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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 17, 2026 has been entered.
Examiner’s Note
The Examiner acknowledges the amendments of claims 1 – 2, the cancellation of claims 3 – 4, and the addition of new claim 8. Claims 1 – 2 & 5 – 8 are examined herein.
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.
Claim(s) 1 – 2 & 5 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hiura (US 2019/0315102 A1), in view of Friedrich et al. (US 2020/0071476 A1).
With regard to claim 1, Hiura teaches a water-soluble polyvinyl alcohol film mainly comprising a polyvinyl alcohol resin (A) comprises a modified polyvinyl alcohol (PVA) resin (a1) and an unmodified polyvinyl alcohol (PVA) resin (a2) (paragraphs [0015] & [0043]). The modified PVA resin (a1) is modified with a carboxyl group (paragraph [0050]), such as maleic acid (paragraphs [0063] & [0072]), wherein the modification amount is preferably 1 mol% to 10 mol% (paragraph [0048]), which includes Applicant’s claimed range of 2 – 4 mol%. Furthermore, the modified PVA resin (a1) has an avg saponification degree of 85 mol% or more (paragraph [0044]), and has a 4 wt.% aqueous solution viscosity at 20°C of preferably 17 mPa-s to 40 mPa-s (paragraph [0045]), which overlaps with Applicant’s claimed viscosity range of 21 mPa-s or more and 45 mPa-s or less. As set forth in MPEP 2144.05, in the case where the claimed range “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 USP2d 1934 (Fed. Cir. 1990).
The unmodified polyvinyl alcohol resin (a2) has a 4 mass% aqueous solution of viscosity of 13 – 45 mPa-s at 20°C (paragraph [0045]), which includes Applicant’s claimed range of 25 mPa-s or more to 45 mPa-s or less, and an average saponification degree of preferably in the range of 90 mol% to 97 mol% (paragraph [0044]), which is within Applicant’s claimed range of 85 mol% or more.
With regard to Applicant’s α limitation, Hiura teaches the unmodified PVA resin is a 4 wt.% aqueous solution viscosity at 20°C of preferably 17 mPa-s to 40 mPa-s (paragraph [0045]). Furthermore, two or more kinds of PVA resins different from each other in viscosity may be used in combination (paragraphs [0049] & [0058]). However, Hiura does not teach the extent of the viscosity difference between the modified and unmodified PVA resins.
Friedrich et al. teach a water-soluble polyvinyl alcohol (PVOH) blend film wherein when a first PVOH copolymer and second PVOH polymer are selected with regard to various criterial related to the 4% solution viscosity of one or both of the PVOH (co)polymers, the resulting water-soluble film formed from the PVOH resin blend exhibits beneficial aqueous dissolution properties, optionally in combination with beneficial tensile strength, and/or tensile modulus properties relative to comparable film formed outside the selected solution viscosity criteria (paragraph [0005]). One such criteria is that the absolute difference of a 4 mass % aqueous solution viscosity at 20°C between the first (modified) PVOH polymer and the second (unmodified) PVOH polymer may be in the range of 0 cP to about 10 cP, more preferably at least 0.5 cp and up to about 10 cp (1 cp = 1 mPa-s) (paragraph [0006), which is within Applicant’s claimed range of 0.1 mPa-s or more to 45 mPa-s or less.
Therefore, based on the teachings of Friedrich et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form the water-soluble film taught by Hiura such that the absolute difference of a 4 mass % aqueous solution viscosity at 20°C between the modified) PVOH polymer and the unmodified PVOH polymer may be in the range of at least 0.5 mPa-s and up to about 10 mPa-s for beneficial aqueous dissolution properties, tensile strength, and/or tensile modulus properties.
With regard to Applicant’s β limitation, Hiura teaches the average saponification degree of each of the PVA resins may be the same or different (i.e., “a difference in average saponification degree between the modified alcohol resin (a1) and the unmodified polyvinyl alcohol resin (a2)” is 0 mol% or more in absolute value) (paragraphs [0049] & [0058]), which includes Applicant’s claimed range of not greater than 4.5 mol%.
With regard to claim 2, Hiura teaches the content weight ratio (modified PVA resin/unmodified PVA) (i.e., “(a1)/(a2)”) of the modified PVA resin to the unmodified PVA resin is preferably 95/5 to 60/40 (paragraph [0051]), which includes Applicant’s claimed range of 93/7 to 80/20. As set forth in MPEP 2144.05, in the case where the claimed range “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).
