DETAILED OFFICIAL 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 .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2023/0312846, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Information Disclosure Statement
The information disclosure statements (IDS) filed 15 July 2025 and 14 August 2025 are in compliance with 37 CFR 1.97 and have been considered.
Response to Amendment
The Amendment filed 15 July 2025 in response to the Non-Final Rejection dated 17 April 2025 (hereinafter “NFOA”) has been entered. New claims 10-20 have been added – as such, claims 1-20 remain pending and are under consideration on the merits.
The rejections under 35 U.S.C. 103 previously set forth in the NFOA [id., ¶7-33] are maintained herein. New grounds of rejection are also set forth, necessitated by the additional of new claims 10-20.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fujiwara et al. (JP 2001-329130-A; “Fujiwara”) (previously cited).
Takafuji et al. (US 2016/0194465; “Takafuji”) (previously cited) is relied upon as an evidentiary reference in support of the rejection of claim 8.
Regarding claim 1, Fujiwara discloses a water-soluble film formed from a resin composition comprising polyvinyl alcohol (PVOH), plasticizer, starch, surfactant, and water (or other solvent), said film suitable for forming unit-dose packaging for chemicals and detergents [0001-0004, 0006, 0024, 0031-0032].
The PVOH (saponified vinyl acetate) may include 20 mol% or less, preferably 5 mol% or less of comonomer units such as, e.g. maleic acid and salts or esters thereof [0008-0009]; the degree of polymerization of the PVOH is from 300 to 10,000, preferably 500 to 8,000 [0012]; the degree of saponification is from 80-95 mol% to optimize, i.e. minimize dissolution time (in water, 20° C) of the film [0013, 0032, 0034].
Based on 100 parts (by weight) of the PVOH, the resin composition includes 5-30 parts of the plasticizer, 1-10 parts of the starch, and 0.01-2 parts of the surfactant [0006]; the solvent content, i.e. volatile content of the resin composition is 50-99 wt.%, preferably 65-90 wt.% [0027]. The plasticizer is, inter alia glycerin [0017-0018] (see MPEP 2131.02(II); MPEP 2144.07). The surfactant is a nonionic-type surfactant and may be, inter alia an alkanolamide type, e.g. lauric acid diethanolamide [0019-0020, 0040] (see MPEP 2131.02(II); MPEP 2144.07).
The film is suitably formed via casting of the resin composition onto a metal drum (i.e. roll) [0024-0025], the (metal) surface of which is at a temperature of from 80-110° C [0028]. The film suitably exhibits a thickness of from 10-100 µm [0029]. Fujiwara discloses exemplary films having thickness of 40 µm, wherein the PVOH exhibits 88 mol% saponification degree and a degree of polymerization of 1,700, and the resin composition (prior to film formation) exhibits a volatile content of 65-80 wt.% – the dissolution times of said exemplary films in water at 20° C are below 50 seconds [0034, 0038-0040].
Fujiwara is silent regarding the dissolution time of the water-soluble film in water at 10° C being 120 seconds or less, and silent regarding the abundance ratio of carbonyl bonds (relative to total carbon bonds, measured by XPS) on at least one side of the film being from 1-5% as claimed.
However, Applicant’s spec indicates that the exemplary water-soluble film (Example 1) is formed from a stock solution comprising 100 parts PVOH which exhibits a saponification degree of 88 mol% and a polymerization degree of 1,700 [0134]. The solution also includes 20 parts glycerin as plasticizer, and 0.05 parts of lauric acid diethanolamide as surfactant, with the balance being water, wherein the volatile content is 60 wt.% [0134]. The spec indicates that the addition of the appropriate surfactant to (the solution which is utilized to form) the water-soluble film, the carbonyl abundance ratio can be “set within a desired range”, i.e. obtained [0078-0079]. That is, the spec explicitly attributes the resultant abundance ratio of carbonyl to the type, and amount of surfactant [0078-0079, 0084-0086].
