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 .
Final Rejection
Claims 1,3,6,7, and 10-17 and 19 are pending. Claim 1 is an independent method claim. Claims 2, 4, 5, 8-9 and 18 are cancelled. Claim 19 is new.
Support for Applicants amendments of independent claim 1 is found in the specification [0031] and original claim 18.
Examiner notes: 16/651,264 are mixer granulation process claims.
16/652,924 are layered core/matrix granule claims.
Response to Amendments
Claims 1,3,6-7, and 10-18 are rejected under 35 U.S.C. 103 as obvious over Herrmann et al. (US 6,204,236 B1).
Response to Arguments
Applicant's arguments filed 12/9/2025 have been fully considered but they are not persuasive. Applicants urge that Herrmann et al. fail to teach a mixer-granulation process. Contrary to Applicant’s arguments, Hermann et al. teach a method carried out in a conical mixer or appropriate mixing apparatus for the granulates. See col.6,ln.25 and claim 2. It is the Examiner’s position that Hermann et al. also teach an extrusion process which extrusion is not excluded in claim 1, note, new claim 19 excludes extrusion.
Applicant’s go on to urge that Herrmann et al. do not teach progressive agglomeration of fine particles into larger granules. Contrary to Applicants arguments, Herrmman et al. specifically teach in col. 6,ln.20-30 preparing a dried premix of the remaining powdered recipe components in an appropriate mixing apparatus, for example, a conical mixer or a plowshare mixer. Then water is added in an amount which is metered in such a way that a mass is formed which is easily shaped and extruded. Usually the moisture content of this mixture is 20-50 wt %. The extrudable mass obtained in this manner is mixed in the mixture until it is homogeneous, and then it is led into an extruder. It is the Examiner’s position that the mass of Herrmann et al. meets the progressive agglomeration of fine particles into larger granules which position is further supported by the art using the same high-shear mixing and granulation system in example 1, namely the Lödige Rapid Mixer Granulator is a high-shear mixing and granulation system designed for pharmaceutical, cosmetic, and food applications, with GMP-compliant design and modular WIP (Work-in-Process) systems. See the attached search notes of common knowledge of the mixer used in the example 1 of Herrmann et al. Accordingly, Herrmann et al. are pertinent to the claims and the claim amendments are addressed below.
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 Herrmann et al. (US 6,204,236 B1).
With respect to the claim 1 Herrmann et al. example 1, using the Lödige Rapid Mixer which is a high-shear mixing encompassed by the specification [0031] encompases the method for preparing a plurality of granules by mixer-granulation.
Claim 1 limitation to wherein the composition comprises a substantially homogenous core having a biological active is met by Herrmann et al. enzyme granulates prepared by processing 4% enzyme concentrate with 0.5-13% kaolin filler and 12% polyethylene glycol solvent binder, and additional granulation and formulation auxiliaries to form a composition which is then granulated. See the Example 1 which Herrmann et al. describe as a homogenous moist mixture that is obtained. In col.9.ln.46.
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 see Hermann et al. col.8,ln.47 teaching an amylase enzyme core comprising 12% PEG3000 (Polyethylene glycol 3000). Specifically regarding the enzyme core, Herrmann et al. teach a core having 0.8-20 wt% alpha amylase enzyme and 5-15% of one or more binders including the claimed nonvolatile liquid polyethylene glycol. See claim 1 with the example in col.8 and col.4,ln.7-10 teaching the polyethylene glycol binder with molecular weights in the range of 200-10,000. It is the Examiner’s position that this MW range taught by Herrmann et al. 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 Herrmann et al., 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 claim 1 because Herrmann et al. 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 polyethylene glycol 3000, 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 limitation.
Claim 1 limitation to wherein the biological active and the non-volatile liquid are not separated, compartmentalized or arranged in discrete layers is met by the Example 1 which Herrmann et al. describe as a homogenous moist mixture that is obtained. See col.9.ln.46.
Claim 1 limitation to wherein mixer-granulation comprises progressive agglomeration of fine particles into larger granules is read upon by Herrman et al. col.6,ln.25-50 guiding one of ordinary skill to use a conical mixer or a plowshare mixer. See col.6,ln25.. It is the Examiner’s position that the claimed mixer granulation comprising progressive agglomeration of fine particles into larger granules as required by claim 1 is met by col.6, disclosing the plurality of granules prepared by mixing enzyme core with PEG binder in a conical mixer or a plowshare mixer and the mixture is homogeneous. See the attached search notes that conical mixers and plowshare mixers are commonly known to be used for agglomeration as claimed. Herrmann et al. meets the progressive agglomeration of fine particles into larger granules which position is further supported by the art using the same high-shear mixing and granulation system in example 1, namely the Lödige Rapid Mixer is a high-shear mixing and granulation system. See the attached search notes of common knowledge of the mixer used in the example 1 of Herrmann et al.
