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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/10/2025 has been entered.
Amendments Received
Amendments to the claims were received and entered on 11/10/2025.
Status of Claims
Claims 1-16 and 18 are cancelled; claims 28-30 are newly added.
Claims 17 and 19-30 are currently pending and under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2020/070133 filed on July 16, 2020 and claims priority to the international application EP19187523.6 filed on July 22, 2019. Acknowledgment is made of applicant’s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). Please note that the international application is in a foreign language and therefore cannot be reviewed. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Rejections
In view of Applicant’s cancellation of claims 1-6, 9 and 18, all rejections of claims 1-6, 9 and 18 are now moot, and are hereby withdrawn.
Maintained/Modified Rejections Necessitated by Amendment
Claims 17 and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US20140017763, cited in the IDS) and Herbst et al. (DE102016210628, cited in the IDS, corresponds to U.S. Patent No. 10941371B2 and relied upon for English translation, cited in a previous office action), as evidenced by Detering et al. (WO2019048474, cited in PTO-892) and Coope-Epstein et al. (WO2018089564, herein “Coope”, cited in PTO-892).
Although claims 17 and 19-26 now depend from claim 27 rather than former claim 1, claim 27 includes all of the limitations relevant to the protease and amino acid substitution features relied upon in the rejections below. Accordingly, the prior rejections are maintained.
Regarding claims 26-27, Wieland et al. teaches washing and cleaning agents comprising protease (Specification, para 0001), wherein said agent can “be in the form of powdered solids, in consolidated particle form or in the form of homogeneous solutions or suspensions” (para 0084). More specifically, Wieland et al. teaches that said agents can be “in liquid, gel or paste form”. Wieland et al. also teaches the cleaning agent “can also contain further hydrolytic enzymes or other enzymes…all enzymes that can develop a catalytic activity in the agent according to the invention are preferably suitable for use as further enzymes, in particular a protease, amylase, cellulase…”, and specifically teaches synergy between the protease and amylase (para 0090). With respect to the composition comprising at least one organic solvent and one non-ionic surfactant, Wieland et al. teaches the inclusion of auxiliary substances such as surfactants and organic solvents (para 0084), specifically disclosing a composition comprising glycerol (6-7 wt%), ethanol (0.3-0.5 wt%), and non-ionic surfactants (24-28 wt%), wherein the composition is in liquid form. Although the disclosed composition is a liquid composition, it would have been obvious to a person of ordinary skill in the art to adjust solvent and water content to achieve a gel phase consistency, wherein concentrations/amounts of organic solvent would be adjusted to higher (free water content would be lower) than the disclosed amounts in the liquid composition. Furthermore, The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art. With respect to the polycarboxylate copolymer, Wieland et al. discloses a preferred “powdered washing agent” composition comprising 3% polyacrylate (para 0030). While the disclosed composition is a powdered (i.e., solid) composition, polyacrylates are well known in the art as polycarboxylate builders and dispersants used in various physical forms of cleaning compositions, including gels and liquids, for the same purpose of preventing redeposition of soils and sequestering hardness ions. One of ordinary skill in the art would have recognized that the choice of physical form does not preclude inclusion of the same builder polymer, and would have found it obvious to incorporate the known polycarboxylate builders disclosed in another composition, to achieve the same effect. Furthermore, although the disclosed composition exemplifies a polyacrylate homopolymer, polycarboxylate copolymers are recognized in the art as functionally interchangeable with polyacrylate homopolymers in detergent compositions and are in fact taught in Herbst et al. (see below) as suitable builder/dispersant components. Therefore, it would be obvious for a person of ordinary skill in the art, to make these substitutions and expect predictable results (see MPEP 2144.06, “Substituting equivalents known for the same purpose”). With respect to the composition comprising polyvinyl alcohol (PVA), Wieland et al. teaches the inclusion of water-soluble polymers such as polyvinylpyrrolidone (PVP) in the liquid washing agent (0.4-0.9 wt%) discussed above (para 0029). Although PVP is not a polyvinyl alcohol, both are well known water-soluble synthetic polymers used in detergents for similar purposes, including formulation stabilization and structural support, depending on the physical form of the composition, wherein the amounts may be optimized to achieve the desired effect (e.g., film formulation, enzyme stabilization, etc.). With respect to the claimed protease variant, Weiland et al. discloses a protease variant set forth in SEQ ID NO: 4, having 99.1% sequence identity to instant SEQ ID NO: 1, and has amino acid substitutions at positions 122 and 222, based on numbering according to instant SEQ ID NO: 1 (see non-final office action of 02/27/2025).
