed is that surfactin is usually produced by prokaryotes such as Bacillus subtilis (see page 3; further it is inherent that Bacillus subtilis is gram positive).
In view of Hiroshi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected surfactin as the surfactant used in the fibers of the web of Yoo because of its processability and reduces irritation to the skin (see the Abstract of Hiroshi).
While Hiroshi does not explicitly state the surfactin is produced by fermentation, Applicant is reminded that product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In the instant case, the Office contends that the surfactin is fully capable of being produced by fermentation absent evidence to the contrary.
Regarding claim 2, modified Yoo discloses the composition as in claim 1, wherein said surfactant is a lipopeptide obtained by Bacillus sp (note the rejection of claim 1 above).
Regarding claim 3, modified Yoo discloses the composition as in claim 2, wherein said surfactant is selected from Surfactins, Pumilacidins and Lichenysins (see the rejection of claim 1 above).
Regarding claim 4, modified Yoo discloses the composition as in claim 1, wherein the additives (which can be a surfactant) are provided up to 40 wt%, and preferably, in the range of 0.01~40 wt%, to the total weight of the final film; the additives do not have a lower limit in content, but should be added in a content of 0.01 wt% or more with respect to the final film so as to exhibit its properties by the addition (see para. [73]).
Modified Yoo fails to disclose the surfactant is concentrated at 0.1-5% by weight of the total weight of said composition. It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected an amount of surfactant in the composition to be between the range of 0.01-40% by weight, including 0.1-5 % by weight, in order to exhibit its properties by the addition.
Regarding claim 7, modified Yoo discloses the composition as in claim 1 except wherein the weight ratio between said first compound to be electrospun and said electrospinning promoter is comprised between 2:1 and 1:2. However, modified Yoo discloses in para. [0053] that the nano fiber forming polymer (A) is added in an amount of 1~99 wt%, and preferably, of about 15~80 wt%, to the composition of the nano web porous film. It must be noted that the first compound and the promoter may be a mixture of the polymer material identified in para. [0053]).
It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
In the instant case, the claimed weight ratio between said first compound to be electrospun and said electrospinning promoter of between 2:1 and 1:2 is within claimed weight range of 1~99 wt% when a mixed polymer A are selected.
It would have been obvious to one having ordinary skill in the art to have selected mixed nano fiber forming polymer A, i.e., the first component and the promoter, in a weight ratio between 2:1 and 1:2 in order to achieve the predictable result developing desired specific physical properties of the fibers.
Regarding claim 11, modified Yoo discloses the method as in claim 8 except wherein the method provides to mix said first compound to be electrospun, said promoter and said surfactant in respective separate aliquots of water and subsequently to combine said aliquots of water.
Instead, modified Yoo discloses a polymer solution can be produced by the following process: dissolving or dispersing (A) a nano web film forming polymer in a solvent in an amount of about 1.5-4.5 times the total amount of the polymer at room temperature or a certain temperature, adding (B) a gelling agent and (C) a plasticizer thereto, followed by dissolving them, and dissolving and dispersing (D) an active component and (E) additives as necessary. Here, water is generally used as a solvent (see para. [0079]).
It would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to have dissolved the additional components separately in water and subsequently combining all the components, in order to make sure the entire amount of the components for preparing the nanofibers are dissolved for incorporation into the fibers.
Regarding claim 13, Yoo discloses a patch product (constituted a nonwoven web porous film dissolved by fluid secreted secrete from the skin, see para. [0044]) comprising a membrane substrate absorbable by the skin, wherein said membrane substrate is formed by at least one electrospun fiber (the polymer melt or solution is spun into nano fibers, and the fibers are stacked, thereby producing a nano web porous film in a network structure, see para. [0074]) based on a first compound (selected from A) to be electrospun, an electrospinning promoter (selected from A, it must be noted that the nano fiber forming polymer can be any components from A and mixtures thereof, the electrospinning promoters can be selected components of A) and a surfactant (see para. [0071]), wherein said first compound to be electrospun is selected from xanthan gum, pectins, chitin, chitosan, dextran, carrageenan, guar gum, agar, cellulose derivatives, albumin, starch, gelatin, collagen, elastin, 3-glucans, glycosaminoglycans, mucopolysaccharides, water-soluble polysaccharides and their derivatives (see para. [0053], which at least discloses xanthan gum), said electrospinning promoter is selected from alginate, pullulan and a mixture thereof (note the disclosure of alginate and pullulan in para. [0053]).
Yoo fails to disclose the surfactant is of biological and organic origin obtained by fermentation of gram positive microorganisms. However, Hiroshi in the disclosure of an analogous electrospun web teaches it is known to use surfactants having lipopeptide structure, typified by surfactin, in the formation of fibers in order to improve processibility (see the abstract and the second paragraph of page 2). Further disclosed is that surfactin is usually produced by prokaryotes such as Bacillus subtilis (see page 3; further it is inherent that Bacillus subtilis is gram positive).