With regard to claim 5, as discussed above for claim 1, Hiura teaches the polyvinyl alcohol resin (a2) has an average saponification degree of preferably in the range of 90 mol% to 97 mol% (paragraph [0044]), which is within Applicant’s claimed range of 90 to 99.9 mol%.
With regard to claim 6, Hiura teaches the PVA resin composition 1 part by weight to 30 parts by weight of a filler (C) (paragraph [0108]), which overlaps with Applicant’s claimed range of greater than 6 parts by mass of a filler (C) based on 100 parts by mass of the polyvinyl alcohol resin (A). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With regard to claim 7, Hiura teaches a chemical agent package comprising a package bag formed from the water-soluble polyvinyl alcohol film according to claim 1; and a chemical agent packaged in the package bag (paragraph [0014]).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hiura (US 2019/0315102 A1), in view of Friedrich et al. (US 2020/0071476 A1) and *Hidehiro (JP 2013-24186 A).
*submitted by Applicant with IDS filed 8/30/2023
With regard to claim 8, Hiura teaches a water-soluble polyvinyl alcohol film mainly comprising a polyvinyl alcohol resin (A) comprises a modified polyvinyl alcohol (PVA) resin (a1) and an unmodified polyvinyl alcohol (PVA) resin (a2) (paragraphs [0015] & [0043]). The modified PVA resin (a1) is modified with a carboxyl group (paragraph [0050]), such as maleic acid (paragraphs [0063] & [0072]), wherein the modification amount is preferably 1 mol% to 10 mol% (paragraph [0048]), which includes Applicant’s claimed modification amount of 2 mol%. Furthermore, the modified PVA resin (a1) has an avg saponification degree of 85 mol% or more (paragraph [0044]), and has a 4 wt.% aqueous solution viscosity at 20°C of preferably 17 mPa-s to 40 mPa-s (paragraph [0045]), which includes Applicant’s claimed viscosity range of 22 mPa-s or more and 30 mPa-s or less. As set forth in MPEP 2144.05, in the case where the claimed range “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 USP2d 1934 (Fed. Cir. 1990).
The unmodified polyvinyl alcohol resin (a2) has a 4 mass% aqueous solution of viscosity of 13 – 45 mPa-s at 20°C (paragraph [0045]), which overlaps with Applicant’s claimed range of 27.5 mPa-s or more to 54 mPa-s or less, and an average saponification degree of preferably in the range of 90 mol% to 97 mol% (paragraph [0044]), which is within Applicant’s claimed range of 85 mol% or more.
With regard to Applicant’s α limitation, Hiura teaches the unmodified PVA resin is a 4 wt.% aqueous solution viscosity at 20°C of preferably 17 mPa-s to 40 mPa-s (paragraph [0045]). Furthermore, two or more kinds of PVA resins different from each other in viscosity may be used in combination (paragraphs [0049] & [0058]). However, Hiura does not teach the extent of the viscosity difference between the modified and unmodified PVA resins.
Friedrich et al. teach a water-soluble polyvinyl alcohol (PVOH) blend film wherein when a first PVOH copolymer and second PVOH polymer are selected with regard to various criterial related to the 4% solution viscosity of one or both of the PVOH (co)polymers, the resulting water-soluble film formed from the PVOH resin blend exhibits beneficial aqueous dissolution properties, optionally in combination with beneficial tensile strength, and/or tensile modulus properties relative to comparable film formed outside the selected solution viscosity criteria (paragraph [0005]). One such criteria is that the absolute difference of a 4 mass % aqueous solution viscosity at 20°C between the first (modified) PVOH polymer and the second (unmodified) PVOH polymer may be in the range of 0 cP to about 10 cP, more preferably at least 0.5 cp and up to about 10 cp (1 cp = 1 mPa-s) (paragraph [0006), which is within Applicant’s claimed range of 0.1 mPa-s or more to 45 mPa-s or less.