The spec also indicates that the drying conditions utilize to form the film constitute one of the methods for controlling the carbonyl abundance ratio [0098]. The spec indicates that the first drying roll (casting drum) is set to a temperature of 50-110° C, preferably 60-105° C [0100], wherein hot, humid air is blown on the non-contact surface of the film being cast onto the first drying roll, said air at a temperature of 50-150° C and a velocity of 1-10 m/s [0101]; additional drying rolls and subsequent heat treatment(s) may be utilized [0102-0103]. Additionally, see [0071] regarding the amount of plasticizer (1-70 phr) and [0086] regarding the amount of surfactant (0.01-10 phr) which is disclosed as suitable for formulating the stock solution utilized to form the water-soluble film; see [0089] regarding the film thickness (preferably 20-100 µm).
In view of the highlighted elements of Applicant’s spec set forth above, it is noted that the film of Fujiwara – as set forth/cited above (based on the general disclosure) – is substantially identical, or identical to Applicant’s disclosed water-soluble film in terms of: (i) the amount, saponification degree, and polymerization degree of the PVOH utilized in the composition; (ii) the amount and species (glycerin) of plasticizer; (iii) the amount and species (lauric acid diethanolamide) of surfactant which is explicitly attributed to the carbonyl abundance ratio; (iv) the amount of volatile content of the composition prior to film formation; (v) the film thickness; (vi) the process of film formation by casting onto a metal drum, and specifically at a drum surface temperature of 80-110° C, (vii) wherein the spec indicates that the carbonyl abundance ratio may be achieved by the amount and species of surfactant and implies that the specific drying conditions/heat treatment are not required to achieve said abundance ratio.
As such, there is a strong and reasonable expectation that the water-soluble film of Fujiwara – substantially identical or identical to the film disclosed in the spec as indicated hereinabove – would have necessarily exhibited a carbonyl abundance ratio of 1-5% and a dissolution time in water at 10° C of 120 seconds or less, as claimed, absent a showing of factually supported objective evidence to the contrary. In support of the foregoing, Applicant is respectfully directed to MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145 and 2145(I).
In view of the totality of the foregoing, the water-soluble film of Fujiwara above reads on the water-soluble film defined by the limitations of claim 1.
Regarding claims 2-3, in view of the grounds of rejection of claim 1 above, it is noted that the spec indicates that the ratio of the abundance ratio of C–C single bonds to the abundance ratio of carbonyl bonds (i.e. the ratio of C–C/C=O); the abundance ratio of C atoms; the abundance ratio of O atoms; and the ratio of the abundance ratio of C to the abundance ratio of O (i.e. the ratio of C/O) can all be adjusted/controlled by addition of the specific species and amount of surfactant [0078-0086; Table 1, Examples 1 and 5]. Given that the surfactant of the film of Fujiwara is identical to that which is disclosed in the spec, and given that the amount of surfactant disclosed by Fujiwara (0.01-2 phr) is within the range (0.01-10 phr) broadly specified [0086], overlaps the range (0.05-0.3 phr) specified as a preference [0086], and overlaps/encompasses the exemplary amounts (0.05 phr and 0.2 phr) reported [Table 1, Examples 1-5], there is a strong and reasonable expectation that the film(s) encompassed within the disclosure of Fujiwara would have necessarily exhibited the claimed ratio C–C/C=O of 10-50, the claimed abundance ratio of C of 50-70%, the claimed abundance ratio of O of 20-35%, and the claimed ratio of C/O of 1.5-3.5, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145 and 2145(I).
Regarding claim 6, the grounds of rejection of claim 1 above read on the package defined by claim 6 – that is, Fujiwara discloses forming a unit dose package from the water-soluble film, wherein e.g. chemicals, detergents, and pesticides are suitably packaged within said package [0002-0004, 0031-0032, 0049].
Regarding claim 7, the grounds of rejection of claim 6 above read on the package defined by claim 7.
Regarding claim 8, in view of the grounds of rejection of claim 6 above, it is noted that Fujiwara discloses that in addition to detergents and pesticides, “other alkaline solids” may be packaged within the package formed from the water-soluble film(s). Fujiwara does not explicitly disclose the aforesaid chemicals being in liquid form, but implies or reasonably encompasses that the chemicals may be in liquid form. In other words, one of ordinary skill in the art readily recognizes/would have readily recognized that said chemicals including detergents and pesticides, may suitably be in solid or liquid form within said package, i.e. that water-soluble packaging formed from films based on PVOH are suitably used to disperse/dissolve either or both of liquids and solids in water upon dissolution of the film, as evidenced by Takafuji [id., 0053].
