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, 7-8, 10-18 are pending. Claim 1 is independent.
No claim is amended in the response filed 2/4/2026
Claim Interpretation
Applicant’s specification [0016] support claim 1 language to “substantially homogenous mixture” is that the biological active and the non-volatile liquid are not separated, compartmentalized or arranged in discrete layers.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of a certified copy of foreign application EPO 17196659.1 having filing date of 10/16/2017, however the present application does not properly claim priority to the submitted foreign application because EP17196659 (date of filing 16-10-2017), discloses granules prepared by mixer-granulation of a composition comprising a biological active and 1-50% of a non-volatile liquid, but it does not disclose layered granules wherein the biological active and the non-volatile liquid are part of the matrix layer. Accordingly, the effective filing date of the instant application is 7/12/2018 filing of priority EPO 18183189.2.
Response to Amendment
The rejection of claim(s) 1, 3, 7-8, 10-18 under 35 U.S.C. 103 as obvious over Andela et al. (WO 96/16151) in view of Arnold et al. (US 5,324,649) is maintained.
The rejection of claim(s) 1, 3, 7-8, 10-18 under 35 U.S.C. 103 as obvious over Arnold et al. (US 5,324,649) is maintained.
Response to Arguments
Applicant's arguments filed 2/4/2026 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's arguments beginning on page 5 of their remarks dated 2/4/2026 that Andela et al. (WO 96/16151) do not exemplify a glycerol coating and instead examples 2-3 use glycerol monostearate which is not a non-volatile liquid, Applicant is reminded the rejection is a 103 combination rejection, not a 102. Further in response, Andela et al. teach the same glycerin, propylene glycol and polyethylene glycol on page 6,ln.18 encompassing the non-volatile polyol liquid. Because Andela et al. is silent as to the claimed 5-30% w/w of the nonvolatile liquid with the biological active enzyme as is required by the claim 1, thus, Andela et al. is combined with Arnold et al. teaching a uniform homogeneous coating of enzyme and non-volatile liquids in figure 2 depicting the core surrounded by Enzyme + PVA), and guiding one of ordinary skill to modify the enzyme layer with PEG’s having MW less than 1000, as also disclosed by Andela et al. See col.6,ln.10-15. Arnold et al. col.6,ln.19-22 teach that the enzyme layer may include any nonenzyme solids including the PVA and PEG plasticizers therein, in an amount of about 5%-70% by weight of the coated granule which teaching does not negate the nonvolatile liquids already disclosed by the Andela et al. One of ordinary skill reading the combination of references is motivated to modify the enzyme containing layer of Andela et al. with the claimed 5-30% w/w of a nonvolatile liquid (already disclosed by Andela et al. teach their enzyme containing liquids include polyethylene glycol PEG400) because Arnold et al. teach it is commonly known to include upto 70% PEGs having MW less than 1000 in an enzyme containing liquid layer in general.
Applicant’s urge on page 6 that Arnold teaches nonenzyme solids including PVA and PEG while the claims are to nonvolatile liquids. In response, Applicant’s arguments are not found persuasive because Arnold guide one of ordinary skill to the hydrolyzed PVA and low viscosity is dissolved in washing liquor to form viscous solution with low to medium viscosity guides one of ordinary skill to the broad scope of a liquid. See col.3,ln.60-65 copied herein:
PNG
media_image1.png
346
768
media_image1.png
Greyscale
Accordingly the rejection is maintained 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.
Claim(s) 1, 3, 7-8, 10-18 are rejected under 35 U.S.C. 103 as obvious over Andela et al. (WO 96/16151) in view of Arnold et al. (US 5,324,649).
Andela et al. (WO 96/16151) teach a layered granule (see title and abstract) comprising a core (see page 5,ln.28). Specifically, page 5,ln.28-29 Andela et al. teach “The granules to be coated comprise a core material to which an enzyme containing layer is applied.” Limitation to the claim 1 matrix layer surrounding the core, wherein the matrix comprises a biological active and 5-30% 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 wherein the biological active is an enzyme, a bacterial spore, a dehydrated yeast cell, or a dehydrated bacterial cell is met by Andela et al. teaching page 5,ln.28-29 Andela et al. teach “The granules to be coated comprise a core material to which an enzyme containing layer is applied.” Page 5,ln.28-29 Andela et al. is copied herein:
PNG
media_image2.png
72
762
media_image2.png
Greyscale
Then on page 6 of Andela et al. teach their enzyme (encompassing biological active) containing liquids include PEG400, propylene glycol, glycerin (encompassing the claimed non-volatile liquids). See page 6,ln.6-18.
On page 6,ln.5-20 Andela et al. teach their enzymes in liquid form which are the same enzymes of instant claim 3, wherein the biological active is an enzyme selected from the group consisting of a protease, lipase, cutinase, amylase, carbohydrase, cellulase, pectinase, mannanase, arabinase, galactanase, xylanase, DNase, perhydrolase, oxidase, laccase, peroxygenase, haloperoxidase, and peroxidase.
Regarding the non-volatile polyol liquid required by claims 7-8, namely, propylene glycol and polyethylene glycol, glycerin, see page 6,ln.18 of Andela et al. also encompassing the claimed properties of surface tension of claim 16, the dynamic viscosity of claim 17, and the elastic parameter of claim 18, since Andela et al. teach the same glycerin, propylene glycol and polyethylene glycol.