Therefore, based on the teachings of Friedrich et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form the water-soluble film taught by Hiura such that the absolute difference of a 4 mass % aqueous solution viscosity at 20°C between the modified) PVOH polymer and the unmodified PVOH polymer may be in the range of at least 0.5 mPa-s and up to about 10 mPa-s for beneficial aqueous dissolution properties, tensile strength, and/or tensile modulus properties. The range of 0.5 – 10 mPa-s taught by Friederich et al. overlaps with Applicants claimed range of 3.5 – 32 mPa-s.
With regard to Applicant’s β limitation, Hiura teaches the average saponification (hydrolysis) degree of each of the PVA resins may be the same or different (i.e., “a difference in average saponification degree between the modified alcohol resin (a1) and the unmodified polyvinyl alcohol resin (a2)” is 0 mol% or more in absolute value) (paragraphs [0049] & [0058]), which includes Applicant’s claimed difference of average saponification degree range of 3.7 mol% to 4.5 mol.%
Hiura do not explicitly teach a range of values for the difference in average saponification degree of the PVA resins.
Hidehero teaches a PVA resin film formed to function as a polarizing film, wherein the PVA resin film contains two or more PVAs with different saponification degrees, preferably a difference of 1 mol% or more and 5.5 mol% or less for suppressing the entrapment of bubbles and achieving uniformity of the entire PVA film (paragraphs [0013], [0036] – [0037], & [0039]).
Therefore, based on the teachings of Hidehiro, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to achieve a PVA film that is uniform and prevents entrapment of bubbles when the PVA film when adhered to other films for forming a packaging material taught by Hiura by adjusting the degree of saponification of two or more polyvinyl alcohol resins such that the difference of the degree of saponification is in the range of 1 – 5.5 mol%, which includes Applicant’s claimed range of 3.7 – 4.5 mol.%.
Furthermore, Hiura teaches the content weight ratio (modified PVA resin/unmodified PVA) (i.e., “(a1)/(a2)”) of the modified PVA resin to the unmodified PVA resin is preferably 95/5 to 60/40 (paragraph [0051]), which includes Applicant’s recited mass ratio of 90/10. As set forth in MPEP 2144.05, in the case where the claimed range “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).
Claim(s) 1 & 5 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Labeque et al. (US 2017/0298216 A1).
With regard to claim 1, A water-soluble polyvinyl alcohol film mainly comprising a polyvinyl alcohol resin blend (Applicant’s “polyvinyl alcohol resin (A)”) (paragraph [0006]) comprises:
The first PVOH polymer (Applicant’s “polyvinyl resin alcohol resin (a1)”) is comprising a carboxylated anionic monomer unit, such as maleic acid (paragraph [0090]) (i.e., “maleic acid-modified PVA resin (a1)”), characterized by a 4% solution viscosity at 20°C of from about 10 cP to about 40 cP (10 mPa-s to about 40 mPa-s) (paragraph [0021]), which includes Applicant’s claimed range of 21 mPa-s or more and 40 mPa-s or less at 20°C. Polymeric viscosities specified in the disclosure should be understood to refer to the viscosity of a 4% aqueous water-soluble polymer solution at 20°C, unless specified otherwise, in accordance with international practice (paragraph [0103]). The degree of hydrolysis (degree of saponification) of all the PVOH polymers included in the water-soluble films of the present disclosure may be in the range of 60 to about 99%, more preferably about 90% to about 99% (paragraphs [0082] & [0107]), which is within Applicant’s claimed range of 85 mol% or more. The carboxylated anionic monomer unit is present in a range from about 0.5 mol% to about 3 mol% (paragraph [0038]), which overlaps with Applicant’s claimed modification degree range of 2 – 4 mol%. As set forth in MPEP 2144.05, in the case where the claimed range “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).
The second PVOH polymer (Applicant’s “polyvinyl resin alcohol resin (a2)”) is characterized by a 4% solution viscosity at 20°C from about 3.0 cP to about 40 cP (3 mPa-s to about 40 mPa-s) (paragraph [0024]), which overlaps with Applicant’s claimed range of 25 mPa-s or more to 45 mPa-s or less. Furthermore, the absolute viscosity difference between the first PVOH polymer and the second PVOH polymer may be in the range of 0 cP to about 10 cP, more preferably at least 0.5 cP and up to 10 cP (paragraph [0104]), which overlaps with Applicant’s claimed range of 1 mPa-s or more to 45 mPa-s or less. The degree of hydrolysis (degree of saponification) of all the PVOH polymers included in the water-soluble films of the present disclosure may be in the range of 60 to about 99%, more preferably about 90% to about 99% (paragraphs [0082] & [0107]), which is within Applicant’s claimed range of 85 mol% or more.