Regarding claim 9, in view of the grounds of rejection of claim 6 and of claim 1 above, Fujiwara is silent regarding the package being configured such that the surface of the film exhibiting the abundance ratio of carbonyl bonds is that which is in contact with the chemical within the package. However, the spec discloses that one or both sides (surfaces) of the water-soluble film may exhibit the aforesaid ratio [0032]; further, the spec indicates/implies that both surfaces may exhibit the aforesaid ratio in the absence of surface treatment (e.g. corona discharge) and therefore as a result of inclusion of the species and particular amount of surfactant [0050-0051, 0079-0086; Table 1]. As such, in the absence of a sufficient showing of factually supported objective evidence to the contrary, there is a strong and reasonable expectation that both surfaces of the water-soluble film of Fujiwara would have necessarily exhibited the carbonyl bond abundance ratio of 1-5% as claimed, and therefore at least one of said surfaces would have necessarily been that which defines the internal surface(s) of the interior compartment of the package (unit dose package, e.g. bag) in which the chemical is disposed. Applicant is respectfully directed to MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145 and MPEP 2145(I).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fujiwara as applied to claim 1 above, further in view of Gruber et al. (US 5,484,881; “Gruber”) and/or Menozzi et al. (US 2022/0204711; “Menozzi”) (both references previously cited).
Regarding claims 4-5, the grounds of rejection of claim 1 above which detail the water-soluble film of Fujiwara are incorporated herein by reference.
Fujiwara is silent regarding treatment of the surface(s) of the film by any of ultraviolet, ozone, corona, and plasma treatment(s).
However, Fujiwara recognizes/desires that the film exhibit blocking resistance (i.e. resistance to sticking to itself) [0003-0004, 0018, 0020, 0028]. In light thereof, Fujiwara teaches that the blocking resistance may be improved by embossing or roll-matting the film surface, or by (powder coating) application of silica or starch to the film surface [0030]. Thus, Fujiwara does not explicitly teach/recognize any of ultraviolet, ozone, corona, or plasma treatment(s) for improving the blocking resistance of the film.
Gruber is directed to compostable/biodegradable films which are based on poly(lactide) and are suitable for use in packaging applications, including, e.g. shrink wrap films, agricultural/mulch films, and bags, wherein the film may be formulated such that it is based on polyvinyl alcohol predominantly by weight (up to 95 wt.% PVOH relative to 5 wt.% poly(lactide)) [col. 1 ln. 14-18, 40-58; col. 2 ln. 13-15; col. 5 ln. 53-56; col. 6 ln. 7-16; col. 7 ln. 1-18]. Gruber teaches that the surface treatments such as corona and flame treatments reduce blocking of the film, wherein said surface treatments are explicitly recognized for preventing blocking/sticking of the film in addition/alternative to use of fillers/silica [col. 13 ln. 66–col. 14 ln. 16].
One of ordinary skill in the art readily recognizes that increased surface energy results in reduction of blocking, i.e. that undesirable “sticking” of the films is resultant from or directly related to low surface energy.
Menozzi teaches that it is well-known to subject polymeric substrates to surface treatments including plasma, corona, and flame treatment(s), in order to change the surface topology and increase the surface energy/wettability thereof [0020-0033]. Such treatment(s) allow for control/alternation of the chemical moieties present at the surface, including formation of carbonyl (C=O) groups within a requisite amount [0020-0033].
Gruber and Menozzi each constitute prior art which is directly analogous the claimed invention; Gruber seeks to reduce blocking of films which may be based predominantly by weight on PVOH, and Menozzi is directed to increasing the surface energy of polymeric films.
In view of the teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have modified the water-soluble film of Fujiwara by subjecting one or both surfaces thereof to a plasma, corona, or flame surface treatment in order to reduce/prevent blocking of the film (as explicitly desired by Fujiwara) – as an alternative or in addition to the methods/compounds disclosed therein (e.g. powder coating and/or embossing). Applicant is respectfully directed to MPEP 2144.06(I) and (II) in support of the aforesaid modification.