Regarding claims 10,13 wherein the core 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 in the last paragraph of page 5 and page 4,ln.25-30 teaching an amount of more than 30wt%.
Page 6,ln.4-5 teaches the limitation of claim 11 wherein the enzyme matrix layer surrounding the core is applied in a fluidized bed spray coater.
The last paragraph on page 5 also encompasses the material limitation to claim 12, wherein the core is devoid of the biological active.
Limitation to claim 14 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 Andela et al. teaching a salt layer on page 7,ln.9-12 and recites the salts in the last paragraph on page 5, which are the same salts in the instant specification, thus would be expected to have the same properties of constant humidity as claimed.
Page 9,ln.20-page 10,ln.32 Andela et al. teach material limitation of claim 15 to a particulate laundry detergent composition comprising a detergent builder (silicates, phosphates), and a nonionic surfactant.
Andela et al. is silent as to the claimed 5-30% w/w of the nonvolatile liquid with the biological active enzyme as is required by the claim 1.
In the analogous art of uniform homogenous coatings of enzyme and non-volatile liquids (see Arnold et al. (US 5,324,649) figure 2 depicting the core surrounded by Enzyme + PVA), and guiding one of ordinary skill to modify the enzyme layer with PEG’s having MW less than 1000 (as also disclosed by Andela et al.) See col.6,ln.10-15. Arnold et al. col.6,ln.19-22 teach that the enzyme layer may include any nonenzyme solids including the PVA and PEG plasticizers therein, in an amount of about 5%-70% by weight of the coated granule. See also claim 32.
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 enzyme containing layer of Andela et al. with the claimed 5-30% w/w of a nonvolatile liquid because Arnold et al. teach it is commonly known to include upto 70% PEGs having MW less than 1000 in an enzyme containing liquid layer in general and Andela et al. teach their enzyme containing liquids include polyethylene glycol PEG400 in general.
One of ordinary skill in the art is motivated to combine the teachings of Andela et al. and Arnold et al. since both are in the analogous art of coating a nonpareil with an enzyme+nonvolatile PEG having MW less than 1000.
Claim(s) 1, 3, 7-8, 10-18 are rejected under 35 U.S.C. 103 as obvious over Arnold et al. (US 5,324,649).
Arnold et al. (US 5,324,649) teach a layered granule (Fig.2) comprising a core and a wet solid matrix layer surrounding the core. Limitation to wherein the matrix comprises a substantially homogenous mixture of a biological active and 5-30% 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 wherein the biological active is an enzyme is depicted by the Enzyme + PVA ///// symbol uniformly around the core along with the teaching in col.6,ln10-15 teaching the enzyme layer can include PEGs of MW less than 1000.
Arnold et al. teach the limitation of claim 3, wherein the biological active in col.2,ln.38-39 teaching , the enzyme is selected from the group consisting of proteases, amylases, lipases, cellulases.
Arnold et al. teach the limitation of claim 7 and 8, wherein the non-volatile liquid is a polyol selected from the group consisting of glycerol, propylene glycol, polyethylene glycol, see col.4,ln.42-55 and col.6,ln10-15 teaching the enzyme layer can include PEGs of MW less than 1000.
Arnold et al. teach the limitation of claim 10 wherein the core 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 by teaching in col.4,ln.5-10 and col.6,ln.19-21 clays between about 5%-70% in general.
Arnold et al. teach the limitation of claim 11 wherein the matrix layer surrounding the core is applied in a fluidized bed spray coater in col.8,ln.8.
Arnold et al. teach the limitations of claim 12-13 wherein the core is devoid of the biological active in their Fig.2 and col.2,ln30-35, the core material is a nonpareil (sugar or salt).
Arnold et al. teach the limitation of claim 14 in the paragraph linking col.7-8 teaching an ammonium sulphate salt layer preferably comprises between about 5%-30% by weight of the coated enzyme granule. This scavenger layer is preferably located between the enzyme layer and the outer coating.
Arnold et al. teach the limitation of claim 15 to a particulate detergent composition comprising a protease + PVA detergent builder, and a NEODOL surfactant in example 5, col.10.
Arnold et al. guide one of ordinary skill to the material limitations of claims 16-18
by teaching the same nonvolatile liquids, including glycerol, propylene glycol, polyethylene glycol having MW less than 1000, which Examiner notes is the same as disclosed in Applicant’s specification [0037-0038]. It is the Examiner’s position that one of ordinary skill can reasonably arrive at the same surface tension, shear rate and elastic parameters as claimed because Arnold et al. teach the same nonvolatile liquids, including glycerol, propylene glycol, polyethylene glycol having MW less than 1000 in general.
Arnold et al. do not exemplify the claimed nonvolatile liquid + biological active surrounding the core.
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 nonvolatile liquid + biological active surrounding the core because the col.6,ln.10-15 along with the Fig 2 guide one of ordinary skill to the claimed enzyme + PEG homogeneous layer surrounding a core.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREETI KUMAR whose telephone number is (571)272-1320. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Angela Brown-Pettigrew can be reached at 571-272-2817. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PREETI KUMAR/Examiner, Art Unit 1761
/ANGELA C BROWN-PETTIGREW/Supervisory Patent Examiner, Art Unit 1761
Prosecution Insights