Herbst et al. teaches Bacillus gibsonii protease variants with better cleaning performance, for use in washing and cleaning agents (Specification, column 1, lines 15-30), and further teaches the incorporation of enzymes into water-soluble films, preferably PVA, and that the water-soluble wrapping may contain PVA or a PVA copolymer, optionally in combination with acid/acrylate copolymers (column 18, lines 19-33). Additionally, Herbst et al. discloses an exemplary composition comprising both a protease (1.5-5 wt%) and an amylase (0.5-3 wt%), in addition to several auxiliary components such as, non-ionic surfactant (2.5-10 wt%) and polycarboxylate (5-10 wt%) (column 23). Herbst et al. also teaches the cleaning agents in gel and solid form (column
While Wieland et al. discloses the use of polymers such as polyvinylpyrrolidone (PVP) at low concentrations in liquid washing agents for the purpose of stabilizing proteases at the molecular level, Wieland et al. further teaches that the disclosed cleaning compositions may be provided in various physical forms, including liquid, gel, or paste. Herbst et al., by contrast, teaches an alternative and well-established approach to stabilizing enzyme-containing detergent compositions, namely through physical containment within a polyvinyl alcohol (PVA)-based water-soluble matrix or wrapping including disclosures of film thickness, molecular weight, and degree of hydrolysis, which would be understood by a person of ordinary skill in the art to require polymer concentrations substantially greater than trace stabilization amounts (columns 18-20), such as those disclosed by Wieland et al. for PVP. For example, as evidenced by Detering et al, in a gel-like detergent/cleaner composition comprising at least one covering and/or coating, comprising polymer film (including PVA, as detailed in the rejection of claims 28-30 below), the polymer film (e.g., PVA) is 0.1-20% by weight of the total composition (Specification, pg. 53-54). As evidenced by Coope, in a unit dose dishwashing detergent composition comprising a solid gel composition, a water soluble co-structuring agent is present in amount from 0.5 to 65 wt% (Specification, para 0009), wherein the “co-structuring agent” includes polyvinyl alcohol (para 0012). Pursuant to MPEP 2144.05, “in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Accordingly, upon selecting polyvinyl alcohol as a stabilizing and structuring component for a gel-phase cleaning composition, a person of ordinary skill in the art would have routinely optimized the polymer concentration.
Regarding claims 17 and 19-25, Herbst et al. discloses Bacillus gibsonii protease variants with “very good cleaning performance” (Abstract), wherein SEQ ID NOs: 3-9 respectively satisfy the claim limitations of instant claims 19-25 (see sequence alignments in final rejection of 08/13/2025) and at least one of the recited amino acid substitutions in claim 27. It is noted that the variants disclosed in SEQ ID NOs: 2-9 are variants of SEQ ID NO: 1, which also corresponds to instant SEQ ID NO: 1 (i.e., wild type B. gisonii protease). Specifically, SEQ ID NO: 3 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising substitutions M122L, N154S, and T156A. SEQ ID NO: 4 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising substitutions M211N and P212D. SEQ ID NO: 5 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising substitutions M211L and P212D. SEQ ID NO: 6 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising the substitution G160S. SEQ ID NO: 7 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising substitutions D127P, M211L and P212D. SEQ ID NO: 8 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising the substitution P212H. SEQ ID NO: 9 corresponds to a protease variant set forth in SEQ ID NO: 1, comprising substitutions Q12L, M122L, and A222S.With respect to claim 17, all of the disclosed variants (i.e., SEQ ID NOs: 3-9 of Herbst et al.) satisfy the claim limitation of claim 17, as comprising at least one of the recited amino acid substitutions (see above for specific substitutions); for example SEQ ID NO: 3 of Herbst et al. discloses a protease variant set forth in SEQ ID NO: 1, wherein the variant comprises the amino acid substitutions M122L, N154S, and T156A, thereby satisfying the claim limitations of instant claim 17.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to arrive at the claimed invention. Before the effective filing date of the claimed invention, the disclosure of several protease variants with improved cleaning performance in Herbst et al., and the teachings of Wieland et al., that cleaning compositions comprising protease can be in the form of a gel, benefits from further comprising an amylase, and often comprise various auxiliary ingredients that support, for example, the structure of the composition (e.g., organic solvents, surfactants, polymers, etc.), would have led said practitioner to modify the cleaning agent of Wieland et al. to incorporate any protease variant selected from SEQ ID NOs: 2-9 (described above), as taught by Herbst et al., for improved cleaning performance. Said practitioner would have a reasonable expectation of success in preparing a cleaning agent comprising at least one protease and one amylase, in a gel phase, because Wieland et al. and Herbst et al. both teach cleaning agents comprising both enzymes and the inclusion of several auxiliary ingredients to achieve the desired structure of the cleaning agent in various physical forms. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Further, while Wieland et al. discloses the use of polymers such as polyvinylpyrrolidone (PVP) at low concentrations in liquid washing agents for the purpose of stabilizing proteases at the molecular level, Wieland et al. further teaches that the disclosed cleaning compositions may be provided in various physical forms, including liquid, gel, or paste, Herbst et al., by contrast, teaches an alternative and well-established approach to stabilizing enzyme-containing detergent compositions, namely through physical containment within a polyvinyl alcohol (PVA)-based water-soluble matrix or wrapping including disclosures of film thickness, molecular weight, and degree of hydrolysis, which would be understood by a person of ordinary skill in the art to require polymer concentrations substantially greater than trace stabilization amounts (columns 18-20), such as those disclosed by Wieland et al. Thus it would be obvious to substitute the PVA of Herbst et al. for the PVP of Weiland et al. While Herst et al does not teach the concentration of PVA in the composition, the appropriate concentration is evidenced by Detering et al, who teach in a gel-like detergent/cleaner composition comprising at least one covering and/or coating, comprising polymer film (including PVA, as detailed in the rejection of claims 28-30 below), the polymer film (e.g., PVA) is 0.1-20% by weight of the total composition (Specification, pg. 53-54). Further evidence of appropriate concentrations is evidenced by Coope, who teach in a unit dose dishwashing detergent composition comprising a solid gel composition, a water soluble co-structuring agent is present in amount from 0.5 to 65 wt% (Specification, para 0009), wherein the “co-structuring agent” includes polyvinyl alcohol (para 0012). Pursuant to MPEP 2144.05, “in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Accordingly, upon selecting polyvinyl alcohol as a stabilizing and structuring component for a gel-phase cleaning composition, a person of ordinary skill in the art would have routinely optimized the polymer concentration.
Thus, claims 17 and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US20140017763, cited in the IDS) and Herbst et al. (DE102016210628, cited in the IDS, corresponds to U.S. Patent No. 10941371B2 and relied upon for English translation, cited in a previous office action), as evidenced by Detering et al. (WO2019048474, cited in PTO-892) and Coope-Epstein et al. (WO2018089564, herein “Coope”, cited in PTO-892).
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. and Herbst et al., as evidenced by Detering et al. (WO2019048474, cited in PTO-892) and Coope-Epstein et al., as applied to claim 27 above, and further in view of Detering et al. (WO2019048474, cited in PTO-892).
The combined teachings of Wieland et al. and Herbst et al. as they apply to claim 27 have already been discussed above. Briefly, Wieland et al. teaches protease and amylase containing washing and cleaning agents which may be provided in various physical forms including liquid, gel, or paste and further comprising various auxiliary components such as solvents and surfactants. Herbst et al. teaches protease variants with improved cleaning performance for use in washing and cleaning agents, and further teaches compatibility of such proteases with conventional detergent ingredients, including surfactants, builders, polymers, and water-soluble polymer systems such as polyvinyl alcohol. Neither Wieland et al. nor Herbst et al. discloses or suggests a cleaning agent comprising 1,3-propanediol, nor do they disclose or suggest a cleaning agent further comprising a polymer comprising a sulfonic acid group-containing monomer, including the specific monomers recited in claim 30.
Regarding claim 28, Detering et al. discloses a detergent or cleaner comprising at least one covering and/or coating comprising or consisting of a washing and cleaning active polymer film, at least one surfactant, optionally at least one builder, optionally at least one bleach system, optionally at least one further additive selected from a group including enzymes, enzyme stabilizers, plasticizers and solvents, and optionally water (claim 19). Detering et al. further teaches that suitable enzymes for such detergent or cleaner compositions include proteases and amylases, including mixtures comprising both a protease and an amylase (Specification, pg. 68–69), and that the detergent or cleaner compositions may be provided in liquid, gel-like, or solid forms (pg. 6). With respect to 1,3-propanediol, Detering et al. teaches the use of plasticizers “to make polymer films more flexible”, that have the benefit of also serving as a solvent, in polymer-containing detergent compositions, and specifically discloses 2-methyl-1,3-propanediol as a suitable plasticizer. Detering et al. further teaches that plasticizers may be present in amounts of about 0.5 to 30 wt% based on the total weight of the composition (pg. 46). It is noted that Detering et al. teaches