In view of the grounds of rejection of claim 1 above and the modification hereinabove, the aforesaid treatment(s) conducted on one or both surfaces of the water-soluble film would have necessarily corresponded to, and/or resulted in, the surface(s) which exhibits/exhibiting the carbonyl abundance ratio as claimed. The corona and plasma treatment(s) read on the corresponding species recited in claim 5.
Claims 11-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fujiwara.
Regarding claim 11, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated for sake of brevity) and read on the water-soluble film defined by claim 11 as dependent upon claim 1. As set forth above, Fujiwara discloses that the PVOH exhibits a degree of saponification of 80-95 mol%, and exemplifies films formed from 88 mol% saponified PVOH [0013, 0040]. The disclosed saponification range of 80-95 mol% is within the claimed range of 64-99.99 mol%.
Regarding claim 12, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated) and read on the water-soluble film defined by claim 12 as dependent upon claim 1. As set forth above, Fujiwara discloses that the PVOH may include 5 mol% or less of (modifying) comonomer units [0009], of which encompasses 0 mol% comonomer modification, i.e. unmodified, partially-saponified PVOH. Fujiwara also exemplifies films formed from unmodified PVOH [0040], i.e. PVOH which does not include comonomer units, i.e. partially- or fully-saponified polyvinyl acetate.
Regarding claim 13, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated) and read on the water-soluble film defined by claim 13 as dependent upon claim 1. As set forth above, the water-soluble film of Fujiwara (in accordance with the general disclosure) is formed from the resin composition which contains a single PVOH resin; the exemplified films are also formed from resin compositions containing a single PVOH resin [0008-0013, 0034, 0038-0040].
Regarding claim 15, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated) and read on the water-soluble film defined by claim 15 as dependent upon claim 1. As set forth above, the water-soluble film of Fujiwara is formed from the resin composition which includes a nonionic surfactant that is, inter alia lauric acid diethanolamide [0006, 0019-0020, 0040]. The aforesaid surfactant is a dialkanolamide (diethanolamide) of an aliphatic dicarboxylic acid (lauric acid), in accordance with claim 15 and Applicant’s spec [0081, 0134]
Regarding claim 16, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated) and read on the water-soluble film defined by claim 16 as dependent upon claim 1.
It is noted that claim 16 constitutes a product-by-process claim. Applicant is respectfully directed to MPEP 2113(I) and (II) – even 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. Further, the structure implied by the process steps should be considered when assessing patentability, in particular where the product can only be defined by the process steps by which it is made or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
In view of the aforecited MPEP sections, the water-soluble film of Fujiwara is formed by a substantially identical or identical process (see [¶12, 15-16] above) to that which is claimed and disclosed in the spec, inclusive of casting the resin composition (in the form of a stock solution) onto a drying roll, of which is at a surface temperature of 80-110° C (within lower bound of, and borders upper bound of claimed range 50-110° C). Thus, the water-soluble film of Fujiwara would have necessarily exhibited the properties defined by claim 1, absent a showing of factually supported objective evidence to the contrary – see [¶16-17] above. See MPEP 2113(I) and (II); MPEP 2112(V); MPEP 2112.01(I) and (II); and MPEP 2145 and 2145(I).
Regarding claims 17-20, the grounds of rejection of claim 16 above are incorporated herein by reference. Claims 17-20 are directly or ultimately dependent upon claim 16, wherein as stated above, claim 16 constitutes a product-by-process claim. Further, each of claims 17-20 recite limitations directed to the process steps/conditions which are utilized to form the claimed water-soluble film and thereby also constitute product-by-process claims. Thus, as set forth in the grounds of rejection of claim 1 and incorporated into the grounds of rejection of claim 16 above, the water-soluble film of Fujiwara (substantially identical to that which is claimed and disclosed) would have necessarily exhibited the abundance ratio of carbonyl groups (1-5%) and dissolution time in water (120 seconds or less), absent a showing of factually supported objective evidence to the contrary, i.e. objective evidence supporting that the film of Fujiwara would not have exhibited the claimed carbonyl abundance ratio and dissolution time in the absence of the process steps defined by claims 17-20 – see MPEP sections cited above, [¶41].