In view of Hiroshi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected surfactin as the surfactant used in the fibers of the web of Yoo because of its processability and reduces irritation to the skin (see the Abstract of Hiroshi).
While Hiroshi does not explicitly state the surfactin is produced by fermentation, Applicant is reminded that product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In the instant case, the Office contends that the surfacing is fully capable of being produced by fermentation absent evidence to the contrary.
Regarding claim 15, modified Yoo discloses the patch product as in claim 13 or 14, wherein said surfactant is a lipopeptide obtained by Bacillus sp (see the rejection of claim 13 above).
Regarding claim 16, modified Yoo discloses the patch product as in claim 15, wherein said surfactant is selected from Surfactins, Pumilacidins and Lichenysins (see the rejection of claim 13 above).
Regarding claim 17, modified Yoo discloses the composition as in claim 2, wherein the additives (which can be a surfactant) are provided up to 40 wt %, and preferably, in the range of 0.01-40 wt %, to the total weight of the final film; the additives do not have a lower limit in content, but should be added in a content of 0.01 wt % or more with respect to the final film so as to exhibit its properties by the addition (see para. [73]).
Modified Yoo fails to disclose the surfactant is concentrated at 0.1-5 % by weight of the total weight of said composition. It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
There, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected an amount of surfactant in the composition be between the range of 0.01-40 % by weight, including 0.1-5 % by weight, in order to so as to exhibit its properties by the addition.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi as applied to claim 1 and further in view of WO 2009/149308 A2 (“Levinson”).
Regarding claim 5, modified Yoo discloses the composition as in claim 1 except wherein the composition has a pH comprised between 6 and 7. However, Levinson in the disclosure an analogous electrospun composition (see page 30, lines 17-25) teaches it is known to use a buffer to control the pH of a composition. Levinson further teaches preferably, the buffers buffer the composition from a pH of about 4 to a pH of about 7.5, more preferably from a pH of about 4 to a pH of about 7, and most preferably from a pH of about 5 to a pH of about 7 (see page 22, lines 32-34).
In view of Levinson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used a buffer to control the pH of the composition such that the composition has a pH between 6 and 7 in order to ensure biocompatibility with the skin of a user and avoid irritation thereof.
Regarding claim 6, modified Yoo discloses the composition as in claim 5, except wherein the composition comprises the basic compound at a concentration lower than 2% by weight of the total weight of said composition.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected the buffer in an amount less than 2% by weight in order to temper the composition such that it is non-acidic to be biocompatible.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi as applied to claim 8 and further in view of Levinson.
Regarding claim 12, modified Yoo discloses the method as in claim 8 wherein the method provides to mix, together with said first compound to be electrospun, said electrospinning promoter and said surfactant (see para. [0049]-[0071] and [0078], which discloses the components are mixed). Modified Yoo fails to disclose a basic compound so as to maintain the pH of the mixture between 6 and 7.
However, Levinson in the disclosure an analogous electrospun composition (see page 30, lines 17-25) teaches it is known to use a buffer to control the pH of a composition. Levinson further teaches preferably, the buffers buffer the composition from a pH of about 4 to a pH of about 7.5, more preferably from a pH of about 4 to a pH of about 7, and most preferably from a pH of about 5 to a pH of about 7 (see page 22, lines 32-34).
In view of Levinson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used a buffer to control the pH of the composition such that the composition has a pH between 6 and 7 in order to ensure biocompatibility with the skin of a user and avoid irritation thereof.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi as applied to claim 2 and further in view of Levinson.
Regarding claim 18, modified Yoo discloses the composition as in claim 2 except wherein the composition has a pH comprised between 6 and 7. However, Levinson in the disclosure an analogous electrospun composition (see page 30, lines 17-25) teaches it is known to use a buffer to control the pH of a composition. Levinson further teaches preferably, the buffers buffer the composition from a pH of about 4 to a pH of about 7.5, more preferably from a pH of about 4 to a pH of about 7, and most preferably from a pH of about 5 to a pH of about 7 (see page 22, lines 32-34).
In view of Levinson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used a buffer to control the pH of the composition such that the composition has a pH between 6 and 7 in order to ensure biocompatibility with the skin of a user and avoid irritation thereof.
Claim(s) 8-10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi and EP 0 463 393 A2 (“Carrera”).
