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 .
Claim Objections
Claim 1 is objected to because of the following informalities: “micrometres” on line 7 should read “micrometers”. Appropriate correction is required.
Claims 2-13 are objected to because of the following informalities: “A water-soluble film” (emphasis added) should read “The water-soluble film”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “polysaccharid” on line 3 should read “polysaccharide”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “chitsoan” on line 2 should read “chitosan”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “the” or “said” should be inserted before “film” on line 3. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: on line 2, “film of to” should read “film to” deleting “of”; on line 6, “the” after “wherein” should be deleted; and on line 13, “micrometres” should read “micrometers”. Appropriate correction is required.
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 1-15 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. Independent claims 1 and 15 recite the limitation "the backbone" in lines 6 and 12, respectively. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 2-14 do not remedy the above and hence are indefinite for the same reason.
Claim 6 is (further) 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. Regarding claim 6, the phrase “e.g.” on line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is also noted that “the sugar units” limitation lacks clear antecedent basis.
Claim 8 is (further) 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 8 recites the limitation "the degree of amidation (DA)" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is 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 10 recites, “wherein the film comprises polyvinyl alcohol (PVOH) at a maximum level of 50%wt %wt based on total dry weight of the film” (emphasis added), however, given the “%wt %wt” recitation, it is unclear as to what the second “%wt” refers.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-6, 9-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miyai (JP4594732, please refer to the attached machine translation for the below cited sections). Miyai discloses a heat-sealable, water-soluble polysaccharide film suitable for packaging foods, cosmetics, pharmaceutics, and chemicals in the form of solids, powders, granules, tablets, etc., providing a packaged product in a packaged state such that the package, e.g., sealed bag or pouch, will dissolve and the contents released (e.g., “water-soluble capsule” as in instant claim 14; Page 2, and paragraph bridging Pages 11-12), wherein the water-soluble polysaccharide film “contains one or more water-soluble polysaccharides that do not have sulfate groups, one or more water-soluble polysaccharides that have sulfate groups, and one or more hydroxy compounds as humidity regulating materials” (paragraph bridging Pages 3-4). Miyai discloses that the water-soluble polysaccharides having no sulfate group used in the invention “are all edible polysaccharides, such as pullulan, elsinan, sodium alginate, agar, pectin, tamarind gum, xanthan gum, guar gum, tara gum, locust bean gum, arabinogalactan, gum arabic, chitosan, amylose, amylopectin, and dextran” (Page 4, lines 1-3), wherein among these, polysaccharides having maltotriose as a repeating unit, namely pullulan or elsinan, are preferred, with pullulan being particularly preferred, taken alone or in combination with one or more water-soluble polysaccharides other than pullulan that do not have sulfate groups (Page 4, lines 4-8). Miyai discloses that, if necessary, polysaccharides having maltotriose as a repeating unit that has been derivatized by modification such as esterification to any degree of substitution can also be used (reading upon “one or more functional groups comprising one or more…carboxylate group”); and that the weight-average molecular weight of the polysaccharide having maltotriose as a repeating unit used in the invention is usually 5,000 Daltons or more, preferably 10,000 to 1,000,000 Daltons, more preferably 50,000 to 500,000 Daltons, wherein the “weight-average molecular weight and molecular weight distribution of polysaccharides having maltotriose as a repeating unit are factors that determine the dissolution rate of the film, so polysaccharides having maltotriose as a repeating unit with appropriate weight average molecular weight and molecular weight distribution can be used depending on the application” (paragraph bridging Pages 4-5). More specifically, Miyai discloses that “[a]lthough it depends on the other ingredients to be blended, generally, if the weight-average molecular weight of the polysaccharide having maltotriose as a repeating unit is less than 10,000 daltons, film formation becomes difficult, and if it exceeds 1,000,000 daltons, the dissolution rate in an aqueous solvent becomes too low, which may be undesirable” (Page 5, lines 4-7).
