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 .
Claims 1,3, 6-7, and 10-17 are pending. Claim 1 is an independent method claim. Claims 2, 4, 5, 8-9 and 18-19 are cancelled.
Support for Applicants amendments after final of independent claim 1 is found in the specification [0032] and original claim 19.
Response to After-Final
The rejection of claims 1,3,6-7, and 10-18 under 35 U.S.C. 103 as obvious over Herrmann et al. (US 6,204,236 B1) is withdrawn upon entry of the after-final claims amendment 7/28/2026.
Response to Arguments
Applicant's arguments after-final filed 7/28/2026 have been fully considered. Upon an updated search, the indication of allowable subject matter is withdrawn and a new ground of rejection is made below
New Grounds Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1,3, 6-7, and 10-17 are rejected under 35 U.S.C. 101 because per the MPEP each claim can be directed to one category. So, either a product or method. Claim 1 is directed to a method in the preamble, but there is no method step, which is incorrect. There are several “wherein clauses” that define what the composition is but there is not one step as to how the composition is prepared by mixer granulation. It has a priviso of what step is not included but not a single step that is required in the mixer granulation. And we don’t know if the method is closed or open. No comprising or consisting of language. For purposes of compact prosecution, Examiner is examining the product and the steps are product by process.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1,3,6-7, and 10-17 are rejected under 35 U.S.C. 103 as obvious over Bach (US 7,273,736).
Bach teach mixer granulation comprising an enzymatic liquid (encompassing claim 1 biological active) with polyethylene glycol molten liquid wax. See col.14,ln.20-55 and example 1.
Claim 1 limitation to wherein mixer-granulation comprises progressive agglomeration of fine particles into larger granules is met by the very concept of mixer-granulation whereby the components of the dry powder will start to adhere and agglomerate and particles will build up, forming granulates comprising the enzyme. See col.2,ln.10-15 teaching the claim limitation does not provide contribution over common knowledge.
Claim 1 limitation to wherein the composition comprises a substantially homogenous core mixture wherein the biological active and the non-volatile liquid are not separated, compartmentalized or arranged in discrete layers is met by col.7,ln.33-35 teaching the enzyme in a crystalline or amorphous form is homogeneously distributed or dispersed within the core. See also col.13,ln.13 teaching homogeneity in the finished granule. Claim 1 limitation to the liquid portion of the homogenous core is explained in col.14,
Claim 1 limitation to 6-30% w/w of a non-volatile liquid having a vapor pressure of less than 1 kPa at 25°C, and a melting point of 25°C or lower, and an elastic parameter, n', lower than 0.1 kPa, when measured in a cone-and-plate rheometer using a sinusoidal frequency, W, of 1 Hz at 25°C is met by the Bach teaching the enzyme core can comprise 0.01-10% enzyme stabilizing agents as conventionally used in the field of granulation (see col.8,ln.10-40) including polyethylene glycol waxes (see paragraph connecting col.8-9). See Bach col.19,ln.65 teaching the enzyme(s) are stabilized using conventional stabilizing agents, e.g., a polyol such as propylene glycol or glycerol.
Claim 1 limitation to wherein the method does not comprise extrusion is taught in col.1,ln.55-60 teaching one of ordinary skill that very high extrusion increases heat generation in the enzyme paste, which is harmful to the enzyme. Col. 13,ln.15-20 teaches the preparation of the enzyme core using techniques known per se in the art. Non-limiting examples of suitable techniques are spray cooling, spray drying, melt granulation and high shear granulation which is a high-shear mixing encompassed by the specification [0031] encompasses the method for preparing a plurality of granules by mixer-granulation.
Bach does not exemplify a substantially homogenous enzymatic core with the nonvolatile liquid elastic parameters and properties as required by claim 1. Example 1 illustrates a protease enzyme dispersed into melted PEG4000 which dispersion cooled is the enzyme core unit. And col.10,ln.3-4 guide one of ordinary skill to modify the example 1 polyethylene glycol 4000, by teaching it is preferred for the enzyme core granulate contain a polyethylene glycol MW in a range less than 1,000 which is the same disclosed by the instant specification [0046] and thus, would necessarily meet the non-volatile liquid elastic parameters and properties of claim 1.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the exemplary teachings of Bach and arrive at the claimed substantially homogenous enzymatic core with the nonvolatile liquid as claimed because Bach suggest a homogenous enzyme core stabilized with glycerol or polyethylene glycol (PEG) of an average molecular weight at or below about 1000 in general. See Bach col.19,ln.65 and example 1 with col.7,ln.33-35 and col.13,ln.13.