Regarding claim 8, Yoo discloses method to prepare a composition to be electrospun (see para. [0049]-[0050] which discloses a composition for nano web porous film and para. [0108] which discloses formation of nano web porous film by electrospinning; thereby disclosing a method to prepare a composition), comprising a step of mixing (components A, B, C, D and E) are mixed together to form the composition for the nano porous web film (see para. [0049]-[0071] and [0078]) a first compound to be electrospun with an electrospinning promoter and a surfactant (see para. 0071)]), wherein said first compound to be electrospun is selected from xanthan gum, pectins, chitin, chitosan, dextran, carrageenan, guar gum, agar, cellulose derivatives, albumin, starch, gelatin, collagen, elastin, 3-glucans, glycosaminoglycans, mucopolysaccharides, water-soluble polysaccharides and their derivatives (see para. [0053], which at least discloses xanthan gum), said electrospinning promoter is selected from alginate, pullulan and a mixture thereof (note the disclosure of alginate and pullulan in para. [0053]).
Yoo fails to disclose said surfactant is of biological and organic origin obtained by fermentation of gram positive microorganisms. However, Hiroshi in the disclosure of an analogous electrospun web teaches it is known to use surfactants having lipopeptide structure, typified by surfactin, in the formation of fibers in order to improve processibility (see the abstract and the second paragraph of page 2). Further disclosed is that surfactin is usually produced by prokaryotes such as Bacillus subtilis (see page 3; further it is inherent that Bacillus subtilis is gram positive).
In view of Hiroshi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have selected surfactin as the surfactant used in the fibers of the web of Yoo because of its processability and reduces irritation to the skin (see the Abstract of Hiroshi).
The combination of Yoo and Hiroshi fails to disclose the surfactin is obtained by fermentation. However, Carrera discloses a method of producing surfactins comprising growing Bacillus subtilis, fermenting it, separating and purifying the surfacing.
Because both Hiroshi and Carrera teach methods for obtaining surfactins, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one method for the other to achieve the predictable result of obtaining surfactins from Bacillus subtilis for use in the method of Yoo.
Regarding claim 9, modified Yoo discloses the method as in claim 8, wherein said surfactant is a lipopeptide obtained by Bacillus sp (see the rejection of claim 8).
Regarding claim 10, modified Yoo discloses the method as in claim 9, wherein said surfactant is selected from Surfactins, Pumilacidins and Lichenysins (see the rejection of claim 8 above).
Regarding claim 19, modified Yoo discloses the method as in claim 9 except wherein the method provides to mix said first compound to be electrospun, said promoter and said surfactant in respective separate aliquots of water and subsequently to combine said aliquots of water.
Instead, modified Yoo discloses a polymer solution can be produced by the following process: dissolving or dispersing (A) a nano web film forming polymer in a solvent in an amount of about 1.5-4.5 times the total amount of the polymer at room temperature or a certain temperature, adding (B) a gelling agent and (C) a plasticizer thereto, followed by dissolving them, and dissolving and dispersing (D) an active component and (E) additives as necessary. Here, water is generally used as a solvent (see para. [0079]).
It would have been obvious to one having ordinary skill in the art before the filing date of the claimed invention to have dissolved the additional components separately in water and subsequently combining all the components, in order to make sure the entire amount of the components for preparing the nanofibers are dissolved for incorporation into the fibers.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi as applied to claim 13 above, and further in view of U.S. Patent Application Publication No. 2006/0085063 (“Shastri et al.”)
Regarding claim 14, modified Yoo discloses the patch product as in claim 13, except wherein said at least one electrospun fiber has the shape of a flat ribbon.
However, Shastri et al. in the disclosure of analogous electrospun polymer fibers teaches it is known to use electrospinning for form fibers having a range of fiber morphologies ranging from common circular cross-sections, to varying amounts of porosity, to flat, ribbon-like polymer fibers.
In view of Shastri et al., it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have electrospun fibers in the shape of a flat ribbon in order to provide increased surface area compared to compared to circular shaped fibers, thereby providing a greater surface area for treatment.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo in view of Hiroshi and Carrera as applied to claim 9 and further in view of Levinson.
Regarding claim 20, modified Yoo discloses the method as in claim 9, wherein the method provides to mix, together with said first compound to be electrospun, said electrospinning promoter and said surfactant (see para. [0049]-[0071] and [0078], which discloses the components are mixed). Modified Yoo fails to disclose a basic compound so as to maintain the pH of the mixture between 6 and 7.
However, Levinson in the disclosure an analogous electrospun composition (see page 30, lines 17-25) teaches it is known to use a buffer, such as the base triethanolamine, to control the pH of a composition. Levinson further teaches preferably, the buffers buffer the composition from a pH of about 4 to a pH of about 7.5, more preferably from a pH of about 4 to a pH of about 7, and most preferably from a pH of about 5 to a pH of about 7 (see page 22, lines 32-34).
In view of Levinson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used a buffer to control the pH of the composition such that the composition has a pH between 6 and 7 in order to ensure biocompatibility with the skin of a user and avoid irritation thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786
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