Miyai discloses that the water-soluble polysaccharide having a sulfate group used in the invention is not particularly limited as long as it is a water-soluble polysaccharide having a sulfate group, wherein in order for the water-soluble film to fully exert its effects, it is preferable for the film to have 0.5 or more sulfate groups per constituent monosaccharide, and more preferably one or more sulfate groups per constituent monosaccharide, with examples thereof including natural polysaccharides such as carrageenan, chondroitin sulfate, heparan sulfate, deltamann sulfate, and heparin, all of which are edible polysaccharides, or salts thereof, or water-soluble polysaccharides that do not originally have sulfate groups or have less than 0.5 sulfate groups per constituent monosaccharide and are sulfated by an appropriate method (Page 5). Miyai discloses that carrageenan (as in instant claim 9) is preferably used because it is readily available and is excellent in imparting physical properties such as strength and flexibility to the film (last two lines of Page 5); and that any commercially available product of the five known types of carrageenan as listed in Table 1, which includes the type of sugar and the number and position of sulfate groups, may be utilized, although given that κ-carrageenan, with 0.5 sulfate groups per constituent monosaccharide, is excellent at improving the strength of the film, while λ- and ι-carrageenan, both with 1 sulfate group per constituent monosaccharide, are excellent at improving the water retention and flexibility of the film, it is preferred that the film contain a combination of various types of carrageenan (Page 6; reading upon the claimed “one or more functional groups comprising one or more of a sulfate” as in instant claim 1, particularly as at least one and no more than 5 of said functional groups per repeating unit as in instant claims 4-5, respectively, with respect to λ- and ι-carrageenan, and also reading upon “said functional groups are linked by ester bonds to sugar moieties, e.g. to hydroxyl groups of the sugar units of the polysaccharides” as in instant claim 6; and wherein it is also noted that the above carrageenan does not having any branching side chains comprising four or more units present at more than one side chain for every four units of the backbone as in instant claim 1).
Miyai discloses that the “dissolution rate [of the water-soluble film] in an aqueous medium can be controlled by appropriately selecting the thickness, size and other shapes of the film, the weight-average molecular weight of the water-soluble polysaccharide, the molecular weight distribution of the water-soluble polysaccharide, the ratio of various water-soluble polysaccharides, and the mixing ratio of various hydroxy compounds, taking into consideration the type, amount and temperature of the solvent, the strength of stirring, the water content of the film at the time of dissolution, etc.” (paragraph bridging Pages 8-9). Miyai discloses that the thickness of the water-soluble film may be determined depending on the application, but is usually selected from the range of 1 µm to 100 µm (substantially overlapped with the instantly claimed thickness range), preferably 10 µm to 50 µm (overlapping the claimed thickness range of 40 to 200 micrometers; Page 9, lines 10-12), with data points at 30 µm (Examples). Miyai specifically discloses various example water-soluble films having a thickness of 30 µm (Examples), formed from water-soluble polysaccharide mixtures comprising κ-, λ-, and/or ι-carrageenan(s) commercially available under the tradenames “GENUGEL” or “GENUVISCO” (known to inherently have a weight average molecular weight Mw within the claimed 100K-1000K g/mol, contain a sulfate group, and do not contain a branching chain comprising four or more units, as evidenced by the attached Wikipedia.org article entitled “Carrageenan” and/or JP2016079172A, Paragraph 0013 for the claimed Mw, see attached machine translation; and/or JP2018199220A, see attached machine translation, Comparative Example 3 for the claimed Mw given that a 0.5% viscosity of 21 mPa·s is about 400-500 kDa, e.g., as in instant claim 3), and hence, the Examiner takes the position that Miyai discloses the claimed invention with sufficient specificity to anticipate instant claims 1, 3-6, 9, and 14.
With respect to instant claim 10, the water-soluble films of the working examples disclosed by Miyai do not include any PVOH, thereby anticipating instant claim 10.