Labeque et al. teach the degree of hydrolysis (degree of saponification) of all the PVOH polymers included in the water-soluble films of the present disclosure may be in the range of 60 to about 99%, more preferably about 90% to about 99% (paragraphs [0082] & [0107]). Therefore, Labeque et al. suggest at least one embodiment in which a difference in an average saponification (also called alcoholysis or hydrolysis) degree between the first PVOH polymer and the second PVOH polymer is not greater than 4.5 mol% in absolute value.
With regard to claim 5, Labeque et al. teach the degree of hydrolysis (degree of saponification) of the PVOH polymers included in the water-soluble films (which includes the second PVOH) of the present disclosure may be in the range of 60 to about 99%, more preferably about 90% to about 99% (paragraphs [0082] & [0107]).
With regard to claim 6, Labeque et al. teach the water-soluble film may further contain filler in the amount of at least 0.01 wt.% and up to about 50 wt.%, more preferably up to about 4 wt.% (paragraph [0113]). The water-soluble polymers (i.e., “polyvinyl alcohol resin (A)”) included in the film in an amount of from about 50 wt.% to about 95 wt.% (paragraph [0084]). Therefore, the amount of filler taught by Labeque et al. overlaps with Applicant’s claimed range of not greater than 6 parts by mass of a filler (C) based on 100 parts by mass of the polyvinyl alcohol resin (A). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With regard to claim 7, Labeque teaches a chemical agent package comprising:
A pouch (Applicant’s “package bag”) formed from the water-soluble polyvinyl alcohol film according to claim 1 discussed above (paragraph [0011]); and common household care compositions, such as laundry or dish detergent (Applicant’s “chemical agent”) packaged in the pouch (paragraph [0002]).
Response to Arguments
Applicant argues, “…the Examiner expresses concern as to whether the degree and type of modification is commensurate in scope between the claims and the data. In response, Applicant herein amends claim 1” (Remarks, Pgs. 6 – 7).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. As previously stated in pgs. 10 – 12 of the final rejection mailed May 28, 2026, a showing of unexpected results must meet numerous standards, not just the standard of data commensurate in scope with the claims. Specifically, to establish unexpected results over a claimed range, Applicant is required to demonstrate criticality of the claimed ranges (or single value) compared to the ranges taught by the cited prior art reference(s). See MPEP 716.02(d).II.
Applicant has argued the difference of average saponification between the modified and unmodified PVAs is critical for achieving the results. However, Applicant’s amendment of the claimed difference of average saponification fails to demonstrate the criticality of the recited lower endpoint (0 mol%) in claim 1 compared to the 0 mol% difference of average saponification taught by the prior art reference.
Furthermore, with regard to claim 8, Applicant fails to demonstrate the criticality of the recited lower endpoint of 3.8 mol% for the difference of saponification degree. A showing of criticality of a claimed range requires comparative examples outside the claimed range.
Lastly, contrary to Applicant’s assertion, Applicant’s examples are not commensurate in scope with the independent claims. For example,
Independent claim 1 does not recite the ratio of resins a1/a2 or the amount of filler, despite the fact that these variables were tested in Applicant’s comparative examples.
Applicant’s claims recite an average saponification of 85 mol% or greater, but Applicant’s data did not test an average saponification degree as low as 85 mol% or higher than 98 mol%.
Applicant’s modified PVA of the working examples was modified with monomethyl maleate, which is a species of the maleic acid modification genus recited in independent claims 1 & 8.
Applicant argues, “…in item 6 on page 16, the Examiner notes that Examples 2 and 3 appear to be exactly the same in composition, structure and manufacturing, but achieve different package breakage times of 38 seconds and 148 second, respectively. Upon comparison of Examples 1 and 2 with Examples 7 and 8, the Examiner considers that examples within the scope of the claims performed worse than examples outside of the claims.