Regarding claims 29 and 30, Detering et al. discloses the known use of PVA film for the packaging of gel detergents, and expressly notes “the biggest disadvantage of the polyvinyl alcohol films is that they only serve as packaging material and make no contribution at all to the washing and cleaning performance”. Detering et al. further teaches that “polymer compositions obtained by polymerizing a monomer containing acid groups in the presence of a polyether compound form stable and homogeneous products” (pg. 1). Specifically, Detering et al. teaches washing and cleaning active polymer films formed as single layer or multi-layer films, wherein the multilayer films comprise at least one layer comprising a polymer (P1) and optionally at least one further layer comprising a polymer (P2) different than P1 (pg. 26-27). Such suitable polymers P2 include homo- and copolymers comprising repeat units derived from vinyl alcohol as well as homo- and copolymers comprising at least one monomer containing sulfonic acid groups (pg. 27-29). Detering et al. specifically teaches an embodiment of P2 comprising copolymers comprising polyvinyl alcohol repeat units and repeat units of at least one anionically modified monomer and identifies suitable anionically modified monomers as including 1-acrylamido-1-propanesulfonic acid, 2-acrylamido-2-propanesulfonic acid, 2-acrylamido-2-methylpropanesulfonic acid (AMPS), and 2-methacrylamido-2-methylpropanesulfonic acid (pg. 30 and 34). Thus, Detering et al. expressly teaches polymers containing monomers having sulfonic acid groups, including specific monomers recited in claim 30, for use in washing and cleaning detergent compositions.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Wieland et al. and Herbst et al. disclose enzyme-containing cleaning compositions comprising protease variants and an amylase that may be provided in gel form and may comprise various auxiliary ingredients to support formulation and performance. Detering et al. teaches that detergent compositions may further comprise plasticizers/solvents such as 1,3-propanediols for improved structural properties (e.g., film flexibility) and washing-active polymers comprising sulfonic acid group-containing monomers that impart cleaning functionality and for improved performance, as opposed to PVA only films that primarily serve a packaging function. In view of these teachings, a person of ordinary skill in the art would be motivated to modify the cleaning agent of Wieland et al. and Herbst et al., to include such 1,3-propanediol and sulfonated polymers, as taught by Detering et al. A person of ordinary skill in the art would have had a reasonable expectation of success in incorporating 1,3-propanediol and sulfonated polymers into an enzyme-containing gel-phase cleaning composition, as these components were known to be compatible with detergent systems and to provide predictable formulation and performance benefits. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. and Herbst et al., as evidenced by Detering et al. (WO2019048474, cited in PTO-892) and Coope-Epstein et al., as applied to claim 27 above, and further in view of Detering et al. (WO2019048474, cited in PTO-892).
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 11/10/2025, Applicant argues that the rejection of claim 27, and therefore all claims dependent therefrom, is improper because Wieland et al. discloses polyvinylpyrrolidone (PVP) only at low concentrations (e.g., 0.4 wt%), whereas amended claim 27 requires polyvinyl alcohol (PVA) in an amount of 8-22 wt% and further argues that Herbst et al. does not disclose descriptive weight percentages of PVA sufficient to remedy this alleged deficiency. These arguments are not persuasive.
While Wieland et al. exemplifies the use of polymers such as PVP at low concentrations in liquid washing agents for enzyme stabilization at the molecular level (and therefore disclosed in trace amounts), Herbst et al. teaches an alternative and well-established approach for stabilizing enzyme-containing detergent compositions, namely through physical containment within a polyvinyl alcohol-based matrix, including water-soluble films or wrappings. Herbst et al. discloses polyvinyl alcohol as a preferred polymer for such matrices and provides detailed teachings regarding molecular weight, degree of hydrolysis, and film thickness, which would have been understood by a person of ordinary skill in the art to require polymer concentrations substantially greater than trace stabilization amounts. Thus, Herbst et al. teaches the use of polyvinyl alcohol as a structural polymer in detergent compositions for the purpose of stabilizing enzymes and maintaining formulation integrity. A person of ordinary skill in the art would have recognized that different physical forms of detergent compositions employ different stabilization modalities. Specifically, trace polymer concentrations may be sufficient for molecular-level stabilization, whereas compositions relying on polymeric matrices for structural integrity require sufficient polymer content to form a continuous network providing structural integrity and stability. Accordingly, upon selecting polyvinyl alcohol as a known stabilizing and structuring polymer for a cleaning composition, a person or ordinary skill in the art would have reasonably expected PVA to be present at percentages plausibly within the claimed range of 8-22 wt%.
Applicant has not provided evidence that the claimed polyvinyl alcohol range of 8–22 wt% is critical or produces unexpected results relative to the prior art. Absent such evidence, optimization of polymer concentration to achieve a gel phase represents routine experimentation involving a result-effective variable.
Accordingly, the rejection of claim 27, and claims dependent therefrom, under 35 U.S.C. §103 is maintained.
Conclusion
No claim is in condition for allowance.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/RICHARD G HUTSON/ Primary Examiner, Art Unit 1652