With respect to instant claims 11-12, Miyai discloses that the one or more hydroxy compounds as humidity regulating materials or humidity-conditioning materials include(s) those as recited in the paragraph bridging pages 6-7, wherein of those listed, it is preferably to contain glycerin (reading upon the claimed “plasticizer” as in instant claim 11), and further preferable to also contain sorbitol (also reading upon the claimed “plasticizer” of instant claim 11), and which may also be blended with lipids to reduce stickiness of the film, such as lecithin and palm oil, sugar fatty acids such as sucrose stearate, glycerin fatty acid esters, and other fatty acid esters; with various carrageenan-containing working examples specifically including a combination of sorbitol, sucrose stearate, and glycerin (Samples 1-3, 5, etc. of Experiment 1) as well as a working example including carrageenan, glycerin fatty acid ester (reading upon the claimed “surfactant” of instant claim 12), sorbitol, sucrose stearate, and glycerin (Page 24). Hence, Miyai anticipates instant claims 11-12.
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.
Alternatively, claims 1, 3-6, 9-12, and 14, as well as claims 2, 7-8, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Miyai (JP4594732), as applied to claims 1, 3-6, 9-12, and 14 above and further discussed below.
With respect to instant claims 1, 3-6, 9-12, and 14, although the Examiner is of the position that the reference is anticipatory for the reasons discussed in detail above, and particularly in light of the thickness range taught by Miyai of 1 µm to 100 µm, preferably 10 µm to 50 µm, with the 30 µm thick exemplified films taught by Miyai comprising a polysaccharide reading upon the instantly claimed polysaccharide and additive limitations as recited in instant claims 1, 3-6, 9-12, and 14, the Examiner alternatively takes the position that the claimed invention as recited in instant claims 1, 3-6, 9-12, and 14 would have been obvious over the teachings of Miyai given that that one having ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to provide the exemplified films in any thickness within the range taught by Miyai, and wherein it is well established that a prima facie case of obviousness exists where the claimed ranges overlap ranges disclosed by the prior art.
Further, with respect to instant claims 1-6 and 9, although Miyai specifically utilizes commercially available carrageenan polysaccharides having sulfate groups and high molecular weights in the working examples reading upon the claimed weight average molecular weight ranges as recited in instant claims 1 and 3, and the claimed functional groups as in instant claims 4-6 as well as the claimed carrageenan of instant claim 9, as discussed in detail above, Miyai also clearly teaches that the polysaccharides having maltotriose as a repeating unit and no sulfate groups may be derivatized by modification such as esterification to any degree of substitution, thereby reading upon and/or rendering obvious the claimed carboxylate group(s) as recited in instant claim 1 and functional groups as in instant claims 4-6; and that the weight-average molecular weight of the polysaccharides having maltotriose as a repeating unit is preferably 10,000 to 1,000,000 Daltons (encompassing the claimed ranges as recited in instant claims 1-3), more preferably 50,000 to 500,000 Daltons (overlapping the claimed ranges as recited in instant claims 1 and 3 and encompassing the claimed range as recited in instant claim 2), wherein the molecular weight is a factor that determines the dissolution rate of the film as discussed above (see also Miyai, paragraph bridging Pages 4-5), and below 10,000 Daltons, film formation becomes difficult, while if it exceeds 1,000,000 Daltons, the dissolution rate in an aqueous solvent becomes too low (Page 5), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize any of the polysaccharides having no sulfate group as taught by Miyai and/or any of the polysaccharides having a sulfate group as taught by Miyai, in a weight average molecular weight falling within the preferred range(s) as taught by Miyai. Hence, the claimed invention as recited in instant claims 1-6 and 9 would have been further obvious over the teachings of Miyai given that it is prima facie obviousness to choose from a finite number of identified, predictable solutions, with a reasonable expectation of success.
With respect to instant claims 7-8, as noted above, Miyai teaches that the polysaccharide may be derivatized by modification and to any degree of substitution, and given that amidation is an obvious modification or derivatization in the art similar to esterification and that Miyai teaches that suitable polysaccharides include chitosan which is a polysaccharide comprising amino groups, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize any known derivatization, such as amidation, and any degree of substitution for the polysaccharides having no sulfate group in the invention taught by Miya such that absent any clear showing of criticality and/or unexpected results, the claimed invention as recited in instant claims 7-8 would have been obvious over the teachings of Miyai.