In view of the foregoing, it is noted that the comparative examples provided in the spec, e.g. Comparative Example 4 [spec, 0143; Table 1] do not provide sufficient evidence demonstrating that the film forming stock solution – inclusive of the PVOH resin and parameters thereof, inclusive of the specific surfactant and amount thereof, and inclusive of the additional additives in amount(s) thereof in accordance with the disclosure of Fujiwara – when subject only to drying on a (first) drying roll at the claimed temperature (claim 16) and not subject to any of the additional processing/drying steps (claims 17-20) (i.e. the scope of the disclosure/teachings of Fujiwara), does not exhibit the claimed carbonyl abundance ratio and dissolution time when formed into a film at said conditions (see MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2113(I) and (II); and MPEP 2145 and 2145(I)).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fujiwara, in view of Friedrich et al. (US 2019/0211289; “Friedrich”) (newly cited).
Regarding claim 10, the grounds of rejection of claim 1 above, specifically [¶7-18], are incorporated herein by reference (not repeated for sake of brevity). As stated, Fujiwara discloses that the PVOH may include 5.0 mol% or less of a comonomer, of which may be, inter alia an ester of maleic acid [0009]. Fujiwara is silent regarding the aforesaid maleic acid ester comonomer being methyl maleate as defined in claim 10. It is noted that claim 10 encompasses both dimethyl maleate and monomethyl maleate.
Friedrich is directed to water-soluble films formed from PVOH-based resin compositions, wherein said films are formed into pouches for containing chemical agents or compositions thereof [Abstract; 0002-0003, 0008-0009, 0020, 0023, 0040-0067, 0070-0071]. Friedrich teaches that the resin composition includes an anionic monomer-modified PVOH [0086-0088], wherein the anionic monomer is suitably a monoalkyl or dialkyl maleate (ester of maleic acid), preferably monomethyl maleate, in an amount of about 1 mol% to about 5 mol% relative to 100 mol% total monomeric units forming the PVOH [0088, 0090, 0092, 0106-0107, 0322; Table 2]. The anionic monomer unit, preferably monomethyl maleate, allows for adjustment of the solubility and tackiness/sealability of the PVOH and resultant film [0091].
Fujiwara and Friedrich each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the water-soluble film of Fujiwara (as set forth in the grounds of rejection of claim 1 and incorporated hereinabove by reference) by utilizing monomethyl maleate as the comonomer unit of the PVOH of the resin composition in an amount of 5.0 mol% or less (in accordance with Fujiwara), as monomethyl maleate would have been readily recognized as a suitable ester of maleic acid intended for use as the comonomer unit forming modified PVOH in water-soluble film packaging applications, e.g. packaging of chemicals or compositions in water-soluble films/pouches formed from modified PVOH-based resin compositions. See MPEP 2144.07 – the selection of a known material based on its suitability for its intended use has been held prima facie obvious.
In accordance with the aforesaid modification, the PVOH of the water-soluble film of Fujiwara (hereinafter “modified Fujiwara”) – exhibiting all of the features/elements as set forth above in the grounds of rejection of claim 1 – would have been a PVOH copolymer comprising 5 mol% or less of maleic acid ester comonomer, said comonomer being monomethyl maleate. The water-soluble film of modified Fujiwara reads on the water-soluble film defined by claim 10 as dependent upon claim 1.
Claims 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Takafuji.
Regarding claims 11 and 13-15, Takafuji discloses a water-soluble film suitable for use in forming unit-dose packages for chemicals [Abstract; 0001, 0006-0009, 0052-0053], said film having a thickness of 1-100 µm [0039] and being formed from a resin composition comprising modified PVOH (100 parts by mass) [0009, 0011-0013]; a plasticizer that is preferably glycerin (40 parts or less) [0030-0031]; and a nonionic surfactant that is, inter alia lauric acid diethanolamide (0.01-5 parts) [0044-0046] (see MPEP 2131.02(II); MPEP 2144.07).The resin composition (and resultant film) does not require the presence of starch [0032]; the films exemplified therein do not include starch [0061-0062; Table 1].