Regarding claim 3, Bach exemplify the claimed biological active is a Savinase protease enzyme. See example 1, col.20.
Regarding claims 6-7 and 10, Bach teach protease enzyme core stabilized using conventional stabilizing agents, e.g., a polyol such as propylene glycol or glycerol (col.19,ln.66-67), examples 1 and 6.
Regarding claim 11 wherein the composition comprises at least 10% w/w crystalline material relative to the non-liquid part of the composition, is taught in col.19,ln.45-50 teaching the detergent may contain 0-65% of a detergent builder or complexing agent such as zeolite, diphosphate, triphos phate, phosphonate, carbonate, citrate, nitrilotriacetic acid, ethylenediaminetetraacetic acid, diethylenetriaminepen taacetic acid, alkyl- or alkenylsuccinic acid, soluble silicates or layered silicates (e.g. SKS-6 from Hoechst). See also col.8,ln.53-57 teaching Inorganics, such as water soluble and/or insoluble inorganic salts such as finely ground alkali sulphate, alkali carbonate and/or alkali chloride, clays such as kaolin, bentonites, talcs, zeolites, calcium carbonate, and/or silicates.
Limitation to claim 12 to an additional salt coating, wherein the coating makes up 5-70% w/w relative to the granule and comprises at least 60% w/w of a salt having a constant humidity at 20°C of at least 60% is met by Bach teaching the enzyme stabilized core has a coating shell unit (See paragraph connecting col.10-11) which is a protective coating having a high constant humidity. See col.10,ln.33 with examples 1,5-8 in col.21-22. And example 8 illustrates 1750 kg calcium carbonate which is the same salt coating materials in the instant specification [0119-0123], thus would be expected to have the same properties of constant humidity as claimed.
Regarding the claim 13, it is the Examiner’s position that Bach disclosing enzyme core range of from 180 μm to 250 μm. in example 5, col.21,ln.66 encompasses the claimed range and the scope of claim 13 is met by claim 8 of Bach teach no more than 700 μm.
With respect to claims 14-15, Bach teaches wherein the enzyme containing granule is a co-granule comprising more than one type of enzyme wherein the enzyme core is prepared using a spray cooling process, a spray drying process, a melt granulation process, an emulsion granulation process or a high shear granulation process. See claims 11 and 14 in col.24, paragraph linking col.7-8 teach enzyme-containing particulate material (col.1,ln30 with col.2,ln.20-25) wherein various high-shear mixers can be used as granulators, granulates consisting of the enzyme, fillers and binders etc. are mixed with cellulose fibres to reinforce the particles to give the so-called T-granulate. Reinforced particles, being more robust, release less enzymatic dust (vide infra).
With respect to the non-volatile liquid properties of claims 16-17, col.10,ln.4 teaching the polyethylene glycol binder with molecular weights in the range of less than 1,000. And col.9,ln.35 teaches excipient in a core unit of enzyme with polyethylene waxes (col.9,ln.1-5) and col.7,ln.33-35 teach Preferably the enzyme in a crystalline or amorphous form is homogeneously distributed or dispersed within the core unit.
Thus, it is the Examiner’s position that this MW range taught by Bach guides one of ordinary skill to the claimed nonvolatile liquid as PEGs are commonly liquids when molecular weights are <1000. (see the attached search notes for a teaching of common knowledge). And Applicant’s specification [0046] also has the same PEGs of Bach, namely the polyethylene glycol binder with molecular weights in the range of 200-1,000. It is reasonable for one of ordinary skill to expect the polyethylene glycol binder with molecular weights in the range of 200 to <1000 of Herrmann et al. to necessarily have the same properties of non-volatile liquid, vapor pressure, melting point, surface tension, dynamic viscosity and elastic parameters as required by claims 16-17 because Bach teaches the same polyol of the instant claims 6-7, namely, polyethylene glycol binder with molecular weights in the range of 200-1,000. See col.4,ln.7-10 guiding one of ordinary skill to modify the exemplary glycol, by teaching it is preferred for the enzyme core granulate contain a polyethylene glycol MW in the range of 200-1,000 which is the same disclosed by the instant specification [0046] and thus, would necessarily meet the non-volatile liquid parameters.
Conclusion
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/PREETI KUMAR/ Examiner, Art Unit 1761
/ANGELA C BROWN-PETTIGREW/ Supervisory Patent Examiner, Art Unit 1761
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