With respect to instant claim 10, it is again noted that Miyai does not include PVOH in the example films and given that Miyai also does not teach the incorporation of PVOH into the film throughout the description of the invention wherein a zero wt% would read upon “at a maximum level of 50%wt %wt”, the claimed invention as recited in instant claim 10 would have been obvious over the teachings of Miyai (regardless of the meaning of “%wt %wt”).
With respect to instant claims 11-13, as noted above, Miyai specifically teaches examples utilizing glycerin and sorbitol as humidity-conditioning materials, reading upon the broadly claimed plasticizer of instant claim 11, as well as glycerin fatty acid ester reading upon the broadly claimed surfactant of instant claim 12, and given that one having ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to utilize any of the humidity-conditioning materials taught by Miyai and/or any of the other additives including lipids as taught by Miyai as well as flavorings as recited on page 8, wherein a “bittering agent” is an obvious species of adverse “flavoring” in the art, particularly when utilizing the water-soluble film for detergents (as evidenced by Labeque, US2017/0298216A1, Paragraphs 0113 and 0117) or other non-edible products as taught by Miyai (Page 15), the Examiner takes the position that the claimed invention as recited in instant claims 11-13 would have been obvious over the teachings of Miyai given that it is prima facie obviousness to combine prior art elements according to known methods to yield predictable results.
With respect to instant claims 14-15, it is again noted that Miyai clearly teaches that the water-soluble polysaccharide film may be used for packaging foods, cosmetics, pharmaceutics, and chemicals in the form of solids, powders, granules, tablets, etc., providing a packaged product such that the package, e.g., sealed bag or pouch, will dissolve and the contents released, with example products listed on page 15 including laundry agents such as detergents (“home care composition”), and although Miyai clearly teaches and/or suggests that the water-soluble polysaccharide film (reading upon the water-soluble polysaccharide film as recited in instant claim 1 as discussed above and thus similarly the film(s) as recited in instant claim 15) may be provided as a water-soluble “capsule” formed from two heat-sealed films and having at least one internal compartment enclosed by the water-soluble film(s) wherein the compartment has an internal space and contains a “home care composition” within the internal space as evidenced by the examples of Miyai, as in instant claim 14 (see particularly Pages 21-22), Miyai does not teach that the water-soluble package is formed wherein the first film is thermoformed to provide a thermoformed recess which is filled with the home care composition prior to sealing with the second film superposed thereon as in instant claim 15. However, given that such water-soluble capsules or pouches, particularly detergent capsules/pouches, are known to be produced by a thermoforming process as instantly claimed utilizing two films with the first film being thermoformed to form a recess and the second film being sealed thereon around edge regions as in instant claim 15 (as evidenced by Denome, US2011/0186468A1, Entire document, particularly Abstract, Paragraphs 0059-0090; or Modliszewski, USPN 7,807,194 B2, cited on IDS dated 1/15/2025, Cols. 11-13, Examples; or Miracle, US2019/0292496A1, Entire document, particularly Abstract, Paragraphs 0001, 0042-0043, 0126, Examples; or Jennewin, US2010/0305020A1, Entire document, particularly Paragraphs 0024-0047), the Examiner takes the position that the claimed invention as in instant claim 14 as well as instant claim 15 would have been obvious over the teachings of Miyai given that it is prima facie obviousness to combine prior art elements according to known methods to yield predictable results.
