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 .
Amendments Received
Amendments to the claims were received and entered on 04/09/2026.
Status of Claims
Claims 29-30 are cancelled and claims 31-32 are newly added.
Claims 17, 19-28 and 31-32 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Withdrawn Rejections
In view of Applicant’s cancellation of claims 29-30, all rejections of claims 29-30 are now moot and hereby withdrawn.
In view of Applicant’s amendments, rejections of claims 17, and 19-27 under 35 USC § 103 over Wieland et al. and Herbst et al., as evidenced by Detering et al. and Coope, are hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 28 under 35 USC § 103 over Wieland et al. and Herbst et al., further in view of Detering et al., is hereby withdrawn.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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), 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), and Antir et al. (WO2016091650 corresponds to US20170342348, relied upon for English translation, cited in PTO-892), as evidenced by Detering et al. (WO2019048474, cited in a previous office action) and Coope-Epstein et al. (WO2018089564, herein “Coope”, cited in a previous office action).
Although the presently amended claim 27 incorporates subject matter previously recited in former claims 29 and 30, the scope of the claim has changed. Former claim 29 merely required that the cleaning agent further comprise a polymer comprising a sulfonic acid group containing monomer and did not require that the polymer be present within the gel phase. Present claim 27, however, affirmatively requires the sulfonic acid group containing monomer to be part of the recited gel phase. Accordingly, the amendment has narrowed the scope of the claims and necessitated an updated prior art analysis with respect to this limitation.
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 claim 28 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.
With respect to the limitation of at least one sulfonic acid group-containing monomer…, Antir et al. teaches enzymatic washing and cleaning agents comprising protease and amylase (para 002), which may be in gel form (0135) and comprise additional detergent ingredients including non-ionic surfactants and solvents (0028), further comprise polymers that “provide cleaning action”, wherein preferred cleaning-active polymers are polymers containing sulfonic acid groups, particularly copolymeric polysulfonates (para 0093-0094). Antir et al. further teaches that preferred sulfonic acid group-containing monomers include acrylamidopropanesulfonic acid, 2-acrylamido-2-methyl-1-propanesulfonic acid, and 2-methacrylamido-2-methyl-1-propanesulfonic acid (para 0099), corresponding to the monomers recited in the instant claims. Antir et al. additionally teaches that the proportion by weight of copolymers containing sulfonic acid groups in the detergent or cleaning agent is preferably 0.1 to 20 wt%, which encompasses the presently claimed range of 5 to 12 wt%.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate the preferred sulfonic acid group-containing polymer taught by Antir et al. into the enzyme-containing gel detergent composition of Wieland et al. because Antir et al. expressly teaches that such polymers are preferred cleaning-active polymers for enzymatic washing and cleaning agents that may be in gel form. The modification merely incorporates a known and preferred cleaning active polymer into another known washing and cleaning agent of similar composition. There is a reasonable expectation of success, because Antir et al. successfully demonstrates the construction of an enzymatic cleaning agent comprising polymers of sulfonic acid group containing monomers, for the purposes of providing cleaning action. 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.
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. gibsonii 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.
Thus, claims 17 and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al., Herbst et al., and Antir et al., as evidenced by Detering et al. and Coope.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al., Herbst et al., and Antir et al., as evidenced by Detering et al. and Coope-Epstein et al., as applied to claim 27 above, and further in view of Detering et al. (WO2019048474, cited in a previous office action).
The combined teachings of Wieland et al., Herbst et al. and Antir 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. Antir et al. similarly discloses enzymatic cleaning agents of similar composition, further comprising polymers containing sulfonic-acid group containing monomers that provide additional cleaning action. Neither Wieland et al. nor Herbst et al. disclose or suggest a cleaning agent comprising 1,3-propanediol. Antir et al. contemplates propanediol as a solvent in its washing and cleaning agents, but does not expressly teach a 1,3-propanediol.
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).
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., Herbst et al. and Antir et al. disclose enzyme-containing cleaning compositions comprising protease, including 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). In view of these teachings, a person of ordinary skill in the art would be motivated to modify the cleaning agent made obvious by Wieland et al., Herbst et al. and Antir et al., to include a 1,3-propanediol, 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 into an enzyme-containing gel-phase cleaning composition, as such a component was known to be compatible with detergent systems and to provide a predictable formulation. 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, claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al., Herbst et al., and Antir et al., as evidenced by Detering et al. and Coope-Epstein et al., as applied to claim 27 above, and further in view of Detering et al.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al., Herbst et al., and Antir et al., as evidenced by Detering et al. and Coope-Epstein et al., as applied to claims 26-27 above, and further in view of Souter et al. (US20180355340, cited in PTO-892).
The combined teachings of Wieland et al., Herbst et al. and Antir et al., as they apply to claims 26-27 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 gel and solids 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. Antir et al. similarly discloses enzymatic cleaning agents of similar composition, further comprising polymers containing sulfonic-acid group containing monomers that provide additional cleaning action. With respect to the solid phase components recited in claim 31, Wieland et al. teaches powdered/solid cleaning agents, as described below.
Regarding claim 30, Wieland et al. discloses an exemplary solid formulation of the washing and cleaning agent described above, comprising sodium bicarbonate (6.5 wt%), sodium percarbonate (17 wt%), amorphous sodium disilicate (4 wt%), non-ionic surfactant (2 wt%), and polyacrylate (3 wt%) (para 0030). However, Wieland et al. does not expressly teach the inclusion of citrate and methylglycine diacetic acid (MGDA) in the solid formulation.
Souter et al. teaches automatic dishwashing detergent compositions comprising citrate builders and MGDA as preferred non-phosphate builders in an amount of at least 1%, 5%, 10%, or at least 20% by weight of the total composition (Specification, para 0054), in addition to sodium percarbonate, silicates including sodium disilicate, nonionic surfactants, and polycarboxylates for use in solid dishwashing detergent formulations (Example 3, pg. 12).
Regarding claim 32, Wieland et al. teaches that the washing and cleaning agent may consist of a plurality of phases and may include solid and gel presentation forms within a single cleaning agent (para 0088-89). Arranging the solid and gel phases in direct contact would have been an obvious design choice and matter of product configuration, absent evidence that the particular spatial arrangement produces new or unexpected results.
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, it would have been obvious to one of ordinary skill in the art to incorporate the citrate builder and methylglycine diacetic acid (MGDA) builder taught by Souter et al. into the solid detergent composition of Wieland et al., because Souter et al. teaches these compounds as preferred non-phosphate builders for automatic dishwashing detergent compositions. With respect to the recited concentrations of the solid phase components, pursuant to MPEP 2144.05, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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). Furthermore, optimization of the relative concentrations of the conventional detergent components, including builders, surfactants, silicates, and bleaching agents, would have been within the level of ordinary skill in the art and would have constituted nothing more than routine optimization to obtain the desired cleaning performance. 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 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al., Herbst et al., and Antir et al., as evidenced by Detering et al. and Coope-Epstein et al., as applied to claims 26-27 above, and further in view of Souter et al.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 04/09/2026, Applicant’s arguments that the applied prior art does not teach or suggest the recited sulfonic acid group containing monomers in the gel phase of the claimed cleaning agent, have been considered. It is noted that the rejection above has been modified in order to address the amended limitations by additionally relying upon Antir et al, which teaches enzymatic cleaning agents of similar composition to those of Wieland et al. and Herbst et al., further comprising polymers of sulfonic acid group containing monomers. Accordingly, the previous rejection has been modified to reflect the amended claim scope.
Conclusion
No claim is in condition for allowance.
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.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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