The modified PVOH comprises 0.1-30 mol% of a comonomer including a 1,3-diol structure [0009, 0011-0012; Chemical Formula (1)], wherein said modified PVOH may be obtained by copolymerizing a vinyl ester monomer, e.g. vinyl acetate and an unsaturated monomer which can be converted to said 1,3-diol structure, followed by saponification to convert vinyl acetate to vinyl alcohol and the unsaturated monomer to the 1,3-diol structure-containing unit, wherein said unsaturated monomer is preferably 1,3-diacetoxy-2-methylenepropane [0009, 0011-0013, 0016-0020, 0024, 0061; Chemical Formula (2), R = methyl group], i.e. 2-methylenepropane-1,3-diyl diacetate, i.e. 2-(acetoxymethyl)allyl acetate. Further, the polymerization degree of the modified PVOH is 100-7,000 [0014]; the degree of saponification is from 80 to 99.99 mol% [0015]; and the PVOH can include additional monomeric units, e.g. esters of maleic acid [0027-0028].
The water-soluble film is formed by casting a film-forming solution inclusive of the resin composition onto a first heated roller (i.e. drum), followed by drying the film on the outer surface of one or more additional heated rollers to cause the volatile components to evaporate and/or by passing the film through a hot-air drier [0043, 0049-0050]; the heated-roller drying and hot-air drying are suitably combined [0050]. The first heated roller suitably exhibits a temperature of 80° C, and the subsequent heat treatment (drying) is suitably conducted at 100 °C for 10 min [0061]. The volatile content of the film-forming solution is preferably 50-95% by mass [0043]. The films exemplified by Takafuji exhibit dissolution times of less than 50 seconds [0059, 0061-0062; Table 1, Examples 1-4].
In view of the foregoing, it is noted that [¶14-15] above regarding the film-forming stock solution composition and process of forming the water-soluble film set forth in Applicant’s spec are incorporated herein by reference.
The water-soluble film of Takafuji is substantially identical or identical to Applicant’s disclosed water-soluble film in terms of: (i) the amount, saponification degree, and polymerization degree of the PVOH utilized in the composition; (ii) the amount and species of plasticizer; (iii) the amount and species of surfactant, of which is explicitly attributed to the carbonyl abundance ratio; (iv) the amount of volatile content of the composition prior to film formation; (v) the film thickness; (vi) the process of film formation by casting onto a heated roller, and specifically at a temperature of 80° C, (vii) wherein the spec indicates that the carbonyl abundance ratio may be achieved by the amount and species of surfactant and implies that the specific drying conditions/heat treatment are not required to achieve said abundance ratio.
As such, there is a strong and reasonable expectation that the (substantially identical/identical) water-soluble film of Takafuji, as set forth above, would have necessarily exhibited a carbonyl abundance ratio of 1-5% and a dissolution time in water at 10° C of 120 seconds or less, as claimed, absent a showing of factually supported objective evidence to the contrary. Applicant is respectfully directed to MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145 and 2145(I); and MPEP 2113(I) and (II).
In view of the totality of the foregoing, the water-soluble film of Takafuji above reads on the water-soluble film defined by each of claims 11 and 13-15, each of which are dependent upon claim 1 – that is, reads on the film defined by claims 1 and 11, claims 1 and 13, claims 1 and 14, and claims 1 and 15. The saponification degree is within the claimed range (claim 11); the film is formed from one type of PVOH (claim 13); the film does not contain starch (claim 14); and the nonionic surfactant included in the film is lauric acid diethanolamide (claim 15).
Claims 11-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hamada et al. (CN 104662071; “Hamada”) (previously cited – see [NFOA, ¶34]; copy previously provided) (newly relied upon).
Regarding claims 11-15, Hamada discloses a film [0148 – Example 1] formed from a film-forming stock solution comprising: 100 parts by mass PVOH homopolymer (saponified vinyl acetate) exhibiting a saponification degree of 99.9 mol% and 2,400 polymerization degree; 12 parts glycerin (plasticizer) [0077-0078]; 0.1 parts lauric acid diethanolamide [0079-0083]; and water, said stock solution exhibiting a volatile content of 66 wt.% [0148].