Claims 1-2, 6, and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Labeque (US2017/0298216A1). Labeque teaches a water-soluble film and water-soluble pouches formed from the water-soluble film and comprising a household care composition such as a detergent (“home care composition”) enclosed by the water-soluble film in at least one compartment (“capsule” as in instant claim 14) formed by shaping the film such as by thermoforming as instant claim 15 (Entire document, particularly Abstract, Paragraphs 0011-0048 and 0177-0179). Labeque teaches that the water-soluble film is formed from a water-soluble PVOH blend of first and second POVH polymers that may further include one or more other water-soluble polymers such as water-soluble natural polymers as recited in Paragraph 0109 including but not limited to, guar gum, xanthan gum, and carrageenan (e.g., a polysaccharide comprising one or more functional groups comprising one or more sulfate groups, and not comprising a branching side chain comprising four or more units of more than one such side chain for every four units of the backbone as recited in instant claims 1 and 15, wherein said sulfate groups are linked by ester bonds to sugar moieties, e.g., to hydroxyl groups of the sugar units of the polysaccharide” as in instant claim 6, and particularly carrageenan as in instant claim 9; Paragraphs 0086 and 0108-0109), wherein the viscosity of the water-soluble polymers including the PVOH polymers and the other water-soluble polymers (e.g., carrageenan) is as recited in Paragraph 0111, and given that the viscosity of a water-soluble polymer (PVOH or otherwise) is correlated with the weight-average molecular weight Mw of the same polymer such that viscosity is often used as a proxy for Mw, Labeque teaches that the weight-average molecular weight of the water-soluble polymers can be in a range of about 30,000 to about 175,000, overlapping the claimed Mw range as recited in instant claims 1-2 and 15, and hence rendering the claimed polysaccharide having (i) a weight average molecular weight and (ii) functional groups as in instant claims 1-2 and 15 obvious over the teachings of Labeque (Paragraphs 0111-0112) given that it is prima facie obviousness to choose from a finite number of identified, predictable solutions, with a reasonable expectation of success, wherein a prima facie case of obviousness exists where the claimed ranges overlap with ranges disclosed by the prior art. Labeque also teaches that the film can have any suitable thickness, wherein for example, the film can have a thickness in a range of about 5 µm to about 200 µm (fully encompassing the claimed thickness range), or in a range of about 20 µm to about 100 µm, or about 35 µm to about 100 µm, or about 40 µm to about 85 µm (reading upon the claimed thickness range), wherein “[w]hen a pouch is made, for example through thermoforming as described below, the film may be deformed, resulting in varying film thicknesses in a pouch” and thus the undeformed thickness may be determined prior to deformation and/or pouch formation (Paragraph 0122). More specifically, Labeque teaches that the water-soluble pouches (“capsule”) can be formed by providing a water-soluble film as described above, shaping the film to form an open compartment or recess such as by thermoforming, providing the household care composition to the open compartment, and sealing the open compartment to form a pouch having a sealed component with the composition enclosed therein, wherein sealing of the open compartment may be with a second film (as in instant claim 15, Paragraph 0181) or with a second sealed compartment to form a pouch having superposed compartments (Paragraphs 0177-0182). Hence, the claimed invention as recited in instant claims 1-2, 6, 9, and 14-15 would have been obvious over the teachings of Labeque given again that it is prima facie obviousness to choose from a finite number of identified, predictable solutions, with a reasonable expectation of success.
With respect to instant claim 10, Labeque teaches that the water-soluble film may contain at least about 50 wt.% of the PVOH resin blend thereby reading upon and/or rendering obvious the claimed “maximum level of 50%wt %wt based on total dry weight of the film” as recited in instant claim 10 (Paragraph 0100).
With respect to instant claims 11-13, Labeque teaches that the water-soluble film can contain other auxiliary agents and processing agents such as, but not limited to, plasticizers as in instant claim 11, surfactants as in instant claim 12, and bitterants as in instant claim 13 (Paragraph 0112), thereby rendering instant claims 11-13 obvious over the teachings of Labeque given that it is prima facie obviousness to choose from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONIQUE R JACKSON whose telephone number is (571)272-1508. The examiner can normally be reached Mondays-Thursdays from 10:00AM-5:00PM.
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/MONIQUE R JACKSON/Primary Examiner, Art Unit 1787