“Applicant respectfully submits that Examples 1 and 2 and Comparative Examples 1 and 2 were performed in one experiment, while Examples 2 – 8 and Comparative Examples 3 and 4 were performed in another experiment. Applicant respectfully submits that it is standard experimental protocol to make comparisons within one set of experimental conditions, and not between two different sets of experimental conditions. As such, Applicant submits that no conclusions should be drawn by a comparison between Examples 7 and 8” (Remarks, Pg. 7).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Applicant has conflated two separate and distinct arguments made by the Examiner regarding Applicant’s assertion of unexpected results.
First, with regard to examples 2 & 3, the Examiner’s point was that Applicant’s specification teaches these experimental conditions were the same, not different.
As shown in the tables 1 – 2, examples 2 & 3 have the same composition. With regard to the method of manufacturing:
Applicant’s Example 2 (specification paragraphs [0111] & [0113]): Film formation caste on PET film, passed through a 3-m long drying chamber (at 105°C) at a speed of 0.350 m/min to be thereby dried. PVA film (water-sol film) having a thickness of 87 µm
Applicant’s Example 3 (specification, paragraph [0118]): Film formation caste on PET film, passed through a 3-m long drying chamber (at 105°C) at a speed of 0.350 m/min to be thereby dried. PVA film (water-sol film) having a thickness of 87 µm was prepared.
Furthermore, according to Applicant's tables, Ex. 2 & 3 underwent the same package breakage test (see last line of Tables 1 – 2 on pgs. 51 – 55 of the originally filed specification).
Applicant asserts Examples 2 and 3 were different experiments in different experimental conditions. So, again, the Examiner requests a more detailed clarification: What were the different experimental conditions Applicant vaguely alludes to?
As shown above, Applicant’s assertion of different experimental conditions appears to contradict the data provided in the originally filed specification. Contrary to Applicant’s assertion, for a reasonable demonstration of unexpected results, it is completely within reason for Applicant to be required to explain contradictions in their results. Applicant has the burden of explaining proffered data. Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Md. Pat. App. & Inter. 1992). See MPEP 716.02(b).II. Therefore, a conclusion of unexpected results cannot be drawn based on the data Applicant has provided.
Second, as a separate issue, the Examiner noted Applicant’s comparative examples performed better than the inventive examples. Applicant’s arguments do not cure this deficiency for demonstrating unexpected results.
Third, Bromby, II et al. (US 2023/0174729 A1) teach a water-soluble film comprising two or more polyvinyl alcohol (PVA) resins having different degrees of saponification leads to improved liquid release time due to reduced stress in the thermoformed film (paragraph [0042]). Optimizing the difference of saponification degrees of the two PVA resins for improved liquid release time is within routine experimentation of one of ordinary skill in the art.
Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). The court held the evidence of nonobviousness was not sufficient to rebut the evidence of obviousness.); In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). See PMEP 716.02(c).
Therefore, Applicant’s data fail to provide reasonable evidence of unexpected results.
Applicant argues, “Applicant respectfully submits that claim 1, and all claims dependent thereon, are patentable over Labeque for similar reasons as discussed above with respect to the rejection based on Hiura and Friedrich” (Remarks, Pg. 8).
EXAMINER’S RESPONSE: Applicant is directed to the discussion above with respect to the reasons given by the Examiner for maintaining the rejection over Hiura and Friedrich.
Applicant argues, “Additionally, Applicant herein adds new claim 8. The ranges of this claim correspond to the Examples of the specification as filed. As such, Applicant respectfully submits that the unexpected results are also commensurate in scope with claim 8” (Remarks, Pg. 8).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. As discussed above, showing of unexpected results for overcoming a prior art reference that teachings overlapping ranges or larger range than taught by Applicant requires demonstrating criticality of the claimed range (or single value) compared to the range taught by the cited prior art reference.
Applicant does not provide any comparative examples that have a difference of of saponification less than the recited lowered endpoint of 3.7 mol%. Thus, Applicant fails to demonstrate the criticality of the recited lower endpoint compared to the teachings of the cited prior art.
Furthermore, as discussed above for claim 1, the modification of PVA in the examples are not commensurate in scope with claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE T GUGLIOTTA whose telephone number is (571)270-1552. The examiner can normally be reached M - F (9 a.m. to 10 p.m.).
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/NICOLE T GUGLIOTTA/Examiner, Art Unit 1781
/FRANK J VINEIS/Supervisory Patent Examiner, Art Unit 1781
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