The film is formed by roller casting utilizing 20 drying rollers – the first roller (onto which the film-forming stock solution is cast) has a surface temperature of 93° C [0149], and hot air (90° C, dew point temperature of 10° C) is evenly blown onto the non-contact surface of the film as it is wound thereon at a speed of 5 m/s [0149]. The use of the subsequent rollers reduces the volatile content of the film to a final volatile content of 3 wt.% [0148-0149]; the resultant film exhibits a thickness of 75 µm [0148]. The temperature of the subsequent rollers (after the first roller) is from about 85-90° C [0148-0150].
In view of the foregoing, it is noted that [¶14-15] above regarding the film-forming stock solution composition and process of forming the water-soluble film set forth in Applicant’s spec are incorporated herein by reference.
The film of Hamada is substantially identical or identical to Applicant’s disclosed water-soluble film in terms of: (i) the amount, saponification degree, and polymerization degree of the PVOH utilized in the composition; (ii) the amount and species of plasticizer; (iii) the amount and species of surfactant, of which is explicitly attributed to the carbonyl abundance ratio; (iv) the amount of volatile content of the film-forming composition prior to film formation; (v) the film thickness; (vi) the process of film formation by casting onto a heated roller, and specifically at a temperature of 80° C, (vii) wherein the spec indicates that the carbonyl abundance ratio may be achieved by the amount and species of surfactant and implies that the specific drying conditions/heat treatment are not required to achieve said abundance ratio.
As such, there is a strong and reasonable expectation that the (substantially identical/identical) film of Hamada, as set forth above, would have necessarily exhibited a carbonyl abundance ratio of 1-5% and a dissolution time in water at 10° C of 120 seconds or less (thus, would have been a water-soluble film), as claimed, absent a showing of factually supported objective evidence to the contrary. Applicant is respectfully directed to MPEP 2112(V); MPEP 2112.01(I) and (II); MPEP 2145 and 2145(I); and MPEP 2113(I) and (II).
In view of the totality of the foregoing, the film of Hamada above reads on the water-soluble film defined by each of claims 11-15, each of which are dependent upon claim 1 – that is, reads on the film defined by claims 1 and 11, claims 1 and 12, claims 1 and 13, claims 1 and 14, and claims 1 and 15. The saponification degree is within the claimed range (claim 11); the PVOH is not modified with any additional comonomer(s) (claim 12); the film is formed from one type of PVOH (claim 13); the film does not contain starch (claim 14); and the nonionic surfactant included in the film is lauric acid diethanolamide (claim 15).
Regarding claims 16-17 and 19-20, it is noted that the analysis (product-by-process claims) set forth above at [¶39-42] is incorporated herein by reference (not repeated for sake of brevity). In view thereof, it is noted that the (film formation) casting process disclosed by Hamada as set forth/cited above in the grounds of rejection of claims 11-15 (as dependent upon claim 1) reads on the process limitations of each of claims 16, 17, 19, and 20. That is, the temperature of the first drying roller onto which the film-forming solution is cast is 93° C, which is within the range defined by claim 16; hot air at a temperature of 90° C is blown onto the non-contact surface side of the film being wound onto the first roller (i.e. the side of the film not in contact with the first roller surface) at a velocity of 5 m/s, wherein said velocity is within the range (1-10 m/s) defined by claim 17; the films is brought into contact with at least a second drying roller after the first drying roller (claim 19); and the second drying roller is at a temperature of about 85-90° C, which is within the range (40-110° C) defined by claim 20.
Response to Arguments
Applicant’s arguments presented on pp. 5-6 of the Remarks filed 15 July 2025 (hereinafter “Remarks”) have been fully considered by the Examiner but not found persuasive.
On p. 5 of the Remarks, Applicant asserts that the water-soluble film of Fujiwara would not inherently (i.e. necessarily) exhibit the claimed abundance ratio and water dissolution time, as the compositions of Fujiwara can include an alkyl ether-type surfactant such as polyoxyethylene lauryl ether [0019], wherein films formed therefrom do not exhibit said ratio and dissolution time as evidenced by Comparative Example 2 of the spec. Applicant also asserts that the examples in Fujiwara include the alkyl ether-type surfactant, and therefore would not have suggested to one of ordinary skill in the art to have selected lauric acid diethanolamide from the list of surfactants disclosed by Fujiwara [id., 0019].