Claim 1 limitation to wherein the biological active is an enzyme is met by Hermann et al. col.8,ln.47 teaching an amylase enzyme core.
Hermann et al. do not exemplify a substantially homogenous enzymatic core with the nonvolatile liquid as required by claim 1. Examiner notes that the example 1 in col.8,ln.47 teaches an amylase enzyme core comprising 12% PEG3000 (Polyethylene glycol 3000) which is a waxy solvent and col.9,ln.46 teaches obtaining a homogenous moist mixture with water. Examiner also notes that col.4,ln.7-10 guide one of ordinary skill to modify the exemplary polyethylene glycol 3000, 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 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 arrive at the claimed substantially homogenous enzymatic core with the nonvolatile liquid as claimed because Herrmann et al. suggest dust-free granulate particles (col.6,ln53) comprising a homogenous enzyme core having polyethylene glycol (PEG) of an average molecular weight at or below about 1000 in general. See claim 1 and example in col.8 with motivation found in col.4,ln.7-10.
Regarding claim 3, Herrmann et al. exemplify the claimed biological active is a thermostable alpha amylase enzyme. See ex in col.8. Also see claim 22-23 guiding one of ordinary skill to select the other claimed enzyme proteins including proteases, amylases, cellulases, hemicellulases, lipases, oxidoreductases, lysozymes and mixtures thereof.
Regarding claims 6-7 and 10, Hermann et al. teach in col.8,ln.47 an amylase enzyme core comprising 12% PEG3000 (Polyethylene glycol 3000) which encompasses the claimed amounts. See col.8,ln.47.
Regarding claim 11 wherein the composition comprises at least 10% w/w crystalline material relative to the non-liquid part of the composition, which is one or more inorganic salts or clays, such as one or more salts of sulfate, carbonate, nitrate, chloride; and/or kaolin, smectite, bentonite, talc is taught by Herrmann et al. teaching in the example in col.8, 0.5-13% kaolin filler. See also claim 1.
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 Herrmann et al. teaching a salt coating layer in the example in col.8 on page 7,ln.9-12 and exemplifies 100 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 diameter, Herrmann et al. teach on in col.6,ln. 50-55 rounded dust-free particles having a diameter of 0.2-1.0 mm and a bulk density of 600-1100 g/L, and which are advantageously Suited as components of powdered or granular detergents and cleansers. It is the Examiner’s position that the diameter disclosed by Herrmann et al. meets the claimed range of from 200 to 700 μm. See also example 1, col.9,ln.55.
With respect to claims 14-15, Herrmann et al. teach their enzyme granulates are prepared by processing 4% enzyme concentrate with 0.5-13% kaolin filler and 12% polyethylene glycol solvent binder, and additional granulation and formulation auxiliaries to form a composition which is then granulated. The resulting moist granulate particles are rounded, and then dried. Optionally the dried granulate particles are then coated with a protective lacquer and they can then be used in powdered or granulated detergent and cleanser formulations. See the Example 1.
With respect to the non-volatile liquid properties of claims 16-17, See claim 1 with the example in col.8 and col.4,ln.7-10 teaching the polyethylene glycol binder with molecular weights in the range of 200-10,000. It is the Examiner’s position that this MW range taught by Herrmann et al. 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 Herrmann et al., 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 Herrmann et al. 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 polyethylene glycol 3000, 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 limitation.
New Grounds of Claim Objections
New claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Herrmann et al. (US 6,204,236 B1) do not teach or suggest the claim 19 method for preparing a plurality of granules by mixer granulation which does not comprise extrusion to achieve the homogenous enzyme core and non-volatile liquid as required by claim 19 and it would not have been obvious to one of ordinary skill in the art to specifically exclude extrusion as recited by the instant claims because the prior art of record teach obtaining a homogenous enzyme granule with PEG granulate by a method including extrusion. None of the prior art of record teach or suggest the instant claim 19 which does not comprise extrusion.
Conclusion
THIS ACTION IS MADE FINAL. 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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/GREGORY R DELCOTTO/ Primary Examiner, Art Unit 1761
/PREETI KUMAR/ Examiner, Art Unit 1761