However, Fujiwara explicitly teaches, via water-soluble film Example 3 [0040], that the nonionic alkanolamide-type surfactant [0019] is suitably, inter alia lauric acid diethanolamide. As such, based on the general disclosure of Fujiwara at [0019] of alkanolamide-type surfactants, and in particular diethanolamides, the use of lauric acid diethanolamide in film Example 3 as nonionic alkanolamide-type surfactant constitutes a direct and specific teaching that the aforesaid species is a suitable alkanolamide-type surfactant for the use intended in accordance with the general disclosure at [0019]. Applicant is respectfully directed to MPEP 2131.02(II) and MPEP 2144.07.
Moreover, Applicant’s has not provided any objective evidence or factually-supported technical reasoning that the water-soluble film of Fujiwara, as set forth in the grounds of rejection which establish the prima facie case of obviousness, would not exhibit the claimed dissolution time and abundance ratio. Applicant is respectfully directed to MPEP 2145 – “arguments presented by Applicant cannot take the place of factually supported objective evidence”. Further, see MPEP 2145(I) – “Arguments presented by Applicant cannot take the place of evidence in the record”. Furthermore, see MPEP 2112.01(I), which states: “When the PTO shows a sound basis for believing that the products of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not” – the prima facie case can be rebutted by evidence showing that the prior art product does not necessarily possess the characteristics of the claimed product. In view of the foregoing, Applicant has not met the burden to successfully rebut the prima facie case of obviousness established in the grounds of rejection.
For the reasons above, Applicants assertions identified above have not been found persuasive.
On p. 6 of the Remarks, Applicant asserts that the type of surfactant does not necessarily determine whether the claimed carbonyl abundance ratio and water dissolution time are exhibited by the water-soluble film, citing to Comparative Example 4 of the spec [0143; Table 1] which included lauric acid diethanolamide as surfactant, but was not dried by hot air having a water content of 4-90 g/m3, and therefore exhibited a carbonyl abundance ratio of 0.8, i.e. outside of the claimed range. Thus, Applicant asserts that the process of Fujiwara is not substantially identical to the process disclosed.
However, while the Examiner agrees that Fujiwara does not disclose the aforesaid drying step with hot air at the specified water content, Fujiwara [0028, 0040] does disclose/exemplify roller drying the film at a temperature range (80-110° C, e.g. 105° C) which is within the range (50-110° C) disclosed and recited in (new) claim 16 [spec, 0100].
In view thereof, it is noted (1) that Comparative Example 4 is not analogous to the water-soluble film of Fujiwara as set forth in the grounds of rejection, as Comparative Example 4 was subject to a first drying temperature (temperature of the first drying roll) of 115° C, of which is greater than the upper bound of the claimed/disclosed range (110° C), and greater than the upper bound of the temperature range disclosed by Fujiwara. Further, the spec (2) explicitly indicates that the carbonyl abundance ratio may be adjusted by the type and amount of surfactant utilized in the film-forming composition [0079, 0084], wherein the (adjustment of) drying conditions are explicitly indicated as an additional method for controlling the abundance ratio [0098] – “adjusting the drying conditions during film formation is also one of the methods for controlling the abundance ratio of C=O on the film surface”. In view of the aforesaid (1) and (2), it is noted that the (3) data presented in the spec does not include any examples utilizing “Surfactant A” where (i) the drying temperature is within the claimed/disclosed range and (ii) the amount of water content in the hot air is below the lower bound of the disclosed range (4 g/m3), of which would constitute at least some degree of evidence in support of nonobviousness. As an additional note, the spec does not provide any examples where the drying temperature of the first roller is greater or lesser than 100° C, and in combination therewith or distinct therefrom, any examples where the water content is greater or lesser than 24.9 g/m3 – that is, every example provided other than Comparative Example 4 is subject to the combination of the first drying roller temperature of 100° C and blown hot air water content of 24.9 g/m3.
For these reasons above, the data relied upon in the spec does not constitute objective evidence to rebut the prima facie case of obviousness established, and Applicant’s assertions have not been found persuasive.
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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782